Why is Alumis stock collapsing today?

Alumis Inc.'s stock experienced a sharp 55% decline on Tuesday following the company's announcement that its Phase 2b LUMUS trial of envudeucitinib for moderate-to-severe systemic lupus erythematosus failed to meet its primary and secondary goals. The trial, which included 408 patients, did not demonstrate improvements in overall disease activity measured by the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Week 48, the main outcome being tracked.

Despite this setback, Alumis highlighted promising results in a specific subset of patients with high interferon gene signature (IFNGS-high), including meeting the primary endpoint and numerous secondary efficacy measures. These IFNGS-high patients, which constitute the majority of moderate-to-severe SLE cases, were notably underrepresented in the study, thus impacting the overall performance.

The drug exhibited good safety profiles with no new safety concerns identified. Pharmacodynamic data confirmed the drug's effectiveness in engaging the interferon pathway, with maximum suppression achieved at the highest dosage of 40mg administered twice daily. Alumis intends to consult with regulators regarding the progression of envudeucitinib's Phase 3 development for this specific patient group.

The absence of targeted oral therapies for SLE underscores the drug's potential importance. Alumis is on schedule to file a New Drug Application for envudeucitinib in moderate-to-severe plaque psoriasis by the end of 2026, having previously achieved positive outcomes with its Phase 3 ONWARD program in this area. Envudeucitinib operates as an oral allosteric inhibitor of tyrosine kinase 2 (TYK2), targeting immune dysregulation in diseases driven by IL-23, IL-17, and Type I interferon.

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