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 ...
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 ...
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 ...
Morningstar

vTv Therapeutics Announces FDA has Lifted Clinical Hold on Cadisegliatin Program for Diabetes

CATT1 Phase 3 trial expected to resume following submission of protocol amendment shortening the overall duration of the trial from 12 to 6 months HIGH POINT, N.C., March 17, 2025 (GLOBE NEWSWIRE) -- ...
finanzen.at

Diamyd Medical Secures FDA Alignment To Accelerate Phase 3 Trial Readout In Type 1 Diabetes

Diamyd Medical announced that it has reached alignment with the U.S. Food and Drug Administration to accelerate the primary efficacy ...
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 ...

Diamyd Medical accelerates primary efficacy readout by 9 months in type 1 diabetes Phase 3 trial following FDA alignment and guidance

Diamyd Medical has reached alignment with the U.S. Food and Drug Administration (FDA) to accelerate the primary efficacy readout in 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 ...
Morningstar

In Support of Possible Expedited Approval Pathway for Crofelemer for Treatment of Microvillus Inclusion Disease (MVID), Jaguar Health Submits Amended Protocol to FDA for ...

SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / November 20, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that, in support of a possible ...