Designation supports the global development of RTX-117 and may provide potential future access to a transferable Priority Review Voucher, subject to approval and applicable requirements Aug. 26, 2026 -- ReviR Therapeutics, a clinical-stage biotechnology company advancing small-molecule therapies through the integration of artificial intelligence and RNA biology, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to RTX-117, the

SK Biopharmaceuticals has strengthened its epilepsy offering by paying $350 million upfront to help speed Biohaven’s Kv7 ion channel activator on its way to market. Biohaven is currently evaluating the daily oral therapy, called opakalim or BHV-7000, in a phase 2/3 study of patients with focal epilepsy. A topline readout is expected later this year. Rather than wait for the results, SK has agreed to hand over the upfront cash—along with another $50 million next year—for the worldwide license t

NBI-1117567 is an investigational oral, muscarinic M1 preferring (M1/M4) selective agonist discovered by Nxera and advancing through clinical development under a multi-program collaboration with Neurocrine Nxera to receive a US$10 million milestone payment upon IND Acceptance, as part of the overall milestone package Nxera retains development and commercialization rights to the M1 receptor agonist for all indications in Japan 26 August 2026 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TS

The first patient has been dosed in the TROPION-Urothelial04 phase 3 trial evaluating Datroway® (datopotamab deruxtecan) plus rilvegostomig or Datroway monotherapy versus current standard of care (durvalumab monotherapy or nivolumab monotherapy or enfortumab vedotin plus pembrolizumab) as an adjuvant treatment (after surgery) in patients with muscle invasive urothelial cancer (MIUC) at high risk of recurrence following radical surgical resection with or without prior neoadjuvant therapy. Datrow

The capital raise supports ongoing Phase 2b/3 clinical trial for prevention of bronchopulmonary dysplasia and associated CMC and analytical activities Approximately 94% of existing investors participated in the Series E-2 round Interim analysis completing the Phase 2b portion of the trial expected by the end of Q2 2027 Aug. 25, 2026 -- Airway Therapeutics, Inc., a late-stage clinical biopharmaceutical company developing novel biologic therapies for respiratory, inflammatory, and infectious dise

Shape Memory Medical Inc., developer of proprietary shape memory polymer technology for endovascular embolization, today announced the closing of a $10 million convertible note financing led by new investor August Global Partners (AGP), joined by fellow new investor Taiwania Capital. The financing provides capital to support continued clinical development of the company’s aortic portfolio, including patient follow-up and data collection in the AAA-SHAPE Pivotal Trial, and advancement of the FLA

COVID-19 remains a public health challenge, particularly among older adults and high-risk populations1 Novavax's partners are ready to bring its protein-based, non-mRNA vaccine with a favorable tolerability profile to global markets, providing an important option for healthcare providers and patients Aug. 28, 2026 -- Novavax, Inc.'s (Nasdaq: NVAX) partners have received approvals for the Nuvaxovid™ formulation to target the SARS-CoV-2 XFG variant for the 2026-2027 vaccination season in major ma

Spyre Therapeutics' stock was down about 14% Wednesday after a topline readout for one of its experimental TL1A antibodies underwhelmed in a Phase II rheumatoid arthritis (RA) study. While SPY072 showed activity, it failed to meet the company's internal efficacy bar for moving it forward as a stand-alone therapy. The candidate is being evaluated in the SKYWAY-RD basket trial across several rheumatic diseases, with separate sub-studies in RA, psoriatic arthritis (PsA) and axial spondyloarthritis

Biohaven on Wednesday said it’s selling the rights to its most advanced experimental medicine to South Korea’s SK Biopharmaceuticals in a deal that may be worth as much as $795 million plus future royalties. The transaction includes access to Biohaven’s Kv7 ion channel technology and the lead asset to emerge from that platform, a treatment for focal epilepsy called opakalim. The drug is currently in late-stage testing, and topline results from a trial called Rise3 are due before the end of the

The RAS revolution is officially here, thanks to the FDA's approval of Rasonque (daraxonrasib) for adults with metastatic pancreatic ductal adenocarcinoma (PDAC) on Wednesday. Revolution Medicines' RAS inhibitor was greenlit less than five months after it first revealed "practice-changing" data suggesting the candidate could help patients live twice as long as standard chemotherapy (see – Spotlight On: Daraxonrasib set to revolutionise pancreatic cancer treatment landscape). "This drug showed u