Satsuma Pharmaceuticals IncSTSA 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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