Nasdaq

Aardvark Therapeutics Announces FDA Alignment on Protocol Amendment Expanding Phase 3 HERO Trial Population for Prader-Willi Syndrome

SAN DIEGO, Oct. 08, 2025 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics ...

FDA Feedback Supports Extension Phase for Jaguar Health's Clinical Trial of Crofelemer for Treatment of Microvillus Inclusion Disease (MVID)

MVID has a lethal natural history requiring life-sustaining parenteral support (PS), which includes total parenteral ...
Nasdaq

FDA Approves CardiAMP® Heart Failure II Protocol Amendment to Use Proprietary Cell Population Analysis Screening to Define Treatment

SUNNYVALE, Calif., Aug. 21, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary ...

enGene Shares Detalimogene NMIBC Trial Changes, FDA Endpoint Shift, and 2027 Approval Path at Conference

Executives from enGene (NASDAQ:ENGN) provided an update on the company’s detalimogene program in non-muscle invasive bladder cancer (NMIBC), discussing recent protocol changes, regulatory interactions ...
Healio

FDA agrees to amend special protocol assessment for trial of Axpaxli in wet AMD

Please provide your email address to receive an email when new articles are posted on . The SOL trial will now include treatment-naïve patients with wet AMD and visual acuity of 20/80 or better at ...
Seeking Alpha

PDS Biotech outlines trial protocol amendment for accelerated PFS endpoint in HPV16-positive cancer

Management described seeking an amendment to the VERSATILE-003 protocol to elevate progression-free survival (PFS) as a surrogate primary endpoint, in addition to maintaining median overall survival ...
Business Wire

Ankyra Therapeutics Announces Trial in Progress Poster Presentation at 2024 ASCO Meeting and Approval of ANK-101 Phase 1 Protocol Amendment

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ankyra Therapeutics, a clinical-stage oncology company developing anchored immunotherapies to improve the therapeutic window for immuno-oncology drugs, announced ...