GH Research Announces FDA Lifts Clinical Hold on GH001, Clearing Path for Global Phase 3 Initiation in 2026

GH001 cleared by FDA for U.S. clinical investigation, enabling U.S. subject enrollmentCompany to seek FDA alignment on global Phase 3 program ...
Morningstar

Newron Announces the US Initiation of Its ENIGMA-TRS 2 Phase III Global Clinical Study With Evenamide as an Add-On Therapy for Patients With Treatment-Resistant Schizophrenia (TRS)

ENIGMA-TRS 2 is a global, randomized, double-blind, placebo-controlled 12-week Phase III clinical study designed to enroll at least 400 patients; topline results are expected by Q4 2026 Evenamide is a ...
TMCnet

Enveda Advances Third Asset to the Clinic With US FDA IND Clearance and Phase 1 Initiation of ENV-6946, a First-in-Class Oral "Multi-Biologic in a Pill" for Inflammatory Bowel ...

This milestone marks Enveda's third asset to enter clinical development, following ENV-294 (atopic dermatitis and asthma) and ENV-308 (obesity), underscoring the productivity of the company's platform ...
Nasdaq

Merck Announces Phase 3 Trial Initiation for Bomedemstat, an Investigational Candidate for the Treatment of Certain Patients With Essential Thrombocythemia

The initiation of a second Phase 3 clinical trial for bomedemstat demonstrates company’s commitment to advancing research in myeloproliferative neoplasms (MPNs) RAHWAY, N.J.--(BUSINESS WIRE)-- Merck ...
Business Wire

MedinCell announces the initiation of Phase 3 study of F14 (mdc-CWM), a therapeutic first-in-class that aims to provide weeks of localized pain relief after Total Knee Replacement

MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: MedinCell (Paris:MEDCL) today announced that its partner, Arthritis Innovation Corporation (AIC), who conducts and finances all development ...
Nasdaq

Longboard Pharmaceuticals Announces Initiation of First-in-Human Phase 1 Clinical Study of LP659 in Adult Healthy Volunteers

Initiated Single-Ascending Dose (SAD) Phase 1 clinical study evaluating LP659 LA JOLLA, Calif.--(BUSINESS WIRE)-- Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical ...
Seeking Alpha

Vir Biotechnology announces initiation of ECLIPSE Phase III program for hepatitis delta virus

CEO Marianne De Backer emphasized Vir's progress in advancing its infectious disease and oncology programs. Key milestones include initiating the ECLIPSE Phase III registrational program for hepatitis ...

Leads Biolabs And Dianthus Therapeutics Announce Initiation of Phase 1 Trial Of LBL-047 (DNTH212) In Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)

LBL-047 (DNTH212) is a bifunctional fusion protein targeting plasmacytoid dendritic cell (pDC) BDCA2 to reduce Type 1 interferon production, ...
Business Wire

Alumis Announces Initiation of Patient Dosing in Phase 2 Clinical Trial of ESK-001 for the Treatment of Plaque Psoriasis

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Alumis Inc., a precision immunology company that is reimagining the discovery, development and treatment of autoimmune disorders, today announced that the ...