Alumis (ALMS) has upcoming FDA regulatory milestones for ESK-001. The table below outlines estimated target dates and event types for these pending regulatory actions.
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
envudeucitinib, ESK-001, and A-005. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Envudeucitinib FDA Regulatory Timeline and Events
Envudeucitinib 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:
- envudeucitinib
- Announced Date:
- March 28, 2026
- Indication:
- in Moderate-to-Severe Plaque Psoriasis
Announcement
Alumis Inc. announced new data from its Phase 3 ONWARD1 and ONWARD2 clinical trials evaluating envudeucitinib, a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor for moderate-to-severe plaque psoriasis.
AI Summary
Alumis Inc. released Phase 3 data from the ONWARD1 and ONWARD2 trials testing envudeucitinib, a next‑generation, highly selective oral TYK2 inhibitor for moderate‑to‑severe plaque psoriasis. Across both trials, broad clinical benefits appeared early. Quality-of-life and itch improvements were seen before major skin‑clearance results (PASI 90) and continued to deepen through Week 24, suggesting symptom relief can begin well before full skin clearance.
Envudeucitinib showed strong results for scalp psoriasis, a hard‑to‑treat area: about three out of four patients achieved clear or almost clear scalp skin (ss‑PGA 0/1) at Week 24, and over 30% responded as early as Week 4. The company is studying long‑term efficacy and safety in the ONWARD3 extension trial and plans to submit a New Drug Application to the U.S. Food and Drug Administration in the second half of this year.
Read Announcement- Drug:
- envudeucitinib
- Announced Date:
- March 18, 2026
- Indication:
- in Moderate-to-Severe Plaque Psoriasis
Announcement
Alumis Inc. announced that results from its Phase 3 ONWARD program evaluating envudeucitinib, a next-generation oral tyrosine kinase 2 (TYK2) inhibitor for moderate-to-severe plaque psoriasis, have been accepted for a late-breaking oral presentation, and that a new biomarker analysis from the Phase 2 STRIDE trial of envudeucitinib has been accepted as an e-poster at the 2026 American Academy of Dermatology (AAD) Annual Meeting, taking place March 27–31, 2026, in Denver, Colorado.
AI Summary
Alumis Inc. announced that data on envudeucitinib, a next‑generation oral tyrosine kinase 2 (TYK2) inhibitor for moderate‑to‑severe plaque psoriasis, will be presented at the 2026 AAD Annual Meeting. Phase 3 results from the ONWARD program (ONWARD 1 and ONWARD 2) were accepted as a late‑breaking oral presentation, highlighting 24‑week randomized, double‑blind, active‑comparator and placebo‑controlled findings.
The late‑breaking oral presentation, titled “Envudeucitinib (ESK‑001) in moderate‑to‑severe plaque psoriasis: 24‑week results from the randomized, double‑blind, active comparator‑ and placebo‑controlled, Phase 3 ONWARD 1 and 2 studies,” is scheduled for March 28, 2026 at 11:12 am MDT in Bellco Theatre 3. A STRIDE Phase 2 biomarker analysis e‑poster, “Envudeucitinib Attenuates Inflammatory Biomarkers in Plaque Psoriasis…,” will appear as poster 73714. Materials will be posted on Alumis’s Publications page on March 28 per AAD embargo rules.
Alumis will host an investor webcast on Sunday, March 29, 2026 at 5:00 pm MDT / 7:00 pm EDT to discuss the presentations.Read Announcement
- Drug:
- envudeucitinib
- Announced Date:
- January 6, 2026
- Indication:
- in Moderate-to-Severe Plaque Psoriasis
Announcement
Alumis Inc. announced positive topline results from its Phase 3 ONWARD1 and ONWARD2 clinical trials of envudeucitinib, a next-generation highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate-to-severe plaque psoriasis.
AI Summary
Alumis Inc. reported positive topline results from its Phase 3 ONWARD1 and ONWARD2 trials of envudeucitinib, a highly selective oral TYK2 inhibitor, in adults with moderate-to-severe plaque psoriasis. Both trials met all primary and secondary endpoints with strong statistical significance (p<0.0001). On average across studies, 74% of patients reached PASI 75 and 59% achieved sPGA 0/1 at Week 16, with deeper responses over time. By Week 24 about 65% achieved PASI 90 and more than 40% achieved PASI 100. Rapid separation from placebo was seen as early as Week 4, and envudeucitinib outperformed apremilast on all PASI measures. Patients also reported meaningful improvements in itch and quality of life.
