Broker N+1 Singer said the decision represented a "material" set back for Vernalis
Companies: VERBUND AG Class A
Shares in AIM-listed pharmaceutical firm Vernalis dropped 14% on Friday after the Company confirmed it had received a Complete Response Letter (CRL) from the FDA regarding its application for CCP-07, stating that questions remained about the drug that precluded its approval at this time.
According to Vernalis, the CRL identified "outstanding items" that needed to be addressed before it could be resubmitted or approved by the FDA, however, Vernalis said it did not raise any concerns with the reformulation or pharmacokinetic profile of the drug itself.
"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 Ian Garland, CEO of Vernalis plc.
The FDA used to send "approval" and "not-approval" letters which offered more immediate transparency on the success of various drugs, but this has changed to Complete Response Letters. The FDA says this is a more consistent and neutral way of conveying information.
Broker N+1 Singer reiterated its "Hold" rating on Vernalis, saying the non-approval of CCP-07 represented a "material setback" for the company.
"Our current forecasts assume launch of CCP-07 in time for the 2017/18 flu season: we will update our expectations as more details become available. It is at this stage not clear to what extent the FDA’s decision could affect the approvability of CCP-08, the third Vernalis/Tris Pharma cough cold programme, by its 4th August PDUFA date. We retain a Hold recommendation."
In a separate RNS Vernalis said it had received a $2m milestone under an existing research collaboration to discover novel small molecules.