Stockwinners Market Radar for December 19, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:36 EST Ellington Financial reports estimated book value per share $14.89 on November 30 - This estimate includes the effect of the previously announced monthly dividend of 15c per share of common stock, payable on December 27, 2022 to holders of record on November 30, 2022, with an ex-dividend date of November 29, 2022.

17:34 EST Lucid Group jumps 7% to $7.74 after announcing $1.515B capital raise

17:29 EST Catalyst to buy U.S. commercial rights for FYCOMPA from Eisai for $160M - Catalyst Pharmaceuticals (CPRX) announced that it has entered into a definitive agreement with Eisai under which Catalyst will acquire the U.S. rights for FYCOMPA or perampanel CIII and an exclusive option period to review, evaluate and negotiate to acquire a rare epilepsy asset currently in Eisai's pipeline. Catalyst has been advised that Eisai's U.S. FYCOMPA net revenues for the 2022 fiscal year ending March 31, will approximate $136M Catalyst expects the acquisition to be accretive upon closing to Catalyst's earnings in 2023 before interest, taxes, depreciation, and amortization and to EPS. Under the terms of the agreement, Eisai will receive an upfront payment of $160M in association with this transaction and, in addition, may receive future milestone payments and royalties. Eisai has also granted Catalyst an exclusive option period to evaluate and negotiate the acquisition of a rare epilepsy compound in Eisai's pipeline. The acquisition is structured as an all-cash purchase with no financing contingencies. The transaction is expected to be completed in the first quarter of 2023, subject to customary closing conditions and regulatory clearances in the United States and does not impact Catalyst's previously reported 2022 full-year FIRDAPSE revenue guidance. Catalyst and Eisai will work closely together to help ensure a seamless transition of

17:23 EST Lucid Group announces capital raise of $1.515B - Lucid Group announced that it has completed its previously announced "at-the-market" equity offering program. Through the program, Lucid sold more than 56.2M shares of its common stock for gross proceeds of approximately $600M. The successful capital raise of approximately $1.515B, which includes approximately $915M that Lucid expects to raise through the private placement of approximately 85.7M shares to an affiliate of the Public Investment Fund, Ayar Third Investment Company, pending settlement in December 2022, will be used, as previously disclosed, for general corporate purposes, which may include, among other things, capital expenditures and working capital. As previously disclosed, the price that Ayar is paying in the private placement equals the volume-weighted average price achieved in the "at-the-market" offering. This private placement is not a part of the "at-the-market" offering and is in addition thereto. Subject to certain exceptions, Ayar has agreed not to, among other things, offer, sell, pledge or otherwise transfer any shares of our common stock for six months after the date of the private placement. Lucid expects that the additional capital raised will further strengthen its balance sheet and liquidity position.

17:18 EST Steel Dynamics to replace Abiomed in S&P 500 at open on 12/22 - Johnson & Johnson (JNJ) is acquiring Abiomed (ABMD) in a deal expected to close soon pending final conditions.

17:10 EST ArrowMark Financial Corp. reports estimated NAV $21.18 as of November 30 - The NAV was up 27c from the prior month.

17:02 EST Teck Resources to sell Quintette coal mine for $120M, ongoing royalties - Teck Resources announced that it has agreed to sell to a subsidiary of Conuma Resources all the assets and liabilities of the Quintette steelmaking coal mine in north-eastern British Columbia. Conuma will pay Teck $120M in cash in staged payments over the next 36 months, and an ongoing 25% net profits interest royalty, first payable after Conuma recovers its investment in Quintette. Closing of the transaction, expected to occur in the first quarter of 2023, is subject to receipt of regulatory approvals and other customary conditions. Quintette has been on care and maintenance since 2000.

17:00 EST GasLog Partners announces IRS regulations will not affect unitholders - GasLog Partners announced that the U.S. Treasury and Internal Revenue Service, or IRS, final regulations that are coming into effect on January 1, 2023, will not affect its unitholders. These regulations oblige brokers, withholding agents and qualified intermediaries to withhold a 10% tax on a non-U.S. partner's disposition of an interest in a publicly traded partnership that is taxed as a partnership for U.S. federal income tax purposes. As a result, certain non-U.S. brokers may not permit non-U.S. persons to hold such PTP interests in their brokerage account. GasLog Partners has elected to be treated as a C corporation for U.S. federal income tax purposes and therefore interests in the partnership are not subject to these regulations.

16:57 EST ANI Pharmaceuticals announces FDA approval of ANDA for Levocarnitine Tablets - ANI Pharmaceuticals announced that it received U.S. FDA approval for the Abbreviated New Drug Application for Levocarnitine Tablets USP, 330 mg. ANI's Levocarnitine Tablets are the generic version of the Reference Listed Drug Carnitor. The current annual U.S. market for Levocarnitine Tablets is approximately $10M, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

16:53 EST Arch Capital increases share repurchase authorization to $1B - Arch Capital Group increased its share repurchase authorization to $1B, which may be effected from time to time in open market or privately negotiated transactions through December 31, 2024. At September 30 approximately $596.4M of share repurchases were available under the Company's share repurchase program. From October 1 through December 14 the Company did not repurchase any common shares. This new program replaces the Company's existing share repurchase authorization.

16:44 EST Borqs Technologies to negotiate with CFIUS to fully divest Holu Hou Energy - Borqs Technologies announced the company has received a letter dated December 13 from the Department of the Treasury on behalf of the Committee on Foreign Investment in the United States, or CFIUS, stating that the company is required to negotiate with CFIUS to fully divest its ownership interests and rights in Holu Hou Energy due to HHE solar energy storage system and EnergyShare technology for Multi-Dwelling Residential Units, or MDU's, being deemed a critical technology and therefore a potential national security risk. As stated in the letter, HHE is considered a top ten solar energy storage supplier in Hawaii, has only been increasing its market share, expects to grow at an exponential rate, and focuses on multi-family dwelling units which are common in military housing. Due to Borqs' IoT software development and hardware sourcing capabilities in China, CFIUS is concerned that through Borqs, the PRC could gain significant visibility and exert influence over HHE's business operations and get access to HHE critical technology. CFIUS is requiring the company to design a plan to mitigate all identified national security risks to the satisfaction of CFIUS. Borqs intends to comply to the requirements from CFIUS and enter into a National Security Agreement with various departments of the U.S. Government with a plan that is effective, monitorable and verifiable to voluntarily divest Borqs' investment interests and rights in HHE. HHE's commercialization of its solar energy storage system and novel EnergyShare technology for MDU's has enabled the company to open up a new market segment for renewable energy in the USA - likely worth several billions of dollars. In the last year the company's MDU development pipeline has reached thousands of individual units in Hawaii alone, with California MDU potential being at least one to two orders of magnitude higher in the coming years. One segment of this new market is for communities of military and other government personnel. Since Borqs' financial support in HHE starting from October 2021, HHE has signed approximately $50M in contracts and has a pipeline approaching half a billion dollars. The company said, "We believe this voluntary mitigation will enable the tremendous inherent value of HHE to be realized and that the divestment can be a profitable transaction for Borqs' shareholders. The plan to mitigate will include engaging a nationally recognized investment bank with experience in administering competitive sales and auction processes, assigning and hiring of security and monitoring personnel to directly communicate with CFIUS, immediate and complete removal of all Borqs administrative and technical influence over HHE, immediate voluntary reduction of Borqs ownership of HHE from a majority to a minority position and with the target of divesting all. The Company believes such points will enable the Company to accomplish the divestment in an orderly manner."

16:43 EST iKena Oncology Chair Ron Renaud to step down, Owen Hughes to replace - Ikena Oncology announced that after a successful 4-year tenure as Chairman of the Board of Directors, Ron Renaud will be stepping down from the role to focus on his new position as Managing Director at Bain Capital Life Sciences. Owen Hughes has been appointed as a new board member and will be assuming the role of Chair of the Board of Directors, effective December 15."On behalf of the Board of Directors and the entire company, I am thrilled to welcome Owen to our board. His leadership will be a key asset as we continue to work towards our goal of expanding patient access to beneficial, targeted oncology treatments. I would like to express our sincere gratitude to Ron for his leadership and commitment to the success of Ikena over the past four years," said Mark Manfredi, PhD, Chief Executive Officer of Ikena. "Ron has been instrumental to our progress since the early days of Ikena, and his impact and guidance will leave a lasting footprint on the future success of the company." Hughes, who serves as Chief Executive Officer of Sail Bio and Co-Founder of Cullinan Oncology, will join as Chairman of the Board of Directors.

16:38 EST ServisFirst raises quarterly dividend 22% to 28c from 23c per share - The dividend is payable on January 6, 2023 to stockholders of record as of January 3, 2023.

16:34 EST Oragenics names Charles Pope chairman of the board - Oragenics announced that on December 16, 2022 the Board of Directors appointed Charles Pope as its Chairman of the Board of Directors succeeding Dr. Frederick W. Telling, who has served as a director since June 2010 and as Chairman since February 2011. Dr. Telling will remain on the Board as an independent director and as a member of both the audit and nominating and corporate governance committees. Dr. Telling stated: "It has been an honor and privilege to serve as Chairman of Oragenics for over a decade and I look forward to assisting with the Company's transition of the Chairman role to Charlie and continuing to serve on the Board as an independent director."

16:33 EST Illinois American Water granted new rates by Illinois Commerce Commission - On Dec. 15, 2022, the Illinois Commerce Commission issued an order adjusting base rates for Illinois American Water, effective Jan. 1, 2023. The rate change request, which was filed in Feb. 2022, was driven primarily by over $1.1 billion in completed or planned investment, reflecting approximately $948 million in water system improvements and $204 million in wastewater system improvements in Illinois from 2018 through 2023. The rate order will result in a total annualized revenue increase of approximately $67 million. The additional revenues will support continued investment in critical water and wastewater infrastructure throughout the state, including the replacement, lining and installation of approximately 141 miles of aging water and wastewater pipelines. Investments would also include, among others, upgrading water and wastewater treatment plants, storage tanks, wells, pumping stations, fire hydrants, meters and manholes across the state.

16:32 EST Installed Building Products acquires ABS Insulating Company - Installed Building Products announced the acquisition of ABS Insulating Company, Inc., ABS Sprayfoam Insulation, Inc., and ABS Coastal Insulating Company, LLC. Established in 1991, ABS serves the greater Charlotte, NC and Myrtle Beach, SC markets, installing fiberglass insulation, spray foam insulation, and gutters into new residential projects. Jeff Edwards, Chairman and Chief Executive Officer, stated, "With approximately $21 million of annual revenue, ABS is a well-established installer throughout the greater Charlotte and Myrtle Beach markets and helps solidify our presence in these compelling geographies. To date in 2022, we have acquired approximately $109 million of annual revenues, exceeding the $100 million expectation announced earlier in the year. Acquisitions remain a key component of our growth strategy and we continue to have a robust pipeline of opportunities across multiple geographies, products, and end markets. On behalf of everyone at Installed Building Products, I want to welcome ABS onto our team," concluded Mr. Edwards.

16:30 EST FuboTV announces carriage agreement with Scripps Networks - FuboTV (FUBO) announced a multi-year distribution partnership with Scripps Networks, the national television network division of The E.W. Scripps Company (SSP). Starting today, FuboTV subscribers can enjoy the popular Scripps networks ION, ION Mystery, ION Plus, Bounce, Grit, Newsy (becomes Scripps News on January 1) and Court TV. The launch of these Scripps networks further expands FuboTV's entertainment and news offerings, which, alongside its leading sports offering, makes Fubo a top streaming TV option for families. "Today's launch gives consumers a new streaming option to watch these top Scripps channels and further diversifies FuboTV's growing programming line-up," said Marisa Elizondo, vice president, content strategy and distribution, FuboTV. "Fubo's mission is to aggregate and distribute a leading sports package, balanced with news and entertainment content, that appeals to every member of the household, all at an affordable price."

16:21 EST Stitch Fix announces Kofi Amoo-Gottfried joins board - Stitch Fix (SFIX) announced that Kofi Amoo-Gottfried, Chief Marketing Officer of DoorDash (DASH), has joined Stitch Fix's Board of Directors, effective immediately. Prior to DoorDash, Amoo-Gottfried held various senior positions in brand and marketing at Meta and Bacardi. He also brings more than a decade of advertising experience from Leo Burnett and Wieden + Kennedy with brands such as Kellogg's, Coca Cola and Nike. "We are pleased to welcome Kofi to our Board of Directors," said Elizabeth Spaulding, CEO of Stitch Fix. "We are excited for the deep customer, marketing channel and brand expertise that Kofi will provide as we continue to execute on our strategy to evolve Stitch Fix into the global destination for personalized shopping, styling and inspiration." "Stitch Fix's mission of changing the way you get dressed so you can show up to the world as your most confident self really resonates with me. With its unique combination of expert stylists and advanced data science, Stitch Fix is well placed to capitalize on the appetite of consumers for experiences and expertise that help them discover the perfect items and outfits they wouldn't have found by themselves.'' said Amoo-Gottfried. "I'm looking forward to working with the Stitch Fix team."

