Stockwinners Market Radar for October 12, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:15 EDT Charles River divests Japan RMS for $63M and CDMO Sweden for $52M - Charles River "announced that it has divested its Research Models and Services operations in Japan, or RMS Japan, and its gene therapy CDMO site in Sweden, or CDMO Sweden, in two separate transactions. The RMS Japan operations provide research models and associated services to support clients in the Japanese market. It has approximately 260 employees and generated annual revenue of $46M in 2020. In connection with this transaction, JAX and Charles River have entered into a technology license agreement for JAX to produce and distribute Charles River's research models in Japan. Charles River will continue to provide research models and services to global clients from its operations in North America, Europe, and China. On October 12th, the Company completed the sale of its gene therapy CDMO site in Sweden to a private investor group for approximately $52M in cash with potential contingent payments of up to an additional $25M, subject to certain adjustments. The company expects both divestitures to reduce revenue by nearly $20M and non-GAAP diluted earnings per share by nearly 10c in Q4 of 2021, which will be reflected in its 2021 financial guidance that will be updated in November."

18:46 EDT Medtronic CEO: We plan to step up the pace of our innovation - In an interview on CNBC's Mad Money, Geoff Martha said Medtronic is at the nexus of health care and technology. The company is training more health care providers virtually than ever before, he added. Martha expects regulatory approval on several diabetes products soon. 20% of Medtronic's revenue will come from new products by 2025, he noted.

18:03 EDT GT Biopharma's treatment of acute myeloid leukemia gets FDA orphan designation - According to a post on the FDA's website, GT Biopharma's treatment of acute myeloid leukemia received orphan designation. Reference Link

17:58 EDT Pfizer's treatment of multiple myeloma receives FDA orphan designation - According to a post on the FDA's website, Pfizer's treatment of multiple myeloma, elranatamab, received orphan designation. Reference Link

17:25 EDT Nutanix CFO Williams sells $1.6M in shares - Nutanix CFO Duston Williams disclosed in a filing that he had sold 43,632 shares of company stock for $37.06 per share on October 7, for a total transaction amount of $1,616,932.

17:06 EDT Aehr Test Systems VP Richmond $263K in company shares - Aehr Test Systems VP Donald Richmond disclosed in a filing that he had sold 13,915 shares of company stock at $18.87 per share on October 8, for a total transaction amount of $262,623.

17:03 EDT Eldorado Gold reports Q3 preliminary production of 125,459 ounces of gold - Eldorado Gold is pleased to announce third quarter preliminary gold production of 125,459 ounces, an 8% increase from 116,066 ounces produced in the second quarter. Based on strong production performance in the first nine months of 2021, the company is reviewing the full year 2021 production guidance ranges and will provide an update with the release of its financial and operational results on October 28.

17:01 EDT Travere Therapeutics announces Chief Medical Officer Noah Rosenberg transition - Travere Therapeutics announced that its Chief Medical Officer, Noah Rosenberg, has chosen to transition for personal reasons to an executive advisor role at the end of 2021. Rosenberg is expected to serve as an advisor to the Company throughout 2022 to assist with clinical trial oversight and regulatory submissions. A search to identify a successor to Rosenberg is underway while the Company continues to execute its clinical programs as planned.

16:46 EDT Vistra announces $2B share buyback - Vistra announced a new $2B share repurchase program and the pricing of a private offering of 1,000,000 shares of its 8% Series A Fixed-Rate Reset Cumulative Redeemable Perpetual Preferred Stock to qualified institutional buyers and to certain non-U.S. persons in accordance with Regulation S under the Securities Act, at an offering price of $1,000 per share. The company will receive gross proceeds of $1B from the sale of the Preferred Stock before deducting the initial purchaser discount and other estimated offering expenses. The offering is expected to close on Oct. 15, 2021.

16:40 EDT CytoSorbents receives full FDA IDE approval to begin STAR-D trial - CytoSorbents announces the full approval of its Investigational Device Exemption application by the FDA to conduct the pivotal STAR-D double-blind, randomized, controlled trial in the United States to support FDA marketing approval. This is being performed under the previously announced FDA Breakthrough Device Designation granted to the DrugSorb-ATR Antithrombotic Removal System for the removal of apixaban and rivaroxaban in a cardiopulmonary bypass circuit to reduce the likelihood of serious perioperative bleeding in urgent cardiothoracic surgery.

16:35 EDT Regulus trading resumes

16:34 EDT Hasbro announces passing of CEO Brian Goldner - Hasbro announces the passing of beloved leader and longtime Chairman and CEO Brian Goldner. Rich Stoddart, Interim CEO, said "Since joining the company more than two decades ago, Brian has been the heart and soul of Hasbro. As a charismatic and passionate leader in both the play and entertainment industries, Brian's work brought joy and laughter to children and families around the world. His visionary leadership, kindness, and generosity made him beloved by the Hasbro community and everyone he touched. On behalf of the Hasbro family, we extend our deepest, heartfelt condolences to his wife, daughter, and entire family."

16:31 EDT Carpenter Technology names Martin Inglis as new chairman - Carpenter Technology announced that the board elected I. Martin Inglis to succeed Gregory Pratt as chairman of Carpenter Technology's board effective immediately. As planned, Mr. Pratt has retired as the chairman of the Board of Directors, a role Mr. Pratt has held since 2009. Mr. Pratt also served as interim President and CEO of the company in 2010 and 2015 and has been a member of the company's board since 2002.

16:30 EDT Victory Capital reports total AUM $159.9B on September 30 - The company also reported that it achieved positive net total flows and positive net long-term flows during the third-quarter period

16:21 EDT AllianceBernstein reports preliminary AUM $742B as of September 30 - Down from $761B at the end of August. Firmwide net inflows were outweighed by market depreciation, resulting in a 2% decline in AUM. In the month of September, net inflows to Retail and Private Wealth were partially offset by net outflows from Institutions.

16:20 EDT Adicet Bio announces Blake Aftab, Ph.D. SVP Chief Scientific Officer - Adicet Bio announced Blake Aftab, Ph.D., has been promoted to the position of Senior Vice President and Chief Scientific Officer. In this role, Dr. Aftab will be responsible for the continued expansion of Adicet's pipeline of therapeutic candidates in solid and hematologic tumors.

16:17 EDT Angi Inc. reports September revenue up 18% - The company said, "As the global pandemic continues to change consumer and business behavior in ways none of us can predict, the volatility of our monthly results will continue and September is no exception."

16:15 EDT Vimeo reports monthly YoY growth trend through September 33% vs. 49% last year - Reference Link

16:13 EDT IAC reports September Angi Inc. total revenue up 18% from last year - As part of its September monthly metrics disclosure, IAC also reports Dotdash revenue up 25%, and its Search business revenue up 74% from last year. Emerging & Other revenue was up 33% from last year. Reference Link

16:10 EDT Homology Medicines announces pheEDIT clinical trial for HMI-103 - Homology Medicines announced the pheEDIT Phase 1 clinical trial for HMI-103, a one-time, in vivo product candidate that utilizes a gene editing approach for phenylketonuria, or PKU, based on the investigational new drug application, or IND, clearance from the FDA. HMI-103 will be the world's first gene editing candidate for PKU to enter clinical trials from Homology's dual gene therapy and gene editing technology platform, and with the launch of pheEDIT Homology moves closer to its goal of offering solutions for both adults and pediatric patients with PKU. The HMI-103 pheEDIT trial is expected to enroll up to nine patients ages 18-55 years old who have been diagnosed with PKU due to PAH deficiency. Once safety and efficacy results are established in the adult population, Homology plans to enroll younger patients in clinical trials. The Phase 1 dose-escalation trial is designed to evaluate three doses of HMI-103 to determine the recommended dose for a future trial. In addition to safety endpoints, the trial will measure serum phenylalanine changes. Homology expects that the first patient in the pheEDIT clinical trial will be dosed following requisite Institutional Biosafety Committee and Institutional Review Board approvals at the clinical sites. The trial will include an 82-day screening/run-in period prior to HMI-103 administration. Homology also announced an update from its ongoing Phase 2 pheNIX clinical trial evaluating HMI-102 gene therapy in adults with PKU. As of September 30, both doses in the trial have been generally well-tolerated and have shown evidence of biological activity, including clinically meaningful reductions in Phe levels, increases in Tyr and reductions in the Phe-to-Tyr ratio. Several new clinical trials sites have also recently been added to pheNIX for a total of 13 with more sites expected shortly. Despite increased interest, enrollment is slower than anticipated due in part to COVID-19 resurgence, and the company anticipates providing a more detailed pheNIX update in mid-2022 when it expects to have a larger dataset.

16:09 EDT Elastic announces expanded integrations with Google Cloud - Elastic (ESTC) announced expanded integrations with Google Cloud (GOOGL). Using Google Cloud Dataflow, Google's native serverless ETL service, new integrations allow customers to quickly and securely ingest data directly into their Elastic Cloud deployments, and a new Google Firestore integration adds search capabilities to Google Firebase mobile and web-based applications. From the Google Cloud Console, customers can now ingest data from Google Cloud Storage, Google BigQuery, and Google Pub/Sub into Elastic using Google Dataflow templates. Google Dataflow templates enable customers to simplify their data pipeline architecture and eliminate operational overhead related to agent installation and management. The capability is available to all users of the Elastic Stack on Elastic Cloud, Elastic Cloud in the Google Cloud Marketplace, or self-managed environments.

16:07 EDT StarTek names Bharat Rao as President, Vivek Sharma as Chief Revenue Officer - Startek "announced the appointment of two executive leaders in a strategic move to enhance its leadership team to best support the company's continued growth and execution of its strategic priorities. Bharat Rao has been named President of Startek. Mr. Rao will focus on transforming Startek into a more customer-centric organization that leverages emerging technologies to deliver innovative solutions in specific industry verticals. Mr. Rao will be responsible for driving business operations, client value, and synergy across the organization and aligning organizational priorities with Startek's long-term strategy. As President, Mr. Rao will assume leadership of the executive team at Startek. Startek also announced the appointment of Vivek Sharma as the Global Chief Revenue Officer. Mr. Sharma will lead the global go-to-market organization, including key client relationships, business growth and industry-specific digital initiatives."

16:06 EDT Crispr announces updated results in trial of CTX110 for large B-cell lymphomas - CRISPR Therapeutics announced updated results from the company's ongoing Phase 1 CARBON trial evaluating the safety and efficacy of CTX110, its wholly-owned allogeneic CAR-T cell therapy targeting CD19+ B-cell malignancies. "We are excited to share positive data from our CARBON trial, which show that CTX110 could offer patients with large B-cell lymphomas an immediately available 'off-the-shelf' therapy with efficacy similar to autologous CAR-T and a differentiated safety profile," said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. "Furthermore, we have the potential to improve upon already observed efficacy with a consolidation dosing strategy. Based on these encouraging results, we are planning to expand CARBON into a potentially registrational trial in the first quarter of 2022." Patients were infused with a single CTX110 infusion following three days of a standard lymphodepletion regimen consisting of fludarabine and cyclophosphamide . Patients could be re-dosed with CTX110 following disease progression. The primary endpoints include safety as measured by the incidence of dose limiting toxicities and overall response rate . Key secondary endpoints include complete response rate, duration of response and overall survival. Additional details may be found at clinicaltrials.gov, using identifier: NCT04035434. Safety CTX110 was well tolerated across all dose levels. The adverse events of interest for all evaluable patients are shown in the table below. There were no cases of Graft versus Host Disease (GvHD) and no infusion reactions to either lymphodepleting chemotherapy or CTX110. All cases of cytokine release syndrome (CRS) were Grade 1 or 2 per the American Society for Transplantation and Cellular Therapy (ASTCT) criteria and either required no specific intervention or resolved following standard CRS management. Neither the frequency nor severity of CRS has increased in patients who were re-dosed with CTX110. The only case of Grade 3 or higher immune effector cell-associated neurotoxicity syndrome (ICANS) was in the patient with concurrent HHV-6 encephalitis who was previously disclosed. There have been no cases of ICANS in any other patients treated at Dose Level (DL3) through Dose Level (DL4).

16:01 EDT SkyWest signs tech transfer, license pact with Deca Technologies - SkyWater Technology announced an agreement for Deca's second generation M-Series fan-out wafer-level packaging technology with Adaptive Patterning within SkyWater's advanced packaging facility in Florida. The companies are endeavoring to establish the first high volume FOWLP capability in the U.S. to bring proven solutions for single and multi-die packaging and advanced heterogeneous integration capability for chiplets through 2.5D and 3D implementations. Deca's first generation technology changed the game with high volume production for leading mobile applications and is well-known for enabling exceptional board-level reliability, end-customer quality and electrical performance. Deca's unique Adaptive Patterning with mask-less laser direct imaging delivers high-density design rules and high production yields in a cost-effective miniaturized format. Deca's second generation FOWLP technology includes 2 microm RDL features combined with industry-benchmark 20 microm bond pad pitch and targets advanced mobile devices, high-performance computing, high-end networking, artificial intelligence, and edge computing as well as high density 3D integration technology in medical and defense applications.

15:50 EDT Score Media announces shareholder approval of acquisition by Penn National - Score Media and Gaming (SCR) announces that holders of its Class A Subordinate Voting Shares and Special Voting Shares have voted in favor of the previously announced acquisition by Penn National Gaming (PENN) by way of a plan of arrangement at the company's special meeting of shareholders held on October 12. Subject to receipt of a final order in respect of the arrangement from the Supreme Court of British Columbia, and satisfaction or waiver of the other conditions to closing contained in the arrangement agreement with Penn National, the arrangement is expected to close on October 19, the company said.

15:28 EDT Kellogg calls union allegations about moving jobs to Mexico 'completely false' - Kellogg Company is publicly addressing the terms of its master labor contract negotiations with the Bakery, Confectionery, Tobacco Workers and Grain Millers International Union for four of its Ready to Eat Cereal plants. Kris Bahner, Kellogg Company spokesperson, stated: "Kellogg is ready, willing and able to continue negotiations at any time," Bahner said. "In the meantime, we have a responsibility to our business, customers and consumers to run our plants, despite the strike. We are continuing operations with other resources and hope that we can reach an agreement soon." In addition, the company said that union allegations that Kellogg has threatened to move jobs to Mexico if they don't agree to the company's proposals "is completely false." "Kellogg has not proposed moving any cereal volume or jobs outside of the U.S. as part of these negotiations," the company stated.

15:19 EDT FDA announces 'first authorization' for marketing of e-cigarette products - The U.S. Food and Drug Administration announced it has authorized the marketing of three new tobacco products, which it noted marks "the first set of electronic nicotine delivery system products ever to be authorized by the FDA through the Premarket Tobacco Product Application - PMTA - pathway." The FDA issued marketing granted orders to R.J. Reynolds Vapor Company, a subsidiary of British American Tobacco, for its Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2. "As the RJR Vapor Company submitted data to the FDA that demonstrated that marketing of these products is appropriate for the protection of public health, today's authorization allows these products to be legally sold in the U.S.," the FDA stated. Today, the FDA also issued 10 marketing denial orders for flavored ENDS products submitted under the Vuse Solo brand by RJR. "Due to potential confidential commercial information issues, the FDA is not publicly disclosing the specific flavored products. These products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. Should any of them already be on the market, they must be removed from the market or risk enforcement. Retailers should contact RJR with any questions about products in their inventory. The agency is still evaluating the company's application for menthol-flavored products under the Vuse Solo brand," the FDA stated. "Today's authorizations are an important step toward ensuring all new tobacco products undergo the FDA's robust, scientific premarket evaluation. The manufacturer's data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products - either completely or with a significant reduction in cigarette consumption - by reducing their exposure to harmful chemicals. We must remain vigilant with this authorization and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth. We will take action as appropriate, including withdrawing the authorization," said Mitch Zeller, J.D., director of the FDA's Center for Tobacco Products.

