Alumis’ Envudeucitinib Delivers Leading Skin Clearance Among Next-Generation Oral Plaque Psoriasis Therapies in Phase 3 Program

Rhea-AI Summary

Alumis (Nasdaq: ALMS) reported positive topline Phase 3 results for oral TYK2 inhibitor envudeucitinib in moderate-to-severe plaque psoriasis from ONWARD1 and ONWARD2.

Key highlights: across both trials PASI 75 74%, sPGA 0/1 59% at Week 16; at Week 24 ~65% PASI 90 and >40% PASI 100. Rapid separation from placebo on PASI 90 by Week 4. Envudeucitinib was superior to placebo and apremilast (p<0.0001) on primary endpoints. Safety through Week 24 was consistent with Phase 2; common TEAEs included headaches, nasopharyngitis, upper respiratory infections, and acne. Alumis plans an NDA submission in H2 2026 and will present additional data at a future medical meeting.

Positive

• PASI 75 achieved by 74% of patients at Week 16
• sPGA 0/1 achieved by 59% of patients at Week 16
• PASI 90 ~65% of patients at Week 24
• PASI 100 >40% of patients at Week 24
• Superior to apremilast and placebo (p<0.0001) on PASI endpoints
• Planned NDA submission in H2 2026

Negative

• Treatment-emergent adverse events included headaches and acne
• Common TEAEs included nasopharyngitis and upper respiratory infections

Key Figures

PASI 75 response 74% of patients Average across ONWARD1 and ONWARD2 at Week 16

sPGA 0/1 response 59% of patients Average across ONWARD1 and ONWARD2 at Week 16

PASI 90 response Approximately 65% of patients Average across trials at Week 24

PASI 100 response More than 40% of patients Average across trials at Week 24

P-value vs placebo p < 0.0001 Co-primary endpoints PASI 75 and sPGA 0/1 at Week 16

Week 16 Week 16 Timing of co-primary endpoint assessment

Week 24 Week 24 Timing of higher-hurdle PASI 90 and PASI 100 endpoints

Week 4 Week 4 Earliest timepoint with clear PASI 90 separation from placebo

Market Reality Check

$18.16 Last Close

Volume Volume 1,837,814 vs 20-day average 1,236,247 (relative volume 1.49x) ahead of the data release. normal

Technical Shares at $8.31 were trading above the $5.28 200-day MA and about 33.2% below the 52-week high.

Peers on Argus

Ahead of the topline data, ALMS was down 7.2% while peers such as CRVS (-6.34%), ERAS (-2.24%), and PRTA (-1.52%) were modestly lower, suggesting a mix of stock-specific pressure and broader biotech softness rather than a coordinated upside move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Jan 05	Data call notice	Neutral	-7.2%	Announced timing of ONWARD Phase 3 topline data and webcast details.
Nov 13	Earnings update	Positive	+0.8%	Reported Q3 2025 results, cash of <b>$377.7M</b>, runway into 2027 and trial timelines.
Nov 04	Conference participation	Neutral	-0.2%	Planned participation in November investor conferences with webcast access.
Aug 29	Conference roadshow	Neutral	-1.3%	Scheduled multiple September healthcare conferences highlighting immune-mediated pipeline.
Aug 13	Earnings & merger	Positive	-0.7%	Q2 2025 results, ACELYRIN merger adding <b>$382.6M</b> cash and significant net income.

Pattern Detected

News flow has been frequent around clinical and corporate milestones, with mostly small price moves and one noted divergence on a positive earnings/strategic update.

Recent Company History

Over the past six months, Alumis has steadily built the envudeucitinib story from enrollment completion to today’s positive Phase 3 topline. The company highlighted cash of $486.3 million in Q2 2025 and $377.7 million in Q3 2025, guiding runway into 2027 while advancing ONWARD and LUMUS. Multiple investor conferences kept visibility high. A prior earnings update with merger-related gains saw a small negative move, indicating that even seemingly favorable financial news has not always translated into upside, which provides context for how markets may digest these strong Phase 3 results.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-07-03

The company has an active S-3 shelf filed on 2025-07-03 that is not yet effective, with no recorded usage to date. This provides a framework for potential future capital-raising once effective, but no specific amounts or takedowns are indicated in the provided data.

Market Pulse Summary

The stock surged +95.3% in the session following this news. A strong positive reaction aligns with the robust Phase 3 efficacy signals, including PASI 75 in 74% of patients and PASI 90 in about 65% at Week 24. Past clinical updates produced only modest moves, so a large upside response would mark a shift in how investors value envudeucitinib’s profile. Investors may also weigh the existing S-3 shelf framework and prior insider buying when assessing how durable any re-rating might be.

