As the Feb. 28, 2023 PDUFA date for the compound nears, Cytokinetics Inc. CEO Robert Blum insisted that his firm is not mulling withdrawal of the marketing application for heart failure drug omecamtiv mecarbil, nor is the company now considering another study, after an unfavorable vote on the drug Dec. 13 by the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee.
Even though Cytokinetics Inc. received applause for testing its heart failure drug, omecamtiv mecarbil, in the second largest global heart disease clinical trial ever, the drug didn’t get a standing ovation from the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) Dec. 13.
What could be Cytokinetics Inc.’s first approved drug will take center stage Dec. 13 at a meeting of the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee. But judging from the FDA’s briefing document for the meeting, the spotlight on the heart failure drug, omecamtiv mecarbil, could be harsh.
RTW Investments LP-backed Ji Xing Pharmaceuticals Ltd. has acquired greater China rights to Cytokinetics Inc.’s omecamtiv mecarbil in a deal worth up to $400 million.
RTW Investments LP-backed Ji Xing Pharmaceuticals Ltd. has acquired greater China rights to Cytokinetics Inc.’s omecamtiv mecarbil in a deal worth up to $400 million.
Cytokinetics Inc. CEO Robert Blum declined to remark upon what one analyst called “the elephant in the room” as the company popped the lid off positive top-line data from the first and second cohorts of the phase II study with CK-3773274 (known by the shorthand CK-274) in hypertrophic cardiomyopathy (HCM).
Vericiguat became the first oral soluble guanylate cyclase stimulator to win FDA approval for use in heart failure patients. The drug, branded Verquvo, was developed by Merck & Co. Inc. as part of a $1 billion deal with Bayer AG. But its commercial potential could be hampered by its modest clinical efficacy and increasing competition in the space, as well as difficulties launching a new drug during a pandemic.
Shares in Cytokinetics Inc. closed down 42% Oct. 8 on news that omecamtiv mecarbil, a heart failure drug which it is developing with Amgen Inc. (with funding and strategic support from Les Laboratoires Servier SAS), failed to demonstrate a survival benefit in a large-scale cardiovascular outcomes study.
Cytokinetics Inc. as a competitor for Myokardia Inc.’s cardiovascular drug, mavacamten, didn’t come up until near the end of the conference call related to the $13.1 billion buyout of the latter company by Bristol Myers Squibb Co., but the prospect is on Wall Street’s mind.
Cytokinetics Inc.’s new deal with RTW Investments gives the company a new presence in Asia and a strong influx of cash that should last at least two or three years.