14:41 EDT Revance down 21% after inspection letter posted to FDA website - Shares of Revance Therapeutics are down $5.80, or 21%, to $21.50 in afternoon trading after the FDA posted a form 483 to its website related to observations made by FDA staff during an inspection of a company facility that was conducted June 21-25, 28-30 and July 1-2, 2021. Reference Link

13:46 EDT Talos Energy sees Q3 average daily production between 56.0-56.5 MBoe/d - Earlier, Talos Energy provided selected estimated operational and financial results for the third quarter, following operational disruptions caused by Hurricane Ida, and updated its production guidance for the fourth quarter and full year 2021. Preliminary estimated results for the third quarter of 2021 include average daily production between 56.0 and 56.5 thousand barrels of oil equivalent, or "MBoe/d," inclusive of several weeks of shut-in production resulting from Hurricane Ida. "That represents between 10.0 and 11.0 MBoe/d of hurricane downtime compared to the company's projections for the quarter pre-hurricane. The production for the quarter was approximately 69% oil and 77% liquids," Talos said. Talos sees realized prices of approximately $68 per barrel of oil, $30 per barrel of NGLs and $4.50 per Mcf of natural gas, and realized hedge losses of approximately $72M in the quarter. Talos said: "Production disruptions following Hurricane Ida were prolonged due to complications affecting third-party downstream service providers. Key refiners, crude oil terminals and pipelines were not fully returned to operation for several weeks due to a mix of storm-related damage and lack of power. The company's assets did not experience significant damage and the majority have been returned to normal operations, producing an average of approximately 66.5 MBoe/d in the last week of September of 2021. Approximately 4.0 MBoe/d of production remains offline across various assets, primarily due to repairs being made to pipelines and other downstream facilities. Talos expects the remaining impacted assets to return to production over the coming weeks and months as the third-party repairs are finalized. Despite these disruptions, Talos continues to expect annual production near the lower end of the previously guided annual range, and expects production for the fourth quarter of 2021 between 64.0 and 66.0 MBoe/d. All other previously guided line items remain within the existing range of guidance. Additionally, the company still expects to generate meaningful free cash flow for the full year 2021."

13:37 EDT Crowdstrike announces CrowdXDR Alliance with partners including Google Cloud - CrowdStrike (CRWD) announced the CrowdXDR Alliance, a unified and open Extended Detection and Response coalition formed with security and IT operations leaders and best-of-breed solutions. The CrowdXDR Alliance will offer integrated solutions for joint customers to protect their organizations from sophisticated cyber adversaries in a rapidly evolving threat landscape, CrowdStrike said in a statement. The CrowdXDR Alliance launch partners include Google Cloud (GOOGL), Okta (OKTA), ServiceNow (NOW), Zscaler (ZS), Netskope, Proofpoint, Extrahop, Mimecast, Claroty and Corelight.

13:01 EDT Graphite Bio presents data supporting GPH101 in sickle cell disease - Graphite Bio announced the presentation of preclinical data for GPH101, an investigational therapy designed to directly correct the genetic mutation responsible for sickle cell disease. Data were presented at the 49th Annual Sickle Cell Disease Association of America National Convention in a poster presentation. "These positive preclinical data are foundational to our sickle cell disease program and support the evaluation of GPH101 in our Phase 1/2 CEDAR trial, for which we are on track to enroll our first patient before the end of the year," said Josh Lehrer, M.Phil., M.D., CEO at Graphite Bio. "These encouraging data reinforce our belief that GPH101 has the potential to directly correct the underlying disease-causing mutation to decrease production of sickle hemoglobin and restore the expression of normal adult hemoglobin with minimal off-target editing." Using Graphite Bio's gene correction platform, which uses an engineered high fidelity Cas9 to reduce off-target cleavage by 30-fold, the company was able to achieve greater than 60% of gene-corrected beta-globin alleles in vitro with minimal off-target activity, the company said.

12:27 EDT Sanofi says sarilumab supply limited due to 'exceptional demand' from Covid - Sanofi said it is currently experiencing an increase in worldwide demand for sarilumab due to an increase in the global demand for IL-6 receptor blockers and the temporary tocilizumab shortage. "Due to this exceptional demand, supply for all four formats of sarilumab is expected to be constrained until early 2022 based on current forecasts," the company said in a statement. It notes that various country and global health authorities have recommended IL-6 receptor blockers for the treatment of patients with severe or critical Covid-19. Sarilumab is not approved or authorized for emergency use for the treatment of Covid anywhere in the world, and Sanofi will continue to prioritize access for indicated patients with rheumatoid arthritis, it added. "Sanofi is working diligently to manage supply to minimize the impact of this increase in demand, and we are committed to proactive and timely communication as the situation evolves," the company said.

12:00 EDT Yatsen falls -7.5% - Yatsen is down -7.5%, or -29c to $3.62.

12:00 EDT Enzo Biochem falls -10.3% - Enzo Biochem is down -10.3%, or -42c to $3.67.

12:00 EDT Ginkgo Bioworks rises 12.2% - Ginkgo Bioworks is up 12.2%, or $1.16 to $10.63.

11:47 EDT HubSpot announces launch of new payments solution - Earlier, HubSpot announced that at INBOUND 2021 the company reported on the launch of its open beta for HubSpot Payments, which it calls "an end-to-end payment solution built to deliver a more delightful and connected buyer experience." The company added: "Built natively as part of the HubSpot CRM platform, HubSpot Payments enables companies to accept payments confidently and seamlessly in less time and with fewer tools... Because HubSpot Payments is built directly into the HubSpot CRM, companies can easily begin accepting digital payments without having to write code or cobble disparate integrations together. Replacing paper checks with digital payments enables companies to get paid faster and eliminate manual, error-prone processes. This also creates a more streamlined, secure buying experience for their customers, allowing buyers to order and pay in just a few clicks using their preferred payment method. Whether the sale is touchless or rep-assisted, customers will have the same seamless experience that integrates natively with a company's website, reporting, automation, and CRM... HubSpot Payments supports all major credit cards and ACH payments, ensuring that companies can enable the payment methods that work for them. To help customers get up and running, HubSpot is also waiving fees on the first $50,000 of ACH transactions processed through HubSpot Payments each month." Stripe, a HubSpot partner since 2018, is helping power HubSpot Payments, the company noted. HubSpot Payments is currently in beta release and is available for U.S. customers only.

11:44 EDT HubSpot up 11% as analyst day meeting continues - Shares of HubSpot are up $74.52, or 11%, to $757.24 approaching midday as the company continues its virtual analyst day meeting, which began at 10:30 am ET.

11:34 EDT Acceleron board had considered contacting other parties regarding acquisition - In a regulatory filing, Acceleron (XLRN) said that on August 5, "The Project Phoenix Committee convened by videoconference with members of the Company's senior management, the Company's financial advisors and Ropes & Gray in attendance... The Project Phoenix Committee discussed the advantages and disadvantages to engaging with Merck (MRK) based on the July 20 Proposal and determined that it was in the best interests of the Company to inform Merck that its initial acquisition proposal was insufficient to justify further engagement. The Project Phoenix Committee also discussed when and whether to contact other potential parties, some of whom had prior interaction with the Company, and others who might have interest in considering a potential acquisition of the Company, including 'Party A,' which the Company Board viewed as the most likely competitive bidder." It said that on August 9, "The Company Board also discussed whether to contact 'Party B,' which had delivered to the Company an indication of interest for a global license and collaboration agreement with respect to sotatercept in April of 2021. At that time, the Company Board had reviewed with the Company's financial advisors Party B's proposed global license and collaboration agreement and declined to pursue it because the indication of interest undervalued sotatercept and was not aligned with the Company's strategic priorities. Following discussion, the Company Board decided to not contact Party B at that time due to concerns regarding prospects for regulatory approval of a sale to Party B and the sharing of sensitive information in any due diligence process."

11:02 EDT Boeing reports total Q3 deliveries of 85 commercial airplanes, 241 YTD - The Boeing Company announced major program deliveries across its commercial and defense operations for the third quarter of 2021. "We made important progress driving stability throughout our operations in the third quarter, as we prioritized safety and quality and worked to deliver for our customers," the company said. "Our defense and services teams delivered across several key programs. In our commercial business, we increased 737 MAX deliveries in the quarter, and progressed in safely returning the 737 MAX to service in more international markets. We are also continuing to complete comprehensive inspections across the 787 production system and within the supply chain, while holding detailed, transparent discussions with the FAA, suppliers and our customers. Production resources remain focused on inspections and rework and the 787 production rate remains lower than five airplanes per month. We will continue to take the time needed to ensure the highest levels of quality. While these efforts continue to impact deliveries, we're confident this is the right approach to drive stability and first-time quality across our operations and to position the program for the long term as market demand recovers." Boeing delivered 66 737s in Q3, 2 747s and 11 767s during Q3.

10:35 EDT FDA says vaccines still afford protection against severe Covid - The FDA said in briefing documents ahead of the Moderna (MRNA) and Johnson & Johnson (JNJ) booster advisory panel later this week: "The expected benefit of booster vaccination will depend on the impact that booster vaccination has in reducing disease relative to the primary series. If the primary series of Moderna COVID19 Vaccine is still effective in preventing important COVID-19-related outcomes, then the benefit of booster vaccination is likely to be more limited than if effectiveness following the primary series has waned substantially...Some real world effectiveness studies have suggested declining efficacy of Moderna COVID-19 Vaccine over time against symptomatic infection or against the Delta variant, while others have not. However, overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States. There are many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions."

10:17 EDT Applied DNA says Sarah Lawrence College implements safeCircle program - Applied DNA Sciences announced that safeCircle has been implemented at Sarah Lawrence College as an addition to the College's in-house testing practice to monitor for the prevalence of COVID-19 during the College's Fall 2021 semester. Testing began this week and is available to asymptomatic students, faculty, and staff on a voluntary basis. The College's population of approximately 2,000 undergraduate and graduate students, faculty, and staff are required to be vaccinated against COVID-19.

10:05 EDT Triumph selected for Sine Draco A321-200 SDF freighter conversion program - Triumph Group announced that its Triumph Actuation Products and Services facility in Clemmons, North Carolina was awarded a contract from Sine Draco Aviation Technology to design, develop and manufacture the main deck cargo door lift actuator and hydraulic power pack assembly for the Sine Draco Airbus A321-200 SDF passenger to freighter conversion. Triumph is a market leader in cargo door actuation and controls systems with installations on the Boeing 787, Airbus A350 and Airbus A380.

10:03 EDT Hoth Therapeutics receives approval to commence cohort 2 in BioLexa trial - Hoth Therapeutics announced that it has received Human Research Ethics Committee clearance to commence cohort 2 of the Phase 1b clinical trial of BioLexa Lotion for the treatment of mild to moderate atopic dermatitis in Australia. Hoth says the trial is a randomized, double-blind, parallel-design, placebo-controlled study. Cohort 2 includes adult patients with mild to moderate atopic dermatitis, it said, adding that the primary goal of the study is to evaluate the safety and characterize pharmacokinetics of topical BioLexa Lotion. Participants will be treated twice daily with topical application directly on skin for 14 days and preliminary efficacy will also be investigated in the atopic dermatitis patient cohort, including change in atopic dermatitis extent of involvement and severity using EASI, SCORAD, IGA as well as patient-centric quality of life assessments. The company expects to start screening and enrolling the first subject(s) of Cohort 2 in October.

10:00 EDT Yatsen falls -6.4% - Yatsen is down -6.4%, or -25c to $3.66.

10:00 EDT Enzo Biochem falls -9.4% - Enzo Biochem is down -9.4%, or -38c to $3.71.

10:00 EDT Tata Motors rises 10.5% - Tata Motors is up 10.5%, or $2.94 to $31.00.

09:47 EDT Yatsen falls -4.6% - Yatsen is down -4.6%, or -18c to $3.73.

09:47 EDT Enzo Biochem falls -7.9% - Enzo Biochem is down -7.9%, or -32c to $3.77.

09:47 EDT Gaotu Techedu rises 7.7% - Gaotu Techedu is up 7.7%, or 31c to $4.32.

09:40 EDT ESS Tech Inc trading resumes

09:33 EDT Harbor Custom Development closes on site in Yelm, Washington for $3.3M - Harbor Custom Development announced that it has closed on the purchase of a 4.31 acre property permitted for the construction of 75 condominium units in Yelm, Washington for $3,325,000.

09:32 EDT Inpixon granted patent to track critical assets using GPS, cellular, and sound - Inpixon announced it has received a Notice of Allowance from the U.S. Patent and Trademark Office allowing its patent application for certain geolocation and state-reporting methods and techniques for weapon tracking and reporting utilizing GPS, cellular, sound and vibration. The technologies could be applied to a range of critical asset tracking use cases, for example, to report the location of a fired weapon.

09:23 EDT Lucid Group announces delisting of warrants - Lucid Group announced that all of its public warrants, which have been listed and traded on The Nasdaq Stock Market under the symbol "LCIDW," will be delisted from Nasdaq effective before market opens on October 13.

09:22 EDT LSB Industries trading halted, news pending

09:20 EDT Alkaline Water sees Q2 revenue approximately $15M, one-estimate $15M - The Alkaline Water Company announced that it anticipates topline revenue for the second quarter of fiscal year 2022 to be approximately $15M. This would be the best quarter on record and represent year-over-year growth approaching almost 50%. The Company reiterates full fiscal year 2022 revenue guidance of $62M. The Company will officially report its full second quarter for fiscal year 2022 results in November. "We anticipate the second quarter sales of fiscal 2022 will be a record and will represent our 34th straight comparable quarter of record growth," stated Ricky Wright, President & CEO of The Alkaline Water Company. "It is now clear to us that our ability to increase production capacity through new co-packers and raw material manufacturers is creating new business opportunities. Just like last year, we are meeting demand when others cannot. This year, we have seen tremendous growth of our single-serve Alkaline88 SKUs. Recent wins like Sam's Club, Giant Food, new SKUs at CVS, United Pacific convenience stores, and adding nine of the largest airports in the country have positioned us to continue significant growth. Another measure of growth is quarterly purchase orders which have steadily increased this year and set a new record in Q2 fiscal 2022. The momentum seems to be continuing in the current quarter."

09:18 EDT Medigus completes corporate rebranding process - Medigus announced it has completed a corporate rebranding process, including but not limited to, a new brand logo, a new website and an investor lobby, http://www.medigus.com/. The company said, "Medigus' corporate rebranding reflects the Company's business direction and plans for positioning itself as an innovative technology company, which is aligned with its strategic targets to provide a greater return to our shareholders."

