FDA Events for LianBio (LIAN)
This 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.
- Drug:
- CAMZYOS® (mavacamten)
- Announced Date:
- September 1, 2024
- Indication:
- For the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy
Announcement
Bristol 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 Summary
Bristol 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- Drug:
- CAMZYOS® (mavacamten)
- Announced Date:
- August 26, 2024
- Indication:
- For the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy
Announcement
Bristol 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 Summary
Bristol 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
As of now, LianBio (LIAN) has not received any FDA approvals for its therapy in the last two years.
In the past two years, LianBio (LIAN) has reported FDA regulatory activity for CAMZYOS® (mavacamten).
The most recent FDA-related event for LianBio occurred on September 1, 2024, involving CAMZYOS® (mavacamten). The update was categorized as "Results," with the company reporting: "Bristol 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)."
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 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
This page (NASDAQ:LIAN) was last updated on 7/12/2025 by MarketBeat.com Staff
