Soleno Class Action Lawsuit: A Complete Timeline [2026]

Soleno is a biopharmaceutical company focused on developing novel therapeutics for the treatment of rare diseases.  At the time of the Soleno class action lawsuit’s filing, Soleno’s only commercial product is diazoxide choline extended-release tablets (“DCCR”) for the treatment of hyperphagia in individuals afflicted with Prader-Willi syndrome (“PWS”).

The Soleno class action lawsuit alleges defendants throughout the Class Period failed to disclose that:

• The Soleno Phase 3 clinical trial program for DCCR had systematically downplayed, misrepresented, and/or concealed significant evidence of safety concerns potentially related to the administration of DCCR, including issues related to excess fluid retention in clinical trial participants;
• As a result, the administration of DCCR to treat hyperphagia in individuals with PWS posed materially greater safety risks than disclosed by Soleno or its executives; and
• Consequently, DCCR had materially lower commercial viability and undisclosed risks related to the likelihood of significant and widespread adverse events after its commercial launch, including risks related to patient discontinuation rates, lower patient adoption, prescriber reluctance, adverse regulatory action, and potential reputational and legal fallout.

Scorpion CapitaL Acticle

• On August 15, 2025, the Soleno class action lawsuit alleges that Scorpion Capital LLC published a critical report regarding Soleno, DCCR, and Soleno’s Phase 3 clinical trial program, titled “Russian Roulette With Prader-Willi Children: How The Latest Rare Disease Price-Gouging Scheme Fleeced the FDA, Parents, And Its Own Study Investigators With A Worthless, Toxic Drug; Suspect Data; And Sham Clinical Trials To Push A $500K/Year Knockoff Of A 50-Year-Old Generic Compound – Triggering One Of The Worst Launch Failures And Safety Catastrophes In Post-Approval History.”
• On this news, the price of Soleno common stock declined nearly 12% over two trading days, the Soleno class action lawsuit alleges.

Patient Death

• Then, on September 10, 2025, Soleno filed with the U.S. Securities and Exchange Commission a current event report on Form 8-K disclosing that a patient had died after taking DCCR, the Soleno shareholder lawsuit alleges.
• On this news, the price of Soleno common stock declined approximately 19% over two trading days, the Soleno class action lawsuit alleges.

Disappointing Fiancial Results

• Finally, on November 4, 2025, Soleno reported its financial results for its third fiscal quarter ended September 30, 2025, revealing that the Scorpion Capital Report had caused a “disruption” in DCCR’s launch trajectory and concerns within the PWS community, with a lower number of patient start forms and increased discontinuations beginning after the report’s publication, the Soleno class action alleges.
• On this news, the price of Soleno common stock declined approximately 27%, the Soleno class action lawsuit alleges

Filing of a Consolidated Complaint: Approximately Six Months After Initial Filing of the Soleno Class Action Lawsuit

• ​​Lead Plaintiff Appointment: After the appointment of lead plaintiff, the court will enter a scheduling order which will include a time, usually about 60 days, for the lead plaintiff to file a consolidated complaint consolidating the allegations all complaints along with any new additional allegations.

The Defendants Motion to Dismiss: Decided Nearly a Year After the Soleno Class Action Lawsuit

• Motion to Dismiss Briefing Schedule: In the same scheduling order, the court will also set a time for the defendants to file a motion to dismiss and schedule a briefing and possibly a hearing on the motion once the briefing is completed. The defendants may have 45 to 60 days to file the motion to dismiss and then the briefing schedule is typically around 60 days, and the court will then enter an order either granting or denying the motion to dismiss.

• One Year Has Passed: Thus, by the time defendants’ motion to dismiss is decided nearly a year has passed since the filing of the original complaint and could be possibly longer given the court’s schedule.

Completion Of Discovery: Two-and-a-Half-Years After Initial Filing of the Soleno Class Action Lawsuit

• Discovery Phase: If the defendant’s motion to dismiss is denied, the parties will move into the discovery phase including the exchange of documents, request for admissions, interrogatories, depositions, and third-party subpoenas, among others.

• Uncovering Facts: It allows both parties to obtain relevant information that may not be readily available, helping to clarify the issues at hand.

Settlement Negotiation and Mediation in the Soleno Class Action Lawsuit

• Settlement Negotiations Heat Up: By now two-and-a-half to three years have passed since the initial filing of the Soleno class action lawsuit. However, it is at this point that nearly all securities class actions result in a settlement, but that process takes time also. Once the parties have reached an agreement, it will have to be preliminarily approved by the court with notice to shareholders with the right to object, obtain final approval of the settlement, and then the claims process begins.

• Third Party Administrator: Usually, a third-party administrator is hired to administer the common fund. If the parties have complied with all the steps for approval, the judge will approve the distribution of the settlement fund by the claim’s administrator. You will receive a court-appointed notice and have to send in a claim form confirming your purchases and sales. This process alone can take up to a year and therefore it may be four years until the case is finally resolved.

Investor Rights in the Soleno Class Action Lawsuit

• Rights of Investors: Investors affected by the . possess specific rights that they can exercise. Understanding these rights is vital for anyone considering involvement in the lawsuit.

• Right to Information:  Investors have the right to receive accurate and timely updates regarding the Soleno class action lawsuit. This includes information on the case’s progress, potential settlements, and any necessary actions they may need to undertake.

• Right to Participate: Affected investors have the right to join the Soleno class action lawsuit. This allows them to collaborate with other investors in seeking compensation for their losses without the burden of filing individual lawsuits.

• Right to Legal Representation: Investors can seek legal counsel to navigate the complexities of the Flawsuit. Legal professionals can provide guidance and support throughout the process. If you suffered substantial losses and wish to serve as lead plaintiff of the Soleno class action lawsuit, or just have general questions about you rights as a shareholder, please contact attorney Timothy L. Miles of the Law Offices of Timothy L. Miles, at no cost, by calling 855/846-6529 or via e-mail at [email protected].

Options for Investors

• Options for Investors: Investors facing losses due to the Soleno class action lawsuit have several options available to them. Each option carries its own implications and potential outcomes.

• Joining the Class Action: One of the most straightforward options for investors is to join the Soleno class action lawsuit. By doing so, they can collectively pursue compensation for their losses without the need for individual litigation.

• Opting Out: In certain situations, investors may opt to file individual claims instead of joining the lawsuit. This option may be appropriate for those who believe their losses are significant enough to warrant separate legal action.

Seeking Legal Advice at No Charge in the Soleno Litigation

• Meet with an Attorney: Consulting with a legal professional experienced in securities law can provide investors with insights into their best course of action. Legal experts can help assess the merits of individual claims versus joining the class action.

• Contingency Fee: No Cost to Hire a Lawyer:  It does not cost anything to hire a lawyer​.  We take all cases on a contingency basis which means we do not get paid unless we win or settle your case. A securities lawyer​ can explain the process of a lawsuit and answer any questions you may have free of charge, so contact securities and shareholder rights attorney​ Timothy L. Miles today for a free case evaluation and see what your options are in the Soleno class action lawsuit.