Oruka Therapeutics Announces Positive Week 16 Data for ORKA-001 from the Ongoing EVERLAST-A Phase 2a Trial in Moderate-to-Severe Plaque Psoriasis

Rhea-AI Summary

Oruka Therapeutics (NASDAQ: ORKA) reported positive interim EVERLAST-A Phase 2a results for ORKA-001 in moderate-to-severe plaque psoriasis. At Week 16, 63.5% (40/63) achieved PASI 100; PASI 90 83%; IGA 0/1 84%. Safety was comparable to placebo with no serious TEAEs; TEAE rates were 51% (ORKA-001) vs 57% (placebo). Updated Phase 1 PK/PD data showed concentrations above effective trough levels for a year, supporting potential annual dosing. Longer-term Week 28 and 52 follow-up data expected in 2H 2026; Phase 2b EVERLAST-B data expected in 2027. Webcast held April 27, 2026 at 8:00 a.m. ET.

AI-generated analysis. Not financial advice.

Positive

• PASI 100 of 63.5% (40/63) at Week 16
• PASI 90 of 83% and IGA 0/1 of 84% at Week 16
• No serious treatment-emergent adverse events reported
• Phase 1 PK/PD support potential annual dosing after a 600 mg dose

Negative

• Interim Phase 2a cohort is limited in size (63 treated), with longer-term outcomes pending
• Cross-trial comparison cited as numerical advantage but not a head-to-head result

News Market Reaction – ORKA

+10.66%

21 alerts

+10.66% News Effect

+63.7% Peak in 20 min

+$411M Valuation Impact

$4.26B Market Cap

0.2x Rel. Volume

On the day this news was published, ORKA gained 10.66%, reflecting a significant positive market reaction. Argus tracked a peak move of +63.7% during that session. Our momentum scanner triggered 21 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $411M to the company's valuation, bringing the market cap to $4.26B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

PASI 100 at Week 16: 63.5% (40/63 patients) Trial enrollment: 84 patients Dose regimen: 600 mg at Week 0 and 4 +5 more

8 metrics

PASI 100 at Week 16 63.5% (40/63 patients) ORKA-001 arm, EVERLAST-A Phase 2a

Trial enrollment 84 patients EVERLAST-A randomized 3:1 ORKA-001 vs placebo

Dose regimen 600 mg at Week 0 and 4 ORKA-001 dosing schedule in EVERLAST-A

PASI 90 at Week 16 83% of participants ORKA-001-treated participants, secondary endpoint

IGA 0/1 at Week 16 84% of participants ORKA-001-treated participants, secondary endpoint

Sites 26 sites Trial conducted in US and Canada

TEAEs ORKA-001 51% of participants Participants experiencing ≥1 treatment-emergent adverse event

Upper respiratory infections 19% ORKA-001 vs 14% placebo Only TEAE occurring in ≥5% of subjects

Market Reality Check

Price: $57.20 Vol: Volume 1,071,425 vs 20-da...

normal vol

$57.20 Last Close

Volume Volume 1,071,425 vs 20-day average 1,268,045 (relative volume 0.84x ahead of the release). normal

Technical Shares at $69.03, just below the $71 52-week high and trading above the $29.27 200-day MA.

Peers on Argus

ORKA was up 1.9% pre-release while peer moves were mixed: ANAB and RZLT appeared...

1 Up 1 Down

ORKA was up 1.9% pre-release while peer moves were mixed: ANAB and RZLT appeared in momentum scans in opposite directions, and no same-day peer news was recorded, pointing to a stock-specific setup.

Historical Context

5 past events · Latest: Mar 12 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Mar 12	Earnings and update	Positive	+25.0%	Q4/FY25 results, strong cash balance, and clear timelines for EVERLAST-A and ORKA-002.
Feb 09	Conference participation	Neutral	+0.6%	Announcement of multiple investor conference appearances and webcast access details.
Jan 12	Clinical data update	Positive	+10.2%	Positive Phase 1 ORKA-002 data and EVERLAST-B initiation with 2027 data timing.
Jan 06	JPM conference plans	Neutral	-1.0%	Scheduling of a J.P. Morgan Healthcare Conference presentation and webcast details.
Dec 11	Board transition	Neutral	-0.1%	New board member appointment and simultaneous resignation in late 2025.

Pattern Detected

Positive clinical and pipeline updates have previously coincided with double‑digit gains, while conference and governance items saw minimal impact.

Recent Company History

Over the last several months, Oruka has steadily built its chronic skin disease story. A Jan 12, 2026 clinical update on ORKA-002 and EVERLAST-B data timelines saw a 10.16% move. The Mar 12, 2026 earnings and pipeline update, highlighting $479.6M in cash and progress in EVERLAST-A, corresponded to a 25.04% gain. In contrast, routine conference participation and a board transition in late 2025 had little price impact. Today’s new EVERLAST-A Phase 2a data builds directly on that clinical momentum.

