OKUR

-- Announced nomination of OKI-355, a next-generation PI3Kα pan-mutant selective inhibitor candidate, in vascular anomalies -- Initiated a discovery research program to expand the company’s pipeline in vascular anomalies -- Announced nomination of OKI-345, a next generation PI3Kα pan-mutant selective inhibitor candidate, in breast cancer -- Closed $150 million private placement to advance next-generation PI3Kα pan-mutant programs into clinical development in 2027 -- $192 million cash and cash equivalents as of March 31, 2026, expected to fund operations into 2029 BOULDER, Colo., May 05, 2026 (GLOBE NEWSWIRE) -- OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines, today reported financial results for the first quarter ended March 31, 2026, and provided recent business highlights. “During the first quarter, we sharpened our strategic focus on advancing our next generation PI3Kα pan-mutant selective inhibitor programs, which we believe represent the most compelling opportunity to deliver differentiated therapies across PI3Kα-driven diseases,” said Nicholas Saccomano, Ph.D., President and Chief Executive Officer of OnKure. “Building on insights gained from our earlier clinical and translational work, we have advanced two highly selective pan-mutant development candidates that were purpose designed to achieve robust target coverage while avoiding class limiting toxicities. As we move forward with OKI-355 in vascular anomalies and OKI-345 in breast cancer, our focus is on translating the strengths of our chemistry platform and deep understanding of PI3Kα biology into programs with the potential to deliver meaningful, differentiated, and durable benefit to patients.” Vascular Anomalies OnKure recently announced the selection of OKI-355, an advanced next-generation PI3Kα pan-mutant selective inhibitor candidate, to lead its development pipeline in vascular anomalies. OKI-355 has been designed to selectively inhibit mutant PI3Kα while sparing wildtype PI3Kα, potentially enabling a wider therapeutic index and avoidance of class-limiting toxicities. High and sustained target coverage across all hotspot PI3Kα mutations can support the potential for deep and durable responses in vascular anomalies. Additionally, the Company initiated a discovery research program to expand OnKure’s pipeline i...

Thermo Fisher Scientific TMO is set to release first-quarter 2026 results on April 23, before the market opens. In the last reported quarter, the company posted adjusted earnings per share (EPS) of $6.57, which surpassed the Zacks Consensus Estimate by 2.18%. The company’s earnings topped estimates in each of the trailing four quarters, the average surprise being 2.78%. The Zacks Consensus Estimate for revenues is pegged at $10.83 billion, indicating an increase of 4.5% from the year-ago reported figure. The same for the company’s EPS implies a 1.2% year-over-year rise to $5.21. Estimates for Thermo Fisher’s Q1 earnings have remained constant at $5.21 in the past 30 days. Here’s a brief review of the company’s performance leading up to the announcement. Similar to recent quarters, the segment’s revenues are likely to have been driven by the Bioproduction business. Within this, Thermo Fisher expanded the single-use portfolio with the launch of the Thermo Scientific 5-liter DynaDrive single-use bioreactor, which might have improved workflow efficiencies for the pharma and biotech customers. Other recent high-impact innovations include two chemically-defined formulations within the Gibco Bacto CD portfolio and the Gibco Efficient-Pro Medium (+) Insulin for insulin-dependent CHO cell lines. The company also expanded its bioprocessing capabilities across Asia, an emerging global hub for biopharmaceutical innovation. Further, the addition of the Filtration and Separation business from Solventum has further strengthened the Bioproduction offerings with advanced filtration technologies and industrial filtration and membrane solutions. We expect all these developments to have positively boosted revenues in the first quarter of 2026. Per the Zacks Consensus Estimate, the Life Sciences Solutions revenues are expected to increase 7.9% year over year. In the first quarter, the segment’s revenues might have been aided by robust growth in the chromatography and mass spectrometry business. On the innovation front, Thermo Fisher introduced the Scios 3 and Talos 12 electron microscopes and an enterprise-ready compliance-focused software platform called Chromeleon 7.4 that unifies chromatography and mass spectrometry workflows. Thermo Fisher Scientific Inc. price-eps-surprise | Thermo Fisher Scientific Inc. Quote The company also launched Orbitrap Exploris EFOX Mass Detector,...

