LianBio (LIAN) FDA Approvals $0.11 +0.00 (+0.09%) As of 05/22/2026 Add Compare Share Share FDA Events Stock AnalysisChartCompetitorsFDA EventsSEC FilingsTrendsBuy This Stock LianBio's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by LianBio (LIAN). Over the past two years, LianBio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CAMZYOS®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. CAMZYOS® (mavacamten) FDA Regulatory Timeline and Events CAMZYOS® (mavacamten) is a drug developed by LianBio for the following indication: For the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy. 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. Presentation - August 25,2025Presentation Drug: CAMZYOS® (mavacamten)Announced Date: August 25, 2025Indication: For the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy Other Companies Involved: NYSE:BMY AnnouncementBristol Myers Squibb announced the presentation of new clinical and real-world data from its cardiovascular portfolio at the European Society of Cardiology(ESC) Congress, taking place August 29 – September 1, 2025, in Madrid, Spain.AI SummaryBristol Myers Squibb announced that it will present new clinical and real-world data from its cardiovascular portfolio at the European Society of Cardiology (ESC) Congress, taking place August 29 – September 1, 2025, in Madrid. The company will share results from the global COLLIGO-HCM observational study, which tracks real-world outcomes of Camzyos (mavacamten) in patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) across five countries. Another highlight is a pooled monotherapy analysis of four Phase 3 trials, demonstrating the efficacy and safety of Camzyos alone in treating oHCM. These presentations build on long-term extension and real-world effectiveness data, showing symptom relief, improved exercise capacity and positive changes in heart structure. Additional oral sessions will feature results from the ODYSSEY-HCM Phase 3 trial in non-obstructive HCM and data on Eliquis (apixaban) through the BMS-Pfizer Alliance. Together, these findings reinforce Camzyos as the first and only approved cardiac myosin inhibitor for symptomatic oHCM, supporting its safety and benefits for diverse patient groups worldwide.Read AnnouncementResults - September 1,2024Results Drug: CAMZYOS® (mavacamten)Announced Date: September 1, 2024Indication: For the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy Other Companies Involved: NYSE:BMY AnnouncementBristol Myers Squibb announced new long-term follow-up results from the EXPLORER-LTE cohort of the MAVA-Long-Term Extension (LTE) study evaluating CAMZYOS® (mavacamten) in adult patients with New York Heart Association (NYHA) class II-III symptomatic obstructive hypertrophic cardiomyopathy (oHCM).AI SummaryBristol Myers Squibb announced new long-term follow-up results from the EXPLORER-LTE cohort of the MAVA-Long-Term Extension study, evaluating CAMZYOS® (mavacamten) in adults with NYHA class II-III symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The study data, collected over up to 3.5 years, showed that patients experienced consistent and sustained improvements in key echocardiographic measures. Specifically, there were notable reductions in resting and Valsalva left ventricular outflow tract gradients and in biomarkers such as NT-proBNP. These improvements also translated into better symptoms and functional capacity, with many patients reaching NYHA class I. Importantly, the safety profile of CAMZYOS remained stable with no new safety signals observed. The findings reinforce the established benefits of CAMZYOS, which is the first approved cardiac myosin inhibitor designed to target the source of symptomatic oHCM.Read AnnouncementData Presentation - August 26,2024Data Presentation Drug: CAMZYOS® (mavacamten)Announced Date: August 26, 2024Indication: For the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy Other Companies Involved: NYSE:BMY AnnouncementBristol Myers Squibb announced the presentation of research across its robust cardiovascular portfolio at the European Society of Cardiology(ESC) Congress, taking place August 30 – September 2, 2024, in London, England. Data to be presented at the meeting includes long-term extension data evaluating the efficacy and safety profile of CAMZYOS® (mavacamten) up to 180 weeks (3.5 years) for the treatment of New York Heart Association (NYHA) class II-III symptomatic obstructive hypertrophic cardiomyopathy (oHCM), as well as data on behalf of the BMS-Pfizer Alliance on ELIQUIS® (apixaban) and the BMS-Johnson & Johnson Collaboration on milvexian.AI SummaryBristol Myers Squibb will showcase its latest cardiovascular research at the European Society of Cardiology (ESC) Congress in London from August 30 to September 2, 2024. The company will present long-term extension data for CAMZYOS® (mavacamten) demonstrating its sustained safety and effectiveness for nearly 3.5 years (180 weeks) in patients with symptomatic obstructive hypertrophic cardiomyopathy (NYHA class II-III). Additionally, Bristol Myers Squibb will share data on behalf of the BMS-Pfizer Alliance regarding ELIQUIS® (apixaban) and results from its collaboration with Johnson & Johnson on milvexian. These presentations emphasize the company’s robust cardiovascular portfolio and its commitment to advancing therapies that address unmet medical needs in cardiovascular diseases.Read Announcement LianBio FDA Events - Frequently Asked Questions Has LianBio received FDA approval? As of now, LianBio (LIAN) has not received any FDA approvals for its therapy in the last two years. What drugs has LianBio submitted to the FDA? In the past two years, LianBio (LIAN) has reported FDA regulatory activity for CAMZYOS® (mavacamten). What is the most recent FDA event for LianBio? The most recent FDA-related event for LianBio occurred on August 25, 2025, involving CAMZYOS® (mavacamten). The update was categorized as "Presentation," with the company reporting: "Bristol Myers Squibb announced the presentation of new clinical and real-world data from its cardiovascular portfolio at the European Society of Cardiology(ESC) Congress, taking place August 29 – September 1, 2025, in Madrid, Spain." What conditions do LianBio's current drugs treat? Currently, LianBio has one therapy (CAMZYOS® (mavacamten)) targeting the following condition: For the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy. 