Satsuma – Waiting To ASCEND The SUMMIT?

Shares of Satsuma Pharmaceuticals Inc. (STSA) have gained more than 45% over the past 1 month and trade around $6.

Satsuma is a clinical-stage biopharmaceutical company developing treatments for migraine and other debilitating conditions. The company’s lead investigational product is STS101, a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate, or DHE, for the acute treatment of migraine.

STS101 is under two pivotal phase III trials, dubbed ASCEND and SUMMIT.

ASCEND is designed to evaluate the long-term safety and tolerability of STS101 5.2 mg for the acute treatment of migraine. As of July 31, 2022, more than 480 subjects had enrolled in the study.

SUMMIT is evaluating the efficacy, safety, and tolerability of single doses of STS101 in the acute treatment of migraine. The trial is fully enrolled with more than 1,400 subjects.

In an earlier phase III efficacy trial, dubbed EMERGE, the results of which were reported in Sep.2020, there were no statistically significant differences between either dosage strength of STS101 3.9 mg and 5.2 mg and placebo on co-primary endpoints of freedom from pain and most bothersome symptom at two hours post-administration.

After analyzing the reasons for the disappointing EMERGE trial outcome, the company decided to use an improved 2nd-generation nasal delivery device to administer STS101.

In the SUMMIT trial, STS101 incorporates the 2nd-generation nasal delivery device, which is designed to provide more consistent nasal dosing.

Near-term Catalysts:

— Topline results from the ASCEND phase III safety trial are due this quarter.
— Topline results from the SUMMIT phase III efficacy trial are expected next quarter (Q4 2022).

Cash position:

As of June 3, 2022, the company had $68.1 million in cash, cash equivalents and marketable securities.

Satsuma Pharma made its debut on the Nasdaq Global Select Market on September 13, 2019, priced at $15 per share.

STSA has traded in a range of $2.51 to $6.70 in the last 1 year. The stock closed Wednesday’s trading at $6.44, up 1.90%.

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