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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, Inc. (Nasdaq: STSA) announced that President and CEO John Kollins will present at the 11th Annual SVB Leerink Global Healthcare Conference on February 17, 2022, at 3:00 p.m. (ET). The presentation will be in a virtual fireside chat format, with an option for investors to participate via webcast. Satsuma is developing STS101, a novel dihydroergotamine nasal powder for acute migraine treatment, aiming to improve patient experience compared to existing DHE products.
Satsuma Pharmaceuticals (Nasdaq: STSA) reported ongoing enrollment in the SUMMIT Phase 3 efficacy trial for STS101, a novel migraine treatment, with topline results expected in H2 2022. The company appointed Mutya Harsch to its Board of Directors, enhancing its governance with her extensive pharmaceutical legal and operational experience. As of September 30, 2021, Satsuma holds $110.1 million in cash, sufficient to fund operations into the second half of 2023, while its Q3 net loss was $13.3 million, or $0.42 per share, slightly higher compared to the prior year. Research and development expenses rose to $10.2 million, reflecting ongoing trial efforts.
Cyrano Therapeutics announced the appointment of John Kollins to its board of directors. Kollins, currently President and CEO of Satsuma Pharmaceuticals (Nasdaq: STSA), brings over 30 years of biopharmaceutical experience. His expertise includes strategic and operational roles, particularly in developing intranasal therapies. Cyrano focuses on treating long-term smell and flavor loss, a condition affecting 5% of the U.S. population, exacerbated by COVID-19. The company previously raised $12.8M in Series A financing to support its development efforts.
Satsuma Pharmaceuticals, a clinical-stage biopharmaceutical company, announced CEO John Kollins will present at two upcoming healthcare conferences. The Credit Suisse 30th Annual Healthcare Conference is scheduled for November 10, 2021, from 3:30 to 4:10 p.m. ET, followed by the Evercore ISI 4th Annual HealthCONx Conference on November 30, 2021, from 11:20 to 11:40 a.m. ET. Both events will allow investors to participate via webcast and schedule one-on-one meetings. Satsuma is developing STS101, a nasal powder formulation for treating migraines, showing promise in its delivery and efficacy.
Satsuma Pharmaceuticals (Nasdaq: STSA) announced the appointment of Mutya Harsch, JD, to its Board of Directors, effective immediately. Harsch brings over 20 years of pharmaceutical industry experience and is currently General Counsel at VYNE Therapeutics. Board Chairman Heath Lukatch emphasized the value Harsch's expertise will bring as Satsuma advances its migraine treatment candidate, STS101, through Phase 3 development towards commercialization. Harsch expressed confidence in the company's strategy and executive leadership, anticipating a possible New Drug Application filing for STS101 next year.
Satsuma Pharmaceuticals announced that CEO John Kollins will present at the Cantor Virtual Global Healthcare Conference on September 30, 2021, from 2:40 to 3:10 PM ET. The company is developing STS101, a nasal powder formulation of dihydroergotamine for migraine treatment, aiming to provide quick and convenient self-administration advantages over current treatments. Investors can participate through a webcast. A replay will be available for 90 days after the event.
Satsuma Pharmaceuticals (Nasdaq: STSA) announced that President and CEO John Kollins will present at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13–15, 2021. The event will be held virtually. Attendees will have access to an on-demand corporate presentation starting September 13 at 7 AM ET for 90 days. Satsuma is developing STS101, a nasal powder formulation of dihydroergotamine for acute migraine treatment, designed to offer significant advantages over current treatments.
Satsuma Pharmaceuticals (Nasdaq: STSA) has initiated the STS101 SUMMIT Phase 3 efficacy trial following positive results from its Phase 1 trial, showcasing favorable pharmacokinetic and safety profiles. This double-blind, randomized trial aims to enroll approximately 1,400 subjects, with topline results expected in the second half of 2022. The company reported a cash position of $121.2 million as of June 30, 2021, providing adequate runway into 2023. For Q2 2021, Satsuma incurred a net loss of $11.8 million or $0.38 per share, compared to a loss of $11.3 million or $0.65 per share in the same period last year.
Satsuma Pharmaceuticals has initiated the SUMMIT Phase 3 trial for STS101, a nasal powder treatment for acute migraine. This trial includes approximately 1,400 subjects and follows FDA guidelines. The co-primary endpoints focus on pain relief and alleviating bothersome symptoms within two hours post-administration. The trial is designed to provide statistical power exceeding 99% for pain relief. Results are anticipated in the second half of 2022, with hopes for FDA approval to differentiate STS101 as the first effective DHE product on established endpoints.
Satsuma Pharmaceuticals, a clinical-stage biopharmaceutical company, is set to present at the SVB Leerink CNS Forum on June 29, 2021. CEO John Kollins will discuss STS101, a novel nasal powder formulation of dihydroergotamine for treating migraines. The SUMMIT Phase 3 trial is underway, evaluating STS101's efficacy in a randomized, double-blind study involving 1,400 participants. STS101 aims to provide a convenient, self-administered treatment option, addressing limitations of existing DHE products. For more information, visit www.satsumarx.com.
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