Armis(ALMS) 'Enburtuzumab', in Phase 3 clinical trials, PASI90 reached up to 68%... FDA approval is expected to increase↑

Alumis (ALMS) is developing an oral TYK2 inhibitor, ‘Embudasitinib’, which has demonstrated significant efficacy and rapid symptom improvement in Phase 3 clinical trials, thereby enhancing expectations for new drug approval. This achievement in the psoriasis treatment market, combined with the strengthening of the company’s financial position, has been assessed as a core opportunity to reinforce the medium- to long-term growth story.

Alumis announced that in the ONWARD1·2 Phase 3 clinical trial conducted on patients with moderate to severe plaque psoriasis, the PASI 90 achievement rates were 68.0% and 62.1% at the 24-week mark, indicating that the PASI 100, which represents complete skin improvement, reached 41.0% and 39.5%, respectively. Notably, starting from the fourth week of treatment, there was a significant difference compared to placebo, with a PASI 75 achievement rate of approximately 74% and an sPGA of 0/1 being 59% at the 16-week mark. These figures far exceed those of existing oral treatment medications, highlighting its “differentiated competitiveness.”

The speed of symptom relief is also noteworthy. The dermatology life quality index (DLQI) improved by approximately 50% within 12 weeks, and itching decreased by more than 4 points within 16 weeks, with patients’ perceived effects confirmed early on. Safety remained consistent with Phase 2 trials, with headache, nasopharyngitis, upper respiratory infections, and acne reported as major adverse reactions.

Alumis plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2026 based on these clinical data. Concurrently, the company will continue to conduct the ONWARD3 extension study to confirm long-term effects and has announced that results from the Phase 2b study targeting systemic lupus erythematosus (SLE) will be released in the third quarter of 2026.

Communication with academia and investors is ongoing. The Phase 3 results will be presented as an “important oral presentation” at the American Academy of Dermatology (AAD) annual meeting on March 28, 2026, and the company plans to explain additional data through a separate investor live stream. Industry evaluations state, “It is rare to demonstrate such a degree of skin improvement rates and speed among oral immunomodulators,” and there is high optimism regarding its potential for commercial success.

The financial foundation has also become more solid. Alumis raised approximately $345.1 million (about 497 billion KRW) through a public offering in January 2026, with cash holdings amounting to $308.5 million (about 444 billion KRW) by the end of the year, ensuring operational funding until the fourth quarter of 2027. Previously, the company successfully expanded and completed a capital increase plan of $300 million (about 432 billion KRW) in phases and conducted an initial public offering of $175 million (about 252 billion KRW), successfully securing funding.

Alumis’ ‘Embudasitinib’ is regarded as a candidate drug that offers both the convenience of administration superior to existing biologics and competitive efficacy. In the future, depending on regulatory approvals and the expansion of additional indications, it is expected to rapidly expand its influence in the global autoimmune disease treatment market. Comments state, “Given that the consistency of clinical data and financial stability have been ensured simultaneously, the execution capability in the future commercialization phase is expected to become a key variable in the company’s value.”