Soleno withdraws EMA bid for VIOKAT in PWS

Soleno Therapeutics, Inc. has voluntarily withdrawn its marketing authorization application for VIOKAT prolonged-release tablets (diazoxide choline) for Prader-Willi syndrome in Europe.

Rhea-AI Filing Summary

Soleno Therapeutics, Inc. has voluntarily withdrawn its marketing authorization application for VIOKAT prolonged-release tablets (diazoxide choline) for Prader-Willi syndrome in Europe. The application had been under review by the European Medicines Agency with a decision previously expected in mid-2026.

The withdrawal is described as a business and strategic decision and preserves the company’s ability to re-engage with regulators later if an appropriate path emerges. The company cautions that there is no assurance it will re-engage with the EMA and includes standard forward-looking statement disclaimers.

Positive

• None.

Negative

• Withdrawal of EMA application for VIOKAT: Soleno has voluntarily withdrawn its marketing authorization application for VIOKAT for Prader-Willi syndrome in Europe, pausing the prior mid-2026 EMA decision timeline and creating uncertainty around future EU regulatory and commercial prospects for this therapy.

Insights

Biopharma regulatory and strategy analyst

Soleno halts EU review of its Prader-Willi therapy, delaying potential regional access.

Soleno Therapeutics has voluntarily withdrawn its European marketing authorization application for VIOKAT, a diazoxide choline prolonged-release tablet for Prader-Willi syndrome. The dossier had been under EMA review, with a decision previously anticipated in mid-2026.

The company frames this as a business and strategic move, emphasizing that withdrawal lets it preserve the option to re-engage regulators if a viable pathway appears. However, the disclosure explicitly notes there is no assurance the company will re-engage with the EMA, highlighting uncertainty around any future EU strategy for this product.

Without a live application, near-term prospects for European approval and commercialization of VIOKAT are effectively paused, and any future regulatory steps would depend on subsequent interactions and decisions that are not detailed in this disclosure.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Key Figures

Patient age range: 4 years and older

1 metrics

Patient age range 4 years and older Treatment population for VIOKAT in Prader-Willi syndrome

Key Terms

marketing authorization application, European Medicines Agency, Prader-Willi syndrome, hyperphagia, +1 more

5 terms

marketing authorization application regulatory

"has voluntarily withdrawn its marketing authorization application (“MAA”) for VIOKAT"

A marketing authorization application is a formal request submitted to a government regulator asking permission to sell a prescription medicine or medical product in a country or region. Think of it like asking for a business license after showing evidence the product is safe and works; investors care because approval determines whether the product can generate sales, how soon revenue starts, and how much regulatory risk and uncertainty remains.

European Medicines Agency regulatory

"under review by the European Medicines Agency (“EMA”), with a decision expected"

The European Medicines Agency is the central drug regulator that evaluates and authorizes medicines for use across the European Union and related countries, similar to a referee or safety inspector who checks that a medicine is safe and effective before it can be sold. Its decisions matter to investors because approvals, rejections, or safety warnings directly affect a drug maker’s ability to sell products, generate revenue, and face legal or reputational risks, which in turn influence stock value.

Prader-Willi syndrome medical

"for the treatment of adults and children aged 4 years and older with Prader-Willi syndrome"

A rare genetic disorder caused by missing or altered instructions on a specific chromosome that leads to constant hunger, low muscle tone, learning challenges, and hormonal problems; think of it as a faulty instruction manual that affects growth, appetite control, and development. Investors care because the condition creates a defined patient population, special regulatory incentives, and long-term medical needs that shape demand for therapies, diagnostics, and care services, influencing market size and risk for drug developers.

hyperphagia medical

"with Prader-Willi syndrome (“PWS”) who experience hyperphagia"

An abnormally strong, persistent urge to eat that leads to excessive food intake beyond normal hunger; it can be a symptom of neurological, hormonal, genetic, or psychiatric conditions. Investors care because therapies that reduce hyperphagia can become measurable drug trial endpoints, define patient populations and market size, and influence regulatory approval, reimbursement prospects and commercial potential in the obesity and rare-disease sectors.

forward-looking statements regulatory

"information contained in this on Form 8-K consists of forward-looking statements"

Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Soleno Therapeutics (SLNO) announce regarding its VIOKAT application in Europe?

