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 ...
Seeking Alpha

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. (AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate ...
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 ...
Nasdaq

BioRestorative Therapies Announces FDA Clearance of Phase 2 BRTX-100 Clinical Study Protocol Amendment

MELVILLE, N.Y., April 16, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based ...
Morningstar

Anixa Biosciences Announces Approval of Protocol Amendment for Ovarian Cancer CAR-T Clinical Trial

SAN JOSE, Calif., Feb. 18, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer today ...
Benzinga.com

FDA Lifts Clinical Hold On vTv Therapeutics' Phase 3 Diabetes Trial, Stock Surges

FDA lifts hold on vTv's Phase 3 trial for cadisegliatin in type 1 diabetes, allowing the company to proceed with a shortened six-month study vTv plans to amend the trial protocol, reducing its ...
Insider Monkey

Aardvark Therapeutics Expands Phase 3 HERO Trial Eligibility for ARD-101 in Prader-Willi Syndrome After FDA Protocol Alignment

Aardvark Therapeutics Inc. (NASDAQ:AARD) is one of the best young stocks with huge upside potential. On October 8, Aardvark Therapeutics announced that the company had reached alignment with the US ...