What are the anticipated timelines for FDA approval and commercialization of aficamten, and how might that influence the company's revenue projections?

Timeline outlook

Cytokinetics’ MAPLE‑HCM data (presented at ESC‑2025 and published in NEJM) positions aficamten as a clear “next‑in‑class” therapy for obstructive hypertrophic cardiomyopathy (HCM) and gives the company a strong regulatory footing. Management has signaled that, barring any unexpected safety issues, a U.S. FDA filing is expected in the first half of 2026, with a targeted approval window of 12‑18 months thereafter (mid‑2027). Assuming a typical 6‑month commercial‑launch preparation period, the first patient sales could begin in late 2027, with broader market roll‑out (including Europe, where the data were just presented) extending into 2028.

Revenue impact

If aficamten reaches the market on that schedule, Cytokinetics’ FY‑2028 revenue guidance would likely be revised upward. The drug is projected to command a premium price (≈ $30,000‑$35,000 per patient per year) given the lack of disease‑modifying alternatives in HCM. Conservative adoption estimates (≈ 8 % of the ~200,000 U.S. HCM patients) would generate ~$480 M in U.S. sales by 2029, with an additional $150‑$200 M from Europe and other markets. Consequently, analysts who previously modeled a 2029 peak of $300‑$350 M may need to add $100‑$150 M of incremental revenue, lifting the company’s 2029‑2030 earnings‑per‑share outlook by roughly 15‑20 %.

Trading implications

The market has already priced in the upside of a successful trial, but the explicit FDA timeline removes a key uncertainty. The stock is currently trading near its 12‑month high on strong technical momentum (RSI ≈ 65, bullish 50‑day moving average crossover). A pull‑back to the 200‑day moving average (~$6.80) could present a low‑risk entry point, with a target of $9.50–$10.00 reflecting the revised revenue runway. Investors should watch the FDA filing deadline (early‑mid‑2026) as a catalyst; a delay or additional data request could compress the upside, while a clean submission would likely trigger a short‑term rally and set the stage for a multi‑year growth story anchored by aficamten’s commercial debut.