Shares of Qiagen (NASDAQ:QGEN) rose +5.13% during regular trading and then an additional 9.57% to $17.29 after it announced it has submitted an approval application to the FDA for its Erbitux treatment for colorectal cancer. The firm says its pipeline of healthcare assays includes a submission in 2012 for an EGFR biomarker test for use with an anticancer medicine for patients with a form of lung cancer.
This is a stock you want to watch on Monday after the company announced early Friday morning that it had completed its second U.S. submission of the therascreen® KRAS RGQ PCR Kit for use as a companion diagnostic paired with Erbitux® (cetuximab), a leading drug for treatment of patients with metastatic colorectal cancer (mCRC). If the shares hold up, the stock could be a trade break-out candidate at best and a bottom bouncer candidate at worst. As you can see in the chart below, shares had been dropping since equities research analysts at Macquarie downgraded shares of Qiagen to a “neutral” rating in a research note to investors in May. Historically, there is support at the $16 price levels dating back to late '09, early '10. The stock bounced off the most recent three year low support level of $15 two sessions ago.
With the news, Qiagen has achieved a key milestone and expects FDA decisions in 2012. Those of you who use our FDA and Worldwide Regulatory Trade Catalyst Calendar know that shares of companies expecting FDA decisions begin to climb well in anticipation of those FDA decisions and QGEN looks like a very attractive candidate to do just that, especially given the bullish remarks from Peer Schatz, Chief Executive Officer who said, "QIAGEN's Personalized Healthcare franchise achieved a double milestone with these two separate U.S. submissions. These innovations show important progress in our strategy to accelerate QIAGEN's growth in 2012 and beyond. We are planning to validate the KRAS assay on our QIAsymphony RGQ platform, and we expect approvals of both PMAs in 2012,"
The first submission of the KRAS assay, earlier in July, paired Qiagen's molecular test with another drug for treatment of metastatic colorectal cancer. Both therapies are monoclonal antibody EGFR inhibitors expected to target a range of cancers. Last year's sales of Erbitux were US$820 million, representing an 18 percent increase over 2009. Erbitux is marketed in the United States by Bristol-Myers Squibb Company (NYSE:BMY) and Eli Lilly and Company (NYSE:LLY). Merck KGaA (NYSE:MRK) has the right to market Erbitux outside the US and Canada.
Qiagen N.V is a provider of sample and assay technologies for life sciences, molecular diagnostics, applied testing and pharma. Its Sample technologies are used to isolate DNA, RNA, and proteins from any biological sample. The company's assay technologies are used to make specific target biomolecules, such as the DNA of a specific virus, visible for subsequent analysis. It was founded in 1984 as a spin-off from the University of Dusseldorf. Its mission is to enable its customers to achieve outstanding success and breakthroughs in life sciences, applied testing, pharma and molecular diagnostics. Its subsidiaries include: DxS Ltd, SABiosciences Corporation and Shenzhen PG Biotech.
The company has a deep list of products including: HPV Testing, Pathogen Detection, HLA Typing, Gene Expression Assays, GeneGlobe Web Portal, Genetic Analysis and Protein Assays, Sample Disruption, Purification, Downstream Reaction Setup, Analysis and Service and Support Automation Accessories, Genomic DNA Preparation - IVD Samples, Human Samples, Animal, Plant, and Other Samples, DNA/RNA/Protein from Same Sample, High-Molecular-Weight DNA, Whole Genome Amplification, PCR Cleanup, Gel Extraction, Enzymatic Reaction Cleanup, DNA Normalization, Genomewide Predesigned siRNA, Custom siRNA Design and Synthesis, Pathogen Detection, Fractionation, Depletion, and Sample Preparation Kits, Detection Kits and Antibodies, Protein Assay Kits & Reagents, Crystallization Kits and Reagents etc.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.