09:17 EDT OneSmart International Education Group Limited (Class A ADS) trading halted, news pending

09:15 EDT Moderna: Covax to buy 176.5M more doses of Covid vax for low-income countries - Moderna announced that Gavi, the Vaccine Alliance has exercised its option to purchase an additional 176.5M doses of the Moderna COVID-19 vaccine for the COVAX Facility. Of these additional doses, 116.5M doses are expected to be delivered in the first quarter of 2022 and 60M doses are expected to be delivered in the second quarter of 2022. All doses are offered at Moderna's lowest tiered price, in line with the Company's global access commitments. COVAX retains the option to purchase 116.5M doses for delivery in the third quarter of 2022 and an additional 116.5M doses for delivery in the fourth quarter of 2022. These doses are in addition to the 34 million doses purchased for delivery in the fourth quarter of 2021. Through this long-term agreement, UNICEF and its procurement partners have been provided access to up to 500M doses of the Moderna COVID-19 vaccine through 2022. This agreement covers the 92 Gavi COVAX Advance Market Commitment low- and middle-income countries. The Company is in discussions to allocate and supply to self-financing participants in the future. COVAX is a global initiative co-led by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations and the World Health Organization, to ensure equitable access to COVID-19 vaccines for all countries, regardless of income levels.

09:14 EDT Moderna says neutralization titers against variants 6- to 7-fold lower - In briefing documents for this week's FDA Advisory Committee meeting, Moderna said, "The efficacy of mRNA-1273 to prevent COVID-19 was demonstrated to be 94.1% in November 2020 with 9 weeks median follow-up and 93.2% after 5.3 months median follow-up, when the original strain and the Alpha variant were the major circulating SARS-COV-2 strains. However, in recent evaluations of antibody persistence 6 to 8- months after completion of the two-dose primary series, neutralization titers against variants of concern including Beta, Gamma, and Delta were observed to be 6- to 7-fold lower compared with those observed 1-month post-dose 2. The waning of antibody titers against VoCs is particularly concerning as peak antibody titers post-dose 2 were lower than those to the original strain, resulting in an increased proportion of individuals with antibody titers below the limit of detection of the assays...These data support the public health benefit of a booster dose of mRNA-1273 approximately 6 months after the second dose of mRNA-1273 to restore antibody titer levels and reduce the number of breakthrough cases, particularly against VoCs." Reference Link

09:11 EDT Genethera enters exclusive real estate agreement with Cushman & Wakefield - GeneThera, Inc. (GTHR) announced that it has entered into an exclusive agreement with Cushman & Wakefield (CWK) to identify land sites and warehouse buildings in the Denver area in connection with the development of GeneThera Zoonotic Disease Alert Shield surveillance network. While the Stationary BSL3 laboratory is built, the Company operation will be primarily focused on the assembly of the Mobile Laboratory Units as part of the ZIDAS surveillance system network. Cushman & Wakefield's initial objective is to identify warehouse spaces where the MLU will be assembled and stored. Colorado will be the first site of a network that will span throughout the US and will continue to grow over the next several years; domestically and internationally.

09:09 EDT Celsion announces oral presentation at International Vaccines Congress - Celsion announces that Khursheed Anwer, Ph.D., executive vice president and chief science officer, will be presenting at the International Vaccines Congress being held virtually October 18-20, 2021. Anwer's presentation is titled "Immunogenicity of DNA Vaccines based on Multicistronic Vectors and Synthetic DNA Delivery Systems." Dr. Anwer will be discussing ongoing proof-of-concept studies in SARS-CoV-2 with the company's DNA-based vaccine approach utilizing its PLACCINE platform. PLACCINE, Celsion's proprietary design for DNA vectors, encompasses molecular elements designed to improve the immune response by targeting multiple antigens of a pathogen or multiple mutants of the same antigen. Dr. Anwer will review the PLACCINE technology and the production of a family of DNA vaccine vectors expressing one or more SARS-CoV-2 surface antigens as a proof-of-concept target, verified vector composition and demonstrated expression of the encoded genes. "The International Vaccines Congress is an ideal forum to discuss our ongoing work with unique approaches to DNA-based vaccines. We view their acceptance of Dr. Anwer's abstract as support for our scientific rigor and the promise of our work," said Michael H. Tardugno, chairman, president and chief executive officer of Celsion. "We previously reported that immunization of Balb-C mice with a plasmid expressing the Spike protein of SARS-CoV-2 resulted in the production of IgG antibodies with evidence of viral neutralization and cytotoxic T-cell response specific to the antigen. We look forward to reporting this and additional data as we continue to make excellent progress with our PLACCINE platform."

09:09 EDT Verizon announces availability of Motorola edge 5G UW - The company said, "Verizon is your exclusive home for the motorola edge 5G UW - a feature-packed 5G phone at an affordable price. For a limited time, you can get a motorola edge 5G UW on us with select Unlimited plans. motorola edge 5G UW is an easy way to tap into all Verizon's 5G flavors, including upcoming enhancements to 5G Ultra Wideband using C-band spectrum. 5G Ultra Wideband lets you take full advantage of the amazing features available on the motorola edge 5G UW, so you can game with low lag, upload your videos and images in seconds, and not worry about whether you can download that movie before you hop on your flight."

09:08 EDT Comtech awarded $1.1M of funding to support City of Baltimore - Comtech announced that during its first quarter of fiscal 2022, it was awarded $1.1M of funding to continue to provide critical Information Technology staffing and support to multiple agencies within the City of Baltimore, including, but not limited to the Baltimore City Information & Technology, BCIT and the Baltimore City Police Department.

09:07 EDT CleanSpark announces purchase of 4,500 units of the Antminer S19 bitcoin machine - CleanSpark announced its purchase of 4,500 units of the Antminer S19 bitcoin mining machine. The purchase was partially funded through a portion of the company's BTC holdings. Delivery of the machines are scheduled to start next month and be completed by July 2022. CleanSpark estimates that its sustainable bitcoin mining capacity will increase by a computing power of 450 PH/s, equivalent to almost 45% of the company's current capacity, after the purchased machines are fully operational. The company expects to have the data center space for the machines ready to plug and play before each consecutive delivery. The company currently operates over 10,000 miners. The total number of miners slated for delivery over the next 12 months is now 24,580.

09:06 EDT Gevo, Axens enter alliance for ETJ technology, sustainable aviation fuel - Gevo and Axens North America have entered into an agreement that establishes a strategic alliance aimed at accelerating the commercialization of sustainable ethanol-to-jet, or ETJ, projects in the United States. As part of the alliance, Axens brings technologies with over 60 related patents; engineering packages; proprietary catalysts; and certain proprietary equipment required to convert ethanol into jet fuel. Axens would also provide process guarantees for commercial ETJ projects. Gevo expects to develop, own, and operate ETJ plants to produce sustainable aviation fuel, utilizing its expertise in renewable alcohol production and technologies; Net-Zero business model; project financing expertise; customer relationships, and contracts. "Our customers want SAF and other low-carbon hydrocarbons sooner, rather than later. The collaboration between Gevo and Axens is expected to allow Gevo to rapidly partner with existing ethanol producers to deploy proven technologies at commercial scales consistent with the airline industry's sustainability goals. We see that there is great potential to convert ethanol into SAF and other hydrocarbons. Additionally, there is synergy with Gevo proprietary isobutanol production technology that is expected to result in unique product blending synergies for producing low-carbon gasoline, SAF, and renewable diesel. We know from our work on the Net-Zero business model that it is possible to drive the fossil-based GHG and related emissions footprint very low or even negative while producing drop-in hydrocarbon fuels like SAF and we think the model can apply to ETJ too," said Dr. Patrick R. Gruber, Chief Executive Officer of Gevo. "Axens is a great partner. They have a lot of patents, expertise, and a track record of success with their technologies to convert olefins into hydrocarbons. In short, Axens de-risks the production technology. Gevo expects to build, own, and operate alcohol-to-jet plants alone or with partners. To any ethanol plant owners out there who want to change their game and get into Net-Zero type SAF and hydrocarbons, please give us a call," continued Dr. Gruber.

09:05 EDT Tetra Tech gets $19.5M contract with USAID for food Innovation hub - Tetra Tech announced that the U.S. Agency for International Development, USAID, awarded the Company a four-year, $19.5M single-award contract to implement the Water and Energy for Food, WE4F, Southern and Central Africa Regional Innovation Hub in collaboration with Open Capital Advisors and the International Water Management Institute "Tetra Tech has supported USAID's energy reform programs-including utility modernization and deployment of advanced off-grid power solutions-in Sub-Saharan Africa for more than 30 years," said Dan Batrack, Tetra Tech Chairman and CEO. "We look forward to continuing to use our Leading with Science approach to create sustainable water and clean energy solutions that build climate resilience and economic prosperity."

09:04 EDT OneSmart suspends education programs in China - OneSmart International Education Group announced the approval by the board of directors of the Company of the suspension of all of the Company's education programs and learning centers in China, primarily due to challenges posed by recent changes in the relevant policy and regulatory landscape in China's private educational service industry and the resulting operational difficulties experienced by the Company. The Company also announced that its independent directors Liang Xu and Yan Gong had resigned from the board recently. The Company intends to appoint two new independent directors in due course.

09:03 EDT Pangaea Ventures announces ESS trading in the NYSE - Pangaea Ventures announced that its portfolio company, ESS, has begun trading on the NYSE under the symbol GWH. ESS designs, builds, and deploys clean, low-cost long-duration energy storage systems with a mission to catalyze a sustainable energy future. Based in Portland, Oregon, ESS has commercialized its unique iron-based flow battery, which is an environmentally benign, long-life energy storage solution for the world's rapidly growing renewable energy infrastructure. Pangaea Ventures led ESS's Series A round in 2015 with a valuation of less than $10M. Since then, Pangaea Ventures has supported several subsequent rounds of financing along with investors such as Breakthrough Energy Ventures and Softbank Energy, as well as with Pangaea limited partners BASF Venture Capital and GC Ventures.

09:02 EDT Chatham Asset offers to acquire R.R. Donnelley for $7.50 per share in cash - Chatham Asset Management, a private investment firm which manages funds that beneficially own approximately 14.9% of the outstanding common stock and which is the largest bondholder of R.R. Donnelley & Sons Company, in a letter sent to RRD's Board of Directors submitted an offer to acquire all the common stock of RRD not already owned by Chatham for $7.50 per share in cash. The Transaction represents a 52.1% premium over yesterday's closing price of $4.93 per share, a 6.2% premium over the 52-week high of $7.06 per share, and a 92% premium over the 365-day volume-weighted average price of $3.91 per share. Chatham would finance the Transaction using cash on hand and external financing, and has secured a highly confident letter from Jefferies Group LLC supporting its ability to raise all necessary funds. To facilitate the Transaction, Chatham is willing to equitize and/or subordinate its entire debt position, reducing RRD's total debt by 23%. As a result, Chatham calculates that annual interest expense on a pro forma basis would decline by approximately $36 million or 33%. "Despite our efforts to engage with the Board on ways to position the business for long-term success, we no longer have confidence in RRD's ability to achieve full and fair value as a public company under the current Board and management team. As longstanding investors in RRD, we believe our offer presents the best path forward for the Company to unlock its intrinsic value, while also providing shareholders immediate and substantial cash," said Chatham.

09:02 EDT Tom Tailor selects Progress Sitefinity Digital Experience Platform - Progress announced that the German lifestyle fashion brand Tom Tailor selected the Progress Sitefinity Digital Experience Platform to supplement its physical brick-and-mortar experience digitally, due to COVID-19. The company said, "With Progress Sitefinity platform, the brand created engaging multi-region digital experiences for its clients and aligned content and commerce to engage and convert customers online."

08:59 EDT Chatham Asset offers to acquire R.R. Donnelley for $7.50 per share in cash

08:54 EDT Tinley Beverage Company to upgrade mini bottling line as part of settlement - The Tinley Beverage Company is pleased to announce that it will be installing an upgraded mini line in its Long Beach facility as part of a comprehensive resolution to the dispute with the vendor for the original facility buildout. In July 2020, one of the contractors that had been retained by the engineering firm managing the buildout of Tinley's Long Beach facility filed a third-party complaint against this engineering firm. The claim was related to work the contractor had performed at the facility. While Tinley's was not a party to the contract, the Company and its landlord were named in the enforcement of a mechanics lien that was placed on the facility. The dismissal, with prejudice, has been filed for the Company, its affiliates and related companies, and for the landlord of the Long Beach facility. The mechanics lien, in favour of the contractor, has now been ordered released by the contractor who was the plaintiff in the litigation. On its most recent financial statements, Tinley's had been reporting accrued accounts payables of $547,642 for such litigation. The Company used this conservative accounting approach in recognition of the possibility that the Company would be responsible for the cost of vacating the lien, in the event the defendant did not fulfill its contractual obligations to the complainant. Under the settlement, Tinley's made a reduced payment to the contractor on the engineer's behalf in return for an agreement for the supply and installation of an upgraded mini line at Tinley's Long Beach facility at a substantially discounted price. The Company believes that the total cost of the settlement payment associated with the dismissal and discounted mini line is contracted at a price that is lower than the cost the Company would have otherwise incurred had it acquired and installed this mini line via other vendors at normal market rates. The Company believes it has satisfied its obligations under the settlement, therefore ongoing litigation is expected to formally end at the final hearing for dismissal, which is scheduled to occur on October 29, 2021. Under a new engineering services and equipment supply agreement with the original engineering firm, Tinley's will receive an upgraded mini bottling line at its Long Beach, California facility. The Company is currently experiencing significant demand for mini bottling services and therefore requires a more versatile, higher capacity line. The current mini line had been acquired via a royalty agreement with the vendor. Under the terms of the royalty agreement, the Company is entitled to a receive a complete return of the cost of the equipment upon delivery of the current mini line equipment to the vendor. The Company will use its existing mini line to service its current and anticipated mini line clients until the installation of the new mini line is complete. The Company currently expects to continue to consummate manufacturing agreements with additional third-party brands that require mini bottle formats.

