FierceBiotech

Bringing clinical trials to the community: a new model for precision enrollment

In the world of clinical trials, patient recruitment is an ongoing challenge. Despite technological advancements, sponsors often struggle to meet enrollment timelines or recruit patients, leading to ...
Business Wire

New Alzheon Peer-Reviewed Scientific Publication Describes Study Design and Baseline Characteristics from APOLLOE4 Phase 3 Trial of Oral ALZ-801/Valiltramiprosate in APOE4/4 ...

FRAMINGHAM, Mass.--(BUSINESS WIRE)--Alzheon, Inc., a clinical-stage biopharmaceutical company developing a portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s ...
Nasdaq

Chemomab Therapeutics Announces FDA Alignment on Phase 3 Trial Design for Nebokitug as Potential First Treatment for Primary Sclerosing Cholangitis

Chemomab Therapeutics has announced that it has successfully completed its End-of-Phase 2 meeting with the FDA, aligning on the design of a single Phase 3 trial for its lead product candidate, ...
Business Wire

Neurogene Announces Registrational Trial Design for Embolden™ Study of NGN-401 Gene Therapy for Rett Syndrome

Written agreement from FDA for single-arm, open-label, baseline-controlled registrational trial evaluating composite primary endpoint of improvement in CGI-I and gain of developmental milestone/skill ...
Nasdaq

Amylyx Pharmaceuticals Announces Pivotal Phase 3 LUCIDITY Trial Design for GLP-1 Receptor Antagonist (Avexitide) in Post-Bariatric Hypoglycemia

- Pivotal Phase 3 LUCIDITY trial will evaluate FDA-agreed upon primary outcome of reduction in hypoglycemia events and designed to align as closely as possible with previous Phase 2 trial designs - ...