FDA feedback on SLK leads MoonLake Immunotherapeutics (NASDAQ: MLTX) event

Rhea-AI Filing Summary

MoonLake Immunotherapeutics reported that it received positive feedback from the U.S. Food and Drug Administration on the clinical evidence strategy for its drug candidate Sonelokimab (SLK) in hidradenitis suppurativa, following a requested Type B FDA meeting. This feedback relates to how the company is generating the clinical data needed to support SLK in this indication.

The company also plans to hold an Investor Day on February 23, 2026 at 8:00 a.m. Eastern Time to discuss the outcomes of the Type B FDA meeting in more detail and to present new clinical data for SLK across multiple indications. A press release with these updates was filed as an exhibit to this report.

Insights

Biotech regulatory analyst

MoonLake gets constructive FDA input on SLK and plans data update.

MoonLake Immunotherapeutics describes positive feedback from the U.S. FDA on its clinical evidence strategy for Sonelokimab (SLK) in hidradenitis suppurativa after a Type B meeting. Type B meetings typically cover key development topics such as trial design and data packages, so favorable feedback can help align the program with regulatory expectations.

The company will host an Investor Day on February 23, 2026 at 8:00 a.m. Eastern Time to explain the meeting outcomes and share new SLK clinical data across indications. The actual impact for shareholders will depend on the specifics of the FDA feedback and the strength of the new data, which are to be presented at that event and summarized in the accompanying press release.

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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): January 8, 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:

☐ 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 January 8, 2026, MoonLake Immunotherapeutics (the “Company”) issued a press release providing an update following the positive feedback received from the U.S. Food and Drug Administration regarding the clinical evidence strategy for Sonelokimab (“SLK”) in Hidradenitis Suppurativa, based on the Type B meeting requested by the Company (the “Type B FDA Meeting”). The Company will hold an Investor Day on February 23, 2026 at 8:00 am, Eastern Time, to further discuss the outcomes of the Type B FDA Meeting and to present new clinical data for SLK across indications.

A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits. The following exhibit is being filed herewith:

Exhibit Number		Exhibit Title or Description
99.1		Press Release, dated January 8, 2026
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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: January 8, 2026	By:	/s/ Matthias Bodenstedt
	Name:	Matthias Bodenstedt
	Title:	Chief Financial Officer

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FAQ

What did MoonLake Immunotherapeutics (MLTX) announce in this 8-K filing?

MoonLake Immunotherapeutics reported positive feedback from the U.S. Food and Drug Administration on the clinical evidence strategy for its drug candidate Sonelokimab (SLK) in hidradenitis suppurativa, following a Type B FDA meeting.

Which drug and indication are highlighted in MoonLake Immunotherapeutics (MLTX)'s update?

The update focuses on Sonelokimab (SLK) and its development in Hidradenitis Suppurativa, with the FDA providing favorable feedback on the company’s clinical evidence strategy for this indication.

What is the purpose of MoonLake Immunotherapeutics (MLTX)'s upcoming Investor Day?

The Investor Day on February 23, 2026 at 8:00 a.m. Eastern Time is intended to further discuss the outcomes of the Type B FDA meeting and to present new clinical data for Sonelokimab across multiple indications.

When will MoonLake Immunotherapeutics (MLTX) hold its Investor Day event?

MoonLake Immunotherapeutics plans to hold its Investor Day on February 23, 2026, starting at 8:00 a.m. Eastern Time, to discuss regulatory feedback and new clinical data for Sonelokimab.

What exhibit is included with MoonLake Immunotherapeutics (MLTX)'s 8-K?

The filing includes Exhibit 99.1, which is a press release dated January 8, 2026, providing additional details on the FDA feedback and the planned Investor Day.

Does the MoonLake Immunotherapeutics (MLTX) filing mention new clinical data for Sonelokimab?

Yes. The company states it will present new clinical data for Sonelokimab (SLK) across indications at its Investor Day on February 23, 2026.