Stockwinners Market Radar for October 19, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

MRK

Hot Stocks

19:34 EDT Merck issues voluntary recall of Cubicin 500 mg due to glass particles - Merck is voluntarily recalling one lot of CUBICIN, or daptomycin for injection, 500 mg, for intravenous use, Lot 934778, Exp June 2022. Because treatment with CUBICIN is likely to be initiated at a hospital or other monitored healthcare setting, the recall is being conducted to the user level, including hospital and administering institutions. Approximately 22,000 vials are affected by this recall. The recall has been initiated following receipt of a customer complaint reporting that a piece of glass was found in a vial of CUBICIN after reconstitution.
APEN

Hot Stocks

18:57 EDT Apollo Endosurgery director buys 684K shares of common stock - In a regulatory filing, Apollo Endosurgery disclosed that director Kent McGaughy bought 684K shares of common stock in a total transaction size of $5.3M.
SPLK

Hot Stocks

18:47 EDT Splunk CEO: Our business is firing on all cylinders - In an interview on CNBC's Mad Money, Doug Merritt said the U.S. government has been a great customer of Splunk for over a decade. He's "excited" about increasing penetration in the government going forward. Cyber business has accounted for at least 50% of the company's revenue for at least the last four to five years, he noted.
NFLX

Hot Stocks

18:38 EDT Netflix says Dahl IP could yield consumer products - Says "vast majority" of subscribers engage on mobile device. Says don't expect company to go on buying spree for games. Says still learning about games business. Says it will likely take years for games business to produce meaningful growth.
NFLX

Hot Stocks

18:25 EDT Netflix says 'Squid Game' popular in every region - Says still wrestling with post-COVID strategy. Says "Squid Game" popular in every region. Says company still "very early" in the video game business. Says "Chestnut Man" in Denmark a big success. Says non-English content growing has growth three times since they started adding such programs. Says still "a few years behind" in the film business.
NFLX

Hot Stocks

18:15 EDT Netflix says customer churn down in Q3 from previous years - Says there was "a lot of variety" in programming in Q3. Says customer churn down from previous years. Says viewing per member fell compared to COVID-distorted 2020. Says price increases slowed growth in Latin America. Sees Latin America slowing growth as temporary. Says not sure if company to return to past growth levels. Comments taken from Q3 earnings call.
SNCY

Hot Stocks

18:14 EDT Sun Country Airlines CEO sells over 1M common shares - In a regulatory filing, Sun Country Airlines CEO Jude Bricker disclosed the sale of 1,050,000 common shares of the company at a price of $31.2813 per share.
VALE

Hot Stocks

18:01 EDT Vale reports Q3 iron ore output up 18.1%, higher than in 2Q21 - Vale's iron ore fines production totaled 89.4 Mt in 3Q21, 18.1% higher than in 2Q21, as a result of: (i) seasonal improvement of weather-related conditions in Northern System, boosting Serra Norte and S11D performance; (ii) Vargem Grande production increase by dry processing while adjusting the flowsheet of one of its wet-processing plants; (iii) Itabira's performance improvement related to better run-of-mine availability; (iv) higher third-party purchase, although proportionally lower than the previous quarter, 5.8% of total production in 3Q21 vs 6.2% in 2Q21; and (v) Fabrica's reaching its full capacity of 6 Mtpy, after the resumption of beneficiation process in 2Q21.
GVA

Hot Stocks

17:31 EDT Granite awarded $19M runway repair contract in New Mexico - Granite "announced the award of a runway repair project at Cannon Air Force Base by the Albuquerque District of the U.S. Army Corps of Engineers. Located in Curry County, on New Mexico's high eastern plains, Cannon AFB is home to units of the Air Force Special Operations Command. The $19M contract is anticipated to be included in Granite's fourth quarter committed and awarded projects. The project is expected to begin in November of 2021 and be complete in July of 2022."
BRO

Hot Stocks

17:30 EDT Brown & Brown raises quarterly dividend 10.7% to 10.25c per share - Brown & Brown announced that the board of directors has declared a regular quarterly cash dividend of 10.25c per share. The dividend is payable on November 17, 2021, to shareholders of record on November 3, 2021. The dividend represents a 10.8% increase from the previous regular quarterly cash dividend of 9.25c per share and is the twenty-eighth consecutive annual dividend increase for the company.
CNM

Hot Stocks

17:28 EDT Core & Main to acquire Catalone Pipe & Supply Co. - Core & Main announced that it has entered into a definitive agreement to acquire substantially all of the assets of Catalone Pipe & Supply Co., a full service provider of waterworks products and services, and custom concrete catch basins, based in Penfield, Pennsylvania.
EAT

Hot Stocks

17:20 EDT Brinker drops 9% to $44.40 after Q1 profit misses estimates
SAIL

Hot Stocks

17:12 EDT SailPoint CEO McClain sells apprximately $1.9M in company shares - SailPoint CEO Mark McClain disclosesd in a filing that he had sold 40,000 shares of company stock at $46.75 per share on October 15, for a total transaction value of $1,870,000.
BAESY

Hot Stocks

17:07 EDT BAE Systems awarded $154.11M Navy contract - BAE Systems was awarded a $154.11M cost-plus-fixed-fee, cost-reimbursable, indefinite-delivery/indefinite-quantity contract. This contract provides engineering support for the rapid integration of command, control, communications, computers, combat systems, intelligence, surveillance, and reconnaissance systems onboard small and large craft, commercial and militarized vehicles, transit cases, mobile communications, fixed base stations, command centers, and intelligence systems in support of the Naval Air Warfare Center Aircraft Division, Webster Outlying Field, Special Communications Mission Solutions Division. Work is expected to be completed in October 2026. No funds will be obligated at time of award; funds will be obligated on individual orders as they are issued. This contract was competitively procured via an electronic request for proposal; one offer was received. The Naval Air Warfare Center Aircraft Division is the contracting activity.
ISRG

Hot Stocks

17:06 EDT Intuitive Surgical narrows FY21 procedure growth view to 27%-29% from 27%-30% - Sees FY21 gross profit margin 71%-71.5% of revenue. Sees FY21 operating expenses up 17%-19%. Sees Q4 effective tax rate 21.5%. Says COVID-19 will continue to impact procedures. Says experienced more challenging supply chain environment in Q3. Says supply chain costs increased in Q3. Says macroeconomic impacts from Covid could impact hospital spending. Says Q3 average selling price increased to $1.75M from $1.55M. Says Q3 procedures were particularly impacted in states with low vaccination rates. Says China procedure growth remained strong. Comments taken from Q3 earnings conference call.
AOS

Hot Stocks

17:01 EDT A.O. Smith acquires Giant Factories - A. O. Smith Corporation announced that it has acquired Giant Factories, a Canada-based manufacturer of residential and commercial water heaters, with trailing twelve-month sales of approximately $105M. The purchase price is approximately $192M in cash, subject to customary adjustments. Taking into account an expected tax benefit of approximately $6.5M that the company will achieve as a result of treating the transaction as a purchase of assets for tax purposes, and projected operating synergies expected to be achieved over a two-year period, the purchase price represents a multiple of approximately 9.5 x adjusted 2023 projected EBITDA. The acquisition is expected to be neutral to fQ4 EPS due to normal purchase accounting adjustments and accretive to EPS in the first full year post closing.
PLMR

Hot Stocks

16:59 EDT Palomar sees Q3 catastrophe losses of $14.5M-$15.5M - Palomar Holdings "announced an estimated range of pretax catastrophe losses of $14.5 million to $15.5 million, net of reinsurance, for the third quarter of 2021. These estimates represent anticipated losses from Hurricanes Ida and Nicholas. Palomar estimates that 70-75% of its gross losses from these events are from its discontinued Admitted All Risk and Louisiana Specialty Homeowners products, lines of business that the Company exited in the fourth quarter of 2020."
AC

Hot Stocks

16:57 EDT Associated Capital sees Q3 book value $42.15-$42.35 per share - Associated Capital Group announced a range of its third quarter preliminary book value of $42.15-$42.35 per share, compared to $42.21 per share at June 30, 2021. This compares to $40.36 at December 31, 2020, and $38.25 at September 30, 2020. Assets under management were $1.68B at September 30, 2021 as compared to $1.251B at September 30, 2020.
AAC AC

Hot Stocks

16:54 EDT Correction: Ares Acquisition did not report Q3 AUM $1.68B - 16:49 story was for Associated Capital (AC).
IBKR

Hot Stocks

16:52 EDT Interactive Brokers VP Frank sells $2.6M in company shares - Interactive Brokers VP Thomas Frank disclosed in a filing that he had sold 36,359 shares of company stock at $71.76 per share between October 15 and October 18, for a total transaction amount of $2,609,213.
AC

Hot Stocks

16:50 EDT Correction: Associated cap reports Q3 AUM $1.680B compared to $1.251B last year - Associated Capital Group announced a range of its Q3 preliminary book value of $42.15-$42.35 per share, compared to $42.21 per share at June 30. This compares to $40.36 at December 31, 2020, and $38.25 at September 30, 2020. Assets under management, or AUM were $1.680B at September 30 as compared to $1.251B at September 30, 2020.
AC

Hot Stocks

16:49 EDT Ares Acquisition reports Q3 AUM $1.680B compared to $1.251B last year - Associated Capital Group announced a range of its Q3 preliminary book value of $42.15-$42.35 per share, compared to $42.21 per share at June 30. This compares to $40.36 at December 31, 2020, and $38.25 at September 30, 2020. Assets under management, or AUM were $1.680B at September 30 as compared to $1.251B at September 30, 2020.
LRN

Hot Stocks

16:45 EDT Stride jumps 6% to $36.25 after Q1 results, above-consensus guidance
AAC

Hot Stocks

16:41 EDT Ares Acquisition reports Q3 AUM $1.680B compared to $1.251B last year - Associated Capital Group announced a range of its Q3 preliminary book value of $42.15-$42.35 per share, compared to $42.21 per share at June 30. This compares to $40.36 at December 31, 2020, and $38.25 at September 30, 2020. Assets under management, or AUM were $1.680B at September 30 as compared to $1.251B at September 30, 2020.
SESN

Hot Stocks

16:40 EDT FDA grants Sesen Bio a Type A meeting on issues from Vicineum CRL - The U.S. Food & Drug Administration granted Sesen Bio's request for a Type A meeting to discuss the Chemistry, Manufacturing and Controls, CMC, issues raised in the FDA's Complete Response Letter, CRL, regarding the Company's Biologics License Application, BLA, for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. The CMC Type A Meeting has been scheduled for October 29. During the CMC Type A Meeting, the Company intends to align on a path forward with the FDA related to the CMC issues raised in the CRL. The Company is also preparing for a separate Type A meeting to discuss the recommendations specific to additional clinical/statistical data and analyses that the FDA raised in the CRL . The Company expects the Clinical Type A Meeting to occur later in the fourth quarter of 2021. As previously disclosed, the Company intends to use the information from the CMC Type A Meeting and the Clinical Type A Meeting to synchronize the regulatory reviews of Vicineum for the treatment of BCG-unresponsive NMIBC in the US and the European Union. The Company looks forward to continuing to work collaboratively with regulators to determine the appropriate path forward.
WDFC

Hot Stocks

16:37 EDT WD-40 drops 9% to $208 after Q4 results, FY22 profit view miss estimates
CLLS

Hot Stocks

16:36 EDT Cellectis to present two presentations at the ESGCT - Cellectis in collaboration with Professor Toni Cathomen, scientific director at the Center for Chronic Immunodeficiency Medical Center at the University of Freiburg, Germany, will present two oral presentations at the European Society of Gene and Cell Therapy, or ESGCT, Congress to be held virtually from October 19-22, 2021. Professor Cathomen's team at University of Freiburg will be presenting pre-clinical data that supports further evaluation of Cellectis' .HEAL platform, an innovative gene therapy platform that uses a genome editing approach based on TALEN, for two product candidates targeting primary immunodeficiencies: RAG1 for Severe Combined Immunodeficiency and STAT3 for Hyper IgE syndrome. Presentations details. Data presentation on preclinical development of a TALEN based genome editing therapy for RAG1 deficiency. Newborns with RAG1 SCID have extremely low levels of B and T cells and a severe risk of recurrent, life-threatening infections. Previous attempts to treat the RAG1 deficiency via conventional gene therapy have produced unsatisfactory results. Using Cellectis' TALEN technology and .HEAL, Professor Cathomen engineered HSCs with a corrected copy of RAG1 that replaced the existing, mutated copy of RAG1. The precise replacement of the mutated gene enabled the corrected RAG1 gene to be expressed at its natural timing and stage of cell development. 30% of gene correction was achieved within the long-term HSC population. The presentation titled 'Preclinical development of a TALEN based genome editing therapy for RAG1 deficiency' will be made on October 21. Presentation Details: Data presentation on a preclinical development of a TALEN based genome editing in T-cells for the treatment of Hyper-IgE- Syndrome. Hyper IgE syndrome is a rare primary immunodeficiency disease that clinically manifests as skin inflammation and recurrent skin and lung infections. Cellectis has developed a strategy applicable in HSCs and T-cells to insert a corrected version of the STAT3 gene into the patient's genome to restore its functionality. In T-cells isolated from patients, 60% integration was achieved. More importantly, the alpha/beta isoforms ratio was restored. The presentation titled 'Preclinical development of a TALEN based genome editing in T cells for the treatment of Hyper-IgE-Syndrome' will be made on October 20.
LRN

Hot Stocks

16:35 EDT Stride reports Q1 total enrollment 189.6K, down 5.8% y/y
UAL

Hot Stocks

16:35 EDT United Airlines sees FY21 adjusted CapEx around $3B - Sees FY22 CASM-ex lower than 2019.
UCBI

Hot Stocks

16:33 EDT United Community Banks reports Q3 net interest margin 3.12%, down 7 bps vs. Q2
EXPR

Hot Stocks

16:33 EDT Express announces departure of CFO Perry Pericleous and transition plan - Fashion apparel retailer Express announced the departure of the Company's Senior Vice President, CFO and Treasurer, Perry Pericleous, effective November 12. Pericleous is leaving the Company to pursue another opportunity. The Company has begun a search for a new CFO, and President & COO Matthew Moellering will serve as Acting CFO in the interim, along with his existing responsibilities. Moellering has served as the Company's President and COO since September 2019. He also served as Interim President and Interim CEO from January 2019 to June 2019, and was the Company's CFO and Treasurer from 2007 to 2011. Pericleous, who reports directly to Moellering, will continue to work closely with Matt over the next month to ensure a smooth transition.
GMED

Hot Stocks

16:32 EDT Globus Medical Premieres ANTHEM mini fragment fracture system at OTA - Globus Medical announced it will feature its new ANTHEM Mini Fragment Fracture System at the annual Orthopaedic Trauma Association meeting in Fort Worth, Texas, Oct 20-23, 2021.
LECO

Hot Stocks

16:32 EDT Lincoln Electric increases quarterly dividend 9.8% to 56c per share - Lincoln Electric announced that its board of directors has approved a 9.8% increase in the quarterly cash dividend, from 51c per share to 56c per share, or to $2.24 per share on an annualized basis. This marks the 26th consecutive annual increase of the dividend. The dividend is payable January 14, 2022 to shareholders of record at the close of business on December 31.
VAL

Hot Stocks

16:31 EDT Valaris announces contract with Petrobras offshore Brazil for drillship - Valaris Limited announced that it has been awarded a contract with Petrobras offshore Brazil for drillship, VALARIS DS-4. The contract is for a minimum term of 548 days. The rig is currently preservation stacked in the UK and will transit to the Canary Islands, where it will be reactivated and then mobilized to Brazil. The contract is anticipated to commence by early Q2 of 2022.
PZN

Hot Stocks

16:30 EDT Pzena Investment reports Q3 EPS 27c vs. 16c last year - Reports Q3 revenue $51.6M vs. $33.9M last year. Reports Q3 AUM $52.4B, up 58% from last year.
AKRO

Hot Stocks

16:27 EDT Akero gets FDA fast track designation for efruxifermin for NASH treatment - Akero Therapeutics announced that the U.S. Food and Drug Administration has granted Fast Track designation to its lead program investigating efruxifermin for the treatment of non-alcoholic steatohepatitis, NASH."The FDA Fast Track designation for EFX is an important step forward in potentially bringing EFX to the growing number of patients impacted by NASH," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "Backed by positive clinical data, including a two-stage improvement in fibrosis for 50% of all treated patients with F2 or F3 fibrosis at baseline, we believe EFX has the potential to be among the first investigational therapies approved for treatment of both advanced fibrotic and cirrhotic NASH. We look forward to working closely with the FDA to bring this promising investigational therapy to NASH patients as expediently as possible."
KRG RPAI

Hot Stocks

16:23 EDT Kite Realty Group, Retail Properties of America shareholders approve merger - Kite Realty Group (KRG) and Retail Properties of America (RPAI) announced that KRG shareholders and RPAI stockholders approved all of the proposals necessary for the closing of the previously announced merger of RPAI into a subsidiary of KRG, with KRG continuing as the surviving public company.
MDT

Hot Stocks

16:23 EDT Medtronic announces clinical data from study with MiniMed 780G system - Medtronic recently announced one-year, real-world clinical data on 3,211 pediatric and adolescent patients with type 1 diabetes 15 years old and below using the MiniMed 780G system with the Guardian Sensor 3. Data on this subset of patients on the system in Europe showed an average Time in Range of 74% - surpassing Clinical Consensus Guidelines and closely mirroring Time in Range for adults at 77%. Overnight Time in Range of 82% also mirrored that of adults demonstrating that the Advanced Hybrid Closed Loop, or AHCL algorithm offers even stronger glycemic control and protection against lows while children are sleeping. The MiniMed 780G system delivers near real-time basal insulin and auto correction boluses to address underestimated carb counts and occasional missed meal doses to deliver more Time in Range.
CNI

Hot Stocks

16:20 EDT Canadian National announces Jean-Jacques Ruest to retire from CEO position - CN announced that Jean-Jacques Ruest will retire as president and chief executive officer and as a member of the Board of Directors of the Company, effective as of the end of January 2022, or such later time as a successor has been appointed to ensure a flawless transition. The Board has appointed a CEO Search Committee consisting of the following Board members to conduct the global search and make recommendations to the full Board
AERI

Hot Stocks

16:18 EDT Aerie Pharmaceuticals interim CFO to resign - In a regulatory filing, Aerie Pharmaceuticals disclosed that on October 15, Christopher Staten, Interim Chief Financial Officer and Vice President of Finance of the company, provided notice to the company of his resignation from his roles at the company, effective as of October 29. "The company is currently conducting a search to fill the position of Chief Financial Officer," Aerie stated.
BFC

Hot Stocks

16:10 EDT Bank First National raises dividend 4.8% to 22c - Bank First's Board of Directors approved a quarterly cash dividend of 22c per common share, payable on January 5, 2022, to shareholders of record as of December 22.
ALSN

Hot Stocks

16:08 EDT Allison Transmission to partner with Zhongtong Bus Partners in Armenia - The company states: "Allison Transmission is pleased to announce a partnership with leading Chinese bus manufacturer Zhongtong Bus Holding Co., Ltd. to deliver 211 compressed natural gas city buses equipped with Allison T270R transmissions to Yerevan, the capital of Armenia."
LAKE

Hot Stocks

16:07 EDT Lakeland Industries makes $2.7M strategic investment in Inova Design Solutions - Lakeland Industries announced that it has made a strategic investment of approximately $2.7M in Inova Design Solutions, doing business as Bodytrak "as a groundbreaking step toward entering the Connected Worker Market for "Smart PPE."Bodytrak's unique ear-based sensor platform uses precise physiological measurements and cloud-based analytics to automate health, safety and performance monitoring, making it an ideal complement to Lakeland's portfolio of industrial protective solutions.
NFLX

Hot Stocks

16:06 EDT Netflix sees being FCF positive on annual basis in 2022 and beyond - Netflix said: "Net cash generated by operating activities in Q3 was $82 million vs. $1.3 billion in the prior year period. Free cash flow - FCF - for the quarter was -$106 million vs. $1.1 billion in Q3'20. FCF in last year's Q3 was helped by COVID-related production shutdowns. Year to date FCF is $410m. With production volume ramping successfully and a lower operating margin in Q4, we anticipate Q4 '21 FCF to be negative. We continue to expect full year 2021 FCF to be approximately breakeven (plus or minus several hundred million dollars depending on the timing of production starts and related cash spending on content). We anticipate being FCF positive on an annual basis in 2022 and beyond."
QGEN

Hot Stocks

16:06 EDT Qiagen launches QuantiFERON-TB tuberculosis test for high-burden regions - Qiagen announced the launch and CE marking of QIAreach QuantiFERON-TB test for tuberculosis infection, in order to help achieve global TB elimination targets by increasing access to easy and reliable TB testing, especially in high burden countries, low-resource regions. A milestone in the fight against a pathogen estimated to be carried by over two billion people worldwide, built on the proven QuantiFERON-TB Gold Plus technology, QIAreach QuantiFERON-TB is a portable device that enables the ultrasensitive digital detection of TB infection with an end-to-end workflow that is simple and cost efficient, and increases access to reliable Interferon Gamma Release Assay testing. QIAGEN will focus on regions that face a high burden of the disease, and where getting access to lab infrastructure and resources for testing are limited. "With QIAreach QuantiFERON-TB we have taken a great step towards leaving no one behind when facing a deadly disease like tuberculosis that is preventable and curable. With this groundbreaking new way to detect TB infections we can aid to prevent patients, especially those in high burden countries, from developing the active form of TB," said Thierry Bernard, CEO of QIAGEN. "It combines QIAGEN's proven QuantiFERON-TB technology with a very portable and field-friendly digital device to deliver extremely reliable results without the need for complex laboratory infrastructure at effective cost."
FCPT

Hot Stocks

16:06 EDT Four Corners Property Trust acquires Raising Cane's property for $2.2M - Four Corners Property Trust announces the acquisition of a Raising Cane's restaurant property for $2.2M from Washington Prime Group.
NFLX

Hot Stocks

16:05 EDT Netflix anticipates 'more normalized content slate' in 2022 - Netflix said: "We're eagerly anticipating the rest of our Q4 slate, which includes a great mix of popular returning English language series like The Witcher, You, Tiger King and Cobra Kai, big returning non-English series like Sintonia and the final chapter of La Casa de Papel (aka Money Heist), as well as exciting new movies... Assuming no new Covid waves or unforeseen events that result in large scale production shutdowns, we currently anticipate a more normalized content slate in 2022, with a greater number of originals in 2022 vs. 2021 and a release schedule that is more balanced over the course of the year, as compared to 2021."
NFLX

Hot Stocks

16:04 EDT Netflix says has started testing games offering in select countries - Netflix stated in its quarterly letter: "We've begun testing our games offering in select countries. It remains very early days for this initiative and, like other content categories we've expanded into, we plan to try different types of games, learn from our members and improve our game library. During Q3, we acquired Night School Studio, the maker of critically acclaimed games like OXENFREE, to help build out our game development capabilities. As a reminder, games on Netflix will be included in members' subscriptions and will not have advertisements or in-app purchases so game play is purely focused on enjoyment versus monetization."
IBKR

Hot Stocks

16:03 EDT Interactive Brokers reports Q3 customers accounts up 57% y/y - In Q3: Customer accounts increased 57% from the year-ago quarter to 1.54M. Customer equity grew 52% from the year-ago quarter to $353.8B. Total DARTs increased 24% from the year-ago quarter to 2.26M. Cleared DARTs increased 24% from the year-ago quarter to 2.02M. Customer credits increased 22% from the year-ago quarter to $86.2B. Customer margin loans increased 67% from the year-ago quarter to $50.2B.
NFLX

Hot Stocks

16:03 EDT Netflix sees Q4 global streaming paid net additions of 8.5M - Netflix said in its quarterly letter to investors: "As a reminder, the quarterly guidance we provide is our actual internal forecast at the time we report and we strive for accuracy. For Q4'21, we forecast paid net adds of 8.5m, consistent with Q4'20 paid net additions. For the full year 2021, we forecast an operating margin of 20% or slightly better. This means that Q4'21 operating margin will be approximately 6.5% compared with 14% in Q4'20. The year over year decline in operating margin is due mostly to our backloaded big content release schedule in this Q4, which will result in a roughly 19% year over year increase in content amortization for Q4'21."
NFLX

Hot Stocks

16:02 EDT Netflix reports Q3 global streaming paid net additions of 4.38M - Netflix said in its quarterly letter to investors: "We under-forecasted paid net adds for the quarter - 4.4m actual vs. our 3.5m projection - while ending paid memberships of 214m was within 0.4% of our forecast. For the second consecutive quarter, the APAC region was our largest contributor to membership growth with 2.2m paid net adds (half of total paid net adds) as we are continuing to improve our service in this region. In EMEA, paid net adds of 1.8m improved sequentially vs. the 188k in Q2 as several titles had a particularly strong impact. The UCAN and LATAM regions grew paid memberships more slowly. These regions have higher penetration of broadband homes although we believe we still have ample runway for growth as we continue to improve our service."
PLUG

Hot Stocks

15:42 EDT Plug Power, HevenDrones enter alliance to commercialize hydrogen-powered drones - HevenDrones announced a bi-lateral alliance with Plug Power. HevenDrones designs its own proprietary operating systems and is the exclusive company selected by the Israeli Ministry of Defense to develop a customized fleet of hydrogen fueled drones. Plug Power and HevenDrones plan to cooperate on the commercialization of hydrogen fuel cell powered heavy-lift actionable drones and related support equipment and infrastructure. Together, the companies plan to provide an integrated solution to power and refuel HevenDrones' next generation fleet with the objective of providing extended flight times and range. The companies aim to develop hydrogen-powered drones of varying sizes capable of lifting heavy weights and flying for extended periods of time. HevenDrones' proprietary stabilizing technology provides the capability to lift and move heavy and unbalanced and kinetic loads with applications across a variety of industries and markets. The effort will also include additional scopes of work to provide an entire hydrogen ecosystem, including, hydrogen supply, infrastructure, fueling and refueling for drone applications.
BOWX WE