08:52 EDT Vallon Pharmaceuticals announces update on ADAIR, ADMIR programs - Vallon Pharmaceuticals provided an update on the progress of its development programs, ADAIR and ADMIR, which leverage the Company's proprietary technology that is designed to resist manipulation for snorting and provide barriers to injection. ADAIR1: Abuse-Deterrent Formulation of Dextroamphetamine: ADAIR is the Company's proprietary abuse-deterrent formulation of immediate-release dextroamphetamine currently in development for the treatment of attention deficit hyperactivity disorder and narcolepsy. ADAIR is being developed leveraging the de-risked 505(b)(2) regulatory pathway and is currently being evaluated in a pivotal intranasal abuse study, the SEAL study. The SEAL study is expected to be the final clinical trial prior to NDA filing. If approved, ADAIR has the potential to address the growing Adderall segment of the ~$9 billion US ADHD market. The SEAL study is a pivotal randomized, double-blind, double dummy, placebo and active-controlled 4 period, 4-way crossover assessing the pharmacodynamics, pharmacokinetics, safety and tolerability of manipulated ADAIR 30 mg when compared to crushed d-amphetamine sulfate and placebo. Safety will be assessed via adverse events, vital signs, ECGs, clinical laboratory tests and other standard measures. Patient enrollment is ongoing with approximately 75% of the target number of subjects completing the study. The final patient visit and completion of treatment is expected in the first quarter of 2022 with topline results expected shortly thereafter. ADAIR is also currently being developed in Europe and the UK through a license and collaboration agreement with MEDICE Arzneimittel Putter GmbH, a leader in the European ADHD market. The Company is in ongoing partnering discussions for additional regional license opportunities for ADAIR. Vallon received its first EU patent for ADAIR in July 2021. The Company has filed additional patents in other major territories that are important ADHD markets in order to bolster its IP protection. ADMIR: Abuse-Deterrent Formulation of Methylphenidate: The Company's second program in development is ADMIR, a novel abuse-deterrent formulation of immediate-release methylphenidate. Ritalin is another commonly prescribed stimulant for treating ADHD that is frequently misused and abused. Vallon has completed its formulation development work and selected a final formulation for ADMIR. This formulation has demonstrated excellent dissolution and abuse-deterrent characteristics in the laboratory setting that the Company believes is compelling for advanced development. Preparations are underway to submit an IND with plans to commence the first human clinical trial in 2022. Additionally, the Company recently entered into an agreement with Catalent to support the development and manufacturing of ADMIR. Catalent is a leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Real World Stimulant Abuse Insights and the Need for Abuse-Deterrent Formulations: In addition to advancing its clinical programs, the Company recently sponsored a large survey on stimulant abuse patterns in adults. The survey was led by researchers at the University of Kentucky and included nearly 500 people who misuse or abuse prescription stimulants. Results of the survey provided important insights into patterns of abuse and confirmed the clinical unmet need for products with abuse deterrent characteristics like ADAIR. Results from the survey have been accepted for presentation at the upcoming American Academy of Child and Adolescent Psychiatry Annual Meeting being held virtually October 18-30, 2021.

08:50 EDT Resonant customers exceed shipment milestone of 100M RF filters - Resonant announced that its customers have cumulatively surpassed the milestone of shipping 100M RF filters designed with the Company's proprietary WaveX technology. Resonant's customers shipped over 47M RF filters year-to-date, and a total of 21M RF filters in the third quarter of 2021, representing a year-over-year increase of approximately 433% and a sequential increase of approximately 23%. The RF filters cover a total of eleven cellular, Wi-Fi, and GPS bands across a combination of tier-1 and tier-2 customers. "Exceeding the 100M milestone for RF filters cumulatively shipped by our customers is a testament to the effectiveness of our foundry partner model, the depth of our proprietary IP, and the effectiveness of our WaveX(TM) software platform in helping IDMs meet the heightened demand for innovative, cost-effective filter solutions," said George Holmes, Chairman and CEO of Resonant. "This acceleration of unit shipment volumes is a key indicator of progress with our strategy to revolutionize the RF filter supply chain with solutions that innately and reliably meet the complex requirements of next-generation, ultra-fast networks. Once designs have been locked in, our licensees have shown they can ramp quickly to mass production. As we continue to further penetrate this multi-billion-dollar opportunity, this proven model gives us confidence that we have a strong foundation to facilitate the high-volume manufacture of our best-in-class XBAR filters with our strategic partner-the largest RF filter manufacturer in the world."

08:49 EDT FDA posts briefing documents ahead of meeting on Moderna, J&J booster shots - Ahead of the Vaccines and Related Biological Products Advisory Committee meeting planned for October 14-15, at which FDA advisors will discuss the EUA of the Moderna (MRNA) COVID-19 mRNA Vaccine for the administration of an booster dose, following completion of the primary series, in individuals 18 years of age and older, and the EUA of the Janssen Biotech (JNJ) COVID-19 vaccine for the administration of a booster dose, to individuals 18 years of age and older, the agency has posted background materials available to the public, including briefing documents prepared by Moderna and Janssen. Reference Link

08:48 EDT Genasys announces follow-on $1.8M LRAD systems order - Genasys announced a $1.8 million LRAD systems order from the U.S. Navy under a three-year indefinite delivery/indefinite quantity contract announced in June 2020. The Navy is replacing its first generation LRADs with next generation LRAD 1000Xi systems.

08:47 EDT Agenus to receive $20M milestone payments from Bristol Myers Squibb - Agenus (AGEN) announced it has triggered the first development milestone payment under its global licensing agreement with Bristol Myers Squibb (BMY) for AGEN1777, an Fc-enhanced bispecific anti-TIGIT antibody. Agenus will receive a $20M cash payment with the dosing of the first patient. "AGEN1777 represents Agenus' latest innovation to activate the immune system against cancer and combat therapeutic resistance, as well as our fifth pharmaceutical collaboration to reach clinical development," said Steven O'Day, MD, Chief Medical Officer of Agenus. "With AGEN1777's unique mechanism of action and Bristol Myers Squibb's immuno-oncology expertise, our goal is to efficiently evaluate AGEN1777's benefit in difficult to treat tumors." This Phase 1 dose escalation study is designed to evaluate the safety, tolerability, and preliminary clinical activity of AGEN1777 as a single agent and in combination with a PD-1 inhibitor in patients with advanced solid tumors. The first patient was treated at Providence Cancer Institute by Dr. Rachel Sanborn. The trial will follow a standard dose-escalation design and will be used to establish the recommended Phase 2 dose. The global license agreement with Bristol Myers Squibb included a $200M upfront payment paid in July 2021, and up to $1.36B in development, regulatory and commercial milestones in addition to tiered double-digit royalties on net product sales. Bristol Myers Squibb is solely responsible for the development and commercialization of AGEN1777 and its related products worldwide. Agenus retains options to conduct clinical studies under the development plan, to conduct combination studies with certain other Agenus pipeline assets, to co-fund global development for increased US royalties, and to co-promote AGEN1777 in the US upon commercialization.

08:45 EDT Rush Street Interactive announces online sportsbook soft launch in Connecticut - Rush Street Interactive announced the soft launch of the PlaySugarHouse online sportsbook in Connecticut. A total of 750 customers across the state can register and place bets beginning after 3:00pm eastern time at www.PlaySugarHouse.com and experience RSI's sports betting platform, on a first-come-first-serve basis. Once the 750-player limit is reached, per Connecticut Department of Consumer Protection regulations, customers who pre-register at www.PlaySugarHouse.com will be added to a waiting list and notified as soon as the full launch is authorized, which is expected to occur as soon as October 19. Waitlisted customers will receive an extra free bet once their PlaySugarHouse accounts can be opened, on top of the $250 first deposit match bonus to which all new players are entitled.

08:44 EDT Emcore introduces SDC500 MEMS IMU for commercial, industrial applications - EMCORE Corporation announced the introduction of its new SDC500 MEMS Inertial Measurement Unit, incorporating EMCORE's market-leading quartz technology and optimized for high-precision civil aerospace, commercial, industrial and marine applications. The SDC500 is non-ITAR controlled and available with no U.S. export license required for most end-users throughout the world.

08:43 EDT First Wave BioPharma announces two additions to Scientific Advisory Board - First Wave BioPharma announced additions to the Company's Scientific Advisory Board to reflect the expanded clinical development opportunities into COVID-19-related gastrointestinal infections, immune checkpoint-associated colitis, and inflammatory bowel diseases following its recent acquisition of First Wave Bio. Effective immediately, Anthony Opipari, M.D., Ph.D., a co-founder and the former Chief Medical Officer of First Wave Bio and Richard Marlink, M.D., Director of the Rutgers Global Health Institute, will join Michael Konstan, M.D., as members of First Wave BioPharma's SAB. In connection with these appointments, it is anticipated that two existing members of the SAB, Darwin Conwell, M.D. and Michael Wilschanski, M.D., will transition onto an adrulipase steering committee for exocrine pancreatic insufficiency for cystic fibrosis and chronic pancreatitis. "We are excited to have added prestigious scientific, medical and industry thought leaders to provide First Wave BioPharma with expert counsel as we advance our multiple pipeline programs," said James Sapirstein, Chairman, President and CEO of First Wave BioPharma. "Each member of our SAB brings his own unique expertise, be it research into treatment for cystic fibrosis, autoimmune and inflammatory bowel diseases, or decades of work establishing large-scale AIDS and HIV antiviral research and treatment programs in the U.S. and Africa. This collection of keen minds, and their collective expertise, should serve us well in the months and years to come."

08:41 EDT Cemtrex provides corporate update on business operations - Cemtrex provided a corporate update on its business operations, financials and industry outlook. Cemtrex is a holding company with operating brands that now include: Vicon Industries; SmartDesk; CXR; Bravo Strong VR; Virtual Driver Interactive; Advanced Industrial Services; and Goodtech, formerly CemtrexLabs. "Throughout the second half of CY 2021 we have continued to see demand improvement as the economy has reopened and businesses are returning to pre-pandemic operations," said Saagar Govil, Cemtrex CEO. "In response we are investing in sales and marketing staff across the board to grow our business and increased R&D spend to drive innovation. We expect these investments to drive top line growth over the next two to three years. Additionally, we continue to evaluate acquisition opportunities for strategic growth. Operationally we are advancing our product development and pipelines across all our brands. Vicon will be launching a proprietary AI based analytics solution next year as well as major improvements to its core software platform Valerus... In the first quarter of 2021, we announced the next generation SmartDesk, the SmartDesk Connect... SmartDesk has experienced some supply chain and delivery issues over the last two quarters resulting in limited product deliveries of SmartDesk Connect. However, we expect these issues to resolve in CY21 Q4 and we plan to ramp up our sales and marketing efforts thereafter... Bravo Strong has continued with the development of our first VR game and expects a beta release of StarForceVR in Oculus Quest App Lab in CY22 Q1... Looking ahead we are highly committed on executing our development roadmap of next generation high tech products in IoT, AR & VR, as well as in Artificial Intelligence and Machine Vision for security applications. Our positive outlook for 2022 is driven by a focus on innovation and product development, and by the achievements of our operating brands. We expect an improvement in our business as the pandemic recedes and with our operational investments are well positioned for long term growth," concluded Govil.

08:40 EDT Berkeley Lights sees Q3 revenue $24M-$24.3M, consensus $23.15M - Berkeley Lights reported preliminary, unaudited revenue for the quarter ended September 30, 2021. The Company's total revenue and platform placements in the third quarter of 2021 was the largest in its history. Total revenue for the third quarter is expected to be in the range of $24.0 million to $24.3 million, representing an increase of approximately 33% compared to $18.2 million in revenue for the third quarter of 2020. These results include 13 new platform placements in the quarter, inclusive of three TechAccess subscriptions booked and announced in the second quarter. Six of the placements were to existing customers expanding their capacity of Berkeley Light's platforms. "Our results this quarter are a testament to the value and broad applicability of the Berkeley Lights platform across multiple disciplines," said Berkeley Lights CEO Eric Hobbs, Ph.D. "Berkeley Lights' technology provides unprecedented functional information at scale. Our new and existing customers are increasingly choosing the Berkeley Lights' platform both for the quality of the data extracted from our platform and the efficiencies that it can help them achieve. With increasing demand for our technology across large, global markets, we look forward to building on our momentum to drive significant value for our customers and shareholders."

08:38 EDT Albireo Pharma announces exclusive licensing agreement with Jadeite for Bylvay - Albireo Pharma entered into an exclusive licensing agreement with Jadeite Medicines for the development and commercialization of Bylvay in Japan for progressive familial intrahepatic cholestasis, Alagille syndrome and biliary atresia. Under the terms of the agreement, Albireo will receive an upfront payment of $15M and will be eligible to receive up to $120M in milestones as well as double-digit royalties. Jadeite Medicines will be responsible for clinical development, regulatory approval and commercialization of Bylvay in Japan. "This agreement exemplifies Albireo's commitment to providing global availability of Bylvay, particularly in areas like Japan where high prevalence translates to a sizable number of patients who currently have no approved treatment option. Jadeite Medicines entrepreneurial, biotech approach makes them the right type of partner to successfully commercialize Bylvay in Japan," said Ron Cooper, President and Chief Executive Officer of Albireo. "The agreement allows for success of both companies, while strengthening Albireo's financial position with the $15M payment added to our strong balance sheet." Bylvay is the first drug approved in Europe for the treatment of all types of PFIC and in the U.S. for the treatment of pruritus in all types of PFIC. A potent, non-systemic ileal bile acid transport inhibitor, Bylvay is administered as a once-daily capsule or opened and sprinkled onto soft foods. Bylvay is currently being evaluated in the ASSERT Phase 3 study for ALGS, the BOLD Phase 3 study for patients with biliary atresia and the ongoing PEDFIC 2 open-label trial in patients with PFIC.

08:36 EDT Esports Technologies plans opening of new office in Malta - Esports Technologies announced the planned opening of a new state-of-the-art office in Malta. The Malta location will house the majority of the Esports Technologies team and direct European market operations, working closely with the Esports Technologies office in Dublin. The additional office location will help accelerate Esports Technologies' aspirations to expand into Western Europe, including the UK, Germany, France, Italy, Spain, Belgium, Denmark, Netherlands and Ireland. The new office is scheduled to be operational on November 15. The Esports Technologies Malta office will join the company's existing locations in Las Vegas and Dublin. The office will have an open floor plan that includes breakout spaces for individual work or small-group collaboration, a full boardroom, and a modern design incorporating esports themes.

08:35 EDT Ciena selected by Telesat for LEO terrestrial network technology - Telesat is deploying Routing and Switching platforms from Ciena for its Telesat Lightspeed terrestrial backhaul network. Ciena's advanced routing and switching technology will ensure that Telesat has a "modern, cost-effective network that takes advantage of emerging technologies including network functions virtualization and edge computing to efficiently support both existing and future customer requirements," the company said. The Telesat Lightspeed network will initially be comprised of 298 advanced Low Earth Orbit, or LEO, satellites that integrate with terrestrial networks. Ciena is supplying hardware and software that will provide high-speed, high-capacity connections to customers for the delivery of 5G, cloud computing, video, and other bandwidth-intensive broadband services. Telesat will use Ciena's 3926 and 5170 platforms to provide MEF-compliant services at its points of presence, as well as terrestrial connectivity to as many as 50 Earth-based landing stations. "Telesat's enterprise customers-MNOs, ISPs, aviation, and maritime companies-are seeking high-throughput, super-low-latency connectivity to support delay-sensitive applications like cloud-based services. Telesat Lightspeed, powered by Ciena networking technology on the ground, makes reliable satellite broadband at fiber-like speeds possible." Bruce Hembree, Vice President and General Manager, Americas, Ciena

08:35 EDT CVR Partners appoints Dane Neumann as EVP, CFO - CVR Partners, LP (UAN), together with CVR Energy (CVI) announced that Dane Neumann has been named Executive Vice President and Chief Financial Officer of the general partner of the Partnership and the Company. Neumann's appointments were effective October 6, 2021. In this position, Neumann will lead all aspects of the finance and accounting functions for the Partnership, the Company and their subsidiaries. Neumann most recently served as Interim Chief Financial Officer of the general partner of the Partnership and the Company since August 2021 and Vice President of Finance & Treasurer since June 2020.

