- Satsuma Pharmaceuticals Inc STSA announced positive results from the ASCEND open-label, long-term safety trial for STS101 intranasal dry powder dihydroergotamine (DHE) drug device for migraine.
- The data show no concerning nasal safety signals, satisfy safety exposure requirements, and provide an encouraging efficacy, with the 2nd-Gen (Mk2) device yielding improved efficacy.
- HC Wainwright reiterated its Buy rating and raised the price target from $15 to $18 on incremental DCF probability of success improvement to 60% from 50% following these ASCEND Mk2 results.
- The company concluded enrollment in SUMMIT Phase 3 Efficacy Trial, with more than 1,400 subjects and data expected by the end of 2022.
- The data bodes well for SUMMIT considering EMERGE saw a 19.3 vs. 14.8% 2-hour pain freedom and 40.5% vs. 33.7% 2-hour freedom from most bothersome symptoms.
- “So, one may presume that SUMMIT should see a bigger efficacy jump vs. EMERGE than in ASCEND with Mk2 vs. Mk1. We expect positive SUMMIT data by November,” HC Wainwright says.
- The analyst expects marketing application filing in Q1 2023, with a launch in 1H 2024 and peak U.S. sales of around $400 million.
- Price Action: STSA shares are up 4.87% at $7.85 on the last check Wednesday.
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