Welcome to our dedicated page for OnKure Therapeutics news (Ticker: OKUR), a resource for investors and traders seeking the latest updates and insights on OnKure Therapeutics stock.
OnKure Therapeutics, Inc. (Nasdaq: OKUR) is a clinical-stage biopharmaceutical company whose news flow is closely tied to the development of precision medicines targeting oncogenic and pathologically activated PI3Kα. The company regularly issues updates on its lead program, OKI-219, a selective PI3KαH1047R inhibitor being evaluated in the PIKture-01 phase 1 trial in advanced solid tumors, including multiple subtypes of metastatic breast cancer.
News about OnKure often covers clinical progress in PIKture-01, such as enrollment status, dose escalation milestones, and preliminary safety, tolerability, and pharmacokinetic data. The company has reported encouraging early results for OKI-219, including descriptions of tolerability and exposure levels, and has detailed the evolution of the trial from monotherapy cohorts to combination and triplet arms with fulvestrant, ribociclib, trastuzumab, and tucatinib in HR+ and HER2+ metastatic breast cancer settings.
Investors and observers can also expect press releases on OnKure’s broader PI3Kα portfolio, including its next-generation pan-mutant selective program and discovery-stage efforts targeting additional PI3Kα mutations such as E542K and E545K. The company has highlighted preclinical data, including combination studies of OKI-219 with standard-of-care therapies in PI3KαH1047R mutant breast cancer models, and has announced scientific presentations at meetings like the San Antonio Breast Cancer Symposium.
In addition, OnKure reports quarterly and annual financial results, business updates, and participation in healthcare and biotechnology investor conferences. These communications provide insight into its cash position, operating expenses, planned milestones, and capital markets activities, including an at-the-market equity offering program disclosed in an 8-K filing. Bookmark this page to follow the latest OKUR news, including clinical updates, pipeline developments, financial disclosures, and corporate presentations.
OnKure Therapeutics (Nasdaq: OKUR) reported Q3 2025 results and a business update. As of September 30, 2025 the company held $70.3M cash, which it says funds operations into the fourth quarter of 2026. Clinical progress includes completion of enrollment in OKI-219 monotherapy and fulvestrant dose-escalation arms (a total of 71 patients dosed as of Oct 14, 2025) and initiation of two triplet expansion arms—OKI-219+fulvestrant+ribociclib and OKI-219+trastuzumab+tucatinib—with first patients dosed in Sept/Oct 2025. Initial clinical data from multiple PIKture-01 arms is expected in Q1 2026. The company also identified multiple next-generation PI3Kα pan-mutant candidates and plans an announcement in Q1 2026; additional details on a vascular malformations expansion are planned for 2026.
OnKure Therapeutics (Nasdaq: OKUR) announced that President and CEO Nicholas Saccomano, Ph.D. will present and hold one-on-one investor meetings at three investor conferences in November–December 2025.
Scheduled appearances: a fireside chat at the Guggenheim Healthcare Innovation Conference in Boston on Nov 10, 2025 at 4:00 p.m. ET; a corporate presentation at the Stifel Healthcare Conference in New York on Nov 12, 2025 at 4:00 p.m. ET; and a fireside chat at the Evercore Healthcare Conference in Miami on Dec 3, 2025 at 12:30 p.m. ET. Live audio webcasts will be available for each event and replays will be posted on the company website for 30 days after the events.
OnKure Therapeutics (NASDAQ:OKUR) has reported significant progress in its clinical trials for OKI-219, their lead precision medicine for cancer treatment. The company has completed enrollment for both monotherapy and fulvestrant combination arms in the PIKture-01 trial, with 70 total patients enrolled. Two new expansion arms were initiated to evaluate OKI-219 in triple combinations: one with fulvestrant and ribociclib for HR+ breast cancer, and another with trastuzumab and tucatinib for HER2+ breast cancer.
Financially, OnKure reported $83.4 million in cash as of June 30, 2025, providing runway into Q4 2026. Q2 2025 resulted in a net loss of $15.4 million ($1.14 per share), compared to $14.1 million in Q2 2024. R&D expenses increased to $12.6 million, up from $10.8 million year-over-year.
