FDA issues complete response letter rejecting Tris Pharma’s narcolepsy candidate; Agenus halts Phase 3 colorectal cancer trial

The U.S. Food and Drug Administration sent Tris Pharma a complete response letter for its experimental treatment for narcolepsy, stating that additional data are required before approval can be considered.

The agency’s feedback effectively stops the current filing and means the company must gather the requested information, which could push back any potential launch timeline.

In a separate development, biotech firm Agenus announced it is abandoning its Phase 3 trial of a colorectal cancer therapy after the study failed to meet its primary endpoints.

Both setbacks highlight the regulatory and clinical hurdles that companies face as they advance new therapies toward market.