08:34 EDT CVR Energy appoints Dan Neumann as EVP, CFO - CVR Energy (CVR) announced that Dane Neumann has been named Executive Vice President and Chief Financial Officer of the Company. Neumann also will serve as Executive Vice President and Chief Financial Officer of the general partner of CVR Energy's nitrogen fertilizer affiliate, CVR Partners, LP (UAN). Neumann's appointments were effective October 6, 2021. In this position, Neumann will lead all aspects of the finance and accounting functions for CVR Energy and its subsidiaries. Neumann most recently served as Interim Chief Financial Officer of the Company and the general partner of the Partnership since August 2021 and Vice President of Finance & Treasurer since June 2020.

08:33 EDT Sensus Healthcare announces Chinese Health Authority renews license for SRT-100 - Sensus Healthcare announces that the Chinese Health Authority has renewed Sensus' license to market the SRT-100 system in Greater China for an additional five years. This new license expires in December 2026 and covers the sale of the Company's superficial radiation therapy to treat non-melanoma skin cancer and keloids in Mainland China. The Chinese Health Authority approved the SRT-100 for the treatment of non-melanoma skin cancer and the prevention of scars following keloidectomy in 2014 and 2017, respectively. Currently there are 46 SRT-100 units installed throughout China in public and private hospitals, as well as in private medical clinics. "China has approximately 20% of the world's population and we are delighted to receive this vote of confidence in our efficacious and non-invasive treatment option," said Joe Sardano, chairman and chief executive officer of Sensus Healthcare. "We are very pleased with the reception to our SRT-100 system in China to date, and post-pandemic sales have rebounded nicely throughout 2021 under the leadership of Benson Suen, Vice President of International Sales, along with the exclusive distribution agreement we signed last year with Ekpac Healthcare." Separately, the Company expects to receive Chinese marketing authorization for its Sculptura radiation oncology system in the later part of 2022. This modulated robotic system provides targeted directional anisotropic radiation therapy and brachytherapy utilizing proprietary, state-of-the-art 3D Beam Sculpting(TM) to treat patients undergoing cancer treatment during surgery, or at the tumor site, quickly and efficiently.

08:32 EDT Jadeite signs license agreement with Albireo for odevixibat in Japan - Jadeite Medicines, a biopharmaceutical company that is backed by Singapore's CBC Group, entered into an exclusive licensing agreement with Albireo Pharma for the development and commercialization of odevixibat in Japan for progressive familial intrahepatic cholestasis, Alagille syndrome and biliary atresia. Under the terms of the agreement, Albireo will receive an upfront payment of $15M and will be eligible to receive up to $120M in milestone payments, as well as double-digit royalties. Jadeite will be responsible for clinical development, regulatory approval and commercialization of odevixibat in Japan, where there is significant market opportunity. Jadeite is backed by CBC, which partners with the world's top entrepreneurs and scientists and leverages its unique "investor-operator" approach to empower global leading healthcare companies to widen access to affordable medical care, catalyze innovations and improve efficiency in fulfilling unmet medical needs worldwide.

08:31 EDT Genco Shipping signs Call to Action for Shipping Decarbonization - Genco Shipping & Trading announced that the company has become a signatory to the Call to Action for Shipping Decarbonization alongside over 160 industry leaders across the maritime value chain. The Call to Action, which was formed in September 2021 by a taskforce of the Getting To Zero Coalition, will be delivered in November 2021 to world governments ahead of the UN Climate Change Conference in Glasgow. The primary objective of the initiative is to fully achieve decarbonization of the international shipping industry by 2050. John Wobensmith, Chief Executive Officer, commented, "Decarbonizing the global shipping industry is of critical importance, and we are pleased to join the Call to Action together with key participants within the maritime sector. To meet this extremely important objective, we remain committed to working collaboratively to ensure zero emission technologies to be developed are safe and reliable in the future with a focus on developing global bunkering infrastructure that enables commercial viability for alternative fuels. We believe that immediate action is required on a global scale given the long useful lives of oceangoing vessels, as we take essential steps to make zero emission shipping a reality."

08:28 EDT Agile Therapeutics applauds Congressional Chair's letter to Biden administration - Agile Therapeutics "applauded" House Congressional Committee leaders in urging the Secretaries of U.S. Departments of Health and Human Services, Treasury, and Labor to enforce the law regarding women's access to contraceptive methods as dictated by the Affordable Care Act. "We applaud the authors of the letter, Energy and Commerce Chairman, Frank Pallone Jr., Ways and Means Committee Chairman Richard E Neal, Education and Labor Chairman Robert C. Scott and Oversight and Reform Chairwoman Carolyn Maloney for bringing this important issue to the forefront. Contraception is a personal choice - one that all women, in consultation with their health care providers, should be empowered to make," said Al Altomari, Chairman and Chief Executive Officer of Agile Therapeutics. "We also recognize the work of the Family Planning Coalition and their 35 members who also sent a letter to the Secretaries on September 24, 2021 expressing similar concerns over barriers to contraceptive access. We support the efforts of these individuals and organizations to seek enforcement of the ACA and to ensure women can access the birth control they need and are entitled to under the law."

08:26 EDT IntelGenx to resume patient screening in Montelukast VersaFilm Phase 2a trial - IntelGenx announced its intention to resume patient screening in the ongoing Montelukast VersaFilm Phase 2a clinical trial in patients with mild to moderate Alzheimer's Disease following Health Canada's issuance of a No Objection Letter in response to IntelGenx's amended Clinical Trial Application As previously disclosed in Q1-2020, IntelGenx received HC authorization to proceed with an amended BUENA clinical trial protocol, which enabled the Company to continue the trial at an increased daily dose. However, because the target study population in the BUENA study is considered to be a higher risk group for severe illness from COVID-19, and out of concern for the health and safety of clinical trial staff, IntelGenx informed HC in the second quarter of 2020 that the study was on a temporary recruitment hold. This NOL now paves the way for patient screening under the amended protocol to resume in October 2021.

08:24 EDT MAD Lions announces partnership with GOIKO - MAD Lions, OverActive Media's professional League of Legends franchise, announced a partnership with GOIKO, a premium hamburger chain with more than 80 locations throughout Spain and France. The two brands have come together to serve up fresh content to fans across MAD Lions' social channels, launching during the 2021 League of Legends World Championship. The partnership is GOIKO's first official foray into esports and includes sponsorship opportunities with MAD Lions' League of Legends LEC and Superliga teams, in addition to the club's roster of Call of Duty: Warzone content creators. Adding MAD Lions' first quick service restaurant partner expands its reach to new audiences while providing an opportunity to create fresh content aligned with its overall brand strategy.

08:23 EDT Digerati Technologies highlights case studies of Cloud UCaas solution - Digerati Technologies pleased to highlight three case studies involving clients from the banking, restaurant and health care industries. T3 Communications, a Digerati operating subsidiary, has become the service provider of choice for several regional and local community banks throughout Texas and Florida. One regional bank has been a client for over ten years. The bank required a unified fiber-optic network to connect its eight branches and meet redundancy protocols to secure its growing operations. The T3 team implemented a fiber optic network and SIP trunking solution for the bank's on-premises PBX. T3's telecom solution allows the bank's customers to call into a single phone system to reach the appropriate branch which played a significant role in business continuity and a positive customer experience. The T3 Team consolidated voice and data services for all branches and streamlined billing into one easy-to-read statement. Enhancements to the network provided by T3 included routing a multicarrier fiber optic network at the bank's main headquarters through separate building access points. The network enhancements established redundancy by routing distinct carriers to a specific location while hosting a mirror image of the bank's PBX and network equipment. This allowed for modernization of the community bank's safety protocols and established full redundancy with a seamless auto failover via BGP and OSPF protocols. A nationwide restaurant chain needed a solution to meet the increased volume of incoming calls for 'to-go' orders. Digerati's operating subsidiary, Nexogy, created a centralized call center environment for callers to reach each of the restaurant locations. This call center solution included an auto-attendant with professional greetings and on-hold music. To improve the caller's experience, the Nexogy team implemented a Centralized IDR and remote agent system, placing the calls in a queue and avoiding busy signals. The IDR enabled the franchise owner to add restaurants to the same account and simplify all services under one provider and bill. In addition, the Nexogy team met the owner's telecom budget per restaurant and offered call reports for monitoring, analytics and measuring performance. The new on-hold features, centralized billing, real-time call reporting, statistics, and even call flow management were excellent IT investments to save time and increase productivity. Another client of T3 Communications is a nationwide healthcare provider specializing in employee health clinics for Fortune 500 corporate campuses. This health care provider required a complete cloud communications system to support its physical clinics and to ramp up its telemedicine and remote medical support services. The T3 team created a dedicated call center, updated their nationwide telco system and network, and tailored a comprehensive UCaaS platform to support physical devices, mobile solutions, and cloud-based applications. As this client continues to adapt and grow in the new work-from-home professional arena, its communications infrastructure is steadily growing in parallel thanks to the innovative approach by the T3 team.

08:20 EDT ATIF's NFT auction platform has entered testing phase - ATIF Holdings announced that its technical team has successfully completed the development of an NFT platform. The NFT platform has entered the testing stage, and is expected to be officially launched by the end of 2021. ATIF's NFT platform will support a wide range of digital product auctions and listings, including, but not limited to, digital art, encrypted collections, celebrity digital signatures, and personal creations while facilitating a safe and efficient trading marketplace for digital assets that ensures scarcity and originality as well as solving the problem of copyright tracing, that will be available to artists, creators, users, and collectors. The NFT platform will be primarily targeted towards US markets but is open to international users as well. Additionally, the NFT platform offers an opportunity for many artists to earn additional income through royalties, of which a portion of such income can be donated as charity purposes. As part of the Company's plan to establish a diversified and decentralized financial service system, ATIF entered the NFT segment and expanded its physical collections to digital collections. ATIF's CEO, Jun Liu, stated that the Company will also seek out innovative decentralized financial service business opportunities to retain the Company's development vitality to bring in additional income. ATIF is expected to see a boom in 2022 as the global epidemic improves and the economy recovers. ATIF believes it will achieve the profitability and expects the Company to turn losses into profits by 2022.

08:20 EDT GM gains 1% in premarket trading after saying LG to reimburse company for recall

08:19 EDT Precigen names Harry Thomasian Jr. as CFO - Precigen announced the appointment of Harry Thomasian Jr. as the company's CFO, effective October 18. Thomasian will oversee the company's corporate financial strategy and planning, and provide a critically important strategic perspective to business development, licensing, and corporate financing initiatives. Thomasian will report to Precigen's President and CEO, Helen Sabzevari, PhD, and will join Precigen's leadership team, which directs Precigen strategy, planning and operations. Prior to Precigen, Thomasian was with EY.

08:18 EDT Xapo partners with Thoughtworks to scale from Bitcoin vault 'to global bank' - Xapo has partnered with Thoughtwork "to drive digital innovation and its global expansion over the next 18 months. "The program will see Xapo become a globally accessible bank, offering an international USD bank account with regulated access to Bitcoin," said the company statement. With a VASP license in place, Xapo has engaged Thoughtworks to mature its offering from a wallet to a fully digital banking service offering debit cards, deposit protection, interest on your balances and more. To ensure that this mission is underpinned by the foundations necessary to scale, Thoughtworks will engage with Xapo across product, technology and delivery. The foundations for growth engagement will strengthen Xapo's technology architecture, enable rapid delivery of value to customers and streamline operations. Seamus Rocca, chief executive officer at Xapo, commented: "Xapo has been very successful as a Bitcoin custodian and that has allowed us to learn a lot about what customers in emerging markets need from our product."

08:17 EDT Lightbridge receives notice of acceptance for patent in Australia - Lightbridge announced that it received a Notice of Acceptance for a key divisional patent from the Australia Patent Office related to Lightbridge's innovative metallic nuclear fuel assembly design. The newly allowed patent is based on the 2015 Patent Cooperation Treaty patent application and covers a fuel assembly having a mixed grid pattern of fuel rods. Lightbridge Fuel has been designed to enhance the safety and economics of nuclear power for both existing and next-generation nuclear reactors. Seth Grae, President and CEO of Lightbridge commented, "We continue to expand our intellectual property portfolio around the world. Australia represents a potential strategic market for Lightbridge, particularly as one the world's leading uranium producers and increasingly considering pursuing nuclear power generation. We recently received similar patents in Japan and Korea for our metallic fuel assembly design with metallic fuel rods arranged in a mixed grid pattern. These patents are an important addition to our rapidly expanding global patent portfolio."

08:16 EDT Apollo Global names William Lewis as Senior Partner - Apollo Global Management (APO) announced William Lewis, Jr. will join the Firm as a Senior Partner and a member of Apollo's Management Committee. Lewis will join Apollo from Lazard (LAZ), where he is Chairman of Investment Banking. In this new role, Lewis will source and execute investment opportunities across the Firm's private equity business and collaborate with executive management on human capital, citizenship and diversity and inclusion efforts. Lewis joined Lazard in 2004 and most recently served as a Managing Director and Chairman of Investment Banking.

08:15 EDT BNY Mellon moves wire payments into Microsoft Azure - BNY Mellon (BK) has collaborated with Microsoft (MSFT) to migrate infrastructure supporting wire payments into Microsoft Azure. As part of this advancement, BNY Mellon has developed a treasury cash management relationship with Microsoft Treasury built on the Azure cloud payment system. This cash management relationship establishes the capability to secure high value wire payments that are critical to the orderly functioning of markets over cloud technology.

08:14 EDT ToughBuilt reports 101% increase in sales through Amazon - ToughBuilt Industries (TBLT) announced today that gross sales through Amazon.com (AMZN) increased 101% to approximately $8.3M for the nine-month period ending September 30, 2021, compared to approximately $4.1M in the year-ago period. Michael Panosian, Chief Executive Officer of ToughBuilt, commented, "We experienced strong e-commerce demand in the third quarter, despite continued industry-wide supply chain disruptions. Our decision to increase inventory levels in the prior quarter enabled us to fulfill the high order volume on Amazon across our product lines. These exciting results from Amazon demonstrate the strength of our e-commerce expansion efforts and the acceptance of new products, which runs in parallel with our geographic expansion into new retail partners."

08:13 EDT Arcturus gets Vietnam okay to proceed on ARCT-154 vaccine study for SARS-CoV-2 - Arcturus Therapeutics announced that the Vietnam Ministry of Health has approved initiation of the Phase 3b part of the placebo-controlled, observer-blind Phase 1/2/3 clinical trial of ARCT-154 self-replicating RNA vaccine targeting the SARS-CoV-2 delta variant and other variants of concern. Arcturus Therapeutics and Vinbiocare remain on track to potentially file an Emergency Use Authorization for ARCT-154 in Vietnam in December 2021. The approval to proceed with the Phase 3b portion of the study follows the review of safety data from the initial 1,000 participants included in the Phase 1/2/3a cohorts of the ARCT-154 study. "I am very pleased with the progress, including the rapid enrollment and dosing in the ARCT-154 trial. Initiation of dosing in the Phase 3b portion of the study brings us one step closer to our goal of filing for EUA and making it available as quickly as possible," said Joseph Payne, President and CEO of Arcturus Therapeutics. "As a low dose vaccine targeting variants of concern, ARCT-154 has a differentiated profile compared to currently available vaccines and we believe that our program has the potential to become a best-in-class option for Vietnam and many other countries around the world."

