NDA
Cogent Biosciences Soars on Positive Phase 3 PEAK Results in Gastrointestinal Stromal Tumors (GIST)
Cogent Biosciences; bezuclastinib; sunitinib; GIST; Phase 3; progression-free survival; objective response rate; NDA submission; clinical trial; stock surge; standard of care
BridgeBio Shifts Filing Plans After Phase 3 Success in Rare Disease Drug BBP-418
BridgeBio; BBP-418; Phase 3 success; limb-girdle muscular dystrophy type 2I/R9; FDA filing; rare disease drug; NDA (New Drug Application); ribitol; full approval; biomarker; acoramidis; commercial strategy
Sanofi’s MS Drug Tolebrutinib Faces FDA Delay Amid Extended Review
Sanofi; tolebrutinib; FDA delay; multiple sclerosis; nrSPMS; Bruton’s tyrosine kinase inhibitor; breakthrough therapy; HERCULES trial; GEMINI trial; PERSEUS trial; NDA; regulatory review
Axsome Therapeutics Narcolepsy Drug AXS-12 Achieves Phase III Success, Paving Way for US FDA Filing
Axsome Therapeutics, AXS-12, narcolepsy, Phase III trial, ENCORE trial, FDA filing, NDA
Innovent’s IL-23 Drug Picankibart Shows Promising Results in Phase 3 Trial for Moderate to Severe Plaque Psoriasis
Innovent Biologics, Picankibart, IL-23 inhibitors, Plaque psoriasis, Phase 3 clinical trial, Chinese regulators, NDA acceptance
Boehringer Ingelheim Prepares NDA Filing for Pulmonary Fibrosis Drug After Positive Phase 3 Results
Boehringer Ingelheim, pulmonary fibrosis, NDA filing, Phase 3 data, nerandomilast, idiopathic pulmonary fibrosis (IPF)
HUTCHMED Withdraws Fruquintinib Application for Second-Line Gastric Cancer Treatment in China
HUTCHMED, fruquintinib, gastric cancer, second-line treatment, China, NDA withdrawal