Soleno Therapeutics, Inc. Securities Lawsuit Investigation

Shamis & Gentile P.A., a law firm that advocates for investors who are victims of securities fraud, is investigating potential claims against Soleno Therapeutics, Inc. (SLNO).

If you purchased or held Soleno Therapeutics securities and suffered losses, you may be eligible to join this securities investigation and seek compensation.

About Soleno Therapeutics

Soleno Therapeutics is a biopharmaceutical company focused on developing and commercializing therapies for rare diseases. The company’s primary product is VYKAT XR, which is designed to address significant unmet needs in the treatment of Prader-Willi syndrome, a rare genetic disorder. Soleno Therapeutics has highlighted VYKAT XR as its flagship and only FDA-approved product, making it central to the company’s business and growth prospects (pr.comtex.com).

In early 2025, Soleno Therapeutics reported strong momentum for VYKAT XR, emphasizing its readiness for launch if approved. The company also announced large financings, including a $158.7 million equity raise and a $200 million loan facility, both contingent on the product’s approval (investors.soleno.life). Key executives’ compensation was reportedly tied to the success of VYKAT XR, with performance-based RSUs vesting upon FDA approval (investors.soleno.life).

Potential Concerns Under Investigation

Lawyers are investigating several potential concerns related to Soleno Therapeutics’ disclosures and actions during the period from Feb. 27, 2025, through Aug. 15, 2025.

One major focus of the investigation is whether Soleno Therapeutics made misleading statements or omitted key information about the safety and commercial prospects of VYKAT XR. For example, in a Feb. 27, 2025 press release, the company touted “strong momentum” for VYKAT XR and its readiness for launch if approved (investors.soleno.life). Later, on May 7, 2025, Soleno Therapeutics highlighted that 268 patient start forms and 131 prescribers had been secured in just a few weeks (soleno.gcs-web.com). The CEO claimed that these metrics reflected “durable demand” and that VYKAT XR addressed a “significant unmet need” (soleno.gcs-web.com).

However, on Aug. 15, 2025, activist fund Scorpion Capital published a highly critical short-seller report. This report alleged that multiple children had been hospitalized for heart failure after receiving VYKAT XR and questioned the authenticity of the company’s launch metrics, calling them “hocus-pocus” and suggesting they were largely driven by a single investigator (pr.comtex.com). The report also warned that VYKAT XR might be pulled from the market and that new prescriptions could “plunge” (pr.comtex.com).

Lawyers may examine whether Soleno Therapeutics adequately disclosed these adverse events and risks to shareholders. Notably, on an Aug. 6, 2025 earnings call, management assured investors that “no new safety signals have emerged” post-launch (za.investing.com), even though the short report cited a “rapid pile-up” of heart failure cases in young patients (pr.comtex.com). Soleno Therapeutics’ press releases and SEC filings did not mention these specific adverse events, even as the FDA label included warnings about fluid overload and heart risks (soleno.gcs-web.com).

The timing of the corrective disclosure is also critical. On Aug. 15, 2025, as Scorpion’s report became public, Soleno Therapeutics’ stock price fell about 13% intraday and closed down 7.4% at $71.63, erasing hundreds of millions in market capitalization (www.streetinsider.com). There were no other major news events affecting the stock that day, suggesting the decline was directly tied to the revelations in the short-seller report (www.streetinsider.com). This scenario may satisfy the loss causation element that attorneys often examine in securities cases.

Another area lawyers may investigate is insider trading. In late March 2025, CEO Anish Bhatnagar sold 699,095 shares at prices around $66–69 per share, netting approximately $47 million (www.secform4.com) (www.secform4.com). These sales were not clearly part of a preplanned 10b5-1 program. Chief Commercial Officer Meredith Manning and Senior Vice President Patricia Hirano also sold shares during this period (whalewisdom.com) (www.stocktitan.net) (techdows.com). Lawyers may examine whether these trades were timed to take advantage of an inflated stock price before negative information became public.

Further, legal professionals might review whether executives had motive and opportunity to mislead investors. Soleno Therapeutics depended almost entirely on VYKAT XR, with no other significant pipeline products. The core patent for VYKAT XR is set to expire in 2026, adding pressure to maximize short-term gains (pr.comtex.com). The company’s own disclosures acknowledged that its success depended on regulatory and clinical outcomes, and there were allegations of “irregularities” and “red flags for data integrity” in clinical trial publications (pr.comtex.com).

The investigation may also focus on the estimated damages to investors. The stock’s decline of approximately $7.4 per share on Aug. 15, 2025, could represent the artificial inflation removed from the stock price (www.streetinsider.com). With tens of millions of shares traded during the class period, aggregate investor losses could reach several hundred million dollars.

Your Rights and Next Steps

If you purchased Soleno Therapeutics securities between Feb. 27, 2025, and Aug. 15, 2025, and suffered financial losses, you may have legal rights. This is an active investigation by securities attorneys, not a filed lawsuit. The investigation aims to determine whether a class action lawsuit should be filed to recover losses for affected investors.

Investors are encouraged to gather documentation of their purchases and losses during the class period. Lawyers are ready to help evaluate whether you may be eligible to participate in any potential recovery. If sufficient evidence of misconduct is found, a class action lawsuit could be filed on behalf of all similarly situated investors.

It is important to act promptly, as securities investigations are time-sensitive and may lead to deadlines for participating in any future class action.

You May Be Entitled to Compensation

Investors who purchased Soleno Therapeutics securities and suffered losses during the class period may be eligible to join any potential class action and seek compensation for their losses. Securities investigations move quickly, and acting now can help protect your rights.

To join the investigation and learn more about your options, complete the form below.