Opinion on  Pharmacyclics Inc. (PCYC)     Sector: Healthcare  >  Industry: Biotechnology & Drugs
Pharmacyclics Challenges FDA

Pharmacyclics is a small start-up pharmaceutical company that has developed a novel cancer treatment for small-cell lung cancer.  Their drug Xcytrin received Orphan drug status and was placed on the fast track due to the promising results of initial trials and the uniqueness of the drug.  They recently completed phase III trials with an international study.  The study results initially did not show significant results.  When exploring further it was determined that the non-US portion of the population received initial treatment significantly later in the process following diagnosis than the participants in the US.  When looking only at the US population the results were significant.  In Dec they filed a New Drug Application and in Feb it was refused stating that the results were not significant to file.

Today they are announcing that they are protesting the  FDA's response.  A recent example of the protest  working is Dendreon (DNDN).  The only difference is that PCYC actually has significant results. http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:...

Stock is up significantly today on yesterdays news.  6 month target $4.50.  Current run target $3.30 but expect a pull back to $2.68 -$2.75 in the short term.  This may take place a couple of times in the next several weeks. Lots of short interest and several months until this issue is finished once and for all with the FDA.  After that, this could easily be a ten bagger like DNDN.  Remember, more drugs in the pipeline as well.

PCYC's drug Xcytrin is two weeks away from being at the same stage in the approval process as Dendreon's drug Provenge.

Xcytrin has a strong case for approval and the main difference between the stock price is the better PR effort by DNDN.  Dr. Miller and his gang have stepped up their efforts in this area and we should see the stock price going higher soon.

Pharmacyclics Announces Presentations on Its Novel and Selective HDAC and Bruton's Tyrosine Kinase Inhibitor Compounds

PR Newswire via Yahoo! Finance Wed, 11 Apr 2007 4:30 AM PDT

Pharmacyclics, Inc. announced today multiple presentations regarding its novel histone deacetylase inhibitor and Bruton's tyrosine kinase inhibitor compounds. The presentations will take place at the American Association for Cancer Research 2007 Annual Meeting being held April 14-18, 2007, at the Los Angeles Convention Center, in Los Angeles, CA.

http://biz.yahoo.com/prnews/070411/sfw018.html?.v=92

Pharmacyclics Identifies Functional Biomarkers for its Novel HDAC Inhibitor and Demonstrates Preclinical Anti-Tumor Activity with Bruton's Tyrosine Kinase Inhibitors.  News was released this week at the AACR conference.

This afternoon, PCYC started its long climb back up from the gap down in Feb.  The stock moved up $.44 or 13.92% to $3.60 following the announcements from the AACR conference.  The potential exists for the stock to move another .20-.40 points up with strong volume. 

The company is starting to get some of the attention in the market.  On April 30th the FDA will begin the required review process for it's lead drug Xcytrin.