08:12 EDT Aethlon Medical announces publication of Hemopurifier study on Covid patients - Aethlon Medical announced the publication of a manuscript in the peer-reviewed journal Frontiers in Medicine describing two cases of critically ill COVID-19 patients treated with the Hemopurifier, Aethlon's therapeutic blood filtration system. The publication is titled "Removal of COVID-19 spike protein, whole virus, exosomes and exosomal microRNAs by the Hemopurifier lectin-affinity cartridge in critically Ill patients with COVID-19 infection." The publication documents two critically ill COVID-19 patients receiving a combined total of nine, six-hour Hemopurifier treatment sessions. These two patient case studies are notable because they are the first descriptions of the Hemopurifier successfully removing exosomes, exosomal microRNAs, and SARS-CoV-2 virus in patients with COVID-19. In the first patient, exosome and exosomal microRNA removal was associated with improved coagulopathy, oxygenation, and clinical recovery. In the second patient, SARS-CoV-2 virus removal by the Hemopurifier was demonstrated, but the patient expired because the disease was advanced and had triggered multiple organ system failures. The patient had completed Hemopurifier treatment and passed away while receiving Continuous Renal Replacement Therapy. Hemopurifier treatment sessions were well tolerated by both patients without side effects.

08:11 EDT Cipher Mining announces agreement to purchase 28,000-56,000 Bitfury mining rigs - Cipher Mining announced that it has entered into an agreement with Bitfury Top HoldCo to make monthly purchases between June and December 2022 of 4,000 to 8,000 Bitfury next generation mining rigs that will each produce approximately 195 TH/s of hashing power and consume approximately 6.3KWh to 6.5KWh of electrical power. In aggregate, upon delivery in accordance with the terms of the agreement, these mining rigs are expected to be capable of producing hashrate of approximately 5.4 EH/s to 10.9 EH/s. The agreement provides for a maximum purchase price of $6,250 per machine. This agreement was executed under the framework of the seven-year Master Supply and Services Agreement between Bitfury and Cipher dated as of August 26, 2021, the MSSA. Under the MSSA, Cipher has a right of first refusal to purchase certain equipment from Bitfury, including mining rigs, and therefore expects to have ongoing access to additional competitively priced machines for future data center deployments. "Signing this agreement is an important milestone as we build out a significant Bitcoin mining footprint in the United States," said Tyler Page, CEO of Cipher. "We were able to secure these mining rigs at an attractive price and demonstrate the unique potential of our relationship with Bitfury."

08:09 EDT Global Crossing Airlines granted flight allocations for Cuba flights - Global Crossing Airlines Group and ViajeHoy, LLC, d/b/a Havana Air are pleased to announce the allocation from the U.S Department of Transportation by Order DOT-OST-2020-001 for GlobalX to operate 508 round-trip charter flights through May 31, 2022. Flight schedules are subject to Cuban governmental approval, with flights targeted to begin in early November 2021.

08:09 EDT IceCure Medical announces updated regulatory strategy in China - IceCure Medical announced the advancement of its regulatory strategy in China with the submission of an amendment to the registration certificate for the IceSense3 system, which was granted by China's National Medical Products Administration. The amendment, if approved, will allow the company to sell its disposable IceSense3 Cryoprobes for commercial procedures. The company expects the NMPA to complete its evaluation of the amendment by the end of 2022. If the amendment is approved, the company expects to then launch its commercial sales program for the IceSense3 system in China in early 2023.

08:08 EDT Krystal Biotech, GeneDx collaborate to provide no-charge testing for DEB - Krystal Biotech (KRYS) and GeneDx, a wholly-owned subsidiary of BioReference Laboratories, an OPKO Health company (OPK), announced a collaboration offering no-charge genetic testing for all types of Epidermolysis Bullosa, or EB. The goal of the program, called Krystal Decode DEB, is to help patients with the dystrophic form of this genetic condition, also known as DEB, get a definitive diagnosis sooner, with accurate results obtained with a blood or cheek swab sample. EB is a rare genetic connective tissue disorder that causes extremely fragile skin that blisters and tears from minor friction or trauma. There are 4 types of EB, each caused by mutations in different genes. The Krystal Decode DEB program utilizes a comprehensive panel of genes to identify DEB or other genetic conditions with similar phenotype to DEB, including other EB types and some other non EB skin blistering conditions, to aid in diagnosis.

08:07 EDT Wendy's, Google Cloud partner on restaurant experience - Wendy's (WEN) and Google Cloud (GOOG, GOOGL) announced a partnership to enhance the Wendy's restaurant experience and unlock new customer, restaurant, and employee experiences through data-driven insights. Wendy's intends to leverage Google Cloud's data analytics, artificial intelligence, machine learning, and hybrid cloud tools to create new ways customers can order food in the drive thru, on their mobile devices and through other touchpoints. By expanding the ways customers can engage with the brand in the future, using technology like speech-to-text and Google Search and Maps, Wendy's is planning to make it faster, easier, and more convenient for customers to access the brand.

08:05 EDT Enlivex Therapeutics' CSO Mevorach publishes paper on COVID-19 vaccine - Enlivex Therapeutics announced that its Chief Scientific Officer, Dror Mevorach, and several co-authors published a foundational peer reviewed paper in The New England Journal of Medicine. The paper, entitled "Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel" was published in collaboration with researchers at several prestigious institutions, including Hadassah Medical Center, University of Jerusalem, Tel Aviv Sourasky Medical Center, the Israel Center for Disease Control, and the Israeli Ministry of Health. "On behalf of Enlivex, I'd like to congratulate Dror for this impressive accomplishment," said Dr. Oren Hershkovitz, Chief Executive Officer of Enlivex. "To be appointed by the Israeli Ministry of Health to lead the surveillance of potential side effects related to the Pfizer-BioNTech vaccine, and to have the results of these efforts published in the New England Journal of Medicine, speaks to his position as a leading expert in immunology and the human body's response to pathogens. Dror's deep knowledge and understanding of these fields has been critical to our development of Allocetra to-date, and we look forward to further leveraging his skill set as we advance its development as a potential treatment for sepsis, COVID-19, and certain types of cancer."

08:05 EDT GM: LG to reimburse GM for Bolt EV recall costs and expenses

08:04 EDT General Motors, LG Electronics reach agreement on Bolt EV recall costs - General Motors (GM) announced that it has reached an agreement under which LG Electronics will reimburse GM for costs and expenses associated with the recall of Chevrolet Bolt EVs and EUVs due to manufacturing defects in battery modules supplied by LG. As a result of the agreement, GM will recognize an estimated recovery in its third-quarter earnings that will offset $1.9B of $2B in charges associated with the recalls, the company said in a statement. "LG is a valued and respected supplier to GM, and we are pleased to reach this agreement," said Shilpan Amin, GM vice president, Global Purchasing and Supply Chain. "Our engineering and manufacturing teams continue to collaborate to accelerate production of new battery modules and we expect to begin repairing customer vehicles this month."

08:04 EDT General Motors, LG Electronics reach agreement on Bolt EV recall costs

08:03 EDT Syros Pharmaceuticals appoints Jason Haas CFO - Syros Pharmaceuticals announced the appointment of Jason Haas as Chief Financial Officer. Mr. Haas brings more than 25 years of healthcare investment banking and corporate finance experience to Syros. "We are pleased to welcome Jason to Syros, who brings an exceptional depth of financial, strategic, and leadership experience in the life sciences space," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "Jason has a proven track record as a strategic advisor to biotechnology and pharmaceutical companies across all stages of development. He joins Syros at a pivotal time, as we advance towards becoming a commercial-stage company, with a growing portfolio in targeted hematology and selective CDK inhibition."

08:02 EDT Achilles Therapeutics joins the NA-ATTC consortium - Achilles Therapeutics announced that it has joined the Northern Alliance for Advanced Therapies Treatment Centre, or NA-AATC, consortium. The NA-ATTC consortium is funded by Innovate UK, the government's innovation agency, and is one of only three Advanced Therapy Treatment Centres in the UK. NA-ATTC was created to address the challenges of bringing pioneering advanced therapy medicinal products to patients. Specifically, the consortium focuses on all elements of the clinical delivery pathway from procurement of starting materials, through to delivery of clinical trials, and adoption and reimbursement across a range of advanced therapies and indications. As an industry partner, Achilles will contribute its knowledge and expertise in supply chain and operations for cell therapies that has been developed with its precision clonal neoantigen-reactive T cell therapy.

08:02 EDT Terex appoints Julie Beck as CFO - Terex announced that Julie A. Beck will become Senior Vice President and CFO, succeeding John D. Sheehan, who is retiring. Beck will join Terex as Senior Vice President, Finance on November 1 and become CFO effective January 1, 2022. She will serve on the corporation's Executive Leadership Team. To help ensure a smooth transition, Sheehan will remain as CFO until December 31, 2021 and retire on April 1, 2022. Beck comes to Terex from NOVA Chemicals, a $5B producer of plastics and chemicals, where she served as SVP and CFO since February 2016. While there, she drove growth through a $2B acquisition, initiated the start of NOVA's digital transformation, and drove a mindset of continuous improvement and value creation that contributed to strong earnings. Before joining NOVA, she spent eight years with Joy Global, at the time a $5B publicly traded mining equipment manufacturer.

07:55 EDT Glatfelter announces offering of senior notes - Glatfelter Corporation announced that it intends to offer $500 million in aggregate principal amount of senior notes due 2029, subject to market conditions. Each of the Company's existing and future domestic restricted subsidiaries that guarantees the Company's obligations under the Company's credit facility, which includes the Company's revolving credit facility and term loan A facility, and/or certain other indebtedness will guarantee the Notes on a senior unsecured basis. The net proceeds from the offering of the Notes, together with cash on hand, are expected to be used to pay the purchase price of the acquisition of PMM Holding, to repay certain indebtedness of Jacob Holm, to repay outstanding revolving borrowings under the Credit Facility, and to pay estimated fees and expenses.

07:53 EDT Allied Properties provides office leasing update for Toronto properties - Allied Properties REIT provided a leasing update for two of its Toronto development properties, QRC West, Phase II, and The Well. QRC West, Phase II: This development property effectively expands QRC West to the southwest corner of Queen Street West and Peter Street. Currently under construction and scheduled for completion in 2023, the building will be comprised of 77,434 square feet of office GLA and 15,700 square feet of retail GLA and will be fully integrated with QRC West, Phase I, which Allied completed in 2015. The building is registered under the LEED green building rating system and is targeting LEED Gold certification. Allied has leased the entire building, 93,134 square feet of GLA, to a leading American educational institution for a term of 12 years. The user plans to animate the ground level of the building in a way that will add vitality to Queen West in particular and the Downtown West submarket generally. The Well: This mixed-use development property is a 50/50 joint venture between Allied and RioCan REIT that includes 1,172,001 of office GLA. At the end of the second quarter of this year, the office GLA was 86% leased to nine knowledge-based organizations. Allied and RioCan are now finalizing lease transactions for an additional 122,809 square feet of office GLA with four new users. If these lease transactions are successfully completed, the office GLA at The Well will be 96.5% leased to 13 knowledge-based organizations.

07:48 EDT Ocugen up 12% in pre-market trading at $8.60 per share - Shares of Ocugen are up about 12% at $8.60 in pre-market trading following yesterday's 8.8% advance. The stock is the highest trending name on StockTwits and is also in the top-10 on WallStreetBets Reddit thread in terms of message volume over the past 24 hours.

07:44 EDT NFI Group receives order for 20 New Flyer transit buses from Long Beach Transit - NFI Group announced that Long Beach Transit has ordered 20 battery-electric thirty-five-foot Xcelsior CHARGE NG heavy-duty transit buses from NFI subsidiary New Flyer of America under a three-year contract. This order is supported by Federal Transit Administration funds.

07:43 EDT Q.E.P. Company upgrades to OTCQX Best Market - Q.E.P. is pleased to announce that it has qualified to upgrade from the Pink Market to the OTCQX Best Market, the top tier of OTC Markets, and will begin trading today on the OTCQX under its existing symbol, "QEPC."

07:41 EDT vTv Therapeutics announces positive results from mechanistic study of TTP399 - vTv Therapeutics announced "positive" results of a mechanistic study of TTP399 in patients with type 1 diabetes. The study demonstrated that patients with T1D taking TTP399 experienced no increase in ketone levels relative to placebo during a period of acute insulin withdrawal, indicating no increased risk of ketoacidosis. Consistent with previous clinical studies, improved fasting plasma glucose levels and fewer hypoglycemic events were observed in the TTP399 treated group during the week of treatment prior to the insulin withdrawal test. vTv, following the FDA's recommendation, conducted this mechanistic study to demonstrate that treatment with TTP399, a liver-selective glucokinase activator, will not result in increased production of ketones, a precursor to ketoacidosis. The study enrolled 23 people with type 1 diabetes using insulin pumps, randomized to receive TTP399 or placebo. On the last day of dosing, an acute insulin withdrawal test was performed by stopping the patients' insulin pumps and measuring levels of beta-hydroxybutyrate and other key metabolic markers over a period of up to 10 hours or until certain safety stopping criteria were met. The study achieved its primary endpoint by demonstrating non-inferiority relative to placebo in the proportion of subjects reaching pre-specified concentration limits of BOHB, a biomarker for ketoacidosis, over the period of acute insulin withdrawal. BOHB is the primary ketone body found in blood. During the insulin withdrawal phase of the study, no significant differences were observed between the active and placebo arms in the patients' BOHB profiles or the mean duration of the test. All patients completed at least three hours of the insulin withdrawal test. During this initial period of time, the area under the curve for the levels of BOHB was numerically lower for the TTP399 treated group than that for placebo. In addition, the concentration of bicarbonate, an important buffer that regulates acidity levels in blood, was higher in the TTP399 treated group than in the placebo group, indicating a lower risk of ketoacidosis in the group taking TTP399. In addition to data collected during the insulin withdrawal test, data collected during the week-long treatment period preceding the insulin withdrawal test demonstrated that patients taking TTP399 experienced reductions in fasting plasma glucose. Furthermore, no increases in BOHB or free fatty acid, a precursor to BOHB, were observed. Consistent with previous clinical studies of TTP399, the drug was well tolerated with fewer subjects reporting treatment-emergent adverse events in the group taking TTP399 than in the placebo group. Importantly, patients taking TTP399 reported no events of hypoglycemia, while four events of hypoglycemia were reported in the placebo group. "It is outstanding to have data supporting TTP399's favorable profile with respect to ketoacidosis, as regulatory agencies have been highly attuned to DKA in their review of potential treatments for type 1 diabetes," said Steve Holcombe, chief executive officer, vTv Therapeutics. "We are making progress towards finalizing the study designs of our Phase 3 pivotal program with the FDA's continued feedback under Breakthrough Therapy designation and we expect to initiate these clinical studies in early 2022."

07:40 EDT Kelly Services appoints Rosie Rivel as CIO - Kelly announced the immediate appointment of Rosie Rivel as chief information officer. Rivel has served as Kelly's interim CIO since February of this year. As CIO, Rivel is responsible for Kelly's information technology function, including IT global business applications, global infrastructure, data & analytics, and IT security and compliance.

