FDA releases briefing docs for Cytokinetics AdCom, says H.C. Wainwright

H.C. Wainwright analyst Joseph Pantginis made no change to the firm’s Buy rating or $75 price target after the FDA released the briefing documents for Tuesday’s AdCom for omecamtiv mecarbil. The analyst, who expects shares to be volatile today, tells investors in a research note that there are no real surprises in the documents, and that the view of the FDA is focused on the overall modest therapeutic impact of GALACTIC-HF, while being a statistically significant study; the role that the large, prospectively defined subgroup of LVEF less than28% can play into a potential label; and defining the final agreement, if approved, of how PK-guided dosing would be implemented, which could also address the FDA’s stated concern regarding safety around the signals around increases in troponon-I and/or NT-proBNP. The analyst thinks omecamtiv should receive a positive vote for recommending approval.