Regulatory & Risk Context

Active S-3 Shelf · $1,000,000,000

Shelf Active

Active S-3 Shelf Registration 2026-04-02

$1,000,000,000 registered capacity

An effective S-3 shelf filed on 2026-04-02 registers up to $1,000,000,000 of securities, with at least one prospectus supplement (424B7 on 2026-04-21) tied to resale of existing shares. The shelf allows flexible future offerings via additional supplements.

Market Pulse Summary

The stock surged +10.7% in the session following this news. A strong positive reaction aligns with O...

Analysis

The stock surged +10.7% in the session following this news. A strong positive reaction aligns with Oruka’s pattern of sizable moves on clinical milestones, such as prior double‑digit gains following ORKA-002 data and EVERLAST-B progress. The robust Week 16 PASI and IGA responses and clean safety profile reinforce that trend. However, investors have an effective $1,000,000,000 shelf and recent resale registration in view, so any extended strength could be sensitive to follow-on offerings or insider liquidity events.

Key Terms

pasi 100, pasi 90, il-23p19, monoclonal antibody, +3 more

7 terms

pasi 100 medical

"ORKA-001 achieved 63.5% (40/63) PASI 100 at Week 16"

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.

pasi 90 medical

"Other key secondary endpoints included PASI 90 at Week 16"

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.

il-23p19 medical

"a novel half-life extended IL-23p19 monoclonal antibody"

IL-23p19 is a specific protein subunit that combines with another piece to form the immune signaling molecule called interleukin‑23; think of it as a unique tooth in a two‑tooth gear that helps the immune system rev up inflammation. It matters to investors because many drugs are designed to block this subunit to calm overactive immune responses in conditions like psoriasis and inflammatory bowel disease, so changes in clinical trial results or regulatory decisions around IL‑23p19 inhibitors can directly affect the value of companies developing those therapies.

monoclonal antibody medical

"ORKA-001, a novel half-life extended IL-23p19 monoclonal antibody"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

treatment-emergent adverse events medical

"There were no serious treatment-emergent adverse events (“TEAEs”)"

Events or symptoms that either appear for the first time or get worse after a patient starts a treatment; think of new or intensified side effects that show up once medicine or a medical device is used. Investors watch these closely because they affect whether a therapy can gain regulatory approval, be prescribed widely, or face legal and commercial setbacks—similar to how early customer complaints can sink a new product’s prospects.

pharmacokinetics medical

"evaluating the safety, efficacy, and pharmacokinetics of ORKA-001"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

anti-drug antibodies medical

"No impact of anti-drug antibodies on PK has been seen"

Anti-drug antibodies are immune system proteins that form in patients in response to a biological therapy, such as a therapeutic protein or antibody, and can bind to the medicine. They matter to investors because they can reduce or eliminate a drug’s effectiveness, create safety problems, force higher dosing or additional testing, and influence regulatory approval and commercial success — like delivery guards accidentally intercepting and stopping a needed package.

AI-generated analysis. Not financial advice.

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ORKA-001 achieved 63.5% (40/63) PASI 100 at Week 16

Favorable safety profile consistent with the IL-23p19 class

Updated Phase 1 PK/PD data continue to support the potential for once-yearly dosing, with longer-term EVERLAST-A data expected in 2H 2026

Management to host a conference call today at 8:00 a.m. ET

MENLO PARK, Calif., April 27, 2026 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases, today announced positive interim results from its EVERLAST-A Phase 2a trial of ORKA-001, a novel half-life extended IL-23p19 monoclonal antibody, in moderate-to-severe plaque psoriasis.

“These data reached the top end of what we could have expected from ORKA-001 across efficacy, tolerability, and potential for long-lasting response,” said Joana Goncalves, MBChB, Chief Medical Officer of Oruka. “We’re thrilled with the profile that is emerging for this program and are excited to see how the data mature with longer-term follow-up. I want to thank the Oruka team, the EVERLAST-A investigators, and the trial participants for getting this study off to a tremendous start.”

“These data with ORKA-001 are highly compelling,” said Dr. Bruce Strober, MD, PhD, Clinical Professor of Dermatology at Yale University School of Medicine and lead investigator for EVERLAST-A. “If this type of efficacy and safety profile could be available with dosing once to twice per year, it would represent a major step forward for the field. I could envision this being the preferred product for any patient with moderate-to-severe psoriasis.”

EVERLAST-A is a randomized, double-blind, placebo-controlled Phase 2a trial evaluating the safety, efficacy, and pharmacokinetics of ORKA-001 in participants with moderate-to-severe plaque psoriasis. The study is being conducted across 26 sites in the United States and Canada, and enrolled 84 patients randomized 3:1 to receive 600 mg of ORKA-001 at Week 0 and 4 or matching placebo. Baseline characteristics were comparable to recent studies in moderate-to-severe psoriasis.

