Shares of clinical-stage biopharmaceutical company, Satsuma Pharmaceuticals, Inc. (STSA - Free Report) plunged after it announced disappointing top-line results from its late-stage study of STS101 (dihydroergotamine [DHE] nasal) powder as an acute treatment for migraine.
The phase III EMERGE efficacy study of STS101 is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study conducted in more than 1,140 migraine patients in the United States.
After establishing full eligibility, EMERGE trial participants were randomized (1:1:1) to receive one of three treatments — STS101 DHE 3.9 mg, STS101 DHE 5.2 mg or a matching placebo — and instructed to treat their next migraine attack of at least moderate pain severity with the allocated blinded study medication.
The top-line data from the study did not show statistically significant differences between either dosage strength of STS101 and placebo on co-primary endpoints of freedom from pain and most bothersome symptom at two hours post-administration.
Nevertheless, both dosage strengths of STS101 demonstrated significant effects on both freedom from pain and most bothersome symptom by three hours post-dose and later time points. Both STS101 dosage strengths were well-tolerated in the EMERGE study, with low adverse event rates and no serious adverse events reported.
Meanwhile, further analysis of the EMERGE study data is ongoing and the company will provide a more detailed update on its business plans after these analyses are completed.
Satsuma’s shares have plummeted 71.4% in the year so far compared with the industry’s decline of 3.2%.
The results disappointed investors, as positive results from the study and the successful development of the candidate would have boosted growth for this clinical-stage company.
Last year, the FDA approved Allergan’s Ubrelvy for the acute treatment of migraine with or without aura in adults. Ubrelvy is the first and only orally-administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the treatment of migraine attacks. Moreover, anti-CGRP drugs like Eli Lilly’s (LLY - Free Report) Emgality and Teva Pharma’s (TEVA - Free Report) Ajovy also received approval from the FDA for migraine treatment.
Satsuma currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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