OnKure Therapeutics (OKUR) FDA Approvals $3.56 +0.02 (+0.56%) As of 09/3/2026 04:00 PM Eastern Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsInsider TradesNews and TrendsOwnershipSEC FilingsShort Interest OnKure Therapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by OnKure Therapeutics (OKUR). Over the past two years, OnKure Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as OKI-219. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. OKI-219 FDA Regulatory Events OKI-219 is a drug developed by OnKure Therapeutics for the following indication: For Breast Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Initial Data - December 10,2024Initial Data Drug: OKI-219Announced Date: December 10, 2024Target Action Date: H2 2025Estimated Target Date Range: July 1, 2025 - December 31, 2025Indication: For Breast CancerAnnouncementOnKure Therapeutics, Inc. announced that initial data are expected in 2H-2025AI SummaryOnKure Therapeutics, Inc. recently shared promising early clinical results for its lead drug candidate, OKI-219, which is under evaluation as a mutant-selective inhibitor for cancer. In the initial phase of their ongoing trial, the drug has been well tolerated at all tested doses, with only minor side effects and no treatment interruptions reported. The drug’s exposure levels have even surpassed those linked to strong antitumor activity in preclinical studies. Building on these encouraging findings, OnKure has now begun Part 1b of the PIKture-01 trial, which will test OKI-219 in combination with fulvestrant in patients with advanced cancers. The company expects to release mature single-agent and early combination data during the second half of 2025, offering further insight into the drug’s potential in oncology treatments.Read AnnouncementData - December 10,2024Data Drug: OKI-219Announced Date: December 10, 2024Indication: For Breast CancerAnnouncementOnKure Therapeutics, Inc. announced encouraging safety, tolerability, and pharmacokinetic data from the ongoing first-in-human trial of OKI-219, a potential best-in-class, mutant-selective PI3KαH1047R inhibitor.AI Summary OnKure Therapeutics, Inc. announced promising early results from its first-in-human study of OKI-219, a potential best-in-class, mutant-selective PI3KαH1047R inhibitor. In the trial, OKI-219 demonstrated a favorable safety and tolerability profile across all dose levels, with no reported dose interruptions, delays, or reductions, and only minor (Grade 1) treatment-related adverse events. The pharmacokinetic data showed that patients reached steady-state exposures that exceed levels associated with strong antitumor activity in preclinical models. These encouraging findings support the progression into Part 1b of the PIKture-01 trial, which will evaluate OKI-219 in combination with fulvestrant in patients with advanced breast cancer. The results indicate that OKI-219 may provide a new, effective treatment option for cancer patients with the PI3KαH1047R mutation. Read Announcement OnKure Therapeutics FDA Events - Frequently Asked Questions Has OnKure Therapeutics received FDA approval? As of now, OnKure Therapeutics (OKUR) has not received any FDA approvals for its therapy in the last two years. What drugs has OnKure Therapeutics submitted to the FDA? In the past two years, OnKure Therapeutics (OKUR) has reported FDA regulatory activity for OKI-219. What is the most recent FDA event for OnKure Therapeutics? The most recent FDA-related event for OnKure Therapeutics occurred on December 10, 2024, involving OKI-219. The update was categorized as "Data," with the company reporting: "OnKure Therapeutics, Inc. announced encouraging safety, tolerability, and pharmacokinetic data from the ongoing first-in-human trial of OKI-219, a potential best-in-class, mutant-selective PI3KαH1047R inhibitor." What conditions do OnKure Therapeutics' current drugs treat? Currently, OnKure Therapeutics has one therapy (OKI-219) targeting the following condition: For Breast Cancer. