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
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.
Pharma & Biotech
Why the PD-L1-high subgroup could be crucial for Summit Therapeutics’ global strategy
Summit shares rise after ivonescimab delivers 30.8-month survival versus 22.6 months for pembrolizumab in China’s HARMONi-2 trial.
Pharma & Biotech
Scholar Rock finally won FDA approval. Why did SRRK stock fall 6% when ISEMBYLD launched?
Scholar Rock starts its ISEMBYLD SMA launch after FDA approval, but SRRK falls as investors weigh a roughly $310,000 annual price and execution.
Pharma & Biotech
BioNTech’s gotistobart delivered 18.5-month survival. Can the pivotal trial confirm it?
BioNTech’s gotistobart posts 18.5-month median survival versus 10 months with docetaxel as the pivotal Phase 3 stage continues.
Pharma & Biotech
What does the PIPE-307 MOONLIGHT-1 miss mean for Contineum Therapeutics stock?
Contineum shares face pressure after Johnson & Johnson’s PIPE-307 misses its Phase 2 depression endpoint, shifting attention to PIPE-791.
Pharma & Biotech
What do Definium Therapeutics’ Panorama results mean for DT120 FDA approval?
Definium’s DT120 delivers another positive Phase 3 anxiety result, putting the FDA filing and commercialization strategy firmly in focus.
Pharma & Biotech
Antibiotics are not always enough for Staph bloodstream infections. Can Armata turn bacteriophages into an FDA-approved adjunct?
FDA grants Breakthrough Therapy status to Armata’s AP-SA02 after randomized data support bacteriophage therapy in complicated Staph bacteremia.