MoonLake Immunotherapeutics

MoonLake Immunotherapeutics initiates Phase 3 IZAR program for sonelokimab in active psoriatic arthritis, with trials IZAR-1 for biologic-naïve patients and IZAR-2 for TNF-IR patients, including risankizumab as an active reference arm. The program aims to evaluate efficacy and safety over 52 weeks, with primary endpoint readout expected in H1 2026.

MoonLake Immunotherapeutics reported increased operating expenses, losses, and net loss per share for Q3 2024, driven by R&D activities. The company advanced Sonelokimab (SLK) in clinical trials for HS and PsA, with positive top-line results. Regulatory bodies supported the Phase 3 program for SLK. MoonLake expanded operations in Switzerland, the UK, and Portugal, and invested in manufacturing for SLK. The company faces risks including dependence on SLK's success, regulatory approval challenges, and financial losses. MoonLake's cash and equivalents total $375.7 million, sufficient to fund operations until 2026.

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On Oct 4, 2024, Biotechnology Value Fund L.P. sold 2M shares of MoonLake Immunotherapeutics, reducing its stake by 9.19% to 19,751,284 shares, representing 31.40% of its portfolio. MoonLake's stock price declined 9.73% post-transaction, with a market cap of $3.13B and a 16.2% YTD price decrease. Biotechnology Value Fund L.P. remains confident in MoonLake's long-term potential.

On Oct 4, 2024, Biotechnology Value Fund L.P. sold 2M shares of MoonLake Immunotherapeutics, reducing its stake by 9.19% to 19,751,284 shares, representing 31.40% of its portfolio. MoonLake, a Swiss biotech firm, focuses on Nanobody tech for immunologic diseases. Despite a 303.4% increase since its 2022 IPO, MoonLake's stock price dropped 9.73% post-transaction, reflecting investor sentiment. Biotechnology Value Fund L.P.'s move may signal strategic rebalancing or risk management.

Biotechnology Value Fund L P and related entities sold $100,003,200 worth of MoonLake Immunotherapeutics shares on Oct 4, 2024, at $50.0016 per share. The sales involved 2,053,000 Class A Ordinary Shares, representing a portion of their significant holdings. Analysts like TD Cowen, H.C. Wainwright, and BTIG maintain Buy ratings, while Wolfe Research downgraded to Peer Perform. MoonLake continues to focus on HS and PsA with ongoing SLK development, despite financial projections showing a decline in earnings per share.

MoonLake Immunotherapeutics reported positive Phase 2 trial results for sonelokimab in hidradenitis suppurativa and psoriatic arthritis, with Phase 3 preparations underway. Financials show $511.0 million in cash, supporting operations until 2026. An R&D Day on March 10 will discuss trial outcomes and future plans.

MoonLake Immunotherapeutics initiates Phase 3 VELA program, evaluating sonelokimab for moderate-to-severe hidradenitis suppurativa (HS), targeting HiSCR75 as the primary endpoint. The program, enrolling 800 patients across the U.S. and Europe, follows positive Phase 2 MIRA trial results, with topline data expected mid-2025.

Sarepta Therapeutics received FDA accelerated approval for Elevidys, a gene therapy for DMD in children aged 4-5, pending confirmatory trial results. Bristol Myers Squibb's Camzyos was approved in the EU for treating obstructive HCM. FibroGen's pamrevlumab failed in a phase III IPF study, leading to discontinuation of related trials. Intercept Pharmaceuticals faced FDA rejection for its NASH treatment, prompting restructuring. MoonLake Immunotherapeutics reported positive phase II results for sonelokimab in treating HS.