The company's Prader-Willi treatment inched closer to FDA approval.
SLNO stock gains 6.3% as FDA accepts regulatory filing for lead candidate, DCCR, to treat hyperphagia associated with PWS under Priority Review.
Soleno Therapeutics, Inc.'s NDA submission of DCCR for the treatment of patients with PWS accepted by the FDA with Priority Review with a PDUFA date of December 27th of 2024. Before the FDA PDUFA date of DCCR for the treatment of patients with PWS, the FDA plans to hold an advisory panel meeting for this drug. If DCCR is granted U.S. marketing approval, it would be the first approved drug of its kind to target hyperphagia and some other problems associated with PWS.
PHILADELPHIA, PA / ACCESSWIRE / June 11, 2024 / Kaskela Law LLC announces that it is investigating Soleno Therapeutics, Inc. (NASDAQ:SLNO) ("Soleno") on behalf of the company's stockholders. The investigation seeks to determine whether Soleno and/or the company's officers and directors violated the securities laws or breached their fiduciary duties to the company's investors in connection with recent corporate actions.