Envudeucitinib Hits 54% PASI 100 in Long-Term Psoriasis Study, NDA Filing Set for Q4
ALMS has more than doubled off its 52-week low of $3.76 on light trading volume (0.4× avg).
Summary
Alumis reported topline 48-week data from the ONWARD3 long-term extension study of its oral TYK2 inhibitor envudeucitinib in plaque psoriasis. In the continuous treatment group, 54% of patients achieved complete skin clearance (PASI 100) and 75% reached PASI 90, with responses sustained or improving over time. The safety profile remained consistent with prior trials, with no new signals. These results position envudeucitinib as the highest-reported PASI 100 among oral therapies, a key differentiator in a market dominated by injectable biologics. The company confirmed it is on track to submit an NDA to the FDA in Q4 2026, with a Phase 2b readout in lupus expected in Q3 2026. This follows the Q1 2026 update that highlighted the drug's competitive profile and the company's strengthened cash position after a $324M offering. The data significantly de-risk the regulatory path and strengthen the commercial case for a first-line oral option in moderate-to-severe psoriasis.
At the time of this announcement, ALMS was trading at $27.69 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $3.5B. The 52-week trading range was $3.76 to $31.35. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.