$MLTX

MoonLake Immunotherapeutics (MLTX) filed an SEC Form 8-K — Other Events. 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-

U.S. stock futures fell Sunday night after President Trump rejected Iran's peace proposal, raising concerns about global energy supplies. Dow, S&P 500, and Nasdaq futures declined, while oil prices rose. Micron (MU) and Sandisk (SNDK) shares surged over 5% due to high demand for memory chips. Everspin (MRAM) and MoonLake (MLTX) also saw significant gains.

U.S. stock futures fell early Monday due to tariff uncertainty and Iran tensions. Nasdaq, S&P 500, and Dow futures declined 0.5%-0.6%. Nvidia's earnings, Netflix's board controversy, and Honeywell's acquisition are in focus. Precious metals rose, with gold above $5,100 and silver near $88/oz.

MoonLake Immunotherapeutics (MLTX) shares surged 11% after Cormorant Asset Management increased its stake to 6.1%. The FDA granted Fast Track designation to Sonelokimab, and retail traders speculate a potential takeover. MLTX is up 33% YTD, with an investor day scheduled for Feb. 23.

MoonLake Immunotherapeutics (MLTX) shares rose 2.5% as investors anticipate late-stage trial results for its lead drug, sonelokimab, focusing on hidradenitis suppurativa. Full 52-week data is expected in Q2, with FDA submission planned for September 2026. Analysts' average price target is $27.62, implying 46% upside. MLTX stock has gained 63% this year, with retail sentiment turning bullish.

MoonLake Immunotherapeutics said its Phase III IZAR-1 trial of sonelokimab in biologic-naive adults with active psoriatic arthritis met the primary endpoint at week 16. In the 60 mg arm, 42.1% achieved ACR50. Secondary results included ACR20 66.5%, MDA 41.2%, PASI90 61%. Patients will be followed 52 weeks, with durability data expected in H1 2027. MoonLake is also running IZAR-2 versus AbbVie’s Skyrizi.

MoonLake Immunotherapeutics (MLTX) reported topline Phase 3 IZAR-1 results for Sonelokimab in biologic-naive adults with active psoriatic arthritis. The trial met the Week 16 primary endpoint, with 42.1% on 60 mg achieving ACR50. Secondary results included 66.5% ACR20, 41.2% MDA, and 61% PASI90. Safety showed no new signals. Full readout is expected in H1 2026.

MoonLake Immunotherapeutics (MLTX) shares fell 21.7% pre-open to $14.30 after Phase 3 IZAR-1 topline results for sonelokimab in biologic-naive psoriatic arthritis met the primary endpoint. The company reported 42.1% ACR50 at Week 16, plus 66.5% ACR20 and 61% PASI90. Investors reacted negatively due to a BLA submission for hidradenitis suppurativa and future commercialization, with no current revenue and recent dilutive equity raises.

MoonLake Immunotherapeutics (MLTX) reported positive topline Week 16 Phase 3 IZAR-1 results for sonelokimab 60 mg in biologic-naive adults with psoriatic arthritis, saying all clinical endpoints were met. It reported 42.1% ACR50 at Week 16 and Q2 2026 net loss of $61.8M, ending with $537.0M cash. R&D was $50.2M. It expects cash runway to mid-2028.

MoonLake Immunotherapeutics (MLTX) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 MoonLake Announces Positive Topline Results from the Phase 3 IZAR-1 Trial of Sonelokimab in Psoriatic Arthritis Demonstrating Significant Improvements Across all Clinical Endpoints, and Reports Second Quarter 2026 Financial Results ● Phase 3 IZAR-1 trial in bio-naïve