Stockwinners Market Radar for December 29, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
DKNG | Hot Stocks20:09 EST Cathie Wood's ARK Investment bought 137K shares of DraftKings today
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COIN | Hot Stocks20:09 EST Cathie Wood's ARK Investment bought 158K shares of Coinbase today
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ROKU | Hot Stocks20:08 EST Cathie Wood's ARK Investment bought 70K shares of Roku today
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TSLA | Hot Stocks20:07 EST Cathie Wood's ARK Investment bought 22.5K shares of Tesla today
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ZM | Hot Stocks20:07 EST Cathie Wood's ARK Investment bought 57K shares of Zoom Video today
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TDOC | Hot Stocks20:07 EST Cathie Wood's ARK Investment bought 200K shares of Teladoc today
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DNA | Hot Stocks20:06 EST Cathie Wood's ARK Investment bought 3.7M shares of Ginkgo Bioworks today
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FCPT | Hot Stocks19:51 EST Four Corners Property Trust acquires portfolio of properties for $11.5M - Four Corners Property Trust "announces the acquisition of three properties leased to Aspen Dental, Addus Homecare, AT&T, WellNow, and Banfield Pet Hospital for $11.5M. The properties are located in a strong retail corridor in Illinois. The tenants are all corporate-operated under net leases with a weighted average five years of term remaining. The transaction was priced at a 6.8% cap rate on rent as of the closing date, exclusive of transaction costs."
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BGNE | Hot Stocks18:56 EST BeiGene CEO sells $2.16M in common stock - In a regulatory filing, BeiGene disclosed that its CEO John Oyler sold 9.6K shares of common stock on December 27 in a total transaction size of $2.16M.
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LEE | Hot Stocks18:54 EST Lee Enterprises discloses listing compliance notice from Nasdaq - Lee Enterprises has received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC indicating that, as a result of the Company's delay in filing its Annual Report on Form 10-K for the fiscal year ended September 25, 2022 within the prescribed time period, the Company is not in compliance with the timely filing requirement for continued listing under Nasdaq Listing Rule 5250(c)(1).
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BTG | Hot Stocks17:21 EST B2Gold informs two employees passed away from injuries from robbery incident - B2Gold said in a statement that it "deeply regrets to report that two B2Gold employees have passed away as a result of injuries sustained in an off-site robbery incident in Mali earlier . All reports have identified this tragic event as the result of a robbery incident and not related to any terrorist activity. B2Gold wants to first and foremost express its deepest condolences to the families of the deceased employees. Our immediate concerns are for the safety and well-being of the B2Gold employees and the public and to minimise the impact on the surrounding area. Mining and processing activities at the Fekola Mine remain unaffected.
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ORIC PFE | Hot Stocks17:17 EST Pfizer discloses 5.38M share stake in Oric Pharmaceuticals - In a regulatory 13G filing, Pfizer (PFE) disclosed that it has taken a 12% or 5.38M share stake in Oric Pharmaceuticals (ORIC). Shares of Oric are up 3% afterhours at $5.44. On December 21st, Oric Pharmaceuticals also initially announced that its plans to partner with Pfizer on ORIC-533 and receive a $25M investment from the company.
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DOOR | Hot Stocks17:14 EST Masonite to incur $15M-$20M costs as part of restructuring plan - In a regulatory filing, the company states: "On December 27, 2022, Masonite International approved a plan intended to (i) better align its organizational structure and its long-term business strategy and (ii) continue to drive cost efficiencies through an optimized manufacturing footprint. This plan includes commencing certain restructuring actions across the Company's North American Residential and Architectural segments. The Company expects to incur pre-tax restructuring and other closure costs of $15.0 to $20.0 million related to the 2022 Restructuring Plan beginning in the fourth quarter of 2022 and continuing through fiscal year 2023, of which approximately 65% will be cash expenditures. The 2022 Restructuring Plan is intended to help improve the Company's profitability and cash flows once fully implemented. The Company expects to complete these actions by the end of fiscal year 2023 and to realize annual cash savings of approximately $15.0 to $20.0 million thereafter. The above costs are estimates and the actual costs may vary significantly based on various factors."
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BRKL PCSB | Hot Stocks17:03 EST Brookline Bancorp receives regulatory approval for PCSB Financial deal - Brookline Bancorp (BRKL) announced that it has received the requisite regulatory approvals from the board of governors of the Federal Reserve System, New York State Department of Financial Services and Massachusetts Board of Bank Incorporation necessary to complete its acquisition of PCSB Financial (PCSB). Brookline and PCSB anticipate closing the transaction on January 1, subject to the satisfaction of customary closing conditions.
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DBX | Hot Stocks16:53 EST CFO of Dropbox Regan sells 3,000 shares of company stock - The CFO of Dropbox Timothy Regan disclosed in a regulatory filing that he had sold 3,000 shares of company stock at $22.30 per share on December 27 for a total transaction amount of $66,901.
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MOH | Hot Stocks16:45 EST Molina Healthcare to record $200M impairment charge in Q4 on leased space - Molina Healthcare "concluded that it will record in Q4 an estimated non-cash, pre-tax impairment charge of approximately $200 million, attributable to leased space. This impairment charge results from the Company's plan to reduce its real estate footprint to accommodate its move to a permanent remote work environment. This charge will be recorded outside of adjusted net income. As a result of this plan, the Company expects a significant decrease in its going-forward leased real estate expense."
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CRWD | Hot Stocks16:44 EST Crowdstrike director Austin buys $2.5M in company shares - Crowdstrike director Roxanne Austin disclosed in a regulatory filing that she had purchased 25,000 shares of company stock at $99.74 per share between December 27 and December 28, for a total transaction amount of $2,493,500.
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SESN | Hot Stocks16:35 EST Sesen Bio to pay out increased special dividend of 34c per share in Carisma deal - Sesen Bio "announced an amendment to their previously announced merger agreement dated September 20, 2022. Under the terms of the amended merger agreement, which has been unanimously approved by the Boards of Directors of both companies, the one-time special cash dividend expected to be paid to Sesen Bio stockholders will be increased to approximately $70 million, or approximately $0.34 per share, representing the amount of excess cash available after Sesen Bio meets a required net cash minimum of $75 million and represents an increase from the previously stated up to $25 million special cash dividend, or up to $0.12 per share. Carisma's previously announced approximately $30 million financing remains committed and is expected to close concurrently with the merger."
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HSII | Hot Stocks16:34 EST Heidrick & Struggles to acquire Atreus, terms undisclosed - Heidrick & Struggles has entered into an agreement to acquire Atreus. The acquisition builds on Heidrick & Struggles' leadership position in the on-demand talent space by expanding this offering into Continental Europe and is an important component of the firm's broader strategy to diversify its suite of executive talent and leadership advisory offerings. "We are seeing a transformation in how organizations are acquiring executive level talent and the expertise they need," said Dan Ryan, Managing Partner, On-Demand Talent, Heidrick & Struggles. "Having access to top talent to fill roles on an interim basis, or to drive major projects forward, is becoming an increasingly important solution for our clients. The acquisition of Atreus will strengthen our already market leading On-Demand Talent platform and extend Heidrick & Struggles' reach in this growing talent market segment, further underscoring our commitment to be at the forefront of delivering an integrated suite of executive talent and leadership advisory solutions." Heidrick & Struggles will acquire 100% of Atreus subject to the satisfaction or waiver of customary closing conditions, including obtaining applicable regulatory approvals. The acquisition is expected to occur early in the first quarter of 2023. Atreus generated annual revenue of approximately $61M in 2021 and will become part of Heidrick & Struggles' existing on-demand talent offering that includes US-based Business Talent Group BTG , acquired in 2021. Atreus will continue to be led by Co-CEOs, Dr. Harald Linne and Rainer Nagel, and operate as a wholly owned subsidiary of Heidrick & Struggles. Financial terms of the acquisition were not disclosed.
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CLLS | Hot Stocks16:33 EST Cellectis, Primera Therapeutics to partner on gene editing platform - The company states: "Following the formation of Mayflower Bioventures, a cell and gene therapy accelerator stood up from Hibiscus BioVentures and Mayo Clinic, comes the launch of their first start-up, Primera Therapeutics, Inc. Cellectis and Primera announced today the execution of a Collaboration Agreement under which the Parties will work collaboratively to edit mutations in the mitochondrial DNA in vivo to treat the root cause of associated diseases. Inherited mitochondrial diseases caused by genetic changes in the mtDNA have very limited to no treatment options, and often result in early childhood death. An estimated 1 in 5,000 people worldwide suffer from mtDNA - associated diseases. Primera is advancing pioneering mtDNA gene editing therapies developed in the Mayo Clinic lab of Drs. Steven Ekker and Karl Clark to precisely fix a patient's mutated mtDNA and potentially achieve a cure for the disease. Primera's initial clinical focus is on rare mitochondrial diseases for which there are no approved treatments. Mayo Clinic excels in delivering and developing advanced care for complex diseases including the interdisciplinary research and clinical treatment through its Mitochondrial Care Research Center."
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BLUE | Hot Stocks16:18 EST Bluebird Bio completes sale pf PRV to Argenx - Following the expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, on December 29, bluebird bio completed the sale of a Rare Pediatric Disease Priority Review Voucher or PRV to Argenx . The Company was awarded the PRV under a U.S. Food and Drug Administration program intended to encourage the development of certain rare pediatric disease product applications. The Company received the PRV when SKYSONA or elivaldogene autotemcel, received accelerated approval by the FDA to slow the progression of neurological dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy. The Asset Sale was pursuant to the terms of an Asset Purchase Agreement, dated November 29 , the material terms of which were previously disclosed by the Company in a Current Report on Form 8-K filed with the Securities and Exchange Commission on November 30 . Pursuant to the PRV Transfer Agreement, Buyer paid the Company $102M in cash upon the closing of the Asset Sale.
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DK | Hot Stocks16:15 EST Delek US enters inventory intermediation pact for up to $800M in capacity - On December 22, 2022, DK Trading & Supply, LLC, an indirect subsidiary of Delek US Holdings, acting on behalf of, and jointly and severally liable with, each of (i) Lion Oil Company, LLC ("Lion Oil"), (ii) Alon Refining Krotz Springs, Inc. and (iii) Alon USA, LP entered into an inventory intermediation agreement with Citigroup Energy Inc. Pursuant to the Inventory Intermediation Agreement, Citi will (i) purchase from and sell to DKTS crude oil and other petroleum feedstocks in connection with processing operations at certain refineries, (ii) purchase from and sell to DKTS all refined products produced by such refineries other than certain excluded products and (iii) in connection with such purchases and sales, DKTS will enter into certain market risk hedges in each case, on the terms and subject to the conditions set forth therein. The Inventory Intermediation Agreement results in up to $800 million of working capital capacity for DKTS. The Inventory Intermediation Agreement has a term of 24 months, subject to extension by Citi for an additional 12 months.
