ORKA

ORKA-001 EVERLAST-A 16-week data showed 63.5% PASI 100 rate and a favorable tolerability profile, with longer-term data expected in 2H 2026 ORCA-SURGE Phase 2 trial of ORKA-002 in psoriasis initiated with data expected 2027 Post-offering cash, cash equivalents and marketable securities expected to fund Company through BLA for ORKA-001 MENLO PARK, Calif., May 13, 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 reported first quarter 2026 financial results and provided a corporate update. “This was an important period for our company as we saw interim data for ORKA-001 that hit the upper end of our expectations on all aspects,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “Based on this data we were able to strengthen our balance sheet and provide runway through completion of late-stage development for that program. We’re looking forward to multiple readouts coming in 2026 and 2027, including additional data from ORKA-001 and the beginning of our readouts for ORKA-002 as well.” First Quarter 2026 and Recent Business and Pipeline Updates ORKA-001: A novel half-life extended IL-23p19 monoclonal antibody In April 2026, the Company presented positive data from its EVERLAST-A trial in moderate-to-severe PsO showing 40 of 63 (63.5%) participants treated with ORKA-001 achieved PASI 100 at Week 16. 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. ORKA-001 was well tolerated with a safety profile similar to placebo and consistent with prior IL-23p19 inhibitors. Also in April 2026, the Company presented updated pharmacokinetics (PK) and pharmacodynamics (PD) data from the Phase 1 trial of ORKA-001, which 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. 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. EVERLAST-B, a...

Oruka Therapeutics (NASDAQ:ORKA) is one of the small-cap stocks that are on fire right now. On April 27, Oruka Therapeutics announced positive interim results from its EVERLAST-A Phase 2a trial for ORKA-001, a long-acting monoclonal antibody targeting moderate-to-severe plaque psoriasis. The study met its primary endpoint, with 63.5% of patients achieving complete skin clearance (PASI 100) by Week 16. These efficacy rates are numerically higher than those of other current IL-23p19 inhibitors, placing ORKA-001 among the top-performing treatments for this condition. The safety profile for ORKA-001 remained favorable and consistent with its drug class, with no serious treatment-emergent adverse events reported in the treated group. Most side effects were mild, with upper respiratory tract infections being the only common event observed. Crucially, updated data from earlier phases suggest the drug maintains effective concentrations for an entire year after a single dose, reinforcing the potential for once-yearly dosing, an improvement over current treatment frequencies. Following these results, Oruka Therapeutics (NASDAQ:ORKA) plans to release longer-term follow-up data, including 52-week results for a subset of patients, in H2 2026. The company is also moving forward with its EVERLAST-B Phase 2b trial, with data expected in 2027. If successful, ORKA-001 could redefine the standard of care by offering high-level skin clearance with substantially fewer injections than existing biologics. Oruka Therapeutics (NASDAQ:ORKA) is a biopharmaceutical company developing next-generation biologics for chronic skin and inflammatory diseases. Its lead antibody programs target plaque psoriasis and psoriatic arthritis, aiming to provide complete disease clearance with maintenance dosing as infrequent as once or twice a year. While we acknowledge the potential of ORKA as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and Cathie Wood 2026 Portfolio: 10 Best Stocks to Buy. Disclosure: None. Follow Insider Monkey on Google News.

ORKA-001 EVERLAST-A 16-week data now expected in 2Q 2026 following rapid enrollment, with longer-term follow-up data expected in 2H 2026 ORCA-SURGE Phase 2 trial of ORKA-002 in psoriasis initiated with data expected 2027 $479.6 million in cash, cash equivalents and marketable securities MENLO PARK, Calif., March 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 reported fourth quarter and full year 2025 financial results and provided a corporate update. “We are very pleased with the progress of both our co-lead programs as we advance into what could be a transformative year for our company,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “Given strong site engagement and enthusiasm, EVERLAST-A completed enrollment in December 2025, enabling us to bring our initial data release into the second quarter of 2026. Meanwhile, we are excited to be starting our Phase 2 efforts with ORKA-002, which we believe could be a very impactful program in psoriatic disease and HS.” Fourth Quarter 2025 and Recent Business and Pipeline Updates ORKA-001: A novel half-life extended IL-23p19 monoclonal antibody Enrollment in EVERLAST-A was completed in December 2025. As a result, the Company now expects to report Week 16 data for all patients in the second quarter of 2026. In addition, the Company plans to provide longer-term data, including Week 28 for all patients and 52-week follow-up for a portion of the cohort in the second half of 2026. The first patients were dosed in EVERLAST-B in December 2025 and enrollment is ongoing. EVERLAST-B is evaluating multiple induction regimens of ORKA-001, with a primary endpoint of PASI 100 at Week 16. Data from EVERLAST-B is anticipated in 2027 and will be used to support initiation of a Phase 3 program. ORKA-002: A novel half-life extended IL-17A/F monoclonal antibody In February 2026, the Company initiated ORCA-SURGE, a Phase 2 trial designed to evaluate the safety and efficacy of ORKA-002 in moderate-to-severe PsO patients. 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 January 2026, Or...

