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 (NASDAQ: MLTX) generates frequent news as it advances sonelokimab, an investigational Nanobody® targeting IL‑17A and IL‑17F, through late-stage clinical development in inflammatory skin and joint diseases. Company updates often center on clinical trial milestones, regulatory interactions, and financing activities that shape the outlook for its lead asset.
News items include detailed readouts from key trials such as the Phase 3 VELA program in adult hidradenitis suppurativa (HS), the adolescent VELA‑TEEN trial, the Phase 3 IZAR program in psoriatic arthritis (PsA), and Phase 2 studies like LEDA in palmoplantar pustulosis (PPP) and S‑OLARIS in axial spondyloarthritis (axSpA). Releases describe endpoints such as HiSCR75 in HS, ACR50 in PsA, PPPASI in PPP, and report on safety profiles, patient-reported outcomes and long-term follow-up analyses.
Investors following MLTX news will also see regulatory updates, including feedback from the U.S. Food and Drug Administration on the clinical evidence package for HS and guidance related to a planned Biologics License Application for sonelokimab. Financial communications, such as quarterly and annual results, equity offerings and a non-dilutive term loan facility, provide context on MoonLake’s ability to fund its clinical programs and preparations for potential commercialization.
In addition, MoonLake issues announcements about Capital Markets Days, R&D-focused webcasts and presentations at medical and investor conferences, where management discusses trial designs, baseline characteristics, interim data and anticipated milestones. This news page aggregates such releases so readers can review the evolving clinical and corporate narrative around sonelokimab and MoonLake’s broader inflammatory disease portfolio.
MoonLake Immunotherapeutics (Nasdaq: MLTX) has initiated its Phase 3 IZAR program evaluating sonelokimab in patients with active psoriatic arthritis (PsA). The program consists of two trials: IZAR-1 for biologic-naïve patients with radiographic progression evaluation, and IZAR-2 for TNF-IR patients, featuring risankizumab as an active reference arm. The trials will enroll approximately 1,500 adult patients across the US, Europe, and Latin America, evaluating 60mg and 120mg doses over 52 weeks. The program follows positive Phase 2 ARGO trial results, with primary endpoint readout expected in H1 2026.
MoonLake Immunotherapeutics (NASDAQ:MLTX) reported Q3 2024 financial results with $493.9 million in cash and equivalents, providing runway through 2026. R&D expenses increased to $35.7 million from $23.7 million in Q2, while G&A expenses rose to $7.4 million from $6.9 million. The company's Phase 3 clinical program in hidradenitis suppurativa is progressing with primary endpoint readout expected mid-2025. Multiple clinical trials are planned, including Phase 3 studies in psoriatic arthritis and adolescent HS, plus Phase 2 trials in palmoplantar pustulosis and axial spondyloarthritis, scheduled to commence around year-end.
MoonLake Immunotherapeutics (Nasdaq: MLTX), a clinical-stage biotech company, will host a Capital Markets Update on September 11, 2024, from 9:00 – 10:30 EST. The event will feature business updates from key executives and provide details on:
- Phase 3 programs for sonelokimab (SLK) in hidradenitis suppurativa and psoriatic arthritis
- Pipeline updates and catalysts for 2024-2026
- Phase 2 trials of SLK in palmo-plantar pustulosis
- Market opportunities and competitor analysis
- Financial presentation
The update will be followed by a Q&A session. Investors and analysts can register for the webcast online.
MoonLake Immunotherapeutics (NASDAQ:MLTX) reported its Q2 2024 financial results and announced a Capital Markets Update for September 11. Key highlights include:
1. Initiation of Phase 3 VELA program for sonelokimab in hidradenitis suppurativa (HS), with topline results expected mid-2025.
2. Positive feedback from FDA and EMA on the regulatory path for Phase 3 program in psoriatic arthritis (PsA).
3. $519.8 million in cash and equivalents, providing runway to end of 2026.
4. R&D expenses increased to $23.7 million, while G&A expenses remained stable at $6.9 million.
5. Upcoming events include initiation of Phase 3 IZAR program in PsA and additional Phase 2 trials in various indications.
MoonLake Immunotherapeutics has received positive regulatory feedback from both the FDA and EMA for its Phase 3 program of Nanobody® sonelokimab targeting psoriatic arthritis (PsA). The program, named IZAR, will enroll around 1,500 patients across two trials (IZAR-1 and IZAR-2). IZAR-1 will focus on bio-naïve patients and radiographic progression, while IZAR-2 will involve TNF-IR patients with risankizumab as a reference arm. The primary endpoint readout is anticipated by end-2026. This follows earlier positive feedback for their Phase 3 VELA program for hidradenitis suppurativa (HS). Recruitment for these trials is set to begin in Q4 2024.
MoonLake Immunotherapeutics has launched the Phase 3 VELA program, testing the Nanobody® sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (HS). The program aims to enroll 800 patients and is expected to report its topline primary endpoint at week 16 by mid-2025. Sonelokimab targets inflammation by inhibiting IL-17A/A, IL-17A/F, and IL-17F/F dimers. The Phase 3 program, following the successful Phase 2 MIRA trial, will use HiSCR75 as its primary endpoint. The trial will last 52 weeks, with an open-label extension up to two years.
MoonLake Immunotherapeutics reported positive feedback on the regulatory path for the Phase 3 program of Nanobody® sonelokimab, significant improvements in ARGO Phase 2 trial, and plans to commence four additional clinical trials across dermatology and rheumatology. The company ended Q1 2024 with $547.1 million in cash and expects a cash runway to the end of 2026.
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