12:00 AM
 | 
Jun 04, 2012
 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones
Regulatory milestones

BioAlliance Pharma S.A. (Euronext:BIO) gained €0.08 to €3.30 last week after FDA accepted for review an NDA for Sitavig acyclovir Lauriad to treat recurrent orofacial herpes. The PDUFA date is undisclosed. BioAlliance submitted the application in 1Q12; a 10-month standard review would place the PDUFA date around year end. The product is also under review in Europe, where it is known as Sitavir.

CSL Ltd. (ASX:CSL) gained A$0.71 to A$37.18 last week after FDA accepted for review a BLA for 4-factor prothrombin complex concentrate (PCC) for the reversal of vitamin K antagonist therapy, including warfarin, in patients with acute major bleeding. The PDUFA date is Jan. 28, 2013.

Exelixis Inc. (NASDAQ:EXEL) was off $0.14 to $4.48 last week after completing submission of a rolling NDA to FDA for cabozantinib to treat medullary thyroid cancer (MTC). The company requested Priority Review (see "Mixed Messages in MTC," A8).

Isis Pharmaceuticals Inc. (NASDAQ:ISIS) was off $0.07 to $9.72 last week after FDA accepted for review an NDA from Genzyme Corp. for Kynamro mipomersen to treat homozygous familial hypercholesterolemia (hoFH). The PDUFA date is Jan. 29, 2013. The acceptance triggered a $25 million milestone payment to Isis. The product is also under review in the...

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