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Oruka Therapeutics (ORKA) has begun dosing healthy volunteers in its Phase 1 trial of ORKA-001, a novel half-life extended monoclonal antibody targeting IL-23p19 for treating chronic skin diseases. The trial will evaluate safety, tolerability, and pharmacokinetics in approximately 24 healthy volunteers across three subcutaneous dose cohorts.
Initial data is expected in H2 2025, followed by a proof-of-concept study in moderate-to-severe psoriasis. The subsequent study will involve about 80 subjects testing six-month and potential yearly dosing schedules, with initial efficacy data anticipated in H2 2026.
Preclinical data suggests potential for once- or twice-yearly dosing, representing a significant improvement over current standards. The company has also secured a worldwide exclusive license agreement with Paragon Therapeutics for ORKA-001 in all indications except inflammatory bowel disease.
Oruka Therapeutics (Nasdaq: ORKA), a biotechnology company focused on developing novel biologics for chronic skin diseases treatment, has announced its upcoming addition to the Nasdaq Biotechnology Index (NBI). The inclusion will be effective before market open on December 23rd, 2024. This addition reflects Oruka's meeting of specific eligibility criteria, including minimum market capitalization requirements, average daily trading volume thresholds, and public company seasoning period. The NBI tracks performance of biotechnology and pharmaceutical companies listed on Nasdaq, using a modified capitalization-weighted methodology with annual evaluation in December.
Oruka Therapeutics (Nasdaq: ORKA), a biotech company focused on developing novel biologics for chronic skin diseases including plaque psoriasis, has announced its upcoming participation at Piper Sandler's 36th Annual Healthcare Conference. The company will engage in a fireside chat scheduled for Tuesday, December 3rd, 2024, at 3:00 PM ET.
Oruka Therapeutics (Nasdaq: ORKA) reported Q3 2024 financial results and corporate updates. The company raised over $475 million through two transactions and completed its public listing on Nasdaq. Key highlights include accelerated clinical timelines for ORKA-001 and ORKA-002, with Phase 1 trials planned for Q1 2025 and Q3 2025 respectively. Financial results show $410.9 million in cash and equivalents, with a net loss of $28.6 million. R&D expenses totaled $25.7 million, while G&A expenses were $3.8 million. The company expects its current cash position to provide runway through 2027.
Oruka Therapeutics (Nasdaq: ORKA), a biotech company focused on developing novel biologics for chronic skin diseases including plaque psoriasis, has announced its participation in two major investor conferences in November 2024. The company will present at the Stifel 2024 Healthcare Conference on November 18th at 2:25PM ET and the Jefferies London Healthcare Conference on November 20th at 2:00PM GMT. Webcasts and replays of the presentations will be accessible through Oruka's investor events website.
Oruka Therapeutics (Nasdaq: ORKA) announced preclinical data for ORKA-001, a novel extended half-life monoclonal antibody targeting IL-23p19, at the European Academy of Dermatology and Venereology Congress. Key findings include:
1. Non-human primate (NHP) half-life of 30.3 days (subcutaneous) and 33.8 days (intravenous), over three times longer than risankizumab.
2. Projected human half-life of ~50 days could enable dosing every six months; ~75 days could allow yearly dosing.
3. Binds to a similar epitope with comparable affinity to risankizumab (below 5 picomolar).
4. Equivalent potency across various in vitro assays.
The extended half-life could result in higher antibody exposures, potentially leading to greater efficacy in treating chronic skin diseases like plaque psoriasis.
Oruka Therapeutics (Nasdaq: ORKA) has announced a $200 million private placement financing. The biotechnology company, focused on developing novel biologics for chronic skin diseases, is selling 5,600,000 shares of common stock at $23.00 per share, 2,439 shares of Series A non-voting convertible preferred stock at $23,000 per share, and pre-funded warrants for 680,000 shares at $22.999 per warrant. The PIPE financing includes participation from both new and existing investors, including major investment firms. Upon closing, Oruka will have approximately 55.1 million shares of common stock and equivalents outstanding. The company plans to use the proceeds for research and development, general corporate expenses, and working capital, expecting to fund its operating plan through 2027.
Oruka Therapeutics (Nasdaq: ORKA) has announced accelerated timelines for its novel biologics targeting chronic skin diseases. ORKA-001, a half-life extended antibody targeting IL-23p19, is now expected to start first-in-human dosing in Q1 2025. ORKA-002, targeting IL-17A/F, is set for first-in-human dosing in Q3 2025.
ORKA-001 shows potential for once or twice yearly dosing, with higher exposures than current IL-23p19 antibodies, potentially leading to higher disease clearance rates. Preclinical data, including a half-life of over 30 days in non-human primates, will be presented at the European Academy of Dermatology and Venereology Congress (EADV) in September.
Interim data for ORKA-001 in healthy volunteers is expected in H2 2025, with initial efficacy data in psoriasis patients in H2 2026. For ORKA-002, interim data from healthy volunteers is anticipated in H1 2026.
Oruka Therapeutics, Inc. (Nasdaq: ORKA) has completed its merger with ARCA biopharma and a $275 million private placement. The company, focused on developing novel biologics for chronic skin diseases, begins trading on Nasdaq on September 3, 2024. Samarth Kulkarni, PhD, has been appointed as Chairman of Oruka's Board of Directors.
Oruka's pipeline includes two lead programs: ORKA-001, a subcutaneous IL-23p19 inhibitor potentially dosed once or twice yearly, and ORKA-002, a subcutaneous IL-17A/F inhibitor. Both aim to offer improved dosing regimens and greater clinical activity for psoriasis and related conditions. The company plans to advance these programs into clinical trials, with initial pharmacokinetic data for ORKA-001 expected next year.
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