Key Terms

pasi 75 medical

"on the co‑primary endpoints of Psoriasis Area and Severity Index (PASI 75)"

PASI 75 is a clinical trial benchmark showing a 75% reduction in psoriasis signs and the area of skin affected compared with a patient’s starting condition, as measured by the Psoriasis Area and Severity Index (PASI). For investors, achieving PASI 75 is a strong signal that a treatment delivers substantial, visible improvement—akin to clearing three quarters of the symptoms—which can influence regulatory chances, market demand, and how a drug stacks up against competitors.

pasi 90 medical

"Approximately 65% of patients achieved PASI 90 and more than 40%"

PASI 90 is a clinical measure showing a 90% reduction in the size and severity of a patient’s psoriasis lesions compared with where they started, based on the Psoriasis Area and Severity Index (PASI). For investors, a drug or therapy that achieves PASI 90 signals very strong effectiveness—like shrinking a visible problem to almost nothing—which can boost the chances of regulatory approval, wider doctor use, higher pricing power and larger sales potential.

pasi 100 medical

"and more than 40% achieved PASI 100 at Week 24, on average"

PASI 100 is a clinical-trial measure meaning a patient’s psoriasis has cleared completely, showing a 100% improvement on the Psoriasis Area and Severity Index. Think of it like a before-and-after photo where all visible signs of the condition are gone. For investors, PASI 100 signals a therapy’s top-level effectiveness claim, which can drive regulatory approval prospects, market adoption and a product’s commercial value.

static physician’s global assessment (spga) medical

"static Physician’s Global Assessment (sPGA) 0/1 at Week 16."

A static Physician’s Global Assessment (sPGA) is a doctor’s single-point rating of a patient’s overall disease severity, usually recorded on a simple numeric or descriptive scale during a clinical visit. Investors watch sPGA because it is often used as a key measure of a treatment’s effectiveness in clinical trials and regulatory filings; like a snapshot grade from a teacher, it helps signal whether a therapy meaningfully improves patients and supports approval and market adoption.

tyrosine kinase 2 (tyk2) medical

"a next-generation highly selective oral tyrosine kinase 2 (TYK2) inhibitor"

Tyrosine kinase 2 (TYK2) is a human enzyme that acts like a switch inside immune cells, helping control signals that turn inflammation and immune responses on or off. Investors watch TYK2 because drugs that block or tweak this switch can treat autoimmune diseases and certain cancers, so clinical trial results, regulatory approval, patents and potential sales can materially change the value of drug developers targeting TYK2.

new drug application regulatory

"Alumis plans to submit a New Drug Application to the FDA in the second half"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

systemic lupus erythematosus medical

"LUMUS Phase 2b trial of envudeucitinib in systemic lupus erythematosus (SLE)"

Systemic lupus erythematosus is a chronic autoimmune disease in which the body's immune system mistakenly attacks healthy tissue, causing inflammation that can affect skin, joints, kidneys, heart, lungs and other organs. It matters to investors because disease severity, prevalence, and gaps in effective treatments drive demand for new drugs and diagnostics—think of it as a large, persistent market need where a successful therapy can change patient outcomes and create significant commercial value.

type i interferon medical

"as well as those driven by Type I interferon"

Type I interferons are natural proteins the body releases like an alarm to warn nearby cells of viral infection and to rally the immune system. For investors, they matter because many drugs and therapies aim to boost, mimic, or block these proteins; changes in how a therapy affects type I interferon signaling can determine a drug’s effectiveness, safety profile, regulatory review and market potential, much like improving or disabling a building’s alarm system changes its real-world value.

AI-generated analysis. Not financial advice.

– Both Phase 3 trials met all primary and secondary endpoints with high statistical significance in patients with moderate-to-severe plaque psoriasis –

– Approximately 65% of patients achieved PASI 90 and more than 40% achieved PASI 100 at Week 24, on average –

– Envudeucitinib demonstrated a favorable safety and tolerability profile consistent with the Phase 2 program –

– Alumis plans to submit a New Drug Application to the FDA in the second half of 2026 –

– Conference call and webcast scheduled for 8:00 a.m. ET today –

SOUTH SAN FRANCISCO, Calif., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharmaceutical company developing next-generation targeted therapies for patients with immune-mediated diseases, today 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.

Envudeucitinib met all primary and secondary endpoints with high statistical significance in ONWARD1 and ONWARD2. In each of these trials, envudeucitinib achieved superior skin clearance compared with placebo (p < 0.0001) on the co‑primary endpoints of Psoriasis Area and Severity Index (PASI) 75 and static Physician’s Global Assessment (sPGA) 0/1 at Week 16. On average across both ONWARD1 and ONWARD2, 74% of patients achieved PASI 75 and 59% of patients achieved sPGA 0/1, with responses deepening over time. In addition, the placebo-adjusted response rates for the co-primary endpoints were consistent between the two trials.