07:38 EDT Windtree Therapeutics reports on results from a US physician survey - Windtree Therapeutics announced the results of a US physician survey and an assessment of worldwide total market value for cardiogenic shock. After two positive istaroxime phase 2 acute heart failure studies provided the rationale, Windtree began clinical development of istaroxime in the second disease state of early cardiogenic shock. Using cardiogenic shock patient US hospital claims and worldwide prevalence data, Windtree estimates the worldwide total market value of cardiogenic shock to be $1.25B. Additionally, Windtree conducted market research to understand how one of its main customer groups views the need for innovation in this disease. The physician market research asked 100 US based clinical cardiologists who treat cardiogenic shock patients how needed was new drug innovation to treat SCAI class B cardiogenic shock patients. 99 out of 100 cardiologists responded that there was high need for pharmacologic innovation in SCAI class B cardiogenic shock patients. Additionally, 84% of the cardiologists responded they would be likely to extremely likely to use a drug with a profile reflective of istaroxime's clinical profile for early cardiogenic shock patients. The majority of the cardiologists also responded they would position a drug with the profile of istaroxime for utilization before use of other existing classes of therapies such as inotropes and vasopressors. The istaroxime Phase 2 study in early cardiogenic shock is an international, randomized study. It will include approximately 60 SCAI class B early cardiogenic shock patients with severe heart failure. The primary endpoint is the difference in SBP area under the curve over six hours after initiating the infusion. Secondary endpoints will include characterization of blood pressure changes over 24 hours, the number of patients requiring rescue therapy, assessment of renal function and measures associated with safety and tolerability. Windtree expects the study to be completed in Q4 2021.

07:37 EDT BridgeBio to feature presentations on several developments - BridgeBio Pharma announced progress in its KRAS cancer portfolio, new programs in gene therapy, and advancements in cardiorenal and early-stage Mendelian programs at its second annual R&D Day. BridgeBio will also discuss how it is broadening the scope of its R&D engine with the launch of its new early-stage research institute, BridgeBioX. BridgeBio's R&D Day will feature presentations by Neil Kumar, BridgeBio founder and CEO; Richard Scheller, chairman of R&D at BridgeBio; Charles Homcy, chairman of pharmaceuticals at BridgeBio; Uma Sinha, Chief Scientific Officer at BridgeBio; and scientists and physicians leading BridgeBio's drug discovery and development programs. BridgeBio has more than 30 programs in its pipeline for patients living with genetic diseases and genetically-driven cancers. Fourteen of those programs are being advanced in the clinic or commercial setting, and earlier this year BridgeBio received its first two FDA drug approvals.

07:35 EDT Intellia to present preclinical data on in vivo, ex vivo genome editing - Intellia Therapeutics announced the presentation of new data at the 29th Annual Congress of the European Society of Gene & Cell Therapy meeting, taking place virtually from October 19-21, 2021. "We are excited to share for the first time important preclinical data and new developments highlighting both our allogeneic T cell therapy platform as well as the utilization of lipid nanoparticle-based delivery of the CRISPR/Cas9 gene editing components to more efficiently engineer T cells for therapeutic use," said Intellia Chief Scientific Officer Laura Sepp-Lorenzino, Ph.D. "Additionally, we will be presenting non-human primate data from our in vivo platform where we have demonstrated our ability to both insert a functional gene and inactivate a gene to treat AATD. For AATD, a genetic disease that can cause lung dysfunction and/or liver disease and which currently has no cure, our modular delivery platform provides us the optionality for patient-tailored treatments relevant to the disease manifestation. We look forward to sharing these data with the scientific community as we continue to advance our mission of delivering breakthrough genome editing treatments for people with severe diseases."

07:35 EDT InflaRx completes enrollment of vilobelimab phase III study in COVID-19 - InflaRx announced the completion of enrollment of the Phase III part of the Phase II/III vilobelimab study in severe COVID-19 patients. The randomized, double-blind and placebo-controlled Phase III part of the Phase II/III study enrolled 369 mechanically ventilated patients with COVID-19 across sites in the EU, South America and other regions. Patients were randomized 1:1 to receive either vilobelimab or placebo; all patients received standard of care. The primary endpoint is 28-day all-cause mortality; key secondary endpoints include assessment of organ support and disease improvement. Treatment is still ongoing and topline results are expected to be available in Q1 2022. Dr. Korinna Pilz, Chief Clinical Development Officer, said: "There remains an urgent need for treatments for critically ill patients with severe COVID-19, and we are pleased that enrollment has completed in this trial. Based on our current expectations regarding when we will be able to lock the database and complete the data analyses, we expect to report topline results in Q1 2022. We are hopeful that vilobelimab can make a meaningful difference for COVID-19 patients. Should the data so warrant, we would then discuss with regulatory authorities the next steps." The Phase II part of the study evaluated vilobelimab treatment plus best supportive care compared to best supportive care alone for up to 28 days. The Phase II part was randomized, open label and enrolled a total of 30 patients. The 28-day all-cause mortality rate was 13% in the vilobelimab treatment arm compared to 27%= in the best supportive care arm. All deaths in the best supportive care arm occurred due to COVID-19-induced multi-organ failure, A temporary, but statistically significant, increase in D-dimer levels in the first days following vilobelimab administration was noted, a potential signal for induction of blood clot lysis. No statistically significant group differences in the primary endpoint of relative change from baseline to day 5 in oxygenation index were detected.

07:33 EDT Venus Concept appoints Ross Portaro as president of global sales - Venus Concept announced the appointment of Ross Portaro to the position of President of Global Sales, effective October 15, 2021. Mr. Portaro will assume the responsibilities of Chad Zaring, who is resigning from his role of Chief Commercial Officer for personal reasons, effective October 15, 2021. Mr. Zaring will continue to support the Company as a consultant through March 31, 2022. Mr. Portaro joined Venus Concept as Vice President of EMEA in May, 2021, responsible for developing the sales strategy and managing all sales and utilization activity via direct and distribution sales channels in the region.

07:32 EDT Vitalhub subsidary S12 Solutions reports two contracts in September - VitalHub is pleased to report that newly acquired subsidiary, S12 Solutions, "continues to achieve market penetration" with two new S12 Solutions contracts signed in September 2021; Oxford Health NHS Foundation Trust and Derbyshire Healthcare NHS Foundation Trust. Both Trusts will utilize the S12 Solution Mental Health Act assessment team organization and electronic claims platform. Derbyshire will also implement the S12 electronic statutory MHA forms solution.

07:26 EDT Fastenal says higher unit sales driven by strong growth in demand - The company states: "Q3 continued to experience strong growth in underlying demand for manufacturing and construction equipment and supplies, which drove higher unit sales that contributed to the increase in net sales that we experienced in the period. This growth was slightly limited by slower growth or contraction in sales of certain products to certain end markets related to the COVID-19 pandemic when compared to the third quarter of 2020. While we did see an uptick in sales of certain COVID-related supplies in the third quarter of 2021, relative to the prior year the marketplace is more orderly and better supplied, while the unit price of many products is down significantly. As a result, the impact on our net sales of the current increase in infections and hospitalizations is significantly reduced from what was experienced in the year earlier period. The overall impact of product pricing on net sales in the third quarter of 2021 was 230 to 260 basis points. We continue to experience pressure related to material and transportation cost inflation. This is true across our offering, but is particularly acute for fasteners and overseas shipping. Pricing actions taken throughout 2021 as part of our strategy to mitigate the impact of marketplace inflation on our gross margin percentage contributed to the increased impact of net pricing on sales in the third quarter of 2021. We will continue to take actions as necessary to mitigate the impact of product and transportation cost inflation in the fourth quarter of 2021. The impact of product pricing on net sales was immaterial during the third quarter of 2020. While pandemic-related effects were still evident when comparing product mix in the third quarter of 2021 to the third quarter of 2020, these impacts were significantly reduced versus what was experienced in the second quarter of 2021."

07:22 EDT CureVac to withdraw CVnCoV COVID-19 vaccine candidate, focus on mRNA vaccine - CureVac (CVAC) announced the strategic decision to focus its COVID-19 vaccine development towards the development of second-generation mRNA vaccine candidates in collaboration with GlaxoSmithKline (GSK) and to withdraw its first-generation COVID-19 vaccine candidate, CVnCoV, from the current approval process with the European Medicines Agency, or EMA. In view of a recent EMA communication, CureVac estimates that the earliest potential approval of CVnCoV would come in the second quarter of 2022. By this time, the companies expect the candidates from the second-generation vaccine program to have progressed to late-stage clinical development. The decision is also aligned with the evolving dynamics of the pandemic response towards a greater need for differentiated vaccines to address the developing endemic SARS-CoV2 situation. As a direct consequence, the existing advanced purchase agreement with the European Commission, which was predicated on employing CVnCoV to address the acute pandemic need, will cease. CureVac is assessing the possibility of leveraging CVnCoV commitments for the second-generation vaccine candidates. CureVac remains in contact with the European Commission and is supportive of its public health efforts. CureVac and GSK have tightened their collaboration by adding further resources and experts to accelerate development and manufacturing of the broad second-generation program. The companies anticipate entering clinical development in the next months, aiming to achieve regulatory approval for market readiness of an improved COVID-19 vaccine in 2022. Published pre-clinical results have shown the potential of the initial second-generation mRNA COVID-19 vaccine candidate, CV2CoV, compared to CureVac's first generation mRNA, CVnCoV. The data demonstrates up to 10x higher immunogenicity in animal models. In parallel to the work on the second-generation mRNA vaccine technology, GSK and CureVac will accelerate efforts to progress the development of modified mRNA vaccine constructs.

07:17 EDT RedHill Biopharma granted U.S. patent for Talicia to treat H. pylori infection - RedHill Biopharma announced the granting of U.S. Patent No. 11,135,172 covering Talicia, its U.S. approved medicine indicated for the treatment of H. pylori infection in adults. This patent reinforces the protection for Talicia through 2034, and the Company plans to list this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. "Talicia's unique all-in-one capsule comprising a proton pump inhibitor and two antibiotics was approved by the U.S. FDA in November 2019 for the treatment of H. pylori infection in adults. Once listed, we will have five Orange-Book listed patents protecting Talicia" said Danielle T. Abramson, PhD., SVP, Global Head of Intellectual Property. "We continue to build an expansive international patent portfolio to protect this innovative formulation, which addresses increasing concerns of resistance related to clarithromycin and metronidazole and which supports ease of adherence and compliance by patients, provides a favorable tolerability and safety profile and is positioned to become the new first-line standard-of-care."

07:15 EDT Nevada Copper enters non-binding term sheet for additional financing - Nevada Copper announced that it has entered into an agreement with its senior project lender and a non-binding term sheet with its largest shareholder to provide additional financing and a significant deferral and extension of its debt facilities, providing substantially greater balance sheet flexibility and support for the completion of the ramp-up of its underground mining operations and subsequent advancement of its open pit project and broader property exploration targets. Highlights: Extension of Senior Project Facility: Two-year deferral of first loan repayments: First debt repayments deferred by two years, with Tranche A repayment only scheduled to begin in July 2025, providing significant additional flexibility; Extension of loan amortization schedule: Extended amortization schedule with final maturity now occurring in July 2029; Additional project completion flexibility: The long stop date for the formal commercial project completion test deferred until June 2023; Consolidation and extension of shareholder loans; Consolidation of shareholder loans: All outstanding shareholder loans consolidated under a single existing shareholder credit facility, as amended; Two-year extension to maturity date: Maturity of the Amended Credit Facility deferred until 2026, with no scheduled payments before final maturity Additional committed liquidity: Increased availability of US$41 million under the Amended Credit Facility.

07:14 EDT Blackstone, Hipgnosis Song Management launch $1B song, music partnership - Blackstone and Hipgnosis Song Management, HSM, announce a new partnership, backed by funds managed by Blackstone, which will initially deliver c.$1 billion to acquire music rights and manage catalogues. Hipgnosis Song Management, founded by Merck Mercuriadis and formerly known as The Family Ltd, is one of the industry's leading advisory firms focused on music assets and is investment advisor to Hipgnosis Songs Fund .

07:13 EDT Red White & Bloom's Florida subsidiary receives cannabis cultivation license - Red White & Bloom Brands has initiated phase one of an aggressive three-phase development strategy for its two cultivation centers in Florida to ensure the Company produces sufficient inventory for the existing and several new dispensary openings planned for the first quarter 2022. Red White & Bloom Florida, a Red White & Bloom Brands subsidiary, acquired a 45,000 sq. ft. greenhouse with 4.7 acres in Apopka, Florida in July 2021. Phase one of the company's initial plans for cultivation in Florida, the build-out of Apopka, is now complete. In addition, the site received regulatory approval to commence operations on Sept. 29, 2021. In anticipation of receiving the cultivation license, RWBFL had prepared mother stock in advance, and these plants arrived at the greenhouse the morning of Sept 30, 2021. The flower production in the initial Apopka licensed area is capable of producing 85 g per plant, with projected annual revenue from this area is in excess of USD $10,000,000 and operations having commenced on Sept 30, 2021. Additionally, the newly designed grow will supply phase two of the Florida plans with the activation of thirty 16' x 40' customized, self-contained growing pods. With a targeted Q4 launch, the pods are anticipated to yield almost 10,000 pounds of dried flower per year representing a current medical market value of USD $30,000,000. Phase three of the Company's initial launch in the State will be the activation of the 113,000 sq. ft. indoor grow facility in Sanderson, Florida. Projecting a Q4 2021 harvest schedule in the Apopka facility, the company has added additional cultivation specialists specifically for the Florida project from the highly-talented local labor market.

07:11 EDT Deciphera gets approval from Swissmedic for Qinlock to treat GIST - Deciphera Pharmaceuticals announced that the Swiss Agency for Therapeutic Products, Swissmedic, has granted approval for QINLOCK , ripretinib, for the treatment of adult patients with advanced gastrointestinal stromal tumor, GIST, who have received prior treatment with three or more kinase inhibitors, including imatinib. "We are committed to delivering this much-needed medicine to patients globally, and are thrilled that we have received approval in Switzerland, which is our seventh approval worldwide and the first in Europe," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "Following a positive opinion earlier this month from the European Medicines Agency's Committee for Medicinal Products for Human Use , we look forward to a potential approval from the European Commission for QINLOCK in the fourth quarter of this year, and to ensuring that GIST patients across the EU have access to this treatment option designed specifically for their disease." The application for QINLOCK approval was supported by efficacy results from the primary analysis of the pivotal Phase 3 INVICTUS study of QINLOCK in patients with advanced GIST as well as combined safety results from INVICTUS and the Phase 1 study of QINLOCK. In INVICTUS, QINLOCK demonstrated a median progression-free survival of 6.3 months compared to 1.0 month in the placebo arm and significantly reduced the risk of disease progression or death by 85% Secondary endpoints as determined by independent radiologic review using modified RECIST include Objective Response Rate and Overall Survival .

