| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
Phase 1a/1b data readout example | Phase 1a/1b | — | Subscribe to access the data. | Small Molecules | Oncology | ||
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Phase 1a/1b data readout example | Phase 1a/1b | — | Subscribe to access the data. | Small Molecules | Oncology |
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Recently added Catalysts
OnKure Therapeutics, Inc.$4.28
-0.18 (-4.04%)
D 35Pipeline Score Overvalued Pharma · Clinical
Market Cap
170.06 M
EPS
-4.33
P/E Ratio
-
Value Trade
1.37 M
SEC Financials
Q1 2026Dilution Risk
R&D Expenses
11.71 M
Operating CF
-12.94 M
Total Assets
198.69 M
Total Liabilities
14.34 M
Equity
184.35 M
D/E Ratio
12,345
29.14 %
Week
-14.26 %
1 Month
59.47 %
3 Month
64.45 %
6 Month
-95.52 %
5 Year
-99.72 %
All Time
Cash Data
Cash Position
192.11 M
Monthly Burn
4.31 M
Runway
42.3 mo
Burn Trend
StableSEC Filing
May 5, 2026
Overview
Volume
193.80 K
52 Week Range
1.91 - 5.38
% held by Insiders
27.81 %
% held by Institutions
51.3 %
Enterprise Value
-21.63 M
Total Shares
40.42 M
Short %
3.53 %
Float Shares
24.90 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for OnKure Therapeutics, Inc.
161Total events
4Upcoming
32Tier-1 (high impact)
2021 – 2027Coverage
Upcoming catalysts 4
Event history 157
May 19, 2026
●Oral PresentationPresentation
Exhibitor and sponsor at ISSVA World Congress 2026
vascular anomaliessource ↗
May 6, 2026
▲Development Candidate NominationOKI-355Preclinical
Nomination of OKI-355 for vascular anomalies
vascular anomaliessource ↗
May 6, 2026
▲Development Candidate NominationOKI-345Preclinical
Nomination of OKI-345 for breast cancer
breast cancersource ↗
May 6, 2026
▼Program DiscontinuationOKI-219DiscontinuedCorporate
Not planning to independently pursue further clinical development of OKI-219
breast cancersource ↗
Mar 27, 2026
▼Program DiscontinuationOKI-219DiscontinuedCorporate
OnKure not planning to pursue further clinical development of OKI-219 independently
HR+ and HER2+ advanced breast cancersource ↗
Mar 26, 2026
▲Enrollment CompleteOKI-219DiscontinuedTrial
Enrollment completed in single-agent OKI-219 dose escalation (n=38) and OKI-219 + fulvestrant dose escalation (n=33)
HR+ and HER2+ advanced breast cancersource ↗
Mar 2026
◆Topline ReadoutOKI-219DiscontinuedClinical Data
Updated data from PIKture-01 trial expected in March 2026
HR+ and HER2+ metastatic breast cancersource ↗
Drug Pipeline Intelligence
D35
Pipeline Score $89M
Pipeline ValueOvervalued
Valuation Signal4
Drugs Scored0.5x
rNPV / MCap Top 47%
Micro Cap (rank 484 of 912)
Percentile RankOnKure Therapeutics, Inc. faces pipeline headwinds (35/100), with $354M risk-adjusted pipeline value, led by Mavodelpar in Primary Mitochondrial Myopathy (Phase 2).
