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Other Disclosures4521KAKEN PHARMACEUTICAL CO.,LTD.Pharmaceuticals

Regarding Alumis' Announcement of Topline Results from the Phase 3 Long-Term Treatment Study ONWARD3 of the TYK2 Inhibitor ESK-001

Alumis announced preliminary 48-week efficacy and safety results from the Phase 3 long-term extension study "ONWARD3" of ESK-001, as well as plans to submit a new drug application to the US FDA in the fourth quarter of 2026. Kaken Pharmaceutical notified stakeholders of the announcement in its capacity as the exclusive holder of the development, manufacturing and marketing rights for ESK-001 in the dermatology field in Japan.

Worth reading
64In focus
0–100. This measures how worthwhile something is to read, not how good or bad the company is.
Direction
Improvement
Direction inferred from the company’s description.
Scale
75
Percentage of patients achieving PASI 90 at week 48 (%)
Wording
Conditional
How definitive the wording is.

Announced details

ESK-001envudeucitinibONWARD3
Applicable field (uses covered by this announcement)

Treatment of adult patients with moderate-to-severe plaque psoriasis; dermatological diseases in Japan.

Contract Date25 March 2025 (the date of publication of the notice regarding the execution of the collaboration and license agreement)
What the company reported numerically
Quantitative Effects

More than 1,509 patients transitioned to ONWARD3, 773 continued treatment for up to 48 weeks, 75% achieved PASI 90 at week 48, 54% achieved PASI 100, and maintenance of skin clearance was approximately 90% among patients enrolled with PASI 90 and approximately 80% among patients enrolled with PASI 100.

Usage history

More than 85% of the 1,509 patients from ONWARD1/2 transitioned to ONWARD3. A total of 773 patients continued treatment with ESK-001 for up to 48 weeks.

Relationship between the counterparty and the company
KAKEN PHARMACEUTICAL CO.,LTD.4521
Relationship with the Company

Kaken Pharmaceutical holds the exclusive development, manufacturing and marketing rights for ESK-001 for dermatological diseases in Japan.

CounterpartyAlumis Inc. (Alumis; Nasdaq: ALMS)

A Nasdaq-listed biotechnology company headquartered in South San Francisco, California, United States. Its chief executive officer is Martin Babler. The company is developing oral therapies and other treatments for immune-mediated diseases.

Registration number and expiry date

ONWARD1: NCT06586112; ONWARD2: NCT06588738. Other information: Not disclosed

In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.

Source (materials cited by the company)

Alumis Inc.'s announcement dated 10 August 2026 (US Pacific Time). Kaken Pharmaceutical stated that readers should refer to the company's announcement.

Announced details
ItemDetails
Names of Products / Services CoveredESK-001, envudeucitinib, ONWARD3
CounterpartyAlumis Inc. (Alumis; Nasdaq: ALMS)
Counterparty overviewA Nasdaq-listed biotechnology company headquartered in South San Francisco, California, United States. Its chief executive officer is Martin Babler. The company is developing oral therapies and other treatments for immune-mediated diseases.
Relationship with the CompanyKaken Pharmaceutical holds the exclusive development, manufacturing and marketing rights for ESK-001 for dermatological diseases in Japan.
Contract Date25 March 2025 (the date of publication of the notice regarding the execution of the collaboration and license agreement)
Applicable areaTreatment of adult patients with moderate-to-severe plaque psoriasis; dermatological diseases in Japan.
Registration number and expiry dateONWARD1: NCT06586112; ONWARD2: NCT06588738. Other information: Not disclosed
Quantitative EffectsMore than 1,509 patients transitioned to ONWARD3, 773 continued treatment for up to 48 weeks, 75% achieved PASI 90 at week 48, 54% achieved PASI 100, and maintenance of skin clearance was approximately 90% among patients enrolled with PASI 90 and approximately 80% among patients enrolled with PASI 100.
Usage historyMore than 85% of the 1,509 patients from ONWARD1/2 transitioned to ONWARD3. A total of 773 patients continued treatment with ESK-001 for up to 48 weeks.
SourceAlumis Inc.'s announcement dated 10 August 2026 (US Pacific Time). Kaken Pharmaceutical stated that readers should refer to the company's announcement.
Items this document does not state (8)
Contract ValueOffering priceLaunch dateAward/certification nameAwarding / certifying bodyLocationLocation scaleImpact on Business Performance

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

Alumis announced preliminary results from ONWARD3. More than 85% of the 1,509 patients who transitioned from ONWARD1/2 entered the study, and 773 continued treatment for up to 48 weeks.

How to read this page

This is not the documentKomori reads the disclosure the company filed and writes this summary. Figures are as stated by the company and are not audited.
Weight is not a verdictIt measures how much this changes what the company had already told the market. It is not a view on the shares.
Corrections happenIf the company reissues this disclosure, the page is rebuilt from the corrected version and the revision number moves up.
Regarding Alumis' Announcement of Topline Results from the Phase 3 Long-Term Treatment Study ONWARD3 of the TYK2 Inhibitor ESK-001 | KAKEN PHARMACEUTICAL CO.,LTD. (4521) timely disclosure | Komori