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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 announced positive results from its STS101 ASCEND Phase 3 trial, showing a favorable safety and tolerability profile for the migraine treatment STS101 (dihydroergotamine nasal powder). With over 8,000 migraine attacks treated, the investigational product achieved freedom from pain in 34.2% and from most bothersome symptoms in 53.4% of treated attacks within 2 hours post-treatment. These findings support a planned NDA submission to the FDA in Q1 2023 and indicate potential market approval for the improved STS101 Mk2 device.
Satsuma Pharmaceuticals (Nasdaq: STSA) announced that CEO John Kollins will present a corporate overview at the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. The presentation will highlight STS101, an investigational nasal powder for acute migraine treatment, emphasizing its quick self-administration and clinical advantages over existing DHE products. The on-demand webcast will be available starting September 12 at 7:00 a.m. ET. Interested parties can schedule virtual meetings with Satsuma during the conference.
Satsuma Pharmaceuticals reported progress in its STS101 development program and financial results for Q2 2022. The company completed enrollment in the pivotal Phase 3 SUMMIT trial with over 1,400 subjects, expecting to announce topline results in Q4 2022. Satsuma also had pre-NDA meetings with the FDA and plans to file for STS101's approval in Q1 2023. Financially, the company recorded a net loss of $16.3 million, up from $11.8 million year-over-year, while research and development expenses rose to $12.5 million. With $68.1 million in cash, Satsuma has the runway to fund operations into late 2023.
Satsuma Pharmaceuticals has completed the enrollment of over 1,400 subjects in its pivotal Phase 3 SUMMIT trial, which evaluates the efficacy of STS101, a nasal powder for acute migraine treatment. This trial, the largest of its kind for a dihydroergotamine (DHE) product, aims to meet FDA guidelines for efficacy. Topline results are expected in Q4 2022, with the potential to include new efficacy claims for STS101 upon successful outcomes.
Satsuma Pharmaceuticals announced that five abstracts on STS101, an investigational drug for acute migraine treatment, were selected for the American Headache Society’s 64th Annual Meeting. The oral presentation titled Long-Term Safety and Tolerability of STS101 will be made by Dr. Stewart J. Tepper on June 11, 2022. STS101, a proprietary nasal powder formulation of dihydroergotamine, aims to improve self-administration and clinical efficacy compared to existing treatments. The meeting will take place from June 9-12, 2022, in Denver, Colorado.
Satsuma Pharmaceuticals (Nasdaq: STSA) announced a Key Opinion Leader (KOL) webinar on June 16, 2022, focused on the treatment of migraines with its investigational product, STS101, a nasal powder formulation of dihydroergotamine (DHE). The webinar will feature insights from migraine experts, Dr. Amaal Starling and Dr. Stewart Tepper, highlighting the existing treatment landscape and the potential of STS101. Satsuma aims to address unmet needs in migraine treatment with its novel therapy, designed for efficient self-administration and improved clinical performance.
Satsuma Pharmaceuticals (Nasdaq: STSA) announced that CEO John Kollins will present at the H.C. Wainwright Global Investment Conference in Miami, FL, on May 24-25, 2022. The presentation, scheduled for 4:00 p.m. ET on May 24, will cover their investigational migraine treatment, STS101, a nasal powder formulation of dihydroergotamine. Satsuma aims to enhance migraine treatment with improved self-administration and clinical benefits compared to existing therapies. A replay of the presentation will be available for 90 days.
Satsuma Pharmaceuticals (NASDAQ: STSA) reported continued progress in its clinical trials for STS101, a novel nasal powder treatment for migraine, as the Phase 3 SUMMIT trial is on track to report topline results in Q4 2022. The company anticipates submitting a New Drug Application (NDA) in Q1 2023. Financially, Satsuma holds $80.6 million in cash and equivalents as of March 31, 2022, which should support operations into the second half of 2023. However, the company posted a net loss of $15.5 million for Q1 2022, up from $10.5 million in Q1 2021.
Satsuma Pharmaceuticals (STSA) announced ongoing enrollment in the SUMMIT Phase 3 efficacy trial for STS101, a nasal powder treatment for migraines, aiming for topline results by Q4 2022. The company reported $95.8 million in cash as of December 31, 2021, sufficient to fund operations into the second half of 2023. Net losses for 2021 were $51.2 million ($1.75 per share), with R&D expenses rising to $37.6 million. Positive trial results could pave the way for a potential NDA filing in Q1 2023.
Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA) announced four abstracts will be presented at the 2022 American Academy of Neurology (AAN) Annual Meeting from April 2 to April 7. These abstracts highlight STS101, a novel nasal powder formulation of dihydroergotamine for migraine treatment. Key presentations include pharmacokinetics, long-term safety, and cardiovascular safety data. Satsuma aims to address limitations of existing treatments through improved administration and efficacy. Full abstracts are accessible on the AAN website.
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