16:18 EST Comtech awarded 5G locations services contact with tier-1 MNO in Canada - Comtech announced that the company was recently awarded a contract to install a 5G virtual Mobile Location Center production site and deliver location-based services for a tier-1 mobile network operator in Canada-further expanding the company's drive to be the world's preferred precise, network-based geolocation services provider. Comtech's vMLC system is used to help pinpoint the location of mobile devices connected to 5G networks. This contract will significantly enhance 9-1-1 rapid response capabilities in a wide variety of emergency situations-allowing the mobile carrier to benefit from a cloud native platform and providing public safety agencies with services to more accurately locate 9-1-1 callers. "As MNOs continue to move to 5G networks, Comtech's vMLC solution will play a critical role in bringing forward the next generation of location-based capabilities," said Ken Peterman, President and Chief Executive Officer of Comtech. "This contract further demonstrates the trust of our partners in Canada as well as Comtech's leadership in cloud native 5G technologies that will help transform mobile networks around the world."

16:15 EST Trinseo announces asset restructuring actions, EU settlement - Trinseo announced updates to its asset restructuring initiatives. In aggregate, these actions are expected to result in approximately $60 million of annual profitability improvement versus the fourth quarter run rate, most of which will be realized in 2023. These actions consist of the following: Closure of manufacturing operations at the styrene production facility in Boehlen, Germany. The closure is the result of an uncompetitive position in the global styrene market due to the site's subscale size, industry capacity additions and elevated natural gas prices in Europe; Closure of one polycarbonate production line in Stade, Germany due to an uncompetitive position in the global polycarbonate market. The Company will continue to produce polycarbonate for use in its downstream compounding business with the remaining assets. The line closure is expected to result in lower costs and significantly less exposure to the cyclical merchant polycarbonate market; Consolidation of the PMMA sheet manufacturing site in Matamoros, Mexico into the continuous sheet manufacturing operation of Aristech Surfaces in Florence, Kentucky; Capacity reduction of SB latex at the Hamina, Finland site starting mid-year 2023 due to over-capacity of SB latex in Europe. Trinseo expects to incur $79 million to $89 million of pre-tax, non-recurring charges related to the cessation of manufacturing activities at these facilities. Of this, $55 million to $61 million is expected to be incurred in the fourth quarter of 2022, with the remainder expected to be incurred through 2024. The cash amount of these charges is expected to be $67 million to $77 million, including approximately $40 million in 2023, with substantially all expected to be incurred through 2024. The actual timing and costs of these actions may differ from the Company's current expectations and estimates, and such differences may be material. These charges are subject to ongoing negotiations with the works councils, industrial associations and government authorities. Additionally, on November 29, 2022, the European Commission issued a final decision imposing a fine to Trinseo in the amount of EUR 32.6 million related to the commission's 2018 investigation of styrene purchasing practices in Europe. This amount was in line with our previously recorded liability and was paid in full in December 2022.

16:11 EST Banc of California promotes John Sotoodeh to company COO - Banc of California announced the promotions of several senior executives effective January 1, 2023. The Company also announced the retirement of Lynn Sullivan as the company's Executive Vice President and Chief Risk Officer, effective as of year-end, following a distinguished career in banking and exceptional service to the Bank. Sullivan will serve as a consultant to the Bank for a six-month transition period. The executive promotions announced by the company are as follows: John Sotoodeh, Chief Operating Officer of the Bank, has been promoted to Chief Operating Officer of the Company and the Bank. In his role as COO of the Company, Mr. Sotoodeh will oversee a broad range of services across the Company, including our operations, technology and payments platforms, along with other key strategic initiatives. Hamid Hussain, President of Commercial and Real Estate Banking, has been promoted to President of the Bank. In his new role, Mr. Hussain will have responsibility for the overall strategy, goals and execution of the Bank's client-facing teams outside the retail branches, expanding our client-base and growing loan and deposit relationships. Ido Dotan, General Counsel of the Company and the Bank, has been promoted to Chief Administrative Officer of the Company and the Bank, in addition to his role as General Counsel. Mr. Dotan's expanded responsibilities will include implementing and facilitating organizational efficiency and coordination across all administrative areas of the Bank. Olivia Lindsay, Deputy Chief Risk Officer, has been promoted to Chief Risk Officer of the Company and the Bank upon Ms. Sullivan's retirement. In her new role as CRO, Ms. Lindsay will oversee the Enterprise Risk Management organization and have responsibility for the Bank's BSA, AML and overarching risk program.

16:10 EST Titan Machinery to acquire Idaho dealership assets of Pioneer Farm Equipment - Titan Machinery announced that it has entered into a definitive purchase agreement to acquire the Idaho dealership assets of Pioneer Farm Equipment. The acquisition includes five full-line Case IH agriculture dealerships located in southeastern Idaho, two of which are also Case Construction equipment dealerships. For full calendar year 2021, Pioneer generated revenue of approximately $60M. The acquisition is expected to close in February 2023.David Meyer, Titan Machinery's Chairman and Chief Executive Officer, stated, "We are excited to announce our agreement to purchase Pioneer's Idaho dealership assets. The Pioneer team has been serving customers in the highly productive Snake River Valley area in southeastern Idaho for over two decades. This acquisition represents an ideal opportunity for us to build upon our recent Heartland acquisition, which has an established presence in the region with commercial application equipment customers. Further, this growing region was of particular interest to us given it supports large industry volumes and has similar crops and machine specifications to other markets served by Titan Machinery. We share similar cultures that are focused on attentive, personal, customer service and we look forward to welcoming their team to the Titan Machinery family."

16:10 EST Simmons First National announces executive appointments - Simmons First National announced changes to certain executive management roles. George Makris, Jr., Simmons' current chairman and CEO, will assume the role of full-time executive chairman of Simmons. Makris has been a director of the company since 1997 and has served as its CEO since 2014. In his new role, Makris will continue to lead Simmons' boards of directors as their chairman and will work directly with Simmons' CEO, as well as the other members of executive management, on strategic initiatives and a smooth leadership transition. Robert "Bob" Fehlman, Simmons' current president and COO, will assume the role of CEO of Simmons. Fehlman has worked for either the company or its affiliates since 1988. Following the transition, Fehlman will lead the development of Simmons' "better bank" initiatives and will manage the day-to-day responsibilities commensurate with the duties of the chief executive officer. James "Jay" Brogdon, Simmons' current executive vice president and CFO, will assume the role of president and CFO of Simmons. Brogdon joined Simmons in 2021 after holding positions at Stephens Inc. and Deloitte. In addition to his current responsibilities, in his new role, Brogdon will also assume oversight of all revenue production for the company and the Bank. The changes described above will be effective January 1, 2023.

16:06 EST NewAmsterdam appoints David Topper CFO effective January 1 - NewAmsterdam Pharma Company announced the appointment of David Topper as Chief Financial Office effective January 1. Mr. Topper served most recently as Partner, Capital Markets at Frazier Healthcare Partners and as Chief Financial Officer and Board Director of Frazier Lifesciences Acquisition Corporation , the Frazier-sponsored special-purpose acquisition company with which NewAmsterdam completed a business combination in November. He succeeds Louise Kooij, who will transition to the role of Chief Accounting Officer.

16:02 EST Nasdaq CEO Adena Friedman to assume additional role of chair of board - Nasdaq announced its board of directors has unanimously elected Adena Friedman to the role of chair of the board of directors, effective January 1, 2023, in addition to her current position as CEO of the company. Friedman succeeds Michael Splinter, who has been elected lead independent director.

14:35 EST Takeda reports Phase 3 AURORA trial did not meet primary endpoint - Takeda announced that in the AURORA trial, a Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study to assess the efficacy and safety of maribavir compared to valganciclovir for the treatment of CMV infection in hematopoietic stem cell transplant, or HSCT, recipients, maribavir demonstrated clinically meaningful efficacy in confirmed CMV viremia clearance, but did not meet its primary endpoint of non-inferiority vs. valganciclovir based on the prespecified non-inferiority margin of 7%. The primary endpoint was defined as the proportion of patients who achieved confirmed CMV viremia clearance after exclusively maribavir compared to valganciclovir at end of treatment phase. At Week 16, the key secondary endpoint, 8 weeks after end of treatment, a numerically higher proportion of patients treated with maribavir maintained CMV viremia clearance and symptom control achieved at Week 8 compared to valganciclovir. This comparable maintenance of effect with maribavir was consistent at all post-treatment evaluations at Study Week 12 and Study Week 20. "Takeda is sharing the AURORA study results with relevant regulatory agencies and will continue to engage with them on a potential path forward for maribavir in asymptomatic first-episode post-transplant CMV infection. Full data results from the AURORA study will also be submitted for publication in a peer-reviewed journal," the company stated.

13:24 EST Charlotte's Web appoints Jessica Saxton as CFO - Charlotte's Web Holdings announced that Jessica Saxton has joined the Company as CFO, effective January 1, 2023. Saxton will transition with outgoing CFO Greg Gould, ahead of his departure at the end of 2022. Saxton most recently served as CFO for EverGrain Ingredients.

13:14 EST Dragonfly Energy Holdings Corp trading halted, volatility trading pause

12:37 EST Honeywell pays $160M to resolve bribery investigations in U.S., Brazil - Honeywell UOP, a U.S.-based subsidiary of Honeywell International, has agreed to pay more than $160M to resolve parallel bribery investigations by criminal and civil authorities in the United States and Brazil "stemming from bribe payments offered to a high-ranking official at Brazil's state-owned oil company. " The Department of Justice's resolution is coordinated with prosecutorial authorities in Brazil as well as the U.S. Securities and Exchange Commission. According to court documents, Honeywell UOP entered into a three-year deferred prosecution agreement with the department in connection with a criminal information filed in the Southern District of Texas charging the company with conspiracy to violate the anti-bribery provisions of the Foreign Corrupt Practices Act. Reference Link

12:13 EST Peloton vows action against accounts with explicit imagery - Peloton Interactive told its members yesterday that it is taking active action against accounts being intentionally created with inappropriate content, including explicit imagery in their profile picture. The company wrote, "These explicit images are a direct violation of our standards and terms of service. We are actively working to block these accounts and continue to moderate explicit images associated with user profiles. Please do not accept or reply to these follow-requests...We apologize to those of you who received these follower requests and were exposed to this content. This is certainly not the community experience we expect for our Peloton Members." Reference Link

12:00 EST Nexa Resources falls -21.0% - Nexa Resources is down -21.0%, or -$1.41 to $5.30.

12:00 EST New Oriental Education rises 7.4% - New Oriental Education is up 7.4%, or $2.54 to $36.94.

12:00 EST ProShares UltraShort Bloomberg Natural Gas rises 13.0% - ProShares UltraShort Bloomberg Natural Gas is up 13.0%, or $2.00 to $17.39.

10:56 EST Sapiens appoints Yaffa Cohen-Ifrah as CMO, head of investor relations - Sapiens appoints Yaffa Cohen-Ifrah as Chief Marketing Officer and Head of Investor Relations. In her new role, Yaffa will be responsible for formulating Sapiens' global marketing strategy and overseeing the development and execution of the company marketing initiatives and brand positioning. She will manage the global marketing team, working hand-in-hand with the business development teams, and will play a vital role in Sapiens' future growth. In addition, Yaffa will be responsible for Sapiens' investor relations strategy and serve as its leader with the investment community. Yaffa recently served as Vitech's CMO.

10:41 EST Viking Therapeutics up 58% after Madrigal announces NASH trial data - Shares of Viking Therapeutics (VKTX) are up $2.34, or 58%, to $6.36 after competitor Madrigal Pharmaceuticals (MDGL) announced topline results from the pivotal Phase 3 MAESTRO-NASH biopsy clinical trial of resmetirom, a liver-directed selective thyroid hormone receptor agonist. MAESTRO-NASH, a registrational Phase 3 trial, achieved both liver histological improvement endpoints that FDA proposed as reasonably likely to predict clinical benefit to support accelerated approval for the treatment NASH with liver fibrosis, Madrigal reported earlier this morning. In morning trading, shares of Madrigal Pharmaceuticals are up $168.03, or 263%, to $231.83.

10:17 EST Cosmos Holdings Inc trading resumes

10:12 EST Cosmos Holdings Inc trading halted, volatility trading pause

10:00 EST MasterBrand falls -13.8% - MasterBrand is down -13.8%, or -$1.28 to $8.02.

10:00 EST PLDT falls -19.8% - PLDT is down -19.8%, or -$5.31 to $21.50.

10:00 EST ProShares UltraShort Bloomberg Natural Gas rises 10.5% - ProShares UltraShort Bloomberg Natural Gas is up 10.5%, or $1.61 to $17.00.

