UCB Shares surge 16% after Bimzelx outperforms competitor in HS trials

Investing.com -- Shares of UCB S.A. jumped more than 16% Monday after data showed its hidradenitis suppurativa treatment, Bimzelx, outperformed competitor MoonLake’s sonelokimab in Phase 3 trials, while Financière de Tubize (TUB), which holds a large stake in UCB, gained 15%.

MoonLake released Phase 3 VELA-1 and VELA-2 data for sonelokimab, a dual IL-17A/F inhibitor.

The VELA-1 trial reported a 17% placebo-adjusted improvement on the Hidradenitis Suppurativa Clinical Response (HiSCR) 75 score at week 16. VELA-2 showed a 9-10% improvement, missing statistical significance due to a higher-than-expected placebo response. 

Combined, the trials demonstrated a 14% placebo-adjusted HiSCR75 benefit. MoonLake is engaging with regulators on the data, though its filing pathway remains unclear.

By comparison, Bimzelx demonstrated a 21-22% placebo-adjusted HiSCR75 benefit in post-hoc analyses of the BE-HEARD I and II trials when adjusted for similar baseline characteristics and antibiotic protocols as the VELA trials. Absolute efficacy for Bimzelx was 36.4%, compared with 15.7% for placebo. 

“While the absolute efficacy benefit demonstrated by selonokimab appears similar to Bimzelx on HiSCR75 (and HiSCR50), the outperformance of the placebo arm and MoonLake failing to achieve statistical significance in the VELA-2 trial, creates a trickier set up,” said analysts at Morgan Stankey in a note.

BofA Securities flagged the contrast, reporting sonelokimab achieved only 10% in VELA-2 and 17% in VELA-1, “ significantly weaker than expectations and a long way short of UCB’s Bimzelx (22% HiSCR-75 on a like-for like).” 

The brokerage added, “MLTX PIII has been a material overhang for UCB given outside possibility of superior efficacy, with headline data is likely a clearing event for UCB.”

Analysts raised biopharmaceutical company’s Bimzelx peak sales estimate to €8.5 billion, including €3.1 billion from HS, assuming a 50-60% share of the IL-17 HS market, projected at $10 billion by 2035. 

Morgan Stanley forecasts Bimzelx sales of €1.85 billion in 2025, €3.5 billion in 2026, and €4.8 billion in 2027, with group sales 6-8% ahead of street estimates over 2026-2028. 

BofA noted Bimzelx ex-HS represents an additional €5 billion-plus opportunity, with strong uptake in psoriasis, including first-line commercial coverage in the U.S.

MoonLake also has Phase 3 data in psoriatic arthritis with a primary endpoint expected in the first half of 2026, though analysts see limited competitive threat following the uncompetitive psoriasis and HS profiles. 

MoonLake has indicated ongoing engagement with regulators, with initial approval plans targeting mid-2027.

Beyond HS, UCB’s broader pipeline includes Galvo (IL-13/17A/F) and Donza (IL-13/22), which analysts suggest could have broader applications across indications.