Soleno Therapeutics ($SLNO) DCCR Safety Risk Case

Investors can submit applications for the lead plaintiff role.

N.D. California

Court

3:26-cv-01979

Case number

03/26/2025

Class period Start

11/04/2025

Class period End

05/05/2026

Lead Plaintiff motion deadline

$SLNO investors filed a claim against Soleno Therapeutics for allegedly hiding safety problems tied to DCCR, including fluid retention and other adverse-event risks seen in trials and after launch.
After a report challenged DCCR’s safety and trial record, a patient death was disclosed, and Soleno Therapeutics later said the controversy had disrupted VYKAT XR’s launch and increased discontinuations. $SLNO fell about 27% on November 5, 2025.
$SLNO investors can join this case to be notified about potential recovery.
Case Details:

Between March 26, 2025 and November 4, 2025, Soleno Therapeutics told investors DCCR, sold as VYKAT XR, had won FDA approval based on a strong Phase 3 program and had a favorable safety profile. Executives emphasized the drug’s label, the lack of new safety signals, and encouraging early launch demand and compliance.

However, during this period, investors allege Soleno Therapeutics was not candid about safety issues tied to DCCR and the effect those issues could have on the drug’s rollout. Soleno Therapeutics allegedly failed to disclose that its Phase 3 DCCR program had downplayed, misrepresented, or concealed significant safety evidence, including excess fluid retention in trial participants; that DCCR posed greater safety risks than investors were told; and that those risks made the launch more vulnerable to discontinuations, weaker adoption, prescriber reluctance, and other commercial fallout.

Then, on August 15, 2025, a detailed report challenged DCCR’s trial conduct, safety profile, and early launch experience, citing alleged edema, diabetes-related issues, and other serious reactions. $SLNO fell nearly 12% by August 18, 2025, closing at approximately $68.  

 Additional revelations followed on September 10, 2025, when Soleno Therapeutics disclosed that a patient had died after taking DCCR, and on November 4, 2025, when the company said the report had disrupted VYKAT XR’s launch trajectory, lowered patient start forms, and increased discontinuations. 

By November 5, 2025, shares had dropped to $47, representing a total decline of at least 39.0% over the correction period.

Based on these events, $SLNO investors filed a claim against Soleno Therapeutics, alleging the company:
It hid serious DCCR safety risks.
It presented DCCR as safer and more commercially durable than investors were told, while downplaying fluid retention, diabetes-related issues, and other adverse events.
It painted an overly positive picture of DCCR’s trial support and launch momentum, and investors were harmed when safety concerns and rising discontinuations became public.
Investors argue Soleno Therapeutics misled the market about DCCR’s safety profile, trial support, and launch strength, causing losses when the truth emerged.

Case Type

US Securities Class Action

Case Status

Lead Plaintiff Submission

Alleged Offence

Misleading Statements,

Fraud,

Failure to Disclose,

Omissions

Suspected Party

Directors,

Management

Security Type

Stocks

Trade Direction

Long

Shock Event Date

08/15/2025

Filing date

03/06/2026

Lead Plaintiff Deadline

05/05/2026

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