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AMC | Hot Stocks16:13 EST AMC Entertainment elects Clark and Putnam to board, Wittlinger steps down - AMC Entertainment announced that the company's board of directors has elected Denise "Dee" Clark and Keri Putnam to the AMC Board of Directors, effective January 1, 2023. "They will each serve as a Class III director of the Company with a term expiring at the Company's 2023 Annual Meeting of Stockholders, and at that meeting will stand for re-election thereafter. Separately, Lee Wittlinger, a Managing Director at leading private investment firm Silver Lake, has served as an AMC Director since 2018 and will resign from his Board role at year end as is the general practice following Silver Lake's exit from an investment. Silver Lake sold its equity stake in AMC in January of 2021. With the appointments of Ms. Clark and Ms. Putnam, along with Mr. Wittlinger's resignation, AMC has made significant progress in reaching its diversity goals, given that three of AMC's nine Directors will be female, versus one of eight currently," the company stated.
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MESA UAL | Hot Stocks16:04 EST Mesa Air finalizes capacity agreement with United Airlines - The company states: "On December 27, 2022, we finalized an amendment and restatement of our capacity purchase agreement with United Airlines. Under the agreement, Mesa will add up to 38 CRJ-900 aircraft, dependent on the number E-175s Mesa is operating. Mesa will begin flying CRJ-900s on behalf of United in March of 2023 and utilize all of the crew and maintenance locations currently operated for American Airlines in Phoenix, Dallas, El Paso, and Louisville, as well as open a CRJ-900 crew base in Houston and a pilot base in Denver. As part of the final agreement, United will also pay Mesa increased block-hour rates to cover the incremental pilot wage increases instituted by Mesa in September 2022, which will remain in effect through September 2025. United will receive a 10% equity position in Mesa and a seat on the Mesa Board of Directors. Additionally, on December 27, 2022, we finalized an agreement with United for a $41.2 million liquidity facility, including the refinancing of $15.7 million outstanding under our CIT revolving credit facility maturing December 31, 2022, and an additional $25.5 million term loan, of which $15.0 million is forgivable if Mesa achieves certain aircraft utilization thresholds. The collateral for the loan is a combination of aircraft parts and a pledge of our equity investment in Archer Aviation, Inc. and Heart Aerospace Incorporated. United also agreed to purchase 30 GE-CF34-8 spare engines from Mesa for $80 million, which is expected to provide over $50 million of net cash proceeds and close in Q1 of 2023."
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ENVX | Hot Stocks16:02 EST Enovix appoints Raj Talluri as CEO - Enovix Corporation (ENVX) announced the appointment of Dr. Raj Talluri as president and CEO, effective January 18, 2023. Talluri is also expected to be appointed to the Enovix board of directors on a later date. Talluri joins Enovix from Micron Technology (MU), where he served as senior VP and General Manager of its Mobile Business Unit. Talluri replaces CEO and co-founder Harrold Rust, who is retiring from his position and the board but will serve in an advisory capacity to support the leadership transition.
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RVP | Hot Stocks15:25 EST Retractable Technologies trading resumes
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HITI | Hot Stocks15:24 EST High Tide closes acquisition of Jimmy's Cannabis Shop BC - High Tide announced the company has completed its acquisition of 100% of the equity interest of 1171882 B.C. Ltd., operating as Jimmy's Cannabis Shop BC, resulting in High Tide's acquisition of two retail cannabis stores currently operated by Jimmy's in British Columbia for $5.3M. The closing of the transaction brings High Tide's nationwide store count to 149, including six in British Columbia. The company also anticipates the organic opening of its location in Kamloops, BC, imminently. High Tide acquired 100% of Jimmy's for 2,595,533 common shares of High Tide valued at $5.3M, on the basis of a deemed price of C$2.0365 per High Tide share. The purchase price is subject to a post-closing working capital adjustment provision, to address any increase or decrease of working capital, inventory or cash estimated as of the closing date. The closing of the transaction remains subject to final approval from the TSX Venture Exchange. Pursuant to the acquisition agreement, 70% of the High Tide shares issued are subject to a four month hold.
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RVP | Hot Stocks15:13 EST Retractable Technologies to repurchase 3M shares in private transaction - Retractable Technologies announces that it has agreed to repurchase three million shares of its common stock in a private transaction with BML Investment Partners, L.P. "Braden Leonard, on behalf of the selling shareholder, approached the company with an offer to sell a block of shares prior to year-end. The company accepted, determining it would be advantageous to buy a large block of shares in one transaction, especially given the stock's low price. The parties negotiated a price of $1.60 per share, being an 8% discount from the $1.74 per share closing price as of December 22," the company stated.
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RVP | Hot Stocks14:50 EST Retractable Technologies trading halted, news pending
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TRP | Hot Stocks14:43 EST TC Energy completes controlled restart of Keystone Pipeline's Cushing Extension - TC Energy said that, "after completing repairs, inspections and testing we proceeded with a controlled restart of the Cushing Extension, safely returning the Keystone Pipeline to service today. The Cushing Extension will operate under plans approved by the U.S. Pipeline and Hazardous Materials Safety Administration. The Keystone Pipeline System is now operational to all delivery points. As always, we continue to monitor the system 24/7 as we deliver the energy customers and North Americans rely on. The pipeline system will operate with additional risk-mitigation measures, including reduced operating pressures. We maintain our commitment to our ongoing safety-led response and will fully remediate the incident site. We will share the learnings from the investigation as they become available."Reference Link
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KALA | Hot Stocks14:35 EST Kala Pharmaceuticals trading resumes
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KALA | Hot Stocks14:30 EST Kala Pharmaceuticals trading halted, volatility trading pause
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ABC | Hot Stocks14:08 EST Justice Department files civil complaint against AmerisourceBergen over opioids - In a civil complaint filed today, the Department of Justice alleges AmerisourceBergen violated federal law in connection with the distribution of controlled substances to pharmacies and other customers across the country, contributing to the prescription opioid epidemic. The complaint alleges that this unlawful conduct resulted in at least hundreds of thousands of violations of the Controlled Substances Act. The Justice Department seeks civil penalties and injunctive relief. The government's complaint alleges that for years AmerisourceBergen flouted its legal obligations and prioritized profits over the well-being of Americans. If AmerisourceBergen is found liable, it could face escalating civil penalties depending on when each violation occurred and the type of controlled substance at issue, specifically, up to $10,000 for each reporting violation before November 2015, up to $16,864 for each violation between November 2015 and October 2018 and for each violation relating to a suspicious order for a non-opioid controlled substance not reported after October 2018, and up to $109,374 for each violation relating to a suspicious opioid order not reported after October 2018, potentially totaling billions of dollars in penalties, the Justice Department said in a statement. Reference Link
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MDWD VCEL | Hot Stocks13:51 EST MediWound confirms FDA approval of NexoBrid triggers $7.5M milestone - MediWound (MDWD) announced that the U.S. Food and Drug Administration has approved NexoBrid for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns. "We are pleased and excited that the FDA has approved NexoBrid, an innovative, non-surgical alternative for the treatment of severe burn injuriesWe appreciate and thank the burn patients who participated in our trials, the clinical investigators, and our researchers for their commitment and efforts to attain this significant achievement. We also thank our partner, BARDA, for their unwavering support since 2015, and our commercial partner, Vericel, who will launch NexoBrid in the U.S. This U.S. FDA approval of NexoBrid validates our enzymatic technology platform. MediWound will continue to pursue its strategic plans to advance the development of novel therapies for burn care, wound care, and tissue repair; we look forward to an exciting and productive 2023," said Ofer Gonen, CEO of MediWound. NexoBrid is already approved for use in 43 countries, including the European Union, Japan, India, and other international markets. Vericel Corporation (VCEL) holds an exclusive license to commercialize NexoBrid in North America. MediWound will receive a $7.5M milestone payment from Vericel Corporation, triggered by the FDA approval of NexoBrid, the company stated.
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VCEL MDWD | Hot Stocks13:49 EST Vericel announces FDA approval of NexoBrid for severe thermal burns - Vericel (VCEL) announced that the U.S. Food and Drug Administration has approved NexoBrid for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns. The FDA approval of NexoBrid is based on multiple preclinical and clinical studies, including the pivotal Phase 3 U.S. clinical study which evaluated NexoBrid in adult patients with deep partial-thickness and full-thickness thermal burns of 3%-30% of total body surface area. The study met its primary endpoint of complete eschar removal as well as all secondary endpoints, including shorter time to eschar removal and a lower incidence of surgical eschar removal compared to standard of care, including both surgical and non-surgical eschar removal methods. A key safety endpoint, non-inferiority in time to greater than95% wound closure compared with patients treated with SOC, was also achieved. NexoBrid is a registered trademark of MediWound (MDWD) and is used under license to Vericel Corporation
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MDWD | Hot Stocks13:43 EST MediWound receives FDA approval of NexoBrid for treatment of severe burns - In a BLA approval letter posted the site of the FDA that was sent to MediWound, the Agency stated: "We are issuing Department of Health and Human Services U.S. License No. 2215 to MediWound, Ltd, Yavne, Israel, under the provisions of section 351(a) of the Public Health Service Act controlling the manufacture and sale of biological products. The license authorizes you to introduce or deliver for introduction into interstate commerce, those products for which your company has demonstrated compliance with establishment and product standards. Under this license, you are authorized to manufacture the product NexoBrid (anacaulase-bcdb) gel which is indicated for eschar removal in adults with deep partial thickness and/or full thickness thermal burns." Reference Link
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ICU NUWE | Hot Stocks13:37 EST SeaStar Medical, Nuwellis announce exclusive U.S. license and distribution pact - SeaStar Medical (ICU) and Nuwellis (NUWE) announce an exclusive U.S. license and distribution agreement by Nuwellis of SeaStar Medical's Selective Cytopheretic Device, or SCD, for the treatment of acute kidney injury in children. Nuwellis will market and distribute the SCD through its direct salesforce to nephrologists and intensive care physicians who are trained in pediatric extracorporeal therapy. SeaStar Medical expects the U.S. Food and Drug Administration to complete a substantive review of a Humanitarian Device Exemption for the use of SCD in children with AKI during the first quarter of 2023, with a potential commercial introduction in the second quarter of 2023, the companies stated. "Nuwellis' established relationships with pediatric nephrology and intensive care key opinion leaders make them the ideal marketing partner for SCD in this indication. With Nuwellis, we have a proven, efficient means to reach our target customers while allowing SeaStar Medical to advance additional indications including a planned pivotal clinical trial in the adult acute kidney injury population, which we expect to initiate during the first quarter of 2023," said Eric Schlorff, CEO of SeaStar Medical.