Hot Stocks

15:01 EDT BowX Acquisition stockholders approve combination with WeWork - BowX Acquisition Corp. (BOWX), a special purpose acquisition company, announced that in a special meeting held today, its stockholders voted to approve its business combination with WeWork. The business combination was supported by 97.9% of the votes cast at the meeting, representing approximately 77.6% of BowX's outstanding shares. "The business combination is expected to provide WeWork with the previously announced gross cash proceeds of approximately $1.3B, which includes the cash held in the trust account, a fully committed PIPE and an equity backstop facility provided by Cushman & Wakefield. In addition, as previously disclosed, upon the closing of the business combination, WeWork will have access to up to 550,000,000 of senior secured debt in the form of 7.5% senior secured notes pursuant to its amended and restated master senior secured notes note purchase agreement with StarBright WW LP, an affiliate of SoftBank Group Corp. BowX and WeWork will combine to create the leading publicly traded provider of flexible space and workplace management solutions, with a platform and global network that will ideally position the company to serve the multi-trillion office space market and enable the future of work," the companies stated. The business combination is expected to close on October 20, subject to the satisfaction or waiver of all closing conditions. Following the close, WeWork and its common stock and warrants are expected to begin trading on the New York Stock Exchange under the ticker symbol "WE", on October 21.
ISRG

Hot Stocks

14:47 EDT Intuitive Surgical says Samath to succeed Mohr to become CFO - Intuitive announced executive leadership changes that it said "reflect the company's growth and plans for advancing minimally invasive care globally." Intuitive has created two new functional organizations: Strategy and Growth, and Global Business Services. "Placing strategy and growth teams within a new organization will create clearer prioritization and stronger alignment for investments in support of the company's long-term growth plan. Given the opportunities for continued growth, the new global business services organization will serve to align and scale processes, manage multi-year IT roadmaps, better use enterprise data for real-time decision-making, and maintain and execute global facilities and maintenance roadmaps," the company stated. The following executives will begin their duties on Jan. 1, 2022: Marshall Mohr will assume the new role of Executive Vice President, Global Business Services, where he will lead Intuitive's continued growth in infrastructure, processes, and systems and facilities. He has served as Chief Financial Officer for more than 15 years; Jamie Samath will succeed Mohr to become Chief Financial Officer, focusing on Intuitive's financial performance, growth objectives, and future fiscal trajectory. Samath has been with Intuitive since 2013, managing most of the finance functions during that time; Dave Rosa will assume the new role of Executive Vice President and Chief Strategy & Growth Officer, leading efforts to identify and realize long-term business opportunities, continuing to build the value of Intuitive's product offerings, and ensuring customers clearly understand the value of Intuitive's ecosystem in creating successful minimally invasive care programs; Henry Charlton will succeed Rosa in the role of Chief Commercial Officer, overseeing global sales, regional marketing, commercial learning and enablement, and services. "These are outstanding and proven leaders. I am confident they will be effective in pursuing our goal to advance minimally invasive care globally in a highly competitive environment. Their efforts will help us operate at the larger scale our customers demand globally," said Intuitive CEO Gary Guthart.
NKLA TSLA

Hot Stocks

14:21 EDT Judge lets Nikola continue $2B patent lawsuit against Tesla - U.S. District Judge James Donato determined that Nikola (NKLA) will be allowed to continue its $2B patent lawsuit against Tesla (TSLA). "Nikola's ostensible reasons for not responding to the Court's orders are not particularly compelling," Donato said in the order. "The case will not be dismissed at this time for failure to prosecute, but that may change if Nikola does not move this case forward to resolution in an efficient and timely manner. A technology tutorial is set for January 13, 2022. The claim construction hearing is set for January 27, 2022. The case will remain administratively closed pending further order." Reference Link
APO

Hot Stocks

13:53 EDT Apollo Global sees pre-tax FRE per share $4.50-$4.75 in 2026 - Sees FRE margin 60%+ by 2026.
APO

Hot Stocks

13:52 EDT Apollo Global sees doubling AUM to $1T by 2026 - Apollo Global is looking to more than double its assets under management to $1T by 2026, the company said in an Investor Day presentation. The company sees fee-related revenue of $4.6B by 2026 and fee related earnings of $2.8B by 2026, it said.
APO

Hot Stocks

13:52 EDT Apollo Global up 8% to $73.91 after longer term guidance at investor day
APO

Hot Stocks

13:51 EDT Apollo Global sees retirement services as $525B business in five years
APO

Hot Stocks

13:50 EDT Apollo Global sees doubling AUM to $1T by 2026 - Apollo Global is looking to more than double its assets under management to $1T by 2016, the company said in an Investor Day presentation. The company sees fee-related revenue of $4.6B by 2026 and fee related earnings of $2.8B by 2026, it said.
SNAP...

Hot Stocks

13:37 EDT Snap partners with Google on new 'Pixel-first' 'Quick Tap to Snap' feature - Snap (SNAP) announced at the Pixel Fall Launch event a new feature on Google's (GOOGL) Pixel 6 called "Quick Tap to Snap," launching later this year. "This partnership with Google marks the first time Snap has created a camera-mode version of Snapchat accessible directly from a phone lockscreen, and will make the Pixel 6 the fastest phone to make a Snap," Snap stated in a press release timed with the product launch event.
ISRG

Hot Stocks

13:26 EDT Intuitive Surgical up 2% after apparent early release of earnings - Intuitive Surgical shares are up $6.85, or 2%, to $339.15 after Bloomberg ran headlines regarding the company's Q3 results. Intuitive Surgical is scheduled to report its Q3 results after today's closing bell with a conference Call to discuss earnings scheduled for 4:30 pm ET.
BAESY

Hot Stocks

13:15 EDT BAE Systems, Sierra Nevada team awarded U.S. Air Force contract - The U.S. Air Force has awarded the BAE Systems-Sierra Nevada Corporation team a contract to provide a prototype design for the next-generation open architecture signals intelligence technology under its Global High-altitude Open-system Sensor Technology program. The award continues BAE Systems, Inc.'s development efforts to provide full-spectrum awareness and actionable intelligence with a SIGINT sensor design, the company said in a statement. Under the contract, awarded earlier this year, the team will provide a sensor prototype that gives insight into adversaries' actions by collecting and analyzing electronic signals. It will exploit the radio frequency spectrum, critical to battlefield superiority, to detect, identify, locate, and track RF emissions.
BNTX PFE

Hot Stocks

13:12 EDT CDC says Pfizer vaccine 93% effective against hospitalization in ages 12-18 - Among hospitalized U.S. patients aged 12 to 18 years, vaccine effectiveness of two doses of the Pfizer-BioNTech vaccine against Covid-19 hospitalization during June through September was 93%, the Centers for Disease Control and Prevention announced. "This evaluation demonstrated that 2 doses of Pfizer-BioNTech vaccine were highly effective in preventing Covid-19 hospitalization among persons aged 12-18 years. Findings reinforce the importance of vaccination to protect U.S. youths against severe Covid-19," the agency concluded. In a test-negative, case-control study at 19 pediatric hospitals in 16 states during June 1 to September 30, the effectiveness of two doses of the Pfizer-BioNTech vaccine against Covid-19 hospitalization was assessed among children and adolescents aged 12-18 years. Among 464 hospitalized persons aged 12-18 years, the median age was 15 years, 72% had at least one underlying condition, including obesity, and 68% attended in-person school. Effectiveness of two doses of Pfizer-BioNTech vaccine against Covid hospitalization was 93% during the period when delta was the predominant variant. Reference Link
GOOG GOOGL

Hot Stocks

13:12 EDT Google introduces Pixel 6 and Pixel 6 Pro - Brian Rakowski, VP, Product Management at Google, announced in a blog post: "The wait is over: Pixel 6 and Pixel 6 Pro, the completely redesigned Google phones, are here. Powered by Google Tensor, Google's first-ever processor, and shipping with Android 12, both phones are fast, smart, secure and designed to adapt to you. Pixel 6 is an outstanding all-around phone and it starts at only $599. If you want all the advanced capabilities and upgraded finishes, Pixel 6 Pro is the right phone for you, starting at $899... The phones will be available on store shelves with all major U.S. carriers starting on October 28. We're also launching a new collection of specially designed cases for Pixel 6, so you can protect your phone in style. We're also introducing Pixel Pass, an easy subscription that delivers the best of Google. Starting at $45 per month for U.S. customers, Pixel Pass gives you a brand new Pixel 6 along with Google One, YouTube Premium and YouTube Music Premium, Google Play Pass and Preferred Care. Pixel Pass with Pixel 6 Pro starts at only $55 per month. After two years, you'll have the option to upgrade to a new Pixel." Reference Link
OCCI

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13:09 EDT OFS Credit sees September NAV $13.68-$13.78 - OFS Credit Company announced the following net asset value estimate as of September 30, 2021. Management's unaudited estimate of the range of the company's NAV per share of its common stock as of September 30, 2021 is between $13.68 and $13.78. This estimate is not a comprehensive statement of our financial condition or results for the month ended September 30, 2021. This estimate did not undergo the company's typical quarter-end financial closing procedures and was not approved by the Company's board of directors.
MO

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12:56 EDT FDA authorizes marketing of four chew tobacco products from Altria - The Food and Drug Administration announced it has authorized the marketing of four new oral tobacco products manufactured by Altria Group's U.S. Smokeless Tobacco Company under the brand name of Verve. Based on the FDA's review of available scientific evidence in the company's premarket tobacco product applications, the agency determined the marketing of these products would be consistent with the statutory standard, "appropriate for the protection of the public health." The four products are: Verve Discs Blue Mint, Verve Discs Green Mint, Verve Chews Blue Mint, and Verve Chews Green Mint. The Verve products are oral tobacco products that contain nicotine derived from tobacco, but they do not contain cut, ground, powdered or leaf tobacco, the FDA notes. The marketing authorizations allow the four tobacco products to be legally sold or distributed in the United States, but it does not mean the products are safe or "FDA approved," as there are no safe tobacco products, the agency added. Reference Link
FB

Hot Stocks

12:51 EDT Facebook settles U.S. claims of reserving jobs for temporary visa holders - The Department of Justice and the Department of Labor announced separate settlement agreements with Facebook regarding its use of the permanent labor certification program. The Justice Department's settlement resolves its claims that Facebook "routinely refused to recruit, consider or hire U.S. workers, a group that includes U.S. citizens, U.S. nationals, asylees, refugees and lawful permanent residents, for positions it had reserved for temporary visa holders in connection with the PERM process." Additionally, the Labor Department's settlement resolves issues it "separately identified through audit examinations of Facebook's recruitment activities related to its PERM applications filed with the Employment and Training Administration's Office of Foreign Labor Certification." Under the DOJ settlement, Facebook will pay a civil penalty of $4.75M to the United States, pay up to $9.5M to eligible victims of Facebook's alleged discrimination, and train its employees on the anti-discrimination requirements of the Immigration and Nationality Act. Under the Department of Labor settlement, Facebook will conduct additional notice and recruitment for U.S. workers and will be subject to ongoing audits to ensure its compliance with applicable regulations. Reference Link
HOTH

Hot Stocks

12:50 EDT Hoth Therapeutics extends partnership agreement with Reprocell - Hoth Therapeutics has extended its partnership agreement with REPROCELL to assess the effect of the HT-003 therapeutic platform in inflammatory bowel disease. Fresh explants of ulcerative colitis and Crohn's disease tissues will be used to investigate the therapeutic potential of Hoth's HT-003 drugs. All testing will be performed at REPROCELL's Centre for Predictive Drug Discovery in Glasgow. "We are delighted to extend this human tissue testing project with Hoth," said Dr David Bunton, CEO of REPROCELL's Center for Predictive Drug Discovery. "They have been a fantastic team to work with, and we have obtained promising data for the HT-003 therapeutic platform so far," he continued. "Our team love to know we are contributing to the development of potential new medicines," stated Cristina Linde, Reprocell's Study Director for the project.
VBFC

Hot Stocks

12:49 EDT Village Bank, Dominion Payroll announce partnership - Village Bank and Dominion Payroll announced a newly forged partnership where Dominion Payroll will serve as Village Bank's endorsed payroll and Human Resources partner. Village Bank commercial customers will now enjoy seamless access to Dominion Payroll's growing list of HR services including Time & Attendance, Applicant Tracking, Employee Onboarding, Benefits Administration, and fractional HR services. "Village Bank places an emphasis on personalized customer service and that aligns with our own approach", states Dominion Payroll's Chief Sales Officer Scott Goldberg. "We support and work with local businesses and are thrilled to announce this partnership with Village Bank."
FB

Hot Stocks

12:46 EDT DOJ, Department of Labor settle with Facebook over labor certification program
MMM

Hot Stocks

12:33 EDT 3M reaches agreement to address PFAS with several parties near Decatur, AL - 3M has reached a collaborative agreement to resolve ongoing litigation and negotiations related to per- and polyfluoroalkyl substances near 3M's Decatur, Ala. facility with parties including The City of Decatur and Morgan County, the plaintiffs in St. John, and the Tennessee Riverkeeper organization. Through these agreements, subject to final approval, 3M will support activities to address PFAS that 3M manufactured or disposed of, the company said in a statement. 3M's contribution to the total amount is reflected in the company's previously disclosed financial reserves for litigation contingent liabilities "We appreciate the importance of our relationship with our neighbors in Decatur. Through this agreement, we can resolve these matters and take action that will strengthen Decatur for the future - a great thing for 3M and this community," said Michelle Howell, Decatur Site Director. "We will continue to take collaborative action for communities where we live and work, our employees, and their friends and families."
DAL

Hot Stocks

12:16 EDT Delta Air Lines to add 100 daily departures from JFK, LGA by November - By November, Delta will add more than 100 total daily departures from John F. Kennedy Airport and LaGuardia Airport compared to the airline's summer 2021 schedule - translating to approximately 8,000 additional seats each day. With domestic consumer travel back to 2019 levels, Delta is focused on restoring capacity safely and reliably as business travel picks up with volumes not seen since the pandemic began. Not only will Delta restore nonstop service to all of New York's 40 most popular domestic markets by next month, but multiple key business markets will also see meaningful boosts in flight options, including Boston, Washington, D.C., Raleigh-Durham and Charlotte. This follows Delta's already expanded service to NYC's biggest corporate markets earlier this fall, like Chicago, Dallas/Ft. Worth and Houston - part of Delta's thoughtful approach to adding capacity in line with the return of demand. Delta also recently launched new LGA service to Toronto and will launch a new flight to Worcester, Massachusetts starting Nov. 1. Reference Link
HSBC

Hot Stocks

12:06 EDT HSBC to launch Banking as a Service offering - HSBC (HSBC) is to launch a Banking as a Service offering that will enable customers to create and provide business banking services through their own platforms, the company said in a statement. HSBC and Oracle NetSuite (ORCL) are working together to provide international payments and expense management services embedded into NetSuite's new SuiteBanking solution, the company said.
GSAH MIR

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12:02 EDT GS Acquisition Holdings Corp II stockholders approve Mirion combination - GS Acquisition Holdings Corp II announced that its stockholders approved the proposals that were conditions to closing of the previously announced business combination with Mirion Technologies at a special meeting of stockholders. A Form 8-K disclosing the full voting results is expected to be filed with the Securities and Exchange Commission. The closing of the Business Combination is expected to occur on or about October 20, 2021, subject to the satisfaction or waiver of all closing conditions. Following closing, the combined company will be known as Mirion Technologies, Inc. and its Class A common stock and warrants are expected to trade on the New York Stock Exchange under the new ticker symbols "MIR" and "MIRW", respectively.
SI

Hot Stocks

12:00 EDT Silvergate Capital falls -10.9% - Silvergate Capital is down -10.9%, or -$17.17 to $141.02.
CEIX

Hot Stocks

12:00 EDT Consol Energy falls -11.6% - Consol Energy is down -11.6%, or -$4.14 to $31.56.
BTU

Hot Stocks

12:00 EDT Peabody Energy falls -16.4% - Peabody Energy is down -16.4%, or -$3.21 to $16.45.
YRD

Hot Stocks

12:00 EDT Yirendai rises 10.8% - Yirendai is up 10.8%, or 35c to $3.60.
YMM

Hot Stocks

12:00 EDT Full Truck Alliance rises 13.8% - Full Truck Alliance is up 13.8%, or $1.99 to $16.37.
DNA

Hot Stocks

12:00 EDT Ginkgo Bioworks rises 18.2% - Ginkgo Bioworks is up 18.2%, or $2.24 to $14.56.
VVOS

Hot Stocks

11:32 EDT Vivos, Candid collaborate for sleep apnea, orthodontic treatment solution - Vivos Therapeutics and Candid Care announced a new collaboration that will seek to provide patients with a comprehensive, whole-mouth solution to diagnose and treat OSA in adult patients and provide orthodontic treatment from the same provider network. At the core of this collaboration, Vivos and Candid will market each company's products and areas of expertise to deliver a comprehensive sleep and oral health solution to patients in the United States and Canada. The focus of the collaboration will be Candid's CandidPro clear aligner for straightening teeth and the Vivos System for treating OSA. The two companies will also share educational resources, training, and key opinion leaders to bridge the gap between airway health and orthodontic therapy. Additionally, under the terms of the agreement, Vivos and Candid will join forces to explore new research and development opportunities for device development and other alliances related to orthodontics, OSA, and snoring.
PENN SCR

Hot Stocks

11:28 EDT Penn National completes acquisition of Score Media - Penn National Gaming (PENN) announced that it has completed its previously announced acquisition of Score Media and Gaming (SCR) for total consideration of approximately $2.0B in cash and stock. The Class A shares of theScore will be delisted from the Toronto Stock Exchange and theScore intends to apply to cease to be a reporting issuer in Canada. The Class A shares of theScore have been suspended from trading and will be delisted from NASDAQ and deregistered under the Securities Exchange Act of 1934 in accordance with applicable law. "We're excited to be creating this powerful new entertainment flywheel that will provide us with multiple growth channels that transcend our current business verticals. We look forward to entering the Canadian gaming market, which represents a compelling new opportunity, and are proud to have John Levy and his family and their entire team bring their best-in-class technology, unique perspective and skill sets to our Penn National family," said Jay Snowden, President and CEO of Penn National Gaming.
AEP

Hot Stocks

11:06 EDT American Electric increases quarterly dividend to 78c from 74c per share - The board of directors of American Electric Power declared a regular quarterly cash dividend of 78c a share on the company's common stock, an increase of 4c per share. "The increase is in line with the company's 5% to 7% operating earnings growth range," the company stated. The dividend is payable Dec. 10 to shareholders of record as of Nov. 10.
IBM

Hot Stocks

11:02 EDT IBM to acquire Adobe Workfront consulting unit and assets from Rego Consulting - IBM (IBM) announced plans to acquire the Adobe Workfront consulting unit and assets from Rego Consulting Corporation. "Building on IBM's strategic partnership with Adobe, the consultancy specializes in work management software consulting for enterprise clients. IBM has been investing aggressively to bolster its hybrid cloud and AI strategy and capabilities, including a heavy focus on acquiring high-value consultative services like the Adobe Workfront business of Rego. The acquisition of Rego's Adobe Workfront business represents the 17th overall acquisition for IBM - and the ninth acquisition in cloud and AI services - since Arvind Krishna took over as IBM CEO in April 2020," IBM stated. Financial details of the deal were not disclosed. The transaction is subject to customary closing conditions.
DKNG...

Hot Stocks

11:00 EDT DraftKings says continuing to engage in talks with Entain about offer - In a notice to the London Stock Exchange, DraftKings (DKNG) noted the announcement made by Entain (GMVHF) earlier today relating to the extension of the deadline, under Rule 2.6 of the City Code on Takeovers and Mergers, for DraftKings either to announce a firm intention to make an offer for Entain in accordance with Rule 2.7 of the Code or to announce that it does not intend to make such an offer in accordance with Rule 2.8 of the Code to 5:00 p.m. London time on November 16, 2021. "DraftKings will continue to engage in discussions between both companies and to conduct more substantive due diligence and analysis regarding its possible offer. DraftKings looks forward to exploring potential benefits that could derive from this possible combination for its and Entain's shareholders, including: Expansion into regulated and regulating markets; Accelerated product growth; Innovation in new and existing verticals. DraftKings further notes that while it progresses its discussions with Entain, it also continues to remain very focused on opportunities in the high growth North America market. This announcement does not constitute an announcement of a firm intention to make an offer under Rule 2.7 of the Code. There can be no certainty that an offer will be made nor as to the terms on which any offer will be made. A further announcement will be made as and when appropriate," DraftKings stated.
MEGGF PH

Hot Stocks

10:40 EDT Meggitt continues to expect Parker-Hannifin acquisition being completed in Q3 - In a notice issued to the London Stock Exchange, Meggitt (MEGGF) stated: "Meggitt PLC notes yesterday's announcement by the Department for Business, Energy and Industrial Strategy that the Secretary of State has referred the recommended acquisition of Meggitt by Parker-Hannifin Corporation to the Competition and Markets Authority on the grounds of a national security public interest consideration. The company also notes that the CMA is required to report to the Secretary of State by midnight at the end of 18 March 2022 and looks forward to engaging constructively with the CMA on its review. Meggitt continues to expect that the acquisition will complete in the third quarter of 2022."
ADM

Hot Stocks

10:18 EDT Archer Daniels enters technology licensing agreement with Solarea Bio - Solarea Bio announced it has signed a technology licensing agreement with ADM. Solarea Bio has developed technologies to harness the power of microorganisms to modulate inflammatory processes in conditions such as osteoporosis in humans, leveraging the company's extensive capabilities in data science and microbial product development experience. This new agreement allows ADM to examine the functionality and potential for use of these microbes in new food and beverage solutions designed to support health and wellness.
GMVHF...

Hot Stocks

10:18 EDT Entain extends 'put up or shut up' deadline related to offer from DraftKings - Following the announcement made by Entain plc (GMVHF) on September 21, the board of Entain has "carefully considered" the proposal received from DraftKings (DKNG) on September 19, along with feedback from Entain shareholders, the company announced. Under the terms of the proposal, DraftKings would offer 2,800 pence per Entain share consisting of 630 pence in cash and the balance payable in new DraftKings Class A common shares. DraftKings proposed that the exchange ratio which would deliver the share element of the 2,800 pence per Entain share would be fixed immediately prior to the first agreed public announcement. "The board has been in discussions with DraftKings in order to explore the merits and feasibility of a potential transaction reserving its position on the appropriateness of the value of the proposal. As part of this, the board will require a number of matters to be satisfactorily resolved that are fundamental to the structure and value of the proposal... In accordance with Rule 2.6(a) of the Code, DraftKings was required, by no later than 5.00 pm on October 19, 2021, to either announce a firm intention to make an offer for Entain in accordance with Rule 2.7 of the Code or announce that it does not intend to make an offer for Entain, in which case the announcement would be treated as a statement to which Rule 2.8 of the Code applied. Discussions between the parties remain ongoing and in accordance with Rule 2.6(c) of the Code, Entain has requested, and the Panel on Takeovers and Mergers has consented to, an extension to the deadline by which DraftKings is required either to announce a firm intention to make an offer for DraftKings in accordance with Rule 2.7 of the Code or to announce that it does not intend to make an offer, in which case the announcement will be treated as a statement to which Rule 2.8 of the Code applies. Such announcement must now be made by not later than 5.00 pm on November 16, 2021. This deadline can be further extended by the Board of Entain, with the consent of the Takeover Panel. The Board strongly believes in the future prospects of Entain, underpinned by its leading market positions, world class management team and industry-leading proprietary technology. Entain has an outstanding track record of growth having delivered 23 consecutive quarters of double digit online NGR growth, and a 3 year CAGR of 19% across 2021," Entain announced.
CMCSA...

