Bimekizumab

Switzerland-based MoonLake Immunotherapeutics (Nasdaq: MLTX) announced the pricing of an upsized underwritten public offering of Class A ordinary shares and pre-funded warrants, raising approximately USD 200 million in gross proceeds to fund pre-commercialization and commercialization activities for sonelokimab ahead of a planned Biologics License Application submission in hidradenitis suppurativa. The offering was upsized from an initial target of USD 150 million announced two days earlier, a 33% increase that indicates strong institutional demand ahead of what would be MoonLake’s first regulatory filing. The offering comprises 9,000,000 Class A ordinary shares priced at USD 20.00 per share, with pre-funded warrants available to certain investors in lieu of shares at USD 19.9999 per warrant, exercisable immediately. Underwriters were granted a 30-day option to purchase up to an additional 1,500,000 shares at the public offering price. MoonLake stated proceeds will be used alongside existing cash to fund sonelokimab research, development, pre-commercialization, and commercialization activities, if approved, and for general corporate purposes. Leerink Partners, Guggenheim Securities, Cantor, and LifeSci Capital are acting as joint bookrunning managers, with H.C. Wainwright and Clear Street as lead managers. Company overview and pipeline MoonLake is a clinical-stage biopharmaceutical company founded in 2021 and built around a single licensed asset, sonelokimab (SLK), acquired from Merck KGaA. Sonelokimab is an approximately 40 kDa humanized Nanobody that simultaneously inhibits IL-17A and IL-17F by blocking the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation, with a third domain binding human serum albumin to extend half-life and facilitate tissue penetration. The lead program is in hidradenitis suppurativa (HS), where the Phase III VELA-1 and VELA-2 trials enrolled 838 patients. Week 52 data reported in June 2026 showed 67.2% HiSCR75 and 33.1% HiSCR100 response rates across both studies. The VELA-TEEN trial in adolescents aged 12–17 reported 68% HiSCR75 at Week 24. Following a positive final pre-BLA meeting with the FDA in April 2026, MoonLake plans to submit the HS BLA by end of September 2026. A US commercial launch, absent Priority Review, is targeted for Q3/Q4 2027. The capital raise is timed to build the commercial infrastructure required ahead of that launch. As of Q1 2026, MoonLake held USD 357.9 million in cash and short-term marketable securities, with a runway projected to end-2027; the USD 200 million raise materially extends that runway into the commercialization phase. In psoriatic arthritis, the Phase III IZAR-1 and IZAR-2 trials are enrolling approximately 1,500 adults, with primary endpoint readouts expected in mid and late 2026, respectively. Sonelokimab also holds FDA Fast Track designation in palmoplantar pustulosis, supported by positive Phase II LEDA data, with a Phase III program planned. The Phase II S-OLARIS trial in axial spondyloarthritis reported 81% ASAS40 response at Week 12 alongside PET imaging evidence of reduced osteoblast activity, though no Phase III program in that indication has been announced. Sonelokimab competes directly with UCB’s bimekizumab (Bimzelx), currently the leading approved dual IL-17A/F inhibitor in HS, as well as established biologics including adalimumab and secukinumab. MoonLake’s Week 52 HiSCR75 data numerically exceed bimekizumab’s reported rates at comparable timepoints, though cross-trial comparisons are constrained by differences in trial design and patient populations. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Switzerland-based MoonLake Immunotherapeutics (Nasdaq: MLTX) reported Week 52 data from its Phase III VELA-1 and VELA-2 trials showing that 67.2% of adults with moderate-to-severe hidradenitis suppurativa treated with sonelokimab achieved HiSCR75 at one year — a response rate MoonLake says exceeds those reported at comparable timepoints in the pivotal trials of every currently approved biologic in the indication. With a BLA submission planned for late September 2026, the data now define the clinical package MoonLake will take to the FDA, and the strength of that package relative to UCB’s Bimzelx (bimekizumab) — the most recently approved and mechanistically closest competitor — will determine whether sonelokimab can carve out meaningful market share in a rapidly crowding field. The VELA program enrolled 