• Wed. Feb 28th, 2024

Despite Trial Failure, Satsuma Pharma Says Its Migraine Candidate Has Potential For Approval – Satsuma Pharmaceuticals (NASDAQ:STSA)

ByVandana Singh

Dec 20, 2022
Despite Trial Failure, Satsuma Pharma Says Its Migraine Candidate Has Potential For Approval - Satsuma Pharmaceuticals (NASDAQ:STSA)

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  • Satsuma Pharmaceuticals Inc 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.

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Image and article originally from www.benzinga.com. Read the original article here.