Adaptive Biotechnologies (ADPT) FDA Approvals $13.88 0.00 (0.00%) Closing price 05/22/2026 04:00 PM EasternExtended Trading$13.60 -0.28 (-2.02%) As of 05/22/2026 06:12 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 EventsFinancialsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock Adaptive Biotechnologies' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Adaptive Biotechnologies (ADPT). Over the past two years, Adaptive Biotechnologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as clonoSEQ. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. ClonoSEQ FDA Regulatory Timeline and Events ClonoSEQ is a drug developed by Adaptive Biotechnologies for the following indication: Treatments for patients with lymphoid 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. Provided Update - December 6,2025Provided Update Drug: clonoSEQAnnounced Date: December 6, 2025Indication: Treatments for patients with lymphoid malignancies.AnnouncementAdaptive Biotechnologies announced growing interventional use of its clonoSEQ® test among the 90 abstracts featuring clonoSEQ data at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place Dec. 6–9, 2025, in Orlando.AI SummaryAdaptive Biotechnologies reported growing interventional use of its clonoSEQ test at the 67th ASH Annual Meeting, where 90 abstracts featured clonoSEQ data. Notably, 17 of those abstracts show how next-generation sequencing (NGS) measurable residual disease (MRD) results are directly guiding clinical actions to improve blood cancer care. Key examples include the phase II EndRAD study, which used NGS MRD to select non–total body irradiation (non‑TBI) transplant conditioning for children and young adults with B‑ALL. Among 51 NGS MRD‑negative patients who received non‑TBI regimens, event‑free and overall survival were excellent and comparable to a TBI cohort, suggesting radiation‑sparing options may be feasible for MRD‑negative patients. Across diseases, investigators presented MRD‑guided strategies in multiple myeloma (32 abstracts), non‑Hodgkin lymphoma (15), chronic lymphocytic leukemia (7) and acute lymphoblastic leukemia (30). Adaptive says the volume and variety of ASH data underscore clonoSEQ’s growing role in tailoring treatment intensity, duration and surveillance decisions using MRD results.Read AnnouncementProvided Update - July 1,2025Provided Update Drug: clonoSEQAnnounced Date: July 1, 2025Indication: Treatments for patients with lymphoid malignancies.AnnouncementAdaptive Biotechnologies announced the integration of Adaptive's clonoSEQ® test for measurable residual disease (MRD) assessment in lymphoid malignancies into OncoEMR®, Flatiron's cloud-based Electronic Medical Record (EMR) platform.AI SummaryAdaptive Biotechnologies has announced that its FDA-cleared clonoSEQ® test for measurable residual disease (MRD) in lymphoid malignancies is now integrated into OncoEMR®, Flatiron Health’s cloud-based electronic medical record platform. This integration allows clinicians at over 1,000 community-based cancer care locations to order and review MRD testing results directly within the platform, simplifying workflows and providing faster access to critical patient data. The streamlined access to MRD data helps healthcare providers make informed, personalized treatment decisions for blood cancer patients. By incorporating the clonoSEQ® test into OncoEMR®, the collaboration aims to enhance patient care by delivering real-time insights into disease status, making it easier for clinicians in community oncology settings to monitor treatment progress and potentially detect relapses earlier.Read AnnouncementPresentation - May 30,2025Presentation Drug: clonoSEQAnnounced Date: May 30, 2025Indication: Treatments for patients with lymphoid malignancies.AnnouncementAdaptive Biotechnologies announced that its next-generation sequencing (NGS)-based clonoSEQ® test for measurable residual disease (MRD) assessment will be included in 30 presentations, including a total of 14 oral presentations, across the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30-June 3 in Chicago and the European Hematology Association (EHA) Congress taking place June 12-15 in Milan.AI SummaryAdaptive Biotechnologies announced that its next-generation sequencing-based clonoSEQ® test for measuring residual disease (MRD) will be highlighted in 30 presentations at major scientific meetings. Of these, 14 are scheduled as oral presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, running from May 30 to June 3, and at the European Hematology Association (EHA) Congress in Milan, held from June 12 to 15. The presentations will share new data supporting clonoSEQ's clinical value in managing blood cancers, particularly in multiple myeloma and chronic lymphocytic leukemia. This news underscores the test's growing role in guiding treatment decisions and aiding drug development. By demonstrating its capability to track MRD with precision, clonoSEQ is proving to be a critical tool in advancing precision oncology and improving patient care in lymphoid cancers.Read AnnouncementNew Data - December 7,2024New Data Drug: clonoSEQAnnounced Date: December 7, 2024Indication: Treatments for patients with lymphoid malignancies.AnnouncementAdaptive Biotechnologies announced new data demonstrating the impact of measurable residual disease (MRD) assessment using Adaptive's next-generation