14:45 , Aug 11, 2017 |  BC Week In Review  |  Clinical News

FDA issues CRL to NDA for Vernalis' CCP-08

Vernalis plc (LSE:VER) said FDA issued a complete response letter to an NDA for CCP-08 to treat cough and cold. The letter follows a CRL issued in April for its other cough and cold candidate...
23:35 , Aug 7, 2017 |  BC Extra  |  Company News

Vernalis gets another CRL in cough and cold pipeline

Vernalis plc (LSE:VER) lost 2p (11%) to 17p Monday after it said FDA issued a complete response letter to an NDA for CCP-08 to treat cough and cold. The letter follows a CRL issued in...
23:40 , Jul 7, 2017 |  BioCentury  |  Finance

Onward and upward

The top three market cap tiers continued to outperform smaller caps in 2Q17, led by companies valued between $1 billion and $9.9 billion. Companies valued below $1 billion failed to carry over their momentum from...
18:56 , Apr 26, 2017 |  BC Week In Review  |  Clinical News

CCP-07 regulatory update

FDA issued a complete response letter to an NDA from Vernalis for 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...
19:57 , Apr 21, 2017 |  BC Extra  |  Company News

Vernalis gets CRL for CCP-07

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...
07:00 , Sep 12, 2016 |  BC Week In Review  |  Clinical News

CCP-07 regulatory update

Tris and Vernalis said FDA accepted for review an NDA for CCP-07 to treat cough and cold. The PDUFA date is April 20, 2017. The acceptance triggered a milestone payment to Tris from Vernalis under...
07:00 , Aug 18, 2014 |  BC Week In Review  |  Company News

Tris Pharma, Vernalis Group deal

The partners said Tris achieved a milestone under a February 2012 deal granting Vernalis exclusive, North American rights to commercialize up to six reformulated prescription cough and cold products using Tris’ OralXR+ extended-release formulation technology....
07:00 , May 5, 2014 |  BC Week In Review  |  Company News

Tris Pharma, Vernalis deal

The partners said Tris achieved the second milestone under a February 2012 deal granting Vernalis exclusive, North American rights to commercialize up to six reformulated prescription cough and cold products using Tris' OralXR+ extended-release formulation...