Oruka Therapeutics Announces Positive Interim Phase 1 Data for ORKA-002 and Initiation of EVERLAST-B Trial of ORKA-001

Rhea-AI Summary

Oruka Therapeutics (Nasdaq: ORKA) reported positive interim Phase 1 data for ORKA-002 and trial updates for ORKA-001 on Jan 12, 2026. ORKA-002 showed a 75–80 day half-life, >3x that of bimekizumab, and comparable Cmax, supporting pharmacokinetic modeling for twice-yearly maintenance dosing in plaque psoriasis and quarterly dosing in hidradenitis suppurativa. The Phase 1 (n=24) safety profile was favorable with no severe or serious TEAEs. Oruka plans a ~160-patient Phase 2 ORCA-SURGE psoriasis trial in 1H 2026 and a Phase 2 HS trial in 2H 2026. EVERLAST-B for ORKA-001 dosed first patients in Dec 2025 with data expected in 2027.

Positive

• ORKA-002 half-life of 75–80 days supporting less frequent maintenance dosing
• No severe or serious TEAEs reported in the Phase 1 healthy volunteer study
• Phase 2 ORCA-SURGE planned to enroll ~160 patients starting 1H 2026

Negative

• Phase 1 data derived from 24 healthy volunteers, not patients
• Efficacy in psoriasis and HS not yet demonstrated; patient readouts expected in 2027
• Study remains blinded, so full safety and efficacy details are pending

News Market Reaction

+10.16%

10 alerts

+10.16% News Effect

+$137M Valuation Impact

$1.49B Market Cap

0.8x Rel. Volume

On the day this news was published, ORKA gained 10.16%, reflecting a significant positive market reaction. Our momentum scanner triggered 10 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $137M to the company's valuation, bringing the market cap to $1.49B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

ORKA-002 half-life: 75–80 days Phase 1 participants: 24 healthy adults ORKA-002 dose cohorts: 160 mg, 320 mg, 640 mg +5 more

8 metrics

ORKA-002 half-life 75–80 days Phase 1 healthy volunteer PK data

Phase 1 participants 24 healthy adults ORKA-002 first-in-human trial enrollment

ORKA-002 dose cohorts 160 mg, 320 mg, 640 mg Single-ascending subcutaneous doses in Phase 1

ORCA-SURGE sample size ≈160 patients Planned Phase 2 PsO trial of ORKA-002

ORCA-SURGE dosing 40 mg, 160 mg, 320 mg Weeks 0 and 4 vs placebo in Phase 2 PsO

EVERLAST-B induction doses 37.5 mg; 300 mg; 600 mg ORKA-001 Phase 2b induction regimens

Primary endpoint PASI 100 at Week 16 Both ORCA-SURGE and EVERLAST-B psoriasis trials

Follow-up duration Up to 24 weeks PD follow-up showing IL-17 inhibition for ORKA-002

Market Reality Check

Price: $34.46 Vol: Volume 529,626 is below t...

normal vol

$34.46 Last Close

Volume Volume 529,626 is below the 20-day average of 730,200, suggesting moderate participation. normal

Technical Price $27.86 is trading above the 200-day MA of $17.94 and 14.64% below the 52-week high.

Peers on Argus

ORKA gained 5.53% while several biotech peers also rose: BCAX +7.1%, ANAB +4.49%...

ORKA gained 5.53% while several biotech peers also rose: BCAX +7.1%, ANAB +4.49%, RZLT +11.91%, and SVRA +0.17%, with PVLA the main decliner at -5.99%.

Historical Context

5 past events · Latest: Jan 06 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 06	Conference presentation	Neutral	-1.0%	J.P. Morgan Healthcare Conference presentation announcement and webcast details.
Dec 11	Board change	Positive	-0.1%	New director with commercial experience appointed, prior director resigned.
Nov 12	Earnings update	Positive	+0.3%	Q3 2025 results with strong cash position and clinical progress update.
Oct 29	Investor conferences	Neutral	+0.6%	Multiple November investor conference presentations scheduled with webcasts.
Sep 17	Private placement	Positive	+8.8%	Announced $180M PIPE financing to fund ORKA-001 and ORKA-002 programs.

