Tag: therapy

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.

ROCKVILLE, Md. and SUZHOU, China, Aug. 17, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that it has received clearance by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to conduct GLORA-4 study (NCT06641414), a global registrational Phase III study of lisaftoclax (APG-2575), a proprietary Bcl-2 inhibitor, in combination with azacitidine (AZA), for the treatment of patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS).

NEW YORK, Aug. 16, 2025 (GLOBE NEWSWIRE) --

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Sarepta Therapeutics, Inc. (NASDAQ: SRPT) between June 22, 2023 and June 24, 2025, both dates inclusive (the “Class Period”), of the important August 25, 2025 lead plaintiff deadline.

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $100,000 In Sarepta To Contact Him Directly To Discuss Their Options

   
- Successfully initiated enrollment in advanced Phase 2 ovarian cancer trial

EMERYVILLE, Calif., Aug. 15, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced that on August 12, 2025, the compensation committee of the Company’s board of directors granted three new non-executive employees 58,900 Restricted Stock Units (RSUs). The RSUs were granted pursuant to the Company’s 2025 Employment Inducement Award Plan, which was approved by the Company’s board of directors in February 2025 under Rule 5635(c)(4) of The Nasdaq Global Market for equity grants to induce new employees to enter into employment with the Company.

NEW YORK, Aug. 15, 2025 (GLOBE NEWSWIRE) -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC, a nationally recognized law firm, notifies investors that a class action lawsuit has been filed against Sarepta Therapeutics, Inc. (“Sarepta” or “the Company”) (NASDAQ: SRPT) and certain of its officers.

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

SAN DIEGO, Aug. 15, 2025 (GLOBE NEWSWIRE) -- Regen BioPharma, Inc. (OTC ID: RGBP and RGBPP) today provided further insight into its planned Phase 1 clinical trial of HemaXellerate, the company’s innovative stem cell-derived therapy, which has already received U.S. FDA clearance. While the initial focus is on treating aplastic anemia, a rare orphan indication, Regen BioPharma is evaluating expanded applications for this groundbreaking therapy in markets poised for significant growth.