This section highlights FDA-related milestones and regulatory updates for drugs developed by Alumis (ALMS).
Over the past two years, Alumis has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
A-005 and ESK-001. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
A-005 - FDA Regulatory Timeline and Events
A-005 is a drug developed by Alumis for the following indication: For Treatment of Neuroinflammatory and Neurodegenerative Diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- A-005
- Announced Date:
- February 27, 2025
- Indication:
- For Treatment of Neuroinflammatory and Neurodegenerative Diseases
Announcement
Alumis Inc. announced the Company will give two data presentations on A-005, a potent, selective, central nervous system (CNS) penetrant tyrosine kinase 2 (TYK2) inhibitor, on Friday, February 28, 2025, at the 10th Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2025.
AI Summary
Alumis Inc. announced that it will present key data on A-005, a powerful and selective tyrosine kinase 2 (TYK2) inhibitor that reaches the central nervous system (CNS), on February 28, 2025. The data will be shared at the 10th Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2025 during two presentations. These sessions will cover how A-005 effectively blocks TYK2-specific signaling in both immune and CNS resident cells, which is important for controlling inflammation in neuroinflammatory diseases.
The findings from the Phase 1 clinical trial show that A-005 was well tolerated and achieved strong TYK2 inhibition across a range of doses. This demonstrates a promising new strategy for treating diseases linked to CNS inflammation, and the positive outcomes may support the upcoming Phase 2 trial for patients with multiple sclerosis later this year.
Read Announcement
ESK-001 - FDA Regulatory Timeline and Events
ESK-001 is a drug developed by Alumis for the following indication: In Moderate-to-Severe Plaque Psoriasis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ESK-001
- Announced Date:
- May 29, 2025
- Indication:
- In Moderate-to-Severe Plaque Psoriasis
Announcement
Alumis Inc. announced the completion of patient enrollment in its pivotal Phase 3 ONWARD clinical program of ESK-001 for the treatment of moderate-to-severe plaque psoriasis.
AI Summary
Alumis Inc. announced that it has completed patient enrollment in its pivotal Phase 3 ONWARD clinical program for ESK-001, a new oral TYK2 inhibitor aimed at treating moderate-to-severe plaque psoriasis. The program includes two global, multi-center, randomized, double-blind, placebo-controlled 24‐week trials, with over 1,700 patients enrolled. This milestone highlights the commitment of the patients, investigators, and the Alumis team to advancing treatment for those suffering from plaque psoriasis.
CEO Martin Babler expressed excitement about reaching this achievement as it moves ESK-001 closer to potentially offering an effective and convenient treatment option compared to current therapies. The company is on track to report topline results in early Q1 2026, which could bring a transformative treatment solution to patients facing challenges with both injectable biologics and less effective oral therapies.
Read Announcement- Drug:
- ESK-001
- Announced Date:
- March 25, 2025
- Indication:
- In Moderate-to-Severe Plaque Psoriasis
Announcement
Alumis Inc announced that the companies have entered into a collaboration and licensing agreement to develop, manufacture and commercialize ESK-001, a highly selective, next-generation oral tyrosine kinase 2 (TYK2) inhibitor, for dermatology indications in Japan, with the option to expand the license to include rheumatological and gastrointestinal diseases.
AI Summary
Alumis Inc. announced a collaboration and licensing agreement with Kaken Pharmaceutical to develop, manufacture, and commercialize its next-generation oral tyrosine kinase 2 (TYK2) inhibitor, ESK-001, for dermatology indications in Japan. Under the deal, Alumis will receive $40 million in upfront and near-term co-development payments, with the potential for about $140 million more through additional milestone and field option payments, plus tiered royalties based on future sales. The agreement highlights the strong potential of ESK-001 in treating immune-mediated skin disorders by leveraging Kaken’s expertise and regional capabilities in Japan.
Additionally, the deal includes an option for Kaken to expand the license to ESK-001 for treating rheumatological and gastrointestinal diseases, indicating broader future applications for the drug.