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BIIB | Hot Stocks13:12 EST House Committee says FDA interactions with Biogen' failed to follow' protocol - The House Committee on Oversight and Reform and Committee on Energy and Commerce presented the findings of an 18-month investigation into the regulatory review and approval, pricing, and marketing of Biogen's Alzheimer's disease drug Aduhelm. The Food and Drug Administration granted accelerated approval for Aduhelm on the basis that the drug reduces amyloid beta plaque in the brain. The FDA's action "came despite the fact that Biogen cancelled clinical trials for Aduhelm in March 2019 due to an independent report indicating the drug was unlikely to effectively slow cognitive and functional impairment and that further clinical study would be futile," the report says. New evidence obtained by the committees shows that an FDA-Biogen working group "engaged in at least 115 meetings, calls, and substantive email discussions over the course of a year, from July 2019 to July 2020, including convening more than 40 meetings to guide Aduhelm's potential approval." The report claims the FDA's interactions with Biogen "were atypical and failed to follow the agency's own documentation protocol." The FDA and Biogen "inappropriately collaborated on a joint briefing document or the PCNS Advisory Committee that did not adequately represent differing views within FDA," the report adds. It also says Biogen set an "unjustifiably high price" for Aduhelm. Reference Link
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BIIB | Hot Stocks13:11 EST Biogen responds to Committee on Oversight, stands by 'integrity' of actions - Biogen issued the following corporate statement on the House Committee on Oversight report: "Since 2021 Biogen has been working cooperatively with the U.S. House Committee on Oversight and Reform and the U.S. House Energy and Commerce Committee regarding their investigations into the launch of Aduhelm, including providing requested information... Biogen has been committed to researching and developing treatments for Alzheimer's disease for more than a decade. We have been focused relentlessly on innovation to address this global health challenge, and have adapted to both successes and setbacks. Biogen stands by the integrity of the actions we have taken. As stated in the congressional report, an FDA review concluded that, 'There is no evidence that these interactions with the sponsor in advance of filing were anything but appropriate in this situation.' Alzheimer's is a highly complex disease and we have learned from the development and launch of Aduhelm. That process is continuing to inform our work as Biogen introduces new innovative treatments to the market. We will continue to appropriately engage diverse stakeholders at every step, including patients and their families, health care providers, and the scientific community. We are dedicated to our mission of bringing innovative and transformative treatments to patients with serious and hard-to-treat conditions." Reference Link
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LUV | Hot Stocks13:04 EST Southwest sees returning to normal on Friday, sets up reimbursement page - Southwest Airlines said in an update on its website: "While Southwest continues to operate roughly one third of its schedule for Thursday, Dec. 29, we plan to return to normal operations with minimal disruptions on Friday, Dec. 30. We are encouraged by the progress we've made to realign Crew, their schedules, and our fleet. With another holiday weekend full of important connections for our valued Customers and Employees, we are eager to return to a state of normalcy. We know even our deepest apologies - to our Customers, to our Employees, and to all affected through this disruption - only go so far. We've set up a page at Southwest.com/traveldisruption for Customers to submit refund and reimbursement requests for meals, hotel, and alternate transportation; as well as to connect Customers to their baggage. We have much work ahead of us, including investing in new solutions to manage wide-scale disruptions. We aim to serve our Customers and Employees with our legendary levels of Southwest Hospitality and reliability again very soon."
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SOXS | Hot Stocks12:00 EST Direxion Daily Semiconductor Bear 3X Shares falls -9.5% - Direxion Daily Semiconductor Bear 3X Shares is down -9.5%, or -$4.14 to $39.46.
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LABD | Hot Stocks12:00 EST Daily S&P Biotech Bear 3x Shares falls -15.6% - Daily S&P Biotech Bear 3x Shares is down -15.6%, or -$3.18 to $17.14.
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BBLU | Hot Stocks12:00 EST Blue Earth falls -22.9% - Blue Earth is down -22.9%, or -$2.40 to $8.08.
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FTCH | Hot Stocks12:00 EST Farfetch rises 11.7% - Farfetch is up 11.7%, or 48c to $4.62.
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CVNA | Hot Stocks12:00 EST Carvana rises 15.9% - Carvana is up 15.9%, or 61c to $4.44.
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IONQ | Hot Stocks12:00 EST IonQ rises 16.4% - IonQ is up 16.4%, or 51c to $3.63.
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BYND MCD | Hot Stocks11:38 EST Beyond Meat rises after McDonald's UK&I announces 'Double McPlant' - McDonald's UK&I (MCD) announced earlier the launch of the Double McPlant in all UK & Ireland restaurants from Wednesday January 4, "just in time for those taking part in Veganuary or those who just simply crave a tasty new burger from McDonalds." The company stated: "The undeniably delicious McPlant, which took over three years to develop, features a patty co-created with Beyond Meat and has already proved wildly successful with customers since its launch in September 2021. It's no secret that people went wild for the taste, with many taking to Twitter to express their desire for a doubled-up version." In Thursday morning trading following the launch announcement, shares of Beyond Meat (BYND) are up $1.49, or 13%, to $12.84. Reference Link
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RSLS | Hot Stocks11:04 EST ReShape Lifesciences Inc trading resumes
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RSLS | Hot Stocks10:59 EST ReShape Lifesciences Inc trading halted, volatility trading pause
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TAL | Hot Stocks10:00 EST TAL Education falls -8.8% - TAL Education is down -8.8%, or -66c to $6.85.
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EDU | Hot Stocks10:00 EST New Oriental Education falls -10.2% - New Oriental Education is down -10.2%, or -$3.72 to $32.65.
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BBLU | Hot Stocks10:00 EST Blue Earth falls -23.2% - Blue Earth is down -23.2%, or -$2.44 to $8.04.
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LSPD | Hot Stocks10:00 EST Lightspeed rises 7.8% - Lightspeed is up 7.8%, or $1.00 to $13.75.
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KOLD | Hot Stocks10:00 EST ProShares UltraShort Bloomberg Natural Gas rises 7.9% - ProShares UltraShort Bloomberg Natural Gas is up 7.9%, or $1.99 to $27.34.
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NOTE | Hot Stocks10:00 EST FiscalNote rises 10.4% - FiscalNote is up 10.4%, or 56c to $5.94.
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TAL | Hot Stocks09:47 EST TAL Education falls -10.1% - TAL Education is down -10.1%, or -76c to $6.75.
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EDU | Hot Stocks09:47 EST New Oriental Education falls -12.0% - New Oriental Education is down -12.0%, or -$4.37 to $32.00.
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BBLU | Hot Stocks09:47 EST Blue Earth falls -23.8% - Blue Earth is down -23.8%, or -$2.49 to $7.99.
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RXO | Hot Stocks09:47 EST RXO Inc. rises 5.4% - RXO Inc. is up 5.4%, or 88c to $17.20.
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MSC | Hot Stocks09:47 EST Studio City rises 5.4% - Studio City is up 5.4%, or 32c to $6.22.
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KOLD | Hot Stocks09:47 EST ProShares UltraShort Bloomberg Natural Gas rises 6.5% - ProShares UltraShort Bloomberg Natural Gas is up 6.5%, or $1.65 to $27.00.
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KSCP | Hot Stocks09:43 EST Knightscope announces four contracts for seven ASRs - Knightscope announces 4 new contracts totaling 7 Autonomous Security Robots as part of its end-of-year push to support the Company's commitment to continue accretively adding to its top-line revenue. Details regarding the new contracts and deployment locations are as follows: One of Houston's top commercial real estate brokerage and property management firms, with dozens of office locations across the U.S., signed an agreement for one K1 Hemisphere and one K1 Tower to protect a large parking structure at one of its many properties. A church in the area of St. Louis/Springfield, Missouri area will soon have a K1 Hemisphere to help curb nefarious activities related to people loitering on their property to take advantage of the beautiful, local scenery. Previously dissatisfied with the unreliable and expensive security guards hired to deter unwanted visitors and criminals at their facility, a Houston manufacturer of premium quality lubricants and associated products for the automotive, industrial and drilling markets contracted Knightscope earlier in 2022 to help better protect its property. Knightscope was deemed a success, and the client added another K5 ASR to its security program. Another expansion comes from a real estate investment company with properties in 14 U.S. states. This client is duplicating its previous order of two K5 ASRs, one K1 Tower and Knightscope+ remote monitoring service in Pittsburgh for one of its other properties in Dallas, Texas.
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RACY | Hot Stocks09:41 EST Relativity Acquisition Corp trading resumes
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MPAC | Hot Stocks09:37 EST Model Performance Acquisition Corp trading resumes
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NUWE | Hot Stocks09:37 EST Nuwellis Inc trading resumes
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FEIM | Hot Stocks09:36 EST Frequency Electronics trading resumes
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BYD... | Hot Stocks09:33 EST Nevada reports November statewide gaming win down 7.62% to $1.22B - Reports Las Vegas Strip gaming win down 11.33% versus last year to $669.48M. Publicly traded companies in the gambling space space include Boyd Gaming (BYD), Caesars (CZR), Churchill Downs (CHDN), DraftKings (DKNG), Flutter Entertainment (PDYPY), Gan Limited (GAN), Las Vegas Sands (LVS), MGM Resorts (MGM), Penn Entertainment (PENN), William Hill (WIMHY) and Wynn Resorts (WYNN).
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MPAC | Hot Stocks09:32 EST Model Performance Acquisition Corp trading halted, volatility trading pause
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NUWE | Hot Stocks09:32 EST Nuwellis Inc trading halted, volatility trading pause
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RACY | Hot Stocks09:31 EST Relativity Acquisition Corp trading halted, volatility trading pause
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FEIM | Hot Stocks09:31 EST Frequency Electronics trading halted, volatility trading pause
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FUTU | Hot Stocks09:30 EST Futu to postpone listing of Class A shares on Hong Kong Stock Exchange - Futu Holdings Limited announces that the company is clarifying certain matters concerning the Group with the Hong Kong Stock Exchange. Consequently, the company has decided to postpone the listing of its Class A Ordinary Shares on the Hong Kong Stock Exchange, it stated.
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AER EADSY | Hot Stocks09:21 EST AerCap delivers first of six new Airbus A330neo Aircraft to Condor - AerCap (AER) announced the delivery of the first of six new Airbus (EADSY) A330-900neo aircraft to German leisure carrier, Condor. The remaining aircraft are scheduled to deliver in summer 2023 through 2024. "We are delighted to announce the delivery of the first of six new Airbus A330-900neo aircraft to Condor, and to see the aircraft painted in their distinctive new striped livery design," said Peter Anderson, the Chief Commercial Officer of AerCap. "The A330neo aircraft is the perfect choice for Condor and will enable them to expand their network using the most modern, fuel-efficient technology while supporting their sustainability commitments. We wish the team every success and we look forward to continuing to build our partnership in the years to come."
