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Cytokinetics Completes Midcycle Review with FDA for Aficamten

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Cytokinetics Completes Midcycle Review with FDA for Aficamten

Cytokinetics ( (CYTK) ) has shared an update.

Cytokinetics has completed its midcycle review with the FDA regarding its new drug application for aficamten, aimed at treating obstructive hypertrophic cardiomyopathy. The FDA has indicated that it does not plan to hold an advisory committee meeting for this application, and a Late Cycle meeting is expected in June 2025. The company anticipates a differentiated label and risk mitigation profile for aficamten if approved, although detailed updates on FDA communications will not be shared.

More about Cytokinetics

Cytokinetics, Incorporated operates in the biopharmaceutical industry, focusing on the development of muscle biology-driven treatments. The company is primarily involved in creating therapies for diseases affecting muscle function, with a market focus on conditions such as obstructive hypertrophic cardiomyopathy.

YTD Price Performance: -11.24%

Average Trading Volume: 1,504,084

Technical Sentiment Consensus Rating: Hold

Current Market Cap: $5.14B

See more data about CYTK stock on TipRanks’ Stock Analysis page.

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