Breaking Biotech: Bristol Does It Again

Well, the last week has gotten just a bit better for Bristol-Myers Squibb BMY thanks to the Federal Drug Administration.

Bristol-Myers won its second breakthrough therapy designation from the FDA in under a week’s time.

Just days after getting the FDA's elite status for its closely-watched anti-PD-1 drug Nivolumab, the agency has followed up with a nod for Elotuzumab.

Elotuzumab is an antibody that binds to the glycoprotein found on myeloma cells and "Natural Killer" cells in a way that focuses the immune system on killing myeloma cells while leaving healthy cells alone.

"Despite recent advances in the treatment of relapsed or refractory multiple myeloma, it remains an area of unmet need," said Michael Giordano, the head of development on oncology and immunosciences at Bristol-Myers Squibb.

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"This Breakthrough Therapy Designation underscores the potential of elotuzumab in this setting and reinforces Bristol-Myers Squibb's longstanding commitment to the research and development of novel medicines to treat hematologic malignancies," stated Giordano.

This FDA designation is validation of Bristol-Myers' decision back in 2008 to in-license Elotuzumab from PDL BioPharma for $30 million upfront and hundreds of millions in additional milestones. 

Bristol’s stock has so far been unaffected by this new designation after dropping on last week’s news.

Bristol Myers had rallied nicely from its $40 low last fall, yet has stalled thus far this year.

Currently, the stock sits near its low for the year at around $47 per share. Investors will hope that these new developments might get the stock moving higher again.

Bristol’s 52-week high currently sits at around $57, which was hit in March of this year. The company’s next earnings report is due on July 24, 2014.