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UroGen takes $7m IntraGel stake as local oncology pipeline expands beyond bladder cancer
UroGen Pharma is investing up to $7 million in IntraGel Therapeutics while securing options on TumoCure and as many as three additional oncology programs built around sustained local drug delivery.
OncoSil wins FDA HDE approval for rare bile duct cancer treatment
OncoSil Medical has received U.S. FDA Humanitarian Device Exemption approval for the OncoSil System in unresectable, non-metastatic distal cholangiocarcinoma, opening its first U.S. commercial pathway.
Werewolf stock doubles as $150m Ambros merger pivots company to Phase 3 pain drug
Werewolf Therapeutics will merge with Ambros Therapeutics in an all-stock transaction that values Ambros at $500 million before financing and backs its Phase 3 neridronate program with a $150 million private placement.
Alvotech (Nasdaq: ALVO) lands $150m Lotus biosimilar deal across US, Asia
The deal covers proposed biosimilars to Imfinzi and Hemlibra, whose reference products generated about $11.9 billion of combined 2025 global sales.
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.