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GRIL | Hot Stocks09:18 EST Muscle Maker's Sadot crosses $100M revenue milestone in first 45 days - Muscle Maker announced its new wholly owned subsidiary, Sadot, has crossed the $100 million revenue milestone in its first 45 days of operation. Sadot generated $54.19M in revenue in November and an additional $55.84M in top line sales through December 19th. Sadot, in its first 45 days of operation, has now generated over $110M in revenue. Total company year-to-date revenue increased by 1,369% to $118.7M since the end of Q3, 2022.
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LEXX | Hot Stocks09:11 EST Lexaria Bioscience receives patent in Canada - Lexaria Bioscience announced its continued accumulation of international patent recognition with the receipt of its first granted patent in Canada, which is its 28th granted patent worldwide. Canadian Patent #3,093,414 is the first granted patent from Lexaria's sixth patent family and is entitled "Transdermal And/Or Dermal Delivery Of Lipophilic Active Agents". The patent is for improved compositions and methods for transdermal and dermal delivery of cannabinoids, including cannabidiol and tetrahydrocannabinol. Similar patent applications for skin-based delivery of DehydraTECH formulations remain pending in many other countries.
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RKLY | Hot Stocks09:10 EST Rockley gets $15.5M for FY20 R&D tax credit from UK government tax agency - Rockley Photonics Holdings announced that it received 12.9 million pounds sterling or $15.5M for its fiscal 2020 R&D tax credit from HMRC, the tax agency of the UK government. The Company filed its fiscal 2021 R&D tax credit application and expects to file its fiscal 2022 R&D tax credit application in 2023.
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OTLK | Hot Stocks09:09 EST Outlook Therapeutics sees funding through FDA approval of ONS-5010 - At September 30, 2022, Outlook Therapeutics had cash and cash equivalents of $17.4 million. Subsequent to September 30, 2022, the Company closed a registered direct equity offering priced at-the-market under Nasdaq rules, resulting in aggregate gross proceeds of approximately $25.0 million. Additionally, the Company closed on an unsecured convertible promissory note with a face amount of $31.8 million and net proceeds of approximately $30.0 million after original issue discount and after deducting the Lender's transaction costs covered by the Company in connection with the issuance. The combined proceeds from the Note and the registered direct offering are expected to provide funding through the anticipated FDA approval of ONS-5010 in the third calendar quarter of 2023.
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TGTX | Hot Stocks09:08 EST TG Therapeutics says about 6-9 months behind U.S. on potential EU approval - Comments from TG Therapeutics' Briumvi FDA approval call and associated slides.
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OTLK | Hot Stocks09:08 EST Outlook Therapeutics announces anticipated milestones - Continued progress with ongoing pre-launch commercial preparations in anticipation of potential approval for ONS-5010 in 2023; PDUFA goal date of August 29, 2023; and Estimated decision date from the EMA's Committee for Medicinal Products for Human Use on the Company's submitted MAA in EU for ONS-5010 expected in early 2024.
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FSTX | Hot Stocks09:07 EST F-star says invoX extended offer, in further extension talks after CFIUS warning - In a regulatory filing, F-star Therapeutics stated: "As previously disclosed, on December 20, 2022, Purchaser, Parent, and the Company entered into Amendment No. 3 to the Merger Agreement, in order to, among other things, amend the Foreign Investment Condition of the Offer with respect to CFIUS to provide that it will be satisfied if: a declaration or notification has been made to or requested by CFIUS with respect to the transactions contemplated by the Merger Agreement, (x) the CFIUS Action with respect to such declaration or notification has occurred or (y) the Parties have not received notification of any actual or threatened commencement of any legal proceeding, issuance of any order, or taking of any other action, by or on behalf of CFIUS that would seek to enjoin, prevent, restrain or otherwise prohibit the consummation of the transactions contemplated by the Merger Agreement. On the evening of December 28, 2022, and prior to the then-scheduled Expiration Date, CFIUS notified Parent that if the Parties intended to proceed with the closing of the transactions contemplated by the Merger Agreement without having resolved CFIUS's identified national security risks, CFIUS would take action to restrict the Parties from consummating the transactions contemplated by the Merger Agreement. Shortly thereafter, CFIUS delivered to the Parties an Interim Order preventing the Parties from consummating the transactions contemplated by the Merger Agreement pending conclusion of CFIUS's review of the transaction, action by the President or revocation of the Interim Order. The Interim Order is intended to provide CFIUS the opportunity to continue its review and investigation. As a result, the Foreign Investment Condition of the Offer with respect to CFIUS has not been satisfied. On December 29, 2022, Purchaser, Parent and SBP extended the Offer to 5:00 p.m., Eastern Time, on December 30, 2022, unless further extended, to provide Purchaser, Parent and SBP an opportunity to discuss with the Company an extension of the End Date to January 29, 2023, the last day of CFIUS's 45-calendar day review period, and any conditions on which Purchaser, Parent and SBP would be willing to agree to such extension. The Offer was previously set to expire at one (1) minute past 11:59 p.m., Eastern Time, on December 28, 2022. The Depositary has advised Purchaser, Parent, and SBP that, as of one (1) minute past 11:59 p.m., Eastern Time, on December 28, 2022, 16,709,745 Shares had been validly tendered into and not properly withdrawn from the Offer, representing approximately 75.99% of the outstanding Shares, and an additional approximately 1,488,292 Shares tendered pursuant to a notice of guaranteed delivery. Unless extended, the End Date will remain one (1) minute past 11:59 p.m., Eastern Time, on December 30, 2022."
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KALU | Hot Stocks09:05 EST Kaiser Aluminum publishes 2021 sustainability report - Kaiser Aluminum published its 2021 Sustainability Report summarizing the Company's focus and initiatives around its environmental, social and governance programming and development as it continues to manage its business for long-term success in a manner that is economically, environmentally and socially responsible. Highlights of the Company's 2021 Sustainability Report: Expanded environmental disclosures to include operational metrics for our Warrick rolling mill, water program case studies for our Trentwood rolling mill, waste information and sustainability goals and highlights focused on greenhouse gas emissions intensity, reduction goals, plans and progress. Expanded the scope of duties and responsibilities of our Board's ESG Committee to provide more focused oversight of the Company's ESG activities and strategic initiatives. Enhanced social disclosures focused on cybersecurity, the Kaiser Aluminum Women's Leadership Program and a link to the Company's Equal Employment Opportunity report. Reported strong 2021 safety performance with a record lost-time case incident rate, representing a 30% reduction compared to 2020. Provided updated governance highlights supporting Board composition best practices and updated supply chain data. Provided additional metrics and enhanced disclosures based upon the Sustainability Accounting Standards Board with the objective over time of more fully aligning with SASB and the Task Force on Climate-Related Financial Disclosures.
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HRTX | Hot Stocks09:04 EST Heron Therapeutics announces filing of sNDA for ZYNRELEF - Heron Therapeutics announced the submission of a supplemental New Drug Application, sNDA, for ZYNRELEF extended-release solution to support the proposed indication for greatly expanded use of ZYNRELEF in soft tissue and orthopedic surgical procedures and a newly passed congressional bill that is anticipated to provide separate reimbursement outside of the packaged surgical payment for ZYNRELEF for almost 3 years. "Submission of this sNDA is designed to further expand ZYNRELEF's indication for use in soft tissue and orthopedic procedures, which would double the current target surgical procedures to 14 million. The combination of the existing Centers for Medicare and Medicaid Services, CMS, pass-through payments with the new legislation providing separate payments for ZYNRELEF in the outpatient setting of care through December 31, 2027 will provide for more than 4 years of separate reimbursement payments after the 10-month anticipated action date for this sNDA," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "Expanding the indicated surgical procedures and gaining almost three additional years of separate payments from CMS is anticipated to significantly accelerate uptake of ZYNRELEF in large hospital systems, and allow many more patients to benefit from superior pain management over 72 hours with a reduced need for opioids."
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BABA | Hot Stocks09:02 EST Alibaba names new CTO as CEO steps in interim cloud head - Alibaba Group unveiled senior management changes on Thursday, including Wu Zeming's rise to the platform company's C-suite as CTO. In a separate move, Jeff Zhang will focus on his role as head of the Alibaba DAMO Academy and no longer serve as President of Alibaba Cloud Intelligence. Jeff will continue to be responsible for Alibaba's proprietary chip development team T-Head and Internet of Things initiatives. In Jeff's stead, Daniel Zhang, Chairman and CEO of Alibaba Group, will assume the role of acting President of Alibaba Cloud Intelligence and responsibility for the communication and collaboration platform DingTalk. Alibaba regularly reshuffles management annually to keep pace with the evolving internet space and with the growth of the team. Wu Zeming succeeds Li Cheng as CTO. After joining Alibaba in 2002, he made partner at Alibaba in 2017. Before Cheng became Alibaba's CTO in 2019, he held various senior roles at its financial services affiliate, Ant Group. Moving forward, Cheng will continue to work with Daniel Zhang as an advisor on technology. Zhou Jingren will serve as CTO of Alibaba Cloud Intelligence in addition to his current role as Deputy Head of the DAMO Academy. On April 1, 2023, Jane Jiang will succeed Judy Tong as Group Chief People Officer, a role she has held since 2017. One of Alibaba's 18 original co-founders, Jiang is a senior executive in the company's human resources team, responsible for personnel management, including the safety, community-building and satisfaction of employees.
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TGTX | Hot Stocks09:02 EST TG Therapeutics says Briumvi annual maintenance WAC price $59,000 - Adam Waldman, Chief Commercialization Officer, said Briumvi is being priced to be "the lowest priced, branded disease modifying therapy approved for MS." Comments from TG Therapeutics' Briumvi FDA approval call and associated slides.
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KULR | Hot Stocks08:51 EST KULR Technology partners with Theory Racing to develop e-bike batteries - KULR Technology Group announced a partnership with Theory Racing. The partnership with Theory comes on the heels of the Company announcing that it will introduce its all-new modular energy storage platform, KULR ONE, at CES 2023 this January 5-8. KULR ONE is a family of next-generation battery packs bringing a combination of safety, performance, intelligence, modularity and reliability to the world's most demanding applications.
