FDA Alignment De-Risks CalciMedica’s Auxora Path in Acute Pancreatitis
FDA aligns with CalciMedica on Auxora Phase 2b endpoints for acute pancreatitis, de-risking the path to registration.
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#XY Event-Driven Stocks↓
FDA Grants Priority Review to PolyPid’s D-PLEX100 for Surgical Infection Prevention
PDUFA date set for Nov 28, 2026, triggering $15M milestone.
Processa Adds Next-Gen BTK Inhibitor VT-7208, Secures $200M Funding Into 2029 — But Ownership Shifts Dramatically
Processa acquires VT-7208, a next-gen brain-penetrant BTK inhibitor for food allergy, CSU & MS. $200M raise funds trials into 2029.
Prelude Shares Jump as Incyte Drops Rival JAK2 Drug
Prelude Therapeutics stock rises after Incyte discontinues INCB160058 to focus on next-gen JAK2V617F therapies, boosting its exclusive option deal.
ProMIS Reports Encouraging Safety and Biomarker Results for Alzheimer’s Candidate PMN310
Blinded six-month interim results show no ARIA-E with PMN310, favorable safety in APOE4 carriers, early biomarker movement, and analyst upgrades.
Altimmune’s Experimental Drug Cuts Heavy Drinking Days in Key Phase 2 Trial
Altimmune’s experimental drug cut heavy drinking and helped weight loss in a mid-stage alcohol use disorder trial. Next: FDA meeting.