Orexigen Therapeutics, Inc. (OREX) Reports In-Line Q2 Loss of 21c/Share

Orexigen Therapeutics, Inc. (NASDAQ: OREX) reported Q2 EPS of ($0.21), in-line with the analyst estimate of ($0.21). Revenue for the quarter came in at $857 thousand versus the consensus estimate of $1 million.

NB32 program update:

• NB32 (32 mg naltrexone sustained-release (SR)/360 mg bupropion SR), an investigational medicine for weight loss and the maintenance of weight loss: In June 2014, the United States Food and Drug Administration (FDA) extended its review of the resubmitted New Drug Application (NDA) for NB32. The new Prescription Drug User Fee Act (PDUFA) action date has been set for September 11, 2014. The FDA indicated that the review extension is needed to reach agreement on the post-marketing obligation related to the previously agreed upon evaluation of cardiovascular (CV) outcomes for NB32. Discussions with the Agency on the post-marketing obligation are progressing, and Orexigen is confident it can reach agreement with the FDA.

Orexigen has licensed North American NB32 rights to Takeda. Takeda is preparing a well resourced primary care U.S. launch for NB32 with approximately 900 sales representatives.

In October 2013 Orexigen submitted a Marketing Authorization Application for NB32 to the European Medicines Agency (EMA). Orexigen received the Day 180 List of Outstanding Issues from the EMA's Committee for Medicinal Products for Human Use (CHMP) and will submit the Company's responses in September.

Orexigen owns NB32 rights outside of North America and will seek a partner to commercialize NB32 in those territories.

For earnings history and earnings-related data on Orexigen Therapeutics, Inc. (OREX) click here.

You May Also Be Interested In

• Blackhawk Network (HAWK) Reports Q2 Loss of $0.07; Offers Guidance
• Innovaro (INV) Misses Q2 EPS by 9c
• 4D Molecular Therapeutics, Inc. (FDMT) Misses Q2 EPS by 3c