Hot Stocks

10:05 EDT Comcast announces launch of 'XClass TV' smart TVs - Comcast (CMCSA) announced the launch of XClass TV, "extending the reach of the company's global technology platform to smart TVs nationwide." Comcast stated: "For the first time, Comcast's award-winning entertainment and voice platform is available direct to consumers across the U.S., without an Xfinity subscription, both inside and outside of Comcast's service areas. Comcast has partnered with Hisense to bring the first XClass TVs to market, combining Hisense's advanced television hardware with Comcast's XClass TV operating system... The first XClass TVs from Hisense are available this week in select Walmart stores and in the coming weeks through Walmart.com." Other makers of smart TVs and operating systems and services for connected TVs include Vizio (VZIO) and Roku (ROKU).
GE

Hot Stocks

10:01 EDT GE Digital, FLAPZ sign MOU to collaborate on safety solutions for business jets - GE Digital announced that it had signed a Memo of Understanding with FLAPZ to work toward a mutual goal: increase safety in Business & General Aviation in Colombia and other parts of Latin America. The companies plan to work together to provide GE Digital's Safety Insight for Business Jets, a C-FOQA software and services solution, to FLAPZ's consortium that will make it easy for business jet operators to improve safety by implementing safety procedures at the highest level of international standards.
STBA

Hot Stocks

10:01 EDT S&T Bancorp raises quarterly dividend to 29c from 28c per share - The dividend is payable November 18 to shareholders of record on November 4.
MAN

Hot Stocks

10:00 EDT ManpowerGroup falls -6.4% - ManpowerGroup is down -6.4%, or -$7.20 to $105.93.
BTU

Hot Stocks

10:00 EDT Peabody Energy falls -10.0% - Peabody Energy is down -10.0%, or -$1.97 to $17.69.
SI

Hot Stocks

10:00 EDT Silvergate Capital falls -11.5% - Silvergate Capital is down -11.5%, or -$18.12 to $140.06.
GATO

Hot Stocks

10:00 EDT Gatos Silver rises 7.0% - Gatos Silver is up 7.0%, or 81c to $12.33.
ETWO

Hot Stocks

10:00 EDT E2open rises 7.1% - E2open is up 7.1%, or 78c to $11.73.
IONQ

Hot Stocks

10:00 EDT IonQ rises 7.3% - IonQ is up 7.3%, or 78c to $11.47.
JNJ

Hot Stocks

09:49 EDT Johnson & Johnson says planning to file for full approval of Covid-19 vaccine - Expects to transition to commercial model from non-profit model for the vaccine, possibly in 2023.
TTM

Hot Stocks

09:47 EDT Tata Motors falls -6.1% - Tata Motors is down -6.1%, or -$2.06 to $31.73.
MAN

Hot Stocks

09:47 EDT ManpowerGroup falls -7.1% - ManpowerGroup is down -7.1%, or -$8.08 to $105.05.
SI

Hot Stocks

09:47 EDT Silvergate Capital falls -11.7% - Silvergate Capital is down -11.7%, or -$18.55 to $139.65.
RLI

Hot Stocks

09:47 EDT RLI Corp. rises 6.9% - RLI Corp. is up 6.9%, or $7.06 to $109.31.
AGQ

Hot Stocks

09:47 EDT ProShares Ultra Silver rises 7.2% - ProShares Ultra Silver is up 7.2%, or $2.52 to $37.62.
RLX

Hot Stocks

09:47 EDT RLX Technology rises 8.5% - RLX Technology is up 8.5%, or 51c to $6.42.
FB COIN

Hot Stocks

09:37 EDT Facebook rolls out Novi digital wallet pilot in U.S., Guatemala - Facebook's David Marcus said via Twitter: "Remittances are a critical way to achieve financial inclusion. Today, we're rolling out a small pilot of the @novi digital wallet app in two countries - the US and Guatemala. People can send and receive money instantly, securely, and with no fees. We're doing a pilot to test core feature functions, and our operational capabilities in customer care and compliance. We're also hopeful this will demonstrate a new stablecoin use case (as a payments instrument) beyond how they are typically used today...The Novi pilot uses USDP (Pax Dollar) through partnerships with @paxos and @coinbase. USDP is a well-designed stablecoin that's been operating successfully for over three years and has important regulatory and consumer protection attributes. I do want to be clear that our support for Diem hasn't changed and we intend to launch Novi with Diem once it receives regulatory approval and goes live. We care about interoperability and we want to do it right. Beyond the pilot, our business model is clear. We're a challenger in payments. We'll offer free person-to-person payments using Novi. Once we have a solid customer base, we'll offer cheaper merchant payments and make a profit on merchant services. Scaling Novi will take time and this pilot is a great chance for us to learn from our early customers. We want to make sure that our wallet has been fully tested before we open Novi up to more people."
RELY FB

Hot Stocks

09:34 EDT Remitly Global partners with Novi for pilot of digital wallet - Remitly Global (RELY) announced a partnership with Novi (FB), a next generation digital wallet. To support its pilot launch, Novi is leveraging Remitly's custom-built global network to enable cash pickup in Guatemala. Remitly's global payments network spans over 1,700 corridors, serving customers in 17 countries, sending to over 115 receive countries. With the launch of the pilot program, Novi is enabling customers to send and receive money using the Pax Dollar stablecoin, securely and without fees. In alignment with its mission, Remitly is pleased to support Novi's initiative to open new channels of financial access and inclusion. Novi is now available to a limited number of customers in the US and Guatemala.
COIN FB

Hot Stocks

09:33 EDT Coinbase chosen by Facebook as custody partner for Novi pilot - Facebook (FB) has chosen Coinbase (COIN) as its custody partner for its pilot of Novi, a new digital wallet that enables people to send and receive money "abroad instantly, securely, and with no fees," Coinbase said in a blog post. For the pilot, Coinbase is supporting Novi via Coinbase Custody, which it says "keeps user funds secure with our proprietary, fully segregated cold storage capability for managing private keys." Novi users who can participate in the pilot can acquire Pax Dollar through their Novi account, which Novi will hold on deposit with Coinbase Custody. Novi users will then be able to transfer USDP between each other instantaneously. Reference Link
OLB

Hot Stocks

09:32 EDT OLB Group launches bitcoin mining operation with 100 Antminer S19j miners - The OLB Group announced that DMint, Inc., a wholly-owned subsidiary of OLB, has initiated Bitcoin mining with its first one hundred Antminer S19j Pro cryptocurrency mining computers. DMint anticipates having a total of 1000 computers in operation at its newly installed Bradford, PA data center by the end of 2021 and projects to reach 24,000 Bitcoin mining computers in the next 24 months.
JNJ

Hot Stocks

09:32 EDT Johnson & Johnson says 'real positive outlook' on Pharmaceuticals business - Says bankruptcy courts will ultimately decided the talc issue. Says focused on competitiveness and innovation. Planning for "strong recovery" in Q4.
AGS

Hot Stocks

09:31 EDT PlayAGS enters game publication agreement with Game Play Network - Game Play Network announced a game publication agreement with AGS to integrate AGS' remote game server and online and mobile games into GPN's B2C website & mobile app. GPN is a licensed gaming company with a patented platform that facilitates the reveal of real money wagers on live horse races to customers via casino-style games. The platform enables its strategic partners to offer their players the immediate, unrivaled ability to offer iGaming for real money in the vast majority of the U.S., reaching 40% more of the population than other iGaming companies, and thus dramatically increasing their total addressable market.
DSX

Hot Stocks

09:30 EDT Diana Shipping files draft registration statement relating to proposed spin-off - Diana Shipping announced that, through a wholly-owned subsidiary, it has filed a registration statement on Form 20-F pursuant to the Securities Exchange Act of 1934 to effect a spin-off of three of the Company's older dry bulk vessels. OceanPal Inc., the newly formed subsidiary that will act as the holding company for the three dry bulk vessels, has applied to have its common shares listed on the Nasdaq Capital Market. In connection with the spin-off transaction, the Company will contribute the three vessel-owning subsidiaries, together with initial working capital in the amount of US$1.0 million, to OceanPal Inc., and will distribute all of the common shares of OceanPal Inc. to the Company's shareholders of record as of October 29, 2021. The Company will also receive preferred shares in OceanPal Inc. that will entitle the Company to certain preferred dividend and voting rights. The registration statement on Form 20-F includes a more detailed description of the terms of the proposed spin-off transaction. A copy of the registration statement on Form 20-F is available at www.sec.gov. The information in the filed registration statement on Form 20-F is not final and remains subject to change. The Company is also announcing that concurrently with the consummation of the spin-off transaction, the Company will pay a cash dividend in the amount of US$0.10 per common share to shareholders as of the aforementioned Record Date. The transaction is expected to be completed on or around November 9, 2021, and remains subject to the registration statement on Form 20-F being declared effective and the approval of the listing of OceanPal Inc.'s common shares on the Nasdaq Capital Market.
TLSA

Hot Stocks

09:29 EDT Tiziana Life Sciences says court sanctions scheme of arrangement - Tiziana Life Sciences announced on 20 August 2021 that it had formally commenced its strategic plan to change its corporate structure by establishing Tiziana Life Sciences, a Bermuda-incorporated company, as the ultimate parent company of the Tiziana Group. The reorganisation will be achieved by a scheme of arrangement under Part 26 of the Companies Act 2006. A Scheme Document setting out full details of the Scheme was posted to the shareholders of Old Tiziana on 3 September 2021. Capitalised terms defined in the Scheme Document shall, unless the context provides otherwise, have the same meanings in this announcement. Old Tiziana announces that earlier today the Court sanctioned the Scheme and confirmed the reduction of capital as part of the Scheme. In order for the Scheme to become effective the Court Order must be delivered to the Registrar of Companies. This is expected to occur, and the Scheme is expected to become effective, on 20 October 2021. As part of the proposals, New Tiziana intends to implement a share consolidation in respect of New Tiziana Shares issued under the Scheme to ensure that the New Tiziana Shares trade initially on NASDAQ at a price more readily comparable to its peers. The ratio of the Share Capital Consolidation will be two-for-one. It is intended that the Share Capital Consolidation will be implemented immediately after the Scheme becomes effective.
FWBI

Hot Stocks

09:27 EDT First Wave receives FDA clearance of IND application for Phase 2a PASSPORT trial - First Wave BioPharma announced hat the U.S. Food and Drug Administration has reviewed the Investigational New Drug application and provided a "Study May Proceed" letter for the Company's Phase 2a PASSPORT trial investigating FW-ICI-AC as a treatment for Grade 1 and Grade 2 colitis and diarrhea in oncology patients receiving treatment with immune checkpoint inhibitors. FW-ICI-AC is a proprietary oral immediate-release tablet formulation of niclosamide, a prescription small molecule with anti-inflammatory and anti-viral properties. The Phase 2a PASSPORT clinical trial is designed as a double-blind, placebo-controlled study to determine the safety, tolerability, and preliminary efficacy of FW-ICI-AC in the treatment of immune checkpoint inhibitor-associated colitis and diarrhea in advanced cancer patients. 60 patients will be enrolled in the trial and divided into two arms. One arm will receive FW-ICI-AC three times daily for two weeks, while the other arm will receive placebo three times daily for two weeks. Following treatment, each patient will enter a four-week evaluation period. The primary endpoint of the trial is safety and tolerability of FW-ICI-AC. Additional endpoints will measure early signals of efficacy, including resolution of the patient's diarrhea, sparing of steroids, and prevention of disease progression. First Wave BioPharma's proprietary formulation of niclosamide is also the subject of a Phase 2 clinical trial as a potential treatment for COVID-19-related gastrointestinal infections and a Phase 2b clinical trial in patients with ulcerative proctitis and ulcerative proctosigmoiditis, two forms of ulcerative colitis - an inflammatory bowel disease.
PROG

Hot Stocks

09:24 EDT Progenity up 10% in pre-market trading at $3.29 per share - Shares of Progenity are up about 10% at $3.29 in pre-market trading following Monday's 39.7% advance. The stock is in the top-5 trending names on StockTwits in terms of message volume over the past 24 hours.
ETWO

Hot Stocks

09:19 EDT E2open CEO buys 40K shares, CFO buys 2K shares of common stock - In regulatory filings, E2open disclosed that its CEO Michael Farlekas bought 40K shares of common stock in a transaction size of $443K and CFO Jarrett Janik bought 2K shares of common stock in a transaction size of $22K on October 18th. Shares of E2open are up 6.2% in pre-market trading at $11.62.
YVR

Hot Stocks

09:18 EDT Liquid Media enters strategic partnership with Slated - Liquid Media Group announced a strategic partnership with Slated, further enhancing the Company's analytic and optimization capabilities and Liquid's four-phase solution engine, which is designed to drive sustainable growth for independent intellectual property owners and producers. Further strengthening the critical first phase of the Liquid solution engine, Liquid and Slated are partnering to bring objective analysis to producers and other creative professionals using data analytics to measure the strength of a production's talent and producing team, the quality of the script or screener and to optimize the potential for financial returns. Additionally, Slated will be offering its newly launched Screening Analysis virtual test screening service, which helps filmmakers optimize their films in post production and match completed films to the right distributors. Liquid is adopting the Slated scoring system under the non-exclusive partnership agreement, as well as other services and tools from Slated to independently and objectively evaluate the development-readiness of select film, TV and other professional video content submitted to Liquid by third parties.
AEE

Hot Stocks

09:17 EDT Ameren appoints Gwen Mizell as Chief Sustainability Officer - Ameren recently announced two organizational changes that will further Ameren's sustainability efforts. Gwen Mizell was named Chief Sustainability Officer, a newly created position. She was also named vice president of innovation at Ameren. Patrick Smith was promoted to vice president of economic, community and business development at Ameren Missouri. Mizell is a 7-year veteran of Ameren. She has served as Ameren's vice president of sustainability and innovation since 2019. She joined Ameren in 2015 as director of diversity and inclusion. Mizell holds a master's degree in management and public policy analysis from Carnegie Mellon University and a bachelor's degree in materials science and engineering from the University of Alabama at Birmingham. Smith has been with Ameren for 36 years in progressively responsible leadership roles, becoming an officer of the company in 2016. He joined the company in 1985 as a meter reader and worked for several years as a journeyman lineman, building and maintaining the electrical distribution system. Smith's strategic thinking and focus on conservative operations have been foundational in providing safe, reliable and affordable energy to Ameren's customers.
GTEH

Hot Stocks

09:17 EDT GenTech to change name to Supplement Group - GenTech Holdings announced that it has recently applied to FINRA to change the Company's name to Supplement Group whilst leaving the symbol as "GTEH". The Company recently announced not only a major retailer as a new Fizzique partner, but also that it had achieved record September topline revenue figures. Provisional numbers for September 2021 show Gross Consolidated Revenues currently at $217k from September's operations, which represents an annual revenue run rate on pace to produce $2.6m. GenTech management believes both of its operating subsidiary's performance is poised for continued growth as tailwinds from increased marketing spend and improved operating conditions become active factors in defining the Company's operational landscape. This includes the impact of wide Covid-19 vaccinations and reduced pandemic impact in the operation of fitness and 'brick and mortar' facilities, which is believed to indirectly impact demand for the Company's products. As world trade begins to operate with a new normal, key inventory items such as bottles, bottle lids and protein will begin to become more easily available, leading to increased revenues as inventory becomes more available through 2022.
WDAY

Hot Stocks

09:14 EDT Workday announces digital experience of employees with Workday everywhere - Workday announced Workday Everywhere, packaged connectors that bring Workday tasks and insights directly into digital workspaces to help organizations elevate their employee experiences. With Workday Everywhere, employees can quickly access Workday in their flow of work, without having to toggle between different applications. Employers can use Workday Everywhere to deliver an experience that improves employee productivity and engagement. "As the latest Workday employee experience offering, Workday Everywhere supports an ongoing effort to increase engagement with an open and frictionless experience that meets people where they are by bringing the power of Workday to them in their digital environment," the company said.
AVID

Hot Stocks

09:13 EDT Avid Technology expand IP content sources for live TV content workflows - Avid announced the interoperability of Sony and TVU Networks IP-connected devices with MediaCentral Stream to dramatically expand the pool of journalists, producers and other production resources who can contribute live streams from anywhere for news and remote live production workflows. MediaCentral Stream is a rapidly deployed, software-only solution that immediately opens the MediaCentral platform to contributions over IP from sources anywhere using any device.
EVRC

Hot Stocks

09:12 EDT Evercel, Inc reports results of 2021 Annual Meeting - Evercel announced the results of its 2021 Annual Meeting of Shareholders, which was held on October 7, 2021. The final vote, which will be certified today, shows that shareholders voted to re-elect Richard Perkins and Patrick McGeehin to serve on the Company's Board of Directors for a term of three years. n addition, shareholders approved a stockholder proposal to amend the Company Bylaws to increase the size of the Board of Directors to nine directors through the conclusion of the 2024 Annual Meeting. To fill these seats, shareholders voted to elect Daniel Lewis as a Class I director to serve a term expiring at the 2024 annual meeting, Richard Lewisohn III as a Class II director to serve a term expiring at the 2022 annual meeting and Alan Mitrani as a Class III director to serve a term expiring at the 2023 annual meeting. Shareholders also approved the Board's appointment of Baker Tilly US, LLP, as the Company's independent registered public accounting firm for the fiscal year ending March 31, 2021.
CHTR

Hot Stocks

09:12 EDT Charter announces a series of executive promotions and appointments - Charter Communications announced a series of executive promotions and appointments to its leadership team with the news that veteran cable executive John Bickham was named Vice Chairman ahead of his previously announced retirement at the end of 2022. Charter's CFO, Chris Winfrey, was elevated to COO, while Jessica Fischer, EVP, Finance will succeed Winfrey as CFO. Additionally, Chief Product & Technology Officer Rich DiGeronimo will add oversight for Charter's Network Operations to his existing responsibilities. The appointments are effective immediately with Bickham, Winfrey, Fischer and DiGeronimo all reporting to Charter Chairman and CEO Tom Rutledge. Bickham joined Charter as COO in 2012 and his operational expertise helped Charter grow into the second largest cable company in the country. He was named President & COO in July 2016 when the transactions with Time Warner Cable and Bright House Networks closed.
RIOT

Hot Stocks

09:11 EDT Riot Blockchain announces first immersion-cooled bitcoin mining operation - Riot Blockchain announces the development of 200 megawatts of immersion-cooling technology at its Whinstone facility, which to the Company's knowledge is the Bitcoin mining industry's first industrial-scale immersion-cooled deployment of Bitcoin mining hardware. The development of 200MW of immersion-cooling at industrial-scale is a direct result of the Company's focus on Bitcoin mining infrastructure development, led by Riot's leadership team at Whinstone. "After months of research and development, utilizing partnerships across industries, Riot is proud to be a pioneer in the use of cutting-edge immersion-cooling technology at an unprecedented scale," said Jason Les, CEO of Riot. "By leveraging technology, industry-leading low power costs, and economies of scale, Riot intends to continue driving operating and capital efficiencies for its self-mining business and its institutional clients. Due to these efficiencies, we anticipate observing an increase in the Company's hash rate and productivity through 2022, without having to rely solely on purchasing additional ASICs." Of the previously announced 400 MW expansion of Whinstone, 200 MW of the infrastructure is committed to utilizing immersion-cooling technology in Bitcoin mining. This development covers two of the buildings under construction and is expected to host approximately 46,000 S19 Antminers from Riot's already-purchased miner fleet. Initial deployment of ASICs in the immersion-cooled buildings is expected to commence by the 4th quarter of 2021.
TECK

Hot Stocks

09:11 EDT Teck Resources announces $4B sustainable financing facility - Teck Resources announced that it has executed a $4.0 billion sustainability-linked revolving credit facility. Under the SL RCF the price paid by Teck will increase or decrease based on the company's performance in reducing carbon emissions, improving health and safety, and strengthening gender diversity in its workforce. The new credit facility matures in October 2026, extending the previous facility by two years. The principal amount outstanding as of October 18 was $198 million as compared to $502 million as of June 30, 2021, and it is expected to be at zero by end of October 2021. The SL RCF is aligned with Teck's long-term sustainability strategy, which sets out goals including reducing carbon intensity by 33% by 2030 and becoming carbon neutral across operations by 2050. Learn more about Teck's sustainability strategy here. In addition to converting and extending its $4 billion revolving credit facility, Teck has also cancelled its $1 billion side car that was scheduled to mature in June 2022. This side car facility was established during the initial months of COVID 19, and market conditions and commodity prices have improved significantly since that time.
CRSR

Hot Stocks

09:09 EDT Corsair Gaming launches ELITE LCD CPU Coolers - Corsair Gaming announced new, highly customizable additions to its ELITE line of all-in-one CPU coolers: iCUE ELITE LCD Display Liquid CPU Coolers. With a vivid 2.1" LCD screen on the pump head to display anything from system vitals to animated GIFs, ELITE LCD coolers offer a unique window into both your PC's performance and your own style and personality. The ultra-bright LCD screen is also available as an upgrade kit for CORSAIR iCUE ELITE CAPELLIX coolers, letting you add a digital dashboard to your existing cooler.
SHIP

Hot Stocks

09:08 EDT Seanergy Marine announces acquisition of 17th Capesize vessel - Seanergy Maritime announced that it has entered into a definitive agreement with an unaffiliated third party to purchase a Capesize vessel. In addition, the Company has recently completed the sale and delivery of its oldest Capesize vessel, the M/V Leadership, 2001-built, to its new owners. The Vessel was built in 2010 at a reputable shipyard in Japan, has a cargo-carrying capacity of approximately 181,500 deadweight tons and will be renamed M/V Dukeship. The M/V Dukeship is expected to be delivered within November 2021, subject to the satisfaction of certain customary closing conditions. Following its delivery, Seanergy's fleet will increase to 17 Capesize vessels with an aggregate cargo capacity exceeding 3M dwt. The Vessel is fitted with a ballast water treatment system, while the special survey was recently completed by the current owner and, therefore, the Company does not anticipate incurring any significant off-hire or capital expenditures for this Vessel for the next two years. The purchase price of $34.3M is expected to be funded with cash on hand. Stamatis Tsantanis, the Company's Chairman & Chief Executive Officer, stated: "I am very pleased to announce our 7th Japanese capesize acquisition within 2021. Our total investment since the beginning of our fleet expansion program in 2020 has reached $205M. The addition of the M/V Dukeship will further enhance our operating leverage as a leading pure-play Capesize company and, given the Vessel's prompt delivery in a strong Capesize market, the acquisition is expected to be immediately accretive for our shareholders. The spot Capesize market currently exceeds $60,000 per day, rendering the latest addition a high revenue-generating investment, while the forward curve indicates that the positive market trend will be sustained for the next years."
SANA BEAM

Hot Stocks

09:08 EDT Sana obtains non-exlusive license to CRISPR Cas12b gene editing technology - Sana Biotechnology (SANA) announced that the company entered into an agreement with Beam Therapeutics Inc. (BEAM) for non-exclusive commercial rights to Beam's CRISPR Cas12b nuclease system for certain ex vivo engineered cell therapy programs. Cas12b is a CRISPR-based nuclease with a high degree of specificity and efficiency that can be used to knock out and/or knock in genes in certain cell types. Under the agreement, Beam granted Sana non-exclusive rights to utilize its Cas12b system with certain allogeneic T cell and stem cell-derived programs, including the ability to make gene edits for Sana's hypoimmune platform. The license does not include any rights to base editing using Cas12b, which remain at Beam. Under the terms of the agreement, Sana agreed to pay Beam an upfront payment of $50 million. Beam is also eligible to receive certain target option exercise fees, certain milestone payments upon the achievement of certain development and sales milestones, and certain royalties on net sales of royalty-bearing products by Sana, its affiliates, its sublicensees and affiliates of its sublicensees.
DOCN

Hot Stocks

09:08 EDT DigitalOcean appoints Gabe Monroy as Chief Product Officer - DigitalOcean Holdings announced the appointment of Gabe Monroy as chief product officer. Monroy will oversee DigitalOcean's product management organization and own the company's product vision that will drive growth and innovation and enhance the customer experience. Prior to DigitalOcean, Monroy was vice president of the Azure Developer Experience group in Microsoft's Developer Division. In this role, he was responsible for the application-centric services and tools on Azure, including compute services, platform services and developer tools. Previously, Monroy was the founder and chief technology officer of Deis, which was acquired by Microsoft in 2017. After joining Microsoft, Monroy started Azure Kubernetes Service, the fastest-growing compute service in Azure's history. As an early contributor to Docker and Kubernetes, and a founding member of the Cloud Native Computing Foundation , Monroy has deep experience in open source software and cloud-native technology.
MBRX

Hot Stocks

09:06 EDT Moleculin receives authorization for Phase 1a clinical trial of WP1122 in the UK - Moleculin Biotech announced it has received authorization from the Medicines and Healthcare Products Regulatory Agency, or MHRA, to commence a Phase 1a clinical trial of WP1122 in the United Kingdom. WP1122, the Company's lead metabolism/glycosylation inhibitor, is a prodrug of a well-known antimetabolite called 2-deoxy-D-glucose currently being developed for inhibition of viral replication and disease manifestations in humans infected with SARS-CoV-2, the virus responsible for COVID-19. The Company also announced it has received a favorable opinion from the London - Riverside Research Ethics Committee in the UK to begin the study, which is expected to be conducted at the Medicines Evaluation Unit in Manchester, UK.
QLGN

Hot Stocks

09:06 EDT Qualigen Therapeutics announces publication of study on FastPack - Qualigen Therapeutics announces the publication of a study in the peer-reviewed, open-source journal, Diagnostics, validating the Company's point of care FastPack IP diagnostic test as comparable to an industry-leading laboratory method in determining thyroid stimulating hormone levels in blood. "The FastPack technology has successfully been utilized for over two decades, and up-to-date real-world clinical evidence is an important pillar in our understanding of its accuracy and utility in the market. This study, which was conducted in a cohort of 100 subjects in Foggia, Italy, corroborates what endocrinologists, diabetologists, and general and internal medicine clinicians have experienced for many years - that FastPack IP provides an easy-to-use, rapid, reproducible - and highly accurate - test for TSH levels, which is essential for prescribing and assessing treatments," commented Michael Poirier, Qualigen's Chief Executive Officer. The Diagnostics study, titled "Comparison between an Emerging Point-of-Care Tool for TSH Evaluation and a Centralized Laboratory-Based Method in a Cohort of Patients from Southern Italy" demonstrated a strong correlation between the FastPack TSH results and those taken from laboratory analysis. Further, the subjects who participated in the study were accustomed to undergoing TSH testing 3-5 times per year and expressed complaints about the time required to receive laboratory results. All patients who participated in the study noted the advantage of the shorter time-to-result that FastPack provides.
TTEK

Hot Stocks

09:06 EDT Tetra Tech gets five-year $25M, single-award for WASH services from Tanzania - Tetra Tech announced that the U.S. Agency for International Development, USAID, awarded the Company a five-year, $25M, single-award contract to support the Government of Tanzania in expanding and sustaining the delivery and management of water, sanitation, and hygiene, WASH, services in urban and rural settings. "Tetra Tech has supported USAID to improve access to water and sanitation in developing countries for more than 40 years," said Dan Batrack, Tetra Tech Chairman and CEO. "We look forward to continuing to support Tanzania to enhance water security and improve community access to critical water and sanitation services."
IBRX

Hot Stocks

09:06 EDT ImmunityBio reports QUILT 3.032 study met primary endpoint in second indication - ImmunityBio announced that Papillary disease, the second indication of its QUILT 3.032 Phase 2/3 study of intravesical BCG plus Anktiva in patients with BCG-unresponsive high-grade NMIBC, also met its primary endpoints with disease-free survival of 57% of patients at 12 months. The company has previously reported that the primary endpoint of Cohort A, patients with CIS disease, has been met with a complete response of 72%. Current standard of care for high-grade papillary disease is intravesical BCG, with a 40% non-response rate. To date, 73 patients have enrolled in Cohort B with a median follow-up of 17.3 months. The primary endpoint was met with a disease-free rate at 12-months of 57% and at 18-months, 53% by Kaplan-Meier analysis. Durable responses were noted in both cohorts and the therapy resulted in significant avoidance of cystectomy. The safety profile of Anktiva in Cohort B was consistent with that seen in Cohort A, which was recently presented at the American Urological Association's 2021 Annual meeting, in which 0% SAEs, including 0% immune-related SAEs, were detected. In addition, 85% of the patients were able to avoid a cystectomy. A full analysis of efficacy and safety data for both Cohorts A and B has been submitted to the American Society of Clinical Oncology Genitourinary Cancer Symposium in February 2022.
SEAT

