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Enliven Therapeutics reports positive phase 1 CML data and FDA alignment for phase 3 trial (ELVN)

Updated ELVN-001 results showed strong molecular response rates in previously treated CML patients, while the FDA aligned ...
Hosted on MSN

Trevi Therapeutics plans two pivotal phase III trials for IPF-related chronic cough as FDA alignment achieved

Trevi plans to initiate two Phase III trials in IPF-related chronic cough, with the first trial starting in Q2 2026 and the second in the second half of 2026, and expects to provide top line data from ...
TMCnet

INmune Bio Receives MHRA Written Alignment Supporting Planned 2026 UK Conditional Marketing Authorization Application for CORDStrom™ in RDEB

MHRA pediatric feedback recognizes MissionEB Phase 2 data as demonstrating clinically meaningful symptomatic benefit, particularity pain and pruritis, and states the data could support positioning as ...
Business Insider

Vera Therapeutics Announces Alignment with U.S. FDA on Earlier ORIGIN Phase 3 Analysis to Support Potential Full Approval for Atacicept in Adults with IgA Nephropathy

Prescription Drug User Fee Act (PDUFA) date of July 7, 2026 for Biologics License Application (BLA) for accelerated approval of atacicept in patients with IgA Nephropathy (IgAN) Revised ORIGIN 3 eGFR ...

BioRestorative Completes Phase 2 Dosing of BRTX-100, Advancing Lead Regenerative Spine Program Toward 2027 Topline Data

Fully enrolled, randomized, double-blind, sham-controlled Phase 2 study has completed treatment administration in 99 patients; Company continues ...
manilatimes

Alterity Therapeutics Achieves Alignment with U.S. FDA on Pivotal Phase 3 Program for ATH434 in Multiple System Atrophy

- Successful End-of-Phase 2 meeting with FDA agreeing on key elements of the proposed Phase 3 design, including study population, dosing regimen, and treatment duration - - FDA agrees on UMSARS Part I ...
Business Wire

Vertex to Present Phase 3 Data Highlighting Suzetrigine’s Potential as a First-in-Class, Highly Selective Pain Signal Inhibitor at the American Society of Anesthesiologists ...

BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the company will present its pivotal Phase 3 data on suzetrigine, an investigational, oral, highly ...