09:57 EST Advent, Vantage Towers Greece launch PoC project to replace diesel generators - Advent Technologies (ADN) launched a proof of concept project with Vantage Towers Greece (VTWRF) to replace diesel generators with fuel cells. By replacing diesel generators with fuel cells at non-permanent sites that are not connected to the power grid, they can be supplied with electricity even more environmentally friendly. Under the PoC, Vantage Towers Greece will explore the applicability of Advent's Serene biomethanol-powered fuel cell systems as back-up and primary power sources for its telecom towers. Following completion of the PoC project in Greece, Advent and Vantage Towers could consider wider deployments.

09:54 EST Prosomnus Inc trading resumes

09:48 EST Fathom Holdings trading resumes

09:47 EST Pinterest trades under PINS falls -10.8% - Pinterest trades under PINS is down -10.8%, or -$2.64 to $21.90.

09:47 EST Perfect Corp. rises 9.0% - Perfect Corp. is up 9.0%, or 59c to $7.14.

09:47 EST Babylon Holdings rises 19.4% - Babylon Holdings is up 19.4%, or $2.19 to $13.49.

09:44 EST FBI reports 2.79M NICS firearm background checks in November - The FBI reported that there were 2,788,138 firearm background checks initiated through the NICS system in November 2022. This compares to 2,717,458 checks in November of 2021 and 2,511,034 in October 2022. Companies in the gun space include Sturm, Ruger (RGR), American Outdoor Brands (AOBC), and Vista Outdoor (VSTO).

09:40 EST Mondee Holdings Inc trading resumes

09:34 EST Mondelez to sell developed-market gum business to Perfetti Van Melle for $1.35B - Mondelez International announced it has entered into definitive agreements to sell its developed-market gum business in the United States, Canada and Europe to Perfetti Van Melle Group for a headline purchase price of $1.35B or 15 times equivalent to estimated current year EBITDA. The divestiture advances the Company's portfolio reshaping strategy, as outlined at its Investor Day in May, enabling greater focus on growth and reinvestment in its core chocolate, biscuit and baked snacks categories. The sale includes manufacturing facilities in Rockford, IL and Skarbimierz, Poland and the gum brands Trident, Dentyne, Stimorol, Hollywood, V6, Chiclets, Bubbaloo and Bubblicious in the United States, Canada and Europe, as well as the European candy brands Cachou Lajaunie, Negro, and La Vosgienne. Mondelez International will continue to operate its gum business outside the United States, Canada and Europe, led by Stride in China, as well as all of its other candy brands and products. The acquisition of Mondelez International's developed market gum business complements the Perfetti Van Melle portfolio-including iconic global brands such as Mentos, Chupa Chups and Alpenliebe. The transaction, which is subject to customary closing conditions, is expected to close in Q4 of 2023. The definitive agreements cover the sale of the business in the United States, Canada and Europe excluding France. The parties have entered into exclusive arrangements for the sale of the business in France.

09:30 EST Mondee Holdings Inc trading halted, volatility trading pause

09:23 EST Calvin B. Taylor Bankshares appoints Thomas Coates as chair of board - Calvin B. Taylor Bankshares announced that the Board of Directors has elected Thomas Coates as Chair of the Board of Directors of the Company and the Bank. Coates first joined the Board of Directors of the Company and the Bank on May 14, 2014. He is a member of Coates, Coates, and Coates, P.A., and has practiced law in the Berlin and Ocean City area since 1985.

09:22 EST Cosmos Holdings announces pricing of $32.5M registered direct offering - Cosmos Health entered into securities purchase agreements with institutional investors for the purchase and sale of 2,828,320 shares of the Company's common stock in a registered direct offering and warrants to purchase up to 2,828,320 common shares in a concurrent private placement. The combined purchase price for one share of common stock and one warrant will be $11.50. The warrants will have an exercise price of $11.50 per share, will be exercisable immediately and will expire five years from the issuance date. The offering includes participation from Grigorios Siokas, CEO of Cosmos Health Inc., as well as existing shareholders of the Company. The aggregate gross proceeds from the offering will be approximately $32.5 million before deducting fees and other estimated expenses. The Company expects to use the net proceeds from the offering for working capital and general corporate purposes. The offering is expected to close on or about December 21, 2022, subject to the satisfaction of customary closing conditions.

09:17 EST M&T Bank's Wilmington Trust to sell CIT business to Madison Dearborn Partners - Wilmington Trust, a wholly-owned subsidiary of M&T Bank, announced an agreement with Madison Dearborn Partners, under which funds affiliated with MDP will acquire Wilmington Trust's Collective Investment Trust business. Upon completion of the transaction, the CIT business will become an independent company with a new brand name owned by funds affiliated with MDP. The CIT business, part of Wilmington Trust's Institutional Client Services division, is an industry-leading provider of third-party trustee and administrative services to asset managers and the employer-sponsored retirement market. The business has delivered consistent year-over-year revenue growth and currently manages approximately $115B in CIT assets for more than 550 funds across a family of about 45 subadvisors -- including AllianceBernstein, BlackRock, Franklin Templeton, MetLife, Neuberger Berman, and Raymond James. The transaction is expected to close no later than mid-2023 and is subject to customary closing conditions and regulatory approvals.

09:09 EST Embark Technology provides first Embark-powered truck to Knight-Swift - Embark Trucks (EMBK) and Knight-Swift Transportation (KNX) have announced that Embark has initiated handover of the first Embark-powered truck as part of the Truck Transfer Program, TTP. TTP marks the first public initiative where a carrier will directly own and operate a truck with select features of Embark's automated driving software, allowing Embark to gain valuable insight from having its system components operating in a carrier customer's duty cycle. For the first time, a carrier - Knight-Swift - will place its own drivers behind the wheel of an Embark-powered truck, allowing Knight-Swift to collect data regarding system safety and operational performance. To meet the uptime requirements of a commercial fleet, Embark has focused on hardening its Embark Universal Interface and Embark Driver software. This system hardening includes improvements in calibration and maintainability of the system, enabling quick troubleshooting so that trucks can get back on the road. Embark and Knight-Swift have been jointly working on several operational initiatives to prepare for the handoff of Embark-powered trucks into Knight-Swift's daily operations. These initiatives include developing maintenance procedures for AV systems, pre- & post-trip inspections, training and certifying Knight-Swift drivers, and escalation policies for maintenance issues. Embark is also training Knight-Swift technicians on how to service and interact with the trucks. Embark CEO Alex Rodrigues said, "Handing over the first Embark-powered truck to the Knight-Swift team tops off a year in which Embark has made critical strides to close the gap between testing our autonomous technology and scaling it across customer fleets. The Truck Transfer Program will be a model for the industry as we move from the R&D and pilot phase toward commercialization."

09:07 EST Aura Minerals changes record, payment dates for December dividend - Aura Minerals announced that, further to the Company's press release dated December 6, 2022 and in order to satisfy certain administrative requirements in Canada, Aura's Board of Directors changed the record date and the payment date for its previously announced dividend of US$0.14 per common share. The record date for the Dividend has been changed from December 15, 2022 to December 23, 2022, and the payment date for the Dividend has been changed from December 21, 2022 to December 30, 2022. In accordance with the Company's dividend policy, the Dividend is in respect of and is based on Aura's expected financial results for the six months ending on December 31, 2022.The Dividend will be paid on December 30, 2022 to shareholders of record as of the close of business on the Record Date. All shareholders of record on the Record Date will receive the Dividend in US dollars. Holders of the Company's Brazilian Depositary Receipts are expected to receive payment by January 10, 2023 as of Record Date previously announced of December 15, 2022 and will receive the Brazilian Reais equivalent of the Dividend, based on a market exchange rate to be disclosed in a future Press Release, in advance of its payment date. Between December 19, 2022 and December 23, 2022, the issuance and cancellation of BDRs will be interrupted. The Dividend is not subject to withholding taxes at the time of payment by the Company.

09:07 EST Interlink Electronics acquires SPEC Sensors and KWJ Engineering for $2M - Interlink Electronics announced that it has acquired the businesses of SPEC Sensors and KWJ Engineering, two industry-leading designers and manufacturers of gas, air and environmental quality sensors, for approximately $2M. SPEC/KWJ's trailing twelve months revenue was over $4M through November 2022.

09:06 EST Shineco subsidiary receives prior approval for supplement from Jiangsu Bureau - Shineco announced that the Company's controlled affiliate Changzhou Biowin Pharmaceutical has received the Prior Approval Supplement from the Jiangsu Medical Products Administration or the marketing approval of "Cardiac 5-minute Test." This product is a combo test of three major cardiac markers and can detect cardiac troponin I, myoglobin and fatty acid binding protein for the clinical diagnosis of acute myocardial infarction in one test. We believe it is a breakthrough of the clinical diagnosis of AMI and takes only 5 minutes to complete detection. "We are very glad to receive the first review report from the Chinese FDA Bureau for our application of the marketing approval of the Cardiac 5-minute Test. This is a very important milestone for our product to be on the market in China soon, and we are expecting to receive the final marketing approval in China within three months," said Dr. Marvin Liu, CEO of CBP and the inventor of this technology, "Our 5-minute test is not only rapid, but also accurate, easy to use, and portable. In addition, it can be used as a point-of-care testing product as well. The POCT market in China, Europe, the United States and other countries has expanded rapidly and maintained a high growth rate in recent years. This high clinical demand, combined with our technological breakthrough for the rapid diagnosis of acute myocardial infarction, will allow us to develop a strong competitive advantage in target markets of China as well as other countries in the world."

09:05 EST Abbott announces FDA approval of Eterna SCS system - Abbott announced the U.S. FDA approval of the company's Eterna spinal cord stimulation system, the smallest implantable, rechargeable spinal cord stimulator currently available on the market for the treatment of chronic pain. Eterna SCS utilizes Abbott's proprietary low-dose BurstDR stimulation, the only SCS waveform technology with the highest level of clinical evidence proven to reduce pain 23% more than traditional waveform technology approaches.

09:04 EST MGM Resorts: MGM Grand Paradise awarded 10-year gaming concession contract - MGM Resorts International announced that MGM Grand Paradise the concession holder of MGM China Holdings, which is 56% owned by MGM Resorts International, has been awarded a new 10-year gaming concession contract. As part of the agreement, MGM China will invest approximately $2B over the next ten years, approximately 50% of which is expected to be treated as capital expenditures and 50% as operating expense1. Approximately 90% of this spend will be earmarked for the development of international tourist markets and non-gaming projects and programming to drive diversification to the region. MGM China will also receive an additional 200 table games raising its total table count to 750, which will support future market share growth opportunity for our business.

09:02 EST Sintx Technologies announces 1-for-100 reverse stock split - SINTX Technologies announced that its Board of Directors has declared a 1-for-100 reverse stock split of the company's common stock. The reverse stock split will become effective on December 20, 2022 at 12:01 AM Eastern Time. The company's common stock is expected to begin trading on a split-adjusted basis when the markets open on December 20, 2022 under the current trading symbol "SINT." The reverse stock split is primarily intended to bring the company into compliance with the minimum bid price requirements for maintaining its listing on the Nasdaq Capital Market. The new CUSIP number following the reverse split will be 829392 604. As a result of the reverse stock split, every 100 shares of the company's common stock issued and outstanding will be automatically reclassified into one new share of common stock.

09:01 EST Sandy Spring Bancorp eliminates non-sufficient fund fees, changes to overdraft - Sandy Spring Bank, the primary subsidiary of Sandy Spring Bancorp, announced it has eliminated non-sufficient funds fees on all personal accounts, and has made changes to its overdraft policy and fees, as part of a comprehensive strategy to regularly review fee structures and make banking easier and more affordable for consumers. "We are always listening to our clients and refining and enhancing products based on their feedback," said Jay O'Brien, Executive Vice President and Chief Banking Officer of Sandy Spring Bank. "Individuals and families want to be in control of their banking in ways that best meet their financial goals, regardless of when, how and where they bank with us. Our bankers bring a personalized approach and consult with each client to help them choose the products and services that best meet their individual needs." The Bank's personal clients also will benefit from changes in fees for overdrafts, imposed when banks accept checks and other debits that overdraw a client's account.

09:00 EST ACNB Corp rebrands Maryland banking divisions - ACNB Corporation announced plans for its banking subsidiary---ACNB Bank---to rebrand its Maryland banking divisions. NWSB Bank and FCB Bank will formally adopt the ACNB Bank name and brand identity in the counties of Carroll and Frederick in central Maryland, respectively, effective January 1, 2023. At that time, ACNB Bank, the legal entity and chartered financial institution, will begin retiring the use of the division names in the Maryland communities served.

08:58 EST SRM Entertainment files S-1 registration for Jupiter Wellness spin-off - Jupiter Wellness announced that SRM Entertainment has filed a registration statement with the Securities and Exchange Commission to separate the company from Jupiter Wellness. Upon completion of the spin-off, SRM and Jupiter Wellness will be two independent and separate public companies. Jupiter Wellness is expected to remain the majority shareholder of SRM. The date for determining which Jupiter Wellness shareholders will receive SRM shares in the spin-off will be announced before the effective date of SRM's registration statement. Once the registration statement is declared effective by the Securities and Exchange Commission, shares of SRM will be distributed to Jupiter Wellness shareholders, who will continue to hold their shares in Jupiter Wellness.