Hot Stocks

09:05 EDT Vivid Seats to begin trading on NASDAQ Global Select - Vivid Seats announced that it has been approved for listing on the NASDAQ Global Select Market under the symbol "SEAT." The Company begins trading at 9:30am ET today, October 19, 2021. Stan Chia, Chief Executive Officer of Vivid Seats, commented, "Today marks the culmination of months of hard work as we list on the NASDAQ Global Select Market. We are thrilled to join one of the most exciting capital markets in the world and list amongst many notable and leading technology companies. Vivid Seats is committed to becoming the ultimate ticketing marketplace for fans and sellers while connecting people to live events around the country. As we move forward as a public company, we will remain focused on our overarching commitment to deliver quality marketplace services for our customers, as well as building and sustaining long-term shareholder value."
GBTC

Hot Stocks

09:05 EDT NYSE Arca files form 19b-4 to convert Grayscale Bitcoin Trust into ETF - Grayscale Investments announced that NYSE Arca has filed Form 19b-4 with the Securities and Exchange Commission to convert Grayscale's flagship product, Grayscale Bitcoin Trust, into a Bitcoin Spot ETF. The move comes on the heels of the SEC's clearance of a Bitcoin Futures ETF. Grayscale has publicly committed the firm's intent to convert GBTC as well as its other 14 investment products into ETFs. Grayscale Bitcoin Trust launched in 2013, received a public quotation in May 2015, and became an SEC reporting company in January 2020. Today, the Trust is the largest Bitcoin investment vehicle in the world, holding approximately 3.44% of all Bitcoin in circulation.
DKNG LGF.A

Hot Stocks

09:04 EDT Autograph partners with Lionsgate and Twisted Pictures - Autograph, the brand co-founded by Tom Brady, has partnered with Lionsgate (LGF.A) and Twisted Pictures to release exclusive digital collectibles from Saw, a horror franchises. This series of frightening digital collectibles will be available exclusively for viewing on Autograph.io and for purchase on DraftKings Marketplace, by DraftKings (DKNG) starting October 26th and leading into Halloween weekend. Following several successful digital drops within the past two months with athlete partners including Tom Brady, Tiger Woods, Simone Biles, Naomi Osaka and Derek Jeter, the Saw launch marks a first-of-its-kind introduction to the entertainment space by Autograph.
ZLAB ETTX

Hot Stocks

09:04 EDT Zai Lab, Entasis Therapeutics announce results for SUL-DUR - Zai Lab (ZLAB) and its partner Entasis Therapeutics (ETTX) announced topline results from the ATTACK triala global Phase 3 registrational trial evaluating the safety and efficacy of SUL-DUR versus colistin in patients with infections caused by Acinetobacter baumannii. SUL-DUR met the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections, demonstrating statistical non-inferiority versus colistin. Mortality analyses favored SUL-DUR versus colistin in CRABC m-MITT and all study populations included in the topline results. At Test of Cure, there was a statistically significant difference in clinical response favoring SUL-DUR over colistin. SUL-DUR met the primary safety objective of the study achieving statistically significant reduction in nephrotoxicity. ATTACK enrolled 207 patients at 95 clinical sites in 17 countries. This was a two-part trial with Part A being the randomized, comparative portion in patients with documented Acinetobacter baumannii hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, ventilated pneumonia, or bacteremia and Part B being an open-labeled portion including ABC infections resistant to or failed colistin or polymyxin B treatment. All patients received imipenem/cilastatin as background therapy. Approximately 95% of baseline Acinetobacter isolates tested were carbapenem resistant. SUL-DUR met the primary efficacy endpoint of 28-day all-cause mortality compared to colistin in the CRABC m-MITT population of Part A. SUL-DUR mortality was 19.0% compared to 32.3% in the colistin arm. Similar trends were observed in 28-day and 14-day all-cause mortality favoring SUL-DUR across all study populations evaluated to date. A statistically significant difference in clinical cure at Test of Cure was observed with 61.9% in SUL-DUR arm compared to 40.3% in the colistin arm. In Part B, the 28-day all-cause mortality was 17.9% and consistent with that observed in Part A. Safety analyses were conducted in a total of 205 patients with at least one dose in Part A and Part B. SUL-DUR met the primary safety objective with a statistically significant reduction in nephrotoxicity as measured by the RIFLE classification. SUL-DUR nephrotoxicity was 13.2% versus 37.6% in the colistin arm. Overall adverse events in the safety population were comparable between treatment groups with 87.9% in the SUL-DUR arm versus 94.2% in the colistin arm in Part A, 89.3% in Part B. Drug related AEs were 12.1% with SUL-DUR compared to 30.2% with colistin in Part A, 10.7% in Part B
JNJ

Hot Stocks

09:04 EDT Johnson & Johnson says investing in R&D at 'competitive levels' - Says continues to advance pipeline of products. Says "encouraged" by positive procedure trends in most markets. Says generating strong free cash flow. Says financial position, balance sheet "remain strong." Expects operating margin improvement of 200bps y/y. Comments taken from Q3 earnings conference call.
SPSC CHRW

Hot Stocks

09:02 EDT SPS Commerce, C.H. Robinson collaborate on streamlined carrier service - SPS Commerce (SPSC) and C.H. Robinson (CHRW) announced a collaboration just in time to help omnichannel retail businesses navigate a busy holiday season and challenging supply chain conditions. The collaboration will make their shipping process easier, more cost-effective and faster by connecting SPS Commerce Fulfillment's Carrier Service LTL directly into C.H. Robinson's Navisphere(R) platform, which unlocks access to the largest less-than-truckload network in North America and competitive rates for more than 95,000 retail suppliers. The new Carrier Service LTL solution from SPS Commerce allows suppliers to instantly view rates across multiple carriers, schedule pickups and book shipments, with automatic access to C.H. Robinson's unmatched LTL carrier network to ensure they get the best pricing available. Additionally, as suppliers book a shipment, it automatically triggers the creation of the bill of lading documents and shipping labels and populates tracking details into the shipping notice to inform the retailer of the pending delivery.
PG

Hot Stocks

09:00 EDT Procter & Gamble 'not immune' to stress put on supply chain globally
OCGN

Hot Stocks

08:52 EDT Ocugen to present preclinical data for OCU410 - Ocugen announced that its head of Research and Development, Arun Upadhyay, PhD, will present pre-clinical data demonstrating how the company's second modifier gene therapy candidate, OCU410, could potentially be an effective therapeutic for Dry Age-related Macular Degeneration, dry AMD. The presentation will showcase how the use of a specific nuclear hormone receptor called RORA presents a unique opportunity to treat people with Dry AMD. RORA plays a central role in many physiological activities, including lipid metabolism, oxidative stress, regulation of Th17 cells, the reduction of inflammation, and obesity. In his presentation, "OCU410: A Novel Modifier Gene Therapy Product using a Multi-Factor Approach for Dry AMD," Dr. Upadhyay will show evidence highlighting how influencing the RORA receptor can attack several underlying factors of this serious blindness disease. OCU410 is the second drug candidate from Ocugen's Modifier Gene Therapy Platform, which is expected to enter clinical trials in 2022.
STIM

Hot Stocks

08:50 EDT Neuronetics launches upgrades of NeuroStar Advanced Therapy - Neuronetics announced the release of the latest evolution of their NeuroStar Advanced Therapy system with upgraded equipment and features. In addition to a refreshed look, the NeuroStar and TrakStar enhancements will allow healthcare professionals (HCPs) to streamline their ability to treat more patients. "This advancement of the NeuroStar Advanced Therapy system underscores our commitment to our NeuroStar providers, their patients, and our mission to transform neurohealth and depression," said Keith Sullivan, President and CEO of Neuronetics Inc. "Our new TrakStar updates will simultaneously simplify the process and improve the usability for providers so more of their patients can benefit from NeuroStar treatment, a proven method to help people who are living with depression." Included in the update is an improved motor threshold algorithm, Fast MT, which reduces the number of steps to determine the recommended MT level, one of the key treatment settings. Clinicians can also automate the treatment pulse ramping profile with SoftStart, which allows HCPs to easily add or remove a sequence of pulses during a treatment session to ramp to the prescribed treatment level.
XELA

Hot Stocks

08:50 EDT Exela Technologies reports SMB user growth for DMR, DrySign - Exela Technologies announced that its Digital Mailroom and DrySign offerings delivered another strong quarter of new customers and users respectively in the third quarter of 2021. DMR expanded its SMB customer base by 71% and DrySign expanded its user base by 47%, as compared to the prior period. "We are pleased to see the overall increase in new customers and users and are excited to see an acceleration in signups as the back to school season began. In lockstep with user growth, we are on track to enhance our digital offering with a proprietary remote notarization module which will not only help onboard DMR customers faster, but be offered as a standalone solution to anyone wishing to notarize online," said Exela's president, Suresh Yannamani.
HUBG

Hot Stocks

08:48 EDT Hub Group announces acquisition of Choptank Transport - Hub Group announced that it acquired Choptank Transport, a provider of non-asset refrigerated transportation solutions. "The acquisition bolsters Hub Group's presence in the refrigerated transportation space and adds a complementary offering to serve its customers' multimodal transportation and logistics needs," the company said. The acquisition enhances Hub's over-the-road refrigerated transportation solutions offering, and complements its growing fleet of 450 refrigerated intermodal containers. Hub Group intends to further invest in its refrigerated transportation offering by purchasing 550 refrigerated intermodal containers in 2022, bringing the size of its fleet to 1,000. In addition to its expansive carrier network, Choptank's 400 employees will join Hub Group. The company has developed a best-in-class proprietary technology platform that Hub will leverage to enhance its Brokerage operation. Cash consideration for the transaction of $130M was funded by cash on hand. In connection with the acquisition Hub Group granted contingent compensation to the owners and senior management team of Choptank to incentivize their retention and drive continued growth of the business.
HLIO

Hot Stocks

08:48 EDT Helios Technologies to transfer listing to NYSE from Nasdaq - Helios Technologies announced that it is transferring the listing of its common stock to the New York Stock Exchange from Nasdaq. Helios expects to commence trading on the NYSE at market open on November 1, under the same ticker symbol (HLIO). The company will continue to trade on the Nasdaq until the transfer is completed.
PG

Hot Stocks

08:47 EDT Procter & Gamble expects pricing to be larger contributor to sales growth
SBET

Hot Stocks

08:46 EDT SharpLink Gaming integrates SharpLink's C4 sports betting conversion - SharpLink Gaming announced that SportsHub Games Network has integrated SharpLink's pioneering C4 Sports Betting Conversion technology with its NFC High Stakes and Fanball Daily Fantasy Sports gaming websites to proactively engage and convert its fantasy game players into sports bettors in states where online betting has been legalized. SportsHub is a trusted industry leading game content provider that distributes real money fantasy sports games and contests through its popular SportsHub Games Network. The integration of the C4 platform with Fanball and NFC High Stakes provides for the linking of the sites' fantasy gamers, located only in legal sports gaming states, with real-time bet offers from sportsbook partners. SportsHub and SharpLink have signed a revenue-share agreement providing for division of affiliate marketing services fees generated by conversion of Fanball and NFC High Stakes players to bettors on the sportsbook partners platform. SharpLink CEO Rob Phythian noted, "Given our close working ties to SportsHub, a major shareholder in SharpLink, it provides SharpLink with an ideal proving ground from which to gain real-time, actionable insight on the operation and performance of our C4 Betting Conversion platform. Moreover, SportsHub's fantasy gaming web properties provides us direct access to a large and growing audience of fantasy game players from which to glean deep behavioral data and user intelligence that we can then leverage and apply in our marketing strategies to educate sportsbooks and sports media operators on the underpinning value proposition inherent in our game-changing C4 technology."
PG

Hot Stocks

08:46 EDT Procter & Gamble sees repurchasing $7B-$9B of common shares in FY22 - Expects to pay over $8B in dividends.
PG

Hot Stocks

08:44 EDT Procter & Gamble sees 'rough patch' from bottom line standpoint
AREC

Hot Stocks

08:44 EDT American Resources to restart Wyoming County Coal mining complex - American Resources Corporation announced that it commenced engineering and planning for the restart of its wholly owned Wyoming County Coal mining complex, near the town on of Oceana, West Virginia. The complex is unique in that it is one of the last fully permitted complexes accessing premium, "mid vol" metallurgical carbon for steel production. Thomas Sauve, President of American Resources Corporation commented, "We acquired Wyoming County Coal in late 2018 for approximately $20 million due to its access of the world's most premium steelmaking carbon and potential for attractive growth and substantial margin. Now that we have re-activated two of our Kentucky complexes, McCoy Elkhorn and Perry County Resources, it makes complete sense to now focus on planning and development of our Wyoming County complex, given the substantial price appreciation of this product in the market since our acquisition. We have recently been approached by numerous parties that desire to work with us on carbon production from this complex given the growing demand of the market, the expectations of prolonged, constrained supply and the fundamental long-term horizon for this quality of metallurgical carbon. Additionally, we feel this complex offers significant value for us based on our owned assets and controlled premium reserves, but it also offers substantial potential value given the vast number of nearby, stranded reserves that could be acquired or strategically folded into the complex given its processing and logistics capabilities."
KKR

Hot Stocks

08:44 EDT KKR purchases KMR Music Royalties II portfolio for $1.1B - KKR and Kobalt Capital announced that KKR, together with its co-invest partner, Dundee Partners, the investment office of the Hendel family, have purchased the KMR Music Royalties II portfolio from KCL for approximately $1.1B. The portfolio is comprised primarily of music publishing copyrights for established works and includes a diverse collection of over 62,000 copyrights by artists and songwriters across genres. Kobalt Music Publishing will continue to administer and service the works in Fund II under a multi-year agreement. The transaction has been completed by Chord Music Partners, a platform established by KKR with Dundee Partners. KKR will also contribute other music assets purchased over the past year to Chord, positioning the platform as owner of a portfolio of music rights.
MGTX

Hot Stocks

08:43 EDT MeiraGTx announce the presentation of two IRD programs, gene regulation platform - MeiraGTx announced three poster presentations at the European Society of Gene and Cell Therapy 2021 Annual Congress. Two pre-clinical programs addressing Inherited Retinal Diseases, or IRD, caused by mutations in KCNV2 and GUCY2D are presented with data supporting the development of these viral vectors as gene therapies. A third presentation outlines MeiraGTx's proprietary gene regulation platform demonstrating tight regulation of gene expression to high dynamic range in mammalian cells and precise regulation in vivo in response to dosing of an oral small molecule. MeiraGTx continues to anticipate up to two new INDs for novel viral vectors addressing IRDs in 2022. "Novel riboswitches regulate AAV delivered transgene expression in mammals via small molecule inducers." MeiraGTx presents a potent gene regulation platform based on rationally designed synthetic riboswitches built in mammalian cells.This platform regulates protein expression with high dynamic range and allows precise control of transgene expression levels. This regulation platform has been demonstrated to work in multiple genes, multiple cell types in vitro and in vivo. MeiraGTx's potent gene regulation system provides a platform for using unique aptamer-ligand pairs to regulate genes in mammals. This platform enables precise temporal and spatial control of gene expression, expanding the range of possibilities for using gene-based vectors as therapies. "KCNV2 retinal organoid disease model for KCNV2 AAV gene therapy development." Assessment of potential AAV gene replacement therapies for KCNV2 mutations demonstrates that AAV-KCNV2-mediated gene therapy is a promising approach to the treatment of patients with cone-dystrophy due to KCNV2 mutations. CRISPR/Cas9 gene editing was used to generate human KCNV2 Knockout and isogenic human control retinal organoids. All vectors tested successfully delivered the hKCNV2 gene to photoreceptors in retinal organoids following transduction, restoring protein expression in the correct subcellular location as well as native protein-to-protein interactions. "GUCY2D retinal organoid disease model for AAV gene therapy development." Assessment of potential AAV gene replacement therapies for GUCY2D mutations demonstrates that AAV-GUCY2D gene therapy constitutes a promising treatment for patients with cone-rod dystrophy due to GUCY2D mutations. Four AAV vectors, packaged into 7m8 capsids, were designed to enable the restoration of GUCY2D-mediated signaling in photoreceptor outer segments via gene replacement. These results indicate that gene replacement in GUCY2D-deficient human retinal organoids restored protein expression and cGMP levels in transduced organoids. This provides support for the potential use of AAV-mediated GUCY2D gene supplementation as a treatment for patients with inherited retinal dystrophy caused by mutations in GUCY2D.
BIG

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08:43 EDT Big Lots parnets with DailyPay - Big Lots partnered with DailyPay to offer Big Lots' 35,000 store and distribution center associates instant access to earned income. This new program comes for the holiday season when Big Lots expects to onboard 15,000 employees to accommodate its "BIGionaire" shoppers during retail's biggest season. DailyPay is a platform that enables employees to access or save their pay as they earn it, without having to wait for a traditional payday.
IIVI

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08:42 EDT II-VI powers all European sites with 100% renewable electricity - II-VI announced that it is powering all its facilities in Europe with 100% renewable electricity sources. The renewable electricity is supplied to II-VI's manufacturing operations, research and development sites, and sales offices throughout six European countries, encompassing 615,000 square feet, or 57,000 square meters, of facility space across 12 sites. To power its footprint across Europe, II-VI is purchasing approximately 38 million kilowatt-hours per year of renewable electricity, and thereby eliminating about 5,800 metric tons of CO2 emissions each year. Globally, II-VI has entered into renewable-electricity contracts for 24 sites, including 14 of them now covering 100% of their annual electricity usage from renewable sources. Over 20% of II-VI's global electricity needs are now being supplied by renewable sources across the U.S. and Europe. The percentage of renewable electricity powering II-VI's operations is expected to grow annually and, in the future, include the company's major manufacturing sites in Asia.
PG

Hot Stocks

08:41 EDT Procter & Gamble: Cost, operational challenges 'not unique to P&G'
HUGE

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08:41 EDT FSD Pharma in pact with Covar for development of Lucid-PSYCH - FSD Pharma announced it has entered into an agreement with Covar Pharmaceuticals to commence work on providing research quantities of FSD's drug candidate, Lucid-PSYCH, on an exclusive basis for further clinical evaluation. A psychoactive compound, Lucid-PSYCH, formerly Lucid-201, has been selected by FSD to advance its research into the treatment of major depressive disorders based on analysis of the drug candidate's pharmaceutical and metabolic properties processed via machine learning algorithms, as well as for its potential proprietary position. "This agreement with Covar continues our momentum in completing advanced preclinical studies and scale-up activities," commented Anthony Durkacz, Interim CEO of FSD Pharma. "This potentially sets the stage for us to achieve our goal of moving Lucid-PSYCH from bench to clinic by obtaining IND approval and initiating a Phase 1 clinical study."
TRU

Hot Stocks

08:41 EDT TransUnion announces $400,000 commitment to advance financial inclusion - More than one billion people around the world today are considered "credit invisible" or "credit disadvantaged," unable to access financial products and services because they have little or no credit. As a global information and insights company committed to financial inclusion, TransUnion is announcing a $400,000 donation to Credit Builders Alliance to help underrepresented consumers in the United States build credit - a prerequisite to participating in the mainstream financial system.
PHUN

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08:39 EDT Phunware closes acquisition of Lyte Technology - Phunware announced it has formally closed the acquisition of privately-held Lyte Technology. The Company financed the closing consideration of $3.32 million with cash on-hand and unsecured, non-dilutive debt. The company said, "Founded in 2018, Lyte is a profitable, rapidly-growing system integrator that specializes in marketing and distributing custom, high-end computer systems off-the-shelf with advanced graphic processing units for gaming, streaming and cryptocurrency mining. Currently located in Illinois, Lyte employs over 25 people and ships thousands of computer systems per quarter to a unique customer network that has largely grown through word-of-mouth." The total consideration for the acquisition consisted of cash and Company common stock valued at up to approximately $10.98 million, a portion of which is characterized as an earn-out payment contingent upon Lyte generating at least $12.00 million in net revenues for the one-year period post-closing. No Company common stock was issued at closing. Lyte enables Phunware to enter the high performance personal computer market, which JPR estimates is a $32 billion USD market that is expected to grow at a 20.4% CAGR over the next five years. Complementary and synergistic go-to-market strategies exist, with no overlap in the companies' relevant partner or customer bases. Lyte's customers represent gamers, developers, content creators and crypto enthusiasts who will support the adoption, scale and infrastructure required for Phunware to deploy its decentralized data economy powered by PhunCoin and PhunToken. For the fourth quarter of fiscal 2021, Phunware expects to report net revenues exceeding $5.00 million. Phunware financed the acquisition with a combination of existing cash on-hand and unsecured debt. Phunware issued a Promissory Note to Streeterville Capital, LLC, borrowing $5.22 million at 0% interest with a 12-month maturity date. Beginning in January 2022, the Company will make equal monthly payments on the outstanding principal. Monthly payments will be made in cash and are subject to a 10% payment premium. In conjunction with closing the Note, the Company received net cash proceeds of $4.74 million. Joseph Gunnar & Co., LLC, served as placement agent for the transaction.
UP...

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08:38 EDT Wheels Up appoints Srikanth Satya as Chief Technology and Development Officer - Wheels Up (UP) announced that Srikanth Satya has joined the Company as Chief Technology and Development Officer. This latest announcement is the third noteworthy technology appointment in the past month for the Company. Satya joins Wheels Up at a pivotal time, with its ongoing digital and marketplace transformation strategy accelerating the overall growth strategy for the organization. Satya comes to Wheels Up after two decades of experience leading technology innovation at Amazon (AMZN), Microsoft (MSFT), and Dell EMC. He brings over 20 years of technology leadership experience, including co-formulating strategies and launching company- and industry-first products in big data analytics, object storage, real-time streaming, messaging systems and container platforms. He is recognized for building large scale distributed cloud services and products for Global Fortune 100 companies. In addition, Satya's vision to set new business directions resulted in the release of foundational products for Amazon Web Services and Dell EMC moving from a storage provider to a modern data platform supplier.
GNSS

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08:38 EDT Genasys announces Zonehaven evacuation contracts with 13 California counties - Genasys announced that 13 California counties have each entered into multi-year Zonehaven software services and evacuation management contracts. First responders, emergency services agencies and the more than 6.9M residents living in Alameda, Contra Costa, Humboldt, Lake, Marin, Napa, Nevada, San Mateo, Santa Clara, Santa Cruz, Sierra, Sonoma and Yuba counties now have access to Zonehaven's critical evacuation planning, alerting and real-time life safety information. "Our Zonehaven software services and evacuation management platform transforms the entire evacuation process by empowering first responders and emergency services agencies with essential tools to plan, train for and execute timely evacuations and orderly repopulations," said Richard S. Danforth, Chief Executive Officer of Genasys Inc. "Know Your Zone awareness campaigns provide public safety resources that better prepare residents and businesses for evacuations and emergency events through the community.zonehaven.com webpage." Over the last two years, the Zonehaven evacuation platform was utilized in California during many major wildfires, including Antelope, Beckworth Complex, Bennett, CZU Lightning Complex, Cache, Coyote, Dixie, Fly, Glass, Glen, Lava, McCash, River Complex and Tenant, as well as local fires. Zonehaven also supported evacuations for active shooter and debris flow hazards across multiple jurisdictions.
MECVF

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08:36 EDT mdf Commerce implements k-ecommerce solution for UAP Heavy Vehicle - mdf commerce announced the implementation of its k-ecommerce ERP-integrated ecommerce solution for UAP Heavy Vehicle, a division of UAP Inc. This implementation highlights that mdf commerce solutions can meet the ecommerce needs of businesses of all sizes in a wide variety of sectors, helping increase overall efficiency, improve user experience and ultimately aiming at increasing sales and generating operational savings. The k-ecommerce ERP-integrated ecommerce solution that was implemented for UAP Heavy Vehicle provides its customers with a high-performing webstore designed both for B2B and D2C users. While this helped build UAP Heavy Vehicle customers' confidence, thanks to an improved user experience and the ability to order 24/7, it also alleviated pressure on the division's call centre. The k-ecommerce solution is purpose-built to easily integrate with a wide variety of ERPs, thereby allowing clients to leverage existing technology ecosystems and ensure a fully integrated digital environment.
EJH

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08:36 EDT E-Home subsidiary excercises option for 100% equity interests of two VIEs - E-Home Household Service Holdings announced that its indirectly wholly owned Chinese subsidiary, E-Home Household Service Technology has exercised the options to acquire 100% equity interests of each of Fuzhou Bangchang Technology and Pingtan Comprehensive Experimental Area E Home Service, two variable interest entities, or VIEs, of the Company from the shareholders of the VIEs. Wenshan Xie, the Chairman and CEO of the Company, beneficially owns more than 50% of each of the VIEs.
CACI

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08:35 EDT CACI gets $4.9M program deal from USAF lab for multi-spectral laser technology - CACI International announced that the U.S. Air Force Research Laboratory at Wright-Patterson Air Force Base, Ohio AFRL awarded CACI a 15-month, $4.9M program to advance high-power multi-spectral laser technology in support of improved electro-optical sensors for a variety of military missions. Under the contract, CACI scientists and engineers will develop a high-power laser prototype that emits light over a very broad range of wavelengths in the optical spectrum, spanning a range that goes from the UV spectrum, through the visible spectrum, and into the Short-Wavelength Infrared SWIR. John Mengucci, CACI President and Chief Executive Officer, said, "We are seeing a strong demand for high-performance lasers that support enhanced functionality for remote sensing systems. Our technology will continue to advance the state of the art with programs like this and bring best-in-class solutions for the Air Force's current and future needs."
VYNT

