UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Emerging growth company
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| 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 | ||||||
Document and Entity Information |
Sep. 10, 2025 |
|---|---|
| Cover [Abstract] | |
| Entity Registrant Name | SOLENO THERAPEUTICS INC |
| Amendment Flag | false |
| Entity Central Index Key | 0001484565 |
| Document Type | 8-K |
| Document Period End Date | Sep. 10, 2025 |
| Entity Incorporation State Country Code | DE |
| Entity File Number | 001-36593 |
| Entity Tax Identification Number | 77-0523891 |
| Entity Address, Address Line One | 100 Marine Parkway |
| Entity Address, Address Line Two | Suite 400 |
| Entity Address, City or Town | Redwood City |
| Entity Address, State or Province | CA |
| Entity Address, Postal Zip Code | 94065 |
| City Area Code | (650) |
| Local Phone Number | 213-8444 |
| Written Communications | false |
| Soliciting Material | false |
| Pre Commencement Tender Offer | false |
| Pre Commencement Issuer Tender Offer | false |
| Security 12b Title | Common Stock, $0.001 par value |
| Trading Symbol | SLNO |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | false |