BioSpace News Archive

BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”) today announced that the U.S. Food and Drug Administration (“FDA”) granted Breakthrough Therapy designation for BNT323/DB-1303 for the treatment of advanced endometrial cancer in patients who progressed on or after treatment with immune checkpoint inhibitors.

4D Molecular Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted the RMAT designation for the investigational genetic medicine candidate 4D-150 for intravitreal treatment of wet age-related macular degeneration (wet AMD).

Longeveron Inc. today announced that it has entered into a definitive agreement for the issuance and sale of an aggregate of 1,355,301 of its shares of common stock at a purchase price of $1.

DENTSPLY SIRONA Inc. announced that its Board of Directors declared a quarterly cash dividend of $0.14 per share of common stock, an indicated annual rate of $0.56 per share.

SomaLogic, Inc. issued an open letter to stockholders highlighting the value maximizing merger entered into with Standard BioTools on October 4, 2023.

Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, recently launched aPAP ClearPath™, a new serum-based blood test that can be used by physicians in the U.S. to obtain a definitive diagnosis of aPAP, a rare autoimmune lung disease mediated by autoantibodies targeting GM-CSF.

DMK Pharmaceuticals Corporation announces that it has regained the full rights to commercialize ZIMHI ® (naloxone) after the termination of an exclusive commercialization and distribution with US WorldMeds, LLC.

Sonnet BioTherapeutics Holdings, Inc., (NASDAQ:SONN) a clinical-stage company developing targeted immunotherapeutic drugs for cancer, announced today the publication of extensive preclinical data on SON-1210 in Frontiers in Immunology.

NightHawk Biosciences today announced its Scorpius BioManufacturing subsidiary (“Scorpius”) completed a demonstration run in the Company’s process development lab for a microbial vaccine program developed by a top-tier research university that is NIH and DTRA (Defense Threat Reduction Agency) funded.

Apnimed, Inc. today announced the first patient dosed in its SynAIRgy Phase 3 study designed to examine the efficacy and safety of AD109 (aroxybutynin/atomoxetine) compared to placebo at six-months.