Welcome to our dedicated page for MoonLake Immunotherapeutics news (Ticker: MLTX), a resource for investors and traders seeking the latest updates and insights on MoonLake Immunotherapeutics stock.
MoonLake Immunotherapeutics reports clinical, regulatory and financing developments for a clinical-stage biotechnology business focused on inflammatory skin and joint diseases. Its updates center on sonelokimab (SLK), a Nanobody designed to inhibit IL-17A and IL-17F, and on programs in hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis and palmoplantar pustulosis.
Recurring news includes Phase 2 and Phase 3 trial data from VELA, VELA-TEEN, MIRA, LEDA, S-OLARIS and IZAR studies, FDA interactions and designations tied to SLK, quarterly financial results, research and development spending, equity and debt financing activity, and shareholder voting or capital-structure matters.
MoonLake (NASDAQ: MLTX) reported a positive final pre-BLA meeting with the U.S. FDA for sonelokimab in hidradenitis suppurativa, with alignment on submission plans and label strategy for adults and adolescents 12+.
The BLA is planned for end-September 2026, with potential Priority Review, and MoonLake held $357.9 million in cash and equivalents at March 31, 2026, guiding cash runway to end-2027 and access to up to $400 million in additional non-dilutive debt funding.
MoonLake (NASDAQ: MLTX) reported Week 40 Phase 3 VELA results for sonelokimab in moderate-to-severe hidradenitis suppurativa. Key highlights: 62% HiSCR75, up to 32% HiSCR100, up to 25% inflammatory remission, HiSQOL improvements of -11.8 and -12.4, and no new safety signals. Data presented at AAD on March 28, 2026.
MoonLake (NASDAQ:MLTX) announced positive topline Phase 2 S-OLARIS results for sonelokimab (SLK) in axial spondyloarthritis (axSpA) and reported 2025 year-end financials. SLK achieved 81% ASAS40 at Week 12 and >80% improvements on ASDAS-CRP and SPARCC MRI; PET imaging showed reduced inflammation and osteoblast activity by Week 12. The safety profile showed no new signals. Financially, MoonLake held $394.0M in cash and equivalents as of December 31, 2025, completed a gross equity raise of $75M, drew $25M under an amended Hercules facility, and has up to $400M in non-dilutive capacity. An Investor Day webcast is scheduled for February 23, 2026.
MoonLake Immunotherapeutics (NASDAQ:MLTX) announced the FDA granted Fast Track designation to sonelokimab (SLK) for moderate‑to‑severe palmoplantar pustulosis (PPP), based on positive Phase 2 LEDA results. The company confirmed a planned BLA submission for HS in H2 2026 and an Investor Day webcast on February 23, 2026 (8:00–9:30am EST) to present PPP plans, Phase 2 S-OLARIS axSpA data, HS interim analyses, label strategy, and 2026 catalysts including IZAR and VELA readouts.
MoonLake Immunotherapeutics (NASDAQ:MLTX) received positive final records from a Type B meeting with the U.S. FDA confirming that a BLA for sonelokimab (SLK) in hidradenitis suppurativa (HS) may establish substantial evidence of effectiveness (SEE) without new HS trials using data from VELA-1, VELA-2 and MIRA.
MIRA 1,000 combined with VELA) showed 43% HiSCR75 response with 120mg SLK (delta vs placebo 29 ppt, p<0.001). VELA-1 met primary and key secondary endpoints; VELA-2 reached significance under a treatment policy strategy but missed the primary composite (p=0.053). FDA advised including VELA-2 results for safety. MoonLake plans BLA submission in H2 2026 and will hold an Investor Day on February 23, 2026.
MoonLake Immunotherapeutics (Nasdaq: MLTX) priced an underwritten offering of 7,142,857 Class A ordinary shares at $10.50 per share, producing gross proceeds of approximately $75 million. The offering is expected to close on or about November 6, 2025, subject to customary closing conditions.
All securities are being sold by MoonLake. Net proceeds, together with existing cash and marketable securities, are intended to fund research and development of sonelokimab and for general corporate purposes. Leerink Partners is sole bookrunning manager. A shelf registration became effective on September 11, 2023.
MoonLake Immunotherapeutics (NASDAQ: MLTX) reported Q3 2025 results and clinical updates. As of September 30, 2025, the company held $380.5 million in cash, cash equivalents and short-term marketable securities, and expects committed debt capacity to provide runway into the second half of 2027. R&D spend for the quarter was $60.6 million vs. $49.8 million in the prior quarter, driven by CRO/CMO, consulting and personnel costs to support trial ramp-up and BLA preparations.
Clinical highlights: Phase 2 LEDA in palmoplantar pustulosis showed a mean PPPASI change −64% at week 16 and PPPASI75 in 39%; safety consistent with prior trials. Interim Phase 3 VELA and VELA-TEEN data showed ongoing benefit in hidradenitis suppurativa, with VELA-TEEN HiSCR75 = 46% (n=11). A Type B meeting with FDA is scheduled for Dec 15, 2025, and a BLA submission is targeted in Q3/Q4 2026.
MoonLake Immunotherapeutics (NASDAQ: MLTX) reported week 16 results from its Phase 3 VELA program testing sonelokimab in moderate to severe hidradenitis suppurativa (HS). The combined trials showed statistically significant improvements across all primary and key secondary endpoints (p0.001).In VELA-1, sonelokimab achieved statistical significance with a 17% delta to placebo (p0.001). VELA-2 showed a (p=0.053) due to higher-than-expected placebo response. Using the treatment policy strategy, both trials achieved significant HiSCR75 at week 16, with sonelokimab showing 35% and 36% response rates versus placebo rates of 18% and 26% respectively.
The drug demonstrated a favorable safety profile with no new safety signals, including absence of suicidal ideation and behavior. The company will seek regulatory guidance for the path to registration while continuing other clinical studies in multiple indications.
MoonLake Immunotherapeutics (NASDAQ:MLTX), a biotechnology company, reported Q2 2025 financial results and significant clinical progress. The company ended Q2 with $425.1 million in cash and secured up to $500 million in non-dilutive financing from Hercules Capital, extending cash runway into 2028.
Key financial metrics include R&D expenses of $49.8 million (up $13.3 million from previous quarter) and G&A expenses of $10.9 million. The company's Phase 3 VELA program in hidradenitis suppurativa (HS) is progressing toward primary endpoint readout around September 2025, with BLA submission expected mid-2026.
Multiple clinical trials for sonelokimab are advancing in various indications including PPP, axSpA, PsA, and adolescent HS, with significant readouts expected through 2026. The company anticipates product launch in 2027.