Celgene (CELG +0.00%) recently released additional data for its multiple myeloma drug candidate pomalidomide ahead of a critical review by the Food and Drug Administration. This is an important transitional period for the big biotech as it attempts to dethrone Takeda's Velcade and challenge Onyx's (NASDAQ: ONXX) Kyprolis in multiple myeloma, along with getting abraxane an expanded indication for pancreatic cancer ahead of would-be competitors like Threshold's (NASDAQ: THLD) TH-302 and Peregrine's (NASDAQ: PPHM) bavituximab.
As you might expect, there are plenty of variables to watch with Celgene. In order to help you answer which ones are the most important, The Motley Fool has composed a brand-new premium research report that explains Celgene's market opportunity, risks, and reasons to both buy and sell today.
In the near term, though, here are a pair of important things that investors need to keep an eye on:
Pomalidomide positives
Circle Feb. 10, 2013, on your calendar. That's the date that the FDA makes a decision on marketing approval for pomalidomide. Celgene also expects to receive a decision from the European Medicines Agency in late 2013.
The initial reports from Celgene on the phase 3 studies were encouraging. Using pomalidomide combined with dexamethasone for multiple myeloma improved both progression-free survival rates and overall survival rates in patients participating in the studies. No safety issues were raised.
A positive decision from the FDA in February should provide a nice boost to the stock. Celgene also expects to complete analysis for the phase 3 study with pomalidomide in treating myelofibrosis by mid-2013. If additional good news from that study is announced, the market should further reward Celgene shareholders.
Abraxane affirmatives
The next few months should tell us a lot about whether Abraxane can live up to expectations for reaching blockbuster status. So far, things look good.
The FDA approved use of the drug for treating non-small-cell lung cancer in October. Just a few days earlier, Celgene announced that the phase 3 study for Abraxane in treating metastatic melanoma achieved its primary endpoint of improvement in progression-free survival rates.
And a recent major milestone may be its most exciting yet. Pancreatic cancer patients taking Abraxane plus gemcitabine achieved statistically significant overall survival rates compared to patients taking gemcitabine alone. There aren't many great treatment alternatives for pancreatic cancer, so oncologists are eagerly awaiting the full data to be released at the ASCO 2013 Gastrointestinal Cancers Symposium on January 24-26, 2013. Approval wouldn't likely come until 2014, but excitement around this drug is another likely catalyst for Celgene shares.
Know your stock
I hope you enjoyed this excerpt from the "three areas you must watch" section of our brand-new report on Celgene.
