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Getting the latest healthcare news for you
Getting the latest healthcare news for you
Alumis's experimental lupus drug missed its phase 2 primary endpoint, sending shares tumbling over 55%. But the company isn't giving up — a subgroup of patients with higher interferon activity showed strong responses, and Alumis plans to discuss a targeted phase 3 trial with regulators. SLE has long been considered a drug-development graveyard, making every advance closely watched.
Alumis's oral TYK2 inhibitor, envudeucitinib, failed to meet the primary endpoint of its mid-stage trial in 408 adults with moderate-to-severe systemic lupus erythematosus (SLE) — a disease notorious for its difficulty in drug development. The miss sent Alumis shares plunging more than 55% in premarket trading, reflecting how much Wall Street had riding on the result.
Still, Alumis isn't walking away. The company identified a subgroup of patients with higher interferon activity — a biomarker tied to lupus severity — who showed strong improvement, including on the trial's main disease-activity measure. Alumis believes this group, which made up a smaller share of the trial population than anticipated, is more likely to respond to therapies targeting the interferon pathway, and plans to engage regulators about a focused phase 3 study in this subset.
On the safety front, the drug was generally well tolerated with no new safety signals. Alumis also confirmed it remains on track to file for U.S. approval of envudeucitinib for moderate-to-severe plaque psoriasis in Q4 2026.
By the Numbers:
55% drop in Alumis share price following the trial miss
200,000 people in the U.S. estimated to have SLE (CDC)
Why it matters: SLE remains one of the hardest diseases to treat and develop drugs for. A biomarker-driven phase 3 strategy — focusing on high-interferon patients — could be a smarter path forward, and may influence how future lupus trials are designed.
