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Cytokinetics Discusses Aficamten with FDA in Late Cycle Meeting

Story Highlights
  • Cytokinetics discussed aficamten’s REMS with the FDA, anticipating approval by December 2025.
  • The company plans to draw $100 million from Royalty Pharma by October 1, 2025.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Cytokinetics Discusses Aficamten with FDA in Late Cycle Meeting

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Cytokinetics ( (CYTK) ) has shared an update.

On September 15, 2025, Cytokinetics participated in a Late Cycle Meeting with the FDA regarding its New Drug Application for aficamten, aimed at treating obstructive hypertrophic cardiomyopathy. The company discussed its Risk Evaluation and Mitigation Strategies (REMS) and anticipates a differentiated label for aficamten, pending FDA approval by December 26, 2025. Additionally, Cytokinetics responded to the European Medicines Agency’s questions about aficamten’s potential EU approval. The company plans to draw $100 million from a loan agreement with Royalty Pharma by October 1, 2025, to support its development efforts.

The most recent analyst rating on (CYTK) stock is a Buy with a $82.00 price target. To see the full list of analyst forecasts on Cytokinetics stock, see the CYTK Stock Forecast page.

Spark’s Take on CYTK Stock

According to Spark, TipRanks’ AI Analyst, CYTK is a Neutral.

Cytokinetics’ overall stock score is primarily impacted by its financial instability and ongoing losses, which are significant risks. However, strong technical indicators and positive corporate events provide some optimism. The company’s future prospects hinge on successful regulatory approvals and commercialization of aficamten.

To see Spark’s full report on CYTK stock, click here.

More about Cytokinetics

Cytokinetics, Incorporated operates in the biopharmaceutical industry, focusing on the development of muscle biology-driven treatments. The company primarily develops therapies for debilitating diseases such as heart failure and amyotrophic lateral sclerosis (ALS), with a market focus on innovative drug solutions.

Average Trading Volume: 1,851,699

Technical Sentiment Signal: Buy

Current Market Cap: $5.92B

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

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