The company plans to announce monotherapy and fulvestrant combination data in Q4 2025, along with nominating a pan-mutant selective PI3Kα inhibitor candidate by year-end.OnKure Therapeutics (NASDAQ: OKUR) reported its Q4 and full year 2024 financial results, highlighting progress in its PI3Ka inhibitor programs. The company's PIKture-01 trial showed encouraging preliminary data, with OKI-219 demonstrating good tolerability across all dose levels. Cash position stands at $110.8 million, expected to fund operations through Q4 2026.
Key financial metrics for Q4 2024 include:
- R&D expenses increased to $14.4 million (up from $8.8 million in Q4 2023)
- G&A expenses rose to $4.3 million (up from $1.1 million in Q4 2023)
- Net loss of $17.4 million or $1.37 per share
The company expects to announce its pan-mutant development candidate in Q2 2025 and provide additional PIKture-01 trial data, including combination results with fulvestrant, in H2 2025.
OnKure Therapeutics (Nasdaq: OKUR), a clinical-stage biopharmaceutical company specializing in precision oncology medicines, has announced its upcoming participation in two major investor conferences.
The company's President and CEO, Nicholas Saccomano, Ph.D., will participate in:
- A fireside chat at the Leerink Partners Global Healthcare Conference in Miami on March 11, 2025, at 4:20 p.m. ET, with a live audio webcast available online
- A fireside chat at the virtual Stifel Targeted Oncology Forum scheduled for April 8-9, 2025
The Leerink conference presentation will be accessible through a webcast link and the company's website, with replays available for 90 days post-event.
OnKure Therapeutics (NASDAQ: OKUR) announced encouraging preliminary data from its PIKture-01 trial of OKI-219, a mutant-selective PI3KαH1047R inhibitor. The drug showed positive safety and tolerability across all dose levels, with no dose interruptions or reductions required. Of 17 treated patients, the most common treatment-related adverse events were mild Grade 1 effects.
At 900 mg twice daily, OKI-219 demonstrated steady-state exposure levels with near-continuous coverage. Two patients with HR+/HER2- breast cancer showed prolonged stable disease, with one patient maintaining >95% reduction in PIK3CAH1047R ctDNA after seven months of treatment. The company has initiated Part 1b of the trial, evaluating OKI-219 in combination with fulvestrant, with initial data expected in 2H-2025.
OnKure Therapeutics (NASDAQ: OKUR) has rescheduled its investor call to review preliminary data from the PIKture-01 trial of OKI-219 to Tuesday, December 10, 2024, at 7:00 a.m. CT, moved from the previously announced December 13 date. The call will coincide with the publication of posters at the 2024 San Antonio Breast Cancer Symposium (SABCS).
Two posters will be presented at SABCS: one showing preliminary results from the PIKture-01 first-in-human study of OKI-219, and another demonstrating OKI-219's enhanced activity in pre-clinical PI3KαH1047R mutant breast cancer models. The PIKture-01 trial investigates OKI-219 as monotherapy in advanced solid tumors and in combination with endocrine or HER2-Targeted therapy for advanced breast cancer.
OnKure Therapeutics (NASDAQ: OKUR), a clinical-stage biopharmaceutical company specializing in precision oncology medicines, has announced its participation in the Stifel 2024 Healthcare Conference. Nicholas Saccomano, Ph.D., President and CEO, will deliver a corporate presentation on November 18, 2024, at 1:50 p.m. ET in New York.
The presentation will be accessible via live webcast through the 'Events' section of OnKure's website, with a replay available for approximately 90 days following the event.
OnKure Therapeutics (NASDAQ: OKUR) announced the presentation of two abstracts featuring preliminary clinical and preclinical data for OKI-219, their mutant-selective PI3KαH1047R inhibitor, at the 2024 San Antonio Breast Cancer Symposium (SABCS). The presentations will cover results from the PIKture-01 first-in-human study and preclinical data on OKI-219's enhanced activity in breast cancer models. The symposium will be held both virtually and in-person from December 10-13, 2024. OnKure will host a conference call on December 13 to discuss the preliminary data and provide a corporate update.