At Week 24, on the higher hurdle skin clearance measures, approximately 65% of patients achieved PASI 90, and more than 40% achieved PASI 100, on average across both trials. Rapid responses were observed, with clear separation from placebo on PASI 90 as early as Week 4. In addition, consistent and clinically meaningful improvements across patient-reported outcomes relating to itch and quality of life were observed. Envudeucitinib also achieved superior skin clearance compared with apremilast in each trial (p<0.0001) on all PASI endpoints at Week 24.

“We believe envudeucitinib demonstrates the full promise of TYK2 inhibition,” said Dr. Jörn Drappa, Chief Medical Officer of Alumis. “By maximally inhibiting TYK2, envudeucitinib blocks both IL‑23 and IL‑17 to deliver comprehensive disease control. In Phase 3, this translated into rapid onset of action, high rates of skin clearance, and meaningful symptom improvements that rank among the strongest reported for an oral therapy. We are deeply grateful to the patients, families, and investigators whose commitment made this milestone possible.”

Treatment with envudeucitinib was generally well tolerated through Week 24 in both trials, with a safety profile consistent with Alumis’ Phase 2 program, including the long-term extension trial. Treatment-emergent adverse event (TEAE) frequency and severity were similar across trials, with the majority being mild to moderate, transient, and responding to standard therapy, if required. The most common TEAEs were headaches, nasopharyngitis, upper respiratory tract infections, and acne. No new safety signals were observed.

“Patients with moderate-to-severe psoriasis have to choose between oral and biologic therapies,” said leading dermatologist and psoriasis expert Dr. Andrew Blauvelt. “And for individuals seeking the best chance for clearance, biologics have long been superior to oral therapies. But now, with these new data on envudeucitinib, we’re seeing an exciting possibility of a new oral drug for psoriasis that can deliver high levels of efficacy in a safe manner.”

“These pivotal data strengthen our conviction in envudeucitinib’s potential to transform the treatment landscape for IL‑23/IL‑17–driven diseases as well as those driven by Type I interferon,” said Martin Babler, Chief Executive Officer of Alumis. “These results reinforce our enthusiasm that envudeucitinib’s highly differentiated clinical profile positions it at the forefront of next-generation TYK2 inhibitors in psoriasis, with potential in systemic lupus erythematosus and beyond as a true pipeline-in-a-pill.”

Alumis plans to present additional results from ONWARD1 and ONWARD2 at an upcoming medical meeting and to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in the second half of this year. Topline data from the LUMUS Phase 2b trial of envudeucitinib in systemic lupus erythematosus (SLE) are expected to be announced in the third quarter of 2026.

Conference Call and Webcast Details
The webcast of the Phase 3 ONWARD topline results will begin today at 8:00 a.m. ET. The live webcast can be accessed via this link or on the Events tab on the Investors section of the Company’s website. A replay of the webcast will be made available on the Company’s website following the call.

About the Phase 3 ONWARD Clinical Program
The Phase 3 ONWARD clinical program includes two parallel global, multi‑center, randomized, double‑blind, placebo and active-comparator‑controlled 24‑week trials—ONWARD1 (NCT06586112) and ONWARD2 (NCT06588738)—evaluating the efficacy and safety of envudeucitinib in adults with moderate-to-severe plaque psoriasis. More than 1,700 patients were enrolled and randomized 2:1:1 to receive envudeucitinib 40 mg twice daily, placebo, or apremilast. Co‑primary endpoints at Week 16 were the proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 and static Physician’s Global Assessment (sPGA) 0/1 compared with placebo. Patients completing Week 24 were eligible to enter ONWARD3, an ongoing long‑term extension study assessing durability, greater maintenance of response, and long‑term safety. The ONWARD clinical trials did not have a fasting requirement.

About Envudeucitinib
Envudeucitinib is a next‑generation, highly selective, oral allosteric inhibitor of tyrosine kinase 2 (TYK2) designed to correct immune dysregulation across a range of diseases driven by proinflammatory mediators, including IL-23, IL-17, and Type I interferon. Clinical data indicate its selective targeting delivered sustained, maximal 24-hour inhibition in patients with psoriasis while minimizing off-target binding and effects. Alumis is currently evaluating the long-term efficacy and safety of envudeucitinib in the Phase 3 ONWARD3 clinical program for moderate-to-severe plaque psoriasis. Envudeucitinib is also being evaluated in LUMUS, a potentially pivotal Phase 2b clinical trial in patients with systemic lupus erythematosus, with topline data expected in the third quarter of 2026.

