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Vernalis gets CRL for CCP-07

April 21, 2017 7:57 PM UTC

Vernalis plc (LSE:VER) lost 2.5p (10%) to 22.12p on Friday after it said FDA issued a complete response letter for an NDA seeking approval of CCP-07 to treat cough and cold. The company said the CRL did not identify issues with the candidate's formulation or pharmacokinetic profile, but declined to discuss further details. Vernalis plans to resubmit the NDA “as quickly as possible.”

CCP-07 is an undisclosed existing cough and cold product that uses OralXR+ extended-release formulation technology from Tris Pharma Inc. (Monmouth Junction, N.J)...

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Vernalis plc