sequencing-based clonoSEQ® test in blood cancer clinical care and drug development.AI SummaryAdaptive Biotechnologies recently shared new data on its clonoSEQ® test, a next-generation sequencing diagnostic that measures minimal residual disease (MRD) in blood cancers. The results demonstrate how clonoSEQ can help tailor treatment decisions during patient care and drug development. For example, in mantle cell lymphoma, the test showed that patients in complete remission with undetectable MRD may not benefit from additional intensive treatments like autologous hematopoietic cell transplantation. Other studies presented indicate that achieving a deep molecular remission—MRD levels below 10⁻⁶—correlates with improved outcomes in several blood cancers, such as chronic lymphocytic leukemia, multiple myeloma, and acute lymphoblastic leukemia. This breakthrough research highlights clonoSEQ’s potential to guide physicians in selecting more personalized therapies, minimizing unnecessary treatments, and ultimately improving long-term results for patients with various blood cancers.Read AnnouncementProvided Update - December 3,2024Provided Update Drug: clonoSEQAnnounced Date: December 3, 2024Indication: Treatments for patients with lymphoid malignancies.AnnouncementAdaptive Biotechnologies , announced that its next-generation sequencing (NGS)-based clonoSEQ® test for measurable residual disease (MRD) assessment will be included in more than 65 abstracts across eight different types of blood cancer at the 66th Annual Meeting of the American Society of Hematology (ASH) taking place December 7-10, 2024, in San Diego.AI SummaryAdaptive Biotechnologies announced that its next-generation sequencing-based clonoSEQ® test for measurable residual disease (MRD) assessment will be featured in over 65 abstracts at the 66th Annual American Society of Hematology (ASH) Meeting in San Diego from December 7-10, 2024. This record-breaking number of presentations spans eight different types of blood cancer and includes a plenary session, a late-breaking abstract, and 25 other oral presentations. The clonoSEQ test is widely recognized for its high sensitivity in detecting MRD and plays a key role in both clinical trials and real-world practice. It is used as a primary endpoint in pivotal studies and helps guide treatment decisions, monitor disease progression, and assess patient responses across various blood cancers, thereby advancing precision medicine in hematology.Read AnnouncementProvided Update - May 31,2024Provided Update Drug: clonoSEQAnnounced Date: May 31, 2024Indication: Treatments for patients with lymphoid malignancies.AnnouncementAdaptive Biotechnologies announced that its next-generation sequencing (NGS)-based clonoSEQ® test for measurable residual disease (MRD) assessment will be included in several oral and poster presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31-June 4 in Chicago and at the European Hematology Association (EHA) Hybrid Congress taking place June 13-16 in Madrid and virtually.AI SummaryAdaptive Biotechnologies announced that its next‐generation sequencing (NGS) based clonoSEQ® test for measurable residual disease (MRD) assessment will be featured in multiple oral and poster presentations at two major hematology and oncology meetings. The presentations will take place at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from May 31 to June 4 and at the European Hematology Association (EHA) Hybrid Congress in Madrid and virtually from June 13 to 16. The clonoSEQ test, known as the gold standard for MRD measurements, helps clinicians monitor blood cancer patients by predicting outcomes, identifying early relapse, and providing guidance for tailored treatment decisions. The inclusion of clonoSEQ data at these conferences reflects its growing role in both clinical practice and drug development, emphasizing its sensitivity and reliability in managing complex blood cancer therapies.Read Announcement Adaptive Biotechnologies FDA Events - Frequently Asked Questions Has Adaptive Biotechnologies received FDA approval? As of now, Adaptive Biotechnologies (ADPT) has not received any FDA approvals for its therapy in the last two years. What drugs has Adaptive Biotechnologies submitted to the FDA? In the past two years, Adaptive Biotechnologies (ADPT) has reported FDA regulatory activity for clonoSEQ. What is the most recent FDA event for Adaptive Biotechnologies? The most recent FDA-related event for Adaptive Biotechnologies occurred on December 6, 2025, involving clonoSEQ. The update was categorized as "Provided Update," with the company reporting: "Adaptive Biotechnologies announced growing interventional use of its clonoSEQ® test among the 90 abstracts featuring clonoSEQ data at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place Dec. 6–9, 2025, in Orlando." What conditions do Adaptive Biotechnologies' current drugs treat? Currently, Adaptive Biotechnologies has one therapy (clonoSEQ) targeting the following condition: Treatments for patients with lymphoid 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 AC Immune FDA EventsAgios Pharmaceuticals FDA EventsAssembly Biosciences FDA EventsBriacell Therap FDA EventsBioLineRx FDA EventsFibroBiologics FDA EventsGilead Sciences FDA EventsOncolytics Biotech FDA EventsRegeneron Pharmaceuticals FDA EventsAbbVie FDA EventsMerck & Co., Inc. FDA