Vernalis shares slide after latest FDA rejection
Shares in UK pharma Vernalis slid more than 15% after the US regulator rejected its cough and cold treatment, known as CCP-08.
The FDA sent Vernalis a dreaded Complete Response Letter (CRL) rejecting CCP-08, although the company gave no further details about the FDA’s reasons for its decision.
This is the latest setback for Vernalis after the FDA rejected its other cough and cold drug CCP-07 in April because of concerns about how the drug moves around the body.
Vernalis said that it will have to address the FDA’s concerns before it can refile the drugs with the agency.
The company had been hoping to get them approved in time for the next cough and cold season, and, given the time it takes the FDA to review drugs, this now looks impossible.
Shares in the company fell by almost 16%, to 16p, following the news, matching a record low from April.
Vernalis CEO Ian Garland said: “Unfortunately, the outstanding items that resulted in a CRL for CCP-07 could not be addressed in time to avoid the same outcome for CCP-08.
“The approval of both CCP-08 and CCP-07 are of the utmost importance to Vernalis, and we are working closely with our partner Tris and the FDA to resubmit both NDAs as quickly as possible.”
The biotech had been backed by fund manager Neil Woodford and his previous employer Invesco.
Vernalis has been developing the drugs as part of a R&D partnership with New Jersey-based Tris Pharma.
The companies are developing six extended-release versions of cough and cold treatments for the US market.
The first product from the partnership, Truzistra XR, was approved by the FDA in 2015.
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