OnKure Therapeutics (OKUR) FDA Approvals $4.45 +0.25 (+5.88%) As of 10:38 AM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock 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 Medicus Pharma FDA EventsPrecigen FDA EventsBioCryst Pharmaceuticals FDA EventsCogent Biosciences FDA EventsJazz Pharmaceuticals FDA EventsKymera Therapeutics FDA EventsAbbVie FDA EventsAC Immune FDA EventsAscendis Pharma A/S FDA EventsC4 Therapeutics FDA EventsCompugen FDA EventsCellectis FDA EventsClimb Bio FDA EventsCaribou Biosciences FDA EventsAlpha Tau Medical 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 BioAge Labs FDA Events CorMedix FDA Events Aura Biosciences FDA Events Avalo Therapeutics FDA Events Design Therapeutics FDA Events Allogene Therapeutics FDA Events Bright Minds Biosciences FDA Events Solid Biosciences FDA Events Candel Therapeutics FDA Events Climb Bio FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:OKUR last updated on 5/19/2025 by MarketBeat.com Staff. 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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
