Soleno Therapeutics Faces Investigation After Disappointing Drug Launch Metrics
Redwood City, Friday, 16 January 2026.
Soleno shares plummeted following allegations of misleading VYKAT XR launch metrics. Investigations now probe claims that data was manipulated by a controversial physician, raising serious concerns for investors.
Legal Scrutiny Intensifies Over Commercial Disclosures
Soleno Therapeutics (NASDAQ: SLNO) is currently navigating a turbulent period as multiple law firms launch investigations into potential securities fraud. As of today, Friday, January 16, 2026, the biopharmaceutical company is facing scrutiny from Hagens Berman and Kirby McInerney LLP regarding allegations that it misled investors about the commercial viability of its lead product, VYKAT™ XR [1][7]. The core of the investigation centers on whether the company provided false or misleading financial statements concerning patient start numbers and discontinuation rates, creating a disparity between public assurances and internal realities [1].
From Optimism to Disruption
The catalyst for the current crisis can be traced back to a sharp divergence in the company’s narrative during late 2025. In September 2025, following FDA approval for VYKAT™ XR, Soleno management projected strong confidence, stating that the launch had “definitely exceeded our expectations” and was proceeding “really well” [1]. However, this optimism was starkly contradicted during the company’s third-quarter earnings call on November 4, 2025. During the call, Soleno executives admitted to a “disruption” in the launch trajectory, citing a lower volume of start forms and an increase in discontinuations attributed to non-serious adverse events [1]. The market reaction was immediate and severe; on November 5, 2025, Soleno’s stock price plummeted by $18.78, representing a decline of approximately 28 percent in a single day [1].
The “Hocus-Pocus” Allegations
Prior to the November disclosure, skepticism had already been mounting due to a critical report released by Scorpion Capital on August 15, 2025. The firm characterized Soleno as a “one-trick pony” and alleged that the company’s launch metrics were “hocus-pocus” [1]. A significant portion of these allegations focused on a “controversial physician” based in Gainesville, Florida. Scorpion Capital suggested this individual acted as an “invisible hand fueling initial start forms” and raised red flags regarding data integrity in the physician’s co-authored papers [1]. The report also cited concerning reports of children hospitalized for potential heart failure, casting doubt on the safety profile and trial data submitted to the FDA [1]. Between the release of this report on August 14 and the November earnings call, Soleno shares lost nearly 40 percent of their value [1].
Financial Outlook and Market Sentiment
Despite the legal headwinds and the stock’s volatility—closing at $41.95 on Thursday, January 15, 2026, after a 1.20 percent daily decrease—some financial analysts retain a positive outlook on the company’s fundamentals [4]. On January 12, 2026, Lifesci Capital raised its Q4 2025 earnings per share (EPS) estimate for Soleno to $0.59, up from $0.46 [3]. This follows a strong earnings report on November 4, where the company posted an EPS of $0.47, significantly beating the consensus estimate of $0.08 by 0.39 [3]. However, technical indicators paint a more cautious picture; the stock has been flagged as a sell candidate since January 9, 2026, and is currently in a falling trend with support found at $41.54 [4]. As the class action deadline of February 17, 2026, approaches for other unrelated securities cases, Soleno investors are now watching closely to see if the alleged governance failures will outweigh the company’s revenue potential in the coming fiscal year [7].