An FDA advisory committee voted against recommending the approval of Bristol-Myers Squibb (BMY) and AstraZeneca's (AZN) diabetes drug candidate dapagliflozin, citing potential liver and cancer-related risks. We don't expect the drug will be approved on schedule in the U.S. in October, but we think dapagliflozin still stands a chance at approval in Europe. This news does not have a significant impact on our fair value estimates for either firm.
The drug is the first in a new class of drugs known as SGLT2 inhibitors, and we think this news could sour prospects for Johnson & Johnson's (JNJ) canagliflozin and Lilly's (LLY) BI10773 as well as Big Pharma's interest in signing a partnership with Lexicon (LXRX) for its own similar drug candidate, LX4211, in the near term.
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