Shares of Satsuma Pharmaceuticals (NASDAQ: STSA) tanked in pre-market trading on Monday by more than 80% after the clinical-stage biopharmaceutical company reported disappointing topline results from the STS101 SUMMIT Phase 3 efficacy trial.
STS101 (dihydroergotamine (DHE) nasal powder) is Satsuma’s novel investigational therapeutic product candidate for the acute treatment of migraine.
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The company stated that STS101 did not show statistically significant superiority to the placebo treatment on the pre-specified co-primary endpoints of freedom from pain and freedom from most bothersome symptom (from among photophobia, phonophobia and nausea) (MBS-free) at two hours post-administration of the treatment.
John Kollins, Satsuma’s President and CEO stated, “We are surprised and disappointed that STS101 did not demonstrate statistically significant superiority over placebo at two-hours post treatment on the SUMMIT study co-primary endpoints. However, based on our interactions to date with the FDA, we believe the results from the STS101 Phase 1 pharmacokinetic and ASCEND Phase 3 open-label, long-term safety trials will support the STS101 NDA filing and marketing approval. “
The company also stated in its press release that it does not intend to invest in commercializing STS101.