Browsing Tag
United States Food and Drug Administration
193 posts
Ecopipam Priority Review puts Teva’s $700m Tourette bet on a Q1 2027 FDA clock
Ecopipam gets FDA Priority Review, putting Teva’s $700m Tourette acquisition on a late-Q1 2027 decision clock after positive Phase 3 data.
Humacyte’s dialysis bet gains momentum, but $0.71 stock still reflects major execution risk
HUMA jumps 22% as peer-reviewed ATEV Phase 3 data strengthen Humacyte’s planned FDA filing for a potentially much larger dialysis market.
Fast Track win puts BlossomHill’s BH-30643’s 50% early response signal gets FDA Fast Track backing as BlossomHill goes public
BH-30643 wins FDA Fast Track status as BlossomHill directs $70m of its fresh IPO capital toward its EGFR-resistant lung cancer program.
Immatics skips interim anzu-cel analysis and adds 90 patients ahead of pivotal 2027 verdict
Immatics adds 90 patients to anzu-cel Phase 3 while its $448.2m liquidity backs a definitive 2027 melanoma readout and planned BLA.
Oncolytics maps accelerated approval path for pelareorep while cash drops to $4.1m
FDA feedback could speed pelareorep toward pivotal colorectal cancer testing, but Oncolytics’ $4.1m cash balance puts financing in focus.
LUGANO failure wipes billions from EyePoint valuation as LUCIA becomes decisive
DURAVYU misses its first Phase 3 wet AMD endpoint as EyePoint shares plunge nearly 70%, making the Q4 LUCIA readout a critical catalyst.
A $50m quarter changes the stakes for UroGen as UGN-103 reaches FDA
UroGen files UGN-103 with the FDA as ZUSDURI sales surge 73%, potentially extending its fast-growing bladder cancer franchise into 2044.
Mesoblast completes 350-patient Phase 3 treatment as mid-2027 back pain readout becomes next valuation test
Mesoblast has completed treatment of 350 Phase 3 back pain patients, putting rexlemestrocel-L on course for a pivotal mid-2027 efficacy readout.
PMV’s $79.4m cash pile now hinges on rezatapopt’s 2027 ovarian cancer FDA bid
PMV completes key rezatapopt enrollment with a 2027 FDA filing ahead as its $79.4m cash balance exceeds its current market value.
New Alzheimer’s imaging approval could help unlock Lantheus’ neurology merger payouts
TAUKLARIFY wins FDA approval as Lantheus expands its Alzheimer’s imaging franchise ahead of Curium’s $8bn acquisition and neurology CVR targets.