Cytokinetics' (CYTK) omecamtiv Approval Highly Likely, Data Are Encouraging and Suggest Useful Benefit, Reiterate Buy - H. C. Wainwright

H.C. Wainwright analyst Joseph Pantginis reiterated a Buy rating and $69.00 price target on Cytokinetics (NASDAQ: CYTK), following announcement that the FDA had accepted company's NDA for omecamtiv mecarbil.

The analyst quotes: "This morning, Cytokinetics announced that the FDA has accepted the company’s NDA for omecamtiv mecarbil for the treatment of patients with HFrEF. The FDA assigned the NDA a standard review with PDUFA date set for November 30, 2022. The FDA also indicated that it is currently not planning to hold an AdCom meeting to discuss the application. We see omecamtiv’s approval highly likely based on its demonstrated clinical benefit, especially in the context of more severe HF patients. When reviewing the data from other drug trials in patients with HFrEF, the relationship between treatment effect and elements such as baseline EF, NT-proBNP, and NYHA class has been variable and highlights the unmet need that omecamtiv could address. As per ACC/AHA guidelines, EF<30% defines patients with severe HF (approximately 2 million patients). In these patients, effective drugs such as beta-blockers, Entresto, SGLT2 inhibitors and Vericiguat show an attenuating treatment effect (on composite risk reduction) in relation with decrease EF... These results are impressive also when considering that this subgroup of patients present with a greater risk of adverse outcome. We believe these data are encouraging and suggest useful benefit in a harder to treat population with severe disease and less likely to tolerate other HF therapies"

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Shares of Cytokinetics closed at $32.09 yesterday.

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