Unicycive Therapeutics Receives FDA Complete Response Letter for Resubmitted OLC NDA
The CRL relates to third-party manufacturing issues, but the FDA raised no concerns about clinical efficacy or safety.
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Prime Medicine Gets Analyst Upgrade to Buy as First In Vivo Prime Editing Trial Moves Forward
H.C. Wainwright cites New Zealand clearance for PM577a — the first in vivo Prime Editing clinical trial for Wilson’s disease.
AbbVie and Genmab Report Positive Phase 3 Results for Epcoritamab Plus Lenalidomide in Relapsed/Refractory DLBCL
New drug combo helps lymphoma patients live longer without worsening disease, cutting risk by ~60%—without chemotherapy.
Abivax Shares Surge as Obefazimod Delivers Strong Phase 3 Results in Difficult-to-Treat Ulcerative Colitis
Abivax advances toward Q4 2026 NDA filing with encouraging remission and safety results.
FDA Clears Gain Therapeutics’ GT-02287 for Phase 2 Parkinson’s Trials
Phase 2 trials in early Parkinson’s to start Q3 2026 in U.S. & Europe after strong Phase 1 biomarker and safety data.
Edwards’ Ecliptis Wins FDA Clearance, Challenges AtriCure in Surgical LAA Market
Edwards got FDA OK for heart clip; it enters a market led by AtriCure, adding competition but not changing the outlook much.