Marker Therapeutics (MRKR) FDA Approvals $1.44 -0.02 (-1.37%) Closing price 04:00 PM EasternExtended Trading$1.46 +0.03 (+1.74%) As of 06:01 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOwnershipSEC FilingsTrendsBuy This Stock Marker Therapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Marker Therapeutics (MRKR). Over the past two years, Marker Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as MT-601. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. MT-601 FDA Regulatory Events MT-601 is a drug developed by Marker Therapeutics for the following indication: Pancreatic 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. Primary Endpoint - August 26,2025Primary Endpoint Drug: MT-601Announced Date: August 26, 2025Indication: Pancreatic cancerAnnouncementMarker Therapeutics, Inc. today provided an update on the progress and clinical observations from the Phase 1 APOLLO study.AI SummaryMarker Therapeutics, Inc. today shared results from its Phase 1 APOLLO study of MT-601, a multi-antigen recognizing T cell therapy for relapsed B-cell lymphoma. In the dose escalation phase, 12 Non-Hodgkin Lymphoma (NHL) patients treated with 100×10⁶–200×10⁶ cells showed a 66% objective response rate, including 50% complete response. Responses lasted 3–24 months, with five patients maintaining response at least six months. Safety was strong across all doses (100×10⁶–400×10⁶ cells). No dose-limiting toxicities or immune-effector cell associated neurotoxicity syndrome (ICANS) occurred. Two cases of mild cytokine release syndrome were reported, and no serious adverse events were observed. The study will now move into a dose expansion phase at 400×10⁶ cells in patients with diffuse large B-cell lymphoma who have relapsed after or are ineligible for CAR-T therapy. A live webcast to discuss these findings will be held today at 8:30 a.m. ET, with a replay available on the company’s website.Read AnnouncementProvided Update - December 19,2024Provided Update Phase 1Drug: MT-601Announced Date: December 19, 2024Indication: Pancreatic cancerAnnouncementMarker Therapeutics, Inc. provided an update on the progress and clinical observations from the Phase 1 APOLLO study, with a data cutoff date of September 10.AI SummaryMarker Therapeutics, Inc. provided an update on the Phase 1 APOLLO study for MT-601, a multi-antigen recognizing T cell therapy for patients with relapsed lymphoma. The study, with data cut off on September 10, showed promising early results. Out of 9 patients treated at 5 clinical sites in the United States, 78% achieved objective responses and 44.4% experienced complete responses at the initial assessment. MT-601 was well tolerated, with no reports of immune-effector cell associated neurotoxicity syndrome and only one case of Grade 1 cytokine release syndrome. The data suggests that lymphodepletion might enhance the expansion and persistence of the therapy’s T cell clones. These early clinical observations have provided hope that MT-601 could offer a new treatment option for patients who have relapsed after prior therapies, including anti-CD19 CAR-T cells.Read Announcement Marker Therapeutics FDA Events - Frequently Asked Questions Has Marker Therapeutics received FDA approval? As of now, Marker Therapeutics (MRKR) has not received any FDA approvals for its therapy in the last two years. What drugs has Marker Therapeutics submitted to the FDA? In the past two years, Marker Therapeutics (MRKR) has reported FDA regulatory activity for MT-601. What is the most recent FDA event for Marker Therapeutics? The most recent FDA-related event for Marker Therapeutics occurred on August 26, 2025, involving MT-601. The update was categorized as "Primary Endpoint," with the company reporting: "Marker Therapeutics, Inc. today provided an update on the progress and clinical observations from the Phase 1 APOLLO study." What conditions do Marker Therapeutics' current drugs treat? Currently, Marker Therapeutics has one therapy (MT-601) targeting the following condition: Pancreatic 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 Acurx Pharmaceuticals FDA EventsAtea Pharmaceuticals FDA EventsBiogen FDA EventsHemab Therapeutics FDA EventsIronwood Pharmaceuticals FDA EventsKura Oncology FDA EventsAvidity Biosciences FDA EventsSpero Therapeutics FDA EventsSupernus Pharmaceuticals FDA EventsAgilent Technologies FDA EventsAligos Therapeutics FDA EventsANI Pharmaceuticals FDA EventsArtelo Biosciences FDA EventsBioMarin Pharmaceutical FDA EventsEnlivex Therapeutics 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 Verrica Pharmaceuticals FDA Events Biomea Fusion FDA Events Anixa Biosciences FDA Events Oncolytics Biotech FDA Events Cognition Therapeutics FDA Events Atara Biotherapeutics FDA Events Rani Therapeutics FDA Events Cardiff Oncology FDA Events Rein Therapeutics FDA Events Athira Pharma FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:MRKR last updated on 8/26/2025 by MarketBeat.com Staff. 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Primary Endpoint - August 26,2025Primary Endpoint Drug: MT-601Announced Date: August 26, 2025Indication: Pancreatic cancerAnnouncementMarker Therapeutics, Inc. today provided an update on the progress and clinical observations from the Phase 1 APOLLO study.AI SummaryMarker Therapeutics, Inc. today shared results from its Phase 1 APOLLO study of MT-601, a multi-antigen recognizing T cell therapy for relapsed B-cell lymphoma. In the dose escalation phase, 12 Non-Hodgkin Lymphoma (NHL) patients treated with 100×10⁶–200×10⁶ cells showed a 66% objective response rate, including 50% complete response. Responses lasted 3–24 months, with five patients maintaining response at least six months. Safety was strong across all doses (100×10⁶–400×10⁶ cells). No dose-limiting toxicities or immune-effector cell associated neurotoxicity syndrome (ICANS) occurred. Two cases of mild cytokine release syndrome were reported, and no serious adverse events were observed. The study will now move into a dose expansion phase at 400×10⁶ cells in patients with diffuse large B-cell lymphoma who have relapsed after or are ineligible for CAR-T therapy. A live webcast to discuss these findings will be held today at 8:30 a.m. ET, with a replay available on the company’s website.Read Announcement
Provided Update - December 19,2024Provided Update Phase 1Drug: MT-601Announced Date: December 19, 2024Indication: Pancreatic cancerAnnouncementMarker Therapeutics, Inc. provided an update on the progress and clinical observations from the Phase 1 APOLLO study, with a data cutoff date of September 10.AI SummaryMarker Therapeutics, Inc. provided an update on the Phase 1 APOLLO study for MT-601, a multi-antigen recognizing T cell therapy for patients with relapsed lymphoma. The study, with data cut off on September 10, showed promising early results. Out of 9 patients treated at 5 clinical sites in the United States, 78% achieved objective responses and 44.4% experienced complete responses at the initial assessment. MT-601 was well tolerated, with no reports of immune-effector cell associated neurotoxicity syndrome and only one case of Grade 1 cytokine release syndrome. The data suggests that lymphodepletion might enhance the expansion and persistence of the therapy’s T cell clones. These early clinical observations have provided hope that MT-601 could offer a new treatment option for patients who have relapsed after prior therapies, including anti-CD19 CAR-T cells.Read Announcement
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