CYTK Stock

The PDUFA Target Action Date for Aficamten is scheduled for September 26, 2025. Preparations for its commercial launch are already in progress as they aim for the first possible approval.

Cytokinetics is developing aficamten, which could compete with Camzyos for treating hypertrophic cardiomyopathy (HCM). They have made important licensing agreements with Sanofi and Bayer to support resources and concentrate on selling in the US. Clinical trials are being conducted to explore more uses for aficamten, including its application as a first-line treatment and for children.

SOUTH SAN FRANCISCO, Calif., Dec. 23, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) has announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for aficamten, a new type of cardiac myosin inhibitor aimed at treating obstructive hypertrophic cardiomyopathy (HCM). The MAA will now undergo evaluation by the Committee for Medicinal Products for Human Use (CHMP).

Cytokinetics, a biotech company from California, ended the trading week on a high note, with its stock price increasing by almost 5% on Friday. This rise was driven by news of a new licensing agreement in an important international market. In comparison, the S&P 500 index only saw a modest gain of just over 1%.

SOUTH SAN FRANCISCO, Calif., Dec. 20, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) has announced that Sanofi will gain exclusive rights to develop and market aficamten from Corxel Pharmaceuticals (CORXEL) for patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) in Greater China. Aficamten is a new type of cardiac myosin inhibitor aimed at treating HCM.

CYTK has started enrolling participants for the phase III COMET-HF study, which focuses on omecamtiv mecarbil for patients experiencing symptomatic heart failure with significantly low ejection fraction.

CYTK's New Drug Application (NDA) is looking for approval for its main candidate, aficamten. The FDA has accepted this application and set a target date for a decision on September 26, 2025.

SOUTH SAN FRANCISCO, Calif., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) has announced that the COMET-HF trial, which aims to confirm the effectiveness of omecamtiv mecarbil in patients with severe heart failure, is now open for enrollment. Omecamtiv mecarbil is a new type of drug being tested to treat heart failure with significantly reduced ejection fraction. This trial is being carried out in partnership with the Duke Clinical Research Institute, a prominent research organization.

Cytokinetics, Incorporated announced that the U.S. Food & Drug Administration (FDA) has accepted its New Drug Application (NDA) for aficamten, a new type of cardiac myosin inhibitor aimed at treating obstructive hypertrophic cardiomyopathy (HCM). The target action date for the PDUFA is set for September 26, 2025. This news was shared on December 2, 2024, from South San Francisco, California.