Vernalis to resubmit NDA to US FDA for drug CCP-07

Vernalis said a complete response letter (CRL) from the US FDA did not raise any concerns with the formulation or pharmacokinetic profile of CCP-07, but identified outstanding items that needed to be addressed prior to the resubmission and approval of a new drug application (NDA).

A CRL was issued by the FDA when it had completed its review of an NDA and questions remained that preclude its approval at this time.

"We remain committed to the approval of CCP-07 and will work closely with the FDA to resubmit the NDA as quickly as possible" said Vernalis' CEO, Ian Garland.

Separately, Vernalis said it had received a $2m milestone under one of its existing research collaborations to discover novel small molecules against an undisclosed target utilising its fragment and structure-based drug discovery platform.