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Biogen FDA EventsC4 Therapeutics FDA EventsClimb Bio FDA EventsDyne Therapeutics FDA EventsHarmony Biosciences FDA EventsInsmed FDA EventsLiquidia FDA EventsMilestone Pharmaceuticals FDA EventsAbbVie FDA EventsBridgeBio Pharma FDA EventsOpus Genetics FDA EventsuniQure FDA EventsUltragenyx Pharmaceutical FDA EventsSELLAS Life Sciences Group FDA EventsSciSparc FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Tectonic Therapeutic FDA Events Capricor Therapeutics FDA Events Eikon Therapeutics FDA Events Artiva Biotherapeutics FDA Events Cabaletta Bio FDA Events Entera Bio FDA Events Prothena FDA Events AgomAb Therapeutics FDA Events Editas Medicine FDA Events C4 Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:OKUR last updated on 5/19/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersA Simple Guide to Options Trading While It's Still FreeA free copy of Options Trading Made Simple is available now but wont stay that way for long. Chris Rowe cal...True Market Insiders | SponsoredHow Long Does $2.5M Last in Retirement?Having $2.5 million saved puts you ahead of most Americans, but how long it lasts depends on the decisions you...SmartAsset | SponsoredBezos… DOOMEDA single FCC filing hints Elon Musk is planning his biggest project yet - bigger than Tesla, SpaceX, and X com...Paradigm Press | SponsoredBefore Anthropic becomes impossible to ignore...Riot Platforms just struck a 20-year, 191-megawatt data-center agreement tied to Anthropic, reportedly worth 9...The Oxford Club | SponsoredHere’s the stock symbol I’ve promisedWhitney Tilson of Stansberry Research has long recommended Berkshire Hathaway as a core retirement holding - b...Stansberry Research | SponsoredMajor Buy Alert Issued for September 30thKeith Kaplan has invested $17 million into his own AI research tools, building a platform now used by 180,000 ...TradeSmith | SponsoredA new income category is drawing serious money - here's whyForbes recently called a new category of exchange-traded income funds a 'golden era,' and Bloomberg noted the ...Investors Alley | SponsoredThree companies about to leapfrog Nvidia [And transform the entire industry]In 1984, a 10000 dollar stake in Apple could have grown to 25 million dollars for early investors who simply g...Eagle Publishing | Sponsored Adding Choose a watchlist: Watchlist Adding You have already added ten stocks to your watchlist. Upgrade to MarketBeat All Access to add more stocks to your watchlist. Adding OnKure Therapeutics, Inc. Please log in to your account or sign up in order to add this asset to your watchlist. Share OnKure Therapeutics With A Colleague Link copied to clipboard. Unlock superior investment research and tools. Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools and reports. Get MarketBeat All Access MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In Email Me a Login Link or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Initial Data - December 10,2024Initial Data Drug: OKI-219Announced Date: December 10, 2024Target Action Date: H2 2025Estimated Target Date Range: July 1, 2025 - December 31, 2025Indication: For Breast CancerAnnouncementOnKure Therapeutics, Inc. announced that initial data are expected in 2H-2025AI SummaryOnKure Therapeutics, Inc. recently shared promising early clinical results for its lead drug candidate, OKI-219, which is under evaluation as a mutant-selective inhibitor for cancer. In the initial phase of their ongoing trial, the drug has been well tolerated at all tested doses, with only minor side effects and no treatment interruptions reported. The drug’s exposure levels have even surpassed those linked to strong antitumor activity in preclinical studies. Building on these encouraging findings, OnKure has now begun Part 1b of the PIKture-01 trial, which will test OKI-219 in combination with fulvestrant in patients with advanced cancers. The company expects to release mature single-agent and early combination data during the second half of 2025, offering further insight into the drug’s potential in oncology treatments.Read Announcement
Data - December 10,2024Data Drug: OKI-219Announced Date: December 10, 2024Indication: For Breast CancerAnnouncementOnKure Therapeutics, Inc. announced encouraging safety, tolerability, and pharmacokinetic data from the ongoing first-in-human trial of OKI-219, a potential best-in-class, mutant-selective PI3KαH1047R inhibitor.AI Summary OnKure Therapeutics, Inc. announced promising early results from its first-in-human study of OKI-219, a potential best-in-class, mutant-selective PI3KαH1047R inhibitor. In the trial, OKI-219 demonstrated a favorable safety and tolerability profile across all dose levels, with no reported dose interruptions, delays, or reductions, and only minor (Grade 1) treatment-related adverse events. The pharmacokinetic data showed that patients reached steady-state exposures that exceed levels associated with strong antitumor activity in preclinical models. These encouraging findings support the progression into Part 1b of the PIKture-01 trial, which will evaluate OKI-219 in combination with fulvestrant in patients with advanced breast cancer. The results indicate that OKI-219 may provide a new, effective treatment option for cancer patients with the PI3KαH1047R mutation. Read Announcement