08:54 EST I3 Energy appoints Ryan Heath to board of directors - i3 Energy confirms, following the completion of relevant AIM rules requirements, the previously announced appointment of Ryan Heath to the Board of Directors as an Executive Director effective immediately. Ryan Heath was appointed President of i3 Canada, following i3's December 2020 acquisition of Toscana Energy Income Corporation, where he served as the CEO since 2019. Ryan John McColl Heath, owns 8,255,374 shares in the Company, representing 0.69% of the issued share capital and has 1,666,666 options over ordinary shares with an exercise price of 11 pence.

08:51 EST Onda expects to close Airobotics merger by end of January - Ondas Holding and American Robotics announced that on December 18, 2022 the shareholders of AIRBOTICS approved the proposed acquisition of Airobotics by Ondas. The transaction is expected to close by the end of January 2023 and will result in Airobotics becoming a wholly owned subsidiary of Ondas. In addition, the Company received approval from the Israel Securities Authority and the Tel Aviv Stock Exchange for its dual listing application. Upon closing of the proposed acquisition of Airobotics, the Company expects its common stock to be dual listed on Nasdaq and TASE.

08:48 EST Conduent selected to provide EMV contactless payment system for Venice - Conduent Transportation (CNDT) announced that Azienda Veneziana della Mobilita, AVM, the Municipality of Venice's public mobility company, has selected Conduent Transportation and Elavon, as well as Visa (V), to provide a convenient EMV payment system across its public transportation network. This technology enhancement will allow riders to pay with contactless credit and debit cards, offering easier access to AVM's local public transport service in the metropolitan area of Venice and the integrated mobility services in the urban area. Implementation will begin in 2023. AVM took an innovative approach in selecting the project's partners, each bringing their expertise and capabilities to the collaboration: Conduent and Elavon, a global payments company, formed a business collaboration to support this project. Conduent will deliver the end-to-end technical infrastructure, including 1,900 validators, to enable contactless payments on the Venice transportation network. Elavon will provide the acquiring service, handling the end-to-end process for credit and debit card payments. "Transportation authorities around the world are upgrading and modernizing their systems to align with consumers who are using technology to make life easier and faster every day. Contactless payment systems are becoming an indispensable solution for these systems," said Lou Keyes, President, Transportation Solutions at Conduent. "Through smart collaboration, AVM will be enhancing their network and the transportation experience for the millions of people who rely on the system annually."

08:46 EST Aclarion announces Uribe will advise company as KOL - Aclarion announced that Juan Uribe will advise the company as a key opinion leader, KOL, nationally. Serving as the current Treasurer of the American Association of Neurological Surgeons and the Congress of Neurological Surgeons Section on Disorders of the Spine, Dr. Uribe is a leader in researching new technologies and advocating for their use to improve clinical care. Aclarion is following a focused strategy of building strong clinical evidence and engaging the payer community through key opinion leader advocacy.

08:44 EST MamaMancini's appoints Henson to board of directors - MamaMancini's (MMMB) announced the appointment of human resources executive Meghan Henson to its Board of Directors. Meghan Henson is a senior executive with over 20 years of experience as a versatile human resources professional, leading HR strategy and execution at leading global organizations. Henson is currently Executive Vice President and Chief Human Resources Officer at Avantor (AVTR)

08:41 EST InterCure enters exclusive international partnership agreement with Binske - InterCure entered into a definitive licensing agreement with Praetorian Global. Pursuant to the Agreement, Praetorian Global agreed to grant InterCure an exclusive multi-year right to cultivate, manufacture, market, and distribute Binske-branded products in major global pharmaceutical markets including Israel, Germany, Australia, UK and others. The company said, "InterCure is of the view that Binske has pioneered the premium medical and recreational markets in the United States through its meticulous focus on standards, quality, and consistency. Laudedfor its proprietary strains, craft ingredients, full product suite of nearly 200 offerings, and best-in-class packaging, "Binske" offers luxury, artisan-quality products using purposefully sourced ingredients that have earned widespread recognition, making it one of the largest and most recognizable brands in the American market. The "Binske" brand has won numerous cannabis related awards including Leafly's Best Overall Brand, Best Edibles and Best Concentrates. The Company considers Binske's sophisticated product offerings, coupled with their innovative brand identity, to set them apart from the rest of the marketplace." The Agreement brings these products exclusively to Intercure's Israeli hub to manufacture and distribute all "Binske" Branded Products under EU-GMP standards, exclusively to the international pharmaceutical space. As part of the Agreement, Binske will provide the Company access to its intellectual property, including genetics, formulations and know-how for cultivation and manufacturing of Binske-branded cannabis products at the Company's facilities. In addition, "Binske" will provide InterCure with IP relating to extraction formulations and the production of downstream products developed by "Binske", and will support InterCure's team with training of manufacturing and cultivation methods that are tailored for Binske's exacting standards. Under the terms of the Agreement, InterCure will produce and distribute the Branded Products leveraging its international supply chain using the Company's medical cannabis-dedicated pharmacy chain. During the 7.5-year term of the Agreement, the same lines of core "Binske" Branded Products launched in North America will be manufactured and distributed exclusively by InterCure in the territories stipulated in the Agreement.

08:39 EST Consumer Portfolio announces new automotive financing platform enhancements - Consumer Portfolio Services has closed out the year with three major partnerships to improve efficiencies, dramatically reduce funding time, and offer more payment options for borrowers. The company has chosen Informed.IQ to automatically calculate income, collect and clear credit stipulations and dealer docs, creating a better dealer and consumer experience throughout the auto lending process. CPS expects Informed.IQ's AI tools to significantly reduce the funding time. For decades, CPS has focused on bringing improved intelligence to auto lending, becoming a leader in FinTech initiatives that enhance the front-end review and financial decision-making process. Now, CPS is also helping automate the backend servicing experiences and has partnered with Prodigal to better manage the collections and servicing workforce and process. For a customer standpoint, CPS named PayNearMe as its primary payments partner. This partnership will accelerate the auto lender's digital transformation and deliver a frictionless customer experience across all digital payment types. PayNearMe will eliminate onsite cash payments, dramatically reduce the number of customers who pay by check and transition the majority of customers to electronic payments through greater pay options.

08:37 EST Quantum Computing launches Dirac-1 Dedicated Subscription service - Quantum Computing has launched the Dirac-1 Dedicated Subscription service, which provides enterprises with limitless access to one of the company's industry-leading Dirac-1 Entropy Quantum Computing systems for their exclusive use. The Dirac-1 10K Qubit EQC binary system takes a different computational approach to existing quantum computing providers and can solve business problems with 10,000 variables. Subscribers are connected via the internet to a photonics-based, room temperature quantum computer in QCI's quantum solutions center.

08:36 EST AMC Entertainment says 'Avatar: The Way of Water' outpaces weekend in 2019 - AMC Theatres announced that based on the strength of premium formats, and a desire by moviegoers to return to Pandora via "Avatar: The Way of Water," the Company finished materially ahead on U.S. and global admissions revenue and food & beverage revenue versus the same weekend in pre-pandemic 2019, which was led by the opening of Jumanji: The Next Level. Tickets for "Avatar: The Way of Water" sold in RealD 3D and Premium Large Formats like Dolby Cinema at AMC, IMAX at AMC, and PRIME at AMC made up more than 70% of all box office gross to the movie at AMC. Overseas, the movie played strong all weekend, but particularly on Saturday, when Saturday, AMC's ODEON Cinemas enjoyed its highest admissions revenue and food & beverage revenue for a single day in 2022. AMC chairman and CEO Adam Aron commented: "At AMC, we're greatly encouraged to see our revenues soar on the opening weekend of AVATAR: THE WAY OF WATER. James Cameron has done it again with a masterpiece of a film that generated revenues at AMC and ODEON Cinemas that were materially ahead of pre-pandemic 2019. AVATAR: THE WAY OF WATER demands to be seen on the biggest screens, with the loudest sounds in the most comfortable seats imaginable. Not only that, but I'd recommend seeing it in one of our premium formats like IMAX at AMC, Dolby at AMC or PRIME at AMC, Laser at AMC, and seeing it in the visually stunning 3D. The film is unlike anything I've ever experienced. All of us at AMC and Odeon extend our eternal thanks to James Cameron for the brilliance of his vision, and to all our friends at Disney for their tireless efforts to make this remarkable and immersive film. I've already seen it twice this past weekend, and I can't wait to go see it again."

08:34 EST Albireo Pharma submits regulatory filings to FDA, EMA for Bylvay in ALGS - Albireo Pharma announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration and a variation application to the European Medicines Agency seeking approval for a second Bylvay indication for use in patients with Alagille syndrome in the second half of 2023. A potent, once-daily, non-systemic ileal bile acid transport inhibitor, Bylvay has minimal systemic exposure and acts locally in the small intestine. Bylvay is already approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of progressive familial intrahepatic cholestasis, and in Europe for the treatment of all types of PFIC in patients aged 6 months or older. Positive data from the Phase 3 ASSERT study recently presented at the 2022 AASLD The Liver Meeting demonstrated that Bylvay provided early, rapid, clinically meaningful and sustained improvements in pruritus, as well as significant reductions in bile acids and improvements in sleep quality across the two most prominent genetic types in Alagille syndrome, JAG1 and NOTCH2, and in a wider age range of ALGS patients. Over 90% of patients were pruritus responders and Bylvay was generally well tolerated; the overall incidence of treatment emergent adverse events was similar to placebo. No patients discontinued the study and 96% of patients rolled over into the open-label extension study. In the U.S., Bylvay received orphan exclusivity for the treatment of pruritus in PFIC and Orphan Drug Designations for the treatment of ALGS, biliary atresia and primary biliary cholangitis. In Europe, Bylvay received orphan exclusivity for the treatment of PFIC and Orphan Drug Designations for the treatment of ALGS, biliary atresia and primary biliary cholangitis. With completed submissions for Bylvay in the U.S. and EU for use in patients with ALGS, the Company anticipates approvals in the second half of 2023. Bylvay is also being evaluated in the Phase 3 BOLD study in biliary atresia, a global gold standard pivotal trial that enrolled 205 patients. Topline results are expected to be available by the end of 2024.

08:34 EST Recon Technology awarded new contract in China - Recon Technology announced that a mainland China variable interest entity's subsidiary, Beijing BHD Petroleum Technology Co., Ltd. was awarded a new $0.19M contract to provide gas flares for oil and gas fields operated by a leading China oil and gas company in the Northwestern Qinghai province. In total, Beijing BHD has generated $1.22M in revenue from awarded bids and contracts for heating furnaces and related accessories since July 2022.

08:25 EST Ensysce Biosciences announces data from PF614-MPAR-101 Part A trial - Ensysce Biosciences announced data demonstrating the overdose protection of its drug product, PF614-MPAR from the clinical study being conducted in Healthy Subjects by Dr. Maria Bermudez MD, at Quotient Sciences, Miami, Florida. PF614-MPAR is designed to provide optimal pain relief at prescribed doses. Accidental or intentional overdose is limited by the overdose protection built into each capsule with the addition of Ensysce's formulated nafamostat ingredient. With MPAR technology, one or two PF614-MPAR capsules taken as prescribed will release the expected concentration of oxycodone required to provide pain relief as intended. However, when three or more capsules are taken, the increased exposure to nafamostat inhibits the trypsin-mediated release of oxycodone from the excess PF614 ingested, allowing the inactive parent drug to pass through the body unmodified. The recently completed Part A of the trial allowed the optimization of the nafamostat formulation by evaluating the PF614/nafamostat combination for both release rate and ratio of the combination. Data from the trial was able to show that in healthy subjects we could deliver oxycodone similarly with PF614 and PF614-MPAR, which was the goal of the study. Additionally, and as anticipated, the results of the study demonstrated that a large overdose of PF614-MPAR would result in diminished oxycodone release and uptake as compared to an equivalent amount of an unprotected opioid. In early 2023, the final formulation selected from this study will be evaluated as increasing dose units of PF614-MPAR in a group of healthy subjects in Part B of the study. MPAR is designed to prevent drug overdose by inhibiting the activation and release of opioid when more than prescribed doses are taken. PF614 is a TAAP prodrug of oxycodone designed to reduce abuse of this opioid pain medication. TAAP chemical modification inactivates the active ingredient in Ensysce's products until they are swallowed and exposed to a digestive enzyme, trypsin. PF614 requires exposure to trypsin, which safely turns 'on' the release of oxycodone. The PF614-MPAR has additional protection of an added trypsin inhibitor, nafamostat, to turn 'off' the release of oxycodone in an overdose situation. The MPAR combination technology of a TAAP prodrug and a trypsin inhibitor is the first platform that the Company expects may prevent all four common methods of opioid abuse - chewing, inhaling, injecting and oral overdose.

