FDA Pushes Cytokinetics' Key HCM Drug Review to December

Cytokinetics (NASDAQ: CYTK) reported Q1 2025 financial results and business updates. Key highlights include: FDA extended the PDUFA date for aficamten in obstructive HCM to December 26, 2025, following a REMS submission. The company maintains $1.1 billion in cash as of March 31, 2025. Financial results show Q1 2025 net loss of $161.4 million ($1.36 per share) compared to $135.6 million in Q1 2024. Revenue was $1.6 million, up from $0.8 million year-over-year. R&D expenses increased to $99.8 million from $81.6 million, while G&A expenses rose to $57.4 million from $45.5 million. The company completed enrollment in ACACIA-HCM trial ahead of schedule and expects topline results from MAPLE-HCM in May 2025. Cytokinetics maintains its 2025 guidance with GAAP operating expenses projected between $670-710 million.

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