Company holds a dedicated meeting with Gates Foundation executives during Bill Gates' visit to Korea. Both reviews expanded cooperation, including next-generation preventive medicines. SEONGNAM, South Korea, Aug. 21, 2025 /PRNewswire/ -- SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, today announced that the company held an exclusive meeting with the Gates Foundation in line with the visit of Bill Gates, Founder and C

At all doses and formulations evaluated in Part 1 of the trial, Z-1018 was well-tolerated and demonstrated a favorable tolerability profile, including lower solicited local and systemic post-injection reactions, versus Shingrix Z-1018 demonstrated robust immune responses in all dose arms, including a 100% humoral vaccine response rate at the dose selected for advancement, with comparable immunogenicity to Shingrix Dynavax selects the optimal dose of Z-1018 for advancement to Part 2 of Phase 1/2

Trial Designed to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SEP-631 in Healthy VolunteersSOUTH SAN FRANCISCO, Calif., Aug. 21, 2025 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today announced the dosing of the first participants in its Phase 1 clinical trial of SEP-631, a selective oral small molecule Mas-related G protein-coupled receptor X2

MUNICH, Aug. 21, 2025 (GLOBE NEWSWIRE) -- VeonGen Therapeutics, a clinical-stage genetic medicine company developing next-generation gene therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to VG801, its lead investigational gene therapy for Stargardt disease and other ABCA4 mutation–associated retinal dystrophies. By delivering a full-length, functional ABCA4 gene, VG801 has the potential to address

CAMBRIDGE, Mass. and FRANKLIN, Tenn., Aug. 21, 2025 (GLOBE NEWSWIRE) -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, and Innovative Renal Care (IRC), a leading comprehensive kidney care provider in the U.S., today announced the broad availability of Vafseo® (vadadustat) for the treatment of anemia due to chronic kidney disease (CKD) in dialysis patients across all IRC clinics. Innovative Renal

CAMBRIDGE, Mass., Aug. 21, 2025 /PRNewswire/ -- Allos Pharma Inc., announces key milestones advancing its mission to deliver effective treatments for Autism Spectrum Disorder (ASD), Fragile X Syndrome, and related neurodevelopmental disorders. Global Rights to Arbaclofen Allos has secured worldwide rights to arbaclofen, a selective GABA-B receptor agonist previously evaluated in multiple Phase II and III trials in ASD, Fragile X syndrome (FXS) and 16p11.2 deletion syndrome. This transfer includ

NEEDHAM, Mass., Aug. 21, 2025 /PRNewswire/ -- Stealth BioTherapeutics, a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the New Drug Application (NDA) for elamipretide for the treatment of Barth syndrome. While the FDA considers the resubmission a complete, class 2 respon

Refinancing extends maturity of most existing debt with improved terms $225 million of convertible notes due in 2031 issued, including a ~$175 million exchange for the retirement of existing convertible notes due in 2027 and ~$50 million of new money GAITHERSBURG, Md., Aug. 21, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced that it has entered into privately negotiated agreements with certain of the holders of its existing 5.00% Convertible Senior Notes due 2027 (the "2027 No

BOSTON, Aug. 21, 2025 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing antibody-drug conjugate (ADC) therapeutics for difficult-to-treat cancers, today announced that Lara S. Sullivan, M.D., President, Chief Executive Officer and Chief Medical Officer, will participate in the following upcoming conferences. Investor Conferences 2025 Cantor Global Healthcare Conference, New York, NY, Wednesday, September 3, 2:45 p.m. ET – Fireside chat and investor

LUND, Sweden, Aug. 21, 2025 /PRNewswire/ -- Hamlet BioPharma, the pharmaceutical company, specializing in the development of drugs for cancer and infections, announces the completion of the successful Phase II clinical trial of the company's drug candidate Alpha1H in patients with cancer in the urinary bladder. The final clinical study report based on extensive analyses of clinical and laboratory data highlights the potent treatment effects. All primary and secondary endpoints of safety and eff