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BRLXF | Hot Stocks08:49 EST Boralex acquires 50% interest in five wind farms totalling 894 MW - Boralex has completed the acquisition of EDF Renewables North America's interest in five operating wind farms with a total installed capacity of 894 megawatts, located in Texas and New Mexico. EDF Renewables' interest represents 447 MW of installed capacity. With this acquisition, Boralex's total installed capacity worldwide will increase to 2,956 MW, marking a significant step towards achieving Boralex's 2025 Strategic Plan. Financial Highlights: Purchase Price, net of cash, and certain production tax credits receivable: C$339.7M, subject to customary post-Closing adjustments. Boralex will fund the Purchase Price from available cash resources. There is no existing project debt and the existing tax equity investors will continue to monetize the remaining production tax credits. The portfolio includes two projects with 13-year busbar power purchase agreements and one project with a 3-year hub-settled PPA; for a remaining weighted PPA average life of 10 years. Additionally, the portfolio includes two fully merchant projects. Expected 2023 contribution to Boralex combined EBITDA of approximately C$39M. The acquisition will be accounted for as an investment in a joint venture in consolidated financial statements. Immediately accretive to discretionary cash flow, with a 2023 contribution of approximately C$25M or C$0.24 per share, a 19% increase over the consolidated amount generated by Boralex in 2021. Boralex has a history of optimizing the life cycle of its sites, as such these wind farms will benefit from years of experience in operation, maintenance, and repowering. Furthermore, this acquisition perfectly pairs with Boralex's organic development activities in the United States. In recognition of its expertise, Boralex will become the managing member of the partnership. Commissioned between 2014 and 2016, EDF Renewables developed and built all five wind farms utilizing Tier 1 turbine manufacturers. The acquisition will balance Boralex's current United States mix of solar and hydro power generation capacity. Three of the wind farms have long-term PPAs that are well structured with well-established off-takers. The PPAs do not contain fixed shape hedges that have caused recent difficulties in these markets. The other two wind farms are in strong and stable merchant markets, and with current condition of inflation, some merchant exposure will be complementary to the PPAs.
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HOTH | Hot Stocks08:47 EST Hoth Therapeutics announces FDA acceptance of IND application for HT-001 - Hoth Therapeutics announced that the U.S. Food and Drug Administration, FDA, has accepted an Investigational New Drug, IND, application for the company's HT-001 therapeutic for the treatment for rash and skin disorders associated with epidermal growth factor receptor, EGFR, inhibitor therapy. "We are excited to begin our trial and bring hope to patients who are suffering. With no specific treatment currently approved for the treatment of skin toxicities associated with EGFRi therapies, this trial brings us one step closer to a new treatment option for underserved cancer patients," said Robb Knie, CEO of Hoth Therapeutics, Inc. "We look forward to advancing HT-001 into the clinical phase as we believe that this novel therapeutic will be a key treatment in the onco-dermatology space. We anticipate beginning our Phase 2a trial in Q1 of 2023."
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TGTX | Hot Stocks08:43 EST TG says 'ideally' Briumvi to be in centers within 30-45 days of new year - TG Therapeutics sees launching in Q1 of 2023 and says that "ideally" Briumvi will be available in centers within 30 to 45 days of the start of the year. Comments from TG Therapeutics' Briumvi FDA approval call.
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CLMT | Hot Stocks08:43 EST Calumet Specialty Products provides 2022 year end operational update - Calumet Specialty Products Partners provided a year-end operational update, including a project and business update at Montana Renewables and company-wide impact from the December arctic blast. Montana Renewables and Montana Refining: Separation of Montana Renewables and the Great Falls Specialty Asphalt refinery was completed during the fourth quarter with both businesses operating in their new services. The 12,000 bpd specialty asphalt refinery is presently running at nameplate capacity on Canadian heavy crude. Montana Renewables commissioned its modified hydrocracker in renewable diesel service on November 5, then retrofitted additional winterization capability during the month of November. Catalyst performance has been consistent and met the expected performance envelope provided by Haldor Topsoe. The current 6,000 bpd capacity will increase to 12,000 bpd with the sequential commissioning of renewable hydrogen, SAF, and feedstock pre-treater which are expected online in that order in 1Q2023. Specialties Business: Calumet's specialty business has performed exceptionally well in 2022, including throughput and profitability records across the system and at most individual plants. This performance was supported by exceptional execution of key turnarounds in Shreveport and Princeton and capital investments targeting reliability and deeper integration between assets, widening a key competitive advantage of this business. Last week, Calumet's production was impacted with nearly all units being either circulated or shutdown during the extreme weather event. Since then, city water has been restored, and the company is currently in startup. All other plants are back up in production. Demand in the specialty business continues to be healthy considering routine seasonal volume patterns. The company sees typical soft winter asphalt margins and continue to experience strong specialty product margins as the company enters 2023.
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TGTX | Hot Stocks08:42 EST TG Therapeutics doesn't see need to raise additional capital at this time - TG Therapeutics sees ending Q4 with $175M in cash and notes ability to draw up to $45M from available facility if needed. Comments from TG Therapeutics' Briumvi FDA approval call.
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ATNF | Hot Stocks08:42 EST 180 Life Sciences CEO says priorities continue to be clinical programs - The company said, "As we come to the end of 2022, I am pleased to provide an update for our shareholders. In keeping with good corporate practice and US Securities and Exchange Commission regulations, we have refrained from answering individual queries from shareholders until we were able to provide information to all shareholders at the same time. Our priorities continue to be our clinical programs, repurposing anti-Tumor Necrosis Factor drugs for treating Dupuytren's disease, frozen shoulder and post-operative delirium. The Dupuytren's contracture trial phase 2B trial, led by Prof Nanchahal, the results of which we have previously announced, exceeded our expectations. It also showed that the treatment is likely to be cost-effective. Now, after obtaining scientific advice from the UK Medicines and Healthcare products Regulatory Agency, the UK equivalent of the US Food and Drug Administration, and after discussions with our regulatory consultants in the United States and United Kingdom, we made the decision to begin preparing all the material necessary to seek marketing authorization in the UK. Based on the guidance received from our regulatory consultants on the time required to prepare the marketing authorization application, we currently plan on filing the application in mid-2023. In seeking a marketing authorization, we plan to engage a specialized consultant, Dr. Keith Watson, who spent nearly five years with the MHRA as a reviewer of biologics product applications, later serving as Director of Global Regulatory Affairs, Biologics Strategic Development Group at AbbVie, and more recently Vice President of Regulatory Affairs for Celltrion Inc. He now manages his own regulatory consulting practice....A published study from the Netherlands showed that increase in nodule size correlates with finger flexion deformity and we reason that a reduction in nodule size would conversely mean that fingers are less likely to contract. As previously disclosed, the MHRA reviewed the primary and secondary endpoints in the phase 2b trial and the data provided by the Company and noted that it has not been shown that reducing nodule size via treatment would lead to improvements in terms of Dupuytren's disease progression. We plan to continue to collect all available data to address the point made by the MHRA. In addition, we may conduct a follow-on study to address the requirements of the MHRA, the EU, and the US FDA. We expect Dr. Watson will provide us advice regarding the best path forward assuming we receive Conditional Marketing Authorization. With the recent financing complete, the Company is proceeding with the preparation of the necessary CMA application documents. It is a very substantial, but worthwhile task...Enrollment to the trial of anti-TNF for early-stage frozen shoulder is slower than anticipated in the UK as patients typically present to physical therapists and the processes are subject to delays. In the USA, all such patients are seen by orthopedic physicians, who are relatively easy to access. The trial team has implemented several strategies to improve recruitment and we hope that these will be effective. Preparation for the trial of anti-TNF to prevent the development of postoperative delirium remains on track and we anticipate that the first patient will be recruited in the first half of 2023...Our HMGB1 program continues to advance slowly. The molecular dynamics for the binding of this molecule are extremely complex and potentially need more extensive research in order to identify a lead candidate. The synthetic cannabinoid program is also moving along, albeit slower than expected, with an emphasis on more effective formulations to ensure that the cannabinoids are much more orally available, as they are currently very poorly absorbed. We are continuing with our research in this field towards the development of a treatment for chronic pain. Assuming that the oral formulation research efforts are successful, we may initiate early trials in patients suffering from chronic pain, perhaps in early 2024. As most of you know, we remain in some ongoing litigation and at this point we have no further update on such matters other than what has been reported in extensive detail in our most recent Quarterly Report on Form 10-Q."
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BEAT | Hot Stocks08:41 EST HeartBeam sees HeartBeam AIMI to be cleared in Q1 time frame - HeartBeam issued a letter to shareholders from its Chief Executive Officer and Founder, Branislav Vajdic, PhD. That letter said in part: "2022 was a transformative year for HeartBeam and for our technology and business, highlighted by ongoing advancements in our product launch timeline for the HeartBeam AIMIGo 12-Lead 3D Vector Electrocardiogram ECG Device and HeartBeam AIMI...Developed by our pioneering team, our HeartBeam AIMI and HeartBeam AIMIGo solutions will transform the way patients and doctors detect heart attacks. By providing remote, 12-lead 3D vector ECG VECG capability, the HeartBeam platform intends to offer fast, accurate detection of heart attacks and complex cardiac arrhythmias for the first time outside of a medical setting. We expect the HeartBeam AIMI system for use in acute care settings to receive regulatory approval in the near future. We are in discussions with the FDA and plan to meet with them soon and expect HeartBeam AIMI to be cleared in the Q1 2023 time frame ..We plan to focus in 2023 and 2024 on the expansion of our core technology features, the 3D VECG data and clinical studies that we believe will establish our platform as the standard of care for ambulatory-based cardiology and taking advantage of the comprehensiveness of our technology."
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ESEA | Hot Stocks08:39 EST Euroseas announces sale of 5,610 teu container vessel - Euroseas announced that it has agreed to sell M/V Akinada Bridge, a 5,610 teu intermediate containership vessel built in 2001, at a gross price of $14.2M. The vessel is expected to be delivered to its buyers in the beginning of January 2023.
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ACER | Hot Stocks08:38 EST Acer Therapeutics regains compliance with Nasdaq listing rules - Acer Therapeutics announced that The Nasdaq Stock Market LLC has formally notified Acer that the company has regained compliance with the $35M market value of listed securities requirement, and otherwise satisfies all other criteria necessary, for continued listing on The Nasdaq Capital Market. Accordingly, the listing matter is now closed and the previously-scheduled hearing before the Nasdaq Hearings Panel has been cancelled.
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BEAT | Hot Stocks08:37 EST HeartBeam sees HeartBeam AIMI to be cleared in Q1 time frame - HeartBeam issued a letter to shareholders from its Chief Executive Officer and Founder, Branislav Vajdic, PhD. 2022 was a transformative year for HeartBeam and for our technology and business, highlighted by ongoing advancements in our product launch timeline for the HeartBeam AIMIGo 12-Lead 3D Vector Electrocardiogram ECG Device and HeartBeam AIMI...Developed by our pioneering team, our HeartBeam AIMI and HeartBeam AIMIGo solutions will transform the way patients and doctors detect heart attacks. By providing remote, 12-lead 3D vector ECG VECG capability, the HeartBeam platform intends to offer fast, accurate detection of heart attacks and complex cardiac arrhythmias for the first time outside of a medical setting. We expect the HeartBeam AIMI system for use in acute care settings to receive regulatory approval in the near future. We are in discussions with the FDA and plan to meet with them soon and expect HeartBeam AIMI to be cleared in the Q1 2023 time frame ..We plan to focus in 2023 and 2024 on the expansion of our core technology features, the 3D VECG data and clinical studies that we believe will establish our platform as the standard of care for ambulatory-based cardiology and taking advantage of the comprehensiveness of our technology.
