Soleno (SLNO) details FAERS death report, says case not tied to VYKAT XR

Rhea-AI Filing Summary

Soleno Therapeutics filed a current report describing a serious adverse event recorded in the FDA’s Adverse Event Reporting System involving a deceased patient who had been treated with VYKAT XR. The treating physician reported, and Soleno agrees, that the case was not related to VYKAT XR.

The patient was a 17-year-old male with Prader-Willi Syndrome and multiple co-morbidities, including lymphedema, superficial thrombophlebitis and severe obesity, and died from an apparent pulmonary embolus. Soleno emphasizes that VYKAT XR was approved after a rigorous clinical program, has an established safety and efficacy profile, and should be used according to its FDA-approved label. The company notes that FAERS reports do not establish causation and cites FDA statements explaining that reported events may stem from underlying disease or other factors.

Soleno explains that Prader-Willi Syndrome is associated with significant co-morbidities and reduced life expectancy, and states that it does not plan to comment on future adverse events, including deaths, unless they are directly related to VYKAT XR use and are unexpected under U.S. Prescribing Information.

Insights

Biopharma safety and regulatory analyst

Soleno discloses a FAERS death case, while stressing no link to VYKAT XR.

Soleno Therapeutics describes a serious adverse event reported in FAERS: a 17-year-old Prader-Willi Syndrome patient on VYKAT XR who died from an apparent pulmonary embolus. Both the treating physician and the company assessed the case as not related to VYKAT XR, which they explicitly state. The discussion reiterates that VYKAT XR received FDA approval after a rigorous clinical program and has a defined safety and efficacy profile.

The company provides medical context, noting the patient’s substantial co-morbidities and that Prader-Willi Syndrome is associated with markedly reduced life expectancy and risks such as cardiac, respiratory events and pulmonary embolism. It also quotes FDA guidance that FAERS reports do not establish causation, and that events can arise from underlying disease or other treatments.

For investors, this is primarily a communications and pharmacovigilance update rather than a new regulatory action. Soleno commits to reporting adverse events as required by law but states it does not intend to comment on individual future cases unless directly related to VYKAT XR and unexpected per U.S. Prescribing Information. The market impact will depend on how stakeholders interpret this disclosure against ongoing safety surveillance.

8-K Event Classification

Item 7.01 — Regulation FD Disclosure

1 item

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Understanding 8-K Material Events →

SOLENO THERAPEUTICS INC false 0001484565 0001484565 2025-09-10 2025-09-10

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): September 10, 2025

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 7.01 Regulation FD Disclosure

Soleno Therapeutics, Inc. is aware that a serious adverse event has been reported in the U.S. Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) regarding a patient who is deceased. The treating physician has reported the case as not related to treatment with VYKAT^™ XR and Soleno’s assessment is the same.

This patient was a 17-year-old male with a history of co-morbidities, including lymphedema, superficial thrombophlebitis (treated and followed by a vascular surgery team), and obesity (326 lbs.) who died from an apparent pulmonary embolus.

VYKAT XR has a proven safety and efficacy profile and was approved by the FDA following a rigorous clinical program. Like any medication, VYKAT XR should be administered in accordance with its FDA-approved label, which describes anticipated side effects. Soleno Therapeutics is committed to reporting all adverse events experienced by individuals who have taken VYKAT XR in accordance with applicable law. Prader Willi Syndrome is a disease where patients have significant comorbidities and have a markedly reduced life expectancy due to reasons that can include cardiac or respiratory events as well as others such as pulmonary embolism. The mean age of death reported from a 40-year mortality study in the U.S. was 29.5 ± 15 years (range: 2 months—67 years). Going forward, Soleno does not intend to specifically comment on adverse events cases (including deaths) unless directly related to VYKAT XR use and unexpected per the U.S. Prescribing Information.

The existence of a report in the FAERS database does not establish causation. The FDA’s website makes this clear: “For any given report, there is no certainty that a suspected drug caused the event. While consumers and healthcare professionals are encouraged to report adverse events, the event may have been related to the underlying disease being treated, or caused by some other drug being taken concurrently, or occurred for other reasons.” Additionally, the FDA states “Submission of a report does not mean that the information included in it has been medically confirmed nor it is an admission from the reporter that the drug caused or contributed the event.”

The information under this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into the filings of the Company under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

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: September 10, 2025
				By:		/s/ Anish Bhatnagar
						Anish Bhatnagar
						Chief Executive Officer

FAQ

What did Soleno Therapeutics (SLNO) disclose about the VYKAT XR safety report?

Soleno Therapeutics disclosed that a serious adverse event in the FDA’s FAERS database involved a deceased patient who had received VYKAT XR, but both the treating physician and Soleno assessed the case as not related to VYKAT XR treatment.

Who was the patient mentioned in Soleno Therapeutics’ 8-K and what was the reported cause of death?

The patient was a 17-year-old male with Prader-Willi Syndrome and co-morbidities including lymphedema, superficial thrombophlebitis and obesity (326 lbs.), and he died from an apparent pulmonary embolus.

How does Soleno describe the safety profile of VYKAT XR in this filing?

Soleno states that VYKAT XR has a proven safety and efficacy profile and that it was approved by the FDA following a rigorous clinical program, emphasizing that it should be used according to its FDA-approved label describing anticipated side effects.

What context does Soleno provide about Prader-Willi Syndrome in relation to the reported death?

Soleno notes that Prader-Willi Syndrome is associated with significant co-morbidities and markedly reduced life expectancy, with deaths often related to cardiac or respiratory events or pulmonary embolism; a cited 40-year U.S. mortality study reported a mean age of death of 29.5 ± 15 years.

What does Soleno say about FAERS reports and causation for VYKAT XR adverse events?

Soleno highlights FDA statements that a report in FAERS does not establish causation, and that events may be due to underlying disease, other drugs, or other reasons, and that submission of a report does not mean the information is medically confirmed.

Will Soleno Therapeutics comment on future adverse events related to VYKAT XR?

Soleno states that going forward it does not intend to specifically comment on adverse event cases, including deaths, unless they are directly related to VYKAT XR use and are unexpected per the U.S. Prescribing Information.