07:09 EDT Inspyr announces new holding company structure, 1-for-75 reverse stock split - Inspyr Therapeutics is announcing a 1-for-75 reverse stock split of its common stock and a holding company restructuring whereby Rebus Holdings, a newly created entity will serve as the new holding company that will replace Inspyr as the public company trading on the OTC Markets trading under the symbol RBSH. The reverse stock split and holding company reorganization will occur concurrently. Inspyr has completed a restructuring consisting of reacquiring its rights to its now lead asset RT-AR-001 and transforming into a holding company structure. Management believes that reacquiring the Adenosine assets and its new structure will lead to a more streamlined company that will increase stockholder value. A pre-IND meeting for RT-AR-001 was held with the FDA in Q1 of 2021. Following that meeting the company has moved forward with manufacturing and non-clinical studies to support the submission of an IND. The company expects to provide a further clinical update in the first half of 2022. The Company is also in the process of launching and rebranding its new corporate website at www.rebus-corp.com. The company anticipates that subsequent to the reverse split it will be able to apply to list its Common Stock on the OTCQB tier of the OTC Markets Group, and eventually apply for a listing on a national exchange, in order to provide stockholders with more liquidity and allow the company more flexibility in accessing the capital markets. Immediately after the 1-for-75 reverse stock split, existing shares of Inspyr common stock will be automatically converted, on a one-for-one basis, into shares of Rebus common stock having the same designation, rights, powers, and preferences and qualifications, limitations, and restrictions as a share of Inspyr common stock immediately prior to the reorganization. Outstanding Inspyr convertible debt securities and warrants will be similarly converted on the same terms into like securities of Rebus. Accordingly, Inspyr stockholders will automatically become stockholders of Rebus with the same ownership percentage of shares as they held in Inspyr immediately prior to the reorganization. Inspyr will subsequently operate as a wholly-owned subsidiary of Rebus. Effective at the open of the market on Tuesday, October 12, 2021, Inspyr will cease to trade under NSPX and Rebus will begin trading under the new ticker symbol RBSH with a CUSIP of 75619J 103. The Board of Directors and the executive officers of Inspyr immediately prior to the reorganization will continue in their same roles at Rebus. The holding company reorganization, which is intended to be a tax-free transaction for U.S. federal income tax purposes for the stockholders, will modernize the Company's operating and legal structure, and will provide financial and administrative flexibility.

07:06 EDT Galera Therapeutics appoints Bachleda as CCO, Stacey as CLCO - Galera Therapeutics (GRTX) announced the appointment of Mark Bachleda as Chief Commercial Officer, or CCO, and Jennifer Stacey as Chief Legal and Compliance Officer, or CLCO, and Secretary. Both executives join Galera with over 25 years of leadership experience within the biopharmaceutical industry. Prior to joining Galera, Bachleda served as Vice President & U.S. Business Unit Head for Bristol Myers Squibb's (BMY) CAR T cell therapy franchise. Previously, Stacey served as Vice President, General Counsel, Secretary and Government Relations at The Wistar Institute, an independent international biomedical research institution.

07:04 EDT Sutro Biopharma, BioNova Pharmaceuticals collaborate on STRO-001 in China - Sutro Biopharma and BioNova Pharmaceuticals jointly announced an option agreement for BioNova to develop and commercialize STRO-001, a CD74-targeting Antibody-Drug Conjugate, for patients with hematologic cancers, in Greater China, including mainland China, Hong Kong, Macau and Taiwan. Under the terms of the agreement, BioNova has the option to obtain exclusive rights to develop and commercialize STRO-001 in Greater China. BioNova will pursue the clinical development, regulatory approval, and commercialization of STRO-001 in multiple indications, including non-Hodgkin's lymphoma, multiple myeloma, and leukemia in the licensed territory. Sutro will retain development and commercial rights of STRO-001 globally outside of Greater China, including the United States. BioNova will pay to Sutro an initial licensing option payment of $4M, with potential payments totaling up to $200M related to option exercise, development, regulatory, and commercial milestones. Sutro will provide STRO-001 to BioNova under appropriate clinical and commercial supply service agreements. Upon commercialization, Sutro will receive tiered, double-digit royalties based on annual net sales of STRO-001 in Greater China.

07:03 EDT Protara Therapeutics announces FDA clearance of IND for TARA-002 - Protara Therapeutics announced the U.S. Food and Drug Administration has cleared the Company's Investigational New Drug, or IND, application for TARA-002, an investigational cell-based therapy being developed for the treatment of non-muscle invasive bladder cancer, or NMIBC. Protara expects to initiate a Phase 1 clinical trial of TARA-002 in adults with high-grade NMIBC by the end of 2021. The Phase 1 dose-finding, open-label trial will evaluate TARA-002 in treatment-naive and treatment-experienced NMIBC patients with high-grade carcinoma in situ and high-grade papillary tumors. In the initial dose escalation phase of the trial, patients will receive six weekly intravesical doses of TARA-002. The primary objective of the trial is to evaluate the safety, tolerability and preliminary signs of anti-tumor activity of TARA-002, with the goal of establishing a maximum tolerated dose and recommended dose for a future Phase 2 clinical trial. TARA-002 is manufactured from the same cell bank as OK-432, an approved therapy in Japan and Taiwan for multiple oncologic indications.

07:02 EDT Poseida Therapeutics enters research collaboration with Takeda Pharmaceutical - Poseida Therapeutics (PSTX) announced that it has entered into a research collaboration and exclusive license agreement with Takeda Pharmaceutical (TAK) to utilize Poseida's piggyBac, Cas-CLOVER, biodegradable DNA and RNA nanoparticle delivery technology and other proprietary genetic engineering platforms for the research and development of up to eight gene therapies. The collaboration will focus on developing non-viral in vivo gene therapy programs, including Poseida's Hemophilia A program. Under the terms of the agreement, the parties will collaborate to initially develop up to six in vivo gene therapy programs utilizing Poseida's novel technology platforms including piggyBac, Cas-CLOVER and biodegradable nanoparticle technology, as well as certain emerging technologies. Takeda also has an option to add two additional programs to the collaboration and is obligated to provide funding for all collaboration program R&D costs. Poseida will receive an upfront payment of $45M and preclinical milestones that together could potentially exceed $125M in the aggregate, if milestones for six programs are achieved. Poseida is also eligible to receive future clinical development, regulatory, and commercial milestone payments with a total potential value over the course of the partnership of up to $2.7B if milestones for all six programs are achieved, and up to $3.6B if the milestones related to the two optional programs are also achieved. Poseida will lead research activities up to candidate selection, after which Takeda will assume responsibility for further development and commercialization.

06:58 EDT Signet Jewelers to acquire Diamonds Direct for $490M in cash - Signet Jewelers announced it has entered into an agreement to acquire Diamonds Direct. Diamonds Direct is an off-mall, jeweler in the U.S. which will be immediately accretive to Signet post-closing. Signet plans to acquire Diamonds Direct for $490M in an all cash transaction which is currently expected to close in Q4 of FY22, subject to customary closing conditions and regulatory approval. Following the acquisition, Diamonds Direct's current leadership team will remain intact with Diamonds Direct president Itay Berger reporting directly to Signet CEO Virginia Drosos. Berger and other Diamonds Direct executives have agreed, subject to the completion of the transaction, to invest a portion of their transaction proceeds in Signet shares. Signet plans to share further details regarding Diamonds Direct following the completion of the transaction.

06:55 EDT NRx Pharmaceuticals sends revised Zyesami investigational new drug module to FDA - NRx Pharmaceuticals announced that a revised investigational new drug module on the manufacturing of Zyesami was submitted to the FDA, containing documentation that confirmed Nephron Pharmaceuticals is prepared to supply Zyesami on a commercial scale. This module will now be used as part of the FDA's rolling review process supporting the new drug application for Zyesami. NRx has also received notification that a European qualified person auditor has completed an inspection at a separate manufacturing facility with no adverse findings.

06:53 EDT Greif implements $60 per ton URB price hike, 7% increase on packaging products - Greif announced that it is implementing a $60 per ton price increase for all grades of uncoated recycled paperboard, or URB, and a minimum 7% increase on all tube and core and protective packaging products. The uncoated recycled paperboard increase is effective immediately with new orders and shipments on and after November 8. The tube and core and protective packaging products increase is effective with shipments on and after November 22. These price increases are in addition to previously announced increases and are in response to strong demand across the Greif paperboard and converting network and increasing energy, transportation, labor and other input costs.

06:49 EDT Johnson & Johnson chief scientific officer Paul Stoffels to retire - Johnson & Johnson announced that Paul Stoffels, currently vice chairman of the executive committee and chief scientific officer of Johnson & Johnson, will retire from the company effective December 31.

06:48 EDT Merck begins tender offer to acquire Acceleron - Merck (MRK) is commencing, through a subsidiary, a cash tender offer to purchase all outstanding shares of common stock of Acceleron Pharma (XLRN). On Sept. 30, Merck announced that it had entered into a definitive agreement to acquire Acceleron. Upon the successful closing of the tender offer, stockholders of Acceleron will receive $180 in cash for each share of Acceleron common stock validly tendered and not validly withdrawn in the offer, without interest and less any required tax withholding. Following the purchase of shares in the tender offer, Acceleron will become a subsidiary of Merck. Merck will file today with the U.S. SEC a tender offer statement on Schedule TO, which provides the terms of the tender offer. Additionally, Acceleron will file with the SEC a solicitation/recommendation statement on Schedule 14D-9 that includes the recommendation of the Acceleron board of directors that their stockholders accept the tender offer and tender their shares. The tender offer will expire at 5:00 p.m., Eastern Time, on Nov. 10, 2021, unless extended in accordance with the merger agreement and the applicable rules and regulations of the SEC. The closing of the tender offer is subject to certain conditions, including the tender of shares representing at least a majority of the total number of Acceleron's outstanding shares, receipt of applicable regulatory approvals, and other customary conditions. The transaction is expected to close in the fourth quarter of 2021.

06:46 EDT EnPro to sell Compressor Products International to Howden for $195M - EnPro Industries announced agreements for the sale of its Compressor Products International business unit (and exclusive negotiations with respect to the French operations of the CPI business unit) to Howden Group, a global provider of mission critical air and gas handling products and services with headquarters in Glasgow, UK. The aggregate purchase price for the transaction is $195M, subject to typical closing date adjustments. The purchase price equates to approximately 10.4x adjusted LTM EBITDA. The transaction is subject to customary closing conditions, including regulatory reviews, and is expected to close in the first quarter of 2022.

06:34 EDT Energous announces partnership with Wiliot - Energous announced a partnership with Wiliot, a Sensing as a Service company and Internet of Things, or IoT, technology. Together, the companies have integrated Energous WattUp 1W active energy harvesting technology as an option to power Wiliot's IoT Pixel tags that are designed for retail, medical, industrial, warehousing, home and industrial automation. Wiliot has developed low-cost, active Bluetooth tags that can be attached to nearly anything, with sensors that monitor light, humidity, proximity, and temperature, among other inputs.

06:32 EDT Hecla Mining reports preliminary Q3 silver production of 2.7M ounces - Hecla Mining announced preliminary production results for the third quarter. Highlights include: Silver production of 2.7M ounces, decreased due to lower grades at Greens Creek based on mine sequencing, partially offset by Lucky Friday production. Gold production of 42,206 ounces, in line with the same period in the prior year. Zinc production decreased due to Greens Creek's lower grades and lead production increased slightly with Lucky Friday being in full production. Silver equivalent production of 8.4M ounces or gold equivalent production of 113,998 ounces. Quarter-end cash position exceeds $190M.

06:13 EDT Cathie Wood's ARK Investment bought 248K shares of Crispr Therapeutics on Monday

06:08 EDT Facebook whistleblower to meet with Oversight Board, Haugen says via Twitter - Facebook whistleblower Frances Haugen said Monday via Twitter that she will meet with the social media company's Oversight Board. "I have accepted the invitation to brief the Facebook Oversight Board about what I learned while working there. Facebook has lied to the board repeatedly, and I am looking forward to sharing the truth with them." Reference Link

06:04 EDT High Tide subsidiary receives license to operate in British Columbia - High Tide announced that its wholly-owned subsidiary, Canna Cabana, is now provincially licensed to operate in British Columbia, or BC, having received due diligence approval from the British Columbia Liquor Distribution Branch, or BCLDB. With this approval in hand, Canna Cabana is now able to proceed with site-specific license applications. BC is the westernmost province of Canada, situated between the Pacific Ocean and the Rocky Mountains, and is a tourist destination, seeing over 6M overnight international visitor arrivals in 2019 according to the Tourism Industry Association of BC. With an estimated population of 5.2M as of 2021, it is also Canada's third-most populous province.

06:04 EDT NanoString launches nCounter ADC Development Panel - NanoString Technologies announced the launch of the nCounter ADC Development Panel, a specialized gene expression tool for use in the rapidly expanding field of Antibody Drug Conjugates, or ADCs. Created in collaboration with leading pharmaceutical and clinical scientists, this novel panel is designed to provide molecular insights into important biological questions and challenges of oncology therapies. ADCs are defined as a new class of highly potent therapeutics composed of an antibody attached via a chemical linker to a biologically active drug or cytotoxic compound. These targeted agents allow for sensitive discrimination between healthy and cancer tissues with the cell-killing ability of cytotoxic drugs.

06:01 EDT Vroom to acquire United Auto Credit Corporation for $300M in cash - Vroom announced that it has entered into a definitive agreement to acquire United Auto Credit Corporation for $300M in cash, subject to adjustment based upon UACC's closing book value. Following the acquisition, UACC will become an indirect wholly-owned subsidiary of Vroom and will continue to operate under the UACC name. Vroom will finance the purchase price through cash on hand. Following the closing, the acquisition is expected to immediately be accretive to Vroom's earnings. The transaction is expected to close either late in the fourth quarter of 2021 or early in the first quarter of 2022, subject to receipt of required regulatory approvals and satisfaction of customary closing conditions.

05:22 EDT Accenture to acquire BRIDGEi2i, terms undisclosed - Accenture has entered into an agreement to acquire BRIDGEi2i, an artificial intelligence, or AI, and analytics firm headquartered in Bangalore, India, with additional offices in the U.S. and Australia. The acquisition will add more than 800 professionals to Accenture's applied intelligence practice. The financial terms of the transaction are not being disclosed.

05:12 EDT Dada Nexus, JD.com launch 'Shop Now' - Dada Group (DADA) and JD.com (JD) announced that they jointly launched "Shop Now", the JD Xiaoshigou, a jointly built new business dedicated for JD's on-demand consumer retail section. Shop Now delivers on the model of "order online, delivery from store, within one hour" and will accelerate Dada Group's and JD's omni-channel operation in the on-demand retail space. The companies said, "With the launch of Shop Now, Dada Group and JD are advancing on-demand retail from the era of "one-hour delivery" to "minutes delivery". The new business was overall undertaken by Dada Group, enabling consumers to enjoy one-hour delivery service when purchasing products labeled "Shop Now" in the JD App. Through joint efforts in consumer experience optimization, Shop Now has been growing rapidly in the testing phase, with a 150% increase in sales in September compared to January, and attracting an increasing number of JD's 530 million annual active consumers. In the long term, the penetration of on-demand retail into JD's consumers is expected to reach 50%."

05:06 EDT Fortuna Silver Mines reports Q3 production of 87,950 gold equivalent ounces - Fortuna Silver Mines reports production results for Q3 from its four operating mines in the Americas and West Africa, the Lindero Mine in Argentina, the San Jose Mine in Mexico, the Caylloma Mine in Peru, and the Yaramoko Mine in Burkina Faso. The company produced 65,425 ounces of gold and 1,711,881 ounces of silver or 87,950 gold equivalent ounces. Gold and silver production for the first nine months of 2021 totaled 131,029 ounces and 5,518,458 ounces, respectively, or 203,640 gold equivalent ounces.