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Satsuma Pharmaceuticals is a biopharmaceutical company dedicated to developing best-in-class products to address the unmet needs of migraine sufferers. As a wholly-owned subsidiary of Shin Nippon Biomedical Laboratories, Ltd. (SNBL), Satsuma is currently in the late stages of seeking regulatory approval from the U.S. Food and Drug Administration for its novel investigational therapeutic product, STS101.
STS101 is a unique nasal powder formulation of the well-established anti-migraine drug, dihydroergotamine mesylate (DHE). Administered via Satsuma’s proprietary nasal delivery device, STS101 aims to offer several benefits over existing acute migraine treatments. These include quick and convenient self-administration and several clinical advantages that current DHE liquid nasal spray products and injectable forms do not offer. The dry powder formulation of STS101 has shown to achieve rapid absorption and high DHE plasma concentrations, necessary for robust efficacy, and sustained plasma levels over time with low dose-to-dose variability.
DHE has long been recommended as a first-line treatment option for acute migraine in published treatment guidelines. However, the invasive and burdensome administration methods and sub-optimal clinical performance of existing DHE liquid nasal sprays and injectables have limited its widespread use. STS101, with its easy-to-carry and easy-to-use form, is designed to overcome these limitations, offering an improved therapeutic solution for acutely treating migraines.
STS101 has recently showcased its sustained efficacy in the Phase-3 Double-Blind, Randomized, Placebo-Controlled SUMMIT Study. The results were presented in an oral presentation, highlighting the potential of STS101 to become a significant advancement in migraine treatment.
Please note that forward-looking statements about the company’s future performance and expectations are subject to risks and uncertainties.
Satsuma Pharmaceuticals (Nasdaq: STSA) announced the acceptance of three abstracts for STS101 at the American Academy of Neurology’s 75th Annual Meeting. The meeting will be held from April 22-27, 2023, in Boston. The accepted abstracts include:
- Interim Analysis of Subject Impression Data for STS101: Shows favorable perceptions of STS101 in comparison to usual migraine medications.
- Long-Term Safety and Tolerability Data of STS101: Indicates that STS101 was well tolerated over long-term use for acute migraine treatment.
- Nasal Safety Data from the ASCEND Study: Demonstrates safety and tolerability of STS101, based on assessments of over 5,500 migraine treatments.
STS101 is a unique nasal powder formulation of dihydroergotamine mesylate designed to provide effective acute migraine relief.
Satsuma Pharmaceuticals (Nasdaq: STSA) has announced a definitive agreement for acquisition by Shin Nippon Biomedical Laboratories (SNBL), offering an upfront cash consideration of $0.91 per share, along with a non-tradeable contingent value right (CVR) of up to $5.77 per share. The deal aims to maximize shareholder value and follows Satsuma's recent submission of a New Drug Application (NDA) to the FDA for STS101, an investigational migraine treatment. The acquisition is conditional upon customary closing requirements, including shareholder approval, and the tender offer is expected to commence soon, lasting for 20 business days. The merger is projected to enhance the potential market for STS101, pending FDA approval.
Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA) announced topline results from the STS101 SUMMIT Phase 3 efficacy trial, indicating STS101 may offer robust anti-migraine effects. The company submitted a New Drug Application (NDA) to the FDA in March 2023 and aims for strategic transaction opportunities to enhance shareholder value. As of December 31, 2022, Satsuma reported $52.5 million in cash and equivalents. However, it plans a 36% workforce reduction effective March 31, 2023, amid financial losses of $70.1 million in 2022. The company believes STS101 could address critical needs in migraine treatment, pending regulatory approval.
Satsuma Pharmaceuticals, a clinical-stage biopharmaceutical company, announced that CEO John Kollins will present at the SVB Securities Global Biopharma Conference from February 14-16, 2023. Kollins is scheduled to speak on February 16 at 1:40 PM ET, with a live webcast available. Satsuma is developing STS101, a novel nasal powder formulation of dihydroergotamine, aimed at providing an improved acute treatment for migraines. STS101 is designed for quick self-administration, with advantages over existing DHE products. The company seeks to enhance therapeutic options for migraine patients, addressing limitations of current treatments.
Satsuma Pharmaceuticals provided an update on STS101, a novel nasal powder treatment for acute migraine, following the SUMMIT Phase 3 trial. The trial showed sustained efficacy on secondary endpoints, although co-primary endpoints did not achieve statistical significance. Market research indicates strong interest from headache specialists, with plans for NDA filing in Q1 2023. Satsuma is also seeking a commercialization partner.
While STS101 demonstrated robust safety, including minimal adverse events, the lack of statistical significance in primary endpoints raises questions about regulatory approval.
Satsuma Pharmaceuticals (Nasdaq: STSA) announces participation of CEO John Kollins in the 5th Annual Evercore ISI HealthCONx Conference on November 30, 2022. He will discuss the regulatory pathway for STS101, a nasal powder treatment for migraines, and implications from the SUMMIT Phase 3 trial results. The session will be held from 1:50-2:10 PM ET in Track 4. A replay will be available on Satsuma's Investor Relations site for 90 days. STS101 aims to improve upon existing migraine treatments with fast absorption and consistent dosing.
Satsuma Pharmaceuticals (STSA) announced topline results from the STS101 SUMMIT Phase 3 trial, developing STS101 for acute migraine treatment. Although STS101 showed numerically favorable results, it did not achieve statistical significance on co-primary endpoints at two hours post-administration. However, it demonstrated significant superiority on multiple key secondary endpoints at all later timepoints (p<0.001). The product exhibited a favorable safety profile, and the company is optimistic about future FDA interactions for NDA filing. Satsuma plans to explore alternatives to maximize shareholder value without investing in commercialization. Estimated cash as of October 31, 2022, is $59.4 million.
Satsuma Pharmaceuticals (STSA) reported its Q3 2022 results and recent developments regarding STS101, a nasal powder for migraine treatment. The company plans to disclose topline results from its Phase 3 SUMMIT efficacy trial in November 2022 and aims to submit a New Drug Application in Q1 2023. As of September 30, 2022, Satsuma holds $64.4 million in cash, providing a runway into the latter half of 2023. Despite rising R&D and administrative expenses, the STS101 trial's completion could significantly impact migraine treatment if successful.
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