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mavodelpar Small molecule | Primary Mitochondrial Myopathy | Phase 2 | NCT04535609 | 27% | $187M | COMPLETED | 213 | - | - | Oct 5, 2023 | - | May 8, 2024 |
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
OKI-219 | breast cancer and other solid tumors | Phase 1 | 2024-12-10 | tolerability: well-tolerated across all doses; adverse events: no dose interruptions, delays, reductions, or discontinuations; exposure levels: exceeding levels associated with robust antitumor activity; patients dosed: 17; common TRAEs: Grade 1 diarrhea 4, Grade 1 nausea 2, Grade 1 pruritus 2; doses: 300 mg BID, 600 mg BID, 900 mg BID Read More | OnKure Announces Encouraging Preliminary Safety, Tolerability, and Pharmacokinetic (PK) Data from its First-In-Human PIKture-01 Trial of OKI-219 -- OKI-219 is well-tolerated across all doses, and no dose interruptions, d Read More | |
OKI-219 | breast cancer and other solid tumors | Phase 1 | 2024-12-10 | tolerability: well-tolerated across all doses; adverse events: no dose interruptions, delays, reductions, or discontinuations; exposure levels: exceeding levels associated with robust antitumor activity; patients dosed: 17; common TRAEs: Grade 1 diarrhea 4, Grade 1 nausea 2, Grade 1 pruritus 2; doses: 300 mg BID, 600 mg BID, 900 mg BID Read More | OnKure Announces Encouraging Preliminary Safety, Tolerability, and Pharmacokinetic (PK) Data from its First-In-Human PIKture-01 Trial of OKI-219 -- OKI-219 is well-tolerated across all doses, and no dose interruptions, d Read More | |
OKI-219 | breast cancer and other solid tumors | Phase 1 | 2024-12-10 | tolerability: well-tolerated across all doses; adverse events: no dose interruptions, delays, reductions, or discontinuations; exposure levels: exceeding levels associated with robust antitumor activity; patients dosed: 17; common TRAEs: Grade 1 diarrhea 4, Grade 1 nausea 2, Grade 1 pruritus 2; doses: 300 mg BID, 600 mg BID, 900 mg BID Read More | OnKure Announces Encouraging Preliminary Safety, Tolerability, and Pharmacokinetic (PK) Data from its First-In-Human PIKture-01 Trial of OKI-219 -- OKI-219 is well-tolerated across all doses, and no dose interruptions, d Read More |
Inside Trades
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in OKUR
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
OKUR Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
OKUROnKure Therapeutics to Host Virtual KOL Event to Discuss PI3Kα Inhibitor Medicines: Selectivity Matters & Pan-Mutant Allosteric Inhibition Delivers, on July 15, 2026
OnKure Therapeutics will host a virtual KOL event on July 15, 2026, to discuss its PI3Kα inhibitor medicines. The event will feature experts Benjamin F. Cravatt and Robert Abraham, who will present OnKure's strategy for developing next-generation pan-mutant PI3Kα inhibitors. The company plans to submit IND applications for two drug candidates in 2027.
Read more →OKUR▼ -10%on this news· ran to -24% by day 3
OnKure Therapeutics Reports First Quarter 2026 Financial Results
OnKure Therapeutics reported its Q1 2026 financial results, highlighting the nomination of two next-generation PI3Kα pan-mutant selective inhibitors, OKI-355 and OKI-345, for vascular anomalies and breast cancer, respectively. The company closed a $150 million private placement, ensuring a strong cash position of $192 million to fund operations through 2029. However, OnKure also reported a net loss of $15.2 million and decided to discontinue the development of OKI-219.
Read more →OKUR▼ -13.1%on this news
OnKure Therapeutics Announces Oversubscribed $150 Million Private Placement to Advance Next-Generation PI3Kα Pan-Mutant Selective Inhibitor Candidates in Breast Cancer and Vascular Anomalies
OnKure Therapeutics has announced a successful $150 million private placement to advance its next-generation PI3Kα pan-mutant selective inhibitors targeting breast cancer and vascular anomalies. The financing, led by Access Biotechnology, will support the clinical development of two candidates, OKI-345 and OKI-355, with IND applications expected in the first half of 2027. Additionally, Liam Ratcliffe has joined OnKure's Board of Directors.
Read more →OKUR▲ +7.4%on this news
OnKure Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results
OnKure Therapeutics reported its financial results for Q4 and the full year 2025, highlighting ongoing progress in its PI3Kα-focused pipeline. The company anticipates announcing data from the PIKture-01 trial and a next-generation drug candidate for HR+ metastatic breast cancer in March 2026. Despite a net loss of $13.5 million, OnKure maintains a strong cash position of approximately $59 million.
