Vivus Inc. (VVUS) - one of the most-watched biotech companies late last year with an obesity drug candidate, QNEXA, whose approval was DENIED by the FDA on 2010-10-29 based on birth defect and cardiovascular concerns. We are expecting to hear FDA's acceptance of QNEXA's NDA resubmission (likey by tomorrow 2011-10-31). A PDUFA action date will be assigned when this occurs and we may see a quick hike-n-slide play.
Pacira Pharmaceuticals (PCRX) - PCRX is expected to deliver a press release Monday morning to disclose the outcome of FDA's decision on EXPAREL, which had an PDUDA date of 2011-10-28 (last Friday). It is widely speculated, based on rumors, that FDA has approved the drug. We will see lots of trading actions tomorrow morning. Unfortunately, no PCRX options are available for trading, making it less attractive for a slide play.
BioSante Pharmaceuticals (BPAX) - though the original November PDUFA date for Company's Bio-T-Gel has been delayed to 2012-02-14, investors' appetites for this stock have not decreased. In fact, BPAX hiked up 17% last week as more investors turned their attentions to the results of Libigel's pivotal trial data, to be announced some time in December. Should the markets remain strong, another great week for BPAX should follow!
pSivida Corp. (PSDV) - PSDV has a PDUFA date next week (2011-11-12) for ILUVIEN. Stock popped 12% on Friday. Based on the high call/put option ratio, most investors are betting on ILUVIEN's approval. This is an interesting stock to follow.
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