MoonLake Immunotherapeutics 8-K

What Happened

• On January 8, 2026, MoonLake Immunotherapeutics filed a Form 8-K and issued a press release saying the U.S. Food and Drug Administration provided positive feedback on the Company’s clinical evidence strategy for Sonelokimab (SLK) in hidradenitis suppurativa following a Type B FDA meeting requested by MoonLake. The company will host an Investor Day on February 23, 2026 at 8:00 a.m. Eastern Time to discuss the meeting outcomes and present new clinical data for SLK across indications. The press release is filed as Exhibit 99.1 to the 8-K.

Key Details

• Filing date: January 8, 2026 (Form 8-K, Item 8.01 disclosed Other Events).
• Drug: Sonelokimab (SLK); indication specifically mentioned: hidradenitis suppurativa.
• Regulatory interaction: positive feedback from the FDA based on a Type B meeting requested by the Company.
• Investor Day: scheduled for February 23, 2026 at 8:00 a.m. ET to present meeting outcomes and new SLK clinical data; press release included as Exhibit 99.1.

Why It Matters

• Positive FDA feedback on the clinical evidence strategy is a de-risking development for SLK’s regulatory pathway in hidradenitis suppurativa and could clarify next clinical or submission steps. The Investor Day offers investors a timely opportunity to hear details, see new clinical data, and learn about potential timelines. The 8-K did not include financial results or commitments; investors should watch the February 23 presentation and company updates for substantive next steps or changes to development timelines.