Read more →OKUR▼ -7%on this news
OnKure Therapeutics Reports Third Quarter 2025 Financial Results and Provides a Business Update
OnKure Therapeutics reported its third quarter 2025 financial results, highlighting significant advancements in its clinical programs. The company has initiated triplet expansion arms in the PIKture-01 trial for its lead candidate, OKI-219, and expects to share clinical data in early 2026. Additionally, OnKure is progressing in its next-generation PI3Kα pan-mutant inhibitor program and plans to expand into vascular malformations.
Read more →OKUROnKure Therapeutics to Participate in Upcoming Investor Conferences
OnKure Therapeutics, a clinical-stage biopharmaceutical company, announced that its CEO, Nichoals Saccomano, will present at upcoming investor conferences and be available for one-on-one meetings. The company focuses on developing precision medicines targeting cancers that lack effective therapies. Their lead program, OKI-219, is a selective PI3KαH1047R inhibitor.
Read more →OKUROnKure Therapeutics Reports Second Quarter 2025 Financial Results and Provides a Business Update -- PIKture-01, a phase 1 clinical trial assessing OKI-219 in patients with advanced solid tumors, including breast cancer,
OnKure Therapeutics reported its second-quarter 2025 financial results, highlighting progress in its PIKture-01 clinical trial for OKI-219, especially in breast cancer treatments. The company has initiated several expansion arms targeting both HR+ and HER2+ metastatic breast cancer. With a cash position of $83.4 million expected to last until Q4 2026, OnKure remains focused on advancing its clinical programs and aims to present comprehensive data in Q4 2025. However, the company continues to face significant net losses amid rising research and development costs.
Read more →OKURLegends Forward-Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties of OnKure Therapeutics, Inc. (“OnKure” or the “Company”
OnKure Therapeutics, Inc. has provided forward-looking statements that articulate the company's strategies and anticipated developments concerning their portfolio of PI3K inhibitors, particularly featuring OKI-219, a selective inhibitor for specific cancer mutations. The presentation outlines significant potential risks, including financial challenges and operational hurdles related to clinical trial management. OnKure intends to advance several programs while capitalizing on their financial runway into late 2026. Despite its competitive landscape, the focus remains on developing targeted therapies that aim for enhanced efficacy and safety.
Read more →OKUR▼ -11.2%on this news· ran to -24% by day 3
OnKure Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights -- Continued progress in the PIKture-01 trial; on track to report additional data in the second half of 2025, including mature sing
OnKure Therapeutics reported their financial results and business highlights for Q1 2025. The company is progressing in the PIKture-01 trial, anticipating a mature update in late 2025. They also plan to announce a pan-mutant selective development candidate by Q2 2025, with sufficient cash reserves expected to support operations until Q4 2026. However, they reported increased net losses and higher operating expenses compared to the previous year.
Read more →OKUROnKure Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights -- PIKture-01 trial update including additional PK data, mature single agent and initial combination data exp
OnKure Therapeutics has reported its financial results for Q4 and full year 2024, highlighting progress in its PIKture-01 clinical trials. The company shared encouraging preliminary data for the OKI-219 single agent and is advancing its pan-mutant PI3K inhibitor program. With cash reserves expected to last until Q4 2026, OnKure is well-positioned to navigate upcoming milestones. However, it faced a net loss of $17.4 million in Q4 2024, reflecting the challenges of development costs.
Read more →OKUR▲ +7.5%on this news
OnKure Therapeutics to Present at Upcoming Leerink and Stifel Investor Conferences
OnKure Therapeutics, a clinical-stage biopharmaceutical company, announced that its CEO, Nicholas Saccomano, will present at upcoming investor conferences and hold one-on-one meetings. The company is focused on developing precision medicines targeting oncogenic drivers in cancer, with its lead program being OKI-219, a selective PI3KαH1047R inhibitor.
Read more →OKUR▼ -8.5%on this news· ran to -34% by day 3
OnKure Announces Encouraging Preliminary Safety, Tolerability, and Pharmacokinetic (PK) Data from its First-In-Human PIKture-01 Trial of OKI-219 -- OKI-219 is well-tolerated across all doses, and no dose interruptions, d
OnKure Therapeutics announced positive preliminary results from the first-in-human trial of its drug OKI-219. The treatment showed strong safety and tolerability, with no adverse dose interruptions reported. Initial pharmacokinetic data indicated sufficient exposure levels associated with effective antitumor activity, supporting the progression to further phases of the trial. The next part of the study will explore the combination of OKI-219 with fulvestrant, with initial data expected in the second half of 2025.