EventsAgenus FDA EventsAdagio Medical FDA EventsAktis Oncology FDA EventsAkari 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 Nuvalent FDA Events Vaxcyte FDA Events Qiagen FDA Events Kymera Therapeutics FDA Events Protagonist Therapeutics FDA Events Mirum Pharmaceuticals FDA Events Rhythm Pharmaceuticals FDA Events Lantheus FDA Events TG Therapeutics FDA Events PTC Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:ADPT last updated on 12/8/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersSpaceX eyes a 1.75 trillion valuation - here's what to knowElon Musk's team has quietly filed confidential paperwork with the SEC for what Bloomberg estimates could be a...Brownstone Research | Sponsored$30 stock to buy before Starlink goes public (WATCH NOW!)In the next 3 minutes… James Altucher – legendary investor and venture capitalist… And someone who’s kno...Paradigm Press | SponsoredYour book attachedBill Poulos is giving away his 'Safe Trade Options Formula' book for free - but only for a limited time throug...Profits Run | SponsoredMy feud with Zohran MamdaniEmmy-winning analyst releases his next big story Whitney Tilson shocked the nation on 60 Minutes when he ac...Stansberry Research | SponsoredSpaceX IPO hides a much bigger storyThe SpaceX IPO could be the biggest in history at $1.75 trillion - but the real story isn't the IPO itself. ...Weiss Ratings | SponsoredSpaceX will mint billionaires. You won't be one of them.By the time a company goes public, 95% of profits have already been made. Insiders bought SpaceX at $20 billio...Behind the Markets | SponsoredSatellite Images Spot Potential $10 Trillion Discovery'Dark Energy': Elon Musk's Next Potential $10 Trillion Move A highly secure site in West Texas now houses a...Altimetry | SponsoredSpaceX just filed. The clock is ticking.Reuters reports Elon Musk filed secretly. Barron's says it's being finalized behind closed doors. CNBC just re...The Oxford Club | 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 Adaptive Biotechnologies Corporation Please log in to your account or sign up in order to add this asset to your watchlist. Share Adaptive Biotechnologies 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.
Provided Update - December 6,2025Provided Update Drug: clonoSEQAnnounced Date: December 6, 2025Indication: Treatments for patients with lymphoid malignancies.AnnouncementAdaptive Biotechnologies announced growing interventional use of its clonoSEQ® test among the 90 abstracts featuring clonoSEQ data at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place Dec. 6–9, 2025, in Orlando.AI SummaryAdaptive Biotechnologies reported growing interventional use of its clonoSEQ test at the 67th ASH Annual Meeting, where 90 abstracts featured clonoSEQ data. Notably, 17 of those abstracts show how next-generation sequencing (NGS) measurable residual disease (MRD) results are directly guiding clinical actions to improve blood cancer care. Key examples include the phase II EndRAD study, which used NGS MRD to select non–total body irradiation (non‑TBI) transplant conditioning for children and young adults with B‑ALL. Among 51 NGS MRD‑negative patients who received non‑TBI regimens, event‑free and overall survival were excellent and comparable to a TBI cohort, suggesting radiation‑sparing options may be feasible for MRD‑negative patients. Across diseases, investigators presented MRD‑guided strategies in multiple myeloma (32 abstracts), non‑Hodgkin lymphoma (15), chronic lymphocytic leukemia (7) and acute lymphoblastic leukemia (30). Adaptive says the volume and variety of ASH data underscore clonoSEQ’s growing role in tailoring treatment intensity, duration and surveillance decisions using MRD results.Read Announcement
Provided Update - July 1,2025Provided Update Drug: clonoSEQAnnounced Date: July 1, 2025Indication: Treatments for patients with lymphoid malignancies.AnnouncementAdaptive Biotechnologies announced the integration of Adaptive's clonoSEQ® test for measurable residual disease (MRD) assessment in lymphoid malignancies into OncoEMR®, Flatiron's cloud-based Electronic Medical Record (EMR) platform.AI SummaryAdaptive Biotechnologies has announced that its FDA-cleared clonoSEQ® test for measurable residual disease (MRD) in lymphoid malignancies is now integrated into OncoEMR®, Flatiron Health’s cloud-based electronic medical record platform. This integration allows clinicians at over 1,000 community-based cancer care locations to order and review MRD testing results directly within the platform, simplifying workflows and providing faster access to critical patient data. The streamlined access to MRD data helps healthcare providers make informed, personalized treatment decisions for blood cancer patients. By incorporating the clonoSEQ® test into OncoEMR®, the collaboration aims to enhance patient care by delivering real-time insights into disease status, making it easier for clinicians in community oncology settings to monitor treatment progress and potentially detect relapses earlier.Read Announcement
