Satsuma’s STS101 did not achieve statistical significance on the co-primary endpoints in Phase 3 EMERGE trials after which STSA plunged almost 76%.
The moment Satsuma Pharmaceuticals, Inc. (STSA) released Phase 3 EMERGE trial results for STS101, the shares price plunged like leaves fall in Autumn and it continued to drop until it finished the day -76% on Thursday.
Satsuma shares have dropped to its lowest in years. A sudden shift from $23 to $5 price mark is quite surprising which reflects that a large number of investors have backed out from STSA.
Satsuma closed at $5.62 on Thursday after its previous close of $23.34. This is almost an -$17.72 decline in the STSA shares. While the market capitalization of the company is around $97.84 million at the moment.
The company faced this major setback after it updated that it failed to achieve the co-primary endpoints of its investigational drug STS101 which was under the Phase 3 study. Satsuma was not able to obtain the statistical significance in the Phase 3 EMERGE study, as STS101 was being evaluated for treating migraine.
STS101, which is a dry-powder formulation of dihydroergotamine mesylate, was under clinical trials being assessed at two different dosing strengths in the study. The company could not either meet any of the co-primary endpoints.
The CEO of Satsuma stated that they are surprised that STS101 failed to achieve statistical significance. He added:
“On behalf of everyone at Satsuma, I’d like to thank the many people with migraine who participated in EMERGE as well as the staff at the trial sites for their dedication and diligence in completing the trial, despite the challenges posed by the ongoing COVID-19 pandemic.”
The topline data presented numerical differences in favor of STS101 3.9 mg and 5.2 mg versus placebo on the pre-specified co-primary endpoints at two hours post-administration.
The company is pretty disappointed with the outcomes, and so are its investors. Satsuma does not have any other pipeline candidates to cover up their loss. The only positive to take from the EMERGE trial was that STS101 dosage strengths were well-tolerated in the study, showing low negative event rates. Moreover, no serious adverse events were reported during the trials.
At the moment, Satsuma Pharmaceuticals is reviewing the ongoing event and is further analyzing the late-stage results for STS101. The company plans to provide a complete update on its business roadmap once they are finished with STS101 analyses.
As of June 30, 2020, the Company had cash, cash equivalents, and marketable securities of $93.7 million.
After a horrific trading session last day, Satsuma Pharmaceuticals, Inc. (STSA) is trading at $5.23 down by almost 7.30% in the pre-market, as of 9:14 A.M. EDT. Currently, it seems that STSA will continue the bearish momentum, until the company’s next update.