Tag: endpoint

- The INDIGO study met its primary and all key secondary endpoints with statistically significant results -

Tokyo, Japan and Cambridge, UK, 2 June 2026 – Nxera Pharma Co., Ltd. (“Nxera” or the “Company”)　 announces that the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea has granted Orphan Drug Designation (ODD) and Global Innovative Products on Fast Track (GIFT) designation to vamorolone for the treatment of Duchenne muscular dystrophy (DMD). The Company plans to submit a Marketing Authorization Application (MAA) for vamorolone in South Korea during 2026.

POWER1 Study in highly refractory patients with focal onset seizures did not meet its primary success measure

NEW YORK, Aug. 17, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Biohaven Ltd. (“Biohaven” or the “Company”) (NYSE: BHVN) and certain officers. The class action, filed in the United States District Court for the District of Connecticut, and docketed under 25-cv-01120, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Biohaven securities between March 24, 2023 and May 14, 2025, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 sand Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.

NEW YORK, Aug. 16, 2025 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of Novo Nordisk A/S (NYSE:NVO), Altimmune, Inc. (NASDAQ:ALT), SelectQuote, Inc. (NYSE:SLQT) and Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided.

Tonmya is the first FDA-approved therapy for the treatment of fibromyalgia in over 15 years

Results support potential of efruxifermin (EFX) to reduce risk of fibrosis progression in patients with pre-cirrhotic (F2-F3) MASH

COSCIENS Board of Directors approves a plan to voluntarily delist from Nasdaq, while retaining the Company’s listing on the TSX