Chemomab Completes Successful End-of-Phase 2 Meeting and Aligns with FDA on Clear and Efficient Path to Potential Regulatory Approval for Nebokitug (CM-101) in Primary Sclerosing Cholangitis
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Chemomab has successfully completed an End-of-Phase 2 meeting with the FDA, aligning on a clear path to regulatory approval for its drug Nebokitug (CM-101) in treating Primary Sclerosing Cholangitis (PSC). A single pivotal Phase 3 study is planned.
February 19, 2025 | 12:15 pm
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Chemomab has reached an agreement with the FDA on a clear path to regulatory approval for its drug Nebokitug (CM-101) in treating PSC, following a successful End-of-Phase 2 meeting. This involves conducting a single pivotal Phase 3 study.
The successful alignment with the FDA on a clear regulatory path is a significant milestone for Chemomab, indicating potential future approval of Nebokitug (CM-101). This news is likely to positively impact CMMB's stock price in the short term as it reduces regulatory uncertainty and advances the drug's development.
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