Read Announcement- Drug:
- ESK-001
- Announced Date:
- March 19, 2025
- Indication:
- In Moderate-to-Severe Plaque Psoriasis
Announcement
Alumis Inc. highlighted recent achievements and upcoming milestones.
AI Summary
Alumis Inc. reported strong progress in 2024, highlighting key achievements and outlining important upcoming milestones. The company showcased promising long-term data for its next-generation oral TYK2 inhibitor ESK-001 in a Phase 2 psoriasis study, which demonstrated robust clinical responses and a consistent safety profile. In addition, positive Phase 1 results for its novel oral TYK2 inhibitor A-005 showed that the drug can cross the blood-brain barrier, supporting its potential for treating neuroinflammatory diseases. Looking ahead, Alumis expects topline data from the pivotal Phase 3 program for ESK-001 in moderate-to-severe plaque psoriasis in the first quarter of 2026 and plans to start a Phase 2 trial of A-005 in multiple sclerosis in the second half of 2025. The announcement also included a strategic merger with ACELYRIN, aimed at strengthening the company’s late-stage portfolio and financial support through 2027.
Read Announcement- Drug:
- ESK-001
- Announced Date:
- March 8, 2025
- Indication:
- In Moderate-to-Severe Plaque Psoriasis
Announcement
Alumis Inc. announced positive 52-week data from the open-label extension (OLE) of its Phase 2 STRIDE clinical trial evaluating ESK-001 in patients with moderate-to-severe plaque psoriasis.
AI Summary
Alumis Inc. announced positive 52-week data from the open-label extension (OLE) of its Phase 2 STRIDE clinical trial evaluating ESK-001, a next-generation oral TYK2 inhibitor, in patients with moderate-to-severe plaque psoriasis. The study showed that patients taking 40 mg twice daily maintained or even improved clinical responses through one year. Key efficacy measures included improvements in PASI 90, PASI 100, and sPGA 0 scores, with a noticeable increase in the percentage of patients reaching these endpoints by week 52 compared to week 12. Additionally, patients reported strong control of itch and improved quality of life. Importantly, ESK-001 was generally well tolerated over the year, with no new safety issues arising. These long-term findings support ESK-001’s potential as a highly differentiated, effective, and best-in-class oral treatment option for those suffering from plaque psoriasis.
Read Announcement- Drug:
- ESK-001
- Announced Date:
- February 28, 2025
- Estimated Event Date Range:
- January 1, 2026 - March 31, 2026
- Target Action Date:
- Q1 2026
- Indication:
- In Moderate-to-Severe Plaque Psoriasis
Announcement
The Company also announced that it now expects to report topline data from its pivotal Phase 3 ONWARD clinical program of ESK-001 for the treatment of moderate-to-severe PsO in the first quarter of 2026.
AI Summary
Alumis Inc. announced that it now expects to report topline data from its pivotal Phase 3 ONWARD clinical program for treating moderate-to-severe plaque psoriasis in the first quarter of 2026. The Phase 3 program consists of two global, multi-center, randomized, double-blind, placebo-controlled trials that each plan to enroll around 840 patients. These studies are designed to assess the safety and efficacy of ESK-001, a next-generation, highly selective oral TYK2 inhibitor. The primary endpoints of the ONWARD trials include significant improvements in the Psoriasis Area and Severity Index (PASI 75) and sPGA 0/1 scores compared to placebo. Alumis believes that reaching this milestone early reflects strong interest from clinical investigators and patients, highlighting the potential of ESK-001 to become an important targeted treatment option for those suffering from psoriasis.
Read Announcement- Drug:
- ESK-001
- Announced Date:
- February 28, 2025
- Indication:
- In Moderate-to-Severe Plaque Psoriasis
Announcement
Alumis Inc. announced the Company will give four data presentations from its Phase 2 OLE study evaluating ESK-001, a next-generation oral tyrosine kinase 2 (TYK2) inhibitor, in moderate-to-severe psoriasis (PsO) patients at the 2025 American Academy of Dermatology (AAD) annual meeting from March 7 to 11, 2025, in Orlando, Florida.
