After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcutis, Ardelyx, Auron, BMS, Celltrion, Gilead, Glaukos, Indivior, Innovent, Insmed, Invivyd, Opus, Porosome, Pyxis, Regeneron, Takeda, Telix, Teva.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allogene, Enodia, Eli Lilly, Foresight, Idorsia, Nxera, Pfizer, Viatris.
Biocity Biopharmaceutics Co. Ltd.’s selective endothelin receptor type A antagonist, SC-0062, met the primary endpoint of reducing proteinuria in a phase II diabetic kidney disease cohort. Conducted at 40 sites across China, the 2-Succeed phase II trial is designed to evaluate the efficacy and safety of SC-0062 in patients with chronic kidney disease with proteinuria.
A panel at Biocom California’s 15th Annual Global Life Science Partnering & Investor Conference covered the emerging use of artificial intelligence (AI) to discover and develop drugs. “We’re in a very different place than we were five years ago, or even three years ago, even two years ago, from our ability to harness AI to make advances,” Marc Tessier-Lavigne, CEO of South San Francisco-based Xaira Therapeutics Inc., told the audience, adding that the development is actually accelerating.
With the closing of its $350.7 million series D, Eikon Therapeutics Inc. has notched two financial high marks for the still young year. The funding is the biggest venture capital round of 2025 and it’s also the first series D.
HBM Alpha Therapeutics Inc. signed a potential $395 million licensing deal Feb. 26 with an unnamed “business partner” for its endocrine asset, HAT-001, adding another contender to the congenital adrenal hyperplasia space.
RSS
