Cogent Biosciences now has three bezuclastinib NDAs under FDA review
Cogent now has three bezuclastinib NDAs under FDA review, with GIST and non-advanced mastocytosis decisions due before year-end.
Pharma & Biotech
Pharma & Biotech
What does Ocular Therapeutix’s positive pre-NDA meeting mean for AXPAXLI approval?
Ocular Therapeutix keeps its AXPAXLI wet AMD NDA on track for Q4 after a positive FDA meeting, but OCUL still falls nearly 5%.
Pharma & Biotech
What went wrong in Connect Biopharma’s Seabreeze STAT asthma trial?
CNTB falls 32% after rademikibart misses its asthma primary endpoint despite a 66% treatment-failure reduction and significant FEV1 gain.
Pharma & Biotech
SELLAS Life Sciences prepares pancreatic cancer SLS009 data for AACR 2026
SELLAS investors await event-driven Phase 3 AML results while SLS009 heads to AACR with preclinical pancreatic cancer combination data.
Pharma & Biotech
Biohaven stock remains under pressure after FDA partial hold on opakalim epilepsy program
Biohaven’s opakalim program faces an FDA partial hold over a rodent metabolite, while a fully enrolled pivotal epilepsy study remains on track.
Pharma & Biotech
IOVA has climbed more than 400% from its low. Can lung cancer turn Amtagvi into a much bigger franchise?
Iovance approaches new lung cancer data as Amtagvi revenue hits $91 million and IOVA trades near a 52-week high after a major 2026 rally.
Pharma & Biotech
What does September 19 UX111 PDUFA mean for Ultragenyx stock?
Ultragenyx faces a September 19 FDA decision for UX111 after RARE plunged on a separate trial failure and manufacturing issues delayed approval.
Pharma & Biotech
Rocket Pharmaceuticals gets FDA path to complete RP-A501 Danon disease pivotal trial
FDA clears Rocket Pharmaceuticals to continue its recalibrated RP-A501 pivotal trial, restoring a defined accelerated approval path in Danon disease.
Pharma & Biotech
TRUTAKNA cut kidney progression risk 76%. Why did VERA stock give up a double-digit rally?
TRUTAKNA cuts IgA nephropathy progression risk 76% through two years, but VERA stock reverses as competition and launch execution come into focus.
Pharma & Biotech
Intellia Therapeutics faces March FDA decision for one-time CRISPR HAE therapy
Intellia faces a March 10 FDA decision for lonvo-z after one CRISPR infusion cut HAE attacks 87% in Phase 3 testing.