AI Summary
Alumis Inc. announced that it will present four new data presentations from its Phase 2 open-label extension (OLE) study of ESK-001 at the 2025 American Academy of Dermatology annual meeting in Orlando, Florida, from March 7 to 11, 2025. ESK-001 is a next-generation oral tyrosine kinase 2 (TYK2) inhibitor being studied in adults with moderate-to-severe plaque psoriasis.
One of the presentations will be a late-breaking oral session featuring 52-week efficacy and safety data, while the other three will be e-poster presentations focusing on patient-reported outcomes, disease biomarker activity, and pharmacokinetic data. These sessions aim to provide the dermatology community with a deeper understanding of ESK-001’s performance and its potential to improve treatment outcomes for patients with moderate-to-severe psoriasis.
Read Announcement- Drug:
- ESK-001
- Announced Date:
- September 27, 2024
- Indication:
- In Moderate-to-Severe Plaque Psoriasis
Announcement
Alumis Inc. announced positive 28-week data from the open-label extension (OLE) period of its Phase 2 STRIDE clinical trial of ESK-001.
AI Summary
Alumis Inc. recently announced positive 28-week data from the open-label extension (OLE) phase of its Phase 2 STRIDE clinical trial, evaluating the oral drug candidate ESK-001 for moderate-to-severe plaque psoriasis. The study results, presented at the European Academy of Dermatology & Venereology Congress in Amsterdam, showed that ESK-001 was generally well tolerated. Notably, most patients taking the highest dose of 40 mg twice daily achieved a PASI 75 response, a key measure of significant skin improvement in psoriasis treatment.
These findings support ESK-001’s potential as a best-in-class oral therapeutic with a favorable safety profile and durable benefits. Alumis is encouraged by the promising results and plans to present the full 52-week data in the first half of 2025 while advancing the ongoing Phase 3 clinical program.
Read Announcement- Drug:
- ESK-001
- Announced Date:
- July 29, 2024
- Indication:
- In Moderate-to-Severe Plaque Psoriasis
Announcement
Alumis Inc. announced that patient dosing has commenced in the ONWARD Phase 3 clinical program.
AI Summary
Alumis Inc. announced that patient dosing has begun in its ONWARD Phase 3 clinical program. This global program will evaluate ESK-001, an oral allosteric TYK2 inhibitor, for treating moderate-to-severe plaque psoriasis. The trials are designed as two identical 24‐week, double-blind, placebo-controlled studies that will assess both the safety and efficacy of ESK-001 in adult patients. The study aims to measure significant improvements in symptoms using endpoints such as PASI 75 and sPGA 0/1 scores. These trials build on positive Phase 2 data, where ESK-001 was generally well tolerated and showed strong therapeutic effects, including sustained responses over time. Alumis believes that if successful, the ONWARD program may pave the way for global regulatory submissions and potentially provide a new, effective oral treatment option for patients with plaque psoriasis.
Read Announcement- Drug:
- ESK-001
- Announced Date:
- July 29, 2024
- Indication:
- In Moderate-to-Severe Plaque Psoriasis
Announcement
Alumis Inc. announced that Topline data anticipated in 2026 –
AI Summary
Alumis Inc. recently announced the start of patient dosing in its pivotal Phase 3 clinical program for ESK-001, an oral TYK2 inhibitor designed for treating moderate-to-severe plaque psoriasis. The program includes two 24‑week global trials, ONWARD1 and ONWARD2, along with a long-term extension study to further assess the durability and safety of the treatment. Early Phase 2 data and ongoing open-label extension results have shown promising clinical effects and a good safety profile, setting the stage for this larger scale evaluation.
Importantly, the company has noted that topline data from these Phase 3 trials is anticipated in 2026. This timeline is crucial as it represents a key step forward in Alumis Inc.’s efforts to secure global regulatory approval and potentially offer patients a new, effective oral treatment option for managing their psoriasis.
Read Announcement
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