Orexigen Therapeutics, Inc. 's ( OREX ) shares were down 14.68% after the company announced that the FDA has delayed the action date for its obesity candidate, NB32, by three months. The news is highly disappointing considering that the market was gearing up for a potential approval in Jun 2014. Now, a final decision from the FDA is expected by Sep 11.
The FDA extended the review period to reach an agreement on a post-marketing obligation related to the previously agreed-upon evaluation of cardiovascular outcomes for NB32. We remind investors that NB32's regulatory application contained interim safety and cardiovascular outcomes data from the ongoing Light study. We note that the FDA did not raise any issue with the data submitted.
Orexigen is also looking to get NB32 approved in Europe. A regulatory decision from the European Commission is expected later this year.
We note that the company has a strong partner in North America in the form of Takeda Pharmaceutical Company Limited ( TKPYY ). Takeda has experience in the metabolic disorder market, which should be beneficial. Orexigen has rights to NB32 outside North America and is looking for a partner to commercialize NB32 in ex-North America territories.
We note that NB32, once launched, will enter a highly crowded obesity market with products like Qsymia and Belviq. Given the Light study data, expectations remain high that the candidate will eventually be approved and will most likely be more successful than currently available obesity treatments.
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