ORKA-001 Phase 1 results presented at EADV show potential for once-per-year dosing, higher efficacy and off-treatment remission Over $500M cash and equivalents provides runway over one year past three key readouts: ORKA-001 Phase 2a and 2b (EVERLAST-A and -B), and ORKA-002 Phase 2 ORKA-002 Phase 1 trial ongoing, with data to be presented around YE 2025 ORKA-001 Phase 2a trial enrolling well with data expected 2H 2026 MENLO PARK, Calif., Nov. 12, 2025 (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 reported third quarter 2025 financial results and provided a corporate update. “We had a very successful quarter where we released our first clinical data as a company and extended our cash runway beyond additional Phase 2 clinical readouts,” commented Lawrence Klein, PhD, Chief Executive Officer of Oruka. “We are seeing increased interest in both of our co-lead programs, with additional appreciation that each could become a very impactful medicine in psoriatic disease and beyond. We’re excited by our continued rapid progress advancing both ORKA-001 and -002 and look forward to sharing our first Phase 2 data in 2026.” Third Quarter Business and Pipeline Updates ORKA-001: a novel half-life extended IL-23p19 monoclonal antibody In September 2025, at the European Academy of Dermatology and Venerology (EADV) Congress, the Company presented interim Phase 1 results in a late-breaking oral session. ORKA-001 demonstrated a half-life of approximately 100 days, greater than three times that of risankizumab, and a Cmax that exceeded risankizumab at an equivalent dose, both of which increase the likelihood of achieving once-yearly dosing, higher efficacy, and extended off-treatment remissions. Single doses of ORKA-001 also showed complete and sustained inhibition of STAT3 signaling, a downstream marker of IL-23 activity. ORKA-001 was well tolerated across all dose levels, with a favorable safety profile consistent with the anti-IL-23 class. The study is ongoing. Enrollment is progressing well in EVERLAST-A, a randomized, double-blind, placebo-controlled Phase 2a trial of ORKA-001 in moderate to severe PsO. Additional details of the study design were presented in an oral present...

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Half-life of approximately 100 days increases likelihood of once-per-year dosing Pharmacokinetic profile supports the ability to achieve exposures that could lead to higher efficacy and extended off-treatment remissions Well tolerated with a favorable safety profile consistent with the IL-23p19 class EVERLAST-A Phase 2a trial enrollment ongoing with data expected 2H 2026 MENLO PARK, Calif., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis (PsO), today announced interim data from its Phase 1 trial of ORKA-001, the Company’s long-acting IL-23p19 antibody, in a late-breaking abstract at the European Academy of Dermatology and Venerology (EADV) Congress in Paris, France. These results, as well as additional details on the EVERLAST-A trial design, will be presented in two oral presentations at the conference. “ORKA-001's approximately 100-day half-life exceeded our expectations and has the potential to enable multiple ‘upside’ scenarios for the program,” said Lawrence Klein, PhD, CEO of Oruka. “We are increasingly confident that ORKA-001 can redefine the standard of care in this important disease. I’m very pleased with how quickly our team has progressed this program and by the enthusiasm we are hearing from investigators and patients.” Interim results from the Phase 1 trial support the potential for ORKA-001 to change the PsO treatment paradigm. The ongoing EVERLAST-A Phase 2a trial is designed to test whether ORKA-001 can enable annual dosing, higher rates of skin clearance than standard of care, and long-term off-treatment remissions. Oruka expects to present initial data from EVERLAST-A in 2H 2026. 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-001 in healthy volunteers. The study enrolled 24 healthy adult participants into three single ascending subcutaneous dose cohorts of 300 mg, 600 mg, and 1200 mg. Interim results from the Phase 1 trial include: PK: ORKA-001 showed a half-life of approximately 100 days, greater than three times that of risankizumab, and a Cmax that exceeded risankizumab at an equivalent dose, based on previously repo...