Soleno Therapeutics announced it has voluntarily withdrawn its European marketing authorization application for VIOKAT prolonged-release tablets for Prader-Willi syndrome. The application had been under EMA review, with a decision previously expected in mid-2026, but that review will now cease.

Why did Soleno Therapeutics (SLNO) withdraw the EMA application for VIOKAT?

The company states that withdrawing the marketing authorization application is based on business and strategic considerations. This step allows Soleno to preserve the option to re-engage with European regulators later if an appropriate regulatory pathway for the VIOKAT program emerges in the future.

Does withdrawal of the VIOKAT EMA application prevent Soleno (SLNO) from reapplying?

No, withdrawal does not prevent future engagement. Soleno explains that stepping back now preserves its ability to re-engage with regulators at a later date, should an appropriate pathway to progress the VIOKAT program in Europe become available through further discussions or new data.

What indication was Soleno’s VIOKAT being developed for in the withdrawn EMA filing?

VIOKAT prolonged-release tablets, containing diazoxide choline, were being developed for adults and children aged 4 years and older with Prader-Willi syndrome who experience hyperphagia. The withdrawn European marketing authorization application covered this patient group for potential treatment.

Does Soleno (SLNO) guarantee future re-engagement with the EMA on VIOKAT?

No, the company explicitly states there can be no assurance it will re-engage with the European Medicines Agency. This caution appears within broader forward-looking statement language, underscoring uncertainty around any future European regulatory plans or timelines for the VIOKAT program.

How does this Soleno (SLNO) update relate to previous expectations for EMA timing?

Soleno had previously indicated that the EMA review of its VIOKAT marketing authorization application was expected to lead to a regulatory decision in mid-2026. With the voluntary withdrawal, this anticipated decision timeline is effectively cancelled, and no alternate regulatory timetable is provided.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 04/07/2026 - 06:58 AM Learn about SEC filing dates

SOLENO THERAPEUTICS INC false 0001484565 0001484565 2026-04-07 2026-04-07

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (date of earliest event reported): April 7, 2026

SOLENO THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware		001-36593		77-0523891
(State or other jurisdiction of incorporation)		(Commission File No.)		(IRS Employer Identification Number)

100 Marine Parkway, Suite 400

Redwood City, CA 94065

(Address of principal executive offices)

(650) 213-8444

(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading symbols		Name of each exchange on which registered
Common Stock, $0.001 par value		SLNO		NASDAQ

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

ITEM 8.01 Other Events

On April 7, 2026, Soleno Therapeutics, Inc. (the “Company”) reported that it has voluntarily withdrawn its marketing authorization application (“MAA”) for VIOKAT prolonged-release tablets (diazoxide choline), which is marketed in the United States as VYKAT^TM XR, its medicinal product for the treatment of adults and children aged 4 years and older with Prader-Willi syndrome (“PWS”) who experience hyperphagia. The Company had previously announced that the application has been under review by the European Medicines Agency (“EMA”), with a decision expected in mid-2026.

The Company’s decision to withdraw the MAA is based on business and strategic considerations. Withdrawal of the application preserves the Company’s ability to re-engage with regulators at a later date should there be an appropriate pathway to progress the program.

Forward-Looking Statements

Except for the factual statements made herein, information contained in this Current Report on Form 8-K consists of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects or future events, as well as words such as “believes,” “intends,” “expects,” “plans” and similar expressions, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Such forward-looking statements are not guarantees of performance and actual actions or events could differ materially from those contained in such statements. For example, there can be no assurance that the Company will re-engage with the EMA. Reference is also made to other factors detailed from time to time in the Company’s periodic reports filed with the Securities and Exchange Commission, including the Company’s most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. The forward-looking statements contained in this Current Report on Form 8-K speak only as of the date of this Current Report on Form 8-K and the Company assumes no obligation to publicly update any forward-looking statements to reflect changes in information, events or circumstances after the date of this Current Report on Form 8-K, unless required by law.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

				SOLENO THERAPEUTICS, INC.
Date: April 7, 2026
				By:		/s/ Anish Bhatnagar
						Anish Bhatnagar
						Chief Executive Officer

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