MoonLake submits sonelokimab for FDA approval

MoonLake expects FDA notice on review acceptance within approximately 60 days and a planned review timeline within approximately 74 days of submission.

Rhea-AI Filing Summary

MoonLake Immunotherapeutics (MLTX) submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration on September 30, 2026, seeking approval of sonelokimab, a tri-specific nanobody, for moderate-to-severe hidradenitis suppurativa in adults and pediatric patients 12 years of age and older. MoonLake expects to be notified whether the FDA accepts the application for review within approximately 60 days of submission and to receive the planned review timeline within approximately 74 days of submission.

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

Pediatric patient age: 12 years of age and older FDA review-acceptance notification: Approximately 60 days Planned review timeline: Approximately 74 days

3 metrics

Pediatric patient age 12 years of age and older Patient population included in the application

FDA review-acceptance notification Approximately 60 days Expected timing after submission

Planned review timeline Approximately 74 days Expected timing after submission

Key Terms

Biologics License Application, tri-specific nanobody, hidradenitis suppurativa

3 terms

Biologics License Application regulatory

"submitted a Biologics License Application"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

tri-specific nanobody technical

"sonelokimab, a tri-specific nanobody"

hidradenitis suppurativa medical

"moderate-to-severe hidradenitis suppurativa"

A chronic skin disease marked by recurring, painful lumps and tunnels under the skin that often leak and leave scars; it behaves like a slow-burning, recurring infection in areas with many sweat glands. For investors, it matters because the condition has few consistently effective treatments and causes long-term healthcare use, making successful new drugs, devices, or diagnostics potentially high-value opportunities while also carrying clinical-trial, regulatory and reimbursement risks.

FAQ

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

What is MLTX seeking FDA approval for?

MoonLake seeks approval of sonelokimab, a tri-specific nanobody, for moderate-to-severe hidradenitis suppurativa in adults and pediatric patients 12 years of age and older.

When does MLTX expect an FDA update on its application?

MoonLake expects to be notified whether the FDA accepts the BLA for review within approximately 60 days of submission and to receive the planned review timeline within approximately 74 days of submission.

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

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Available on EDGAR 09/30/2026 - 04:15 PM Accepted by SEC EDGAR 09/30/2026 - 04:15 PM Learn about SEC filing dates

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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 30, 2026

MOONLAKE IMMUNOTHERAPEUTICS

(Exact Name of Registrant as Specified in Its Charter)

Cayman Islands		001-39630		98-1711963
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

Dorfstrasse 29

6300 Zug

Switzerland

(Address of principal executive offices and Zip Code)

41 415108022

(Registrant’s Telephone Number, Including Area Code)

N/A

(Former Name or Former Address, if Changed Since Last Report)

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 (see General Instruction A.2 below):

☐	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 Symbol(s)		Name of each exchange on which registered
Class A ordinary share, par value $0.0001 per share		MLTX		The Nasdaq Capital Market

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 September 30, 2026, MoonLake Immunotherapeutics (the “Company”) submitted a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”), seeking approval of its tri-specific nanobody sonelokimab for the treatment of moderate-to-severe hidradenitis suppurativa in adults and pediatric patients 12 years of age and older. The Company expects to be notified by the FDA whether the BLA submission is accepted for review within approximately 60 days of submission, and to receive the planned review timeline within approximately 74 days of submission.

Cautionary Statement Regarding Forward-Looking Statements

This Current Report on Form 8-K contains certain “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding the Company’s expectations, hopes, beliefs, intentions or strategies regarding the future, including, without limitation, statements regarding whether and when the FDA will accept the Company’s BLA submission for review, the timing of the Company’s receipt of the planned review timeline from the FDA, and the potential approval, timing of approval and commercialization of sonelokimab. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that the statement is not forward-looking.

Forward-looking statements are based on current expectations and assumptions that, while considered reasonable by the Company and its management, as the case may be, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with the Company’s business in general and limited operating history; difficulty enrolling patients in clinical trials; state and federal healthcare reform measures that could result in reduced demand for the Company’s product candidates; reliance on third parties to conduct and support its preclinical studies and clinical trials; and the other risks described in or incorporated by reference into the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent filings with the SEC.

Nothing in this Current Report on Form 8-K should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this Current Report on Form 8-K, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. The Company does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based.

1 

SIGNATURE

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.

	MOONLAKE IMMUNOTHERAPEUTICS
Date: September 30, 2026	By:	/s/ Matthias Bodenstedt
	Name:	Matthias Bodenstedt
	Title:	Chief Financial Officer

2 

Filing Exhibits & Attachments

3 documents

Other Documents

• EX-101 XBRL SCHEMA FILE 2.9 KB
• EX-101 XBRL LABEL FILE 33.4 KB
• EX-101 XBRL PRESENTATION FILE 21.8 KB