1. Cytokinetics' MYQORZO approved in China for obstructive HCM treatment. 2. Sanofi triggers $7.5 million milestone payment to Cytokinetics. 3. Cytokinetics stands to earn up to $142.5 million in future payments. 4. FDA reviewing aficamten with PDUFA date set for December 26, 2025. 5. CHMP recommended aficamten for EU approval, decision expected Q1 2026.
FAQ
Why Bullish?
The approval of MYQORZO represents increased revenue potential, enhancing investor confidence and stock price.
How important is it?
Milestone payments and approvals directly affect financial outlook and investor sentiment for CYTK.
Why Long Term?
Successful commercialization in China and upcoming FDA decision could boost long-term profitability.
Cytokinetics Receives NMPA Approval for MYQORZO® in China
SOUTH SAN FRANCISCO, Calif., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) has announced that its drug MYQORZO® (aficamten) has been approved by the China National Medical Products Administration (NMPA) for the treatment of adults suffering from New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM). This significant approval is aimed at improving exercise capacity and alleviating symptoms in affected patients.
Financial Implications of NMPA Approval
The approval of MYQORZO in China has triggered a milestone payment of $7.5 million from Sanofi to Cytokinetics, which holds exclusive licensing terms in Greater China. Additionally, Cytokinetics remains eligible to receive up to $142.5 million in further development and commercial milestone payments from Sanofi, along with royalties ranging from low to high teens on future sales of MYQORZO in the region.
Current Status of MYQORZO (Aficamten)
While MYQORZO is now approved in China, the drug is currently under regulatory review in the United States, with a New Drug Application (NDA) pending at the FDA. The PDUFA target action date is set for December 26, 2025. In Europe, the Committee for Medicinal Products for Human Use (CHMP) of the EMA has positively recommended marketing authorization, with a final decision expected from the European Commission in the first quarter of 2026.
Overview of MYQORZO® (Aficamten)
MYQORZO (aficamten) is a selective cardiac myosin inhibitor designed to mitigate the hypercontractility associated with hypertrophic cardiomyopathy (HCM). Preclinical studies have demonstrated that MYQORZO effectively decreases myocardial contractility by binding to cardiac myosin and preventing it from entering a force-producing state. The drug exhibited positive results in the pivotal Phase 3 SEQUOIA-HCM trial aimed at symptomatic obstructive HCM.
Understanding Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy is a condition characterized by the abnormal thickening of the heart muscle, which can lead to reduced exercise capacity and severe symptoms such as chest pain and shortness of breath. Approximately 280,000 patients are diagnosed with HCM in the U.S., and estimates suggest that another 400,000 to 800,000 remain undiagnosed. With two-thirds of patients having obstructive HCM, the condition puts individuals at increased risk for serious cardiovascular events.
Cytokinetics: A Leader in Cardiovascular Drug Development
Cytokinetics has over 25 years of pioneering research in muscle biology and is committed to developing innovative medicines for cardiac muscle dysfunction. The company’s flagship product, MYQORZO (aficamten), has marked a significant milestone with its approval in China. With ongoing regulatory reviews in both the U.S. and Europe, Cytokinetics aims to broaden the impact of its treatments for HCM globally.
The Collaboration with Sanofi
In 2024, Sanofi acquired exclusive rights to further develop and commercialize MYQORZO (aficamten) from Corxel Pharmaceuticals for both obstructive and non-obstructive HCM in Greater China. This partnership underscores the strategic importance of collaboration in advancing treatment options for HCM patients.
Forward-Looking Statements
This announcement includes forward-looking statements regarding Cytokinetics' expectations for future developments, including potential approval and commercialization timelines for aficamten. These forward-looking statements involve risks and uncertainties, and actual results may differ significantly from current expectations.