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Fri, May 30, 2025
11:18 PM
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Last Updated
28 days ago
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29 days ago
Updated 28 days ago
FDA Delays Aficamten Approval Review to December 26
FDA Delays Aficamten Approval Review to December 26

FDA Delays Aficamten Approval Review to December 26

News summary

The FDA has delayed its decision on Cytokinetics' heart drug aficamten for obstructive hypertrophic cardiomyopathy, extending the review period by three months to December 26 after requesting a Risk Evaluation and Mitigation Strategy (REMS) plan. Cytokinetics initially submitted its application without a REMS, but the FDA later determined the plan was necessary due to the drug’s characteristics. No additional clinical data or studies have been requested, and the delay is viewed as a standard procedural extension rather than a negative indicator for approval. The announcement triggered a double-digit drop in Cytokinetics’ share price, reflecting short-term investor uncertainty. However, most analysts remain optimistic about aficamten’s prospects and believe the extension does not diminish the drug's approval chances. The company and analysts anticipate a differentiated label and REMS for aficamten compared to existing treatments.

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Yahoo! Finance
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FDA Pushes Potential Approval For Cytokinetics' Experimental Heart Drug By Three Months
28 days ago
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Cytokinetics Shares Fall After FDA Extends Review of Heart Drug Aficamten
29 days ago
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Yahoo! Finance
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FDA Pushes Potential Approval For Cytokinetics' Experimental Heart Drug By Three Months
28 days ago
Read Full Article
alt
MarketWatch
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Center
Cytokinetics Shares Fall After FDA Extends Review of Heart Drug Aficamten
29 days ago
Read Full Article
Bias Distribution
50% Center
Information Sources
daae85f0-2883-42fc-b085-888140adf30d98605d3a-f647-49a6-87c7-2db995124a5a
Left 50%
Center 50%
Coverage Details
Total News Sources
2
Left
1
Center
1
Right
0
Unrated
0
Last Updated
28 days ago
Bias Distribution
50% Center
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23Serious

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Story Coverage
alt
Yahoo! Finance
Left
FDA Pushes Potential Approval For Cytokinetics' Experimental Heart Drug By Three Months
28 days ago
Read Full Article
alt
MarketWatch
$
Center
Cytokinetics Shares Fall After FDA Extends Review of Heart Drug Aficamten
29 days ago
Read Full Article
alt
Yahoo! Finance
Left
FDA Pushes Potential Approval For Cytokinetics' Experimental Heart Drug By Three Months
28 days ago
Read Full Article
alt
MarketWatch
$
Center
Cytokinetics Shares Fall After FDA Extends Review of Heart Drug Aficamten
29 days ago
Read Full Article
Ask VT AI
Bias Distribution
50% Center
Information Sources
daae85f0-2883-42fc-b085-888140adf30d98605d3a-f647-49a6-87c7-2db995124a5a
Left 50%
Center 50%

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