-- Data from the ongoing PIKture-01 trial is expected to be announced in March 2026; continued enrollment in breast cancer triplet combinations -- Next-generation PI3Kα pan-mutant inhibitor development candidate for HR+ metastatic breast cancer is expected to be announced in March 2026 -- Approximately $59M in cash and cash equivalents at the end of Q4 2025 BOULDER, Colo., March 12, 2026 (GLOBE NEWSWIRE) -- OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided recent business highlights. “We are pleased with the continued progress across our PI3Kα‑focused pipeline, including the steady execution of the PIKture‑01 trial of OKI-219. We look forward to sharing updated data from this trial later this month,” said Nicholas Saccomano, Ph.D., President and Chief Executive Officer of OnKure. “We are also excited to announce our next‑generation pan‑mutant inhibitor development candidate for HR+ metastatic breast cancer this month and provide additional information on our program in vascular malformations later this year. Overall, we believe our progress to date underscores the power of our mutation‑selective approach to PI3Kα inhibition and reinforces the momentum we are building as we work to deliver scientifically differentiated therapies to patients.” OKI-219 Program Highlights OnKure’s lead product candidate, OKI-219, is a highly selective PI3kαH1047 mutant specific inhibitor. OKI-219 is being evaluated in the PIKture-01 phase 1a/1b clinical trial for the treatment of patients with HR+ and HER2+ metastatic breast cancer. Parts A and B – Enrollment in both the monotherapy and fulvestrant combination dose escalation arms of the PIKture-01 trial has been completed and closed. A total of 71 patients have been dosed across both arms: 38 in monotherapy and 33 in combination with fulvestrant. The Company expects to report updated safety, tolerability, and clinical activity data from Parts A and B in March 2026. Part E – The Company continues to enroll patients with PI3KαH1047R mutated, HR+ metastatic breast cancer in the triplet expansion arm evaluating OKI-219 in combination with fulvestrant and ribociclib. A total of 17 patients have been dosed with OKI-219 in combination with fulves...

-- First patients dosed in triplet expansion arms of the PIKture-01 trial evaluating OKI-219 in combination with fulvestrant and ribociclib, and in combination with trastuzumab and tucatinib in patients with metastatic breast cancer -- Clinical data from OKI-219 PIKture-01 single agent and fulvestrant combination arms are maturing and is now expected to be reported together with initial data from the triplet expansion arms in the first quarter of 2026 -- Significant progress in next-generation PI3Kα pan-mutant inhibitor program; multiple candidates identified - announcement planned for the first quarter of 2026 -- Expansion into Vascular Malformations - additional information to be provided in 2026 BOULDER, Colo., Nov. 06, 2025 (GLOBE NEWSWIRE) -- OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines, today reported financial results for the third quarter ended September 30, 2025 and provided a business update. “We have made steady progress advancing our lead clinical development program, OKI-219, and are committed to leading the advancement of selective PI3Kα inhibitors for the treatment of patients with breast cancer and rare diseases. Based on its selectivity and safety profile, the differentiated value of OKI-219 is best demonstrated in early lines of therapy. This fact is at the heart of our clinical strategy. It is important to note that the single agent and fulvestrant dose ranging combination arms of our PIKture-01 trial have supported the expanded development of OKI-219 with the recent initiation of two triplet arms of the trial, including an evaluation of OKI-219 in combination with fulvestrant and ribociclib. We are at an exciting time in our company’s history, and we look forward to sharing clinical data from several arms of our ongoing PIKture-01 trial of OKI-219 in the first quarter of 2026,” said Nick Saccomano, Ph.D., President and Chief Executive Officer of OnKure. “While the team has been hard at work advancing the development of OKI-219, we have also continued to fuel the future growth of OnKure, with important advancements in our next-generation PI3Kα pan-mutant inhibitor program and the beginnings of an expansion program in vascular malformations. We look forward to offering additional details on these programs as our activities ramp up over the next several m...

