Tag: diseases

Ad hoc-Mitteilung gemäss Art. 53 KR

- CMT-SORD program advances; meeting scheduled with the FDA in Q3 2025 to discuss govorestat for the treatment of CMT-SORD

PHOENIX, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a clinical-stage biotechnology company focused on regenerative and immune cellular therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead investigational therapy, CELZ-201-DDT, for the treatment of degenerative disc disease (DDD), a major cause of chronic lower back pain and disability.

Pratteln, Switzerland, 13 August, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces the signing of an exclusive agreement with Gen İlaç ve Sağlık Ürünleri San. ve Tic. A.Ş. (GEN) for the distribution and promotion of AGAMREE® (vamorolone) in Türkiye for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older.

BOSTON, Aug. 12, 2025 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (“Compass”) (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today announced the pricing of an underwritten public offering of 33,290,000 shares of its common stock at a price to the public of $3.00 per share and pre-funded warrants to purchase up to an aggregate of 6,710,000 shares of its common stock at a price to the public of $2.9999 per pre-funded warrant to purchase one share of the common stock, which represents the per share public offering price for the common stock less the $0.0001 per share exercise price for each such pre-funded warrant. The gross proceeds from the offering to Compass are expected to be approximately $120 million, before deducting underwriting discounts and commissions and other offering expenses. The offering is expected to close on or about August 14, 2025, subject to customary closing conditions. In addition, Compass has granted the underwriters a 30-day option to purchase up to 6,000,000 additional shares of common stock at the public offering price, less the underwriting discount.

•   First study participant randomized in Phase 3 CATT1 trial evaluating cadisegliatin for the treatment of type 1 diabetes with data expected in second half of 2026