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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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.
Mixed Q2 for Humana: Earnings Beat and Cost Control, but No Guidance Raise Sparks Selloff
Humana posts $7.61 adjusted EPS, topping estimates as costs remain in line; shares decline after full-year guidance is reaffirmed without an increase.
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.
FDA Raises Serious Doubts Over Replimune’s RP1 Melanoma Therapy Ahead of Key Panel
FDA briefing docs criticize Replimune’s RP1 trial data, raising doubts over effectiveness and sending shares down ahead of Thursday’s panel.