Presentation - May 30,2025Presentation Drug: clonoSEQAnnounced Date: May 30, 2025Indication: Treatments for patients with lymphoid malignancies.AnnouncementAdaptive Biotechnologies announced that its next-generation sequencing (NGS)-based clonoSEQ® test for measurable residual disease (MRD) assessment will be included in 30 presentations, including a total of 14 oral presentations, across the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30-June 3 in Chicago and the European Hematology Association (EHA) Congress taking place June 12-15 in Milan.AI SummaryAdaptive Biotechnologies announced that its next-generation sequencing-based clonoSEQ® test for measuring residual disease (MRD) will be highlighted in 30 presentations at major scientific meetings. Of these, 14 are scheduled as oral presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, running from May 30 to June 3, and at the European Hematology Association (EHA) Congress in Milan, held from June 12 to 15. The presentations will share new data supporting clonoSEQ's clinical value in managing blood cancers, particularly in multiple myeloma and chronic lymphocytic leukemia. This news underscores the test's growing role in guiding treatment decisions and aiding drug development. By demonstrating its capability to track MRD with precision, clonoSEQ is proving to be a critical tool in advancing precision oncology and improving patient care in lymphoid cancers.Read Announcement
New Data - December 7,2024New Data Drug: clonoSEQAnnounced Date: December 7, 2024Indication: Treatments for patients with lymphoid malignancies.AnnouncementAdaptive Biotechnologies announced new data demonstrating the impact of measurable residual disease (MRD) assessment using Adaptive's next-generation sequencing-based clonoSEQ® test in blood cancer clinical care and drug development.AI SummaryAdaptive Biotechnologies recently shared new data on its clonoSEQ® test, a next-generation sequencing diagnostic that measures minimal residual disease (MRD) in blood cancers. The results demonstrate how clonoSEQ can help tailor treatment decisions during patient care and drug development. For example, in mantle cell lymphoma, the test showed that patients in complete remission with undetectable MRD may not benefit from additional intensive treatments like autologous hematopoietic cell transplantation. Other studies presented indicate that achieving a deep molecular remission—MRD levels below 10⁻⁶—correlates with improved outcomes in several blood cancers, such as chronic lymphocytic leukemia, multiple myeloma, and acute lymphoblastic leukemia. This breakthrough research highlights clonoSEQ’s potential to guide physicians in selecting more personalized therapies, minimizing unnecessary treatments, and ultimately improving long-term results for patients with various blood cancers.Read Announcement
Provided Update - December 3,2024Provided Update Drug: clonoSEQAnnounced Date: December 3, 2024Indication: Treatments for patients with lymphoid malignancies.AnnouncementAdaptive Biotechnologies , announced that its next-generation sequencing (NGS)-based clonoSEQ® test for measurable residual disease (MRD) assessment will be included in more than 65 abstracts across eight different types of blood cancer at the 66th Annual Meeting of the American Society of Hematology (ASH) taking place December 7-10, 2024, in San Diego.AI SummaryAdaptive Biotechnologies announced that its next-generation sequencing-based clonoSEQ® test for measurable residual disease (MRD) assessment will be featured in over 65 abstracts at the 66th Annual American Society of Hematology (ASH) Meeting in San Diego from December 7-10, 2024. This record-breaking number of presentations spans eight different types of blood cancer and includes a plenary session, a late-breaking abstract, and 25 other oral presentations. The clonoSEQ test is widely recognized for its high sensitivity in detecting MRD and plays a key role in both clinical trials and real-world practice. It is used as a primary endpoint in pivotal studies and helps guide treatment decisions, monitor disease progression, and assess patient responses across various blood cancers, thereby advancing precision medicine in hematology.Read Announcement
Provided Update - May 31,2024Provided Update Drug: clonoSEQAnnounced Date: May 31, 2024Indication: Treatments for patients with lymphoid malignancies.AnnouncementAdaptive Biotechnologies announced that its next-generation sequencing (NGS)-based clonoSEQ® test for measurable residual disease (MRD) assessment will be included in several oral and poster presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31-June 4 in Chicago and at the European Hematology Association (EHA) Hybrid Congress taking place June 13-16 in Madrid and virtually.AI SummaryAdaptive Biotechnologies announced that its next‐generation sequencing (NGS) based clonoSEQ® test for measurable residual disease (MRD) assessment will be featured in multiple oral and poster presentations at two major hematology and oncology meetings. The presentations will take place at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from May 31 to June 4 and at the European Hematology Association (EHA) Hybrid Congress in Madrid and virtually from June 13 to 16. The clonoSEQ test, known as the gold standard for MRD measurements, helps clinicians monitor blood cancer patients by predicting outcomes, identifying early relapse, and providing guidance for tailored treatment decisions. The inclusion of clonoSEQ data at these conferences reflects its growing role in both clinical practice and drug development, emphasizing its sensitivity and reliability in managing complex blood cancer therapies.Read Announcement
