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Investing.com -- Shares of Cytokinetics (NASDAQ:CYTK) tumbled 10% after the company disclosed that the U.S. Food and Drug Administration (FDA) requires additional time to review a safety plan for its experimental heart drug, aficamten. The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date to December 26, 2025, to fully assess the company’s proposed Risk Evaluation and Mitigation Strategy (REMS).
The FDA’s request for a REMS, considered a Major Amendment to the New Drug Application (NDA), follows Cytokinetics’ initial submission of the NDA without an accompanying REMS. The FDA had previously accepted the NDA for filing. The submission of the REMS has resulted in a standard three-month extension to the original PDUFA action date. Notably, the FDA has not requested additional clinical data or studies from Cytokinetics.
Despite the delay, JMP analyst Jason Butler maintained a Market Outperform rating and a $78.00 price target on Cytokinetics. Butler expressed continued confidence in aficamten’s potential as best-in-indication for obstructive hypertrophic cardiomyopathy (oHCM), viewing the extension as a non-concerning event and anticipating a differentiated label and REMS program for aficamten compared to competitors.
Other analysts have also weighed in, with Leerink Partners Research’s Roanna Ruiz acknowledging the delay as a potential disappointment for investors but remaining optimistic about the stock. Mizuho (NYSE:MFG) Securities’ Salim Syed does not see the extension as a negative indicator for the drug’s approval, though he notes short-term uncertainty for investors. Raymond (NSE:RYMD) James’ Sean McCutcheon cited unclear reasons for the FDA’s need for more time, while Citi’s David Lebowitz suggested the delay might be related to recent FDA downsizing. Stifel’s James Condulis considered the share price drop a potential buying opportunity, despite investor frustration.
The market’s reaction to the delay reflects investor uncertainty as the company navigates the regulatory process. Cytokinetics’ focus remains on demonstrating the safety and efficacy of aficamten to satisfy FDA requirements and ultimately bring the drug to patients with oHCM.