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08:35 EDT Vyant Bio, MASORI therapeutics announce new partnership - MASORI Therapeutics and Vyant Bio announced they entered into an agreement to pursue co-development and out-licensing partnerships with pharmaceutical and biotechnology companies. MASORI Therapeutics combines healthcare and digital expertise that enables life sciences companies to leverage artificial intelligence, machine-learning, and virtual reality to achieve brand growth and better analysis, targeting, and execution. The company's work with Vyant Bio will initially focus in Japan and will center on providing key insights into the application and intersection of their technologies to accelerate partnership-based therapeutic discovery and development. "Partnerships are central to scientific advancement, and for patients with CNS and oncology diseases, time is of the essence to uncover new treatments as quickly as possible," said Jay Roberts, president and chief executive officer of Vyant Bio. "Our relationship with MASORI Therapeutics will identify and drive drug development partnerships that leverage our capabilities to accelerate the discovery and delivery of such treatments."
POAI

Hot Stocks

08:33 EDT Predictive Oncology launches website on AI-powered cancer research advancements - Predictive Oncology launched a website that emphasizes its role in advancing its mission. The website features information about Predictive Oncology and its subsidiaries, Helomics, Soluble Biotech and TumorGenesis which are all integral to the overarching goal of eliminating cancer by predicting treatment outcomes and aiding in the development and optimization of cancer drugs.
PG

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08:33 EDT Procter & Gamble: Earnings growth should improve sequentially - Earnings growth should improve sequentially through balance of year, P&G said on its Q1 earnings conference call.
EHC

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08:33 EDT Encompass Health and Baptist Health to build inpatient rehabilitation hospital - Encompass Health and Baptist Health announced they have received a certificate of need to build and operate a 40-bed inpatient rehabilitation hospital in Louisville, KY. The hospital is expected to operate as a joint venture between Encompass Health and Baptist Health. The parties anticipate the future hospital will be located near the intersection of Blankenbaker Parkway and Bluegrass Parkway in Jeffersontown and will replace Baptist Health's 29-bed unit currently located on the Baptist Health Louisville campus. The new hospital is expected to begin providing inpatient rehabilitation services in the Q4 of 2023.
SGRP

Hot Stocks

08:33 EDT SPAR Group expands distribution staffing services business - SPAR Group reported an investment in a larger team and resources to provide expanded distribution center staffing services to retailers and consumer goods companies. "The accelerated growth of online sales has increased demand for distribution center resources. With many years of experience providing services to merchants, we are expanding our business to serve clients in both stores and distribution centers - everywhere they need us," said William Linnane, Chief Strategy and Growth Officer. "We have been working in distribution centers for the last several years, but we recognize the new market need and focus; and have expanded our US capacity and operational leadership. Whether it's a special project, eCommerce omni-channel fulfillment or seasonal needs, we have resources to help."
JUPW

Hot Stocks

08:33 EDT Jupiter Wellness doses first patient in first degree burns study - Jupiter Wellness announced the enrollment and dosing of the first patient in the study. The double-blinded placebo-controlled study will enroll 50 patients with newly diagnosed first degree burns of superficial partial thickness on 10% or less of the patient's total body surface area. The primary endpoint is time to full re-epithelialization of the wound. This is an investigational international study with a protocol similar to a FDA Phase I study.
SF

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08:33 EDT Stifel Financial appoints Mark Kelley as managing director, senior analyst - Stifel Financial announced that Mark Kelley has joined the firm as a Managing Director and Senior Equity Research Analyst covering the internet sector. He is based in the firm's Chicago office. Mr. Kelley has been covering internet companies as a senior analyst since 2015 and joins Stifel from Walleye Capital, a multi-strategy hedge fund.
CLVR

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08:32 EDT Clever Leaves partners with PharmaLab PHL Laboratories - Clever Leaves Holdings announced the commercial commencement of a partnership with Pharmalab PHL Laboratories in Colombia. Pharmalab is a Colombian healthcare group specializing in the commercialization and distribution of medicines, dietary supplements and cosmetics. Pursuant to the partnership, Clever Leaves will supply pharmaceutical-grade cannabinoid formulations to Pharmalab for the distribution of magistral medications in Colombia, which are used to treat painful and inflammatory pathologies. The partnership was made possible by President Ivan Duque Marquez's recent signing of a new Decree allowing drugstores to distribute and sell magistral medicinal cannabinoids in Colombia, marking a major step towards fulfilling the unmet needs of Colombian patients.
GRWG

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08:31 EDT GrowGeneration announces strategic investment in Total Grow Control - GrowGeneration announced a strategic investment in Total Grow Control, a Houston-based controlled environment agriculture, or CEA, engineering and manufacturing company specializing in facility design, nutrient delivery systems, water filtration solutions, and a complete integrated control platform operated from a cloud-based user interface.. As part of the transaction, GrowGen has the right to exercise an option to purchase 100% of the assets of Total Grow Control. Total Grow Control's programmable control systems and software help growers automate their operations for efficiency, consistency, and uniformity. Total Grow Control's signature offering, the Eden Environmental Control System, offers a comprehensive and easy-to-use customer interface that communicates with new and existing atmospheric controls and lighting systems.
NXTC

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08:31 EDT NextCure announces three new members of its SAB - NextCure announced the appointments of Elizabeth Jaffee, M.D., Ursula Matulonis, M.D., and Weiping Zou, M.D., Ph.D., to its Scientific Advisory Board, or SAB. Ethan Shevach, M.D., will retire from the SAB. Drs. Lieping Chen, M.D., Ph.D., Mario Sznol, M.D., and Stephen Miller, Ph.D., will continue to serve on the SAB. Elizabeth Jaffee is Deputy Director of the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, the Dana and Albert "Cubby" Broccoli Professor of Oncology at Johns Hopkins University and an international leader in immune based therapies. Ursula Matulonis is Chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. Weiping Zou is the Charles B. de Nancrede Professor; Professor of Pathology, Immunology, Biology and Surgery; Director of the Center of Excellence for Cancer Immunology and Immunotherapy; and Co-Director of the Cancer Hematopoiesis and Immunology Program at the University of Michigan School of Medicine and Rogel Cancer Center.
SYF

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08:29 EDT Synchrony sees Q4 net interest margin consistent with Q3 - Says spend per active Synchrony Mastercard account is up 40% from 2019. Says expects continued purchase volume strength into holiday season. Sees sequential modest loan receivables acceleration. Sees Q4 net interest margin consistent with Q3. Sees slight sequential increase in operating expense. Says expects RSA as percent of average loans receivable to moderate. Comments taken from Q3 earnings conference call.
BTCS

Hot Stocks

08:28 EDT BTCS adds Cosmos to blockchain infrastructure operations - BTCS announced the ongoing expansion its blockchain infrastructure segment with the addition of Cosmos, a $7 billion interoperable blockchain platform that connects large numbers of independent blockchains within the Cosmos network. BTCS has deployed its own node which is generating revenue by validating transactions on the Cosmos blockchain.
ENNV

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08:27 EDT HellermannTyton leverages Fast Radius' cloud manufacturing platform - Fast Radius is working with HellermannTyton to manufacture new wire routing aids for the automotive industry. HellermannTyton uses Fast Radius' Cloud Manufacturing Platform to produce cable management products allowing their customer, a Tier 1 automotive OEM, to bring a new vehicle to market. The company said, "The pivot from traditional manufacturing processes to additive manufacturing enables HellermannTyton to save approximately $1MM in project costs and eight weeks of lead time."
DTEA LBLCF

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08:27 EDT DavidsTea extends product offering in select Loblaw locations - DAVIDsTEA (DTEA) announces that it is expanding its agreement with Loblaw Companies (LBLCF), enhancing its offering in communities across the Atlantic provinces, Ontario, Manitoba, Saskatchewan, Alberta and British Columbia, with new products now available in Real Canadian Superstore and Atlantic Superstore locations. Select DAVIDsTEA products are available in over 1,250 Loblaw grocery and pharmacy storefronts across Canada. "DAVIDsTEA is excited to further strengthen its relationship with Canada's food and pharmacy leader, allowing us to offer our customers access to an even broader selection of our high-quality teas," said Sarah Segal, Chief Executive Officer and Chief Brand Officer, DAVIDsTEA. "We want Canadians to know how easy it is to enjoy loose leaf tea, and we aim to do this by increasing DAVIDsTEA's presence on retail shelves nationwide with standout flavours in loose leaf tea, and unique matcha options," she added. DAVIDsTEA has added an assortment of flavours in loose-leaf tins and fruity matcha single-serves to Loblaw's existing assortment of DAVIDsTEA sachet product selection. The new loose-leaf offer features five of DAVIDsTEA's most popular flavours, including Blood Orange Boost, Headache Halo, Valerian Nights, Vanilla Cappuccino, and the iceable favourite Frozen Raspberry.
BIOYF

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08:26 EDT Biosyent announces launch of FeraMAX Pd Powder 15 - BioSyent announced the launch of FeraMAX Pd Powder 15 by its subsidiary, BioSyent Pharma Inc., in Canada. FeraMAX Pd Powder 15 is the second product incorporating Polydextrose-Iron Complex, a patented oral iron supplement delivery system. In November 2020, BioSyent Pharma Inc. launched FeraMAX Pd Therapeutic 150, the first product using the PDIC formulation in Canada.
AYRWF

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08:25 EDT Ayr Wellness receives noteholder consent for amendment to trust indenture - Ayr Wellness announced that it has received the requisite consent of holders of its 12.5% senior secured notes due 2024 for the proposed amendment to the trust indenture governing the Notes. As announced on October 1, 2021, a meeting of Noteholders was scheduled for October 26, 2021. However, as Noteholders representing a majority of the principal amount of the outstanding Notes delivered valid consents in favor of the proposed amendment by 4:00 p.m. on October 18, 2021, the resolution approving the proposed amendments has been passed and the meeting has been cancelled. The amendment is described in the joint notice of meeting and consent solicitation statement and accompanying management information circular which was filed on SEDAR on October 1, 2021. As described in the Circular, Noteholders who responded to the Consent Solicitation and provided consent will receive a consent fee of US$0.25 for each $1,000 principal amount of Notes. The amendment to the trust indenture will be filed on SEDAR following its execution.
SWM

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08:23 EDT Scape Healthcare business signs technology licensing agreement with Synedgen - Scapa Healthcare, an SWM International business, and Synedgen announced that they have signed an exclusive worldwide licensing agreement for two novel innovative wound care treatments developed using Synedgen's proprietary glycochemistry technology platform. The agreement also gives Scapa Healthcare the right to use Synedgen's glycopolymer technology in conjunction with other wound care technologies. Under the terms of the agreement, Scapa Healthcare has exclusive rights over Synedgen's glycopolymer technology in the field of dermal wounds and surgical care applications both over the counter and in the professional setting. The glycopolymer-based wound cleanser and wound hydrogel formulae are proven to control infection and promote wound healing by limiting bacterial infection, disrupting mature biofilm, and reducing inflammation and scarring of acute and chronic wounds and surgical incisions. "We are delighted to be entering into this agreement with Synedgen, a company that shares our commitment to deliver innovative medical solutions that truly enhance people's lives" said John Petreanu, president of the Scapa Healthcare business. "This novel glycopolymer technology strengthens our portfolio of advanced wound care products and enables us to bring cutting-edge wound management solutions to our customers in a variety of formats leveraging our skin contact adhesive and topical technologies."
AVDL

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08:22 EDT Avadel Pharmaceuticals presents new data from Phase 3 REST-ON trial of FT218 - Avadel Pharmaceuticals announced new data from the completed pivotal Phase 3 REST-ON clinical trial of FT218, also known as ON-SXB. The post-hoc data are being presented in as two separate posters at the American College of Chest Physicians annual meeting, taking place virtually October 17 - 20, 2021, along with the results of a discrete choice experiment to understand patient preference. FT218 is the Company's lead drug candidate, an investigational formulation of sodium oxybate designed to be taken once at bedtime for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy. FT218 is currently under review at the U.S. Food and Drug Administration. Sleep Latency Response with FT218, a Once-Nightly Sodium Oxybate: Post-Hoc Responder Analyses from the Phase 3 REST-ON Clinical Trial. ON-SXB treatment was associated with statistically significant improvements compared to placebo on mean sleep latency in the Phase 3 REST-ON clinical trial: a significantly greater proportion of participants who received ON-SXB compared to placebo experienced increased mean sleep latency change from baseline. Improvement was evident as early as week 3 at the 6-g dose and increased with the 7.5-g dose at week 8 and the 9-g dose at week 13. The most common adverse drug reactions with ON-SXB 9 g were enuresis, dizziness, and vomiting. Cataplexy Response with FT218, a Once-Nightly Sodium Oxybate: Post-Hoc Responder Analyses from the Phase 3 REST-ON Clinical Trial. ON-SXB treatment was associated with statistically significant improvements compared to placebo on the number of weekly cataplexy episodes, as shown by the results of the pivotal Phase 3 REST-ON clinical trial: A significantly greater proportion of participants treated with ON-SXB compared to placebo experienced 25%, 50% and 75% reductions in the number of weekly cataplexy episodes with once-at-bedtime doses of 6, 7.5, and 9 g. Of participants taking the two highest doses of ON-SXB, approximately 10% had complete elimination of their cataplexy, while approximately half had a 50% reduction and one-third had a 75% reduction in their weekly cataplexy episodes. The most common adverse drug reactions with ON-SXB 9 g were enuresis, dizziness, and vomiting. The Utility of Discrete Choice Experiment in Evaluating Treatment Preferences Among Patients with Narcolepsy. A discrete choice experiment evaluated drivers of patient preference for sodium oxybate and demonstrated that dosing frequency was the single most important attribute of a narcolepsy treatment, with once-nightly dosing significantly more preferred than twice-nightly dosing. The number of nightly doses was also the most important driver observed of "taking the medication exactly as directed" and "reduced anxiety/stress", with once-nightly dosing preferred over twice-nightly dosing.
RNGTF

Hot Stocks

08:21 EDT Osisko Development announces drilling results from Cariboo project - Osisko Development is pleased to announce drilling results from the 2021 exploration and category conversion drill program campaign at its Cariboo Gold Project in central British Columbia. A total of 6 diamond drill rigs are currently active on the Project. A total of 147,000 meters have been drilled thus far in 2021, of which 10,000 meters were drilled at Mosquito and 58,000 drilled at Shaft. Recent assay results include holes IM-21-087 to IM-21-101 from Mosquito and Shaft Zones on Island Mountain. IM-21-089 intersected 20.40 g/t Au over 6.55 meters at Shaft Zone and included high grade samples of 92.30 g/t Au over 0.60 meter, 50.70 g/t Au over 0.60 meter, 28.10 g/t Au over 0.60 meter and 22.40 g/t Au over 1.25 meters. IM-21-090 tested both Shaft and Valley Zones, intersected multiple mineralized vein corridors in both zones including 48.10 g/t Au over 2.40 meters with 117.0 g/t Au over 0.90 meter on the Shaft Zone and 5.50 g/t Au over 12.25 meters including 54.5 g/t Au over 0.90 meter on the Valley Zone. Assay Highlights: 15.48 g/t Au over 3.40 meters in hole IM-21-088 including 28.80 g/t Au over 0.80 meter; 20.40 g/t Au over 6.55 meters in hole IM-21-089 including 92.30 g/t Au over 0.60 meter and 50.70 g/t Au over 0.60 meter; 48.10 g/t Au over 2.40 meters in hole IM-21-090 including 117.00 g/t Au over 0.90 meter; 5.50 g/t Au over 12.25 meters in hole IM-21-090 including 54.50 g/t Au over 0.90 meter; 97.40 g/t Au over 0.50 meter in hole IM-21-092; 63.40 g/t Au over 0.50 meter in hole IM-21-092; 9.85 g/t Au over 5.80 meters in hole IM-21-093 including 37.80 g/t Au over 1.15 meters; 8.27 g/t Au over 6.30 meters in hole IM-21-097; 34.03 g/t Au over 1.00 meter in hole IM-21-097 including 48.70 g/t Au over 0.50 meter; 49.40 g/t Au over 0.80 meter in hole IM-21-097; 35.68 g/t Au over 2.25 meters in hole IM-21-097 including 155.50 g/t Au over 0.50 meter; 6.23 g/t Au over 6.50 meters in hole IM-21-097 including 30.50 g/t Au over 1.00 meter; 16.39 g/t Au over 2.70 meters in hole IM-21-098 including 52.60 g/t Au over 0.50 meter; 7.61 g/t Au over 4.15 meters in hole IM-21-101. Vein corridors are defined as a high-density network of mineralized quartz veins within the axis of the last folding event and hosted within a brittle meta-sandstone or calcareous meta-sandstone. Vein corridors are modelled at a minimum thickness of 2 meters and average about 4.5 meters true width. Individual mineralized veins within these corridors have widths varying from centimeters to several meters and strike lengths from a few meters to over 50 meters. These corridors have been defined from surface to a vertical depth averaging 300 meters and remain open for expansion at depth and along strike. Gold grades are intimately associated with quartz vein-hosted pyrite as well as pyritic, intensely silicified wall rock haloes in close proximity to the veins. True widths are estimated to be 60% to 75% of reported core length intervals. Intervals not recovered by drilling were assigned zero grade. Top cuts have not been applied to high grade assays.
EDSA

Hot Stocks

08:20 EDT Edesa says EB05 demonstrated mortality reductions in multiple patient groups - Edesa Biotech announced additional results from the Phase 2 part of an ongoing Phase 2/3 clinical study evaluating the company's monoclonal antibody candidate, designated EB05, as a single-dose treatment for hospitalized COVID-19 patients. The Phase 2 data were preemptively unblinded last month by the study's Data and Safety Monitoring Board DSMB due to a clinically important efficacy signal detected among the most critically ill patients. Since then, the analysis of the results has continued in other patient groups. Edesa believes EB05 regulates the overactive and dysfunctional immune response associated with Acute Respiratory Distress Syndrome ARDS - the leading cause of death in COVID-19 patients. Edesa reported that EB05 demonstrated mortality reductions in multiple patient groups beyond the initial findings, which showed that critically ill hospitalized patients treated with EB05 + Standard of Care treatment SOC had a 68.5% reduction in the risk of dying when compared to placebo + SOC at 28 days. Additional efficacy signals have also been identified. Due to the lack of treatments available to critically ill patients and the clinically meaningful impact observed with respect to 28-day mortality, the company has decided to focus on this patient segment for the Phase 3 portion of the study. Edesa may also advance other subgroups of patients into Phase 3 at a later time. Michael Brooks, PhD, President of Edesa, said that this approach could substantially reduce the number of additional patients needed for the Phase 3 study and put the company in the position to potentially file for its first marketing authorization application sooner than anticipated. "The Phase 2 part of the study met its primary objective of identifying efficacy signals among the various patient stratifications. We are excited to see supportive efficacy signals across multiple patient segments. We plan to continue forward into the Phase 3 study prioritizing critically ill patients and are evaluating the most efficient way to utilize the existing dataset to support future regulatory filings, trials and applications," said Dr. Brooks.
GRVI

Hot Stocks

08:17 EDT Grove board approves up to 1M share repurchase authorization - Grove announced that its Board of Directors authorized a share repurchase program for up to 1 million shares of its outstanding common stock. Purchases under the share repurchase program may be made from time to time in the open market, through block trades, the Company's 10b5-1 plan or privately negotiated transactions in accordance with applicable laws, rules and regulations. The timing of stock repurchases and the number of shares of common stock to be repurchased will depend upon prevailing market conditions and other factors. The share repurchase program does not commit the company to repurchase shares of its common stock and it may be amended, suspended or discontinued at any time at Grove's discretion.
HCTI...

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08:17 EDT Healthcare Triangle announces advancement to Google Cloud Premier Partner status - Healthcare Triangle (HCTI) announces that it has advanced to Google (GOOG;GOOGL) Cloud Premier Partner status. This advancement to 'Premier' status is based on its building, deploying, and managing Google Cloud solutions for regulated healthcare and life sciences organizations and building data analytics platforms on Google Cloud's infrastructure. Through the Google Cloud Partner Advantage Program, Healthcare Triangle solves healthcare and life sciences organizations' complex challenges with solutions in areas such as data analytics, AI, security, compliance, blockchain capabilities, cloud DevOps and other key cloud products. With the Premier Partner status, Healthcare Triangle continues to deploy the scalable and secure infrastructure on Google Cloud to maximize customers' operational efficiencies. "Being named a Google Cloud Premier Partner highlights Healthcare Triangle's commitment to innovative, strategic relationships that allow us to deliver cloud insights and solutions that drive meaningful outcomes for our clients," says Suresh Venkatachari, CEO of Healthcare Triangle. "As a Premier Partner, we are committed to helping our customers realize the benefits of Google Cloud and providing a solid foundation including hybrid, multi-cloud, and cloud-native environments, as well as DevOps automation, smart analytics and AI, healthcare industry solutions, infrastructure and application modernization."
XFOR

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08:16 EDT X4 Pharmaceuticals appoints Francoise de Craecker to board of directors - X4 Pharmaceuticals announced the appointment of Francoise de Craecker to the company's Board of Directors and the recent hiring of Karolyn Park to the newly created role of Vice President, U.S. Commercial, significantly strengthening the company's depth and breadth of commercial leadership experience. Ms. de Craecker's appointment expands the X4 Board of Directors to nine members. Ms. de Craecker currently serves as an Independent Director of the French biopharmaceutical company GenSight. Previously, she served as General Manager Europe, Middle East, and Africa at AveXis Europe. Ms. Park joined X4 in September 2021 as Vice President, U.S. Commercial, bringing nearly 20 years of experience in life science marketing and commercial planning, development, and execution. Previous to X4, she served in multiple roles at Takeda Pharmaceuticals, including Senior Director, U.S. Hematology Portfolio Strategy and Director, U.S. Trintellix Strategy & HCP Marketing Lead.
XP

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08:15 EDT XP Inc. acquires minority stake in AZ Quest - XP announced the acquisition of a minority stake in AZ Quest, one of the largest and traditional independent asset management companies in Brazil, and part of Italian Azimut Group since 2015. AZ Quest has a platform of products that include Equities, Macro, Private Credit and Arbitrage strategies. The acquisition is part of XP's strategy to develop the most complete ecosystem of managers and distributors in Brazil. The transaction is a co-investment with XP Private Equity fund. XP and XP PE will have the option to increase their stake within the next 2 years. With this transaction, XP expects to increase synergies in its distribution platform, increasing penetration for AZ Quest funds across the largest funds open platform in Brazil. Azimut and XP will seek to expand cooperation across other areas, including the wider range of Azimut's global products.
GNLN

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08:15 EDT Greenlane to acquire DaVinci, no terms - Greenlane Holdings announced it has entered into a definitive agreement to acquire DaVinci, "a leading developer and manufacturer of premium portable vaporizers. DaVinci is an industry leading brand differentiated through its groundbreaking Clean First innovation, which employs medical grade materials and total quality manufacturing processes to ensure the cleanest technology goes into the development of its products. DaVinci's product line has grown significantly since the launch of its award-winning IQ vaporizer in 2016 to include new innovative models such as the MIQRO, the world's smallest premium loose-leaf vaporizer, IQ2, the world's first on-device dosage control, and the IQC, equipped with a patented ShareSafe mouthpiece created from an FDA-approved antimicrobial polymer.The acquisition is subject to customary closing conditions, and is expected to close in the fourth quarter of 2021. Upon completion, the acquisition is expected to be immediately accretive to Greenlane's revenue and earnings," noted the company.
BXC

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08:15 EDT BlueLinx appoints Ryan Taylor as VP, investor relations, treasury - BlueLinx Holdings announced the appointment of Ryan Taylor as Vice President of Investor Relations and Treasury, effective October 11, 2021 and reporting to Kelly Janzen, Senior Vice President, CFO and Treasurer. In this newly created role, Taylor will lead the investor relations and treasury functions, with an emphasis on enhancing engagement with the investor community and maintaining a prudent capital structure to support the Company's growth strategy.. Most recently, Taylor served as Chief Strategy Officer at SPX FLOW where he played a leading role in the development, execution and communication of a transformational strategy which delivered significant value for SPX FLOW shareholders.
ZGNX

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08:12 EDT Zogenix reports granting of inducement awards - Zogenix announced that the compensation committee of the company's board of directors granted inducement awards to thirty-four new non-executive employees. The awards were made on October 15, 2021, under Zogenix's 2021 Employment Inducement Equity Incentive Award Plan, which was approved by the company's board of directors under Nasdaq Marketplace Rule 5635(c)(4), for granting equity awards to new employees of Zogenix as an inducement to join the company. The awards consist of options to purchase an aggregate of 75,480 shares of Zogenix common stock and 37,790 restricted stock units. The options have a ten year term and an exercise price equal to $15.77, the closing price per share of the common stock on the grant date, and vest over a four-year period, with 25% of the options vesting on the first anniversary of each employee's respective start date and the remainder vesting in equal monthly installments over the three years thereafter. The restricted stock units vest over a four-year period in four equal annual installments beginning on the first anniversary of the vesting commencement date.
BEEM

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08:11 EDT Beam Global announces California state DMV purchases 15 EV ARC charging systems - Beam Global announced the California State Department of Motor Vehicles, or DMV, has purchased fifteen EV ARC solar-powered EV charging systems for public use. The systems were purchased through the California Department of General Services Contract #1-18-61-16. "Contracts like the California DGS contract and the federal GSA contract make EV ARC systems as easy to procure as they are to deploy for government entities across the nation," said Beam Global CEO Desmond Wheatley. "Because of California Governor Gavin Newsom's desire to deploy 1.2M EV chargers by 2030, we're seeing more multi-unit orders from government entities, which is promising for the future." The California DMV's fifteen units will offer free public charging at locations across the state for DMV visitors to charge their EVs while they conduct business at the DMV. Each solar-powered EV ARC system generates and stores its own clean electricity and delivers that electricity to power two Enel X JuiceBox Pro EV charging stations. The transportable but permanent systems include the Emergency Power Panel option for first responder use during blackouts and emergencies.
KTOS

