Aficamten clears pivotal Phase 3 test in non-obstructive HCM as Cytokinetics prepares FDA filing
Aficamten hits both Phase 3 ACACIA-HCM endpoints as Cytokinetics prepares an FDA filing. See what the results mean for Myqorzo growth.
Pharma & Biotech
Pharma & Biotech
Gilead Sciences’ Bixlenvo turns up to 11 HIV pills into one, but who benefits most?
Gilead Sciences has secured U.S. Food and Drug Administration approval for Bixlenvo, a once-daily tablet combining bictegravir and lenacapavir for virologically suppressed adults with HIV, including patients whose resistance or treatment history has kept them on complex multi-tablet regimens.
Pharma & Biotech
A once-daily pill just changed dermatomyositis treatment. What the FDA’s LISRAYA approval means
The U.S. Food and Drug Administration has approved Priovant Therapeutics’ LISRAYA, or brepocitinib, for adults with dermatomyositis, creating the first FDA-approved oral treatment for the rare systemic autoimmune disease. The decision converts positive Phase 3 VALOR data into Roivant Sciences’ first commercial opportunity for a drug that is also being developed across several other immune-mediated
Pharma & Biotech
Nicox reaches FDA review with NCX 470 after two Phase 3 trials beat glaucoma pressure baseline
FDA has accepted Kowa’s NDA for NCX 470 and set an April 30, 2027 PDUFA date after two Phase 3 trials established noninferiority to latanoprost in lowering intraocular pressure.
Pharma & Biotech
Lytix moves ruxotemitide toward registrational melanoma trial after FDA backs EFS endpoint
FDA raised no objection to a randomized Phase 3 comparing neoadjuvant ruxotemitide plus pembrolizumab with pembrolizumab alone and indicated that one well-controlled study could potentially support an NDA.
Pharma & Biotech
New soquelitinib data support Corvus Pharmaceuticals’ pivotal push in relapsed T-cell lymphoma
Soquelitinib shows durable T-cell lymphoma responses and 28.1-month median survival as Corvus Pharmaceuticals advances its Phase 3 trial.
Pharma & Biotech
SK Biopharmaceuticals bets up to $795m on Biohaven’s opakalim before pivotal data
SK Biopharmaceuticals is acquiring worldwide rights to opakalim and Biohaven’s Kv7 platform, providing $400 million in near-term cash and assuming additional obligations while pivotal RISE3 data remain due in the second half of 2026.
Pharma & Biotech
FDA approves RASONQUE after 500-patient trial nearly doubles pancreatic cancer survival
Revolution Medicines’ once-daily daraxonrasib improved median overall survival to 13.2 months from 6.7 months with chemotherapy in RASolute 302, giving metastatic pancreatic adenocarcinoma its first FDA-approved broad RAS-targeted therapy.
Pharma & Biotech
Lancet Oncology publishes Summit’s global ivonescimab Phase 3 with PFS at 6.8 months versus 4.4
Global HARMONi data show ivonescimab plus chemotherapy reduced progression or death risk by 48% after third-generation EGFR-TKI failure, while overall survival had not reached statistical significance at the primary analysis.
Pharma & Biotech
Jazz wins first-line Ziihera approval as HERIZON-GEA-01 resets the HER2 treatment benchmark
FDA has approved two Ziihera-based first-line regimens in HER2-positive advanced gastroesophageal adenocarcinoma after the Tevimbra combination improved median overall survival from 19.2 to 26.4 months.