Marker Therapeutics (MRKR) FDA Approvals $1.31 -0.06 (-4.38%) Closing price 04:00 PM EasternExtended Trading$1.31 0.00 (0.00%) As of 06:58 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 Cybin FDA EventsREGENXBIO FDA EventsViking Therapeutics FDA EventsWAVE Life Sciences FDA EventsMerck & Co., Inc. FDA EventsAgomAb Therapeutics FDA EventsAmylyx Pharmaceuticals FDA EventsCoherus Oncology FDA EventsDiaMedica Therapeutics FDA EventsEntera Bio FDA EventsGalectin Therapeutics FDA EventsGilead Sciences FDA EventsJaguar Animal Health FDA EventsKalaris Therapeutics FDA EventsMicrobot 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 Cardiff Oncology FDA Events Anixa Biosciences FDA Events Atara Biotherapeutics FDA Events Biomea Fusion FDA Events Aardvark Therapeutics FDA Events Cypherpunk Technologies FDA Events Rein Therapeutics FDA Events Athira Pharma FDA Events Gain Therapeutics FDA Events Pliant Therapeutics 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. We continuously monitor for new FDA events and market data. From Our PartnersThe Treasury just bought its own debtOn April 16th, the U.S. Treasury executed a $15 billion buyback of its own debt - the largest in history - whi...Golden Portfolio | SponsoredFirm That Predicted 2008, 2020, 2022: Right Now Looks WorseThe firm that predicted the dot-com crash, the 2008 financial crisis, the 2020 COVID crash, and the 2022 bear ...TradeSmith | SponsoredVWAV: An Under-the-Radar Defense PlayVisionWave Holdings (NASDAQ: VWAV) is developing a multi-domain defense platform combining AI-powered analytic...Equiscreen | SponsoredBlackRock is hoarding it. JPMorgan is hoarding it. Do you own it?BlackRock, JPMorgan, Goldman Sachs, and Fidelity are reportedly accumulating a scarce blockchain asset - one t...Awesomely, LLC | SponsoredBuy this stock todayMarc Chaikin, founder of Chaikin Analytics, is sharing a strategy he calls 'Sell This, Buy That' - a way to mo...Chaikin Analytics | SponsoredPH: Do THESE 4 things to your bank account now …In a few short months, the US government could gain unprecedented powers over personal bank accounts - includi...Weiss Ratings | SponsoredMan who predicted COVID 19 Crash warns of new crisisA former CIA and Pentagon economic advisor predicted the 2008 financial crisis two years early - a warning so ...Paradigm Press | SponsoredMy feud with Zohran MamdaniNearly 40% of Americans now hold a positive view of socialism - and former hedge fund manager Whitney Tilson s...Stansberry Research | 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 Marker Therapeutics, Inc. Please log in to your account or sign up in order to add this asset to your watchlist. Share Marker Therapeutics With A Colleague Link copied to clipboard. Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial 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.
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
Free MRKR Stock Alerts