Thanks to a trial design that, according to Evercore ISI analyst Cory Kasimov, “played out exactly as drawn up,” Cytokinetics Inc. hit both of the phase III co-primary endpoints with aficamten in symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).
The U.S. FDA approved 27 drugs in December, the highest month of 2025. This compares to 18 approvals in November and brings the full year total to 226. This places 2025 just below the 228 approvals recorded in 2024 but well above approval numbers seen in most prior years of the past decade.
For years, the J.P. Morgan Healthcare Conference (JPM) kicked off with splashy headlines of major M&A activity among biopharma companies, but in 2026, the hype outweighed reality and in the end, no major merger announcements were made during the conference for companies developing therapeutics.
Cytokinetics Inc. scored U.S. FDA marketing clearance Dec. 19 for Myqorzo (aficamten) 5-mg, 10-mg, 15-mg, and 20-mg tablets to improve functional capacity and symptoms in adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Shares of the South San Francisco-based firm rose 4.6%, or $2.88, on Dec. 22 to close at $65.60.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) is joining the U.S. FDA and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) in approving Anktiva (nogapendekin alfa inbakicept-pmin) in patients with non-muscle invasive bladder cancer (NMIBC) who have not responded to immune stimulation treatment with Bacillus Calmette-Guérin (BCG) vaccine and would otherwise require surgical removal of the bladder.
Word Sept. 4 from Agios Pharmaceuticals Inc. that the U.S. FDA extended the PDUFA date for the sNDA related to Pyrukynd (mitapivat), after the Cambridge, Mass.-based firm submitted a proposed risk evaluation and mitigation strategy (REMS), drew Wall Street’s attention to the regulatory approach.
Braveheart Bio Inc. is paying $65 million up front to license Jiangsu Hengrui Pharmaceuticals Co. Ltd.’s oral hypertrophic cardiomyopathy drug candidate called HRS-1893.
Braveheart Bio Inc. is paying $65 million up front to license Jiangsu Hengrui Pharmaceuticals Co. Ltd.’s oral hypertrophic cardiomyopathy drug candidate called HRS-1893.
Cytokinetics Inc. has disclosed fast type myosin-binding protein C (MYBPC2) inhibitors reported to be useful for the treatment of neuromuscular disorders.
Wall Street immediately set to weighing the long-term import of Cytokinetics Inc.’s regulatory delay with aficamten, but the short-term impact was evident, as shares (NASDAQ:CYTK) dipped to close May 2 at $37.35, a loss of $5.57 or 13%.