First patients dosed in the EVERLAST-A Phase 2a trial of ORKA-001, with data expected in 2H 2026 ORKA-001 Phase 1 data and EVERLAST-A design to be presented at EADV in September 2025 ORKA-002 Phase 1 trial ongoing, with data to be presented around YE 2025 MENLO PARK, Calif., Aug. 11, 2025 (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, today reported second quarter 2025 financial results and provided a corporate update. “We are very pleased to have initiated our EVERLAST-A study, and we expect nearly all our sites to be open and enrolling by the end of the month,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “This study could demonstrate three different aspects of ORKA-001’s differentiation – an ultra-long dosing interval, higher efficacy than other IL-23 inhibitors, and the potential for off-treatment remissions. Together with our ORKA-002 program and ORKA-021 sequential combination that are following close behind, we are confident we can have the best biologic regimens in psoriatic disease, an area that continues to reward innovation in biologics.” Second Quarter Business and Pipeline Updates ORKA-001: a novel half-life extended IL-23p19 monoclonal antibody Enrollment is ongoing in EVERLAST-A following clearance from both the U.S. FDA and Health Canada in July, and the first patients have been dosed in the study. EVERLAST-A is a randomized, double-blind, placebo-controlled Phase 2a trial designed to enroll approximately 80 patients with moderate-to-severe plaque psoriasis. Patients will be randomized 3:1 to receive ORKA-001 or placebo with a primary endpoint of PASI 100 at Week 16. At Week 28, patients who have achieved PASI 100, or completely clear skin, will be randomized 2:1 to either (1) an arm where they do not receive another dose until disease recurs or (2) ORKA-001 every six months. This “no-dose” arm will provide evidence for both yearly dosing and the potential for extended off-treatment remissions. Additional details on the EVERLAST-A design will be presented at the European Academy of Dermatology and Venereology (EADV) Congress in September. The Company expects to share efficacy and response duration data from EVERLAST-A in 2H 2026. Psoriasis...

Continued operational excellence leading to acceleration of multiple timelines: ORKA-001, targeting IL-23p19, Phase 1 trial dosing complete, with data expected in 3Q 2025 ORKA-001 Phase 2a initiation expected in 2H 2025, with efficacy readout expected in 2H 2026 that will provide multiple opportunities to show differentiation over standard of care ORKA-002, targeting IL-17A/F, Phase 1 initiation accelerated to 2Q 2025, with initial PK data now expected around YE 2025; data will support both ORKA-002 and ORKA-021 psoriasis studies Strong cash position of $373 million provides runway through 2027, over one year past anticipated ORKA-001 Phase 2a data in psoriasis MENLO PARK, Calif., May 14, 2025 (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, today reported first quarter 2025 financial results and provided a corporate update. “We are thrilled with the continued rapid progress we are making to advance our co-lead programs, which we think could set a new standard in the treatment of psoriatic disease,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “We’re excited to soon have both of our co-lead programs, ORKA-001 and ORKA-002, in the clinic and release our first clinical data on ORKA-001. As we ramp up preparations for our first psoriasis studies, we are energized by the reception from physicians who clearly see the potential to advance the treatment paradigm in this important disease.” First Quarter Business and Pipeline Updates ORKA-001: a novel half-life extended IL-23p19 monoclonal antibody Oruka’s Phase 1 trial of ORKA-001 is progressing, with dosing completed for all 24 subjects across three dose levels. The trial is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, and pharmacokinetics (PK) of ORKA-001. The Company expects to share interim data from this trial, including initial PK data, in 3Q 2025 (previously 2H 2025). Based on PK modeling, the Company expects that a human half-life of 50 days or more will support dosing every six months whereas a half-life of 75 days or more could support dosing once per year. In comparison, currently approved IL-23p19 inhibitors require maintenance dosing every two or...