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08:11 EDT Kratos breaks gigabit barrier with OpenSpace virtualized wideband receivers - Kratos announced that it has broken the gigabit throughput barrier with its OpenSpace virtualized wideband receivers delivering over a gigabit per second performance running solely on commercially available, off-the-shelf x86-based computers. This achievement drastically lowers the cost of downlinks, while raising performance for Earth Observation and Remote Sensing missions. The company said, "More and more high bandwidth EO and RS data is being beamed from satellites and the infrastructure on the ground must keep up. This is particularly driven by the challenge of EO/RS applications that rapidly download data on the fly during the short time periods when satellites are over the ground system, as well as the need to process the data as fast as possible. Kratos breaking the gigabit milestone demonstrates that the high throughput required by EO/RS satellites can be achieved by software receivers running on x86-based general purpose computers that do not require specialized hardware such as Field Programmable Gate Array or Graphics Processing Units . This level of performance demonstrates that operations can be streamlined by leveraging virtualized solutions or deploying in the cloud without the need for expensive hardware acceleration. It also showcases the performance of Kratos' OpenSpace software receivers, which are taking advantage of the standard DVB-S2 waveform to make much more efficient use of the spectrum."
IKT

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08:10 EDT Inhibikase doses first Parkinson's patient in clinical trial of IkT-148009 - Inhibikase Therapeutics announced dosing of the first Parkinson's patient in its Phase 1b clinical trial of IkT-148009, an Abelson Tyrosine Kinase, or c-Abl, inhibitor for the treatment of Parkinson's disease. The Phase 1b extension study is a 3:1 randomized, placebo-controlled trial investigating the safety, tolerability and pharmacokinetics of IkT-148009. The trial will enroll a total of 24 patients with Parkinson's disease across 3 escalating doses (8 patients per cohort). The study will also assess cognitive, motor function, gut motility and measures of alpha-synuclein aggregate clearance in multiple compartments, as exploratory endpoints. The Company previously reported results from its Phase 1 study of IkT-148009 in older and elderly healthy volunteers, which achieved high drug exposure between 12.5 and 100 mg with no clinically significant adverse events across 56 patients. These results were consistent with exposures observed in animal efficacy studies of inherited and sporadic progressive Parkinson's disease.
CADL PFE

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08:09 EDT Candel Therapeutics appoints Mace Rothenberg as senior advisor to CEO - Candel Therapeutics, Inc. (CADL) announced it has appointed Mace Rothenberg, MD, as a senior advisor to its President and CEO, Paul Peter Tak, MD, PhD, FMedSci. Prior to joining Candel, Dr. Rothenberg served as Chief Medical Officer of Pfizer (PFE). During that time, the company initiated, completed, and obtained emergency use authorization for its COVID-19 vaccine.
IDCC

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08:08 EDT InterDigital appoints Joshua Schmidt as Chief Legal Officer, Corporate Secretary - InterDigital announced that Joshua Schmidt has been appointed as the company's new Chief Legal Officer and Corporate Secretary, reporting to Liren Chen, President and Chief Executive Officer of InterDigital. Richard Gulino, who has served as InterDigital's Chief Legal Officer since January 2020 will remain as a Strategic Advisor to the company and will be retiring on December 3rd of this year. Schmidt joined InterDigital in March 2015 and has since served in a series of roles within the legal department, most recently as Deputy General Counsel.
ULTA

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08:08 EDT Ulta Beauty targets FY22-FY24 EPS up low double digits - Targets FY22-FY24 revenue up 5%-7%. Targets FY22-FY24 comparable sales up 3%-5% annually. Targets FY22-FY24 net new store growth of 50 stores per year. Targets FY22-FY24 capital expenditures 4%-5% of sales. Ulta Beauty will host its 2021 virtual analyst and investor conference starting at 8:30 a.m. Central Time. In conjunction with the event, the company announced longer-term financial targets and providing an update on its strategic priorities. "Reflecting our understanding about how the consumer and beauty category are evolving, we have refreshed our strategic framework, and we are excited to share our vision for Ulta Beauty's future. We have a long record of disruption, creativity and success, and we intend to build on this foundation and continue to lead the beauty category, seamlessly connecting physical and digital channels, expanding our market share, and increasing member loyalty," said Dave Kimbell, chief executive officer. "We are optimistic about the opportunities ahead and believe the power of the beauty category, paired with our proven business model, experienced leadership team, and values-based culture, positions Ulta Beauty to continue to deliver long-term value for shareholders."
PME

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08:07 EDT Pingtan Marine Enterprise receives determination notice letter from Nasdaq - Pingtan Marine Enterprise announced that it received a determination notice letter dated October 13 from the Listing Qualification Staff of The Nasdaq Stock Market notifying that the Company did not meet the terms of exception granted by Staff. As previously disclosed, the Company received notices on April 15, May 25, and August 23, from the Staff notifying that the Company did not comply with listing requirements set forth in Listing Rule 5250 because it had not filed its Form 10-K for the period ended December 31, 2020, and its Forms 10-Q for the periods ended March 31 and June 30 with the SEC. As required by these notices, Pingtan submitted a plan and supporting materials to Nasdaq outlining its plan to regain compliance with respect to these delinquent reports and the Staff granted the Company an exception until October 12, 2021 to regain compliance with the Rule. The Company intends to submit a request for a hearing to appeal the determination and a request for a stay of the suspension of the Company's securities for up to 15 days from the date of request, pending the hearing. Before the Hearings Panel notifies the Company of its conclusion, the Determination Notice does not have an immediate effect on the trading of the Company's securities. The Company is currently working diligently to finalize and file the Forms 10-Q.
FLEX

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08:06 EDT Bertram Capital exits Anord Mardix with sale to Flex - Bertram Capital announced its portfolio company Anord Mardix has entered into an agreement with Flex, pursuant to which Flex will acquire Anord Mardix. Headquartered in Kendal, UK, Anord Mardix is a global provider of critical power solutions and services for the data center and industrial markets. The $540M all-cash transaction has been unanimously approved by Flex's Board of Directors and is expected to close in the fourth quarter of calendar 2021, subject to customary closing conditions, including regulatory approval.
GANX AUTL

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08:06 EDT Gain Therapeutics appoints Matthias Alder as COO - Gain Therapeutics (GANX) announced the appointment of Matthias Alder as COO to advance the Company's strategic and operational objectives, including the establishment of additional industry partnerships and the transition of the Company's lead program in Gaucher and Parkinson's Disease into clinical trials, which is expected to occur in 2022. Most recently, Mr. Alder was Chief Business Officer at Autolus Therapeutics (AUTL), a biotechnology company focused on developing CAR T-cell therapies for hematological and solid tumors, where he led the corporate development, legal, IP and HR functions.
CHPT

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08:06 EDT ChargePoint announces Lisa Mulrooney Gross - ChargePoint Holdings announced the addition of Lisa Mulrooney Gross to its leadership team. As chief people officer at ChargePoint, Mulrooney Gross will oversee HR for the company as it continues its expansion across North America and Europe. In her new role, Mulrooney Gross will be responsible for scaling the company culture and workforce and implementing talent initiatives globally to fuel ChargePoint's growth.
QMCO IBM

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08:05 EDT Quantum announces partnership with IBM for next generation of LTO technology - Quantum (QMCO) announced a partnership with IBM (IBM) on the next generation of LTO technology. Under the terms of the agreement, Quantum will collaborate with IBM in its development of LTO-10 tape drives and media in order to accelerate time-to-market, capacity, and performance. The specific terms of the agreement are confidential and will not be disclosed. Linear Tape Open, also known as the LTO Ultrium format, is an open tape format designed for high-capacity long term storage and is used by many of the world's largest hyperscalers and enterprises for archiving data and protecting data against ransomware.
DELL VMW

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08:04 EDT Dell Technologies lists record, distribution dates for VMware special dividend - The Dell Technologies (DELL) board of directors has approved distribution of a special stock dividend to Dell Technologies stockholders of all its shares of Class A and Class B common stock of VMware (VMW). This represents approximately 81% of the outstanding shares of VMware common stock. Each share of VMware Class B common stock will be converted into one share of VMware Class A common stock in connection with the distribution and prior to the receipt by Dell Technologies stockholders of such shares. The distribution of shares will be made to all Dell Technologies shareholders of record as of 5:00 p.m. ET on October 29. The distribution will take place in the form of a pro rata common stock dividend to each Dell Technologies shareholder as of the record date. Dell Technologies' spin-off of VMware is expected to be completed on November 1, subject to certain conditions. The final distribution ratio will be determined and announced on the record date. It will be calculated by dividing the shares of VMware common stock to be distributed by the number of shares of Dell Technologies common stock outstanding on the record date. Dell Technologies shareholders would receive approximately 0.44 shares of VMware for each share of Dell Technologies that they hold, based on shares outstanding. No fractional shares of VMware common stock will be distributed. Instead, Dell Technologies shareholders will receive cash in lieu of any fraction of a share of VMware common stock that they otherwise would have received. The distribution is generally intended to qualify as tax free to Dell Technologies stockholders for U.S. federal income tax purposes.
CLVS

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08:04 EDT Clovis Oncology and ITM announce Lutetium-177 clinical supply agreement - Clovis Oncology and ITM Isotope Technologies Munich announced the signing of a clinical supply agreement that provides Clovis Oncology with ITM's therapeutic radioisotope no-carrier-added Lutetium-177 or n.c.a. 177Lu, EndolucinBeta for use in the clinical development of FAP-2286, Clovis' fibroblast activation protein, FAP-targeting therapeutic candidate. FAP-2286 is the first peptide-targeted radionuclide therapeutic PTRT candidate directed against fibroblast activation protein undergoing clinical testing and is currently being investigated in the Phase 1/2 LuMIERE study for patients with advanced solid tumors. The agreement covers an initial period of five years. Further details of the agreement were not disclosed. "Clovis Oncology is committed to advancing FAP-2286's clinical development program and emerging as a leader in targeted radionuclide therapy. A critical element to advance this program is ensuring long-term supply of radioisotopes, and this agreement allows us to achieve that goal," said Patrick Mahaffy, President and CEO of Clovis Oncology. "In particular, we value ITM's radiopharmaceutical expertise and global reach as we advance our targeted radionuclide therapy program into the clinic."
VYNE

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08:03 EDT VYNE Therapeutics enrolls first patient in trial of FMX114 - VYNE Therapeutics announced that it has enrolled the first patient in its Phase 1b/2a clinical trial evaluating FMX114 for the treatment of mild-to-moderate atopic dermatitis. FMX114 is VYNE's proprietary investigational combination gel formulation of tofacitinib and fingolimod. The product is being developed to address both the source and cause of inflammation in AD by developing a distinct combination of tofacitinib and fingolimod which approaches the reduction of inflammation by inhibiting migration of inflammatory cells, and in addition may also directly support skin barrier recovery. FMX114 has the potential to be the first topical combination JAK inhibitor for the treatment of AD as well as the first topical product in clinical development that utilizes the sphingosine 1-phosphate receptor mode of action. The planned 25 patient Phase 2a study comparing the safety and efficacy of FMX114 gel with vehicle gel will also incorporate a preliminary Phase 1b evaluation of the safety and pharmacokinetics of FMX114 in 6 patients with mild to moderate atopic dermatitis for up to two weeks. The Phase 1b/2a study is a randomized, double-blinded trial designed to compare the safety and efficacy of FMX114 gel with vehicle gel. The study is expected to enroll 31 subjects, with each subject serving as their own control. The enrollment criteria specifies that subjects must have two comparable target AD lesions for treatment upon entry. Participants will have FMX114 gel applied to one of these lesions and vehicle gel to the other. Six subjects will be initially treated twice daily with FMX114 and vehicle for up to two weeks to evaluate preliminary safety of FMX114 and the pharmacokinetics of tofacitinib, fingolimod and fingolimod 1-phosphate. A further 25 subjects will receive FMX114 and vehicle treatment applied twice daily for four weeks in a double-blinded phase of the study to further evaluate safety, pharmacokinetics and efficacy. After completion of this phase, these subjects may continue into a two-week open-label treatment phase and will be able to apply the active drug to both lesions.
FTRP

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07:57 EDT Field Trip Health continues expansion of psychedelic-assisted therapy centers - Field Trip Health announced the opening of their Seattle clinic, their sixth in the United States, along with the recent opening of a location in Fredericton, NB, and the imminent opening of a location in Vancouver, BC.
BVXV

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07:56 EDT BiondVax to enter pact with Max Planck Society, UMC Gottingen in Germany - BiondVax Pharmaceuticals announced the signing of a term sheet that includes binding financial terms of contemplated definitive agreements with the Max Planck Society and the University Medical Center Gottingen in Germany. The parties intend to enter into a 5-year strategic research collaboration including an option for BiondVax to license innovative VHH antibodies. Frequently referred to as nanobodies, VHH antibodies have the potential to serve as therapeutics and diagnostics for many diseases. The transaction is subject to execution of definitive agreements. Upon execution of definitive agreements based on the term sheet, the collaboration will begin with BiondVax's exclusive worldwide licensing of novel COVID-19 VHH antibody candidates shown in Gorlich and Dobbelstein's labs to neutralize all known major COVID-19 variants of concern at around 100-times lower drug concentrations than current COVID-19 mAbs and all other reported COVID-19 VHH antibodies. BiondVax anticipates completing preclinical proof-of-concept inhalation studies in 2022 and initiating human clinical trials in 2023. Gorlich and Dobbelstein will also conduct research on additional molecular targets for which the parties believe VHH antibodies have clear advantages over existing drugs used against various diseases. These targets are the basis for validated and currently marketed mAbs including for autoimmune conditions such as psoriasis, asthma, macular degeneration, and psoriatic arthritis. BiondVax will have an exclusive option for an exclusive worldwide license to advance these additional VHH antibodies through preclinical and clinical development, manufacturing, and commercialization. Notably, these VHH antibodies can be mass-produced through recombinant protein manufacturing in sites such as BiondVax's state-of-the-art facility in Jerusalem.
SPGI INFO

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07:54 EDT S&P Global and IHS Markit provide update on competition concerns in UK - S&P Global (SPGI) and IHS Markit (INFO) provided the following update regarding the decision by the UK Competition and Markets Authority, or CMA, that the merger of S&P Global and IHS Markit does not raise potential competition concerns, except in relation to certain commodity and petrochemical price assessments in the UK. To address the CMA's potential concerns, S&P Global and IHS Markit have previously discussed the divestiture of IHS Markit's Oil Price Information Services, or OPIS; Coal, Metals and Mining; and PetroChem Wire businesses. As previously announced, the parties have agreed to a sale of these businesses to News Corp, subject to approval of relevant antitrust authorities. The companies have further discussed with the CMA the divestiture of IHS Markit's base chemicals business to address any remaining concerns. S&P Global and IHS Markit will now formally submit these remedy proposals to the CMA. The companies consider the proposed remedies sufficient to address the CMA's competition concerns and obtain clearance for their transaction in Phase 1. The CMA will provisionally decide whether the remedy proposals are sufficient by November 2.
ACN SPLK

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07:54 EDT Accenture, Splunk form AI-powered IT operations business group - Accenture (ACN) and Splunk (SPLK) have formed a business group with a particular focus on AI-powered IT operations, security automation and intelligent supply chain. The Accenture Splunk Business Group expands the partnership between the two companies.
DMTTF

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07:51 EDT Small Pharma doses first patient in Phase IIa DMT-assisted therapy trial - Small Pharma announced that the first patient has been dosed in the Company's Phase IIa clinical trial for its lead N,N-dimethyltryptamine candidate, SPL026, which, in combination with psychotherapy, is intended to serve as a possible treatment of Major Depressive Disorder. The first of 42 patients with MDD have now been dosed in the blinded, randomized, placebo-controlled, proof-of-concept Phase IIa study of SPL026 in combination with psychotherapy. The Phase IIa portion of the Phase I/IIa study, being held at two UK clinical trial sites - Hammersmith Medicines Research and MAC Clinical Research - will assess the efficacy of one versus two doses of SPL026 in combination with psychotherapy in patients with MDD, while furthering the Company's safety and tolerability dataset. Efficacy will be assessed using the Montgomery-Asberg Depression Rating scale to measure any potential reduction in the patients' depression. Topline results are anticipated in the first half of 2022.
GRTX

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07:46 EDT Galera Therapeutics falls 70% after its Avasopasem trial did not meet endpoint
AVIR

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07:44 EDT Atea Pharmaceuticals down 70% to $12.10 after AT-527 trial did not meet endpoint
WBX NVVE

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07:42 EDT Nuvve and Wallboxx announce V2G collaboration in Iberia - Wallbox (WBX) and Nuvve Holding (NVVE), announced "a first of its kind vehicle-to-grid V2G partnership in Iberia designed to reduce mounting pressure on the grid and offer users significant financial incentives. The partnership will incorporate Wallbox's pioneering hardware, Quasar, the world's first DC bidirectional home charger, into Nuvve's patented V2G software technology, GIVe. The partnership comes at an opportune time, when pressure on the grid is rapidly rising in the Iberian peninsula, where household energy prices have risen by 35% over the past year..."Building on our experience with Wallbox for the E-Flex project in the United Kingdom, this new collaboration on their award-winning Quasar product helps extend the positive benefits of V2G to the Iberian peninsula, furthering the reach of V2G in Europe," said Christian Blom, director of European operations for Nuvve. "Giving residents access to this cutting-edge technology allows EV users to multiply the positive effects of their investment in zero emission vehicles and contribute to a cleaner planet."
STAB

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07:40 EDT Statera BioPharma announces IRB approval for STAT-205 study in acute COVID-19 - Statera Biopharma announced that it has received Institutional Review Board approval to conduct a Phase 1 pilot study at Loma Linda University Health to evaluate STAT-205 as a treatment to mitigate SARS-CoV-2 progression, the virus that causes COVID-19. STAT-205 is an immune-modulator designed to decrease elevated inflammatory responses associated with viral infection and inhibit viral replication in human lung cells. The randomized, single-blind, placebo-controlled study will enroll 24 patients that are age 18 years or older who test positive for acute SARS-CoV-2 and show symptoms of mild infection that are at high risk for disease progression. The study is designed to assess the pharmacokinetics, early predictive biomarkers, and safety of STAT-205. During preclinical in vitro studies, STAT-205 demonstrated an ability to inhibit the replication of coronaviruses in human lung cells. Previous data also suggest that STAT-205 could prevent life-threatening lung inflammation caused by COVID-19, as well as lessen the risk of reinfection. Statera is also developing STAT-205 as a treatment for patients with post-acute COVID-19 syndrome, also known as "long haulers." Approximately 30% of patients with acute COVID-19 develop "long haul" syndrome, and these patients also represent a significant unmet medical need. A Phase 2 study in post-acute COVID-19 patients is expected to commence by year-end 2021.
DRNA

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07:39 EDT Dicerna says secondary efficacy endpoints not met in nedosiran PH3 study - Dicerna Pharmaceuticals, announced top-line results from its PHYOX4 study designed to evaluate the safety and tolerability of a single subcutaneous dose of nedosiran, Dicerna's late-stage investigational GalXC RNAi therapeutic candidate in development for primary hyperoxaluria PH, compared to placebo in patients with PH type 3 PH3. Nedosiran demonstrated safety and tolerability results in this trial consistent with previously reported studies in the PHYOX clinical development program. Patients administered nedosiran also showed a trend in urinary oxalate, Uox, reduction; however, these reductions did not meet prespecified secondary efficacy endpoint criteria. Dicerna plans to submit an NDA to the FDA for nedosiran for the treatment of PH1 in the fourth quarter of 2021. "The favorable safety and tolerability results, coupled with the encouraging trends in Uox reduction observed in the first clinical trial of any investigational therapy in patients with PH3, provide important initial data for nedosiran in PH3," said Shreeram Aradhye, M.D., Executive Vice President and Chief Medical Officer at Dicerna. "While we have refined our near-term nedosiran strategy primarily to focus on the treatment of PH1, there is a significant unmet medical need in PH3, and we plan to analyze these data further as part of our discussions to out-license the commercialization of nedosiran. I would like to extend our sincere thanks to the patients, caregivers, investigators and their staff involved in the PHYOX4 study for their important contributions." No serious AEs were reported in the study. No subjects in either group achieved the prespecified secondary efficacy endpoint, which was a greater than 30% decrease from baseline in 24-hour Uox excretion on at least two consecutive visits over the three-month observation period. However, all patients administered a single dose of nedosiran demonstrated Uox reductions relative to baseline at one or more time points during the three-month period
EFRTF

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07:39 EDT Nexus Real Estate enters into $98.2M purchase, sale agreement - Nexus Real Estate Investment Trust announced that it has entered into an agreement to acquire a 50% interest in a newly constructed automated grocery customer fulfilment centre strategically located in Pointe-Claire, Quebec. The newly built 309,000 square foot Class A property is located at 2400 Trans-Canada Highway in Pointe-Claire, Quebec, and is fully leased on an absolutely triple net basis to a subsidiary of Empire on a long-term basis. The purchase price is expected to be partially satisfied through the assumption of mortgage financing in the principal amount of approximately $61,500,000 with approximately 15 years remaining term, with the balance expected to be satisfied in cash. The REIT has sufficient liquidity available from its credit facilities and unencumbered properties to finance this acquisition and the other properties the REIT has under contract. The purchase and sale agreement is conditional upon mortgage assumption and other approvals and the acquisition is expected to close in December 2021.
DKNG

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07:38 EDT DraftKings, Foxwoods launch online sports betting, iGaming in Connecticut - The Mashantucket Pequot Tribal Nation, Foxwoods Resort Casino and DraftKings announced that online and mobile sports betting and online casino launched in Connecticut after successfully completing the required soft launch testing which began a week ago. Now all customers 21 years of age and older in the state of Connecticut can place a variety of sports bets and play casino games such as slots, blackjack and roulette using the co-branded Foxwoods and DraftKings Sportsbook and Casino app on their mobile device. The Mashantucket Pequot Tribal Nation and DraftKings will be holding a virtual press briefing to officially kickoff and welcome online sports betting and iGaming across the state.
KMPH

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07:37 EDT KemPharm announces uplisting to Nasdaq Global Select Market - KemPharm announced that its shares of common stock have been approved for listing to The Nasdaq Global Select Market. Trading on the exchange will commence effective with the open of business on October 19, 2021, under KemPharm's current ticker symbol, "KMPH".
IFRX

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07:37 EDT InflaRx awarded up to $50.7M grant by German Government - InflaRx announced that the German Ministry of Education and Research and the German Ministry of Health have notified InflaRx that the Company has been awarded a grant of up to $50.7M to support the development of vilobelimab for the treatment of severely ill, mechanically ventilated COVID-19 patients. The grant was awarded as part of a government initiative, which the German Federal Government announced earlier this year, to accelerate the development of promising therapeutic options for the treatment of COVID-19 in patients at all stages of disease. "We are pleased to receive this significant grant from the German Federal Government, which has recognized the need to invest in the late-stage development of new and promising therapies to treat patients with COVID-19. The emergence of new virus variants and COVID-19 outbreaks in unvaccinated populations worldwide are still leading to a significant number of hospitalizations, highlighting the ongoing need for efficacious treatment options," commented Thomas Taapken, CFO of InflaRx. "The funding will enable us to speed up certain vilobelimab development activities and initiate several work streams in parallel, including transfer of the manufacturing process to a site in Germany. We believe this will allow us to reduce the time to a potential drug approval, provided positive clinical results are shown in our ongoing Phase III study." The purpose of the grant is to advance clinical development activities in COVID-19 and to secure manufacturing capacity for vilobelimab in Germany. The initial tranche amounts to approximately $29.9M and is structured as reimbursement of 80% of certain pre-specified expenses related to the clinical development and manufacturing of vilobelimab. The remainder of the grant will be awarded in three additional subsequent tranches, each conditional on reaching agreed-upon development and manufacturing-related milestones for the preceding tranche and structured as reimbursement for Company expenses. Individual tranches will not be paid if the preceding milestone of a tranche is not met. Payments from this grant to the Company are expected to begin in Q4 2021. The Phase III part of the Phase II/III study with vilobelimab in critically ill, mechanically ventilated COVID-19 patients has been fully enrolled and treatment is ongoing across sites in the EU, South America and other regions worldwide. Top-line results from this study are expected in Q1 2022.
HTGC

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07:36 EDT Locus Biosciences secures financing up to $25M from Hercules Capital - Locus Biosciences announced that the company has entered a credit facility of up to $25 million with Hercules Capital. The funds under the facility will be available in tranches upon the achievement of specific clinical and business milestones.
SPGI...

