REDWOOD CITY, Calif. – Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided an update following a recent interaction with the U.S. Food and Drug Administration (FDA) regarding the development of once-daily DCCR (diazoxide choline) extended-release tablets for...
treatment News
REDWOOD CITY, Calif. — Soleno Therapeutics, Inc. (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to diazoxide choline for the treatment of adults and children ages 4 years...
FRISCO, Texas – Soleo Health, an innovative leader and national provider of complex specialty pharmacy and infusion services, announced today it has joined the treatment center directory for GIVLAARI® (givosiran), managed by Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company. This inclusion allows Soleo Health to administer GIVLAARI in adults with Acute...
CHARLESTOWN, Mass. — Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced a non-exclusive worldwide license and collaboration agreement with Armatus Bio for the use of Solid’s proprietary capsid AAV-SLB101 for the development and commercialization of Armatus’ vectorized RNAi...
CHARLESTOWN, Mass. — Solid Biosciences Inc., a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced that it has been granted orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for SGT-003, the company’s next-generation Duchenne muscular dystrophy (Duchenne) gene therapy candidate....
CHARLESTOWN, Mass. — Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation for SGT-003, the company’s next-generation Duchenne muscular dystrophy (Duchenne) gene therapy candidate. “Solid’s receipt...
PRINCETON, N.J. — Soligenix, Inc., a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today a publication describing the preclinical efficacy of a novel, single-vial, bivalent vaccine providing 100% protection against both Sudan ebolavirus (SUDV) and Marburg...
PRINCETON, NJ – Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has been granted a Pediatric Investigation Plan (PIP) product-specific waiver from the Medicines and...
PRINCETON, NJ – Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the U.S. Food and Drug Administration (FDA) has conditionally accepted HyBryte™ as the proposed brand...
Nagoya, Japan – An international team, led by researchers at Nagoya University in Japan, may have determined why the diffuse anaplasia (DA) subtype of Wilms tumor (WT) resists chemotherapy. This subtype grows even when it has a high burden of DNA damage and increases the mutation rate of tumor protein...