This company has been marked as potentially delisted and may not be actively trading. Leap Therapeutics (LPTX) FDA Approvals Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsEarningsFDA EventsOwnershipTrendsBuy This Stock Leap Therapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Leap Therapeutics (LPTX). Over the past two years, Leap Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as DKN-01. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. DKN-01 FDA Regulatory Events DKN-01 is a drug developed by Leap Therapeutics for the following indication: Advanced gynecological malignancies. 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. Results - October 20,2025Results Phase 2Drug: DKN-01Announced Date: October 20, 2025Indication: Advanced gynecological malignanciesOther Companies Involved: NASDAQ:CYPH AnnouncementLeap Therapeutics, Inc. announced final results from Part B of the DeFianCe study (NCT05480306), a Phase 2 study of sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in combination with bevacizumab and chemotherapy (Sirexatamab Arm) compared to bevacizumab and chemotherapy (Control Arm) in patients with microsatellite stable (MSS) colorectal cancer (CRC) who have received one prior systemic therapy for advanced disease.AI SummaryLeap announced final results from Part B of the Phase 2 DeFianCe study. The trial compared sirexatamab plus bevacizumab and chemotherapy against standard bevacizumab-chemotherapy in microsatellite-stable colorectal cancer patients after one prior therapy. In patients with DKK1 levels above the median (n=88), the Sirexatamab Arm had an objective response rate of 38.0% versus 23.7% in the Control Arm. Median progression-free survival was 9.03 versus 7.06 months (HR 0.61; p=0.0255), and overall survival was not reached versus 14.39 months (HR 0.42; p=0.0118). In the highest DKK1 quartile (n=44), response rates were 44.0% versus 15.8%, median PFS was 9.36 versus 5.88 months (HR 0.46; p=0.0168), and median OS was not reached versus 9.66 months (HR 0.17; p<0.001). Sirexatamab added to standard therapy was well tolerated. Leap will support further development in DKK1-high CRC patients and pursue a biomarker-focused registrational trial.Read Announcement Leap Therapeutics FDA Events - Frequently Asked Questions Has Leap Therapeutics received FDA approval? As of now, Leap Therapeutics (LPTX) has not received any FDA approvals for its therapy in the last two years. What drugs has Leap Therapeutics submitted to the FDA? In the past two years, Leap Therapeutics (LPTX) has reported FDA regulatory activity for DKN-01. What is the most recent FDA event for Leap Therapeutics? The most recent FDA-related event for Leap Therapeutics occurred on October 20, 2025, involving DKN-01. The update was categorized as "Results," with the company reporting: "Leap Therapeutics, Inc. announced final results from Part B of the DeFianCe study (NCT05480306), a Phase 2 study of sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in combination with bevacizumab and chemotherapy (Sirexatamab Arm) compared to bevacizumab and chemotherapy (Control Arm) in patients with microsatellite stable (MSS) colorectal cancer (CRC) who have received one prior systemic therapy for advanced disease." What conditions do Leap Therapeutics' current drugs treat? Currently, Leap Therapeutics has one therapy (DKN-01) targeting the following condition: Advanced gynecological malignancies. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Aptevo Therapeutics FDA EventsAscendis Pharma A/S FDA EventsBridgeBio Pharma FDA EventsBriacell Therap FDA EventsEupraxia Pharmaceuticals FDA EventsErnexa Therapeutics FDA EventsMedicus Pharma FDA EventsModerna FDA EventsTonix Pharmaceuticals FDA EventsUnited Therapeutics FDA EventsVertex Pharmaceuticals FDA EventsNuvation Bio FDA EventsAllarity Therapeutics FDA EventsAvalo Therapeutics FDA EventsCellectar Biosciences 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 Immuneering FDA Events Evolus FDA Events Silence Therapeutics FDA Events Monopar Therapeutics FDA Events Opus Genetics FDA Events Bicycle Therapeutics FDA Events Palisade Bio FDA Events DiaMedica Therapeutics FDA Events Cabaletta Bio FDA Events Abeona Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:LPTX last updated on 10/20/2025 by MarketBeat.com Staff. 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Results - October 20,2025Results Phase 2Drug: DKN-01Announced Date: October 20, 2025Indication: Advanced gynecological malignanciesOther Companies Involved: NASDAQ:CYPH AnnouncementLeap Therapeutics, Inc. announced final results from Part B of the DeFianCe study (NCT05480306), a Phase 2 study of sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in combination with bevacizumab and chemotherapy (Sirexatamab Arm) compared to bevacizumab and chemotherapy (Control Arm) in patients with microsatellite stable (MSS) colorectal cancer (CRC) who have received one prior systemic therapy for advanced disease.AI SummaryLeap announced final results from Part B of the Phase 2 DeFianCe study. The trial compared sirexatamab plus bevacizumab and chemotherapy against standard bevacizumab-chemotherapy in microsatellite-stable colorectal cancer patients after one prior therapy. In patients with DKK1 levels above the median (n=88), the Sirexatamab Arm had an objective response rate of 38.0% versus 23.7% in the Control Arm. Median progression-free survival was 9.03 versus 7.06 months (HR 0.61; p=0.0255), and overall survival was not reached versus 14.39 months (HR 0.42; p=0.0118). In the highest DKK1 quartile (n=44), response rates were 44.0% versus 15.8%, median PFS was 9.36 versus 5.88 months (HR 0.46; p=0.0168), and median OS was not reached versus 9.66 months (HR 0.17; p<0.001). Sirexatamab added to standard therapy was well tolerated. Leap will support further development in DKK1-high CRC patients and pursue a biomarker-focused registrational trial.Read Announcement
