NDA submission

Oculis secures FDA Special Protocol Assessment for Privosegtor Phase 3 trial, de-risking path to potential $7 billion optic neuritis market.

Pharvaris director's modest 1.80% stock sale matters less than upcoming Phase 3 data and FDA submission catalysts arriving in 2026.

Teva acquires Emalex Biosciences for $700M upfront plus $200M in milestones for first-in-class Tourette syndrome therapy, closing by Q3 2026.

Immunome's Chief Scientific Officer trimmed his stake by 30%, but the real catalyst is varegacestat's planned Q2 2026 FDA submission following positive Phase 3 trial results.

Nasus Pharma reports positive Phase 2 data for NS002 intranasal epinephrine, planning pivotal study Q4 2026 with strong cash position through Q2 2027.

Gyre Therapeutics posts 10% FY2025 revenue growth to $116.6M, guides 2026 lower due to regulatory prioritization and Cullgen acquisition for TPD expansion.

Cogent Biosciences presented expanded SUMMIT trial data showing bezuclastinib achieved significant symptom reduction and tryptase normalization in systemic mastocytosis patients, supporting its FDA regulatory applications.

BVF Partners liquidated its $170M Protagonist stake despite 120% gains, likely due to changing risk profile as company awaits FDA decision on blood disorder treatment.

Clene outlines 2026 regulatory milestones for ALS drug CNM-Au8, including FDA meeting, NDA submission, and Phase 3 trial, backed by $28 million funding.