This section highlights FDA-related milestones and regulatory updates for drugs developed by Oruka Therapeutics (ORKA).
Over the past two years, Oruka Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ORKA-001 and ORKA-002. 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.
ORKA-001 FDA Regulatory Timeline and Events
ORKA-001 is a drug developed by Oruka Therapeutics for the following indication: Inhibitor IL-23p19.
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:
- ORKA-001
- Announced Date:
- July 21, 2025
- Indication:
- Inhibitor IL-23p19
Announcement
Oruka Therapeutics, Inc announced that the U.S. FDA cleared its investigational new drug (IND) application for its Phase 2a trial of ORKA-001 (the Company's long-acting anti-IL-23p19 antibody) in moderate-to-severe psoriasis, called EVERLAST-A.
AI Summary
Oruka Therapeutics announced that the U.S. Food and Drug Administration cleared its IND for EVERLAST-A, a Phase 2a study of ORKA-001, its long-acting anti-IL-23p19 antibody, in moderate-to-severe psoriasis.
EVERLAST-A is a randomized, double-blind, placebo-controlled trial in about 80 patients. Participants are assigned 3:1 to receive a single dose of ORKA-001 or placebo. The main goal is to measure PASI 100, or full skin clearance, at Week 16. Patients who achieve PASI 100 at Week 28 are rerandomized to either no further treatment until disease returns or dosing every six months, testing the potential for once-a-year therapy and extended remission. Others receive six-month dosing.
Oruka plans to share interim Phase 1 data and detailed trial design at the European Academy of Dermatology and Venereology Congress in September. Efficacy and response duration results from EVERLAST-A are expected in the second half of 2026.
Read Announcement- Drug:
- ORKA-001
- Announced Date:
- March 6, 2025
- Indication:
- Inhibitor IL-23p19
Announcement
Oruka Therapeutics, provided a corporate update.
AI Summary
Oruka Therapeutics provided a corporate update, highlighting significant progress and financial strength. The company successfully raised over $475 million during its go-public transaction in 2024, ensuring a cash runway through 2027. This robust financial position underpins its ongoing clinical development efforts in chronic skin diseases, including plaque psoriasis.
Oruka is advancing ORKA-001, a novel IL-23p19-targeting monoclonal antibody, which entered a Phase 1 trial ahead of schedule in December 2024. The company expects to share initial pharmacokinetic data in the second half of 2025 and plans to initiate a Phase 2a proof-of-concept study later that year, with efficacy data anticipated in the second half of 2026. The update emphasizes the company’s strategy to deliver new clinical catalysts every six months, aiming to solidify its position as a leader in psoriatic disease treatment.
Read Announcement- Drug:
- ORKA-001
- Announced Date:
- September 25, 2024
- Indication:
- Inhibitor IL-23p19
Announcement
Oruka Therapeutics, announced new preclinical data on ORKA-001, a novel extended half-life monoclonal antibody targeting IL-23p19, from its presentation at the European Academy of Dermatology and Venereology Congress (EADV).
AI Summary
Oruka Therapeutics recently presented new preclinical data on ORKA-001 at the European Academy of Dermatology and Venereology Congress (EADV). ORKA-001 is a novel monoclonal antibody designed to treat chronic skin diseases by targeting IL-23p19. The data revealed that in non-human primates, the drug achieved a half-life of 30.3 days with subcutaneous dosing and 33.8 days with intravenous dosing—over three times longer than risankizumab. This extended half-life could allow for dosing as infrequently as once every six months, or even once a year, in humans. Additionally, ORKA-001 demonstrated equivalent potency to risankizumab, binding to a similar epitope with very high affinity. These promising results support ORKA-001’s potential to offer improved treatment experiences and effectiveness for patients with conditions like plaque psoriasis.
Read Announcement- Drug:
- ORKA-001
- Announced Date:
- September 12, 2024
- Indication:
- Inhibitor IL-23p19
Announcement
Oruka Therapeutics announced updated pipeline progress and timelines, as well as an upcoming scientific presentation at the European Academy of Dermatology and Venereology Congress (EADV).
AI Summary
Oruka Therapeutics recently shared updates on its pipeline progress and future timelines. The company’s first drug candidate, ORKA-001—a novel half-life extended IL-23p19 monoclonal antibody—will begin first-in-human dosing in healthy volunteers in the first quarter of 2025. Preclinical studies showed ORKA-001 has a half-life of over 30 days in non-human primates, suggesting it may be dosed only once or twice a year while possibly offering higher rates of disease clearance for conditions like plaque psoriasis.
Oruka also announced that its second candidate, ORKA-002, which targets IL-17A/F, is expected to start first-in-human dosing in the third quarter of 2025. The company will present its preclinical data on ORKA-001 at the European Academy of Dermatology and Venereology Congress in Amsterdam this September.
