Orexigen Therapeutics Sees Shares Slide Pre-Market; Eli Lily Edges Up

Shares of Orexigen Therapeutics (NASDAQ:OREX) slipped in Tuesday’s pre-market session, after the developer of drug treatments for obesity and related disorders said it received a Day 120 List of Questions regarding the marketing authorization application for its NB32 weight-loss drug candidate from the European Medicines Agency’s Committee for Medicinal Products for Human Use. The company said the EMA reviewers’ questions “are consistent with issues raised by the United States Food and Drug Administration during the course of NB32 development and the initial review of the New Drug Application, such as manufacturing and quality, non-clinical studies, dosing regimen, and, most significantly, cardiovascular safety.”

Orexigen said it is “confident that it can successfully address all of the questions posed.” Chief Executive Michael Narachi added “We remain highly confident that NB32 will receive a positive opinion from the CHMP at the conclusion of its review.” OREX was down 2.2% at $7 in recent pre-market trading. It has a 52-week range of $4.59 to $7.84.

Shares of Eli Lilly (NYSE:LLY) edged up in Tuesday’s pre-market session, after the pharmaceutical company reported its sixth Assessment of Weekly Administration of LY2189265 in Diabetes trial for once-weekly dulaglutide 1.5 mg, a candidate being studied as a treatment for type 2 diabetes, achieved the primary endpoint of noninferiority to once-daily liraglutide 1.8 mg.

“Dulaglutide is the only GLP-1 agonist to show non-inferiority against liraglutide’s highest-approved dose in a Phase III trial,” said Enrique Conterno, president of Lilly Diabetes. “The AWARD-6 data, along with the previous five AWARD studies, give us confidence that dulaglutide can be an important treatment option for people with type 2 diabetes. If approved, dulaglutide would be the only GLP-1 agonist that is both once-weekly and ready-to-use.” Once-weekly dulaglutide has been submitted to the U.S. Food and Drug Administration, the European Medicines Agency and other regulatory bodies, Lilly noted. Shares were up 0.5% at $58.30 in recent pre-market trading. They have a 52-week range of $47.53 to $58.90, with the high end of that range set Monday.