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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 has announced positive results from a Phase 1 trial of STS101 for acute migraine treatment. All tested dose strengths were well-tolerated, achieving the target pharmacokinetic profile. This supports the initiation of the SUMMIT Phase 3 efficacy trial with the 5.2 mg dosage. Top-line results are expected in the second half of 2022. The company aims to demonstrate robust anti-migraine activity with its improved second-generation nasal delivery device, which is designed to enhance self-administration consistency compared to previous trials.
Satsuma Pharmaceuticals (Nasdaq: STSA) announced financial results for Q1 2021, reporting a net loss of $10.5 million ($0.48 per share). The company's cash position stands at $133 million, which is expected to fund operations into H2 2023. Key upcoming milestones include initiating the SUMMIT Phase 3 trial for STS101 in mid-2021 and completing the ongoing Phase 1 trial by Q2 2021. The ASCEND trial continues, with over 290 subjects enrolled and low adverse event rates. Satsuma plans to file a New Drug Application for STS101 by the end of 2022.
Satsuma Pharmaceuticals (Nasdaq: STSA) announced an updated development plan for STS101, a migraine treatment, including a new Phase 3 efficacy trial starting mid-2021, with topline results expected in late 2022. The company completed an $80 million private placement financing, enhancing its cash resources to over $148 million, ensuring operations funding into the second half of 2023. Financial results showed 2020 net losses of $47.6 million, with significant R&D investments. Satsuma also expanded its intellectual property portfolio with new patents.
Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA) announced its participation in the 31st Annual Oppenheimer Healthcare Conference on March 16, 2021, at 3:10 PM Eastern Time. The conference will be held virtually from March 16 to 18, with a live webcast available for following the presentation. Satsuma is focused on developing STS101, a novel treatment for acute migraine, utilizing a proprietary dry-powder formulation of dihydroergotamine mesylate (DHE) that simplifies self-administration. The company aims to enhance the clinical effectiveness of DHE while addressing limitations of existing treatments.
Satsuma Pharmaceuticals (NASDAQ: STSA) has announced a private investment in public equity (PIPE) financing, selling 14,084,507 shares of common stock to institutional investors. This transaction is expected to garner approximately $80 million in gross proceeds at an offering price of $5.68 per share. The financing is set to close on March 3, 2021. The funds will support the Phase 3 clinical development of STS101, a treatment for migraines, as emphasized by CEO John Kollins. The company will also file a registration statement with the SEC for the resale of these shares.
Satsuma Pharmaceuticals (Nasdaq: STSA) announced plans for a new Phase 3 trial of STS101, an investigational acute migraine treatment, set to begin mid-2021 with topline results anticipated in late 2022. The decision follows the EMERGE trial, where STS101 showed numerical efficacy but lacked statistical significance. To fund operations into late 2023, the company secured $80 million through private placement financing. Satsuma continues to gather support for STS101's development from healthcare investors and clinical advisors.
Satsuma Pharmaceuticals, a clinical-stage biopharmaceutical company, announced its participation in the Evercore ISI 3rd Annual HealthCONx Conference from December 1-3, 2020. The event will feature one-on-one virtual meetings with management. Satsuma is developing STS101, a novel therapeutic for acute migraine treatment, leveraging a proprietary dry-powder formulation of dihydroergotamine mesylate. This drug-device combination aims to simplify self-administration, addressing limitations of existing treatments. For more information, visit satsumarx.com.
Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA) reported Q3 2020 financial results, highlighting a net loss of $12.0 million ($0.69/share), up from $8.3 million ($2.26/share) in Q3 2019. The company holds $82.1 million in cash and equivalents, projected to fund operations through 2021. In the EMERGE Phase 3 trial for STS101, results showed numerical superiority for migraine treatment, achieving statistical significance beyond two hours post-administration. Satsuma is analyzing these outcomes and plans to update on development steps by early 2021.
Satsuma Pharmaceuticals (Nasdaq: STSA) announced its participation in two upcoming virtual healthcare conferences. The Credit Suisse 29th Annual Healthcare Conference will take place from November 9-12, 2020, featuring one-on-one meetings with management. Following this, Satsuma will attend the Stifel 2020 Virtual Healthcare Conference from November 16-18, 2020, also involving one-on-one management meetings. Satsuma focuses on developing STS101, a novel migraine treatment utilizing a proprietary nasal delivery device for rapid self-administration.
Satsuma Pharmaceuticals (Nasdaq: STSA) announced that CEO John Kollins will present at several upcoming conferences in September 2020. The events include:
- H.C. Wainwright 22nd Annual Global Investment Conference on September 15 at 4:00 PM ET
- Cantor Fitzgerald Virtual Global Healthcare Conference on September 16 at 1:20 PM ET
- Morgan Stanley Virtual 18th Annual Global Healthcare Conference on September 17 at 4:15 PM ET
Links to webcasts of the presentations will be available on their investor webpage. The company is developing STS101, a potential treatment for migraines.
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