Tranzyme falls after ulimorelin misses Phase III endpoint

Tranzyme Inc. (NASDAQ:TZYM) fell $2.20 (43%) to $2.90 on Monday after ulimorelin missed the primary endpoint of time to recovery of GI function vs. placebo in the Phase III ULISES 007 trial to treat post-operative ileus (POI). GI function was defined as the time from the end of surgery to the later of the first bowel movement or tolerance of solid food.

Tranzyme said it is still planning to analyze data expected next quarter from the identical Phase III ULISES 008 trial of ulimorelin, but will stop all other NDA activities for the product. Norgine B.V. (Amsterdam, the Netherlands) has exclusive rights in Europe, Australia, New Zealand, the Middle East, and South and North Africa from Tranzyme to develop and commercialize ulimorelin. The product is an IV ghrelin receptor agonist. ...