Read more →OKUROnKure Announces New Date for Upcoming Investor Call
OnKure Therapeutics has rescheduled its investor call to December 10, 2024, where it will share preliminary data from its first-in-human PIKture-01 trial for the drug OKI-219. This trial focuses on the use of the selective PI3KαH1047R inhibitor in treating advanced solid tumors, including breast cancer. Additionally, the company will present posters related to this trial at the 2024 San Antonio Breast Cancer Symposium. The event underscores OnKure's ongoing commitment to advancing cancer treatments through innovative drug development.
Read more →OKURINDEX TO UNAUDITED CONDENSED FINANCIAL STATEMENTS UNAUDITED CONDENSED FINANCIAL STATEMENTS: Page Independent Auditors' Review Report 2 Unaudited Balance Sheets as of
OnKure, Inc. has released its unaudited financial statements for the periods ending September 30, 2024 and 2023. The results indicate a notable increase in net loss and a decrease in cash reserves compared to the previous year. The company also reported an increase in total liabilities and a growing stockholders' deficit. Independent auditors found no material modifications needed for compliance with U.S. GAAP.
Read more →OKUR▲ +7.9%on this newsshared move
OnKure to Present at the Stifel 2024 Healthcare Conference
OnKure Therapeutics, Inc. will present a corporate overview at the Stifel Healthcare Conference on November 18, 2024. Nicholas Saccomano, the President and CEO, will highlight the company's progress in developing precision medicines for oncology. The presentation will discuss OnKure's lead program, OKI-219, which is focused on targeting oncogenic PI3Kα. The company aims to lead in this therapeutic area with multiple advanced programs planned.
Read more →OKUR▼ -6.9%on this newsshared move
OnKure to Present Clinical and Preclinical Data for OKI-219 at the 2024 San Antonio Breast Cancer Symposium
OnKure Therapeutics announced that two abstracts for OKI-219 have been selected for presentation at the 2024 San Antonio Breast Cancer Symposium. This includes preliminary clinical data from the PIKture-01 study, which targets specific mutant solid tumors. A conference call will be held following the symposium to further discuss the findings. OnKure is focused on developing precision oncology therapies, with OKI-219 as a lead program in their promising pipeline.
Read more →OKURReport of Independent Registered Public Accounting Firm To the Board of Directors and Stockholders OnKure, Inc.: Opinion on the Financial Statements We have audited the accompanying balance sheets of OnKure, Inc. (the Co
OnKure, Inc. has released a report from its independent registered public accounting firm, which audited its financial statements for the years ending December 31, 2023, and 2022. While the audit opinion states that the financial statements present fairly in all material respects, the firm also highlighted substantial doubts about the company's ability to continue as a going concern due to recurring operational losses. As of December 31, 2023, OnKure reported significant losses and an accumulated deficit, raising concerns about its financial viability moving forward.
Read more →OKUROnKure Announces Closing of Merger with Reneo Pharmaceuticals and Concurrent Private Placement of $65 Million
OnKure Therapeutics, Inc. has successfully completed its merger with Reneo Pharmaceuticals, with shares set to begin trading under the ticker symbol OKUR on October 7, 2024. Concurrently, the company raised $65 million through a private placement to support their development pipeline. With expected cash reserves sufficient for operations through Q4-2026, OnKure aims to advance its lead clinical candidate, OKI-219, for the treatment of PI3KαH1047R mutations in breast cancer, with early trial data projected to be released by the end of 2024.
Read more →OKURReneo Pharmaceuticals Reports Second Quarter 2024 Financial Results
Reneo Pharmaceuticals announced its financial results for the second quarter of 2024, reporting a reduced net loss compared to the same quarter in the previous year. The company is set to merge with OnKure, which will create a new entity focused on precision oncology therapies. Following the merger, Reneo expects to have around $120 million available in cash and investments. However, the merger's completion is contingent upon stockholder approval and other conditions, alongside significant risks related to uncertainties in the pharmaceutical sector.
