Browsing Tag
United States Food and Drug Administration
135 posts
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.
RESTORE trial could turn NVG-291 into NervGen’s defining spinal cord injury asset
NVG-291 heads into Phase 3 as NervGen deploys its $61m cash runway behind a 150-patient test of hand-function recovery in chronic tetraplegia.
Fate Therapeutics bets on outpatient CAR T as FT819 enters potentially registrational study
FT819 enters a potentially registrational lupus nephritis trial with outpatient dosing as Fate tests whether off-the-shelf CAR T can scale.
Sagimet’s acne strategy enters its biggest test after FDA clears denifanstat Phase 3
FDA clearance sends denifanstat into an 800-patient U.S. Phase 3 as Sagimet deploys its $257.6m cash base. See what the pivotal test means.
Mapi Pharma targets cariprazine lifecycle extension with once-monthly injectable
Mapi’s monthly Cariprazine Depot clears its first safety hurdle as a $3.6bn oral franchise approaches a key 2029 patent transition.
Can a nasal therapy bypass the blood-brain barrier? NEO100’s Phase 2a data offer an early answer
NEO100 posts 48.9% six-month PFS and 26-month median survival, but NeOnc’s $2m cash balance puts funding and FDA strategy in focus.
Theriva targets Phase 2/3 VCN-01 trial after early eye-preservation signal
Theriva plans a VCN-01 Phase 2/3 retinoblastoma trial after early eye-preservation signals, but its $11.3m cash runway raises the stakes.
Rapid NOVA-2 enrollment brings LB Pharmaceuticals closer to its first potential FDA filing
LB-102 Phase 3 data move into H1 2027 as LB Pharmaceuticals deploys $150m to expand its psychiatry pipeline ahead of a pivotal test.
Sutacimig Phase 3 path puts Hemab’s $457.5m post-IPO cash base to work
Sutacimig gets an FDA-backed Phase 3 path as Hemab deploys its $457.5m post-IPO cash base. See what the pivotal trial means for growth.