Pattern Detected

Clinical and financing milestones have often seen positive alignment, while conference and governance news show mixed or modest reactions.

Recent Company History

Over the last six months, Oruka has advanced ORKA-001 and ORKA-002 while strengthening its balance sheet. A $180M PIPE on Sep 17, 2025 supported funding through key readouts, coinciding with positive ORKA-001 Phase 1 data. Subsequent earnings on Nov 12, 2025 highlighted $500.9M in cash and ongoing clinical progress. Board changes in Dec 2025 added commercial expertise. Today’s positive ORKA-002 Phase 1 data and EVERLAST-B update continue this clinical execution trajectory.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-10-14

An active Form S-3/A shelf dated Oct 14, 2025 covers up to 39,425,806 shares for resale by existing stockholders. The company is not selling shares in this registration and will not receive proceeds from these resales other than nominal warrant exercise cash. This structure can add secondary supply without primary capital raise.

Market Pulse Summary

The stock surged +10.2% in the session following this news. A strong positive reaction aligns with e...

Analysis

The stock surged +10.2% in the session following this news. A strong positive reaction aligns with earlier responses to favorable clinical updates, such as prior ORKA-001 data. The 5.53% move came while shares already traded above the $17.94 200-day MA, with volume below the 730,200 average. Investors may weigh future secondary supply from the active resale and shelf programs against the promising long-interval dosing profiles described.

Key Terms

phase 1, phase 2, phase 2b, pasi 100, +4 more

8 terms

phase 1 medical

"ORKA-002 interim Phase 1 data demonstrates a half-life of 75-80 days"

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

phase 2 medical

"Phase 2 studies for ORKA-002 expected to begin in 1H 2026 for psoriasis"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

phase 2b medical

"EVERLAST-B Phase 2b trial of ORKA-001 in December 2025"

Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.

pasi 100 medical

"The primary endpoint will be 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.

il-17 medical

"In an ex vivo IL-17 stimulation assay, ORKA-002 was shown to potently inhibit"

IL-17 is a small protein produced by immune cells that acts like a smoke alarm, signaling and amplifying inflammation in the body. Investors care because blocking or measuring IL-17 is a common strategy for drugs and diagnostics aimed at autoimmune and inflammatory diseases; changes in clinical trial results, regulatory decisions, or biomarker data around IL-17 can strongly affect the commercial prospects and risk profile of related therapies.

treatment-emergent adverse events medical

"There were no severe treatment-emergent adverse events (TEAEs) or serious"

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.

placebo-controlled medical

"randomized, double-blind, placebo-controlled trial designed to evaluate the safety"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

monoclonal antibody medical

"a novel half-life extended monoclonal antibody targeting IL-17A/F"

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.

AI-generated analysis. Not financial advice.

ORKA-002 interim Phase 1 data demonstrates a half-life of 75-80 days supporting potential for twice-per-year dosing in psoriasis and quarterly dosing in hidradenitis suppurativa

Phase 2 studies for ORKA-002 expected to begin in 1H 2026 for psoriasis and 2H 2026 for hidradenitis suppurativa

First patients dosed in EVERLAST-B Phase 2b trial of ORKA-001 in December 2025 with data expected in 2027

MENLO PARK, Calif., Jan. 12, 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 including plaque psoriasis (PsO), today announced positive interim data from its Phase 1 trial of ORKA-002 and updates from the ongoing trials of ORKA-001.

“We’re thrilled with the rapid progress we are making with both ORKA-001 and ORKA-002 and their emerging potentially best-in-class product profiles,” said Lawrence Klein, PhD, CEO. “We continue to build conviction that each of these assets could play a very important role in the future treatment of psoriatic disease and beyond. This Phase 1 data for ORKA-002 increases our confidence in its potential differentiation in both psoriasis and hidradenitis suppurativa (HS), and we’re highly encouraged by how quickly our EVERLAST trials are progressing and the enthusiasm we are seeing for ORKA-001’s paradigm-changing potential.”

ORKA-002: Key Phase 1 Interim Findings

The Phase 1 trial is a first-in-human, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and pharmacokinetics (PK) of ORKA-002 in healthy volunteers. The study enrolled 24 healthy adult participants into three single-ascending subcutaneous dose cohorts of 160 mg, 320 mg and 640 mg. Interim results from the trial as of the January 2026 data cutoff are as follows, and additional data will be presented at an upcoming medical meeting.

