Core Insights - The FDA has extended the PDUFA date for aficamten in obstructive HCM to December 26, 2025, allowing more time for the review of a REMS submission [3][2] - Cytokinetics is advancing its specialty cardiology pipeline and expects topline results from MAPLE-HCM in May 2025 and from ACACIA-HCM in the first half of 2026 [2][3] Financial Overview - As of March 31, 2025, the company reported approximately $1.1 billion in cash, cash equivalents, and investments, a decrease from $1.2 billion at the end of 2024 [9] - Total revenues for Q1 2025 were $1.6 million, up from $0.8 million in Q1 2024 [10] - R&D expenses for Q1 2025 were $99.8 million, compared to $81.6 million in Q1 2024, primarily due to advancing clinical trials [11] - G&A expenses for Q1 2025 were $57.4 million, an increase from $45.5 million in Q1 2024, attributed to investments in commercial readiness [12] - The net loss for Q1 2025 was $161.4 million, or $(1.36) per share, compared to a net loss of $135.6 million, or $(1.33) per share, in Q1 2024 [13] Clinical Development Updates - Enrollment in ACACIA-HCM has been completed, with over 500 patients enrolled, and topline results are expected in 1H 2026 [3][5] - The primary endpoint for ACACIA-HCM has been updated to include both KCCQ Clinical Summary Score and peak VO2 change [5] - Ongoing clinical trials include COMET-HF for omecamtiv mecarbil and AMBER-HFpEF for CK-586, with expected completion of enrollment in 2026 [4] Corporate Activities - The company is enhancing its commercial readiness for aficamten, including recruiting sales force and establishing distribution partnerships [5] - Cytokinetics has launched EARTH-HCM, an online public health education tool, and awarded grants to patient advocacy organizations [15] - The company maintains its full-year 2025 financial guidance, projecting GAAP operating expenses between $670 million and $710 million [16][17]