BUZZ-Cytokinetics falls on standard review for heart disease drug

Reuters12-02

** Shares of Cytokinetics fall 2.3% to $50.67 premarket

** CYTK says U.S. Food and Drug Administration has accepted to review its marketing application for heart disease drug aficamten

** FDA has assigned an action date of Sept. 26, 2025 - CYTK

** At least two analysts said CYTK shares could be weak today due to the standard review period for aficamten vs investor expectations of a priority review that could have led to an earlier launch

** Company is seeking approval of the drug to treat obstructive hypertrophic cardiomyopathy, in which heart muscles become stiff and can cause cardiac arrest

** Truist analysts say that standard review gives CYTK opportunity to submit data for drug as a first-line treatment, which could help set it apart from rival drug, Bristol Myers'

Camzyos

** Piper Sandler says FDA acceptance boosts confidence in the success of the drug, and maintains strong conviction of a less strict label compared to Camzyos

** As of last close, CYTK was down ~48% YTD

(Reporting by Bhanvi Satija in Bengaluru)

((Bhanvi.Satija@thomsonreuters.com; Outside U.S. +91 9873062788;))

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap
Leave a comment