-- PIKture-01, a phase 1 clinical trial assessing OKI-219 in patients with advanced solid tumors, including breast cancer, is on track for single agent and fulvestrant combination data in Q4 2025 -- Initiated a new expansion arm of PIKture-01 to evaluate OKI-219 in combination with fulvestrant and ribociclib in HR+ metastatic breast cancer -- Initiated a new expansion arm of PIKture-01 to evaluate OKI-219 in combination with trastuzumab and tucatinib in HER2+ metastatic breast cancer -- Cash position of $83.4M expected to provide cash runway into Q4 2026 BOULDER, Colo., Aug. 12, 2025 (GLOBE NEWSWIRE) -- OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines in oncology, today reported financial results for the second quarter ended June 30, 2025 and provided a business update. “We are encouraged by the continued progress in the development of our lead asset, OKI-219, as we have completed the enrollment of the single agent and the fulvestrant combination arms and have initiated two new triplet arms. Given the clinical performance of OKI-219 to date, we are eager to move broad and deep in both HR+ and HER2+ breast cancer with OKI-219,” said Nick Saccomano, Ph.D., President and Chief Executive Officer of OnKure. “We believe OKI-219 has the potential to become an important medicine in the first-line hormone receptor positive setting and have initiated an arm to evaluate OKI-219 in combination with fulvestrant and ribociclib in PI3KαH1047R mutated, metastatic HR+ breast cancer. We also see an opportunity for OKI-219 in HER2+ breast cancer and have initiated an arm to evaluate OKI-219 in combination with trastuzumab and tucatinib. We look forward to sharing OKI-219 monotherapy and fulvestrant combination data as well as announcing the expansion of our PI3Kα franchise with the nomination of a pan-mutant selective PI3Kα inhibitor later this year.” PI3Kα Portfolio Progress PIKture-01 Monotherapy and Fulvestrant Combination – The Company has completed and closed enrollment in both the monotherapy and fulvestrant combination dose escalation arms in the PIKture-01 trial. As of August 5, 2025, the Company dosed a total of 70 patients across both arms: 36 in monotherapy and 34 in combination with fulvestrant. OnKure expects to report data from both arms in the fourth quarter of 2025. PIKture-01 R...

-- Continued progress in the PIKture-01 trial; on track to report additional data in the second half of 2025, including mature single agent and initial combination data -- Expansion of the Company’s PI3Ka franchise with the planned announcement of a pan-mutant selective development candidate in Q2 2025 -- $96.7M in cash and cash equivalents expected to be sufficient to fund operations through multiple anticipated milestones into Q4 2026 BOULDER, Colo., May 06, 2025 (GLOBE NEWSWIRE) -- OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines in oncology, today reported financial results for the quarter ended March 31, 2025, and provided business highlights. “OnKure looks to define a new standard of performance for precision targeted agents. We designed OKI-219 and our ongoing PIKture-01 trial to set a high bar for achieving considerable selectivity in targeting oncogenic PI3KαH1047R. Late last year, we announced preliminary data that showed OKI-219 was well tolerated across all dose levels, allowing us to complete the dose escalation portion of the study up to 1500 mg BID. We anticipate presenting a mature clinical update in the second half of 2025 that could demonstrate a clear and meaningful benefit in treating this very challenging patient population. This exciting next step in our program would further solidify OnKure’s place as a leader in developing PI3Ka inhibitors,” said Nick Saccomano, Ph.D., President and Chief Executive Officer of OnKure. “Building on the advancement of our initial candidate, our research and development team is advancing towards a second development candidate in the second quarter of 2025; a true pan-mutant inhibitor with a selectivity profile that augurs well for rendering all major PI3Ka mutants actionable.” Business Highlights and Upcoming Anticipated Milestones PIKture-01 trial Part A Monotherapy – The Company has completed dose escalating and closed enrollment in Part A with dose limiting toxicities observed in only one patient to date and at the highest dose level. OnKure expects to provide a mature clinical update in the second half of 2025. OnKure previously announced encouraging preliminary safety, tolerability, and pharmacokinetic (“PK”) data from the part A single-agent arm of the PIKture-01 trial, with a data cut-off of October 28, 2024. These...