Despite Trial Failure, Satsuma Pharma Says Its Migraine Candidate Has Potential For Approval

Author: Vandana Singh | December 20, 2022 01:46pm

• Satsuma Pharmaceuticals Inc (NASDAQ:STSA) provided an update on its STS101 development program and corporate update.
• Further analysis of results from the recently-completed SUMMIT Phase 3 efficacy trial of STS101 for the acute treatment of migraine shows differentiating and sustained antimigraine effects on clinically critical secondary endpoints.
• Satsuma believes the results of its STS101 clinical trial program support the planned FDA marketing application filing in Q1 2023 and potential approval.
• The company said there is a compelling rationale, with regulatory precedents, for including a portion of the SUMMIT trial efficacy results in the STS101 prescribing information, despite STS101 not achieving statistical significance versus placebo.
• Consistent with prior guidance, Satsuma remains on track to submit the STS101 NDA in the first quarter of 2023. 
• In parallel, the company is working to secure a commercialization partner for STS101.
• Price Action: STSA shares are up 11.70% at $0.9050 on the last check Tuesday.

Posted In: STSA