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Oruka Therapeutics to Participate in Multiple Upcoming Conferences
Globenewswire· 2026-02-09 12:00
Core Viewpoint - Oruka Therapeutics is actively participating in multiple upcoming conferences to present its advancements in the treatment of chronic skin diseases, particularly plaque psoriasis [1][2]. Group 1: Conference Participation - Oruka will present at the Guggenheim Emerging Outlook: Biotech Summit on February 12, 2026, at 10:30 AM ET [1]. - Additional conferences include the TD Cowen 46 Annual Health Care Conference on March 3, 2026, at 1:10 PM ET, and the UBS Biotech Summit Miami on March 9, 2026 [2]. - Other notable events are the Jefferies Biotech on the Beach Summit on March 10, 2026, the Leerink Global Healthcare Conference on March 11, 2026, at 1:00 PM ET, and the Barclays 28 Annual Global Healthcare Conference on March 12, 2026, at 10:30 AM ET [2]. Group 2: Company Overview - Oruka Therapeutics is focused on developing novel biologics aimed at setting a new standard for treating chronic skin diseases, with a mission to provide patients with significant freedom from conditions like plaque psoriasis [3]. - The company is advancing a proprietary portfolio of potentially best-in-class antibodies engineered by Paragon Therapeutics, targeting the core mechanisms of plaque psoriasis and other dermatologic and inflammatory diseases [3].
Oruka Therapeutics Announces Positive Interim Phase 1 Data for ORKA-002 and Initiation of EVERLAST-B Trial of ORKA-001
Globenewswire· 2026-01-12 12:00
Core Insights - Oruka Therapeutics announced positive interim data from its Phase 1 trial of ORKA-002, indicating a half-life of 75-80 days, which supports potential dosing of twice a year for psoriasis and quarterly for hidradenitis suppurativa [1][6] - Phase 2 studies for ORKA-002 are expected to begin in the first half of 2026 for psoriasis and the second half of 2026 for hidradenitis suppurativa [1][4] - The first patients were dosed in the EVERLAST-B Phase 2b trial of ORKA-001 in December 2025, with data anticipated in 2027 [1][5] ORKA-002 Phase 1 Trial Findings - The Phase 1 trial was a randomized, double-blind, placebo-controlled study involving 24 healthy adult participants across three dosing cohorts: 160 mg, 320 mg, and 640 mg [3] - ORKA-002 demonstrated a half-life greater than three times that of bimekizumab, with a comparable Cmax at equivalent doses [6] - The safety profile of ORKA-002 was favorable, with no severe treatment-emergent adverse events reported [6] ORKA-002 Phase 2 Trials - ORCA-SURGE, a Phase 2 trial for ORKA-002 in moderate-to-severe psoriasis patients, is expected to start in the first half of 2026, aiming to enroll approximately 160 patients [6] - The primary endpoint for ORCA-SURGE will be PASI 100 at Week 16, with maintenance dosing evaluating the potential for twice-yearly administration [6] ORKA-001 Updates - The EVERLAST-B trial is evaluating three induction dose levels of ORKA-001, with data expected in 2027 [5][7] - The study design includes re-randomization for patients achieving PASI 100 at Week 28, testing the potential for yearly dosing and extended off-treatment remissions [7] Company Overview - Oruka Therapeutics is focused on developing novel biologics aimed at setting a new standard for chronic skin disease treatment, particularly plaque psoriasis [8] - The company's mission is to provide high rates of complete disease clearance with infrequent dosing, potentially as little as once or twice a year [8]
Oruka Therapeutics to Present at the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-06 12:00
Core Viewpoint - Oruka Therapeutics is set to present at the 44th Annual J.P. Morgan Healthcare Conference, highlighting its focus on developing novel biologics for chronic skin diseases, particularly plaque psoriasis [1]. Company Overview - Oruka Therapeutics is a clinical stage biotechnology company dedicated to creating innovative biologics aimed at establishing a new standard for treating chronic skin diseases [2]. - The company's mission is to provide patients with chronic skin diseases, such as plaque psoriasis, the highest possible freedom from their condition, targeting high rates of complete disease clearance with infrequent dosing, potentially once or twice a year [2]. - Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies engineered by Paragon Therapeutics, which target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases [2].
