Grace Therapeutics Gets FDA Feedback on GTx-104: No New Clinical Trials Needed, Resubmission Planned
FDA flagged fixable issues for GTx-104, not rejection. No new trials needed. IV drug may improve brain bleed ICU treatment.
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#XY Event-Driven Stocks↓
IKS Health Acquires TruBridge to Boost Rural Healthcare Access
IKS Health is buying TruBridge to improve rural US healthcare using AI. Deal helps 2000 hospitals, closes 2026.
Amneal Acquires Kashiv BioSciences in $1.1B Deal to Ride $300 Billion Biosimilar Wave
Amneal is buying Kashiv BioSciences for up to $1.1 billion to become a global leader in affordable biosimilar drugs. Strong Q1 results beat expectations and 2026 guidance raised.
Kyverna’s miv-cel Scores Historic Win in Stiff Person Syndrome – First CAR-T Poised for FDA Approval
Kyverna’s CAR-T drug greatly improved rare SPS: patients walked 46% faster, many stopped meds; FDA filing planned 2026.
Merck and Eisai Phase 3 Miss Shakes Up Kidney Cancer Race – Analysts Split on Arcus
Merck’s new kidney cancer combos failed in Phase 3, missing key goals; analysts see mixed impact for Arcus and its drug.
Ionis’ Zilganersen Stabilizes Walking and Motor Skills in Alexander Disease Study
Ionis drug zilganersen showed promise for rare brain disease (Alexander disease), improving symptoms; FDA decision due Sept 2026.