Read Announcement
ORKA-002 FDA Regulatory Timeline and Events
ORKA-002 is a drug developed by Oruka Therapeutics for the following indication: IL-17A/F mAb.
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:
- ORKA-002
- Announced Date:
- May 20, 2025
- Indication:
- IL-17A/F mAb
Announcement
Oruka Therapeutics, announced that it has initiated dosing of healthy volunteers in its first clinical trial of ORKA-002, the Company's novel, subcutaneously administered, half-life extended monoclonal antibody targeting IL-17A and IL-17F (IL-17A/F).
AI Summary
Oruka Therapeutics announced it has begun dosing healthy volunteers in its first clinical trial of ORKA-002. This innovative treatment is a subcutaneously administered, half-life extended monoclonal antibody designed to target both IL-17A and IL-17F, hormones linked to psoriasis and other chronic skin diseases. The Phase 1 trial is a double-blind, placebo-controlled, single ascending dose study assessing the safety, tolerability, and pharmacokinetics of the drug in about 24 volunteers. Researchers are eager to see if ORKA-002 can offer benefits such as dosing only two to three times per year, a major improvement over existing therapies that require more frequent administrations. Pending positive Phase 1 data, the company plans to kick off a Phase 2 study in patients with moderate-to-severe psoriasis in the first half of 2026.
Read Announcement- Drug:
- ORKA-002
- Announced Date:
- March 7, 2025
- Indication:
- IL-17A/F mAb
Announcement
Oruka Therapeutics, announced new preclinical data on ORKA-002, a novel extended half-life monoclonal antibody targeting IL-17A/F, from its presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting.
AI Summary
Oruka Therapeutics recently shared promising preclinical findings on ORKA-002 at the 2025 American Academy of Dermatology Annual Meeting. ORKA-002 is a novel extended half-life monoclonal antibody designed to treat skin conditions by targeting interleukin-17A and IL-17F. Its preclinical data in non-human primates revealed a half-life of over 30 days—more than three times longer than bimekizumab—indicating the potential for dosing just two to three times a year in human patients. Additionally, ORKA-002 demonstrated comparable potency and binding affinity to bimekizumab in various assays, which supports its effectiveness in neutralizing IL-17A/F. These characteristics suggest that ORKA-002 might provide improved convenience and potentially better outcomes for patients with chronic skin diseases, such as psoriasis and psoriatic arthritis. The first human dosing is expected to begin in the third quarter of 2025.
Read Announcement- Drug:
- ORKA-002
- Announced Date:
- March 7, 2025
- Estimated Event Date Range:
- July 1, 2025 - September 30, 2025
- Target Action Date:
- Q3 2025
- Indication:
- IL-17A/F mAb
Announcement
Oruka Therapeutics, announced that First subject dosed with ORKA-002 expected in Q3 2025
AI Summary
Oruka Therapeutics announced that the first subject is expected to be dosed with their novel drug, ORKA-002, in the third quarter of 2025. This clinical milestone is an important step for the company as ORKA-002 is designed to treat chronic skin diseases like plaque psoriasis by targeting the IL-17A/F proteins linked to inflammation.
The drug has shown a long half-life in non-human primate studies, lasting more than 30 days, which is more than triple that of similar treatments like bimekizumab. This promising feature suggests that patients might only need treatment two to three times per year, offering a more convenient treatment schedule. By extending dosing intervals, ORKA-002 could potentially improve patient adherence and overall quality of life.
Read Announcement- Drug:
- ORKA-002
- Announced Date:
- September 12, 2024
- Estimated Event Date Range:
- July 1, 2025 - September 30, 2025
- Target Action Date:
- Q3 2025
- Indication:
- IL-17A/F mAb
Announcement
Oruka Therapeutics ORKA-002, a novel half-life extended IL-17A/F mAb, first-in-human dosing now expected third quarter 2025
AI Summary
Oruka Therapeutics announced an important update for its pipeline with ORKA-002, a novel half-life extended interleukin-17A/F monoclonal antibody. The company plans to start first-in-human dosing of ORKA-002 in healthy volunteers in the third quarter of 2025. This innovative drug targets both IL-17A and IL-17F, aiming to deliver high rates of complete skin clearance for plaque psoriasis patients. Dual inhibition has shown promise in increasing treatment effectiveness, especially for patients who also experience psoriatic arthritis or recalcitrant skin disease. Additionally, there is potential for ORKA-002 to offer less frequent dosing compared to current therapies. Such improvements may provide greater patient convenience and improved outcomes, setting a new standard in the management of chronic skin conditions.
Read Announcement
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