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Chemomab Aligns with FDA on Phase 3 Trial Path for PSC Drug

Story Highlights
  • Chemomab aligns with FDA on a Phase 3 trial design for nebokitug targeting PSC.
  • The trial aims to position nebokitug as the first FDA-approved therapy for PSC by focusing on clinically significant events.
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Chemomab Aligns with FDA on Phase 3 Trial Path for PSC Drug

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An update from Chemomab Therapeutics ( (CMMB) ) is now available.

On February 19, 2025, Chemomab Therapeutics announced the completion of its End-of-Phase 2 meeting with the FDA, aligning on a Phase 3 trial design for its drug nebokitug (CM-101) targeting primary sclerosing cholangitis (PSC). This marks a significant milestone as it provides regulatory clarity and sets a path for potential FDA approval with a single pivotal trial, eliminating the need for liver biopsies and additional confirmatory studies. The trial will focus on clinically significant events associated with PSC progression, aiming to enroll around 350 patients. This development has the potential to position nebokitug as the first FDA-approved therapy for PSC, offering hope to patients with this debilitating and often fatal disease.

More about Chemomab Therapeutics

Chemomab Therapeutics is a clinical-stage biotechnology company based in Tel Aviv, Israel, specializing in the development of innovative therapeutics for fibro-inflammatory diseases with high unmet medical needs. Their lead product candidate, nebokitug (CM-101), is a first-in-class dual activity monoclonal antibody targeting CCL24, which is involved in inflammatory and fibrotic pathways. The company focuses on diseases such as primary sclerosing cholangitis (PSC), for which there are currently no FDA-approved treatments.

YTD Price Performance: -7.98%

Average Trading Volume: 94,013

Technical Sentiment Consensus Rating: Sell

Current Market Cap: $28.14M

See more data about CMMB stock on TipRanks’ Stock Analysis page.

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