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 PDS Biotechnology FDA Events Lixte Biotechnology FDA Events Cingulate FDA Events KALA BIO FDA Events Cassava Sciences FDA Events BeyondSpring FDA Events MiNK Therapeutics FDA Events Dogwood Therapeutics FDA Events Instil Bio FDA Events Kezar Life Sciences FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:LIAN last updated on 8/25/2025 by MarketBeat.com Staff. 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Presentation - August 25,2025Presentation Drug: CAMZYOS® (mavacamten)Announced Date: August 25, 2025Indication: For the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy Other Companies Involved: NYSE:BMY AnnouncementBristol Myers Squibb announced the presentation of new clinical and real-world data from its cardiovascular portfolio at the European Society of Cardiology(ESC) Congress, taking place August 29 – September 1, 2025, in Madrid, Spain.AI SummaryBristol Myers Squibb announced that it will present new clinical and real-world data from its cardiovascular portfolio at the European Society of Cardiology (ESC) Congress, taking place August 29 – September 1, 2025, in Madrid. The company will share results from the global COLLIGO-HCM observational study, which tracks real-world outcomes of Camzyos (mavacamten) in patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) across five countries. Another highlight is a pooled monotherapy analysis of four Phase 3 trials, demonstrating the efficacy and safety of Camzyos alone in treating oHCM. These presentations build on long-term extension and real-world effectiveness data, showing symptom relief, improved exercise capacity and positive changes in heart structure. Additional oral sessions will feature results from the ODYSSEY-HCM Phase 3 trial in non-obstructive HCM and data on Eliquis (apixaban) through the BMS-Pfizer Alliance. Together, these findings reinforce Camzyos as the first and only approved cardiac myosin inhibitor for symptomatic oHCM, supporting its safety and benefits for diverse patient groups worldwide.Read Announcement
Results - September 1,2024Results Drug: CAMZYOS® (mavacamten)Announced Date: September 1, 2024Indication: For the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy Other Companies Involved: NYSE:BMY AnnouncementBristol Myers Squibb announced new long-term follow-up results from the EXPLORER-LTE cohort of the MAVA-Long-Term Extension (LTE) study evaluating CAMZYOS® (mavacamten) in adult patients with New York Heart Association (NYHA) class II-III symptomatic obstructive hypertrophic cardiomyopathy (oHCM).AI SummaryBristol Myers Squibb announced new long-term follow-up results from the EXPLORER-LTE cohort of the MAVA-Long-Term Extension study, evaluating CAMZYOS® (mavacamten) in adults with NYHA class II-III symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The study data, collected over up to 3.5 years, showed that patients experienced consistent and sustained improvements in key echocardiographic measures. Specifically, there were notable reductions in resting and Valsalva left ventricular outflow tract gradients and in biomarkers such as NT-proBNP. These improvements also translated into better symptoms and functional capacity, with many patients reaching NYHA class I. Importantly, the safety profile of CAMZYOS remained stable with no new safety signals observed. The findings reinforce the established benefits of CAMZYOS, which is the first approved cardiac myosin inhibitor designed to target the source of symptomatic oHCM.Read Announcement
Data Presentation - August 26,2024Data Presentation Drug: CAMZYOS® (mavacamten)Announced Date: August 26, 2024Indication: For the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy Other Companies Involved: NYSE:BMY AnnouncementBristol Myers Squibb announced the presentation of research across its robust cardiovascular portfolio at the European Society of Cardiology(ESC) Congress, taking place August 30 – September 2, 2024, in London, England. Data to be presented at the meeting includes long-term extension data evaluating the efficacy and safety profile of CAMZYOS® (mavacamten) up to 180 weeks (3.5 years) for the treatment of New York Heart Association (NYHA) class II-III symptomatic obstructive hypertrophic cardiomyopathy (oHCM), as well as data on behalf of the BMS-Pfizer Alliance on ELIQUIS® (apixaban) and the BMS-Johnson & Johnson Collaboration on milvexian.AI SummaryBristol Myers Squibb will showcase its latest cardiovascular research at the European Society of Cardiology (ESC) Congress in London from August 30 to September 2, 2024. The company will present long-term extension data for CAMZYOS® (mavacamten) demonstrating its sustained safety and effectiveness for nearly 3.5 years (180 weeks) in patients with symptomatic obstructive hypertrophic cardiomyopathy (NYHA class II-III). Additionally, Bristol Myers Squibb will share data on behalf of the BMS-Pfizer Alliance regarding ELIQUIS® (apixaban) and results from its collaboration with Johnson & Johnson on milvexian. These presentations emphasize the company’s robust cardiovascular portfolio and its commitment to advancing therapies that address unmet medical needs in cardiovascular diseases.Read Announcement
