Month: May 2022

New PDUFA goal date of December 28, 2022 NEW YORK, May 31, 2022 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date to December 28, 2022, for the Biologics License Application (BLA) for ublituximab as a treatment for patients with relapsing forms of multiple sclerosis (RMS). The FDA extended the PDUFA goal date to allow time to review a submission provided by the Company in response to an FDA information request, which the FDA deemed a major amendment. The submission comprised an integration and summary of certain clinical information that was previously provided to the FDA by the Company. Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “While we are disappointed...

SHENZHEN, China, May 31, 2022 (GLOBE NEWSWIRE) — Aesthetic Medical International Holdings Group Limited (Nasdaq: AIH) (the “Company” or “AIH”), a leading provider of aesthetic medical services in China, today announced that the Company, founder and senior executive of the Company and investors on May 30, 2022, entered into an amendment (the “Amendment”) to the share subscription agreement originally entered into among the Company, founder and senior executive of the Company and Lafang China Co., Ltd (“Lafang”) on May 16, 2021 (the “Original SSA”), which the Company disclosed on a Form 6-K furnished with the Securities and Exchange Commission (“SEC”) on May 17, 2021. The Amendment amended the aggregate subscription amount and subscription price of the Original SSA, among other things. Pursuant to the Amendment, Hawyu (HK) Limited...

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PRESS RELEASE – NO. 1 / 2022 Zealand Pharma Announces Multiple Presentations at the 82nd Annual American Diabetes Association Scientific Sessions, Including Initial Clinical Data on GLP-1/GLP-2 Dual Agonist DapiglutideA total of five presentations with Zealand Pharma products have been accepted for presentation at the American Diabetes Association (ADA) Abstracts include oral presentation of data from a Phase 1 Multiple Ascending Dose Trial with dapiglutide Data highlight and reinforce the Company’s commitment to advancing research and development of new treatment options for the management of diabetes and obesityCopenhagen, DK and Boston, MA, U.S. May 31, 2022 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced...

CHICAGO, May 31, 2022 (GLOBE NEWSWIRE) — Vivid Seats Inc. (NASDAQ: SEAT) (“Vivid Seats” or the “Company”), a leading marketplace that utilizes its technology platform to connect millions of buyers with thousands of ticket sellers across hundreds of thousands of events each year, today announced that Stan Chia, Chief Executive Officer and Lawrence Fey, Chief Financial Officer, will be presenting at William Blair’s 2022 Growth Conference on Wednesday, June 8, 2022 at 4:20 p.m. ET. A live webcast of the presentation will be accessible on the Vivid Seats Investor Relations website at https://investors.vividseats.com/ under “News & Events.” About Vivid SeatsFounded in 2001, Vivid Seats is a leading online ticket marketplace committed to becoming the ultimate partner for connecting fans to the live events, artists, and teams they...

NEW YORK, May 31, 2022 (GLOBE NEWSWIRE) — OTC Markets Group Inc. (OTCQX: OTCM), operator of regulated markets for 12,000 U.S. and international securities, today announced Foresight Financial Group Inc. (OTCQX: FGFH), a financial holding company established under the Federal Reserve, has qualified to trade on the OTCQX® Best Market. Foresight Financial Group Inc. upgraded to OTCQX from the Pink® market. Foresight Financial Group Inc. begins trading today on OTCQX under the symbol “FGFH.” U.S. investors can find current financial disclosure and Real-Time Level 2 quotes for the company on www.otcmarkets.com. Graduating to the OTCQX Market marks an important milestone for community banks in the U.S. public markets. The OTCQX Market enables banks to maximize the value of being a public company by providing transparent trading and easy...

MALVERN, Pa., May 31, 2022 (GLOBE NEWSWIRE) — TELA Bio, Inc. (“TELA”) (NASDAQ: TELA), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions that optimize clinical outcomes by prioritizing the preservation and restoration of the patient’s own anatomy, today announced that the Company has entered into a new credit facility with MidCap Financial (“MidCap”), providing TELA with access to up to $50 million in total credit. A portion of the proceeds from the new credit facility were used to fully repay TELA’s existing $30 million credit facility with OrbiMed Royalty Opportunities II, LP, with the remaining proceeds under the credit facility available for working capital needs and other corporate purposes. “We are excited about our new partnership with MidCap...

BEDMINSTER, N.J., May 31, 2022 (GLOBE NEWSWIRE) — Matinas BioPharma (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on improving the intracellular delivery of nucleic acids and small molecules with its lipid nanocrystal (LNC) platform technology, announced today that Jerry Jabbour, Chief Executive Officer, has been invited to present at the LD Micro Invitational XII Conference on Tuesday, June 7, 2022, at 3:30 p.m. ET (12:30 p.m. PT). The conference is being held at the Four Seasons Hotel in Westlake Village, Calif. Investors interested in arranging a meeting with the Company’s management during the conference should contact the LD Micro conference coordinator. A webcast of the presentation will be available on the IR Calendar page of the Investors section of the Company’s website (www.matinasbiopharma.com)...

BOSTON and LOUISVILLE, Ky., May 31, 2022 (GLOBE NEWSWIRE) — Talaris Therapeutics, Inc. (Nasdaq: TALS), a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation and severe immune and blood disorders, today announced that Scott Requadt, Chief Executive Officer of Talaris, will present at the Jefferies Healthcare Conference on Wednesday, June 8, 2022 at 10:30 AM ET at the Marriott Marquis in New York, NY. A live webcast of the fireside chat will be available on the investors section of the Talaris website at www.talaristx.com. After the live webcast, the event will remain archived on the Talaris website for 30 days. About Talaris TherapeuticsTalaris Therapeutics, Inc. is a late-clinical stage cell therapy company developing therapies with the...

Research Directed by Faculty of the Center for Transplantation Sciences, Massachusetts General Hospital NEW YORK, May 31, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced two upcoming oral presentations by faculty at the Center for Transplantation Sciences, Massachusetts General Hospital at the 2022 American Transplant Congress (ATC), being held June 4-8, 2022, in Boston, Mass. The research groups are led by Professor Tatsuo Kawai and Professor Richard Pierson. The research involves studies of Tonix’s TNX-1500 (Fc-modified anti-CD40L monoclonal antibody) in development for the prevention of rejection of organ transplants. The molecular target of TNX-1500 is CD40-ligand (CD40L), which is also known as CD154. Copies of the...