Read more →OKUROnKure Announces the Appointment of Dylan Hartley, Ph.D. as Chief Scientific Officer
OnKure, Inc. has appointed Dylan Hartley, Ph.D., as its new Chief Scientific Officer. Dr. Hartley, with over 20 years of experience in drug research, will lead the company's research organization. He aims to advance innovative medicines for cancer patients while continuing the momentum of OnKure's PI3Kα franchise. Former CSO James Winkler will transition to an advisory role.
Read more →OKUROnKure Announces the Appointment of Rogan Nunn, J.D., as General Counsel and Secretary
OnKure, Inc. has appointed Rogan Nunn as its new General Counsel and Secretary, effective immediately. Nunn, who brings extensive experience from roles at ADC Therapeutics and Array Biopharma, will contribute to the company's legal and compliance functions and be part of its Executive Team. OnKure aims to develop precision medicines targeting key cancer drivers, and Nunn's legal expertise is anticipated to support ongoing and future initiatives in this area.
Read more →OKURReneo Pharmaceuticals and OnKure Announce Proposed Merger
Reneo Pharmaceuticals and OnKure have announced a definitive merger agreement to create a Nasdaq-listed biopharmaceutical company focused on oncology. The combined entity will operate under the name OnKure Therapeutics and is expected to have $120 million in cash resources at closing. The merger is subject to stockholder approval and regulatory conditions, with expected completion in 2024.
Read more →OKURReneo Pharmaceuticals and OnKure Announce Proposed Merger Merger to create a Nasdaq-listed, clinical-stage biopharmaceutical company focused on advancing OnKure s portfolio of novel precision medicines in oncology Combin
Reneo Pharmaceuticals and OnKure have announced a proposed all-stock merger to create a clinical-stage biopharmaceutical company that will trade under the symbol OKUR on Nasdaq. The new entity will prioritize advancing OnKure's promising pipeline of precision medicines, particularly the mutant-selective PI3K inhibitor OKI-219, which is in a Phase 1 clinical trial for solid tumors. The merger is expected to close in 2024, pending stockholder approvals and customary conditions, with around $120 million available in cash resources to support the combined company's operations. This merger may enhance shareholder value and provide significant advancements in cancer therapies.
Read more →OKURReneo Pharmaceuticals Reports First Quarter 2024 Financial Results
Reneo Pharmaceuticals reported its financial results for the first quarter of 2024, revealing a net loss of $8.4 million. The company did not meet the primary and secondary endpoints in its pivotal STRIDE study of mavodelpar, leading to the suspension of all related development activities. Additionally, Reneo has implemented drastic cost-cutting measures, including a 90% workforce reduction. The company's cash reserves stood at $82.8 million as of March 31, 2024, despite the reported losses.
Read more →OKURReneo Pharmaceuticals Reports Fourth Quarter And Full Year 2023 Financial Results And Business Update
Reneo Pharmaceuticals reported its financial results for the fourth quarter and full year 2023, revealing significant challenges. The pivotal STRIDE study of mavodelpar failed to meet its efficacy endpoints, leading to the suspension of its development and a workforce reduction by 90%. The company reported a net loss of $77.4 million for the year, which has prompted the retention of a financial advisor to explore strategic alternatives. Despite these struggles, Reneo anticipates having approximately $82 million in cash and equivalents in the near term.
Read more →OKUROnKure Announces the Appointment of Samuel Agresta, M.D., as Chief Medical Officer
OnKure, Inc. announced the appointment of Dr. Samuel Agresta as its new Chief Medical Officer. Dr. Agresta brings over 15 years of experience in oncology drug development, which will be crucial for leading OnKure’s clinical development and regulatory operations. He will play a key role in advancing the upcoming PIKture-01 trial of OKI-219. OnKure focuses on developing precision medicines targeting drivers of underserved cancers.