Efficacy

40 of 63 participants (63.5%) treated with ORKA-001 achieved the primary endpoint of PASI 100 at Week 16, representing complete skin clearance. Identical results were observed for IGA 0. Other key secondary endpoints included PASI 90 at Week 16, achieved by 83% of participants, and IGA 0/1 at Week 16, achieved by 84% of participants. One of 21 participants receiving placebo reached PASI 100, IGA 0, PASI 90, and IGA 0/1 at Week 16, in line with historical psoriasis trials. All response rates were calculated using non-responder imputation. Based on a cross-trial comparison, these data with ORKA-001 demonstrate numerically higher rates of skin clearance than all other IL-23p19 inhibitors and are comparable to the highest reported in plaque psoriasis for any mechanism of action.

Safety

ORKA-001 was well tolerated with a safety profile similar to placebo and consistent with prior IL-23p19 inhibitors. There were no serious treatment-emergent adverse events (“TEAEs”) and one severe TEAE, which occurred in the placebo group. Most TEAEs were mild in severity. The overall rate of TEAEs was comparable across groups, with 51% of participants treated with ORKA-001 and 57% of participants receiving placebo experiencing at least one TEAE. The only TEAE that occurred in 5% or more of subjects in either group was upper respiratory tract infection (19% for ORKA-001 and 14% for placebo). There were no injection site reactions.

Pharmacokinetics (“PK”) and Pharmacodynamics (“PD”)

Updated PK and PD data from the Phase 1 trial of ORKA-001 continue to support the potential for annual dosing. Following a single 600 mg dose, ORKA-001 concentrations remained well above effective trough levels for an entire year, with sustained inhibition of IL-23 pathway signaling observed throughout that time period. No impact of anti-drug antibodies on PK has been seen in either the Phase 1 or EVERLAST-A trials.

Upcoming Milestones for ORKA-001

Oruka plans to share longer-term data from EVERLAST-A, including efficacy at Week 28 for all patients and 52-week follow-up for a subset of the cohort, in the second half of 2026. The Company also continues to advance the Phase 2b EVERLAST-B trial, with data expected in 2027.

Webcast Details

Oruka Therapeutics’ live webcast of the EVERLAST-A results will begin today at 8:00 a.m. ET. The live webcast can be accessed via this link, or through the Investors section on the company’s website at https://ir.orukatx.com/news-events/events-presentations. A replay of the webcast will be available following the call.

About Oruka Therapeutics 

Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn. 

Forward Looking Statements 

Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Oruka’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, Oruka’s ability to achieve the expected benefits or opportunities with respect to ORKA-001, including timelines to clinical and data release milestones, the details of its planned clinical trials and the potential dosing interval of ORKA-001. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Oruka will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Oruka’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those uncertainties and factors described under the heading “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in Oruka’s most recent filings with the Securities and Exchange Commission (SEC), including its most recent Annual Report on Form 10-K. Should one or more of these risks or uncertainties materialize, or should any of Oruka’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein and in Oruka’s SEC filings. Oruka does not undertake or accept any duty to make any updates or revisions to any forward-looking statements. 

Investor Contact:  
Alan Lada  
(650)-606-7911  
alan.lada@orukatx.com

FAQ

What were ORKA-001 Week 16 results in the EVERLAST-A trial (ORKA)?

ORKA-001 achieved 63.5% PASI 100 at Week 16. According to Oruka, 40 of 63 treated participants reached complete skin clearance, with PASI 90 at 83% and IGA 0/1 at 84% using non-responder imputation.

Does ORKA-001 support once-yearly dosing for ORKA according to the company?

Potential for annual dosing is supported by PK/PD data. According to Oruka, a single 600 mg dose maintained concentrations above effective trough levels and IL-23 pathway inhibition for a year in Phase 1 data.

What safety profile did ORKA-001 show in EVERLAST-A (ORKA results)?

ORKA-001 showed a safety profile comparable to placebo with no serious TEAEs. According to Oruka, overall TEAE rates were 51% for ORKA-001 and 57% for placebo; most events were mild and no injection site reactions occurred.

When will Oruka report longer-term EVERLAST-A data and next milestones for ORKA-001 (ORKA)?

Longer-term data are expected in the second half of 2026. According to Oruka, Week 28 data for all patients and 52-week follow-up for a subset will be shared in 2H 2026; Phase 2b EVERLAST-B data expected in 2027.

How do Oruka’s ORKA-001 results compare to other IL-23p19 inhibitors according to the company?

Oruka reports numerically higher skin clearance rates versus other IL-23p19 inhibitors in cross-trial comparison. According to Oruka, these data are numerically higher but not from a head-to-head trial, so direct comparison is limited.