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What will be the next significant regulatory milestone for ISM6331 by August 2025?
2
Resolution / Starting Odds
Phase 2 Clinical Trial Approval • 25%
Breakthrough Therapy Designation • 25%
Priority Review Designation • 25%
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FDA announcements and Insilico Medicine's official press releases
Story
Insilico's AI-Designed ISM6331 Gets FDA Approval, Orphan Drug Status for Tumors
Aug 10, 2024, 01:00 AM
Insilico Medicine has achieved a significant milestone with its AI-designed TEAD inhibitor, ISM6331, receiving both FDA Investigational New Drug (IND) approval and Orphan Drug Designation. This innovative therapy targets solid tumors and mesothelioma, marking a notable advancement in the company's clinical pipeline. Since 2021, Insilico Medicine has nominated 18 preclinical drug candidates, with nine advancing to further stages. The approval of ISM6331 underscores the potential of AI in drug discovery and development.
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