08:22 EST Soleno Therapeutics announces financing commitment for up to $60M - Soleno Therapeutics announced it has entered into a Securities Purchase Agreement with Nantahala Capital Management, LLC, Abingworth LLP and Vivo Capital, LLC for up to $60M. Under the terms of the agreement, the investors have committed to pay $10M in exchange for warrants to purchase common stock upon the Company's announcement of enrollment completion in the randomized withdrawal period of Study C602, anticipated in Q1 2023. The warrants consist of two tranches. Tranche A warrants to purchase up to 8,598,870 shares of common stock at $1.75 for a total of approximately $15M are required to be exercised within 30 days of announcement of top-line data from the randomized withdrawal period of Study C602. Tranche B warrants to purchase up to 14,000,000 shares of common stock at $2.50 for a total of $35M expire upon the earlier of 3.5 years from the date of issuance and 30 days following receipt of U.S. Food and Drug Administration approval of DCCR for the treatment of PWS. The total possible proceeds raised under this agreement is $60M for the issuance of 22.6M shares at an average price of $2.65 per share, which represents a substantial premium over the December 16, 2022, closing price of $0.91. The randomized withdrawal period of Study C602 is a multi-center, randomized, double-blind, placebo-controlled study of DCCR in approximately 80 patients with PWS at 17 sites in the U.S. and 5 sites in the U.K. The randomized withdrawal period consists only of patients currently enrolled in Study C602. Patients are randomized to receive either DCCR or placebo for a period of four months.

08:18 EST SomaLogic offers 7,000-plex SomaScan platform as Japan's first SomaLogic site - SomaLogic announced that Tokyo-based FonesLife Corporation, will be the first SomaLogic Certified Site in Japan. The new site will offer the 7,000-plex SomaScan(R) Assay in their labs and provide SomaScan data to their customers. By becoming a SomaLogic Certified Site, FonesLife can now run assays on SomaLogic's SomaScan Platform-the largest commercially available proteomic platform-and accelerate their own research and provide additional opportunities to utilize the industry-leading platform in the Asia-Pacific region. The SomaLogic Certified Site program gives labs and institutions-including academia and contract research organizations-access to the SomaScan Assay, with more than 7,000 protein measurements per sample and up to 90 samples per assay kit. SOMAmer reagents have been optimized for specificity with specific binding to target epitopes with coefficients of variation of approximately 5 percent, versus polyclonal antibodies that can result in non-specific binding, with CVs as high as 25 percent. "The Certified Sites program allows us to expand the availability of our platform to labs and institutions around the world," said Executive Vice President of SomaLogic's Life Sciences business, Adam Taich. "Japan is a rapidly growing market for translational work in life sciences and clinical research and we are excited about this opportunity to deepen our long partnership with FonesLife."

08:16 EST Zscaler becomes member of JCDC to enhance U.S. cybersecurity position - Zscaler announced its membership in the Joint Cyber Defense Collaborative, JCDC, underscoring the company's commitment to improving the nation's cyber resiliency. JCDC, established by the Cybersecurity and Infrastructure Security Agency, CISA, in 2021, leads the development and implementation of joint cyber defense plans and operations through critical partnerships with the private sector, Federal government and state, local, tribal and territorial governments. Zscaler will work with JCDC to enhance the collective cybersecurity posture of the United States and strategic international partners. As the operator of the world's largest in-line security cloud, Zscaler and the Zscaler ThreatLabz research team will analyze unique threat telemetry from 270+ billion transactions and 250,000 cloud updates per day - securing users globally. Additionally, Zscaler will participate in future cyber strategy planning with JCDC and its members. "We founded Zscaler with the vision to create a modern cloud-native architecture for the seamless and secure exchange of information," said Jay Chaudhry, CEO, chairman and founder of Zscaler. "Today, digital transformation has accelerated organizations' move to cloud-based SaaS models and the internet is now the new corporate network -- rendering 30 years of networking and security principles ineffective. We are honored to be working with JCDC to leverage the threat intelligence in Zscaler's zero trust platform to help stop large-scale cyberattacks, prevent data exfiltration, and block debilitating ransomware attempts."

08:15 EST Kratos Defense receivs $13M potential value single award contract - Kratos Defense & Security Solutions announced that it has recently received an approximate $13M potential value, Single Award Contract for electronic warfare related system products and solutions. The contract is expected to be incrementally funded over the relative periods of performance. Work under this program award will be performed at secure Kratos engineering and production facilities. Due to competitive, security related and other considerations, no additional information will be provided related to this contract award.

08:15 EST Fortress Biotech appoints Lu to board of directors - Fortress Biotech (FBIO) announced that Lucy Lu, M.D., has been appointed to its Board of Directors. Dr. Lu is an accomplished executive with over 20 years of experience in a wide range of financial and drug development matters in the biotech and healthcare sectors as an investment banker, equity research analyst and executive at several biotech companies. Since April of 2022, Dr. Lu has served as Chief Operating Officer of Innovative Cellular Therapeutics. Additionally, she is currently a member of the Board of Directors of Inventiva (IVA).

08:13 EST ProSomnus enrolls first patient in study on efficacy, safety of ProSomnus EVO - ProSomnu announced the enrollment of the first patient in its Severe Obstructive Sleep Apnea, SOS, study. The SOS study is a prospective, FDA-reviewed, multi-center, single-arm study evaluating the safety and efficacy of precision oral appliance therapy with the ProSomnus EVO Sleep and Snore device in individuals with severe OSA. ProSomnus intends to use data from the SOS study to apply for an expanded indication for use with the FDA. If successful, the ProSomnus EVO would be the first intraoral medical device cleared for the treatment of patients with Severe OSA. Efficacy and safety are the two primary endpoints for the study. Researchers in the study will assess the ProSomnus EVO's efficacy by measuring participants' apnea-hypopnea index and oxygen desaturation indeDI) six months after initiation of precision OAT. Participants in the study will receive a custom ProSomnus EVO and be tested using a Type II home sleep apnea test to determine if they have achieved an AHI of less than 15 h-1 with the device in place. Researchers will administer HSATs at predetermined intervals. To determine the ProSomnus EVO's efficacy, participants will complete a set device advancement and testing protocol and a final HSAT six months after precision OAT begins. During each visit after precision OAT begins, researchers will conduct safety evaluations which, along with dental examinations and adverse event reports, will be used to determine the ProSomnus EVO's safety. After collecting data for the study's primary endpoints for six months after precision OAT begins, researchers will monitor participants for six more months.

08:11 EST Dr. Reddy's tocilizumab biosimilar candidate met endpoints in Phase 1 study - Dr. Reddy's Laboratories announced that its tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary endpoints in a Phase 1 study. This Phase 1 study used a subcutaneous formulation to evaluate the pharmacokinetic equivalence, safety and immunogenicity of Dr. Reddy's tocilizumab biosimilar candidate in comparison to reference products. The Phase 1 study entitled 'A Single Dose, Double-Blind, Two-Period, Crossover, Comparative Pharmacokinetic Study of Three Tocilizumab Products Administered by the Subcutaneous Route to Normal Healthy Volunteers' met all primary and secondary endpoints. Pharmacokinetic equivalence of DRL_TC to the EU reference medicinal product* and the U.S. reference product** was successfully demonstrated. The clinical trial also confirmed the similarity between DRL_TC and the EU* and U.S.** reference products in terms of pharmacodynamic parameters and found no noteworthy differences in safety and immunogenicity across these three treatment groups. The successful outcome of this study represents an important milestone in Dr. Reddy's commitment to making high-quality biosimilar products more accessible and affordable to healthcare providers and patients around the world. Dr. Reddy's is developing the proposed tocilizumab biosimilar as both subcutaneous and intravenous formulations.

08:10 EST Cocrystal reports safety, tolerability results from Phase 1 study of CC-42344 - Cocrystal Pharma announces highly favorable safety and tolerability results for its orally administered replication inhibitor CC-42344 in its Phase 1 study. CC-42344 is a broad-spectrum antiviral for the treatment of pandemic and seasonal influenza A with a novel mechanism of action. The randomized, double-controlled Phase 1 study was conducted in Australia to evaluate the safety, tolerability and pharmacokinetics of CC-42344 given orally at single doses up to 800 mg and daily doses up to 14 days in 56 healthy volunteers. Approximately 50% of the participants who received a single dose of CC-42344 across all dose levels experienced adverse events, similar to the proportion of placebo subjects who also experienced adverse events. In the multiple-dose section of the study, the incidence of adverse events was 67% for both CC-42344 and placebo. The vast majority of adverse events were mild in severity. The most frequently reported adverse event was headache, which occurred at similar rates in CC-42344-treated and placebo-treated participants. There were no serious adverse events or drug discontinuation due to adverse events. Cocrystal plans to apply to the United Kingdom Medicines and Healthcare Products Regulatory Agency to conduct a Phase 2a human challenge study in early 2023. Subject to regulatory clearance, the study is expected to be initiated in the second half of 2023. "On average about 8 percent of the U.S. population contracts influenza each season according to the Centers for Disease Control and Prevention. In addition to the health risk, influenza is responsible for approximately $10.4 billion in direct costs for hospitalizations and outpatient visits in the U.S. annually. We are highly focused on advancing CC-42344 through the clinical process and toward making a meaningful contribution to improving health and reducing the cost of care," said James Martin, Cocrystal's CFO and interim Co-CEO.

08:08 EST Terex announces new $150M share repurchase program - Terex announced that its Board of Directors authorized a new share repurchase program of up to $150M. The new authorization is in addition to the share repurchase program announced in July 2018, under which the company has approximately $43M remaining.

08:08 EST Black Diamond Therapeutics announces changes to board of directors - Black Diamond Therapeutics, (BDTX) announced that Chairman of the Board of Directors, Robert Ingram, has stepped down due to personal reasons. Existing Board member, Mark Velleca, M.D., Ph.D., has been appointed to succeed Ingram as the next Chairman. Dr. Mark Velleca has been a member of our Board since August 2021. Dr Velleca is currently the CEO of StrideBio, a gene therapy company. Previously, Mark served as CEO of G1 Therapeutics (GTHX) until 2021y.

08:07 EST Voyager Digital announces agreement for Binance.US to acquire its assets - Voyager Digital announced that its operating company Voyager Digital LLC selected U.S. exchange BAM Trading Services as the highest and best bid for its assets after a review of strategic options with the core objective of maximizing the value returned to customers and other creditors on an expedited timeframe. Binance.US is headquartered in Palo Alto, CA, and is incorporated in Delaware. It is an independent legal entity and has a licensing agreement with Binance.com. The Binance.US bid, which sets a clear path forward for Voyager customer funds to be unlocked as soon as possible, is valued at approximately $1.022 billion and is comprised of (i) the fair market value of Voyager's cryptocurrency portfolio at a to-be-determined date in the future, which at current market prices is estimated to be $1.002 billion, plus (ii) additional consideration equal to $20 million of incremental value. The company's claims against Three Arrows Capital remain with the bankruptcy estate, and any future recovery on these and other non-released claims will be distributed to the estate's creditors. The Binance.US bid aims to return crypto to customers in kind, in accordance with court-approved disbursements and platform capabilities. Binance.US will make a $10 million good faith deposit and will reimburse Voyager for certain expenses up to a maximum of $15 million. Should the deal not close by April 18, 2023 subject to a one-month extension, the agreement allows Voyager to immediately move to return value to customers. Voyager Digital LLC will seek Bankruptcy Court approval to enter into the asset purchase agreement between Voyager Digital LLC and Binance.US at a hearing on January 5, 2023. The sale to Binance.US will be consummated pursuant to a Chapter 11 plan, which will be subject to a creditor vote and is subject to other customary closing conditions. Binance.US and the Company will work to close the transaction promptly following approval of the chapter 11 plan by the Bankruptcy Court.

08:06 EST Immix Biopharma ships Tislelizumab for patient dosing in trial with IMX-110 - Immix Biopharma announced that it has shipped Good Manufacturing Practice, GMP, manufactured batches of Tislelizumab for clinical trial patient dosing. Tislelizumab, Beigene/Novartis anti-PD-1 antibody, will be combined with IMX-110 in a clinical trial for patients with advanced solid tumors. GMP manufactured IMX-110 was already released and shipped on December 12, 2022. "Having shipped both IMX-110 and Tislelizumab to sites completes drug supply preparations and puts us on a launching pad for this exciting combination clinical trial," said Ilya Rachman, MD PhD, CEO of ImmixBio. "We expect to begin reporting clinical data from this trial beginning in Q1 2023."

08:04 EST Vaxart names Phillip Lee as Chief Financial Officer - Vaxart announced that it has appointed Phillip Lee as its Chief Financial Officer, CFO, effective immediately. Most recently, Lee was CFO and Chief Operating Officer at Clover Biopharmaceuticals and prior to that held finance leadership positions at several biotechnology companies.

08:04 EST The Oncology Institute expands into Chino, California - The Oncology Institute has acquired the Chino, CA practice of Dr. Labib Hashimi. The acquisition enhances TOI's geographic coverage in California, with the Chino practice marking TOI's 42nd clinic in the Golden State. This expansion comes in response to the continued strong demand for TOI's differentiated care model which focuses on quality clinical outcomes, access for underserved populations, and value for the healthcare ecosystem.