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07:36 EDT S&P Global, IHS Markit to submit remedy proposals to CMA - S&P Global (SPGI) and IHS Markit (INFO) provided the following update regarding the decision by the UK Competition and Markets Authority, or CMA, that the merger of S&P Global and IHS Markit does not raise potential competition concerns, except in relation to certain commodity and petrochemical price assessments in the UK. To address the CMA's potential concerns, S&P Global and IHS Markit have previously discussed the divestiture of IHS Markit's Oil Price Information Services, or OPIS; Coal, Metals and Mining; and PetroChem Wire businesses. As previously announced, the parties have agreed to a sale of these businesses to News Corp (NWSA), subject to approval of relevant antitrust authorities. The companies have further discussed with the CMA the divestiture of IHS Markit's base chemicals business to address any remaining concerns. S&P Global and IHS Markit will now formally submit these remedy proposals to the CMA. The companies consider the proposed remedies sufficient to address the CMA's competition concerns and obtain clearance for their transaction in Phase 1. The CMA will provisionally decide whether the remedy proposals are sufficient by November 2.
FCN

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07:35 EDT FTI Consulting appoints Anthony Primiano as senior managing director - FTI Consulting announced the appointment of Anthony Primiano as a Senior Managing Director in the Broker-Dealer Regulatory & Litigation group within the firm's Financial Services practice. Primiano, who is based in New York, will provide FTI Consulting clients with compliance advisory and risk management services and will bring his unique experience and skillset to assist with regulatory investigations, internal reviews, compliance risk assessments and compliance remediation planning, particularly in domestic and international wealth management. Primiano joins FTI Consulting from UBS Financial Services, where he was Americas Head of Global Wealth Management Compliance and Operational Risk Control.
VERO

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07:34 EDT Venus Concept receives FDA 510k clearance for Venus Freedom - Venus Concept announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the Venus Freedom device in the United States. Venus Freedom is a noninvasive, non-ablative device with three applicators for the delivery of non-thermal radiofrequency energy combined with massage and magnetic field pulses. It is intended for the treatment of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation. "Following the receipt of Health Canada authorization for our Venus Fiore Feminine Health System in July, we are very pleased to further expand our portfolio of technologies that can treat a broad range of common women's health conditions with the FDA 510(k) clearance of Venus Freedom," said Domenic Serafino, Chief Executive Officer and Director of Venus Concept Inc. "Venus Concept devoted nearly six years to developing this technology in order to create a comprehensive, safe and effective system that has the ability to treat a variety of different women's wellness issues, addressing important medical needs and supported with significant clinical data. We look forward to commencing a limited launch of the Venus Freedom in the U.S. during the first quarter of 2022. We intend to sell the Venus Freedom using a unique utilization-focused business model which we believe will make the return on investment of this system very attractive for both Venus Concept and the OBGYN community." The receipt of FDA 510(k) clearance for Venus Freedom follows the recent receipt of Health Canada authorization to market the Venus Fiore Feminine Health System in July 2021.
AXON

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07:34 EDT Axon's digital evidence management solution selected by Scottish Government - Axon and its U.K. subsidiary, Axon Public Safety UK, announced that the Scottish Government has selected Axon's digital evidence management solution, Axon Evidence, as part of their commitment to invest in the development of a Digital Evidence Sharing Capability for Scotland's public safety authorities. This modernization initiative will connect all Scottish justice sector partners and stakeholders, including the police, courts, prosecutors and defense agents.
ASMB

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07:34 EDT Assembly Biosciences, Antios Therapeutics enter collaboration agreement - Antios Therapeutics and Assembly Biosciences announced that the companies have entered into a clinical collaboration agreement to evaluate a triple combination treatment in patients with chronic hepatitis B virus infection. A single cohort in the ongoing Antios Phase 2a ANTT201 clinical trial will evaluate ATI-2173, Antios' investigational proprietary active site polymerase inhibitor nucleotide, vebicorvir, Assembly Bio's investigational lead core inhibitor candidate, and tenofovir disoproxil fumarate, a nucleotide reverse transcriptase inhibitor. The multi-center, double-blinded, placebo-controlled cohort will evaluate the safety, pharmacokinetics, and antiviral activity of this all-oral triple combination. This cohort is expected to start in the first half of 2022 and will enroll 10 treatment naive or off-treatment HBeAg negative or positive patients in a 12-week treatment study.
ASMB

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07:33 EDT Assembly Biosciences, Antios Therapeutics announce clinical collaboration - Antios Therapeutics and Assembly Biosciences announced that the companies have entered into a clinical collaboration agreement to evaluate a triple combination treatment in patients with chronic hepatitis B virus infection. A single cohort in the ongoing Antios Phase 2a ANTT201 clinical trial will evaluate ATI-2173, Antios' investigational proprietary active site polymerase inhibitor nucleotide, vebicorvir, Assembly Bio's investigational lead core inhibitor candidate, and tenofovir disoproxil fumarate, a nucleotide reverse transcriptase inhibitor. The multi-center, double-blinded, placebo-controlled cohort will evaluate the safety, pharmacokinetics, and antiviral activity of this all-oral triple combination. This cohort is expected to start in the first half of 2022 and will enroll 10 treatment naive or off-treatment HBeAg negative or positive patients in a 12-week treatment study. "Our collaboration with Antios emphasizes our commitment to evaluating the backbone of our core inhibitors plus a nucleos(t)ide analogue in combination with other mechanisms to treat HBV, a cause of chronic infection that can lead to a higher risk of death from cirrhosis and liver cancer," said John McHutchison, AO, MD, Chief Executive Officer and President of Assembly Bio. "The commitment that we and Antios share to pursue finite and curative therapies for HBV unites us in these research efforts and offers hope for patients."
EVRC

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07:33 EDT Stockholder Group: Independent inspector of election certifies Evercel election - James Gerson and Richard Krantz, the collective owners of approximately 12.0% of the outstanding voting stock of Evercel, Inc. announced that the independent inspector of elections for Evercel's 2021 Annual Meeting of Stockholders held on October 7, 2021, has certified the results of the Annual Meeting and the Stockholder Group's three nominees - Daniel Lewis, Richard Lewisohn III and Alan Mitrani - have been elected to Evercel's Board of Directors. The independent inspector of elections also certified that each of the Stockholder Group's other business proposals to restore and amend the Bylaws in order to increase the size of the Board to nine members through the 2024 annual meeting of stockholders and allow stockholders to fill the resulting vacancies have been approved by Evercel stockholders.
PSTV

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07:32 EDT Plus Therapeutics announces FDA clearance on NDA for 186RNL - Plus Therapeutics announced clearance of its Investigational New Drug, or IND, application from the U.S. Food and Drug Administration for Rhenium-186 NanoLiposome, 186RNL, for the treatment of leptomeningeal metastases (LM). The Company expects to initiate patient accrual in a Phase 1 dose escalation trial of 186RNL in the fourth quarter of 2021. The ReSPECT-LM trial is a multicenter, sequential cohort, open-label, single dose, dose escalation Phase 1 study. It will evaluate the maximum tolerated dose, maximum feasible dose, safety, and efficacy of a single administration of 186RNL via intraventricular catheter for LM following standard surgical, radiation, and/or chemotherapy treatment. The primary endpoint of the study is the incidence and severity of adverse events/serious adverse events and dose limiting toxicities. Secondary endpoints include overall response rate, duration or response, progression free survival, and overall survival. "Leptomeningeal metastasis is a neurologically devastating and fatal complication of cancer," said Marc Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "Our latest approved IND application is part of a multifaceted plan to expand our radiotherapeutic pipeline with promising, innovative drugs to treat a variety of rare and difficult to treat cancers." The ReSPECT-LM Phase 1 clinical trial follows preclinical studies in which tolerance to doses of 186RNL as high as 1,075 Gy was shown in animal models with LM with no observed significant toxicity. Treatment led to marked reduction in tumor burden in both C6 and MDA-231 LM models.
LIND

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07:31 EDT Lindblad Expeditions acquires 80% stake in Classic Journeys - Lindblad Expeditions Holdings announced that it has acquired an 80% stake in Classic Journeys, a leading luxury cultural walking tour company. This acquisition further broadens and deepens Lindblad's platform of high-quality experiential product offerings in robust adventure travel sectors, including the cultural walking tour market. Similar to the acquisitions of Natural Habitat, Off the Beaten Path and DuVine Cycling + Adventure, Lindblad will leverage its experience and resources to accelerate the growth of Classic Journeys and capitalize on the growing demand for authentic and immersive adventure travel and wellness around the world.
AVIR

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07:31 EDT Atea Pharmaceuticals trading resumes
GRTX

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07:30 EDT Galera Therapeutics Inc trading resumes
MRK AVIR

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07:28 EDT Merck rises 2% after Atea Covid drug fails in Phase 2 study - Shares of Merck (MRK) after up 2% to $78.94 in premarket trading after Atea Pharmaceuticals (AVIR) reported that AT-527 in the outpatient setting did not meet the primary endpoint of reduction from baseline in the amount of SARS-CoV-2 virus in patients with mild or moderate Covid compared to placebo. Merck's and Ridgeback Biotherapeutics' molnupiravir is currently under review at the Food and Drug Administration, and, if authorized, it will be the first oral antiviral to treat Covid patients in the U.S.
AIM

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07:27 EDT AIM ImmunoTech submits IND application for Phase 2 trial of Ampligen - AIM ImmunoTech announced that it has submitted an Investigational New Drug application and an accompanying application for Fast Track status with the U.S. Food and Drug Administration for a planned Phase 2 study of the company's drug Ampligen as a therapy for locally advanced or metastatic late-stage pancreatic cancer. The planned AMP-270 clinical trial of approximately 250 subjects will be a Phase 2, randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen when added to SOC versus SOC alone for subjects with advanced pancreatic carcinoma recently treated with FOLFIRINOX chemotherapy regimen. Secondary objectives include comparing safety and tolerability. Amarex Clinical Research will manage the AIM-sponsored study. The Buffett Cancer Center at the University of Nebraska Medical Center and Erasmus MC in The Netherlands are expected to be the primary study sites, although additional sites are anticipated. Key support for both the study and the application for Fast Track status includes statistically significant clinical data in an Erasmus MC early-access program of 27 subjects where the overall survival of the Ampligen-treated cohort was 19.2 months from the start of FOLFIRINOX, compared to 12.5 months in the historical control group, for an increase in survival of 6.7 months. Additionally, several subjects are still alive more than three years later.
GRTX

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07:23 EDT Galera Therapeutics to resume trading at 07:30ET
AVIR

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07:23 EDT Atea Pharmaceuticals to resume trading at 07:30ET
FITB

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07:22 EDT Fifth Third: Capital plans support buyback of shares totaling $300M in Q4
FITB

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07:22 EDT Fifth Third continuing to target 9.5% CET1 by June 2022
FITB

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07:21 EDT Fifth Third sees Q4 NII down 1%, or up 1% excluding PPP impacts - Sees average loans and leases up 1%, or up 2% excluding PPP impacts. Sees Q4 noninterest income up 6%, or relatively stable excluding the impact of $44M Q4 TRA revenue. Sees noninterest expense stable to up 1%, with a net charge-off ratio of 10-15bps and an effective tax rate of 22%-23%. Comments taken from Q3 earnings conference call presentation slides.
QURE

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07:18 EDT uniQure announces presentations at ESGCT annual meeting - uniQure announced that four data presentations, including one oral presentation, will be delivered at the European Society of Gene and Cell Therapy 28th Annual Meeting taking place virtually through October 22, 2021. Featured in the oral presentation are preclinical data of AMT-191, uniQure's gene-therapy candidate for the treatment of Fabry disease which is advancing into IND-enabling studies. AMT-191 is a one-time administered AAV5 gene therapy incorporating an alpha-galactosidase A transgene. New preclinical data confirms high efficiency and cross correction of AMT-191 in a Fabry mouse model, with increased GLA-activity in the liver, kidney, heart, and brain and normalized Gb3 levels in main target organs. In addition, a single administration of AMT-191 led to phenotype improvement of nociception or a faster reaction time to physical stimulus. These new data build on earlier preclinical studies comparing multiple product candidates, including constructs incorporating a modified alpha-N-acetylgalactosaminidase transgene where AMT-191 demonstrated robust and sustained increases in GLA activity and subsequent functional improvement. Moreover, pre-clinical studies in non-human primates with AMT-191 demonstrated robust and sustained increases in GLA activity in multiple organs. Specific details on uniQure's preclinical data presentations at ESGCT include: Oral Presentation Title: Pre-clinical proof of concept of an AAV5-GLA gene therapy for Fabry disease results in cross-correction in GLA-KO mice and non-human primates in target organs. Summary: AMT191, the company's investigational AAV5 gene therapy for Fabry disease, containing a proprietary promoter and the GLA enzyme, reduces GB3 accumulation in mouse liver, kidney, heart and brain. Title: Dose dependent lowering of alpha-synuclein and rescue of motor phenotype by miRNA-based AAV gene therapy. Summary: AMT-230, the company's investigational AAV gene therapy for Parkinson's Disease, reduces alpha synuclein in dopaminergic neurons and rescues motor phenotypes in a genetic model of Parkinson's Disease. Title: Efficacy of C9orf72 ALS gene therapy using miQURE and widespread distribution in cortical and spinal regions in non-human primates. Summary: AMT-161, the Company's investigational AAV gene therapy for ALS, reduces the expression of c9ORF72 in human iPSC derived neurons, reduces C9ORF72-containing RNA foci in a model of the disease and is distributed to relevant regions of the spinal cord and brain when expressed in non-human primates. Title: An AAV9 vector expressing engineered miRNA targeting knockdown of GluK2-containing kainate receptors as a novel gene therapy approach for treating intractable temporal lobe epilepsy. Summary: AMT-260, the Company's investigational AAV gene therapy for temporal lobe epilepsy, efficiently reduces the expression of GluK2 in cortical neurons, reduces epileptiform activity and hyperlocomotion in a preclinical model of epilepsy and blocks epileptiform discharges in organotypic slices from patients with TLE.
LGIH

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07:15 EDT LGI Homes announces new single-family plans in Oklahoma City - LGI Homes announced a brand-new line-up of five floor plans in its Oklahoma City-area communities. Priced from the $220s, this new collection of homes offers homebuyers value for a newly constructed home situated in a premier family-friendly community. Ranging in size from 1,405 to 2,483 square feet with three to five bedrooms, and two to three bathrooms, these new homes are brimming with curb appeal and overflowing in upgrades. Crafted with the CompleteHome package, each one and two-story home features a host of impressive, included upgrades at no additional cost. Inside each of these new plans you will find a full suite of stainless steel Whirlpool kitchen appliances, sprawling granite countertops, designer wood cabinetry with crown molding, luxury vinyl-plank flooring, programmable thermostats and more.
MEDIF

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07:15 EDT Medipharm Labs completes new cannabis oil delivery to Vayamed - MediPharm Labs announces another GMP cannabis extract delivery to Germany. This export is a key milestone in the Company's goal of leveraging its pharmaceutical GMP licenses to increase consistent international medical sales. The cannabis extract has been shipped to Vayamed from the company's GMP facility located in Victoria, Australia. The company's Australian operations have been licensed by the Office of Drug Control and Therapeutic Goods Administration of the Australian Government's Department of Health, which has allowed the company to unlock markets with strict regulatory requirements, including Australia and the European Union. "As a pharmaceutical company specializing in precision-based cannabinoids MediPharm Labs continues to execute on delivering to its international partners. Making the deliveries to a leading company like Vayamed shows not only the demand for our quality products but the ability to navigate the complex regulations of international medical cannabis trade," said Warren Everitt, CEO Asia Pacific, MediPharm Labs. "It further demonstrates the value provided by our Australian business, which is already becoming a key asset for the Company as it continues to ship GMP product to a growing international market."
BOOM

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07:14 EDT DMC Global's DynaEnergetics announces global price increase - DynaEnergetics, a business of DMC Global, announced it will re-implement a 5% global price increase on all products shipped on or after November 22, 2021. DynaEnergetics announced a price increase in this year's second quarter, but postponed its implementation. Ian Grieves, president of DynaEnergetics, said, "Concurrent with improved industry fundamentals that include sharply higher oil and gas prices and increased well completion activity, there has been a considerable escalation in labor and material costs. This price adjustment is necessary to offset those increases, as well as the anticipated wind down of the federal government's CARES Act." Grieves added, "In today's tight labor market, the efficiency and performance benefits of DynaEnergetics' perforating systems are especially pronounced. Our DS systems are the only perforating products that are fully integrated, and factory assembled. They are delivered just in time to the wellsite, enabling customers to reduce inventory, streamline their supply chains, eliminate assembly operations and deploy fewer people to location."
CMPS

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07:12 EDT Compass Pathways granted U.S. patent for crystalline psilocybin - COMPASS Pathways announced that it has been granted its fourth patent by the US Patent and Trademark Office. This is COMPASS's first patent with claims covering its Form A hydrate psilocybin. The Form A hydrate is distinct from the anhydrate psilocybin for which the company has already been granted eight patents in the US, UK, Germany and Hong Kong, and which is used in COMP360, COMPASS's synthesised psilocybin formulation being developed for psilocybin therapy in treatment-resistant depression. The new patent, US Patent No 11,149,044, was granted on 19 October 2021, with composition claims to an alternative crystalline psilocybin, pharmaceutical formulations containing crystalline psilocybin and methods of treating major depressive disorder with the crystalline psilocybin.
CDNA ELDN

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07:12 EDT CareDx, Eledon Pharmaceuticals announce collaborative research agreement - CareDx (CDNA) and Eledon Pharmaceuticals (ELDN) announced a collaborative research agreement to use AlloSure to help assess the efficacy of Eledon's investigational AT-1501 in the prevention of rejection in upcoming renal transplantation trials. In July of this year, Eledon announced that it had received approval from Health Canada to commence human trials of AT-1501 in renal transplantation. Eledon anticipates initiating the trial in the fourth quarter of this year with interim data read-outs beginning in late 2022. "This collaboration agreement provides Eledon with access to CareDx's best-in-class technologies," stated David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. "Our partner's experience with biomarkers and predictive algorithms gives us the opportunity to gather important insights on the potential for longer term allograft survival rates as we advance AT-1501 through clinical development. We are pleased to partner with the market leader in broader transplantation services and look forward to working together towards supporting transplant patients."
AVRO

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07:12 EDT Avrobio reports safety data across gene therapies for Fabry, Gaucher disease - Avrobio reported new safety data from the first lentiviral gene therapy clinical trials for Fabry disease and Gaucher disease, as well as new high-resolution cellular data providing insights into the mechanisms of action of its gene therapies. The data are being presented at the virtual 28th Annual Congress of the European Society of Gene & Cell Therapy ESGCT, Oct. 19-22. "We have worked from the very beginning and at every turn to incorporate a strong safety focus in our proprietary plato gene therapy platform, by having carefully selected clinical indications; an optimized, state-of-the-art vector; closed and automated manufacturing; use of innovative analytics; and a personalized conditioning regimen, to bring lentiviral gene therapies to patients with lysosomal disorders," said AVROBIO President and CEO Geoff MacKay. "We believe the data shared this week continue to support the predictable safety profile of our investigational gene therapies targeting lysosomal disorders. Additionally, we're particularly proud to unveil new industry-leading techniques that are designed to provide additional insight throughout the process, including safety monitoring at the DNA level within different bone marrow and blood cell types."
OXBDF

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07:11 EDT Oxford says Boehringer Ingelheim exercises option on gene therapy treatment - Oxford Biomedica announces that Boehringer Ingelheim has exercised its option to license Oxford Biomedica's lentiviral vector technology to manufacture, register and commercialise BI 3720931, a lentiviral vector-based gene therapy for the treatment of cystic fibrosis. Under the terms of the option and license agreement with Boehringer Ingelheim, originally announced in August 2018, Boehringer Ingelheim will pay Oxford Biomedica an option exercise fee of GBP3.5 million. Oxford Biomedica is further entitled to development, regulatory and sales milestones of up to a further GBP27.5 million, in addition to a tiered low single digit royalty on net sales of a CF gene therapy product. This option exercise by Boehringer Ingelheim follows on another recent signature of a Development & Supply Agreement which was announced in April 2021, relating to the clinical manufacture of various types of viral vector based products. In parallel, Boehringer Ingelheim has also exercised its option to license intellectual property and know-how from IP Group and the UK Cystic Fibrosis Gene Therapy Consortium relating to the same lentiviral vector-based product candidate for the treatment of CF. This development partnership between academia, Pharma and Biotech focuses on the development of a novel, replication deficient lentiviral vector, in an inhaled formulation, to selectively introduce a CFTR gene into the relevant target cell. This approach has demonstrated high gene transfer efficiency and offers the possibility of repeated administration to maintain a therapeutic effect. In addition, the approach has the potential to address all of the more than 2,000 different known gene mutations across CF patients, and therefore offers a gene-independent disease-modifying treatment option for patients. Should the program progress into clinical development, Oxford Biomedica expects to produce large quantities of lentiviral vectors using its highly efficient GMP-compliant manufacturing process in bioreactors.
PZG

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07:10 EDT Paramount Gold Nevada completes geophysical survey of Bald Peak project - Paramount Gold Nevada announced that it has completed a promising ground geophysical survey of its recently acquired Bald Peak Project located in Mineral County, Nevada. The Controlled Source Audio-frequency Magnetotellurics Survey, CSAMT, totaling 21.4 km over 15 lines defined three-dimensional continuity of silicified zones which appear to be the source of surface gold on the property. These zones are identified as areas of resistivity by CSAMT. The Company's technical team has reviewed and verified surface samples from these zones completed by previous operators which returned gold values of up to 8 g/T associated with strong silicification and occasional brecciation. Paramount President and COO, Glen Van Treek, commented: "We are encouraged to find strong resistivity zones immediately below surface rock samples grading over 2 g/T and up to 8 g/T Au in this never before drilled project. The next phase of exploration is to design and execute our initial drill program."
KRKR INTC

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07:09 EDT 36Kr Holdings provides customized video advertising solutions to Intel - 36Kr Holdings (KRKR) announced that the Company has provided customized short-form video advertising solutions for Intel (INTC) , representing a brand new marketing collaboration between the two companies. 36Kr's innovative marketing solution promotes Intel Evo platform-based laptops in a professional, illustrative and user-friendly manner. It includes a 7-minute video featuring the design concept and performance of Intel's premium laptops, as well as three 4-minute short-form videos demonstrating three of Intel's original technologies: Intel Wi-Fi 6, ThunderboltTM 4 and Iris Xe Graphics, respectively. These customized videos are being distributed through 36Kr's own network as well as its various distribution outlets among major third-party traffic platforms.
ATAI

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07:09 EDT Atai Life Sciences launches new philanthropic program, atai Impact - atai Life Sciences announced the launch of its new philanthropic program, atai Impact, in line with atai Life Sciences' vision, to heal mental health disorders so that everyone can live a more fulfilled life. The initial focus of atai Impact will be on the psychedelic sector, given its emerging potential in tackling the growing mental health crisis. Supporting and collaborating with nonprofits and institutions that share its vision of healing mental health disorders, atai Impact will operate across three central pillars: Education, Access, and Ecosystem. "The launch of atai Impact is a very proud moment for everyone at atai Life Sciences and for me, personally. While we believe a for-profit model is the best way to get new treatments to patients in need, not all aspects of the global mental health crisis can be effectively addressed by this model alone," said Florian Brand, Chief Executive Officer and Co-founder of atai Life Sciences. "I've been moved by the huge volume of support, internally and externally, that we have had in bringing atai Impact to life and by the commitment of so many of our staff, founders and investors who've already joined me in contributing a portion of their own company equity to this important program. We are in active discussions with multiple stakeholders towards meaningful initiatives that we believe can help make a real difference to the future of psychedelic medicine and mental health care worldwide."
CSTL

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07:08 EDT Castle Biosciences to acquire Cernostics for $30M in initial consideration - Castle Biosciences announced it has signed a definitive agreement to acquire Cernostics , an Illumina Ventures company. Cernostics specializes in spatial biology and artificial intelligence-driven image analysis of tissue biopsies. Its TissueCypher Barrett's Esophagus Assay is the first precision medicine test designed to predict future development of high-grade dysplasia HGD and/or esophageal cancer in patients with Barrett's esophagus BE. "We are pleased to welcome Cernostics into the Castle family," said Derek Maetzold, president and CEO of Castle Biosciences. "Acquiring the TissueCypher platform is aligned with our commitment to utilizing innovative technology to provide clinically actionable information that guides disease management and improves patient outcomes. The TissueCypher Barrett's Esophagus Assay addresses an unmet need in BE, as it is designed to objectively and accurately predict progression from non-dysplastic, indefinite for dysplasia and low-grade dysplasia BE to HGD or esophageal adenocarcinoma EAC. This is critical, as EAC is highly lethal, with five-year survival rates under 20%1, and intervention, ablation, in patients with BE has been proven to reduce progression to EAC. Unfortunately, the incidence of esophageal cancer is increasing at one of the fastest rates of all cancers in the U.S., so we need new clinical tools to reverse this growth trend in the diagnosis of EAC. Under the terms of the definitive agreement, Cernostics will become a wholly owned subsidiary of Castle Biosciences. At closing, Castle will pay $30M in initial consideration to Cernostics security holders, which may consist entirely of cash or $20M in cash and $10M in common stock of Castle, at Castle's sole discretion. The purchase price is subject to customary working capital and other adjustments. Further, up to an additional $50M in cash and/or common stock, at Castle's sole discretion, is payable in connection with the achievement of certain milestones based on 2022 performance. The transaction is expected to close prior to year-end 2021, subject to the delivery of certain financial statements to the Company, continued employment of certain Cernostics personnel and satisfaction of other customary conditions to closing. Upon finalization of the transaction, Hoerres and Cernostics' executive management team and other staff based in Pittsburgh are expected to stay with the Company. Cernostics' laboratory and operations will remain in Pittsburgh.
PHRRF

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07:07 EDT PharmaTher engages Alcami for clinical, commercial manufacturing - PharmaTher Holdings announces it has entered into an agreement with Alcami Corporation for the clinical and commercial manufacturing of the Company's proprietary ketamine products. PharmaTher is focused on building a specialty ketamine-based product pipeline to support its internal product pipeline, including rare and near-rare neurological disorders such as Parkinson's disease and ALS. The ability to manufacture and supply ketamine products in different dosage forms enables PharmaTher to not only guarantee delivery on its product pipeline but creates opportunity to partner in other value creation opportunities. The Company expects to form partnerships with research labs, ketamine clinics and pharmaceutical companies that are: seeking a secure supply of cGMP ketamine and ketamine products for current portfolios; exploring alternative dose forms for multiple existing indications; and requiring support to develop and eventually commercialize specific ketamine products for new indications. It is expected that PharmaTher's proprietary ketamine drug product will be available for FDA Phase 3 clinical studies and commercial use in H2-2022. On September 29, 2021, Alcami announced an additional $31 million investment to expand its sterile development and manufacturing operation in Charleston, SC, that will substantially increase its fill-finish and lyophilization capacity. This expansion will also be able to support PharmaTher's ketamine product development and commercialization plans globally.
EVGN