About Plaque Psoriasis
Plaque psoriasis is a chronic, immune-mediated disease driven by dysregulated IL-23 and IL-17 pathways that cause painful, itchy, scaly patches. It affects more than 8 million adults in the U.S. and often involves high-impact areas such as the scalp, face, hands, feet, and nails, significantly disrupting daily life. According to the National Psoriasis Foundation, about one in four patients has moderate-to-severe disease based on quality-of-life impact and body surface area involved. Many remain inadequately controlled on current oral and topical treatments, underscoring the need for more effective, safe, and durable oral options that address the full burden of disease.

About TYK2 in Immune-Mediated Disease
Tyrosine kinase 2 (TYK2) is a key immune-signaling enzyme that regulates pathways across innate and adaptive immunity, including the IL-23/IL-17 axis and Type I interferon signaling that drive many high-burden immune-mediated diseases. Selective TYK2 inhibition has been widely validated as an effective, safe, and well-tolerated therapeutic approach. Genomic analyses conducted by Alumis highlight TYK2’s broad therapeutic potential, showing that it contributes to the pathogenesis of roughly 20 immune-driven conditions—including psoriasis, lupus, psoriatic arthritis, rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. Additional evidence supports a genetic rationale for TYK2 inhibition in neuroinflammatory and neurodegenerative diseases such as multiple sclerosis, where targeting TYK2 may offer a novel approach to treatment.

About Alumis
Alumis is a late-stage biopharma company developing next-generation targeted therapies with the potential to significantly improve patient health and outcomes across a range of immune-mediated diseases. Leveraging its proprietary data analytics platform and precision approach, Alumis is developing a pipeline of oral tyrosine kinase 2 inhibitors, consisting of envudeucitinib for the treatment of systemic immune-mediated disorders, such as moderate-to-severe plaque psoriasis and systemic lupus erythematosus, and A-005 for the treatment of neuroinflammatory and neurodegenerative diseases. In addition, the pipeline includes lonigutamab, a subcutaneously delivered anti–insulin-like growth factor 1 receptor therapy for the treatment of thyroid eye disease, as well as several preclinical programs identified through this precision approach. For more information, visit www.alumis.com or follow us on LinkedIn or X.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, including the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements. All statements, other than statements of historical facts, including without limitation those regarding Alumis’ plans to submit an NDA in the second half of 2026, the potential for envudeucitinib to transform the treatment landscape for IL‑23/IL‑17–driven diseases as well as those driven by Type I interferon, the potential for envudeucitinib to meaningfully elevate care for and effectively reduce the full burden of disease for patients with moderate-to-severe plaque psoriasis, the timing of Alumis’ topline readout in its LUMUS Phase 2b program and statements regarding Alumis’ future plans and prospects, including development of its clinical pipeline; and any assumptions underlying any of the foregoing, are forward-looking statements. Any forward-looking statements in this press release are based on Alumis’ current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in Alumis’ forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to whether regulatory authorities determine that envudeucitinib in moderate-to-severe plaque psoriasis is sufficiently safe and efficacious and grant regulatory approval; whether regulatory authorities accept for filing Alumis’ planned NDA submission; Alumis’ ability to obtain regulatory approval of and ultimately commercialize Alumis’ clinical candidates, the timing and results of preclinical and clinical trials, Alumis’ ability to fund development activities and achieve development goals, and Alumis’ ability to protect its intellectual property. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Alumis’ filings and reports with the Securities and Exchange Commission (SEC) under the heading “Risk Factors” and elsewhere in such filings and reports, including any future reports Alumis may file with the SEC from time to time. Alumis explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Alumis Contact Information
Teri Dahlman
Red House Communications
teri@redhousecomms.com

FAQ

What were the Week 16 efficacy results for Alumis (ALMS) envudeucitinib in ONWARD1 and ONWARD2?

Across both trials PASI 75 was 74% and sPGA 0/1 was 59% at Week 16.

How effective was ALMS envudeucitinib at Week 24 on higher skin‑clearance endpoints?

At Week 24 approximately 65% achieved PASI 90 and >40% achieved PASI 100 on average across both trials.

When does Alumis plan to submit an NDA for envudeucitinib (ALMS)?

Alumis plans to submit a New Drug Application in the second half of 2026.

How did envudeucitinib compare with apremilast in the Phase 3 trials for ALMS?

Envudeucitinib achieved superior skin clearance versus apremilast on all PASI endpoints at Week 24 (p<0.0001).

What safety findings were reported for envudeucitinib in ALMS Phase 3 trials through Week 24?

Safety was consistent with Phase 2; most TEAEs were mild to moderate, commonly headaches, nasopharyngitis, URTI, and acne, and no new safety signals were observed.

When and where can investors access Alumis' Phase 3 ONWARD topline webcast for ALMS?

The webcast began on Jan. 6, 2026 at 8:00 a.m. ET and a replay is available via the company’s investor website.