08:03 EST Avita Medical submits FDA PMA application to expand indication of Vitiligo - AVITA Medical announced today the submission of a Premarket Approval, PMA, application to the U.S. Food and Drug Administration, FDA, for its RECELL System. The application, if approved, will expand the indication of RECELL to include the treatment of stable vitiligo. "We are pleased to take the next step towards expanding the clinical application of RECELL into a treatment for vitiligo," said Jim Corbett, AVITA Medical Chief Executive Officer. "RECELL offers first-in-class repigmentation of vitiligo lesions through the transplantation of melanocytes. Once approved, this indication will dramatically expand our reach in a huge market with limited treatment options. We anticipate a full launch of this treatment option in January 2025." This PMA application includes the recently released results of the pivotal trial for vitiligo. The study achieved its primary effectiveness endpoint of super-superiority. The study compared repigmentation success rates in treating patients with segmental and non-segmental stable vitiligo. The RECELL System earned FDA Breakthrough Device designation for its proposed indication of vitiligo. Under the program, AVITA Medical will receive prioritized review and interactive communication with the FDA throughout the premarket review phase. The standard FDA review timeline for a PMA application is 180 days.

08:02 EST Arcutis Biotherapeutics submits sNDA application to FDA for ZORYVE - Arcutis Biotherapeutics announced the submission of a supplemental new drug application, sNDA, to the U.S. Food and Drug Administration, FDA, for the expanded indication of ZORYVE cream 0.3% for the treatment of plaque psoriasis in children ages 2 to 11. As with adults and adolescents, plaque psoriasas is the most common form of psoriasis in children 2 to 11 years of age, with very similar clinical features. ZORYVE was approved by the FDA in July 2022 for the topical treatment of plaque psoriasis in adults and adolescents 12 years of age and older. "Safety and tolerability are critically important in the treatment of children, and today young children lack treatment options for plaque psoriasis. This submission is an exciting step in our efforts to expand the availability of an effective, steroid-free treatment for children with plaque psoriasis," said Patrick Burnett, MD, PhD, FAAD, Chief Medical Officer at Arcutis. "ZORYVE is the first PDE4 approved for the treatment of psoriasis and, if approved by the FDA with the new data, dermatology clinicians will be able to treat patients down to 2 years of age."

07:49 EST Bioasis amends arrangement agreement with Midatech Pharma - BIOASIS TECHNOLOGIES announced the following amendments to the terms of the previously announcement arrangement agreement with Midatech Pharma: Midatech is no longer required to seek delisting from AIM following completion of the arrangement; and the $750,000 bridge loan to be provided by Midatech to Bioasis will now be advanced in three equal tranches of $250,000 instead of the entire amount being advanced immediately, as previously contemplated.

07:42 EST Biohaven treatment of spinal muscular atrophy granted orphan designation - On December 16, Biohaven Pharmaceuticals' Taldefgrobep Alfa was granted orphan designation as a treatment of spinal muscular atrophy, according to a post to the FDA's website. Reference Link

07:41 EST Wave Life Sciences announces update from PoC study of WVE-N531 - Wave Life Sciences announced an update from the initial cohort of the Phase 1b/2a proof-of-concept study of WVE-N531 in three boys with Duchenne muscular dystrophy amenable to exon 53 skipping. High muscle concentrations of WVE-N531 and exon skipping were observed six weeks after initiating biweekly multidosing at 10 mg/kg, achieving proof-of-concept in the study. WVE-N531 also appeared safe and well-tolerated. "These data provide early evidence that WVE-N531 is working as intended, leading to substantial exon skipping after just three consecutive doses. This is the earliest timepoint at which exon skipping has been reported in a clinical trial of boys with DMD," said Anne-Marie Li-Kwai-Cheung, CDO. "While dystrophin was below the lower limit of detection, it is expected that dystrophin protein production would lag splicing of the RNA transcript. We are encouraged by these early results and are evaluating next steps for the program, including the continuation of this initial cohort. We would like to express our sincerest gratitude to the boys, their families, and the investigators who participated in the study." Three ambulatory boys participated in this open-label, intra-patient dose escalation clinical trial. The boys received single escalating doses of 1, 3, 6 and 10 mg/kg; and in the multidose portion of the study, the same boys received three doses of 10 mg/kg every other week. A muscle biopsy was taken two weeks after the third and final dose. Results included: WVE-N531 resulted in a mean tissue concentration of 42 micrograms/gram; RNAscope results indicated WVE-N531 is reaching the nucleus in muscle cells; WVE-N531 resulted in mean exon skipping of 53% as measured by RT-PCR; Mean dystrophin production was 0.27% of normal as measured by Western blot, which was below the level of quantification; Plasma concentrations and other pharmacokinetic parameters following a single dose of 10 mg/kg demonstrate a half-life of 25 days, which may support monthly dosing; Adverse events were all mild, except for a COVID-19 infection of moderate intensity. There were no serious adverse events, no trends in labs, and no oligonucleotide class-related safety events.

07:38 EST AstraZeneca says PEARL trial didn't achieve statistical significance on endpoint - The PEARL Phase III trial for AstraZeneca's Imfinzi did not achieve statistical significance for the primary endpoints of improving overall survival versus platinum-based chemotherapy as a monotherapy treatment of patients with Stage IV non-small cell lung cancer, or NSCLC, whose tumor cells express high levels of PD-L1, or in a subgroup of patients at low risk of early mortality, the company announced. "There was an improvement in OS with Imfinzi monotherapy, which was clinically meaningful in the subset of patients with PD-L1 tumor expression greater than 50%, a secondary endpoint. The trial was conducted primarily in Asia," the company added. Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "With PEARL, we set out to answer important scientific questions in the treatment of metastatic non-small cell lung cancer at a time when patient selection for immune checkpoint inhibitors was still evolving. We are encouraged to see patients in the metastatic setting at a higher level of PD-L1 tumour expression demonstrate the most benefit with Imfinzi monotherapy treatment, as is commonly seen in this class. We remain steadfast in our dedication to developing new and improved medicines and regimens for patients with lung cancer across our diverse portfolio." The company stated: "The safety and tolerability profile for Imfinzi was broadly consistent with the known profile of the medicine, and no new safety signals were identified. The data will be shared in due course."

07:37 EST ProPetro Holding appoints John Mitchell as General Counsel - ProPetro Holding announced the appointment of John J. Mitchell as General Counsel and Corporate Secretary, effective January 1. Mr. Mitchell, who currently serves as Vice President and Deputy General Counsel of ProPetro, will succeed Newton W. Wilson III, who will retire, effective December 31. Sam Sledge, ProPetro Chief Executive Officer, said, "We are pleased to announce Jody's appointment as ProPetro's next General Counsel. Jody has quickly become a valuable member of the ProPetro leadership team with his significant legal expertise, commercial acumen, leadership capabilities, and well-rounded experience in our industry. I'm excited to continue working alongside Jody as we focus on executing our strategy and delivering value to our shareholders."

07:36 EST Enghouse to acquire Qumu in all cash transaction - Qumu and Enghouse Systems jointly announced the execution of a merger agreement by which Enghouse will acquire Qumu. Under the terms of the agreement, which has been approved unanimously by the board of directors of both companies, a newly formed wholly-owned subsidiary of Enghouse will commence a tender offer for all outstanding shares of Qumu for 90c per share in cash, for a total equity value of approximately $18M. The purchase price of 90c per share represents a premium of approximately 105% over the 44c per share closing price of Qumu common stock on December 16. Under the merger agreement, a wholly-owned subsidiary of Enghouse will commence a tender offer for all the shares of common stock of Qumu followed by a merger to acquire any untendered shares, all at the price of US$0.90 per share in cash. The tender offer and the merger are subject to certain customary and other closing conditions. The merger agreement transaction is expected to be closed in February 2023. The Qumu board of directors, executive officers and certain shareholders, have entered into a tender and support agreement with Enghouse committing to tender all of their Qumu shares in the tender offer. "The Qumu board is committed to maximizing shareholder value and has unanimously approved the transaction with Enghouse," said Neil Cox, Chairman, Qumu board of directors. "We believe this transaction will deliver excellent value to our shareholders."

07:35 EST Paratek Pharmaceuticals announces data from pilot efficacy study on NUZYRA - Paratek Pharmaceuticals announced positive top line data from a pilot rabbit efficacy study evaluating NUZYRA's effectiveness in the treatment of pulmonary anthrax. In the study, a 100% survival rate was observed in omadacycline-treated rabbits at the specified endpoint of 35-45 days post Bacillus anthracis challenge, while all rabbits treated with placebo died due to anthrax infection within three days. Positive top line data from this study triggered the second procurement under the Company's Project BioShield Contract with Biomedical Advanced Research and Development Authority, part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. Accordingly, Paratek has delivered 2,500 treatment courses of NUZYRA to BARDA. The acceptance of this procurement allows the Company to recognize $38.1 million in revenue, comprised of $36.4 million from BARDA and approximately $1.7 million in deferred revenue related to postmarketing commitments under the Project BioShield contract. "This positive top line data represents further validation of NUZYRA's potential to treat pulmonary anthrax as well as the continued commitment by BARDA to our ongoing partnership," said Randy Brenner, chief development and regulatory officer, Paratek. "We believe that NUZYRA is well-positioned to help address potential public health emergencies, including biothreats and pandemics."

07:33 EST Soligenix initiates Phase 2 clinical trial of SGX302 - Soligenix announced that patient enrollment has been opened for its Phase 2a study evaluating SGX302 in the treatment of mild-to-moderate psoriasis.

07:32 EST Biogen reaches agreement with Genentech related to glofitamab commercialization - Biogen Inc. (Nasdaq: BIIB) announced that it has reached an agreement with Genentech, a member of the Roche (RHHBY), related to the commercialization and sharing of economics for glofitamab. Under the terms of the agreement, Biogen will have no payment obligations and will receive tiered royalties on potential net sales of glofitamab within the United States as part of the companies long-standing collaboration on antibodies targeting CD20. Glofitamab is an investigational CD20xCD3 T-cell engaging bispecific antibody being developed by Roche for the treatment of B-cell non-Hodgkin's lymphomas, including diffuse large B-cell lymphoma, mantle cell lymphoma, and other blood cancers. Data from the Phase II NP30179 study investigating glofitamab in patients with relapsed/refractory DLBCL have been submitted for review to the European Medicines Agency, and submissions to additional health authorities worldwide, including the U.S. Food and Drug Administration, are ongoing. If approved, glofitamab has the potential to be a first-in-class fixed-duration CD20xCD3 T-cell engaging bispecific antibody in DLBCL. Genentech will have sole decision-making rights on the commercialization of glofitamab within the United States and, in the event of approval, Biogen is eligible to receive tiered royalties in the mid-single digits range on potential net sales of glofitamab within the United States.

07:31 EST Equifax offers to acquire Boa Vista Servicos in Brazil for R$8.00 per share - Equifax has made an offer to the Boa Vista Servicos Board of Directors to acquire all outstanding shares of Boa Vista Servicos, the second largest consumer credit bureau in Brazil, for R$8.00 per share, implying an estimated total enterprise value of $583M based on a USD/BRL exchange rate of 5.3180. If accepted, this proposal would deliver compelling value to Boa Vista Servicos shareholders by providing immediate liquidity, a substantial 89% premium over the closing price on December 15, 2022, and an opportunity to exchange part of their Boa Vista Servicos stake into a globally diversified Equifax stock. This acquisition would expand Equifax capabilities in the large and fast-growing Brazilian market and would offer Boa Vista Servicos access to Equifax's expansive global capabilities and cloud-native data, products, decisioning and analytical technology for the rapid development of new products and services, and expansion into new vertical industries. The transaction is subject to review and approval by the Boa Vista Servicos Board of Directors. If approved by the Boa Vista Servicos Board of Directors, the transaction would be subject to Boa Vista Servicos shareholder approval and other customary closing conditions. Following the completion of the proposed transaction, Boa Vista Servicos would become a subsidiary of Equifax Brasil.

07:27 EST AstraZeneca reports Forxiga recommended for extend indication in EU by CHMP - AstraZeneca's Forxiga has been recommended for approval in the European Union to extend the indication for heart failure with reduced ejection fraction, or HFrEF, to cover patients across the full spectrum of left ventricular ejection fraction, or LVEF, including HF with mildly reduced and preserved ejection fraction, or HFmrEF and HFpEF, the company announced.

07:22 EST Enghouse to acquire Qumu for 90c per share, or $18M - Qumu and Enghouse Systems, a global provider of enterprise software solutions serving certain enterprise vertical markets, jointly announced the execution of a merger agreement by which Enghouse will acquire Qumu. Under the terms of the agreement, which has been approved unanimously by the board of directors of both companies, a newly formed wholly-owned subsidiary of Enghouse will commence a tender offer for all outstanding shares of Qumu for 90c per share in cash, for a total equity value of approximately $18M. The purchase price of 90c per share represents a premium of approximately 105% over the 44c per share closing price of Qumu common stock on December 16, 2022. Under the merger agreement, a wholly-owned subsidiary of Enghouse will commence a tender offer for all the shares of common stock of Qumu followed by a merger to acquire any untendered shares, all at the price of 90c per share in cash. The tender offer and the merger are subject to certain customary and other closing conditions. The merger agreement transaction is expected to be closed in February 2023. The Qumu board of directors, executive officers and certain shareholders, have entered into a tender and support agreement with Enghouse committing to tender all of their Qumu shares in the tender offer.

