Levi & Korsinsky LLP
04/30/2026 | Press release | Distributed by Public on 04/30/2026 12:05
Soleno Shareholders Allege DCCR Risks Were Kept Below the Surface
Soleno promised a breakthrough. A first of its kind treatment for a rare disorder. Executives said their drug VYKAT XR was safe, effective, and ready to change lives.
But investors later heard a very different story.
In March 2025, Soleno celebrated FDA approval of its drug for Prader Willi syndrome. Executives said the clinical data was strong and the launch was off to a great start.
Then in August 2025, a massive investigative report raised concerns about the company's clinical trials and potential safety risks. According to the report, some clinical investigators said they had concerns about the drug and were hesitant to prescribe it. Soon after, reports of adverse events began piling up and the launch started to unravel.
By November 2025, Soleno admitted the controversy had disrupted the drug's rollout and patient use was dropping.
The stock plunged about 27% in a single day.
Investors have now filed a securities fraud class action lawsuit.
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