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
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.
Pharma & Biotech
Zasocitinib beat an approved TYK2 rival head to head. Can Takeda turn that into a new oral psoriasis benchmark?
FDA grants Priority Review to Takeda’s zasocitinib after Phase 3 psoriasis studies, including head-to-head superiority versus deucravacitinib.
Medical Devices & Diagnostics
Telix Pharmaceuticals wins FDA approval for PIXCLARA glioma imaging
FDA approves Telix Pharmaceuticals’ PIXCLARA, the first FET-PET drug for differentiating glioma progression from treatment-related change.
Pharma & Biotech
CSL Seqirus Phase 3 influenza vaccine study tests triple-enhancement strategy in older adults
CSL Seqirus’ 7,699-person Phase 3 study supports its enhanced flu-vaccine strategy, though one A/H3N2 comparison missed non-inferiority.
Pharma & Biotech
Full-Life wants to carry actinium-225 directly to c-MET tumors. Can FL-261 widen targeted alpha therapy beyond prostate cancer?
FDA clears Full-Life’s actinium-225 FL-261 for Phase 1 testing in c-MET-positive lung cancer as the radiopharmaceutical company expands its pipeline.