DURHAM, N.C., June 15, 2023 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company currently seeking regulatory approval from the U.S. Food and Drug Administration for STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395), today announced that three abstracts describing efficacy and safety results from the STS101 Phase 3 efficacy trial were selected for presentation at the American Headache Society's (AHS) 65th Annual Scientific Meeting. The 2023 meeting will be held in a hybrid virtual and in-p

January 2024 PDUFA date expectedIf approved, STS101 would become the only DHE product evaluated in a randomized, placebo-controlled trial (the SUMMIT trial) against modern outcome measures recommended by both the U.S. Food and Drug Administration (FDA) and International Headache SocietyUnlike current DHE products, STS101 is designed to be easy-to-carry, quick and easy to self-administer within seconds without need for involved administration procedures and to rapidly achieve high drug plasma levels believed necessary for robust efficacy and to be below those levels associated with adverse events such as nausea and vomiting As announced on April 13, 2023 Satsuma entered into a definitive agre

SOUTH SAN FRANCISCO, Calif., April 21, 2023 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (NASDAQ:STSA), a development-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced that three abstracts highlighting STS101 were accepted at the American Academy of Neurology's (AAN) 75th Annual Meeting. The 2023 meeting will be held in a hybrid virtual and in-person format in Boston, Massachusetts from Saturday, April 22 to Thursday, April 27, 2023. Full abstracts are now available on the AAN website. Accepted Abstracts Title:Interim Analysis of Subject I

Transaction delivers immediate value and liquidity to Satsuma stockholders SNBL to acquire all outstanding shares of Satsuma for upfront cash consideration of $0.91 per share Satsuma stockholders to also receive non-tradeable CVR of up to $5.77 per share With the goal of maximizing value for stockholders, Satsuma's Board has carefully considered strategic options for Satsuma and STS101 and fully supports this transaction with SNBL SOUTH SAN FRANCISCO, Calif., April 16, 2023 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. ("Satsuma") (NASDAQ:STSA) today announced that it has entered into a definitive agreement to be acquired by Shin Nippon Biomedical L

- Announced topline results from STS101 SUMMIT Phase 3 efficacy trial that the company believes demonstrate STS101 provides differentiated, robust and sustained anti-migraine effects - - Submitted STS101 New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) in March 2023 - - Company seeking to maximize value for stockholders via strategic transaction - - ~36% workforce reduction to be implemented effective March 31, 2023 - - $52.5 million in cash, cash equivalents and marketable securities as of December 31, 2022 - SOUTH SAN FRANCISCO, Calif., March 28, 2023 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (NASDAQ:STSA), a development-stage biopharmaceutical company

SOUTH SAN FRANCISCO, Calif., Feb. 02, 2023 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (NASDAQ:STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced that John Kollins, President and Chief Executive Officer, will deliver a company presentation during the SVB Securities Global Biopharma Conference, which is being held virtually February 14-16. Mr. Kollins will also host virtual one-on-one meetings with investors. Mr. Kollins is scheduled to present at 1:40pm ET on Thursday, February 16. A live webcast of the presentation can b

Further analysis of results from recently-completed SUMMIT Phase 3 efficacy trial of STS101 for the acute treatment of migraine shows differentiating robust and sustained antimigraine effects on clinically important secondary endpointsQualitative and quantitative primary market research conducted post-SUMMIT trial readout and incorporating updated STS101 profile consistent with SUMMIT trial results indicates headache specialists continue to have strong interest in STS101, with high prescribers of migraine therapeutics anticipating prescribing it to approximately 30% of their migraine patientsBased on communications with FDA in multiple Type C meetings and May 2022 Type B clinical pre-NDA mee

SOUTH SAN FRANCISCO, Calif., Nov. 23, 2022 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (NASDAQ:STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced that John Kollins, its President and Chief Executive Officer, will participate in a Fireside Chat at the 5th Annual Evercore ISI HealthCONx Conference, which is being held virtually November 29 - December 1. Mr. Kollins plans to discuss Satsuma's STS101 program, including the planned U.S. regulatory pathway and potential implications of recently-reported STS101 SUMMIT Phase 3 ef

STS101 was not statistically superior to placebo at two hours post-administration on the co-primary endpoints of freedom from pain and most bothersome symptom STS101 showed superiority (p<0.001) differences versus placebo on freedom from pain and most bothersome symptom at all timepoints after two hours post-administration (3, 4, 6, 12, 24 and 48 hours), as well as on multiple key secondary endpoints, including pain relief at 2 hours post-administration and all timepoints thereafterSTS101 demonstrated a favorable safety and tolerability profile, consistent with clinical trial experience to dateBased on previous interactions with the FDA, Satsuma believes results from the STS101 Phase 1 PK an

- On track to report topline results from STS101 SUMMIT Phase 3 efficacy trial in November 2022; NDA submission planned in Q1 2023 - - $64.4 million in cash, cash equivalents and marketable securities as of September 30, 2022, provides runway into second half of 2023 - SOUTH SAN FRANCISCO, Calif., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (NASDAQ:STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today reported financial results for the third quarter of 2022 and summarized recent business highlights. "We are pleased to