The treatment was generally well tolerated through Week 24, with most adverse events mild to moderate and similar to Phase 2 findings; common events included headaches, nasopharyngitis, upper respiratory infections, and acne. Alumis plans to submit an NDA in the second half of 2026 and will present additional data at upcoming medical meetings.
Read Announcement- Drug:
- envudeucitinib
- Announced Date:
- January 5, 2026
- Indication:
- in Moderate-to-Severe Plaque Psoriasis
Announcement
Alumis Inc. announced that the Company will report topline data from the Phase 3 ONWARD clinical program evaluating envudeucitinib in patients with moderate-to-severe plaque psoriasis on Tuesday, January 6, 2026. Following the announcement, the Company will host a conference call and webcast at 8:00 a.m. ET to discuss the results.
AI Summary
Alumis Inc. announced it will report topline data from the Phase 3 ONWARD clinical program evaluating envudeucitinib in patients with moderate-to-severe plaque psoriasis on Tuesday, January 6, 2026. The company said the update will provide an initial look at the key efficacy and safety outcomes from the trial.
Following the announcement, Alumis will host a conference call and live webcast at 8:00 a.m. ET the same day to discuss the results. Interested parties can access the live webcast via the link on the "Events" page in the Investors section of Alumis’s website at www.alumis.com.
A replay of the webcast will be posted on the company website after the call. Alumis is a late-stage biopharma developing oral tyrosine kinase 2 inhibitors, including envudeucitinib, for immune-mediated diseases such as plaque psoriasis.
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:
- July 24, 2025
- Target Action Date:
- Q3 2026
- Estimated Target Date Range:
- July 1, 2026 - September 30, 2026
- Indication:
- In Moderate-to-Severe Plaque Psoriasis
Announcement
Alumis Inc. announced that Topline Readout Expected in Q3 2026
AI Summary
Alumis Inc. has finished enrolling 408 patients in its global LUMUS Phase 2b trial of ESK-001, an oral TYK2 inhibitor designed to treat systemic lupus erythematosus (SLE). This randomized, double-blind, placebo-controlled study will run for 48 weeks and measure improvements in disease activity using the BICLA assessment at Week 48.
ESK-001 selectively targets key inflammatory drivers, including type 1 interferon, aiming to deliver strong inhibition while reducing off-target effects. Earlier data in psoriasis studies showed full, sustained target inhibition and good tolerability, suggesting it could offer biologic-level responses in lupus.
Alumis expects to share topline results from the LUMUS Phase 2b trial in the third quarter of 2026. After the main study, eligible participants can join an open-label extension or complete a four-week safety follow-up. This milestone moves Alumis closer to potentially bringing a new oral therapy to people living with SLE.
Read Announcement- Drug:
- ESK-001
- Announced Date:
- July 24, 2025
- Indication:
- In Moderate-to-Severe Plaque Psoriasis
Announcement
Alumis Inc. announced the completion of patient enrollment in its global LUMUS Phase 2b trial of ESK-001, a highly selective, next-generation oral tyrosine kinase 2 (TYK2) inhibitor, for the treatment of systemic lupus erythematosus (SLE), the most common form of lupus.
AI Summary
Alumis Inc. announced on July 24, 2025, that it has completed patient enrollment in its global LUMUS Phase 2b trial of ESK-001 for systemic lupus erythematosus (SLE). The trial enrolled 408 adults with moderate-to-severe, autoantibody-positive SLE and is set to deliver topline data in the third quarter of 2026. The company said this milestone highlights the dedication of clinical partners, investigators, patients, and the Alumis team.
ESK-001 is a next-generation oral tyrosine kinase 2 (TYK2) inhibitor designed to selectively block key inflammatory drivers, including type 1 interferon. By focusing on these pathways, the drug aims to control disease activity while minimizing off-target effects. Early clinical data in psoriasis showed full, sustained target inhibition and a favorable safety profile.
The randomized, double-blind, placebo-controlled study will assess improvements in overall disease activity using the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at week 48. After the main study, participants may join an open-label extension or complete a four-week safety follow-up.
Read Announcement- 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
- Target Action Date:
- Q1 2026
- Estimated Target Date Range:
- January 1, 2026 - March 31, 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 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- 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
A-005 FDA Regulatory 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
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