Satsuma Pharmaceuticals, Inc. Stock Price, News & Analysis

Satsuma Pharmaceuticals (STSA) announced the completion of the EMERGE Phase 3 efficacy trial for STS101, preparing to report top-line results by early October 2020. They initiated the ASCEND Phase 3 open-label safety trial aiming to enroll 300 migraine patients. Financially, Satsuma reported a net loss of $11.3 million for Q2 2020, with cash reserves of $93.7 million expected to sustain operations through 2021. R&D expenses rose to $8.8 million, attributed to increased trial activities, while general administrative expenses also saw a significant uptick.

Satsuma Pharmaceuticals (Nasdaq: STSA) has initiated patient enrollment in the ASCEND trial, a Phase 3 open-label study assessing the safety and tolerability of STS101 (dihydroergotamine nasal powder) for acute migraine treatment. The trial aims to enroll up to 300 subjects, evaluating long-term safety and efficacy. Results are expected to support a New Drug Application filing in Q4 2021, alongside data from the EMERGE trial. This study marks a significant step in developing STS101 as a potential treatment for migraine sufferers.

Satsuma Pharmaceuticals (STSA) appointed Thomas M. Soloway to its Board of Directors effective July 2, 2020. Soloway, an industry veteran with extensive operational and financial expertise, currently serves as Executive Vice President and COO of Audentes Therapeutics. His experience is expected to advance Satsuma during Phase 3 development and prepare for the commercialization of STS101, a novel treatment for acute migraines. The company anticipates topline results from the EMERGE Phase 3 trial in the second half of 2020, positioning STS101 as a significant player in migraine therapeutics.

Satsuma Pharmaceuticals (Nasdaq: STSA) has announced that its two poster presentations on the efficacy and safety of dihydroergotamine (DHE) for treating migraines will be showcased at the American Headache Society’s Annual Scientific Meeting, starting June 13, 2020. The posters, titled Safety of Dihydroergotamine for the Acute Treatment of Migraine: Reality vs Perception and The Efficacy of Dihydroergotamine versus Emerging Acute Migraine Medications, will be accessible on Satsuma's website. The company is developing STS101, a novel nasal delivery system for DHE, currently in Phase 3 clinical trials.

Satsuma Pharmaceuticals (Nasdaq: STSA) announced the completion of enrollment for its pivotal Phase 3 EMERGE trial of STS101, a nasal powder formulation of dihydroergotamine for migraine treatment. The trial, involving over 1,140 patients across 121 sites, aims to demonstrate STS101's efficacy and safety. The company is set to report topline results in the second half of the year, with plans to initiate a second Phase 3 trial (ASCEND) in Q3 2020. If successful, data from both trials could support a New Drug Application by late 2021.

Satsuma Pharmaceuticals (Nasdaq: STSA) has announced that CEO John Kollins will present at the Jefferies Virtual Healthcare Conference on June 3, 2020, at 1:00 p.m. ET. The presentation will be accessible via a live audio webcast on the company’s website, with a replay available for 90 days after. The conference will feature over 400 healthcare companies and discussions on investment opportunities within the industry. Satsuma is developing STS101, a novel treatment for migraines, currently in Phase 3 development.

Satsuma Pharmaceuticals announced that two abstracts from its development program for STS101, an intranasal Dihydroergotamine (DHE) formulation, have been selected for presentation at the 2020 AAN Annual Meeting. The presentations focus on the pharmacokinetic comparison of STS101 with other DHE formulations and the effectiveness of a water-insoluble mucoadhesive formulation for rapid drug absorption. STS101, currently in Phase 3 development, promises to offer a non-injectable, easy-to-use option for migraine treatment if approved.

Satsuma Pharmaceuticals (Nasdaq: STSA) has announced that its STS101 EMERGE Phase 3 efficacy trial is on track, with topline data expected in the second half of 2020. Despite the COVID-19 pandemic, the company reports no significant delays in program timelines. As of Q1 2020, Satsuma had cash and equivalents totaling $104.1 million, offering sufficient runway through a planned NDA filing by the end of 2021. The company reported a net loss of $11.8 million for Q1 2020, with increased R&D expenses attributed to ongoing clinical trials and operational costs.