Read more →OKUROnKure Announces IND Clearance by U.S. FDA Enabling Phase 1 Initiation for its Mutant Selective PI3Kα inhibitor, OKI-219
OnKure, Inc. has received FDA clearance for its Investigational New Drug application for OKI-219, a selective PI3Kα H1047R inhibitor. This drug targets a common mutation found in various cancers, particularly breast cancer. The company plans to initiate a first-in-human trial in early 2024, focusing on patients with advanced solid tumors harboring this mutation. OKI-219 demonstrates strong efficacy with minimal toxicity, indicating a promising therapeutic option.
Read more →OKURReneo Pharmaceuticals Reports Third Quarter 2023 Financial Results Topline data results from the pivotal STRIDE study are expected in December 2023
Reneo Pharmaceuticals reported its third-quarter financial results, highlighting an expected release of topline data from the pivotal STRIDE study in December 2023. The company experienced a notable increase in both research and development expenses and general and administrative costs, leading to a net loss of $19.2 million for the quarter. However, Reneo celebrated a high participation rate in their ongoing studies and the successful enrollment of a patient with a nuclear DNA defect. Additionally, a patent concerning the use of PPAR-Delta agonists was allowed, promising potential development advantages for their therapy, mavodelpar.
Read more →OKURFocused on Improving the Lives of Patients with Rare Genetic Mitochondrial Diseases K Ke ey y O Opi pin niio on n L Le ead ade er r an and d Man Manag age em me en nt t U Updat pdate e
Reneo Pharmaceuticals is focused on developing mavodelpar for treating rare genetic mitochondrial diseases, specifically primary mitochondrial myopathy (PMM) and long-chain fatty acid oxidation disorders (LC-FAOD). Recent presentations highlighted the drug's potential benefits and the ongoing clinical trials aimed at demonstrating its effectiveness. The company anticipates key data releases, including topline results from the STRIDE Study expected in December 2023. However, mavodelpar is still under investigation and has not yet received regulatory approvals, which poses risks for future commercialization efforts.
Read more →OKUROnKure Therapeutics Appoints Ann Howell, Pharm.D., as Vice President of Regulatory Affairs
OnKure Therapeutics has appointed Ann Howell, Pharm.D., as Vice President of Regulatory Affairs. Dr. Howell brings significant experience in managing regulatory strategies for biopharmaceutical companies, particularly in oncology. She has successfully led numerous NDA submissions and is expected to contribute to OnKure's pipeline of precision medicines aimed at benefiting cancer patients globally.
Read more →OKURReneo Pharmaceuticals Reports Second Quarter 2023 Financial Results Topline results of the STRIDE study, the pivotal mavodelpar clinical trial in adult patients with primary mitochondrial myopathies (PMM) due to mitochon
Reneo Pharmaceuticals reported its second quarter financial results, indicating a net loss of $19.5 million. The company is expecting topline results from its pivotal STRIDE study in the fourth quarter of 2023. They have successfully enrolled over 130 patients in their STRIDE AHEAD open-label study and have raised $68.3 million from public offerings. Reneo's lead product candidate, mavodelpar, is in clinical development for primary mitochondrial myopathies.
Read more →OKUROnKure Therapeutics Announces $54 Million Series C Financing
OnKure Therapeutics has successfully raised $54 million in Series C financing, led by Surveyor Capital with contributions from various investors, including Deep Track Capital and BlackRock. The funds will support their pipeline of precision oncology medicines, specifically advancing their lead program, OKI-219, into clinical trials. CEO Tony Piscopio expressed optimism about the company's vision to develop tumor-agnostic therapies. OnKure focuses on innovative drug design targeting cancer drivers, intending to file their second IND in 2023.
Read more →OKURReneo Pharmaceuticals Reports First Quarter 2023 Financial Results • Completed enrollment of the pivotal STRIDE study; topline results anticipated 4Q 2023 • Raised $68.3 million in gross proceeds from a con
Reneo Pharmaceuticals reported its financial results for Q1 2023, highlighting the completion of patient enrollment in the pivotal STRIDE study for mavodelpar, which exceeded initial targets. The company raised $68.3 million through a public offering and private placement to bolster its financial position for upcoming commercial activities. Additionally, it received Fast Track Designation from the FDA for mavodelpar, aimed at treating rare mitochondrial diseases. Despite these positive developments, Reneo reported a net loss of $15.1 million and increased expenses compared to the previous year.