838 adults across two identical, randomized, double-blind, placebo-controlled trials. The Week 52 results are as-observed analyses from 396 treated patients. Beyond the headline HiSCR75 rate, 33.1% of patients achieved HiSCR100 — complete resolution of abscesses and inflammatory nodules — and 26.0% reached IHS4-100, defined as 100% reduction in abscesses, nodules, and draining tunnels simultaneously. Quality-of-life data reinforced the efficacy signal: the mean HiSQOL score improved by approximately 15 points from baseline, representing an average shift from “severe” to “mild” disease-related impairment, and 46.5% of patients with meaningful baseline pain achieved at least a three-point reduction on the worst skin pain numerical rating scale. Approximately 90% of patients across all arms enrolled in the two-year open-label extension, a retention figure that speaks to both tolerability and the convenience of the once-monthly 120 mg subcutaneous dosing regimen. No new safety signals were detected through Week 52. Competitive context The HS biologic landscape has expanded considerably since AbbVie’s Humira (adalimumab) received the first approval in 2015. Novartis’s Cosentyx (secukinumab), an IL-17A inhibitor, was approved for adult HS in October 2023, and UCB’s Bimzelx (bimekizumab), a dual IL-17A/F inhibitor, followed in November 2024. MoonLake’s own press release draws a direct comparison, noting that sonelokimab’s Week 52 HiSCR75 rate of 67.2% exceeds the one-year HiSCR75 rates reported for approved IL-17A inhibitors (approximately 40%) and for the approved dual IL-17A/F inhibitor (approximately 60%), based on pooled end-of-parental-trial analyses. Cross-trial comparisons are limited by differences in patient populations, trial design, and statistical handling of intercurrent events, and no head-to-head data exist. Notably, VELA-2 narrowly missed statistical significance on its primary composite endpoint at Week 16 (p\=0.053), a complication MoonLake attributed to higher-than-expected placebo response driven by intercurrent events; the combined program met all primary and key secondary endpoints. Sonelokimab is a trivalent Nanobody — a small-format biologic format derived from camelid heavy-chain antibodies — that simultaneously inhibits IL-17A and IL-17F dimers, with a third albumin-binding domain intended to extend half-life and enrich the molecule at sites of inflammatory edema. Its smaller molecular size (\~40 kDa versus \~150 kDa for conventional monoclonal antibodies) is proposed to support deeper tissue penetration, though this mechanistic claim has not been directly validated against bimekizumab in HS. Regulatory and strategic significance The Week 52 data arrive with the pre-BLA process already complete. MoonLake confirmed in May 2026 that the FDA aligned on including the Phase II MIRA trial data to establish substantial evidence of effectiveness, accepted the VELA-TEEN adolescent data as pivotal, and identified no remaining gaps. The proposed label is expected to cover patients aged 12 and above — a potentially meaningful differentiator, given that bimekizumab’s pediatric HS status remains unconfirmed. MoonLake plans to request Priority Review; if granted, a launch could come approximately one quarter earlier than the otherwise anticipated Q3/Q4 2027 window. The adolescent data add a further dimension to the submission. Interim Week 24 results from the open-label VELA-TEEN trial, which enrolled 35 patients aged 12–17, showed approximately 68% achieving HiSCR75 — higher than the adult VELA program at comparable timepoints. Novartis’s Cosentyx received FDA approval for pediatric HS in March 2026 based on pharmacokinetic extrapolation rather than a dedicated pivotal trial, which means sonelokimab’s prospective pediatric data could support a more differentiated label in that population. The competitive window in adolescent HS, however, is narrowing. The broader HS pipeline adds further pressure on timing. Pennsylvania-based Avalo Therapeutics (Nasdaq: AVTX) reported positive Phase II data for abdakibart, an anti-IL-1β antibody, in May 2026, and has since raised approximately USD 431 million to fund a Phase III program. A BLA for sonelokimab filed in September 2026 would, if approved on a standard review timeline, place it in a market already occupied by three approved biologics and potentially facing new entrants within two to three years. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.