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ICU NUWE | Hot Stocks08:37 EST SeaStar Medical, Nuwellis enter license, distribution deal for SCD for AKI - SeaStar Medical Holding (ICU) and Nuwellis (NUWE) announce an exclusive U.S. license and distribution agreement by Nuwellis of SeaStar Medical's Selective Cytopheretic Device for the treatment of acute kidney injury in children. Nuwellis will market and distribute the SCD through its direct salesforce to nephrologists and intensive care physicians who are trained in pediatric extracorporeal therapy. SeaStar Medical expects the U.S. Food and Drug Administration to complete a substantive review of a Humanitarian Device Exemption for the use of SCD in children with AKI during the first quarter of 2023, with a potential commercial introduction in the second quarter of 2023.
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BLIN SHOP | Hot Stocks08:35 EST Bridgeline, Shopify partner for prescriptive marketing dashboard eCommerce360 - Bridgeline Digital (BLIN) announced that its prescriptive marketing dashboard, eCommerce360, is now available within the app store on the Shopify (SHOP) platform. Shopify has partnered with Bridgeline to power analytics and prescribe new revenue strategies for their base of more than 4 million users across 175 countries. Users now can integrate the Bridgeline eCommerce360 app to their Shopify sites and use the e360 dashboard directly within the Shopify admin interface.
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SGBX | Hot Stocks08:35 EST Safe & Green files second SEC complaint on shareholder group - Safe & Green announced that it has filed a second complaint with the U.S. Securities and Exchange Commission's Delinquent Filing Group within the Division of Enforcement against a group of affiliated beneficial shareholders believed to own a significant amount of the company's common stock, who have failed to report their ownership as required under Section 13 of the Exchange Act. Safe & Green said, "The company has made multiple attempts since becoming aware of the issue to encourage the connected shareholders to come into compliance with Section 13 of the Exchange Act, yet no action has been taken by them. Given this group of shareholders is believed to control a significant amount of the Company's float, yet not disclosing this publicly, the Company felt it had no choice but to file its second complaint with the SEC to ensure that all shareholders and potential investors have accurate information, as required by law, as to its top shareholders." "Today's announcement reaffirms Safe & Green Holdings' commitment to all shareholders to ensure fairness and transparency as to our shareholder base and operations," said CEO and chairman Paul Galvin. "Our recently announced proposed spin-off of Safe and Green Development Corporation, coupled with our consistent efforts of working to uncover trading irregularities and create ownership transparency, highlight our commitment to ensuring a maximization of value for all shareholders big and small."
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OBNNF | Hot Stocks08:08 EST Osisko Mining announces TSX approval to renew normal course issuer bid - Osisko Mining announces that the Toronto Stock Exchange has approved the Corporation's notice of intention to make a normal course issuer bid. Under the terms of the NCIB Program, Osisko may acquire up to 29,053,640 of its common shares from time to time in accordance with the normal course issuer bid procedures of the TSX. The normal course issuer bid will be conducted through the facilities of the TSX or alternative trading systems, if eligible, and will conform to their regulations. Purchases under the normal course issuer bid will be made by means of open market transactions or such other means as a securities regulatory authority may permit, including pre-arranged crosses, exempt offers and private agreements under an issuer bid exemption order issued by a securities regulatory authority. Repurchases under the NCIB Program may commence on January 2, 2023 and will terminate on January 1, 2024 or on such earlier date as the NCIB Program is complete. Daily purchases will be limited to 126,972 Common Shares, other than block purchase exemptions, representing 25% of the average daily trading volume of the Common Shares on the TSX for the six-month period ending November 30, 2022, being 507,890 Common Shares. The price that the Corporation may pay for any Common Shares purchased in the open market under the NCIB Program will be the prevailing market price at the time of purchase (plus any brokerage fees) and any Common Shares purchased by the Corporation will be cancelled. In the event that the Corporation purchases Common Shares by pre-arranged crosses, exempt offers, block purchases or private agreements, the purchase price of the Common Shares may be, and will be in the case of purchases by private agreements, as may be permitted by the securities regulatory authority, at a discount to the market price of the Common Shares at the time of acquisition.
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NVEE | Hot Stocks08:06 EST NV5 Global awarded $9M for NYC Parks & Recreation facility improvements - NV5 Global announced that it has been awarded a $9M contract by the New York City Department of Parks and Recreation to provide landscape architectural design services throughout New York City. The agreement carries an initial term of three years, as well as a two-year renewal option. Under this contract, NV5 will design improvements for facilities such as sports fields, playgrounds, skate parks, tracks, waterfront, natural areas, and shoreline restoration. Special focus will be placed on sustainable design to improve the connection between parks and neighborhoods, as well as the utilization of green infrastructure techniques to promote resiliency. This is NV5's second consecutive agreement of its kind with the New York City Department of Parks and Recreation.
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VSAT | Hot Stocks08:04 EST ViaSat awarded five-year $325M IDIQ contract by U.S. SOCOM - Viasa announced it was awarded an indefinite delivery, indefinite quantity, IDIQ, contract award worth up to $325M over a five-year period to support the U.S. Special Operations Command, SOCOM. This sole-source IDIQ is an extension of a $350M IDIQ contract awarded to Viasat in 2017. Under the contract award, Viasat will continue to provide advanced mission equipment, services and support to sustain and improve situational awareness, integration, terrestrial networking, intelligence, surveillance and reconnaissance, tactical satellite communications, information assurance and network management capabilities of Special Operations Forces. "This contract award reaffirms Viasat's deep commitment and partnership with the SOCOM community to understand and address the capability needs of forces for the most complex missions," said Craig Miller, president of Viasat Government Systems. "Networking and communications needs across the modern battlespace are continually evolving and we're excited to help SOCOM maintain the advantage with solutions that deliver the performance, flexibility and resilience Special Operations Forces require to successfully operate independently and interoperate effectively with joint forces."
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RAIN | Hot Stocks08:03 EST Rain Therapeutics announces name change to Rain Oncology - Rain Therapeutics announced that it will change its name to Rain Oncology Inc. effective tomorrow, December 30, 2022, to better reflect the company's focus on addressing unmet needs for cancer patients through precision oncology. In connection with the name change, Rain will have a new corporate website at www.rainoncology.com. No action is required from current stockholders in connection with the name change. The company's common stock will continue to be listed on The Nasdaq Global Select Market and the CUSIP will not change. The number of outstanding shares of the company's common stock is not affected by the name change. The company's ticker symbol "RAIN" will remain the same.
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RNAZ | Hot Stocks08:02 EST Transcode announces FDA authorization to proceed with first-in-human trial - TransCode Therapeutics announced that it has received written authorization from the U.S. Food and Drug Administration that it may proceed with its First-in-Human Phase 0 clinical trial. The planned clinical trial is to evaluate TransCode's lead therapeutic candidate, TTX-MC138, in up to 12 cancer patients with advanced solid tumors. TTX-MC138 is designed to inhibit the pro-metastatic RNA, microRNA-10b, described as the master regulator of metastasis in a number of advanced solid tumors. TransCode believes that TTX-MC138 could be used as a treatment for many of these cancers. The Company believes that TTX-MC138 has the potential to dramatically improve clinical outcomes in a range of cancers, including breast, pancreatic, ovarian and colon cancer, glioblastomas and others. In a preclinical murine model of triple-negative breast cancer model, treatment with low-dose chemotherapy and TTX-MC138 eliminated pre-existing local metastases in 100% of treated animals representative of stage II/III metastatic cancer. In a more aggressive murine model representative of stage IV metastatic cancer, treatment with low-dose chemotherapy and TTX-MC138 resulted in elimination of distant metastases in 65% of animals treated. In a murine model of pancreatic adenocarcinoma, administration of TTX-MC138 as monotherapy resulted in complete responses, manifested as regression without recurrence, in 40% of treated animals. In addition to murine models of cancer, TTX-MC138 was successfully delivered and demonstrated preliminary efficacy in a case study of spontaneous feline mammary carcinoma. A Phase 0 clinical trial is an exploratory study conducted under an Investigational New Drug application. In TransCode's planned clinical trial, up to 12 patients will be given a single dose of radiolabeled TTX-MC138 followed by noninvasive positron emission tomography-magnetic resonance imaging. The trial is intended to quantify the amount of radiolabeled TTX-MC138 delivered to metastatic lesions and the pharmacokinetics of the therapeutic candidate in cancer patients. The trial could yield critical data regarding therapeutic dose, timing, and potential safety that could inform later stage clinical trials. This trial is not intended to demonstrate any therapeutic effect.
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DCGO | Hot Stocks07:40 EST DocGo co-founder Stan Vashovsky to continue as chairman - DocGo announced that its co-founder and current chairman of the board and CEO Stan Vashovsky will continue to serve as non-executive chairman of its board of directors beginning on January 1, 2023 and following his retirement as CEO of the company. The company had previously announced that Vashovsky will retire as CEO of the company as of December 31 and step down from the board of directors and his chairman position at the same time. The company believes it is in its best interests to have Vashovsky continue to serve as chairman given DocGo's strong growth outlook. Ira Smedra, who was to succeed Vashovsky as chairman on January 1, 2023, will continue serving as a member of DocGo's board of directors. As previously disclosed, current president Anthony Capone will succeed Vashovsky as CEO beginning on January 1, 2023.
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ARDX | Hot Stocks07:40 EST Ardelyx up 9% in pre-market at $2.73 after FDA grants appeal for XPHOZAH
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EFLVF | Hot Stocks07:32 EST Electrovaya announces credit facility extension, repayment of promissory note - Electrovaya announced it has amended its loan agreement with its lender. Key amendments include a reduction in the interest rate calculation by 1% and extension of the term by 6 months with an option for a further 6 months under the same terms. The fees for the 6 month extension are 0.5% of the facility and will be paid in shares. Electrovaya has also repaid and closed its C$6M promissory note with the same lender in November.
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WETG | Hot Stocks07:32 EST WeTrade enters strategic cooperation with Fujian Super Solar Energy Technology - WeTrade Group announced that the Company has entered into strategic cooperation with Fujian Super Solar Energy Technology, under which the two parties will work together to develop portable energy storage products and distribute them globally. Seeing the booming downstream application, the two groups will work together to meet the demand of market, and push the rapid growth in their respective business scale. This cooperation also marks the official entry of WeTrade Group into the new energy market. Hechun Wei, Chief Executive Officer of the Company, commented, "This entry into the new energy market has been a part of the company's strategy and an important step up in 2023. The entry will further consolidate the Company's market position, improve brand awareness and benefit shareholders."