Read more →OKURFocused on Improving the Lives of Patients with Rare Genetic Mitochondrial Diseases Nasdaq: RPHM Corporate Presentation May 2023 Forward-Looking Statements This presentation contains forward-looking statements that are b
Reneo Pharmaceuticals presented its forward-looking strategies and expectations related to its investigational drug mavodelpar, aimed at treating rare genetic mitochondrial diseases such as primary mitochondrial myopathy (PMM) and LC-FAOD. The company highlighted its ongoing clinical trials, financial projections, and potential commercialization plans, although it acknowledged various risks and uncertainties that could impact its operations. Patients impacted by these rare conditions are in need of innovative treatments, making Reneo's endeavors critical in this niche medical field.
Read more →OKURReneo Pharmaceuticals Announces Proposed Public Offering of Common Stock
Reneo Pharmaceuticals has announced a proposed underwritten public offering of common stock as part of its efforts to raise capital. The company intends to offer shares with an option for underwriters to purchase additional shares. In a concurrent private placement, Reneo expects to sell shares to Abingworth Bioventures, generating gross proceeds of up to $5 million. The offering is subject to market conditions, and there is uncertainty regarding its completion.
Read more →OKURReneo Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
Reneo Pharmaceuticals has reported its financial results for Q4 and full year 2022, alongside significant updates on its clinical programs. The company reached target enrollment in the pivotal STRIDE study and anticipates topline results in Q4 2023. Reneo's mavodelpar has shown positive Phase 1b results for long-chain fatty acid oxidation disorder, with plans to advance into Phase 2 development. However, the company also reported a net loss of $52.0 million for the year, underscoring ongoing financial challenges.
Read more →OKURForward-Looking Statements This presentation contains "forward-looking" statements that are based on our management's beliefs and assumptions and on information currently available to management. Forward-looking statemen
The presentation outlines forward-looking statements from Reneo Pharmaceuticals regarding their investigational drug, mavodelpar (REN001), aimed at treating rare genetic mitochondrial diseases. It emphasizes the potential benefits and patient population, alongside various risks such as reliance on external organizations and compliance with regulatory standards. The company highlights preliminary positive results from clinical trials but also notes the uncertainties predominant in the drug approval process and market acceptance.
Read more →OKUROnKure Therapeutics Appoints Robbie Alton, Pharm., as Vice President of Clinical Operations
BOULDER, Colo., Dec. 06, 2022 (GLOBE NEWSWIRE) -- OnKure, Inc., a clinical-stage biopharmaceutical company discovering and developing the next generation of oncology precision medicines, today announced the appointment of Roberta (“Robbie”) Alton, Pharm., as Vice President of Cli
Read more →OKURReneo Pharmaceuticals Reports Third Quarter 2022 Financial Results
Reneo Pharmaceuticals Reports Third Quarter 2022 Financial Results IRVINE, Calif., November 8, 2022 (GLOBE NEWSWIRE) -- Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM), a clinical-stage pharmaceutical company focused on the development and commercialization of therapies for patients
Read more →OKURReneo Pharmaceuticals Reports Second Quarter 2022 Financial Results
Reneo Pharmaceuticals Reports Second Quarter 2022 Financial Results IRVINE, Calif., August 9, 2022 (GLOBE NEWSWIRE) -- Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM), a clinical-stage pharmaceutical company focused on the development and commercialization of therapies for patients w
Read more →OKUROnKure Therapeutics Appoints Kevin S. Litwiler, Ph.D., as Senior Vice President of DMPK and Clinical Pharmacology
BOULDER, Colo., June 21, 2022 (GLOBE NEWSWIRE) -- OnKure, Inc., a clinical-stage biopharmaceutical company discovering and developing the next generation of oncology precision medicines, today announced the appointment of Kevin S. Litwiler, Ph.D., as Senior Vice President of DMPK
Read more →OKUROnKure Therapeutics Announces First Patient Dosed in the Phase 1b/2 Nautilus Trial of OKI-179 in Combination with Binimetinib in Patients with Advanced NRAS-Mutated Melanoma
