J.P. Morgan Reiterates Overweight Rating on HeartWare International Following CAP Approval

In a report published Monday, J.P. Morgan analyst Michael Weinstein reiterated an Overweight rating on HeartWare International HTWR.

In the report, J.P. Morgan noted, “Overall, we view the CAP approval as a positive that should help to alleviate investor concerns about the DT data set. Heartware has been in negotiations with the FDA for several months about the structure the CAP would take, principally due to the company's desire to amend the original trial protocol to include more rigorous blood pressure management. Retrospective analysis of earlier HVAD studies has shown that centers that more closely managed MAP experienced a lower incidence of neurological complications, particularly hemorrhagic stroke. By implementing these protocol changes, the company hopes to generate a data set that can supplement the pivotal ENDURANCE cohort and show that better patient management can also reduce event rates in the DT population. Recall that unadjudicated interim data included in the HVAD's IFU following its approval under a BTT indication appeared to show a higher stroke rate with the HVAD than Thoratec's HeartMate II.”

HeartWare International closed on Friday at $91.40.