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Vernalis hurt by unexpected FDA response

The early-stage drugs company needs to provide US regulators with more information in order to receive approval for its new cough and cold remedy
April 24, 2017

Vernalis's (VER) quest to launch a second cough and cold product before the start of the 2017 winter has received a setback. The drug - which was filed with the US Food and Drug Administration (FDA) earlier this year - has not been granted approval due to "outstanding items" in the company's new drug application.

IC TIP: Hold at 22p

The good news is the FDA did not raise any concerns about the drug's formulation so it is likely approval will ultimately be granted. Indeed, analysts at Cantor Fitzgerald think it's not a case of "if" the drug will be approved but "when". But timing will be crucial for Vernalis as launch after the 2017 cough and cold season is likely to cause a sharp setback to sales forecasts.