3 Biotech Catalysts to Hit Before 2014 Print E-mail
By Brian Wilson - Lead Contributor   
Wednesday, 30 October 2013 09:01
We’re about to start November 2013, and we’re wrapping up what should be an exceptionally good year for the biotech sector and the stock market as a whole. At time of writing, the NASDAQ Biotechnology index is up over 54% since the start of the year and looks poised to actually finish higher. Meanwhile, the S&P 500 is up 24% and continues to surprise many investors with record-setting performance.

There is certainly are many events to look forward to in 2014, although a number of major events are still scheduled to occur within the next two months. Here are some of the biggest:

1.) Auxilium (NASDAQ: AUXL) PDUFA for XIAFLEX in Peyronie’s Disease

Auxilium has an upcoming PDUFA date of December 6, 2013 after a three month extension that was implemented by the FDA for XIAFLEX – a treatment for a relatively common disorder that affects connective tissues in the penis. This is a large indication, and should be considered extremely important to a sexual health-focused company like Auxlium.

PDUFA Extensions cannot be clearly interpreted as good or bad in many cases, although the market seems to be very optimistic about chances for approval here. While the testosterone gel product Testim is also extremely important to the valuation of this biotech stock, the fate of XIAFLEX should have a noticeable impact on the company’s performance going forward.

2.) Vanda (NASDAQ: VNDA) Adcom for Tasimelteon in insomnia patients

There is a PDUFA date scheduled for the prospective insomnia drug Tasimeleton on January 31st, 2014. However; there will first be a panel discussion and vote on the NDA package that was submitted by Vanda to the FDA earlier this year. The drug is designed to modify patients’ circadian rhythm (the body’s “clock”), which appeared to be viable given the positive Phase III data that was presented. This vote is scheduled for November 14th, and remains very difficult to predict at this point. There seems to be no clear bias against speculators either.

3.) Amarin (NASDAQ: AMRN) PDUFA for Vascepa in ANCHOR Indication

Although Vascepa was already approved for a triglyceride-lowering indication in 2011, the FDA advisory committee that voted on the Vascepa sNDA for something known as the ANCHOR indication (more here) gave the drug a very apparent thumbs down with a 2-9 vote against approval without the data from a large cardiovascular risk trial that the company is currently conducting. The FDA does not have to issue a complete response letter to Amarin because of the adcom vote, although investors should note that it is very rare for the FDA to give approval to a drug after such a disastrous adcom meeting. The decision is due on December 20th, 2013.

Investors should note that PDUFA events are binary events (approval/CRL), while advisory committee meetings result in a vote by the FDA panel. Advisory committee meetings require more interpretation from the market, although they have the capacity to move a stock just as much (if not more) than PDUFA events.




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