07:20 EST Freshii to be acquired by Foodtastic for $2.30 per share in cash - Freshii announced that it has entered into an arrangement agreement pursuant to which Foodtastic Inc. will acquire all of the issued and outstanding shares of Freshii for $2.30 per share in cash, representing total consideration of approximately $74.4M on a fully diluted basis. The consideration represents a 148% premium to the 20-day volume-weighted average price per share for the period ending on December 16, 2022, and a 142% premium to the closing price on December 16, 2022. The transaction will be implemented by way of a statutory plan of arrangement under the Business Corporations Act and is expected to close in the first quarter of 2023, subject to receipt of shareholder and court approvals and certain other customary closing conditions. Completion of the transaction is not subject to a financing condition. The transaction resulted from a process overseen by a special committee of independent directors of Freshii. The Board, on the unanimous recommendation of the Special Committee and in consultation with its financial and legal advisors, unanimously determined that the Arrangement is fair to Freshii shareholders and is in the best interests of Freshii, and resolved to recommend that Freshii shareholders vote in favour of the Arrangement. In connection with such determinations and resolutions, the Special Committee and the Board received an opinion from CIBC Capital Markets to the effect that, as of December 18, 2022, the consideration to be received by the holders of Freshii shares is fair, from a financial point of view, to such holders, subject to the limitations, qualifications, assumptions and other matters set forth in such opinion. The Special Committee and the Board also received an independent fairness opinion from Fort Capital Partners, on a fixed-fee basis, as to the fairness of the consideration to be received by the holders of the Class A subordinate voting shares from a financial point of view as of that same date, and subject to the limitations, qualifications, assumptions and other matters set forth in Fort Capital Partners' opinion. Pursuant to the terms of the arrangement agreement, Foodtastic will acquire all of the Freshii shares for a purchase price of $2.30 per share in cash. All shareholders will be entitled to receive the same per-share Consideration under the Arrangement, regardless of class. The vesting of all outstanding but unvested restricted share units and performance share units will be accelerated, and these share units, together with the outstanding DSUs, will be acquired under the Arrangement at the same price per share. Completion of the Arrangement is not subject to any financing condition. The Arrangement will be subject to the approval of at least two-thirds of the votes cast by holders of all Freshii shares present in person or represented by proxy at the special meeting of Freshii shareholders to be called to consider the Arrangement, voting together as a single class. Because the Arrangement constitutes a "business combination" for purposes of Multilateral Instrument 61-101 Protection of Minority Shareholders, it will also be subject to the approval of a majority of the votes cast by holders of the Class A subordinate voting shares and Class B multiple voting shares, excluding the votes cast by shareholders that are required to be excluded from voting pursuant to MI 61-101. It is currently expected that only approximately 1.5% of the Class A subordinate voting shares will be excluded from voting, and that none of the Class B multiple voting shares would be excluded. Matthew Corrin, Freshii's founder and Executive Chair, together with each of Freshii's other directors and officers, have entered into voting support agreements pursuant to which they have each agreed, among other things, to vote all Freshii shares owned or controlled by them in favour of the Arrangement at the special meeting, in each case subject to the terms and conditions of their respective agreements. Mr. Corrin beneficially owns Class A subordinate voting shares and Class B multiple voting shares that together represent approximately 69.4% of the votes attaching to all issued and outstanding Freshii shares. The arrangement agreement includes certain non-solicitation covenants applicable to Freshii, subject to certain "fiduciary out" rights. Freshii has agreed to pay Foodtastic a termination fee of approximately $2.6M in the event that the arrangement agreement is terminated in certain circumstances. Freshii expects to call and hold a special meeting of shareholders late in the first quarter of 2023. The Arrangement is expected to close before the end of the quarter, subject to receipt of the required shareholder and court approvals and other customary closing conditions.

07:16 EST Else Nutrition announces investment for gross proceeds of up to $13.75M - Else Nutrition announce that the Company has entered into a definitive convertible security funding agreement with Lind Global Fund II. Under the terms of the Agreement, the Company will on closing issue an initial convertible security with a face value of $5,100,000, which would provide $4,133,125 in funds after deduction of the original issue discount and closing fees. On closing, the Initial Convertible Security will have a 36-month maturity date, and will be convertible into common shares of the Company after completion of a 120 day lock-up period. Lind will be able to convert 1/20th of the face value each month at a conversion price equal to 85% of the five-day volume weighted average price of the Shares immediately prior to each conversion, subject to a right to increase conversions in certain circumstances. The outstanding face value of the Initial Convertible Security, after 180 days, may be repaid in cash at the discretion of the Company, with a 5% premium. Following the Initial Convertible Security issuance, the Company would have the right to draw a further US$1,250,000, subject to the terms of the formal agreements, and thereafter an optional follow-on investment of up to US$6,500,000, upon mutual agreement, in exchange for the issuance of additional convertible notes.

07:14 EST Telesat Holdings appoints Harlow as President of Telesat Government Solutions - Telesat announced the appointment of Philip Harlow as President of Telesat Government Solutions, a U.S.-incorporated, wholly-owned subsidiary of Telesat that is focused on providing resilient and secure satellite solutions to the U.S. Government and allied nations. Harlow most recently was the President and CEO of DTC Communications. Harlow will replace Tom Eaton, who announced this past summer that he would be retiring from the company at the end of the year after serving as President of Telesat Government Solutions since October 2021.

07:12 EST Madrigal Pharmaceuticals announces results from Phase 3 MAESTRO-NASH trial - Madrigal Pharmaceuticals announced positive topline results from the pivotal Phase 3 MAESTRO-NASH biopsy clinical trial of resmetirom, a liver-directed selective thyroid hormone receptor agonist. MAESTRO-NASH, a registrational Phase 3 trial, has achieved both liver histological improvement endpoints that FDA proposed as reasonably likely to predict clinical benefit to support accelerated approval for the treatment NASH with liver fibrosis. MAESTRO-NASH Week 52 Results: MAESTRO-NASH is an ongoing blinded Phase 3 clinical trial, and enrolled patients continue on therapy after the Week 52 liver biopsy for up to a total of 54 months to accrue hepatic clinical outcome events including histologic conversion to cirrhosis and hepatic decompensation events. Efficacy Results: Patients meeting eligibility requirements for MAESTRO-NASH were randomized 1:1:1 to receive resmetirom 80 mg, resmetirom 100 mg, or placebo taken orally once daily. Baseline characteristics in the 966 randomized patients in the primary analysis NASH population were balanced across treatment arms. Medications included 49% on statins, 14% on GLP-1 agonists, 14% on SGLT2 inhibitors. A second biopsy was conducted after 52 weeks of treatment for assessment of the dual primary endpoints. The primary efficacy analysis assessed histological response at 52 weeks in 955 patients with biopsy-confirmed NASH with fibrosis that excluded 11 ITT patients who had their Week 52 biopsy after Week 60 due to COVID-related reasons per regulatory guidelines. Patients without a second biopsy due to early study discontinuation or missing liver biopsy were included and considered as non-responders in the primary efficacy analyses. The compliance to treatment was high and minimally impacted by COVID pandemic restrictions. Biopsy endpoints were achieved independent of baseline fibrosis stage or diabetes status, including similar statistical significance and magnitude of effect at both doses in subgroups of F2, F3, and F2/F3 patients. Other secondary liver biopsy endpoints that were achieved at both doses include greater than or equal to2 point reduction in NAS with no worsening of fibrosis, greater than or equal to2 point reduction in NAS with greater than or equal to1-stage improvement in fibrosis, NASH resolution with greater than or equal to1-stage improvement in fibrosis, and a 2-stage reduction in fibrosis without worsening of NAS. Multiple secondary endpoints were achieved, including statistically significant reduction from baseline in liver enzymes. Reductions in atherogenic lipids and lipoproteins, fibrosis biomarkers and imaging tests were observed in resmetirom treatment arms as compared with placebo. Safety Results: Resmetirom was safe and well-tolerated at both the 80 mg and 100 mg doses. The frequency of serious adverse events was similar across treatment arms: 11.8%, 12.7% and 12.1% for the 80 mg, 100 mg, and placebo groups, respectively. The rate of study discontinuation for adverse events was low: 2.8%, 7.7% and 3.7% for the 80 mg, 100 mg and placebo groups, respectively. SAEs occurred at expected rates based on the patient population.

07:09 EST Pfizer opts in to LianBio rights to RSV therapeutic candidate sisunatovir - Pfizer Inc. (PFE) and LianBio (LIAN0 announced that Pfizer opted in to the right to develop and commercialize sisunatovir, a respiratory syncytial virus therapeutic candidate, in Mainland China, Hong Kong, Macau, and Singapore pursuant to the companies' existing strategic collaboration to expand patient access to novel therapeutics in Greater China. Sisunatovir is an investigational, orally administered fusion inhibitor designed to block RSV replication by inhibiting F-mediated fusion with the host cell. Sisunatovir is being evaluated for the potential treatment of RSV infection in pediatric and adult patients. In June 2022, Pfizer acquired ReViral Ltd. and its portfolio of RSV therapeutic candidates with the exception of development and commercialization rights for sisunatovir in Mainland China, Hong Kong, Macau, and Singapore, which LianBio had previously in-licensed from ReViral in March 2021. Under the terms of Pfizer's opt-in to sisunatovir rights, LianBio will receive a $20 million upfront payment, to be released from previously restricted cash paid by Pfizer to LianBio in 2020 under the companies' existing strategic collaboration. Additionally, LianBio is eligible to receive up to $135 million in potential development and commercial milestone payments and tiered low single digit percent of sisunatovir net sales in the territories. Pfizer will assume all development and commercial activities and costs in the region and will release LianBio from its royalty and milestone obligations for sisunatovir.

07:08 EST Revolution Medicines announces publication on design, synthesis of RMC-5552 - Revolution Medicines announced publication of a manuscript in the Journal of Medicinal Chemistry that details the discovery efforts leading to RMC-5552, the company's first-in-class, bi-steric mTORC1-selective inhibitor. The manuscript describes the unprecedented compound profile that includes 40-fold selectivity for mTORC1 over mTORC2 and greater than 53-fold selectivity over other lipid kinases. The paper also shows that selective mTORC1 inhibition using the company's related preclinical tool compound in combination with a covalent KRASG12C inhibitor induced tumor regressions in a preclinical model of KRASG12C mutant non-small cell lung cancer that exhibits resistance to KRASG12C inhibitor monotherapy. "The Journal of Medicinal Chemistry manuscript details the sophisticated structure-based chemical design and synthesis employed by our drug discovery team that produced RMC-5552," said Steve Kelsey, M.D., president, research and development at Revolution Medicines. "The differentiated antitumor and tolerability profile of RMC-5552 in the preclinical setting compared to earlier mTORC inhibitors provides a strong rationale for evaluating it in patients with tumors that have abnormally high mTORC1 growth signaling, including in combination with our RAS Inhibitors in patients with tumors that have both RAS and mTORC1 pathway co-mutations."

07:06 EST Xortx Therapeutics announces completion of dosing in XRX-OXY-101 study - XORTX Therapeutics announces the completion of dosing in the XRX-OXY-101 pharmacokinetics bridging study. Dosing of XORTX's proprietary oral oxypurinol formulation, XORLOTM, in each of Part 1 through 4 included: Part 1 - Single dose pharmacokinetics; Part 2 - Single dose in food effect pharmacokinetics; Part 3 - Single dose proportionality pharmacokinetics; and Part 4 - Multi-dose pharmacokinetics in both fasted and fed state. Previously topline results from Part 1 and 2 have been reported in the Company's press releases of July 13 and August 22, 2022. Plasma sample analysis and topline results from both part 3 and part 4 are expected within the next several weeks. Consolidated topline results from each part are anticipated to be reported in January 2023. Dr. Allen Davidoff, CEO of XORTX stated, "We are pleased to have reached this key milestone regarding the development of the XRx-008 program for the treatment of autosomal dominant polycystic kidney disease. Much of the credit for the rapid advancement of the XRx-008 program can be attributed to the skill and experience of our Chemistry, Manufacturing and Controls group, and the Clinical and Regulatory teams who have worked meticulously to reach this point. The characterization of XORTX's proprietary oxypurinol formulation, XORLOTM, will provide key information for dose selection, guide population pharmacokinetic modeling, and importantly provide foundational information for partnering discussions and future FDA submissions for marketing approval of this XORLOTM product in ADPKD."

