Early indications that the FDA is likely to approve an implantable heart pump made by HeartWare International (NSDQ:HTWR) pushed its shares up nearly 7% this week, prompting the NASDAQ stock exchange to halt trading of the shares today as an agency panel considers the company’s pre-market approval application.
HTWR shares gained 6.8% Monday after documents released ahead of the meeting indicated that the Center for Devices & Radiological Health’s circulatory devices panel is likely to recommend approval of the HeartWare left ventricular assist device.
HeartWare wants the federal watchdog agency to approve the pump for use in patients with end-stage heart failure who are waiting for a heart transplant. If the FDA OKs the device, it will plunge HeartWare further into competition with rival Thoratec (NSDQ:THOR), which already has bridge-to-transplant approval for its HeartMate II LVAD.
HeartWare shares opened at $68.80 Monday morning on Wall Street, spiking to $72.28 before closing at $71.71 on heavy volume – nearly a million HTWR shares changed hands that day, as investors reacted to analysts’ predictions of success before the circulatory devices panel.
"While there are a number of ‘panel risks’ that will come into focus at HTWR’s 4/25 FDA meeting (which we believe pressured shares over the last 2 months), we believe the most probable outcome is that HTWR’s HVAD device receives a recommendation for approval," Barclays analyst Matthew Taylor wrote in a note to investors after upgrading his rating to "overweight." "On that basis, we think that the stock will work in the near term and are upgrading shares in anticipation of a favorable panel vote."
HTWR shares moved even higher yesterday, peaking at $72.41 before logging a $69.27 close.
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