Key October FDA Catalysts - Part One Print E-mail
By Patrick Crutcher   
Monday, 27 September 2010 03:35

Here we review some upcoming FDA decisions to keep you informed on guard. Many susbcribers to BioMedReport's FDA catalyst calendar took positions before many of these companies started to gain momentum and volume. In many cases, we have also been featuring, examining and methodically interpreting the particulars and data behind some of these stocks.

We always teach BioMedReports readers to assume one thing: "The price of a biotech/pharma company's stock will go up as the key FDA decision dates and key clinical trial data approaches. So one of the most simple ways (and there are several) that investors make money is to buy stocks with key pending FDA catalysts 1-3 months BEFORE those dates arrive.

As the FDA decison date approaches, big crowds of speculators and traders start coming in to buy shares of the same stock. As supply runs out and demand goes up, so does the price of the stock. We invite you to get your daily updates to our FDA Calalyst and Clinical Trial Data Calendar, if you don't already subscribe to it. Get it here: http://biomedreports.com/fda-calendar/fda-calendar.html

Alexza Pharmaceuticals Inc.(NASDAQ: ALXA) has a Prescription Drug User Fee Act (PDUFA) goal date of October 11, 2010(Monday) for AZ-004. Alexza filed the AZ-004 NDA on December 11, 2009 and is seeking marketing approval for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. We are bullish on ALXA’s approval chances. See our previous post on ALXA.

Initial coverage on ALXA: http://bit.ly/dB5dan
Recent commentary on ALXA: http://bit.ly/bamkGx

Alkermes Inc.(NASDAQ:ALKS) has two PDUFA dates. ALKS has a PDUFA date of October 12, 2010(Tuesday) for the sNDA of VIVITROL. If approved for opioid dependence, VIVITROL would be the first and only non-narcotic, non-addictive medication for the treatment of opioid dependence available in a once-monthly formulation. ALKS had a 11-2 positive vote of approval on September 16th from the FDA panel review.

Additionally, ALKS has another PDUFA date on October 22, 2010(Friday) for the NDA of BYDUREON. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA, which has been available in the U.S. since June 2005 and is used in approximately 60 countries worldwide to improve glycemic control in adults with type 2 diabetes.

Based on the panel review for VIVITROL and the third submission of BYDUREON, it seems ALKS could likely see 2 FDA approval in October. See our previous research on ALKS.

Our take on ALKS: http://bit.ly/bK4lrX

AVANIR Pharmaceuticals (NASDAQ:AVNR)‎
has a PDUFA date of 10/30/10 (Saturday) for AVP-923 (formerly Zenvia). AVP-923 is a novel combination of dextromethorphan and quininide for the treatment of pseudobulbar affect (PBA) in patients with underlying amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS). PBA is a neurologic condition characterized by involuntary, unpredictable and disruptive outbursts of laughing or crying in patients with certain underlying neurologic diseases or injuries. We are bullish on AVNR’s approval chances for AVP-923. AVNR has very positive analysts ratings and $7-9 target prices. See our previous post on AVNR.

Our opinion of AVNR: http://bit.ly/dzo62G

Part two of this report will appear in this space tomorrow. Paid subscribers can access it now.




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