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AFYA | Hot Stocks07:19 EST Afya announces medical seats increase in FASA Itabuna - Afya announced that the Secretary of Regulation and Supervision of Higher Education of the Ministry of Education, or MEC, authorized the increase of 64 medical seats of Faculdade Santo Agostinho, in the city of Itabuna, located in the state of Bahia. With the authorization, Afya reaches 149 medical seats on this campus, and 2,823 total approved seats, which will represent around 20,326 students at maturity, considering FIES and PROUNI. In September 30, Afya had 17,997 medical students.
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LASE | Hot Stocks07:08 EST Laser Photonics demonstrates CleanTech laser systems for soldiers - Laser Photonics recently provided a demonstration of two CleanTech laser systems for soldiers at the Anniston Army Depot in Anniston, AL. Soldiers at the Anniston Army Depot were introduced to two CleanTech handheld laser cleaning systems, the CleanTech 2000-CTH JobSite and the CleanTech LPC-300-CTH. The demonstration allowed soldiers on the base responsible for MRO to gain first-hand exposure to the benefits of LPC's CleanTech laser cleaning systems over abrasives and other cleaning processes, including safety, efficiency and environmental concerns.
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RYAM | Hot Stocks07:07 EST Rayonier: Force majeure by nat gas provider had $4M EBITDA impact to company - Rayonier Advanced Materials announced that the force majeure declared by its natural gas provider, Southern Natural Gas Company, due to an unscheduled outage of the Elba Express Pipeline's Hartwell Compressor Station has been cancelled. The Event impacted natural gas supply to the Company's facility in Jesup, Georgia, and has resulted in an estimated $4M EBITDA impact to the Company. The Company continues to reserve all rights to more fully examine, and potentially contest, the validity of the financial penalty it has been assessed.
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FRGT | Hot Stocks07:06 EST Freight Technologies supports industrial electric motor manufacturer - Freight Technologies now supports cross-border logistics requirements for a global electric-electronic equipment company with eighteen different factories and distribution centers across the US and Mexico.
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ARDX | Hot Stocks07:05 EST Ardelyx announces FDA granted appeal for XPHOZAH - Ardelyx announced that the Office of New Drugs, OND, Center for Drug Evaluation and Research of the U.S. Food and Drug Administration, FDA, granted the appeal to the Complete Response Letter, CRL, for the New Drug Application, NDA, for XPHOZAH. In the response letter, OND directed the FDA's Division of Cardiology and Nephrology to work with Ardelyx to develop an appropriate label. Ardelyx believes that a label could reflect an indication for patients whose hyperphosphatemia is insufficiently managed on binder therapy. In addition, the letter guided Ardelyx to request a meeting with the DCN to determine specific information that will form the basis for resubmission of the NDA for XPHOZAH. Ardelyx will request this meeting as soon as possible to enable the company to resubmit the NDA in the first half of 2023. "By granting the appeal, we believe that OND has sent a powerful message regarding the importance of bringing innovation to the more than 400,000 patients on dialysis who struggle every day, at every meal, to control their phosphorus levels and yet are unable to do so. For more than 60 years, the only choice physicians had for patients has been phosphate binders, and the patients have desperately needed novel mechanism therapies. This is a momentous day for Ardelyx and for all the members of the broader kidney disease community who have supported the development of XPHOZAH over the past ten years," said Mike Raab, president and chief executive officer of Ardelyx. "We appreciate the FDA's responsiveness to the clear guidance from the Cardiovascular and Renal Drugs Advisory Committee, recognizing the importance of providing a novel therapy for physicians. This could not have been accomplished without the support from members of the kidney community who spoke at the Advisory Committee meeting about the significant unmet patient need and the important role XPHOZAH could play in the hyperphosphatemia treatment paradigm. We look forward to working with the FDA to bring this important medicine to patients and their treating physicians."
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HCYT | Hot Stocks07:05 EST H-CYTE completes acquisition of SkinDisc from Scion Solutions - H-CYTE announced that the Company completed its acquisition of SkinDisc. Highlights: SkinDisc acquisition further diversifies H-CYTE's asset portfolio; Early clinical outcomes of SkinDisc application demonstrated significant results relative to current treatment options in wound healing and limb salvage; Currently in dialogue with the FDA and have a manufacturer established; Over 500 patients treated with SkinDisc to date; Single application can achieve healing in 4-9 weeks; H-CYTE will submit a De Novo 510(k) pathway request for SkinDisc in the first half of 2023; Equity proceeds funded the acquisition of SkinDisc. From a single application, SkinDisc provides an active cellular matrix that maintains complete full wound contact and depth fill during the healing process, resulting in rapid growth of the host tissue. The SkinDisc product achieves healing in four to nine weeks, compared to current treatment approaches that require weekly applications and can take 12-20 weeks to heal, on average.
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ORGN | Hot Stocks07:03 EST Origin Materials anticipates delay to timeline for completion of Origin 1 - Origin Materials announced a construction update on Origin 1, the company's first commercial manufacturing plant. Due to severe weather conditions, the company anticipates a slight delay to its previously disclosed timeline for mechanical completion of Origin 1. Barring any further unforeseen circumstances, Origin expects the plant to be mechanically complete in January 2023. All equipment necessary for completion is onsite and will be installed once current weather conditions subside. Plant commissioning has started and we anticipate that commissioning will remain on track for completion by the end of Q1 2023, with start-up beginning shortly thereafter.
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ANTE | Hot Stocks07:02 EST AirNet Technology regains compliance with Nasdaq minimum bid price - AirNet Technology announced that it received a notification letter from the Listing Qualifications Department of The Nasdaq Stock Market on December 27, 2022, indicating that the Company has regained compliance with the minimum bid price requirement set forth in Rule 5550(a)(2) of the Nasdaq Listing Rules. According to the Notification Letter on Compliance, the staff of Nasdaq has determined that for the last 10 consecutive business days, from December 12, 2022 through December 23, 2022, the closing bid price of the Company's ADSs had been at $1.00 per ADS or greater, and the Company has regained compliance with Rule 5550(a)(2) of the Nasdaq Listing Rules.
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BITF | Hot Stocks07:02 EST Bitfarms appoints Geoffrey Morphy to CEO - Bitfarms appointed President and COO Geoffrey Morphy to the position of President and CEO, effective immediately. Emiliano Grodzki has resigned as CEO and will remain a Director on the Board. Co-founder Nicolas Bonta will shift from the position of Executive Chairman to the role of Chairman of the Board of Directors.
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ASXC | Hot Stocks06:58 EST Asensus Surgical announces Senhance program initiation at Kashiwa Kosei - Asensus Surgical announced that Kashiwa Kosei General Hospital in Kashiwa, Japan has entered into an agreement to lease and utilize a Senhance Surgical System.
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GLSI | Hot Stocks06:56 EST Greenwich LifeSciences provides year-end update - Greenwich LifeSciences provided the following year end update. At the 2022 San Antonio Breast Cancer Symposium, the Company met with the Flamingo-01 Steering Committee and met with clinicians from the US and various countries in Europe who are participating or planning to participate in Flamingo-01. The Steering Committee is comprised of the following members and may be expanded as Flamingo-01 is expanded into Europe: Dr. Mothaffar Rimawi - Professor of Medicine at the Baylor College of Medicine and Executive Medical Director and Co-Leader, Breast Cancer Program of the Dan L Duncan Comprehensive Cancer Center; Dr. William J. Gradishar - Professor of Medicine at the Feinberg School of Medicine at Northwestern University, Chief of Hematology and Oncology in the Department of Medicine, and Betsy Bramsen Professor of Breast Oncology; Dr. Sara A. Hurvitz - Professor of Medicine at the David Geffen School of Medicine at UCLA, Medical Director of the Jonsson Comprehensive Cancer Center Clinical Research Unit, Co-Director of the Santa Monica-UCLA Outpatient Oncology Practices, Director of the Breast Cancer Clinical Trials Program at UCLA, and Chief Medical Officer of TRIO-US; Dr. Joyce A. O'Shaughnessy - Celebrating Women Chair in Breast Cancer, Baylor University Medical Center and Chair, Breast Cancer Program, Texas Oncology, US Oncology, Dallas, Texas. Approximately 20 clinical sites with 63 locations at multiple hospitals and the largest oncology network in the US are currently recruiting patients. The Company has added a new page to its website to provide updates to Flamingo-01 which includes a map of participating clinical sites in the US.
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STR MNRL | Hot Stocks06:51 EST Sitio Royalties, Brigham Minerals announces completion of merger - Sitio Royalties Corp. (STR) and Brigham Minerals (MNRL) announced the completion of their merger, combining as Sitio Royalties Corp. The company said, "The combination brings together two of the largest public companies in the mineral and royalty sector with complementary high-quality assets in the Permian Basin and other oil-focused regions, creating an industry leader with a proven track record of consolidating oil and gas mineral and royalty interests operated by a diverse set of E&P companies."
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PFE | Hot Stocks06:50 EST Pfizer announces topline results from Phase 3 study of fidanacogene elaparvovec - Pfizer announced top-line results from the Phase 3 BENEGENE-2 study evaluating fidanacogene elaparvovec, an investigational gene therapy, for the treatment of adult males with moderately severe to severe hemophilia B. The BENEGENE-2 study met its primary endpoint of non-inferiority and superiority in the annualized bleeding rate of total bleeds post-fidanacogene elaparvovec infusion versus prophylaxis regimen with Factor IX, administered as part of usual care. The results demonstrated superiority with a mean ABR for all bleeds of 1.3 for the 12 months from week 12 to month 15 compared to an ABR of 4.43 during the lead-in pre-treatment period of at least six months, resulting in a 71% reduction in ABR after a single dose of 5e11 vg/kg of fidanacogene elaparvovec. Key secondary endpoints demonstrated a 78% reduction in treated ABR and a 92% reduction in annualized infusion rate. Mean FIX activity was 27% at 15 months by one-stage SynthASil assay and 25% at 24 months. The mean steady-state FIX:C was significantly higher than the pre-specified threshold of 5%/ Fidanacogene elaparvovec was generally well-tolerated, with a safety profile consistent with Phase 1/2 results. Fourteen serious adverse events were reported in seven patients, with two assessed as related to treatment, a duodenal ulcer hemorrhage occurring in the setting of corticosteroid use, and an immune-mediated elevation of liver aminotransferase levels. No deaths, SAEs associated with infusion reactions, thrombotic events, or FIX inhibitors were reported. Fidanacogene elaparvovec is a novel, investigational vector that contains a bio-engineered adeno-associated virus capsid and a high-activity human coagulation FIX gene. The goal of this gene therapy for people living with hemophilia B, once treated, is that they will be able to produce FIX via this one-time treatment rather than having to regularly receive exogenous FIX. In this Phase 3 trial, eligible study participants completed a minimum six months of routine exogeneous FIX prophylaxis therapy during the lead-in study and then received one intravenous dose of fidanacogene elaparvovec at a dose of 5e11 vg/kg. Participants in the BENEGENE-2 study were screened with a validated assay designed to identify individuals who test negative for neutralizing antibodies to the gene therapy vector. Clinical trial participants will be evaluated as part of a long-term study over the course of 15 years. Pfizer currently has three Phase 3 programs investigating gene therapy in populations where there is a high unmet need: hemophilia B, hemophilia A, and Duchenne muscular dystrophy. A Phase 3 trial is also ongoing investigating marstacimab, a potential novel subcutaneous therapy option being studied for the treatment of people with hemophilia A and B with and without inhibitors. Fidanacogene elaparvovec has been granted breakthrough, regenerative medicines advance therapy, and orphan drug designations from the US Food and Drug Administration, as well as PRIority MEdicines and orphan drug designation from the European Medicines Agency. Pfizer will discuss these data with regulatory authorities in early 2023. Additional key data will be presented at a scientific conference in early 2023 as well.
