| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | June 8, 2023 |
| Accession Number: | 0001193125-23-163096 | ||||||
| Submission Type: | POS AM | ||||||
| |||||||
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| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 10/10/2022 | $15.00 | Mkt Perform → Outperform | SVB Leerink |
| 8/31/2022 | $16.00 | Buy | Ladenburg Thalmann |
SVB Leerink upgraded Satsuma Pharmaceuticals from Mkt Perform to Outperform and set a new price target of $15.00
Ladenburg Thalmann initiated coverage of Satsuma Pharmaceuticals with a rating of Buy and set a new price target of $16.00
Mizuho upgraded Satsuma Pharmaceuticals from Neutral to Buy and set a new price target of $15.00 from $7.00 previously
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
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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
DELRAY BEACH, Fla., Nov. 9, 2021 /PRNewswire/ -- Cyrano Therapeutics, a clinical stage regenerative medicine company developing a novel intranasal therapy to restore smell and flavor function, today announced that it has appointed biopharmaceutical industry veteran John Kollins to its board of directors. Kollins is currently President and Chief Executive Officer of 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 currently in Phase 3 trials.
SOUTH SAN FRANCISCO, Calif., Oct. 12, 2021 (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 the appointment of Mutya Harsch, JD to its Board of Directors, effective immediately. Ms. Harsch is a highly regarded and established pharmaceutical industry professional who brings over 20 years of legal, corporate governance, corporate transaction, and operating experience to Satsuma. She currently serves as General Counsel, Chief Legal Officer and Secretary of VYNE Therapeutic