07:06 EST Zymeworks announces zanidatamab results from HERIZON-BTC-01 trial - Zymeworks announced positive topline results from the pivotal Phase 2b HERIZON-BTC-01 open-label, single-arm clinical trial investigating zanidatamab, a HER2-targeted bispecific antibody, as monotherapy in patients with previously treated HER2-amplified and expressing BTC. The positive topline results showed that 41.3% of enrolled patients with HER2-amplified and expressing disease achieved an objective response as assessed by independent central review. The median duration of response was 12.9 months . The safety profile of zanidatamab in this trial was consistent with that observed in previously reported monotherapy studies, with no new safety signals identified. Full results from the pivotal trial are expected to be presented at a medical meeting in 2023. The positive topline results showed that 41.3% of enrolled patients with HER2-amplified and expressing disease achieved an objective response as assessed by independent central review. The median duration of response was 12.9 months . The safety profile of zanidatamab in this trial was consistent with that observed in previously reported monotherapy studies, with no new safety signals identified. Full results from the pivotal trial are expected to be presented at a medical meeting in 2023

07:05 EST Perpetua Resources unit awarded $24.8M under Title III of DPA - Perpetua Resources announced that its wholly owned subsidiary, Perpetua Resources Idaho, was awarded a Technology Investment Agreement of up to $24.8M under Title III of the Defense Production Act. The funding objective of the Technology Investment Agreement, issued by the Air Force Research Laboratory, is to complete environmental and engineering studies necessary to obtain a Final Environmental Impact Statement, a Final Record of Decision, and other ancillary permits to sustain the domestic production of antimony trisulfide capability for defense energetic materials.

07:04 EST PureTech Health announces topline results from LYT-300 study - PureTech Health announced topline results from the completed, multi-part Phase 1 trial of LYT-300. PureTech announced topline results for LYT-300, a therapeutic candidate in development for neurological and neuropsychological conditions. The results show that oral administration of LYT-300 achieved blood levels of allopregnanolone at or above those associated with therapeutic benefit and results in exposure-dependent target engagement of GABAA receptors. Additional data from the Phase 1 trial will be presented in a scientific forum, and a Phase 1b/2a trial is expected to begin in the first half of 2023. Topline results announced show that oral administration of LYT-300 achieved blood levels of allopregnanolone at or above those associated with therapeutic benefit1 and resulted in exposure-dependent target engagement with gamma-aminobutyric-acid type A, or GABAA, receptors. Earlier this year, PureTech announced that LYT-300 also demonstrated oral bioavailability of allopregnanolone approximately ninefold greater than third-party reported data with orally administered allopregnanolone.1 Additional data from the Phase 1 trial will be presented in a scientific forum, and a Phase 1b/2a trial is expected to begin in the first half of 2023. Allopregnanolone is a natural neurosteroid with well-validated biological effects. It has demonstrated a rapid onset of action for the treatment of depression, as well as the potential to treat other neurological conditions, but its poor oral bioavailability has limited its therapeutic potential. The FDA has approved a 60-hour intravenous infusion formulation of allopregnanolone for the treatment of postpartum depression, or PPD, though this method of administration has inherent limitations. To overcome this, synthetic oral analogs of allopregnanolone have been developed, though these may not capture the full therapeutic potential of natural allopregnanolone. To potentially harness the broad applicability of this natural neurosteroid through oral administration, PureTech has applied its GlyphTM platform, which is designed to enable the oral administration of certain therapeutics with low oral bioavailability due to first pass metabolism. The Glyph platform has yielded two candidates to date. Overall, 72 healthy volunteers were dosed in the multi-part, Phase 1 clinical trial, which was designed to evaluate oral bioavailability, safety and tolerability of LYT-300 across a range of doses, and to inform dose selection moving forward. As part of the trial, single and multiple ascending doses were evaluated along with cohorts to evaluate the effect of food on oral absorption. The impact of LYT-300 on b-EEG and other markers of GABAA target engagement were also assessed. LYT-300 was generally well-tolerated with no treatment-related severe or serious adverse events observed. Doses have been selected to carry forward into the planned Phase 1b/2a clinical trial. A second candidate from the Glyph platform, LYT-310, an oral cannabidiol, or CBD, is designed to greatly expand the therapeutic application and potential of CBD. LYT-310 has demonstrated a three to fourfold increase in oral exposure versus unmodified CBD in multiple preclinical models, including large animal and non-human primate. This has the potential to translate into improved safety and reduced side effects. Lymphatic transport has also been confirmed in preclinical models, with up to 30% of LYT-310 entering the lymphatics, compared to 5% for unmodified CBD - which further supports the novel Glyph mechanism of enhancing oral bioavailability. LYT-310 is expected to enter the clinic in Q4 of 2023.

07:03 EST BioXcel Therapeutics announces first patient dosed in TRANQUILITY III study - BioXcel Therapeutics announced that the first patient has been dosed in the pivotal Phase 3 TRANQUILITY III trial of BXCL501 sublingual film, the Company's proprietary, orally dissolving film, under investigation for the acute treatment of agitation in patients with Alzheimer's disease, AD. The TRANQUILITY program includes two investigational studies, TRANQUILITY II and TRANQUILITY III, which are designed to evaluate the safety and efficacy of BXCL501 for the acute treatment of Alzheimer's-associated agitation in adults 65 years and older in assisted living or residential care facilities and nursing homes. "The prevalence of Alzheimer's disease is unfortunately increasing and there remains no FDA-approved product indicated for patients experiencing agitation associated with this condition," said Robert Risinger, M.D., Chief Medical Officer, Neuroscience of BioXcel Therapeutics. "With two pivotal trials underway in our TRANQUILITY program, we are aiming to expand BXCL501's potential to treat the full spectrum of episodic and intermittent chronic agitation market, and address the costly health-care burden related to Alzheimer's agitation."

07:02 EST Kamada CFO Chaime Orlev to depart - Kamada announced that its CFO Chaime Orlev will transition out of his role to pursue other opportunities, effective March 15, 2023, following the expected filing date of Kamada's Annual Report on Form 20-F. Kamada has a search underway to identify a successor to Mr. Orlev, who has served as the Company's CFO since 2017. Mr. Orlev will provide transitional support to the new CFO to be appointed by Kamada.

06:57 EST Cardinal Health announces Aaron Alt as chief financial officer - Cardinal Health (CAH) and its board of directors announced that Aaron Alt will become the company's new chief financial officer, or CFO. Alt will succeed interim CFO, Trish English and will report to CEO, Jason Hollar, as a member of the company's executive committee effective February 10. In his capacity as CFO, Alt will lead financial activities across the enterprise, including financial strategy, capital deployment, treasury, tax, investor relations, accounting, and reporting. Additionally, he will lead the corporate development team. Alt most recently served as EVP and CFO for Sysco (SYY).

06:52 EST Eagle Pharmaceuticals: FDA approves additional indication for PEMFEXY combo - Eagle Pharmaceuticals announced that the U.S. FDA has approved an additional indication for PEMFEXY in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations. Eagle's approved PEMFEXY is a ready-to-dilute novel liquid intravenous formulation developed to eliminate the reconstitution step of the Listed Drug, ALIMTA. "With this fifth indication, PEMFEXY is now approved for all of the same indications as ALIMTA, and we believe it allows for key advantages such as eliminating the need for reconstitution. Since its initial launch in February 2022, PEMFEXY has been an important addition to Eagle's hospital and acute care product portfolio, and we are pleased to bring this treatment option to patients undergoing chemotherapy. At the same time, we also believe that Eagle is well positioned to capture the commercial opportunity that PEMFEXY represents," stated Scott Tarriff, President and CEO of Eagle Pharmaceuticals. Effective October 1, 2022, the company amended its agreement to reduce future royalties related to PEMFEXY profits from 25% to a range of 0% to 12.5% based on aggregate profits achieved in exchange for a one-time payment of $15M.

06:36 EST Kineta completes reverse merger with Yumanity Therapeutics - Kineta (KA) announced the completion of its reverse merger with Yumanity Therapeutics (YMTX). The combined company will operate under the name Kineta, and its shares will commence trading on The Nasdaq Capital Market under the ticker symbol "KA" on December 19, 2022. Immediately prior to the merger, Yumanity effected a reverse stock split of its common stock at a ratio of one share for every seven shares. Kineta plans to execute on its clinical development program to unlock the potential of KVA12123. KVA12123 is expected to be a differentiated VISTA blocking immunotherapy to address the problem of immunosuppression in the tumor microenvironment. A Phase 1 / Phase 2 clinical trial evaluating KVA12123 alone and in combination with pembrolizumab in patients with advanced solid tumors will begin enrolling patients in January 2023. Additionally, the company is advancing an anti-CD27 agonist immunotherapy to address the problem of exhausted T cells and is planning to submit an Investigational New Drug application in the first half of 2024.

06:32 EST Cerevel Therapeutics reports 'positive' results from Phase 1 emraclidine trial - Cerevel Therapeutics announced results from the Phase 1 randomized, double-blind trial studying the effect of emraclidine on 24-hour ambulatory blood pressure over an eight-week period in people living with schizophrenia. The objective of the trial was to accurately characterize any potential blood pressure effect for both doses of emraclidine studied. On the primary endpoint, emraclidine demonstrated a mean change from baseline at week eight in 24-hour ambulatory systolic blood pressure of -2.7 mmHg for the 10 mg QD group and -0.4 mmHg for the 30 mg QD group. The upper bound of the two-sided 95% confidence interval for the change from baseline at week eight was -0.3 mmHg for the 10 mg QD group and 2.1 mmHg for the 30 mg QD group. As a result, the trial ruled out an increase in blood pressure for both doses. The secondary endpoints of the trial demonstrated findings consistent with the primary endpoint, corroborating the overall trial results. Emraclidine was generally well-tolerated in this trial, with a side effect profile consistent with prior trials.

06:24 EST Musk polls users over whether he should step down as Twitter CEO - Tesla and Twitter CEO Elon Musk polled users on Twitter on Sunday over whether he should step down as head of the social media company. Musk claimed he would abide by the results of the poll, which is due to close early Monday morning, but it is unclear whether or not he will actually do so. Reference Link

06:12 EST Biodesix announces first four private payer coverage policies for Nodify XL2 - Biodesix announced positive coverage decisions from four private payers including Blue Cross Blue Shield of North Carolina, Blue Cross Blue Shield of South Carolina, Blue Cross Blue Shield of Kansas City, and Capital District Physician's Health Plan of New York, all effective fourth quarter 2022. Biodesix's Nodify XL2 test will now be covered for more than 2.3M enrollees of Blue Cross of North Carolina, 1.2M enrollees of Blue Cross Blue Shield of South Carolina, 0.5M enrollees from Blue Cross Blue Shield of Kansas City, and 0.4M enrollees of CDPHP across New York State.

06:10 EST Lindsay enters strategic partnership with Ceres Imaging - Lindsay announced a strategic partnership with Ceres Imaging, an Oakland, California, provider of high-resolution imagery analytics with support for precision agriculture. The Ceres Imaging technology will populate high-resolution images in Lindsay's FieldNET platform, which enhances growers' ability to remotely monitor, control, analyze and apply irrigation recommendations. The addition of Ceres' imagery and access to its analytics platform will allow growers to monitor and adjust operations based on key indicators of crop performance such as emergence, canopy density, soil composition, water stress and nitrogen content. These indicators will provide valuable insights into crop health in alignment with Lindsay's smart pivot innovation roadmap and enhance the ability of growers to choose solutions uniquely tailored to their needs.

06:06 EST RadNet: DeepHealth receives FDA clearance for Saige-Density software - RadNet announced that its subsidiary DeepHealth, a developer of artificial intelligence for mammography interpretation, has received FDA clearance of its mammography density assessment software, Saige-Density. Saige-Density is a breast density assessment tool that automatically generates an ACR BI-RADS breast density category, assisting radiologists in making accurate and consistent determinations using AI. The tool helps to reduce the subjectivity inherent in visual analysis.

05:21 EST Innate Pharma, Sanofi expand collaboration for NK cell therapeutics - Innate Pharma (IPHA) and Sanofi (SNY) announced an expansion of their collaboration, with Sanofi licensing a natural killer, or NK, cell engager program targeting B7H3 from Innate's ANKET platform. Sanofi will also have the option to add up to two additional ANKET targets. Upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization. Innate and Sanofi signed a first NK cell engagers collaboration in 2016 for the generation and evaluation of up to two bispecific NK cell engagers, which are currently being evaluated by Sanofi's R&D team, with one of these molecules already in clinical studies.

05:11 EST Hutchmed initiates filing of rolling submission of fruquintinib NDA - Hutchmed announced that it has initiated the filing of a rolling submission of a new drug application, or NDA, to the FDA for fruquintinib, a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3, for the treatment of refractory metastatic colorectal cancer, or CRC. HUTCHMED plans to complete the NDA submission in the first half of 2023, to be followed by filing of a marketing authorization application, or MAA, to the European Medicines Agency or EMA, and an NDA to the Japan Pharmaceuticals and Medical Devices Agency, or PMDA.