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07:06 EDT Evogene subsidiary launches its two first cannabis medical products - Canonic, a wholly-owned subsidiary of Evogene, announced the full commercial launch of its first two medical cannabis products, known as G200 and G150, following positive feedback received from patients during the company's pre-launch campaign. These products were originally expected to be released to market during 2022.
AGFY

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07:06 EDT Agrify introduces Vertical Farming Unit next generation technology - Agrify announced new and improved technology for its micro-environment-controlled Vertical Farming Units, or VFUs, which the Company will unveil at MJBizCon 2021, booth C3512, being held October 19-22 in Las Vegas, Nevada. The upgraded VFUs offer updated features integral to cultivator success, including industry-first 3.0 micro-moles per Joule, NSF certified lighting, cameras, soil sensors, and automated harvest weight tracking, and will be available in the first quarter of 2022. "These enhancements which seamlessly integrate with our Agrify Insights software should maximize the ability of our customers to produce more consistent, efficient, and higher quality crop yields," said Agrify CEO Raymond Chang. "The latest VFU innovations reflect our long-standing mission to continuously improve our products to deliver the best fully integrated end-to-end indoor growing solution. We believe our new VFUs further raise the bar for the whole cannabis cultivation sector by optimizing cultivation and minimizing risk. The efficiencies they deliver are unprecedented, allowing post-harvest plant processing times to be greatly reduced so our customers can go to market faster and generate greater ROI."
IRDM

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07:05 EDT Iridium sees FY21 OEBITDA $375M - Sees Full-year 2021 OEBITDA of approximately $375M (previous outlook was for OEBITDA of between $365M-$375M). OEBITDA for 2020 was $355.6M.
PM

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07:05 EDT Philip Morris: Semiconductor shortage resulting in tight IQOS device supply - The global semiconductor shortage is resulting in a tightness in IQOS device supply. This is affecting the availability and assortment of IQOS devices in certain markets, which is hampering the company's ability to operate at full commercial and competitive capacity to fully meet demand. This has been reflected in lower IQOS user growth rates in the third quarter. At this stage, supply forecasting remains volatile. PMI therefore assumes that the tight supply situation will persist into the first half of 2022 and, where necessary, the company will prioritize device replacements for existing IQOS users over device sales targeting user acquisition. PMI is also adjusting its launch timeline for IQOS ILUMA outside Japan, with additional major launches now assumed for the second half of 2022. PMI views this as a temporary phenomenon and expects IQOS user growth to re-accelerate once shortages ease, as consumer demand remains robust. PMI confirms its confidence in its 2021 to 2023 organic compound annual growth targets for net revenues and adjusted diluted EPS (more than 5% and 9%, respectively), though there are short-term shortage scenarios under which the transitory IQOS device supply impact on user growth could result in full-year 2022 organic growth rates below the company's 2021 to 2023 growth targets.
AVIR RHHBY

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07:05 EDT Atea says Phase 2 MOONSONG trial results did not meet primary endpoint - Atea Pharmaceuticals reported that the global Phase 2 MOONSONG trial evaluating AT-527 in the outpatient setting did not meet the primary endpoint of reduction from baseline in the amount of SARS-CoV-2 virus in patients with mild or moderate COVID-19 compared to placebo in the overall study population, of which approximately two thirds of patients were low-risk with mild symptoms. However, in high-risk patients with underlying health conditions, a reduction of viral load of approximately 0.5 log10 at Day 7 was observed at 550 mg and 1,100 mg BID compared with placebo. Based on the MOONSONG topline and additional recent results for AT-527 as well as the evolving COVID-19 environment, Atea, together with Roche, are assessing potential modifications to the global Phase 3 MORNINGSKY trial including the trial's primary endpoint and patient population. As a result, we now anticipate Phase 3 MORNINGSKY data in the second half of 2022. Atea and Roche are jointly developing AT-527 as an oral direct-acting antiviral for the treatment of COVID-19. Its unique mechanism of action, with dual targets including chain termination and NiRAN inhibition, has the potential to create a high barrier to resistance with broad antiviral coverage to different variants of SARS-CoV-2. Atea has completed a comprehensive nonclinical program to characterize the safety profile of AT-527. Results from these nonclinical studies demonstrate that AT-527 is non-mutagenic and has no effects on fertility and reproduction. The global Phase 2 MOONSONG trial is a randomized, double-blind, multi-center, placebo-controlled trial, evaluating the antiviral activity, safety and pharmacokinetics of AT-527 550 mg and 1,100 mg administered twice daily in adult patients with mild or moderate COVID-19 versus placebo. The primary endpoint of this virology trial, which enrolled patients who were SARS-CoV-2 positive, is change from baseline in amount of SARS-CoV-2 virus RNA as measured by RT-PCR at specified timepoints. In the topline analysis, treatment with AT-527 did not meet the primary endpoint as it did not show a clear reduction in SARS-CoV-2 viral load in the overall population of patients with mild or moderate COVID-19 compared to placebo. Overall, approximately two-thirds of the patients had mild symptoms with no underlying health conditions and were on average 37 years old. Additionally, COVID-19 vaccinated patients were among the patients included in the overall study population. In high-risk patients with underlying health conditions, a reduction of viral load of approximately 0.5 log10 at Day 7 was observed with administration of 550 mg as compared to placebo and with administration of 1,100 mg BID as compared to placebo. In addition to baseline patient characteristics, several factors may have impacted the MOONSONG data results, which evaluated viral kinetics. These potential factors include different variants emerging during the study, greater penetration of vaccinations within the enrolled population and a pooled placebo patient population. The pooled placebo patient population included different vaccination status and may have included different COVID-19 variants. Consistent with previous studies, AT-527 was generally safe and well tolerated. In the MOONSONG study, the proportion of patients experiencing any adverse event was 20% in the placebo group, 20% in the AT-527 550 mg BID group and 27% in the AT-527 1100 mg BID group. There were 3 non-drug related serious adverse events in each of the treatment groups and all other AEs were grade 1 or 2. Gastrointestinal-related AEs were the most commonly reported AEs: 8% in the placebo group; 7% in the AT-527 550 mg BID group; 17% in the AT-527 1100 mg BID group, with mild to moderate nausea/vomiting resulting in premature study drug discontinuation of 3% in the placebo group, 0% in the AT-527 550 mg BID group and 17% in the AT-527 1100 mg BID group. No clinically significant differences in laboratory abnormalities were observed in the treatment arms as compared to placebo. In addition to the MOONSONG results announced today, results from the bronchoalveolar lavage study and Phase 2 hospitalized trial are being presented at the International Society for Influenza and Other Respiratory Virus Diseases-World Health Organization Virtual Conference, in a poster and oral session held virtually October 19-21, 2021.
GRTX

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07:05 EDT Galera Therapeutics Phase 3 ROMAN trial did not meet primary endpoint - Galera Therapeutics announced results from the Phase 3 ROMAN trial of avasopasem manganese for severe oral mucositis in patients with locally advanced head and neck cancer undergoing standard-of-care radiotherapy. The trial did not meet its primary endpoint of reduction in the incidence of SOM. The Company is continuing to analyze the results. "While the data, as in previous trials, showed reductions in the incidence, duration and severity of SOM, we are surprised and disappointed that the trial did not achieve statistical significance in its primary endpoint," said Mel Sorensen, M.D., Galera's President and CEO. "We would like to extend our heartfelt thanks to the patients who participated in this trial while they underwent radiotherapy for head and neck cancer. As we evaluate next steps for this program, we remain committed to our goal of transforming radiotherapy in cancer treatment with our selective dismutase mimetics." Key findings include: 16% relative reduction in the incidence of SOM in the avasopasem treatment group vs. placebo group, primary endpoint; 56% relative reduction in the number of days of SOM in the avasopasem treatment group vs. placebo group, secondary endpoint; 27% relative reduction in the severity of SOM in the avasopasem treatment group vs. placebo group, secondary endpoint; and Avasopasem was generally well tolerated with similar rates of adverse events in the active and placebo arms.
PM

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07:04 EDT Philip Morris confirms confidence in 2021-2023 growth targets - The company said: "We confirm our confidence in our 2021 to 2023 growth targets, despite device constraints that could persist into the first half of 2022, with temporarily lower IQOS user growth rates."
PM

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07:04 EDT Philip Morris sees FY21 adjusted EPS at upper half of previous range
LEE

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07:02 EDT Lee Enterprises announces partnership with Mudd Advertising - Lee Enterprises announced a strategic partnership with Mudd Advertising. The partnership leverages a customized version of Lee's Vision platform enabling Mudd to fully support the cross-channel marketing efforts of retail automotive dealers and manufacturers across the United States. Vision is a proprietary sales enablement and execution software, powered by Lee's national agency, Amplified Digital. "This partnership demonstrates the commitment to digital solutions for both organizations," said Kevin Mowbray, Lee president and chief executive officer. "The Vision platform has transformed local advertising for Lee Enterprises as part of our digital transformation strategy, and it aligns perfectly with the direction of Mudd Advertising."
MYOV PFE

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07:02 EDT Myovant Sciences and Pfizer to present data from relugolix studies - Myovant Sciences (MYOV) and Pfizer (PFE) announced the presentation of new data from clinical studies of its once-daily relugolix combination therapy in premenopausal women with uterine fibroids and in women with endometriosis pain. The data are being presented in oral sessions during the American Society for Reproductive Medicine, or ASRM, 2021 Congress.
TRV

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06:58 EDT Travelers reports Q3 book value per share of $115.74 - Reports Q3 book value per share of $115.74, up 5% from September 30, 2020; adjusted book value per share of $104.77, up 10% from September 30, 2020.
CARR

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06:56 EDT Carrier Global acquires Cavius, terms undisclosed - Carrier Global has acquired Cavius, a Danish residential alarm company that provides a range of smoke, heat, flood and carbon monoxide alarms. Cavius is a pioneer in the advancement of alarms, including the invention of the world's smallest photoelectric smoke alarm, which is distinguished by its award-winning European-approved micro-design. Cavius will strengthen Carrier Fire & Security's residential fire safety solutions in Europe, which includes Kidde products. The terms of the transaction were not disclosed.
SAH

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06:56 EDT Sonic Automotive acquires Bobby Ford Chrysler Dodge Jeep RAM - Sonic Automotive announced the acquisition of Bobby Ford Chrysler Dodge Jeep RAM in Sealy, Texas. Effective today, the Company will operate the dealership as Momentum Chrysler Dodge Jeep RAM of Sealy, marking the 88th franchised location in the Company's portfolio and its first Chrysler Dodge Jeep RAM, or CDJR, dealership. The dealership serves residents of Houston, Katy, Columbus, Brookshire, Sealy and surrounding areas of South Texas with new and pre-owned vehicles.
GRTX

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06:55 EDT Galera Therapeutics Inc trading halted, news pending
LLY

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06:55 EDT Eli Lilly announces tirzepatide results published in The Lancet - Adults with type 2 diabetes with increased cardiovascular, or CV, risk experienced superior A1C and body weight reductions from baseline across all three doses of tirzepatide compared to titrated insulin glargine in results from Eli Lilly's SURPASS-4 clinical trial, which were published in The Lancet. At 52 weeks, the highest dose of tirzepatide led to an A1C reduction of 2.58% and reduced body weight by 11.7 kg compared to results for those treated with insulin glargine for the efficacy estimand. SURPASS-4 is the largest and longest clinical trial completed to date of the phase 3 program studying tirzepatide as a potential treatment for type 2 diabetes. The primary endpoint was measured at 52 weeks, with participants continuing treatment up to 104 weeks or until study completion. The completion of the study was triggered by the accrual of major adverse cardiovascular events, or MACE, to assess CV risk. In newly published data from the treatment period after 52 weeks, participants taking tirzepatide maintained A1C and weight control for up to two years. The overall safety profile of tirzepatide, assessed over the full study period, was consistent with the safety results measured at 52 weeks, with no new findings up to 104 weeks. Gastrointestinal side effects were the most commonly reported adverse events, usually occurring during the escalation period and then decreasing over time. SURPASS-4 achieved each of its primary and key secondary endpoints. All three doses of tirzepatide led to statistically significant and superior A1C and body weight reductions compared to insulin glargine for both estimandsii at 52 weeks. For the treatment-regimen estimand, all three doses of tirzepatide led to superior A1C and weight reductions at 52 weeks. Hypoglycemia less than 54 mg/dL was reported in 8.8%, 6.1% and 8% of participants in the tirzepatide arms and in 19.1 percent of participants in the insulin glargine arm over the full study period. Episodes of hypoglycemia were seen more often in participants who had a background therapy of a sulfonylurea. In an additional exploratory endpoint, all three doses of tirzepatide led to favorable changes from baseline in fasting lipids at 52 weeks. Specifically, at the highest dose of tirzepatide: total cholesterol was reduced by 5.6%, triglycerides were reduced by 22.5%, low-density lipoprotein, or LDL, cholesterol was reduced by 7.9%, very low-density lipoprotein cholesterol was reduced by 21.8%, and high-density lipoprotein, or HDL, cholesterol was increased by 10.8%. The most commonly reported adverse events over the full study period in the tirzepatide arms were gastrointestinal-related and generally mild to moderate in severity. For study participants treated with tirzepatide, nausea, diarrhea and vomiting were more frequently experienced compared to insulin glargine. Treatment discontinuation rates due to adverse events over the full study period were 7.3%, 7.9% and 8.9%, compared to 1.9%. A safety analysis evaluated adjudicated MACE-4, a composite endpoint of death from cardiovascular causes, myocardial infarction, stroke and hospitalization for unstable angina. Within SURPASS-4, comparing pooled tirzepatide to insulin glargine, no increased cardiovascular risk was identified with tirzepatide; a hazard ratio of 0.74 was observed.
AVIR

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06:55 EDT Atea Pharmaceuticals trading halted, news pending
HAL

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06:47 EDT Halliburton CEO: I see a multi-year upcycle unfolding - "Our third quarter performance demonstrates the effectiveness of both our strategy and our execution. Total company revenue increased 4% sequentially, and adjusted operating income grew 6% with solid margins in both divisions," commented Jeff Miller, Chairman, President and CEO. "Both operating divisions experienced revenue growth in the international and North America Land markets. Our Completion and Production division delivered solid mid-teens margins, and our Drilling and Evaluation division margins maintained their steady momentum. I am pleased with our strengthening free cash flow profile. In the third quarter, we generated $469 million of free cash flow, retired $500 million of debt, and maintained our cash balance at $2.6 billion. I see a multi-year upcycle unfolding. Structural global commodity tightness drives increased demand for our services, both internationally and in North America. I believe Halliburton is uniquely positioned in both markets to benefit from this improving environment. I believe our value proposition, technology differentiation, digital adoption, and capital efficiency will allow us to deliver profitable growth internationally and maximize value in North America. Halliburton will continue to execute our key strategic priorities to deliver industry-leading returns and strong free cash flow for our shareholders," concluded Miller.
BRO

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06:47 EDT Brown & Brown acquires all stock of Remedy Analytics - J. Scott Penny, chief acquisitions officer of Brown & Brown, and the shareholders of Remedy Analytics, announced that Brown & Brown, has acquired all of the stock of Remedy Analytics. Founded in 2011 by current CEO, Scott L. Martin, Remedy Analytics uses its proprietary PharmaLogic data-based medication platform to offer pharmacy consulting services to employers throughout the U.S. Following the acquisition, the Remedy Analytics team will continue operating from their existing Milwaukee, Wisconsin location under the leadership of current chief operating officer, Jennifer Hill. Martin will continue to support the Remedy Analytics business as a consultant. The Remedy Analytics business will operate within Brown & Brown's Retail segment and report to Mark Abate, who oversees Brown & Brown's Strategic Benefit Advisors operations.
HAL

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06:46 EDT Halliburton reports Q3 cash flow from operations $617M, free cash flow $469M
BLDE

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06:43 EDT Cathie Wood's ARK Investment bought 157K shares of Blade Air Mobility on Monday
ADGI

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06:42 EDT Adagio Therapeutics announces in vitro data related to mAb ADG20 - Adagio Therapeutics announced new in vitro data demonstrating retained neutralizing activity of its monoclonal antibody, or mAb, ADG20, against a diverse panel of circulating SARS-CoV-2 variants, including the newly emerged Lambda and Mu variants. Notably, findings show that ADG20 demonstrated potent in vitro neutralizing activity against all SARS-CoV-2 variants of concern tested, including those with reduced susceptibility to mAb products currently available under Emergency Use Authorization, or EUA, or in late-stage development. These data will be presented during a poster session at the 2021 ISIRV-WHO Virtual Conference, which is being held October 19-21, 2021. In addition, Adagio will present an encore poster highlighting recently announced data from the company's ongoing Phase 1 trial of ADG20 in healthy participants. In addition to the Phase 1 healthy participant trial, Adagio is advancing two ongoing global Phase 2/3 trials with ADG20, a treatment trial, or STAMP, and a prevention trial, or EVADE. The company anticipates submitting an EUA application to the FDA for ADG20 in the Q1 of 2022.
BEAM

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06:40 EDT Beam Therapeutics reports new preclinical data for GSDIa new approach - Beam Therapeutics reported new preclinical data demonstrating the ability of its liver-targeted base editing approach to directly correct R83C, one of the primary disease-causing mutations of glycogen storage disease type Ia, or GSDIa. The data will be presented at the European Society of Gene and Cell Therapy 2021 Virtual Congress in an oral presentation on Wednesday, October 20, 2021, during the Liver & Metabolic Disease I Session 3a. "The data we will present at ESGCT highlight the continued innovation of our in vivo, liver-targeted base editing approach for GSDIa, which aims to directly correct R83C, a highly prevalent disease-causing mutation in this patient population," said Giuseppe Ciaramella, president and Chief Scientific Officer of Beam.
WATT

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06:38 EDT Energous gains FCC approval for Active Energy Harvesting transmitter technology - Energous announced that its 900MHz 1W Active Energy Harvesting transmitter technology has received U.S. Federal Communications Commission Part 15 grant of equipment authorization for wireless power transfer at any distance. This approval complements a similar unlimited distance wireless charging approval in Europe, announced in May, 2021, expanding the ecosystem reach -- including customers, OEM partners and standards organizations -- for WattUp. The 1W Active Energy Harvesting transmitter can charge multiple devices at once, enabling at-any-distance over-the-air charging for the growing ecosystem of Internet of Things devices such as retail sensors, electronic shelf labels, industrial devices and more.
GMAB JNJ

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06:36 EDT Genmab announces Q3 worldwide sales of Darzalex were $1.580B - Genmab (GMAB) announced that worldwide net trade sales of DARZALEX, including sales of the subcutaneous formulation, as reported by Johnson & Johnson (JNJ) were $1.580B in the Q3 of 2021. Net trade sales were $841M in the U.S. and $739M in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC formulations, under the exclusive worldwide license to Janssen Biotech, to develop, manufacture and commercialize daratumumab. As previously announced, Janssen is reducing its royalty payments to Genmab by what it claims to be Genmab's share of Janssen's royalty payments to Halozyme, cf. company announcement No. 39 of September 22, 2020.
FITB

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06:34 EDT Fifth Third reports Q3 net interest margin 2.59% vs. 2.58% a year ago
SAGE BIIB

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06:33 EDT Sage Therapeutics, Biogen to submit NDA for zuranolone to FDA - Sage Therapeutics (SAGE) and Biogen (BIIB) announced their plan to submit a New Drug Application to the U.S. FDA for zuranolone, an investigational two-week, once-daily therapeutic in the second half of 2022. The planned initial submission package will seek approval of zuranolone for the treatment of major depressive disorder and an additional filing for postpartum depression is anticipated in the first half of 2023. The decision to submit the application follows recent discussions with the FDA, including a pre-NDA meeting held this fall. Data from completed studies in the LANDSCAPE and NEST programs, as well as data from the ongoing clinical and pharmacology studies, are planned to be included as part of the submission packages.
DANOY

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06:28 EDT Danone: FY recurring operating margin to be broadly in line with 2020
DANOY

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06:28 EDT Danone sees returning to profitable growth in 2H
ZM

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06:22 EDT Zoom Video invests undisclosed amount into DTEN - DTEN announced an investment made in the company by Zoom Video. The investment allows DTEN to accelerate new product and services innovations.
TRMR

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06:17 EDT Tremor International acquires Spearad for $14.7M - Tremor International announces the strategic acquisition of Spearad, a global CTV Video ad server and media management platform purpose-built for broadcasters and TV content companies to deliver seamless TV-like experiences in CTV and Over-the-Top, or OTT, environments, with the same advanced controls and capabilities of linear TV. The consideration for the Acquisition is $14.7M, of which $11.0M is being satisfied from the Company's existing cash reserves, with the remaining $3.7M being satisfied by the issue of 370,000 ordinary shares of NIS 0.01 in the Company, subject to transfer and other contractual restrictions to be released gradually over a three-year period. Spearad's ad server technology will be integrated into Tremor's Unruly SSP, enabling CTV header bidding, channel inventory and ad pod management - complementing the Company's existing robust end-to-end technology stack, which also includes the Tremor Video DSP.
ACN

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06:09 EDT Accenture acquires Xoomworks, terms not disclosed - Accenture has acquired Xoomworks Group, a consulting and technology company that specializes in procurement technology, digital innovation and software solutions development. The acquisition will expand Accenture's capabilities for helping clients accelerate technology-led business and procurement transformation. Terms of the transaction were not disclosed.
OPT

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06:09 EDT Opthea announces patient enrollment for OPT-302 Phase 3 clinical program - Opthea announced that the first clinical trial sites in the Asia-Pacific region are now open for patient enrollment into the OPT-302 Phase 3 pivotal clinical program for the treatment of wet age-related macular degeneration, or AMD. The clinical trial sites, located in Australia, further build upon the progress of other international regions including the U.S., Canada and Europe that are also actively recruiting patients. The ShORe and COAST studies are both double-masked, sham-controlled Phase 3 registrational trials to evaluate efficacy and safety of intravitreal 2.0 mg OPT-302 in combination with either 0.5 mg ranibizumab, or Lucentis, or 2.0 mg aflibercept, or Eylea, respectively. The primary endpoint of the studies is the mean change in best corrected visual acuity from baseline to week 52 for OPT-302 combination therapy compared to standard of care anti-VEGF-A monotherapy. The read-out of the top-line results through 52 weeks is anticipated in the second half of 2023, and following completion of this primary efficacy phase, the Company plans to file Biologics License and Marketing Authorization Applications with the FDA and the European Medicines Agency respectively.
WMT

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06:03 EDT Walmart to build high-tech distribution center in Spartanburg County - Walmart announced plans to build a new, high-tech distribution center for fresh and frozen groceries in Spartanburg County, set to open in 2024. The 720,000+ square-foot facility will create more than 400 full-time jobs and will rely on the combination of Walmart associates, automation technology, robotics and machine learning to process grocery perishables and deliver them to nearby stores. The high-tech facility marks Walmart's largest grocery distribution center to date and will move 2x's more product than a traditional grocery DC in addition to presenting new technology-focused job opportunities in the region.
RDY

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05:28 EDT Dr. Reddy's receives FDA approval for Lenalidomide capsules ANDA - Dr. Reddy's announced the final approval of its abbreviated new drug application, or ANDA, for Lenalidomide capsules, in 2.5 mg and 20 mg strengths, and tentative approval for 5 mg, 10 mg, 15 mg, and 25 mg strengths, a therapeutic equivalent generic version of Revlimid capsules, from the FDA. With this approval, Dr. Reddy's is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg.
NIU

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05:20 EDT Niu Technologies appoints Fion Zhou as chief financial officer - Niu Technologies (NIU) announced that the board of directors of the company has appointed Fion Zhou as the new chief financial officer with an effective date November 15. Fion Zhou will bring to NIU 15 years of experience working in financial and public companies. Prior to joining NIU, she served as the chief financial officer of Sogou (SOGO), where she led financial operations, legal matters, strategic investment, investor relationship and internal controls.
BTG

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05:16 EDT B2Gold reports Q3 gold production 310,261 ounces - B2Gold announced its gold production and gold revenue for Q3. Total gold production in Q3 was 310,261 ounces, above budget by 7% and consolidated gold production was 295,723 ounces from the company's three operating mines, above budget by 7%. Consolidated gold revenue in Q3 was $511M on sales of 286,650 ounces at an average realized price of $1,782 per ounce. Record quarterly gold production was achieved by both the Fekola Mine of 165,557 ounces and Otjikoto Mine of 68,959 ounces in Q3.
PSFE

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05:13 EDT Paysafe expands partnership with zen.com - Paysafe announced that it has extended its partnership with payments provider zen.com. Paysafe's eCash solution, Paysafecash, can now be used by individual customers as well as business clients across 25 countries in Europe to make fast and secure cash deposits into zen.com's virtual wallets.
R

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05:11 EDT Ryder, Gatik enter partnership to establish autonomous logistics network - Ryder and Gatik announced a multi-year partnership designed to establish an autonomous logistics network for Gatik's customers in the U.S. and Canada. Gatik's latest funding round totaling $85M includes an investment from Ryder's corporate venture capital fund RyderVentures, which aims to invest in and partner with early-stage companies that are developing new technologies and business models that deliver advancements and automation in the logistics and transportation industries. The funding represents RyderVentures' first investment in an autonomous trucking company. Through the broader partnership, Gatik will lease from Ryder a fleet of medium-duty, multi-temperature box trucks designed for transporting goods to retail locations from micro-fulfillment centers or dark stores-distribution centers that cater exclusively to e-commerce. Gatik will integrate its commercial-grade autonomous driving technology into the leased fleet, enabling Gatik to provide its Autonomous Delivery as a Service model to its new and existing customers. In addition to providing the leased vehicles, Ryder will service and maintain the trucks, including calibration of autonomous vehicle sensors and the necessary pre- and post-trip inspections. Going forward, Ryder and Gatik will explore opportunities for Ryder to manage the logistics operations of the autonomous fleet as well, allowing Gatik to focus on its end-to-end ADaaS business model.