Wednesday, April 23, 2014

Daily Dose - Spectrum Pharmaceuticals, OncoGenex Pharmaceuticals

The Nasdaq Biotech Index pulled back 1.54% after two strong days of gains.  Here are some highlights for the day.

Spectrum (SPPI) announced that it's multiple myeloma treatment met it's primary endpoint and the company plans to submit an NDA in the 3rd quarter of this year with an expected PDUFA date in 2015.  The drug is an improved form of the chemotherapy drug melphalan.  If approved, analysts believe the peak sales of the drug could be as high as $50 million annually.  This is another near term potential catalyst for Spectrum on top of it's August 9th PDUFA date for it's lymphoma drug Belinostat.  The company already markets four drugs with sales of $155 million in 2013 and a number of other drugs in it's pipeline and partnerships with Biogen, Allergen, Bristol-Myers Squibb and others.  With a market cap of $453 million I consider the company to be a great value which is why I hold a long position in the company. 

OncoGenex (OGXI) announced the company and Teva received the Fast Track designation for it's partnered compound Custirsen in 2nd line castration resistant prostate cancer.  The drug already has Fast Track status for the same drug in first line CRPC and lung cancer, all of which are currently in phase 3 trials.  I wouldn't too much value on the designation as it's worthless if the drug isn't successful in it's phase 3 pivotal trial.  They expect enrollment to be complete in the 2nd line CRPC trial in the 2nd half of this year so I would expect top line results in the middle of 2015.  In the meantime, they should report top line results of the first line CRPC any time within the next few months.  They already announced the required number of events (deaths) have occured and that they are now analyzing the data so fingers crossed!

Hope everyone is having a great week and feel free to email or tweet me any questions,


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