Soleno Investors Alerted to Pending Securities Fraud Lawsuit

Hagens Berman law firm says Soleno misled investors about safety issues and inflated launch metrics for its Prader-Willi drug VYKAT XR

Apr. 14, 2026 at 8:06pm

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A photorealistic studio still life featuring a shattered glass vial, a cracked pill capsule, and a stack of medical documents, conceptually representing the alleged safety issues and data integrity concerns surrounding Soleno's Prader-Willi drug.A shattered medical trial raises questions about transparency and integrity in the pharmaceutical industry.Gainesville Today

A securities fraud class action lawsuit has been filed against Soleno Therapeutics, Inc. (NASDAQ: SLNO) alleging the company misled investors about safety concerns and inflated launch metrics for its flagship drug VYKAT XR (DCCR) for treating Prader-Willi syndrome. The lawsuit covers the period from March 26, 2025 to November 4, 2025, and the lead plaintiff deadline is May 5, 2026.

Why it matters

The lawsuit raises serious questions about Soleno's handling of clinical trials and the commercial launch of VYKAT XR, which is a critical product for the company. Investors allege Soleno downplayed safety issues and used questionable metrics to maintain an inflated stock price, causing significant losses when the truth emerged.

The details

The complaint alleges Soleno failed to disclose significant evidence of safety concerns with VYKAT XR, including excess fluid retention and potential heart failure in children. It also claims the company's Phase 3 trials relied on a physician in Florida whose data exhibited irregularities. Additionally, Soleno allegedly fueled an 'invisible hand' to artificially inflate the number of 'start forms' for the drug's launch, rather than reflecting genuine market demand.

  • On August 15, 2025, an activist short seller report triggered a double-digit stock decline by detailing adverse patient reactions and investigator skepticism.
  • On November 4, 2025, Soleno reported Q3 2025 results, admitting to a disruption in VYKAT XR's launch and increased discontinuations, causing the stock to plummet 27% in a single day.

The players

Soleno Therapeutics, Inc.

A biopharmaceutical company focused on the development and commercialization of therapeutic products for the treatment of rare diseases.

Reed Kathrein

A partner at the law firm Hagens Berman leading the investigation into the alleged claims against Soleno.

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What they’re saying

“Our investigation centers on the complaint's claims that Soleno allegedly bypassed critical safety protocols and used questionable metrics to maintain an inflated stock price.”

— Reed Kathrein, Partner, Hagens Berman

What’s next

The lead plaintiff deadline for the securities fraud class action lawsuit against Soleno is May 5, 2026. Investors who purchased Soleno stock between March 26, 2025 and November 4, 2025 and suffered significant losses are encouraged to submit their information to the law firm leading the investigation.

The takeaway

This case highlights the importance of transparency and integrity in the biopharmaceutical industry, where investor trust is critical. The allegations against Soleno raise concerns about potential safety issues and questionable marketing tactics that could have serious implications for patients and shareholders alike.