BOULDER, Colo., June 02, 2022 (GLOBE NEWSWIRE) -- OnKure, Inc., a clinical-stage biopharmaceutical company discovering and developing the next generation of oncology precision medicines, today announced that the first patient has been dosed in the Phase 1b/2 Nautilus trial of OKI
Read more →OKURReneo Pharmaceuticals Reports First Quarter 2022 Financial Results
Reneo Pharmaceuticals Reports First Quarter 2022 Financial Results IRVINE, Calif., May 10, 2022 (GLOBE NEWSWIRE) -- Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM), a clinical stage pharmaceutical company focused on the development and commercialization of therapies for patients with
Read more →OKUROnKure Therapeutics Expands Boulder Footprint with the Opening of a New Research Laboratory
BOULDER, Colo., April 25, 2022 (GLOBE NEWSWIRE) -- OnKure, Inc., a clinical-stage biopharmaceutical company discovering and developing the next generation of oncology precision medicines, today announced that the Company is expanding its operations with the opening of a research
Read more →OKUROnKure Therapeutics Announces Promising Preclinical Data on OKI-179 in RAS-Mutated Tumor Models Presented in a Late-Breaking Session at AACR
OKI-179 demonstrated chemical synthetic lethality when combined with MEK and BRAF inhibitors in RAS pathway mutated cancer models The Company plans to initiate the OKI-179-230 Phase 1b/2 trial of OKI-179 in combination with Pfizer’s MEK inhibitor, binimetinib, in advanced NRAS-m
Read more →OKURReneo Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update Irvine, Calif.
Reneo Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update Irvine, Calif. March 23, 2022 -- Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM), a clinical stage pharmaceutical company focused on the development and commercialization of
Read more →OKUROnKure Therapeutics to Present Late-Breaking Preclinical Data on OKI-179 at the AACR Annual Meeting 2022
BOULDER, Colo., March 08, 2022 (GLOBE NEWSWIRE) -- OnKure, Inc., a clinical-stage biopharmaceutical company discovering and developing the next generation of oncology precision medicines, today announced that preclinical data demonstrating synergy between OKI-179, the Company’s o
Read more →OKUROnKure Therapeutics Appoints Jason Leverone, CPA, as Chief Financial Officer
BOULDER, Colo., Feb. 08, 2022 (GLOBE NEWSWIRE) -- OnKure, Inc., a clinical-stage biopharmaceutical company discovering and developing the next generation of oncology precision medicines, today announced the appointment Jason Leverone, CPA, as Chief Financial Officer. Mr. Leverone
Read more →OKURReneo Pharmaceuticals Reports Third Quarter 2021 Financial Results Irvine, Calif.
Reneo Pharmaceuticals Reports Third Quarter 2021 Financial Results Irvine, Calif. November 11, 2021 -- Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM), a clinical stage pharmaceutical company focused on the development and commercialization of therapies for patients with rare genetic
Read more →OKURReneo Pharmaceuticals Reports Second Quarter 2021 Financial Results First patient dosed in STRIDE study of REN001 in primary mitochondrial myopathies Irvine
Reneo Pharmaceuticals Reports Second Quarter 2021 Financial Results First patient dosed in STRIDE study of REN001 in primary mitochondrial myopathies Irvine, August 11, 2021 -- Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM), a clinical stage pharmaceutical company focused on the de
Read more →OKURNasdaq: RPHM August 2021 Focused on Improving the Lives of Patients with Rare Genetic Mitochondrial Diseases 2 Forward-Looking Statements This presentation may not be reproduced, retransmitted or further distributed to a
(10 years in Europe and Japan) - 6 months additional exclusivity for pediatric populations Clinical Milestones 27 REN001 Clinical Development Roadmap 2023 2022 2021 PMM Open-label enrollment begins (1H 2022) PMM Phase 2b topline results (2023) PMM Phase 2b first patient dosed Jul
Read more →OKURReneo Pharmaceuticals Reports First Quarter 2021 Financial Results
Reneo Pharmaceuticals Reports First Quarter 2021 Financial Results SAN DIEGO, May 20, 2021 -- Reneo Pharmaceuticals, Inc., a clinical stage pharmaceutical company focused on the development and commercialization of therapies for patients with rare genetic, mitochondrial diseases
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