Novo: FDA decision on degludec delayed

Novo Nordisk (OMX: NOVO B) said that the U.S. FDA has tentatively scheduled an Advisory Committee meeting to discuss the NDA for the ultra-long-acting insulin degludec and insulin degludec/insulin aspart on November 8th 2012. This delay was a disappointment for the market, where hopes of a direct path into approval decision had been raised. There hasn’t been any communication regarding a new action date. The stock which boasts highest market cap in the Nordic exchanges is down 1% in early afternoon session.

A target price hike has helped Novo in today’s trading somewhat. The FDA approval of another obesity drug in Qnexa, that will be marketed as Qsymia, from Vivus (NASDAQ: VVUS)however should not have had any particular effect on Novo at this point when it was already clear earlier, that drugs can be approved in this space after all.