Chemomab Therapeutics Secures FDA Alignment on CMC and Toxicology Milestones, Advancing Phase 3 Development of Nebokitug for PSC

Reuters
2025/06/11
Chemomab <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Secures FDA Alignment on CMC and Toxicology Milestones, Advancing Phase 3 Development of Nebokitug for PSC

TEL AVIV, Israel, June 11, 2025 -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB), a clinical stage biotechnology company, announced positive feedback from two recent meetings with the FDA, facilitating the advancement of their drug nebokitug into a Phase 3 clinical trial for Primary Sclerosing Cholangitis $(PSC.AU)$. The FDA has aligned with Chemomab on essential Chemistry, Manufacturing, and Controls $(CMC)$ requirements, ensuring the quality and consistency of the drug supply, and has also agreed to allow non-clinical toxicology studies to proceed concurrently with the Phase 3 clinical trial. This regulatory progress supports the timely advancement of nebokitug's development program as Chemomab continues discussions with potential strategic partners.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Chemomab Therapeutics Ltd. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9466553-en) on June 11, 2025, and is solely responsible for the information contained therein.

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