Feb 28 (Reuters) - Cytokinetics Inc (CYTK.O)said on Tuesday the U.S health regulator declined to approve its oral drug for a type of heart failure, citing lack of sufficient data to show the drug was effective, and sending shares down 3% after the market trade.
Dec 13 (Reuters) - The U.S. Food and Drug Administration's panel of outside experts did not lend its support to Cytokinetics Inc's (CYTK.O) heart drug, citing insufficient data on safety and efficacy.
Dec 9 (Reuters) - U.S. Food and Drug Administration staff reviewers on Friday identified safety and efficacy concerns about Cytokinetics Inc's heart drug, according to briefing documents published on the agency's website.
Cytokinetics Announces Availability of Briefing Documents for FDA Advisory Committee Meeting on Omecamtiv Mecarbil
SOUTH SAN FRANCISCO, Calif., June 24, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has informed the company...
SOUTH SAN FRANCISCO, Calif., May 17, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the Company recently participated in a mid-cycle communication meeting with...
In the most recent trial, omecamtiv mecarbil did not beat placebo at improving cardiopulmonary exercise testing after 20 weeks of treatment in patients with HFrEF, Cytokinetics said Tuesday. The phase 3 trial, dubbed Meteoric-HF, enrolled 276 patients.
SOUTH SAN FRANCISCO, Calif., Feb. 04, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food & Drug Administration (FDA) has accepted and filed the company’s New Drug Application (NDA) for omecamtiv mecarbil, an investigational, selective, small molecule cardiac myosin activator, for the treatment of heart failure with reduced ejection fraction (HFrEF).
After offloading China rights to a heart failure drug, Cytokinetics has found a partner in Royalty Pharma for the rest of the world. Royalty will pay up to $450 million for the chance to support the commercial launch of omecamtiv mecarbil.
SOUTH SAN FRANCISCO, Calif., and SHANGHAI, China, Dec. 20, 2021 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) and Ji Xing Pharmaceuticals Limited (JI XING), a biopharmaceutical company based in Shanghai and backed by RTW Investments, LP (RTW), today announced an expansion of their collaboration by entering into an exclusive license and collaboration agreement to develop and commercialize omecamtiv mecarbil for the proposed treatment of heart failure with reduced ejection fraction (HFrEF) in Greater China. In addition to the license and collaboration agreement with JI XING, Cytokinetics has also entered into Common Stock Purchase Agreements that provide for the sale and issuance to entities affiliated with RTW of 511,182 of shares of Cytokinetics common stock at a price per share of $39.125.