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OnKure Therapeutics, Inc.

OKUR
Fair ValuePharma · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$2.41
▲ +0.13 · +5.65%

Financials

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52W LOW $2.1352W HIGH $5.38
Volume
774.54 K
Value Traded
584.11 K
Short % Float
4.94%
-8.37%Week
-22.26%1 Month
-41.36%3 Month
-45.84%6 Month
-95.52%5 Year
-99.72%All Time

Cash Data

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  • Monthly Burn
  • Burn Trend
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  • SEC Filing

Key Stats

Market Cap
97.35 M
EPS (TTM)
-1.45
P/E Ratio
-
Ent. Value
-79.03 M
Total Shares
40.36 M
Float Shares
27.84 M
Insiders
31.26%
Institutions
65.09%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
Phase 1a/1b data readout
OKI-219
HR+ and HER2+ advanced breast cancer
Phase 1a/1bSmall MoleculesOncology
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

OKUR Catalyst Timeline

Dated clinical, regulatory and corporate events for OnKure Therapeutics, Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for OnKure Therapeutics, Inc.

168Total events
5Upcoming
30Tier-1 (high impact)
2021 to 2029Coverage

Upcoming catalysts 2

T2Runway Guidance Update
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T2IND Submission
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OKI-345

Event history 50

●Quarterly UpdateCorporate
Q2 2026 financial results reported
●Oral PresentationPresentation
Key Opinion Leader event hosted
●Oral PresentationPresentation
Exhibitor and sponsor at ISSVA World Congress 2026
vascular anomaliessource ↗
▲Development Candidate NominationOKI-355Preclinical
Nomination of OKI-355 for vascular anomalies
vascular anomaliessource ↗
▲Development Candidate NominationOKI-345Preclinical
Nomination of OKI-345 for breast cancer
breast cancersource ↗
●Quarterly UpdateCorporate
Q1 2026 financial results reported
▼Program DiscontinuationOKI-219DiscontinuedCorporate
Not planning to independently pursue further clinical development of OKI-219
breast cancersource ↗
●Poster PresentationPresentation
Exhibitor and sponsor at ISSVA World Congress 2026
●Other Regulator MilestoneEx-US Regulatory
Participation at ISSVA World Congress 2026
▼Equity OfferingCorporate
Closed $150 million private placement
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Past FDA Catalysts and PDUFA Decisions

How OKUR actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2026-03-31OKI-219 Phase 1a/1b data readout Phase 1a/1b
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

D36 / 100
Pipeline Score
$98M
Pipeline Value
Fair Value
Valuation Signal
4
Drugs Scored
1.0x
rNPV / MCap
Top 52%
Micro Cap
(rank 344 of 660)
Percentile Rank
OnKure Therapeutics, Inc. faces pipeline headwinds (36/100), with $391M risk-adjusted pipeline value, led by OKI-179 in Advanced Solid Tumors (Phase 1).
Showing 1 of 4 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
OKI-179 Small moleculeCompletedNCT05340621RAS MutationPhase 2 COMPLETED 36Jan 1, 2025
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Clinical Trial Results

Readouts, endpoints and source filings for every OKUR program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
OKI-219 breast cancer and other solid tumorsPhase 12024-12-10tolerability: 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 BIDRead MoreOnKure 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, dRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Leverone Jason A.Officer (Chief Financial Officer)Sell -302 18,500 held$2.97 09/21/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
RA CAPITAL MANAGEMENT, L.P. 0.2 % 18.23 M 4.00 M
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Shares held by hedge funds each quarter, and who bought or sold.

OKUR Institutional Ownership Trends

Options Data

Option Volume

Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-10-16
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Real-Time Option Chain

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LastVolOILastVolOI
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Calls vs Puts by Expiry

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Competitive positioning

How OKUR ranks across every disease it competes in

Competitive Position is a premium feature
See how OKUR ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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OKUR News

OKUR
Aug 31, 2026
OKURConferences/Events

OnKure Therapeutics to Participate in the Morgan Stanley Global Healthcare Conference

OnKure Therapeutics, a clinical-stage biopharmaceutical company, has announced its participation in the Morgan Stanley 24th Annual Global Healthcare Conference. This event is an opportunity for the company's senior management to engage with investors and discuss their development of novel precision medicines.

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OKUR
Aug 4, 2026
OKURGeneral

OnKure Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Highlights

OnKure Therapeutics reported its Q2 2026 financial results, highlighting advancements in its PI3Kα inhibitor pipeline. The company is preparing for IND submissions for two candidates, OKI-345 and OKI-355, in the first half of 2027. With a cash position of $176 million, OnKure aims to fund operations through 2029, despite ongoing net losses.

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OKUR
Jul 2, 2026
OKURConferences/Events

OnKure 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.

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OKUR
May 6, 2026
OKURGeneral
▼ -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.

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OKUR
Mar 27, 2026
OKURGeneral
▼ -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.

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OKUR
Mar 13, 2026
OKURGeneral
▲ +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.

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OKUR
Nov 6, 2025
OKURGeneral
▼ -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.

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OKUR
Nov 4, 2025
OKURConferences/Events

OnKure 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.

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OKUR
Aug 12, 2025
OKURPhases

OnKure Therapeutics Reports Second Quarter 2025 Financial Results and Provides a Business Update

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.

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OKUR
Jun 26, 2025
OKURPhases

Legends Forward-Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties of OnKure Therapeutics, Inc. (“OnKure” or the “Company&#x201d

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.

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OKUR
May 6, 2025
OKURPhases
▼ -11.2%on this news· ran to -24% by day 3

OnKure Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights

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.

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OKUR
Mar 10, 2025
OKURPhases

OnKure Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights

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.

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OKUR
Mar 4, 2025
OKURConferences/Events
▲ +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.

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OKUR
Dec 10, 2024
OKURPhases
▼ -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.

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OKUR
Nov 25, 2024
OKURConferences/Events

OnKure 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.

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OKUR
Nov 7, 2024
OKURGeneral

INDEX 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.

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OKUR
Nov 5, 2024
OKURConferences/Events
▲ +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.

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OKUR
Nov 1, 2024
OKURConferences/Events
▼ -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.

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OKUR
Oct 8, 2024
OKURGeneral

Report 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.

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OKUR
Oct 4, 2024
OKURGeneral

OnKure 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.

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About OnKure Therapeutics, Inc.

Boulder, CO 45 employees onkuretherapeutics.com
Headquarters6707 WINCHESTER CIRCLE, SUITE 400, BOULDER, CO, 80301
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