Celldex drops on delayed Rintega timeline

Celldex Therapeutics Inc. (NASDAQ:CLDX) fell $4.39 (21%) to $16.96 on news that the company does not expect to submit U.S. and EU regulatory applications for glioblastoma multiforme (GBM) vaccine candidate Rintega rindopepimut until it has data from the ongoing Phase III ACT IV trial.

Celldex anticipates receiving data from the second interim analysis of ACT IV in late 2015 or early 2016, and a final analysis is expected by YE16. The company had hoped to apply for accelerated approval based on data from the Phase II ReACT trial, but Celldex said FDA expressed concerns about the study's small sample size. ...