Bristol-Myers, Bluebird Bio to Resubmit FDA Bid for Myeloma Treatment

Bristol-Myers Squibb and Bluebird Bio say the FDA declined to move forward on the application for their experimental multiple myeloma treatment.
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Bristol-Myers Squibb  (BMY) - Get Report and Bluebird Bio  (BLUE) - Get Report said Wednesday the U.S. Food and Drug Administration declined to move forward on the application for their experimental multiple myeloma treatment. 

Bristol-Myers Squibb said it plans to resubmit the application in July.

Shares of New York-based Bristol-Myers Squibb were up slightly to $63.42, while Cambridge, Mass.-based Bluebird Bio shares were off slightly to $56.61. 

Bluebird and Bristol-Myers said they are seeking approval for idecabtagene vicleucel, a chimeric antigen receptor (CAR) T cell immunotherapy. 

"Upon preliminary review, the FDA determined that the Chemistry, Manufacturing and Control (CMC) module of the Biologics License Application (BLA) requires further detail to complete the review," Bristol-Meyers aid in a statement. "No additional clinical or non-clinical data have been requested or are required."

Bluebird Bio, which is  building a manufacturing plant in Durham, N.C., said on Monday that Bristol-Myers  would give the company a one-time payment of $200 million to buy out obligations for future royalties on sales outside the United States of two cancer therapies they were developing.

The treatments are part of a class of drugs called CAR-T therapies that involve drawing white blood cells from a patient, processing them to target cancer cells, and infusing them back into the patient.

The companies will continue to equally share profits and losses in the United States, Bluebird said.

Separately, Bluebird reported earlier this week a first-quarter loss of $202.6 million compared with a loss of $164.4 million a year ago. Revenue totaled $21.86 million, up from $12.47 million a year ago.