Alumis beams as pivotal data on Sotyktu rival drive stock surge

 A pair of phase 3 psoriasis studies of Alumis’ TYK2 inhibitor have hit their primary endpoints, setting the biotech up to file for approval of a potential challenger to Bristol Myers Squibb’s Sotyktu. With the news, Alumis’ shares more than doubled in premarket trading. 

The biotech tested its TYK2 inhibitor, envudeucitinib, in two studies that collectively enrolled more than 1,700 adults with moderate to severe plaque psoriasis. About half of the participants received Alumis’ oral drug candidate twice daily. The other half of the patients were split up to receive either apremilast, which Amgen sells as Otezla, or placebo. 

On average across the two trials, 74% of people on envudeucitinib experienced at least a 75% improvement in their symptoms, as measured on the Psoriasis Area and Severity Index (PASI), at Week 16. Alumis said 59% of patients scored zero or one on the static Physician’s Global Assessment (sPGA) at Week 16. The PASI 75 and sPGA results met the trials’ co-primary endpoints.

At Week 24, 65% of patients experienced at least a 90% improvement on the PASI. Alumis reported “clear separation from placebo” on PASI 90 as early as Week 4. More than 40% of patients met the PASI 100 criteria by Week 24, indicating that they had completely clear skin. Alumis also said it saw clinically meaningful improvements in patient-reported outcomes related to quality of life and itch.

BMS reported PASI 75 response rates of 53% and 58% at Week 16 in the phase 3 trials quoted (PDF) on the Sotyktu label. At Week 24, the proportion of patients achieving PASI 90 on Sotyktu ranged from 32% to 42%. BMS reported PASI 100 results in 10% to 14% of patients in the two Sotyktu studies. 

With the caveat that cross-trial comparisons can be unreliable, the results appear to favor Alumis' envudeucitinib over Sotyktu. The envudeucitinib results look to be in line with the expectations Alumis CEO Martin Babler set at an investor event in September. 

Noting that Alumis saw a 64% placebo-adjusted PASI 75 at Week 12 of a phase 2 trial, Babler said a result in the 50% to 60% range at Week 16 would be competitive. Alumis’ phase 3 release lacks results from the placebo arm. Between 9% and 13% of patients on placebo in BMS’ Sotyktu trials met the PASI 75 criteria at Week 16.

With no new safety signals emerging in its phase 3 trials, Alumis plans to file for FDA approval in the back half of 2026. FDA approval could add to the pressure on Sotyktu, which generated $206 million for BMS over the first nine months of 2025 and has underperformed prelaunch expectations.

Envudeucitinib is on course to come to market after icotrokinra, the oral IL-23 blocker Johnson & Johnson is lining up as a challenger to Sotyktu. J&J filed for FDA approval in adults and adolescents with plaque psoriasis in July. Icotrokinra performed similarly to envudeucitinib in two phase 3 trials, racking up PASI 75 rates of 74% and 77% at Week 16.

While J&J could be a tough competitor, the psoriasis market’s size, fragmentation and level of treatment switching mean there is room for multiple big products. Alumis plans to focus on the efficacy, safety and convenience of envudeucitinib as it tries to carve out a piece of the market. In parallel, the biotech will work to validate its molecule in lupus, where potentially pivotal phase 2b data are due this year.

In premarket trading Tuesday, Alumis' shares were up 115% to nearly $18 from a Monday closing price of $8.31.

https://www.fiercebiotech.com/biotech/alumis-beams-pivotal-data-sotyktu-rival-drive-stock-surge