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Cytokinetics Inc (NASDAQ: CYTK) is a biopharmaceutical leader pioneering muscle-targeted therapies for cardiovascular and neuromuscular diseases. This dedicated news hub provides investors and researchers with timely updates on the company's clinical developments, regulatory milestones, and strategic initiatives.
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Bookmark this page for streamlined monitoring of Cytokinetics' innovations in cardiac muscle activators and neuromuscular treatments. Regular updates provide essential insights into the company's progress addressing conditions like heart failure and ALS through novel therapeutic approaches.
Cytokinetics (NASDAQ: CYTK) announced FDA approval of MYQORZO™ (aficamten) tablets (5 mg, 10 mg, 15 mg, 20 mg) for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.
The approval is based on SEQUOIA-HCM and includes a Boxed WARNING for risk of heart failure due to reduced LVEF, a REMS requirement, and echocardiogram monitoring recommendations. MYQORZO is expected to be available in the U.S. in the second half of January 2026. The company will host an investor call on Dec 19, 2025 at 4:30 PM ET.
Cytokinetics (NASDAQ: CYTK) announced NMPA approval of MYQORZO (aficamten) in China for adults with NYHA class II-III obstructive hypertrophic cardiomyopathy to improve exercise capacity and symptoms.
The approval triggers a $7.5 million milestone payment from Sanofi and leaves Cytokinetics eligible for up to $142.5 million additional development/commercial milestones plus royalties in the low-to-high teens on Greater China net sales. MYQORZO is currently approved only in China.
Regulatory progress noted: a U.S. NDA is under FDA review with a PDUFA date of December 26, 2025, and the EMA CHMP adopted a positive opinion on December 12, 2025, with a European Commission decision expected in Q1 2026.
Cytokinetics (Nasdaq: CYTK) announced inducement equity awards made on December 15, 2025 to 10 employees who began work in November–December 2025. The company granted 21,399 stock options and 14,422 restricted stock units (RSUs) to be settled in common stock.
The RSUs vest over 3 years (40%/40%/20% annual schedule). Options vest over 4 years (25% at one year, then monthly over 36 months), have a $62.16 exercise price (closing price on Dec 15, 2025) and a 10-year term. Awards follow Nasdaq Listing Rule 5635(c)(4).
Cytokinetics (Nasdaq: CYTK) announced a positive CHMP opinion recommending EU marketing authorization for MYQORZO (aficamten) to treat symptomatic (NYHA II-III) obstructive hypertrophic cardiomyopathy in adults.
A final European Commission decision is expected in Q1 2026. The CHMP opinion cites clinical evidence from the SEQUOIA-HCM trial. Aficamten is also under review by the FDA with a PDUFA date of Dec 26, 2025 and under Priority Review by China’s NMPA CDE.
Cytokinetics (Nasdaq: CYTK) announced inducement equity awards dated November 15, 2025 for new hires. The company granted options to purchase 87,297 RSUs (settled in shares) to Jeffrey Hessekiel, who began employment November 14, 2025, and granted options for an aggregate of 13,175 shares plus 8,881 RSUs to three additional employees who started in October–November 2025.
RSUs vest over 3 years (40%/40%/20%). Stock options have an exercise price of $66.44 (closing price on November 14, 2025), vest over 4 years with a one-year 1/4 cliff and monthly vesting thereafter, and a 10-year term. Awards were made under the 2004 Equity Incentive Plan in accordance with Nasdaq Rule 5635(c)(4).
Cytokinetics (Nasdaq: CYTK) announced on November 17, 2025 its support for a three-year American Heart Association initiative to improve diagnosis, access, and treatment for people living with hypertrophic cardiomyopathy (HCM).
The company said it will back efforts to expand participation in a national HCM Registry powered by Get With The Guidelines®, broaden certification for referring centers, introduce patient support services at key HCM centers, and pilot the Association’s HCM detection algorithm to reduce underdiagnosis.
The initiative targets systemic barriers to more consistent, equitable care for the estimated one in 500 U.S. people living with HCM.
Cytokinetics (Nasdaq: CYTK) announced additional MAPLE-HCM data presented Nov 10, 2025 showing aficamten was superior to metoprolol on multiple clinical measures after 24 weeks.
Key findings: a pre-specified responder analysis found 78% of aficamten patients had a positive/complete response vs 3% with metoprolol (p<0.001). Patient-reported outcomes improved more with aficamten (KCCQ-OSS 16.6 vs 8.9; between-group difference = 7.8 points, p=0.001). NT-proBNP fell 73% on aficamten vs rose 42% on metoprolol (treatment effect -81%, p<0.001); hs-cTnI fell 43% vs 17% (treatment effect -28%, p=0.001).
Overall AE rates were similar (73.9% aficamten vs 75.9% metoprolol); hypertension was more frequent with aficamten (10.2% vs 2.3%) and dizziness more frequent with metoprolol (17.2% vs 5.7%).
Cytokinetics (NASDAQ: CYTK) reported Q3 2025 results and a business update ahead of a PDUFA action date of December 26, 2025 for aficamten for obstructive HCM. The company reported approximately $1.25 billion in cash, cash equivalents and investments as of September 30, 2025, and completed a $750.0 million convertible notes offering in September 2025.
Clinical highlights include MAPLE-HCM superiority on pVO2 (+2.3 mL/kg/min, p<0.001) versus metoprolol and ongoing global regulatory reviews with an EMA decision possible in 1H 2026. Financials: Q3 revenue $1.9M, R&D expense $99.2M, G&A expense $69.5M, and net loss $306.2M (includes $121.2M debt conversion expense). 2025 GAAP operating expense guidance updated to $680M–$700M.
Cytokinetics (Nasdaq: CYTK) said members of its management team will participate in two investor conferences in November 2025: a Stifel 2025 Healthcare Conference fireside chat on Tuesday, November 11, 2025 at 11:20 AM ET in New York, and a Jefferies Global Healthcare Conference fireside chat on Monday, November 17, 2025 at 2:30 PM GMT in London.
Interested parties can access live webcasts via the Investors & Media section of the Cytokinetics website. Webcast replays will be archived on the site for 90 days after each event.
Cytokinetics (Nasdaq: CYTK) announced multiple presentations at the Hypertrophic Cardiomyopathy Medical Society Scientific Sessions on November 7, 2025 and the American Heart Association Scientific Sessions November 7–10, 2025 in New Orleans.
Highlights include three Late Breaking Science presentations and multiple oral, poster and moderated poster sessions covering MAPLE-HCM (aficamten vs metoprolol), FOREST-HCM, SEQUOIA-HCM and other HCM and heart-failure trial insights.
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