NervGen Pharma Corp.: NervGen Pharma Announces Successful End-of-Phase 2 Meeting and FDA Alignment on RESTORE, a Phase 3 Registrational Study of NVG-291 for Chronic Tetraplegia

Alignment with the FDA across proposed study parameters of RESTORE, a 16-week registrational study evaluating NVG-291 in chronic tetraplegia.Primary endpoint will be the change from baseline in GRASSP ...
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, ...
Nasdaq

IMUNON, Inc. Announces Presentation of Promising Overall Survival Data from Phase 2 OVATION 2 Study for Advanced Ovarian Cancer and Initiation of Phase 3 Trial Sites for IMNN-001

Highly encouraging overall survival data from the Phase 2 OVATION 2 Study of IMNN-001 has been accepted for oral presentation at the prestigious ASCO Annual Meeting, indicating strong interest in the ...
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Acurx signals progress in Phase 3 ibezapolstat program with $12M credit line following regulatory alignment

David Luci, President and CEO, highlighted several significant developments, including the closing of a $2.5 million registered direct offering and the receipt of positive regulatory guidance from the ...
Seeking Alpha

Exclusive BAC Article: Elicio Therapeutics; Q3 Of 2025 ELI-002 PDAC Data, Phase 3 FDA Alignment 2nd Half Of 2025 And Catalysts

I believe that a good speculative biotech to go over for the "Exclusive BAC Subscribers Article" would be Elicio Therapeutics (ELTX). The reason why I want to go over this biotech next is because it ...
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 ...