Soleno Therapeutics, Inc. (SLNO)
Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Soleno Therapeutics, Inc. ("Soleno" or "the Company") (NASDAQ: SLNO). The investigation concerns whether Soleno and certain of its officers and/or directors have violated federal securities laws.
On March 8, 2021, Soleno issued a press release that “provided an update following recent interactions with the U.S. Food and Drug Administration (FDA) regarding the development of once-daily DCCR (diazoxide choline) extended release tablets for the treatment of Prader-Willi Syndrome (PWS).” Soleno’s press release stated, in relevant part, that “[s]ubsequent to the previously disclosed Type C meeting with the FDA on November 12, 2020 regarding the potential adequacy of data from studies with DCCR to support a New Drug Application (NDA) for the treatment of PWS, Soleno submitted additional analyses to the FDA from the Company’s Phase 3 trial, DESTINY PWS (C601). These data were from study visits that were completed prior to the significant disruptions caused by the COVID-19 pandemic. The data analyses showed statistically significant changes for DCCR compared to placebo in the primary and key secondary endpoints. Following its review of the data submitted by Soleno, the FDA informed the Company on March 5, 2021 that an additional controlled clinical trial will be necessary to support an NDA submission for DCCR in PWS.” On this news, Soleno’s stock price fell $1.31 per share, or 48.7%, to close at $1.38 per share on March 8, 2021.
If you are aware of any facts relating to this investigation, or purchased Soleno shares, you can assist this investigation by visiting contacting the firm. You can also contact Peretz Bronstein or his Investor Relations Analyst, Yael Hurwitz of Bronstein, Gewirtz & Grossman, LLC: 212-697-6484.
Bronstein, Gewirtz & Grossman, LLC is a corporate litigation boutique. Our primary expertise is the aggressive pursuit of litigation claims on behalf of our clients. In addition to representing institutions and other investor plaintiffs in class action security litigation, the firm’s expertise includes general corporate and commercial litigation, as well as securities arbitration. Attorney advertising. Prior results do not guarantee similar outcomes.