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Rein’s $57.5m financing buys LTI-03 time, but Phase 2 IPF data now carry the valuation
LTI-03 wins FDA Fast Track status as Rein deploys its $43.6m cash position behind a closely watched Phase 2 IPF readout due in 2026.
Amylyx (Nasdaq: AMLX) upsizes offering to $500m as avexitide advances
The biotechnology company is selling 14.09 million shares at $35.50 after avexitide cut severe hypoglycemic events by 55% in pivotal Phase 3 testing.
Nuvation Bio adds FDA Fast Track to safusidenib as Phase 3 enrollment builds
Nuvation Bio has secured FDA Fast Track designation for safusidenib in IDH1-mutant glioma, adding regulatory momentum to a program backed by long-term Phase 2 responses and an expanding Phase 3 strategy.
Ceigall India advances Rs 225cr Himachal drug park infrastructure contract
Ceigall India has received the formal Letter of Award for a ₹225 crore infrastructure package at Himachal Pradesh’s Bulk Drug Park, converting an earlier 2025 Letter of Intent into an executable contract milestone.
REGN rises 3.8% as Pasatru opens a new rare-disease franchise for Regeneron
Pasatru wins FDA approval after cutting new FOP lesions 90%, expanding Regeneron’s rare-disease portfolio as pediatric development approaches.
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.
Ipsen closes Kartos Therapeutics acquisition as $1.75bn potential bet moves into Phase III execution
Ipsen completes its Kartos Therapeutics acquisition, adding Phase III navtemadlin under a deal worth up to $1.75bn. See what comes next.
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.