Wednesday, January 12, 2011

ISIS' (NASDAQ:ISIS) NDA for HoFH May Be Shifted to 2H11

The original guidance for the NDA for HoFH for ISIS' (NASDAQ:ISIS)may be transferred to the second half of 2011 from the prior expectation of it being performed in the first half of the year.

Needham says, "Yesterday, ISIS updated the regulatory strategy for mipomersen, following partner Genzyme’s (Nasdaq:GENZ) (N/R) recent discussions with the FDA. In the US, the NDA for HoFH may be shifted to 2H11 from previously guided 1H11, due to subdividing the application into HoFH (no new data needed) and severe HeFH hypercholesterolemia (12 month follow-up study needed). In the EU, the regulatory filing timeline has remained unchanged. Genzyme will submit a MAA for mipomersen for HoFH in 1H11, which may include severe HeFH. While we had confidence that the HoFH FDA submission package was sufficient to address the safety/efficacy issues in HoFH, we note a timeline delay for submission will be necessary as the Company splits the two proposed indications into two applications in the US."

Needham & Company maintains a "Hold" rating on ISIS Pharmaceuticals, which closed Tuesday at $10.04, dropping $0.13, or 1.28 percent.

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