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NTRB | Hot Stocks06:37 EST Nutriband to launch AI Tape brand in Q1 - Nutriband announced that it has begun production of its AI Tape brand with an expected launch of the product line in Q1 2023. AI Tape is designed to share many of the benefits of traditional Kinesiology Tape. AI Tape further adds soothing and therapeutic ingredients held in suspension with a proprietary adhesive mix. AI Tape is manufactured in the USA at the Company's Pocono Pharmaceutical facility in North Carolina.
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GOTU... | Hot Stocks06:35 EST Edtech companies under pressure as China publishes new set of restrictions - China's Ministry of Education has published a new set of restrictions that limit the fees and operating times of private tutoring services for primary and middle school students. Among the new requirements is the standardization of daily operations, with companies offering non-curricular tutoring having to end physical classes by 8.30pm and online by 9pm. The new set of rules also limits one-time charges to $720 and mandates a special trust account with state-designated banks for pre-paid fees. "The training fees of non-disciplinary training institutions are managed by designated banks, special accounts, and special funds. The fees charged by training institutions should all be entered into the special account of the institution for charging, and other accounts of the institution or accounts other than the institution shall not be used to collect training fees, and the charging account shall be disclosed to the public," stated the Ministry of Education. Publicly traded companies in the space, such as Gaotu Techedu (GOTU), TAL Education (TAL), and New Oriental Education (EDU), are under pressure in premarket trading. Reference Link
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KC | Hot Stocks06:31 EST Kingsoft Cloud announces results of extraordinary general meeting - Kingsoft Cloud Holdings announced that the shareholders of the Company duly adopted all the resolutions proposed by the Company at its extraordinary general meeting of shareholders held in Beijing today, with high approval rate, paving way to Company's proposed listing on Main Board of The Stock Exchange of Hong Kong Limited. Earlier on December 23, 2022, the Company announced the proposed dual primary listing of its ordinary shares, par value US$0.001 per share by way of introduction on the Main Board of The Stock Exchange of Hong Kong Limited. Subject to final listing approval from the SEHK, the Shares are expected to commence trading on the Main Board of the SEHK on December 30, 2022 under the stock code "3896". Upon listing on the Main Board of the SEHK, the Company's American Depositary Shares, each representing 15 Shares, will continue to be primarily listed and traded on The NASDAQ Global Select Market, and the Shares listed on the Main Board of the SEHK will be fully fungible with the ADSs listed on the NASDAQ. On the same day, the Company also announced the appointment of Mr. Haijian He, CFO, as a member of the Board of Directors and a member of the Corporate Governance Committee of the Board, effective on December 20, 2022. Resolution 1: As a Special Resolution: to amend and restate the existing Amended and Restated Memorandum of Association and Articles of Association of the Company by the deletion in their entirety and by the substitution in their place of the Second Amended and Restated Memorandum of Association and Articles of Association, conditional upon and with effect from the consummation of the Company's proposed listing on The Stock Exchange of Hong Kong. Resolution 2: As a Special Resolution: to change the name of the Company from Kingsoft Cloud Holdings Limited to Kingsoft Cloud Holdings Limited by adoption of the dual Chinese name , which will be reflected in the Proposed M&AA Amendment. Resolution 3: As an Ordinary Resolution: a general mandate be granted to the Directors to allot, issue or deal with additional shares of the Company not exceeding 20% of the total number of issued shares immediately following completion of the Listing, and which is conditional upon the Listing. Resolution 4: As an Ordinary Resolution: a general mandate be granted to the Directors to exercise powers of the Company to repurchase shares of the Company representing up to 10% of the total number of issued shares immediately following completion of the Listing, and which is conditional upon the Listing. Resolution 5: As an Ordinary Resolution: subject to an approval of the Issuance Mandate and the Repurchase Mandate and conditional upon the Listing, an extension to the Issuance Mandate be approved, such that the number of shares of the Company repurchased under the Repurchase Mandate will also be added to extend the Issuance Mandate, provided that such additional amount shall not exceed 10% of the number of issued shares of the Company immediately following completion of the Listing. Resolution 6: As an Ordinary Resolution: the authorization to each of the directors of the Company or the Company's registered office provider to take any and all action that might be necessary to effect the foregoing resolutions and make all necessary filings at the Cayman Registry as such director or the Company's registered office provider, in his, her or its absolute discretion, thinks fit.
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CHKP INTC | Hot Stocks06:08 EST Check Point expands collaboration with Intel for anti-ransomware capabilities - Check Point Software Technologies (CHKP) announced an extended collaboration with Intel Corporation (INTC) to offer enhanced anti-ransomware capabilities for Check Point Harmony's customers. As ransomware attacks increase in scale and sophistication, integrating the Intel vPro platform's Threat Detection Technology within Check Point Harmony Endpoint helps provide enterprises with processor level anti-ransomware security at both the hardware and software levels, at no extra cost.
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CMNDF | Hot Stocks06:06 EST Clearmind announces shareholders meeting results - Clearmind Medicine announced that all of the matters put forward before shareholders for consideration and approval at its meeting held on December 28, 2022, as set out in the Company's Management Information Circular dated November 28, 2022, were approved by the requisite majority of votes cast at the Meeting, including the approval of the Company's rolling stock option plan and an increase to the amount of options available for issuance thereunder, and an increase to the amount of restricted share units, and underlying common shares, available for issuance pursuant to the Company's Restricted Share Unit Plan.
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AFIB | Hot Stocks06:05 EST Acutus Medical says AcQForce Flutter abstract accepted for presentation - Acutus Medical announced the acceptance of the AcQForce Flutter abstract titled "AcQForce Flutter Trial Clinical Results: Force Sensing RF Ablation with Low Flow Gold Tip Catheter for Typical Flutter" for presentation during the Late-Breaking Clinical Trials and First Report Investigations session at the AF Symposium in Boston. This abstract - including full study results - will be presented on Friday, February 3, 2023. The AcQForce Flutter clinical study was submitted to the FDA as part of Acutus' PMA submission for the AcQBlate Force Sensing Ablation Catheter, the only force-sensing ablation catheter with a gold tip electrode, and System. The irrigated gold tip ablation catheter has 4x thermal conductivity compared to platinum catheters, which allows for significantly more energy delivery at a lower temperature and requires less saline flow. This is the first PMA submission by Acutus and the first time the company is presenting at a Late-Breaking Clinical Trials session.
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SLI | Hot Stocks06:04 EST Standard Lithium receives notice of allowance for U.S. patent on DLE process - Standard Lithium announced that the United States Patent and Trademark Office has issued a Notice of Allowance for Standard Lithium's third U.S. patent application serial no. 16/895,783 titled "Process for Recovering Lithium from Brines", This third U.S. patent application is in addition to Standard Lithium's other two U.S. patent applications for which Notices of Allowance have been earlier issued by the USPTO. These three U.S. patent applications comprise a portion of Standard Lithium's novel and proprietary technique for continuous Direct Lithium Extraction from lithium brines. A Notice of Allowance is issued by the USPTO after examination of a patent application and a determination that a patent should be granted from the application. Standard Lithium anticipates the issue of the formal registration of this third U.S. patent application in the coming months.
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GRFX | Hot Stocks06:02 EST Graphex enters MOU with Reforme Group for graphite manufacturing facilities - Graphex Technologies announced that it has entered into a non-binding Memorandum of Understanding with Reforme Group to create a strategic alliance joint venture to provide key feedstock and critical minerals and processing technologies for the production of electric vehicle Li-ion power batteries to the global EV industry. Reforme was founded by the team that developed a world first in the sorting and beneficiating of iron ore has since become a leader in the industry. Through experience with the strategic metals supply chain, Reforme has developed relationships with government and industry for sourcing mining and beneficiation of key materials from industrial processors and mines, expected to provide automotive original equipment manufacturers and battery makers with a high-quality, high-volume and stable supply of strategic metals materials needed for production of Li-ion batteries. Graphex has over a decade of commercial experience producing 10,000 metric tons per annum of battery grade purified spherical graphite to the power battery market. The intent of the MOU is to evaluate collaborative opportunities to strategically locate, construct, and operate mid-stream graphite processing facilities throughout the world to support the global electrification of mobility. Whether near graphite mining resources or locations close to point-of-use - namely battery gigafactories and EV OEMs in the US and Europe - the strategic alliance will leverage shared expertise between Graphex and Reforme in technology, design, financing, equipment sourcing, and plant operations along with established upstream and downstream relationships with key stakeholders and companies in the automotive and battery industries to provide end-to-end stable supply of battery grade anode material for EVs. An initial focus of the JV will be an already identified graphite opportunity in Australia where critical mineral mining and processing momentum is accelerating quickly. Reforme and its strategic relationships in Australia have secured mineral deposits and/or rights to mineral deposits across the country, including first right of refusal on several projects that have the potential to produce flake graphite concentrate within 18-24 months of a quality and quantities sufficient to sustain operations of mid-stream graphite processing facilities for a minimum of 10 years. Reforme's relationships with state and local governments and experience in the construction and operations of production facilities in the mining and supply chain space, coupled with Graphex's mid-stream production experience in the transformation of graphite into battery anode material is an ideal combination to quickly ramp up stable end-to-end supply of battery grade graphite to the EV industry for years to come.
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SLI | Hot Stocks05:05 EST Standard Lithium issued third Notice of Allowance for brines from USPTO - Standard Lithium announced that the United States Patent and Trademark Office, or USPTO, has issued a Notice of Allowance for Standard Lithium's third U.S. patent application serial no. 16/895,783 titled "Process for Recovering Lithium from Brines", This third U.S. patent application is in addition to Standard Lithium's other two U.S. patent applications for which Notices of Allowance have been earlier issued by the USPTO. These three U.S. patent applications comprise a portion of Standard Lithium's novel and proprietary technique for continuous Direct Lithium Extraction, or DLE, from lithium brines.
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