Oruka Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-08-11 20:04
Core Insights - Oruka Therapeutics has initiated the EVERLAST-A Phase 2a trial for ORKA-001, with data expected in the second half of 2026 [1][6] - The company aims to establish ORKA-001 as a leading treatment for chronic skin diseases, particularly plaque psoriasis, by demonstrating its unique dosing interval and efficacy [2][14] Company Updates - ORKA-001 is a novel half-life extended IL-23p19 monoclonal antibody, while ORKA-002 is a half-life extended IL-17A/F monoclonal antibody currently in Phase 1 trials [3][4] - The EVERLAST-A trial is designed to enroll approximately 80 patients with moderate-to-severe plaque psoriasis, focusing on achieving complete skin clearance [6] - The company has completed dosing for all 24 subjects in the Phase 1 trial of ORKA-001, with results to be presented at the EADV Congress in September 2025 [6] Financial Performance - As of June 30, 2025, Oruka had cash, cash equivalents, and marketable securities totaling $351.5 million, with a net cash usage of $23.1 million in Q2 2025 [9] - Research and Development (R&D) expenses increased to $24.1 million in Q2 2025 from $18.7 million in Q2 2024, primarily due to employee compensation [10] - General and Administrative (G&A) expenses rose to $4.3 million in Q2 2025 from $2.8 million in Q2 2024, reflecting growth in operations and public company costs [11] Pipeline Developments - ORKA-002's Phase 1 trial is ongoing, with interim data expected around the end of 2025 and a Phase 2 trial planned for the first half of 2026 [4] - The company is also advancing ORKA-021, a sequential combination regimen of ORKA-002 and ORKA-001, aimed at providing rapid and deep responses in psoriatic disease treatment [7][8]
Oruka Therapeutics to Present at the Jefferies Global Healthcare Conference
Globenewswire· 2025-05-21 11:00
Core Insights - Oruka Therapeutics, Inc. is a clinical stage biotechnology company focused on developing novel biologics for chronic skin diseases, particularly plaque psoriasis [1][2] - The company aims to provide patients with significant freedom from chronic skin conditions by achieving high rates of complete disease clearance with infrequent dosing, potentially as little as once or twice a year [2] - Oruka is advancing a proprietary portfolio of antibodies engineered to target the core mechanisms of plaque psoriasis and other dermatologic and inflammatory diseases [2] Event Announcement - Oruka will present at the Jefferies Global Health Care Conference in New York on June 4, 2025, at 12:50 PM ET [1] - A webcast and replay of the presentation will be available on the Oruka investor events website [1] Company Information - Oruka Therapeutics is committed to setting a new standard in the treatment of chronic skin diseases through innovative biologics [2] - The company’s mission emphasizes achieving high rates of disease clearance for patients suffering from conditions like plaque psoriasis [2]
Oruka Therapeutics Announces First Participants Dosed in Phase 1 Trial of ORKA-002, its Novel Half-life Extended Anti-IL-17A/F Antibody
GlobeNewswire News Room· 2025-05-20 20:01
Core Insights - Oruka Therapeutics is advancing its clinical trials for ORKA-002, a novel monoclonal antibody targeting IL-17A and IL-17F, with dosing of healthy volunteers initiated and pharmacokinetic data expected by the end of 2025 [1][2][5] - The company plans to start a Phase 2 study for ORKA-002 in moderate-to-severe psoriasis in the first half of 2026, focusing on safety and efficacy across multiple dosing regimens [3][4] Group 1: Clinical Development - ORKA-002 is currently in a Phase 1 trial, which is a double-blind, placebo-controlled study involving approximately 24 healthy volunteers [2][3] - Interim data from the Phase 1 trial is anticipated around the end of 2025, which will inform the subsequent Phase 2 study [2][3] Group 2: Product Differentiation - ORKA-002 has the potential to be dosed two to three times per year, significantly less frequent than current therapies, which typically require monthly dosing [5] - The dual inhibition of IL-17A and IL-17F by ORKA-002 is expected to provide superior efficacy compared to existing treatments that only target IL-17A [5] Group 3: Company Vision - Oruka Therapeutics aims to set a new standard for treating chronic skin diseases, particularly plaque psoriasis, by achieving high rates of complete disease clearance with infrequent dosing [6] - The company is focused on developing a proprietary portfolio of potentially best-in-class antibodies targeting the underlying mechanisms of chronic skin diseases [6]
Oruka Therapeutics to Present at Bank of America Securities 2025 Health Care Conference
GlobeNewswire News Room· 2025-04-29 11:00
Core Insights - Oruka Therapeutics, Inc. is a clinical stage biotechnology company focused on developing novel biologics for chronic skin diseases, particularly plaque psoriasis [1][2] - The company aims to provide patients with significant freedom from chronic skin conditions by achieving high rates of complete disease clearance with infrequent dosing, potentially as little as once or twice a year [2] Company Overview - Oruka Therapeutics is advancing a proprietary portfolio of potentially best-in-class antibodies engineered by Paragon Therapeutics, targeting the core mechanisms of plaque psoriasis and other dermatologic and inflammatory diseases [2] - The company is set to present at the Bank of America Securities 2025 Health Care Conference on May 13th, 2025, at 3:55 PM PT, indicating its active engagement with the investment community [1]