• PK: ORKA-002 showed a half-life of 75-80 days, greater than three times that of bimekizumab, and a comparable C_max to bimekizumab at equivalent doses based on previously reported bimekizumab data. Pharmacokinetic modeling based on these results supports achieving twice-yearly maintenance dosing in PsO and quarterly maintenance dosing in HS.
• Pharmacodynamics (PD): In an ex vivo IL-17 stimulation assay, ORKA-002 was shown to potently inhibit IL-17 signaling at all dose levels through last follow-up (up to 24 weeks), further supporting the potential for twice-yearly dosing.
• Safety: ORKA-002 was well tolerated at all dose levels, with a favorable safety profile consistent with the anti-IL-17 class. There were no severe treatment-emergent adverse events (TEAEs) or serious adverse events, and no discontinuations. The only TEAEs to occur in more than two subjects were contusion, headache, skin abrasion and upper respiratory tract infection. The study remains blinded, and all subjects remain on study.
  

ORKA-002: Phase 2 Trials in Plaque Psoriasis and Hidradenitis Suppurativa

• ORCA-SURGE, a randomized, double-blind, placebo-controlled, dose-ranging Phase 2 trial designed to evaluate the safety and efficacy of ORKA-002 in moderate-to-severe PsO patients, is expected to commence in the first half of 2026. ORCA-SURGE is designed to enroll approximately 160 patients randomized 1:1:1:1 to receive 40 mg, 160 mg or 320 mg of ORKA-002 at Weeks 0 and 4, or matching placebo. The primary endpoint will be PASI 100 at Week 16. Maintenance dosing will evaluate the potential for twice-yearly dosing with ORKA-002. Data from ORCA-SURGE is anticipated in 2027.
• In addition, the Company expects to initiate a Phase 2 trial of ORKA-002 in HS patients in the second half of 2026.

ORKA-001 Updates

• The first patients were dosed in EVERLAST-B in December 2025, and enrollment is ongoing. EVERLAST-B is evaluating three induction dose levels of ORKA-001: 37.5 mg at Week 0, 300 mg at Weeks 0 and 4, and 600 mg at Weeks 0 and 4, versus placebo. The primary endpoint is PASI 100 at Week 16. At Week 28, patients receiving ORKA-001 will be re-randomized 1:1 if they have achieved PASI 100 to either a 600 mg dose once-yearly or placebo. Patients who have not achieved PASI 100 will receive a 300 mg dose every six months. Building on EVERLAST-A, this design will further test the potential for ORKA-001 to achieve yearly dosing, higher efficacy and extended off-treatment remissions. Data from EVERLAST-B is anticipated in 2027.
• The EVERLAST-A study is ongoing, and the Company continues to expect to share PASI 100 data at Week 16 for all patients, as well as response duration data out to approximately one year for some patients, in 2H 2026.

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 and ORKA-002, including timelines to clinical and data release milestones, and the details of its planned clinical studies, as well as the potential dosing intervals of ORKA-001 and ORKA-002. 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 Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. 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 did Oruka announce about ORKA-002 on January 12, 2026 (ORKA)?

ORKA-002 interim Phase 1 data showed a 75–80 day half-life, favorable safety in 24 healthy volunteers, and PK modeling supporting twice-yearly psoriasis dosing.

How could ORKA-002 dosing differ from current IL-17 therapies for psoriasis (ORKA)?

Oruka reports ORKA-002 half-life >3x bimekizumab and modeling that supports twice-yearly maintenance dosing in psoriasis and quarterly dosing in HS.

When will ORKA-002 Phase 2 psoriasis data (ORKA) be available?

The ORCA-SURGE Phase 2 trial is expected to start in 1H 2026 with data anticipated in 2027.

What is the status and timeline for ORKA-001 EVERLAST-B (ORKA)?

First patients in EVERLAST-B were dosed in December 2025; enrollment is ongoing and data are expected in 2027.

How many patients will ORCA-SURGE enroll and what is the primary endpoint (ORKA)?

ORCA-SURGE is designed to enroll approximately 160 patients with the primary endpoint of PASI 100 at Week 16.