Join +750K new investors every month who copy stock picks from billionaire's portfoliosSign Up Free

Vernalis hit by fresh U.S. setback for cough and cold drug

Published 07/08/2017, 09:02
Vernalis hit by fresh U.S. setback for cough and cold drug
VER
-

LONDON (Reuters) - Shares in Vernalis (L:VER) fell more than 15 percent on Monday as the British biotech company backed by fund manager Neil Woodford and his previous employer Invesco announced a fresh setback for a key new drug in the United States.

The company said its cough and cold treatment CCP-08 had received a so-called complete response letter (CRL) from the Food and Drug Administration (FDA), meaning the agency is not prepared to approve it at this time.

Vernalis shares fell as much as 15.8 percent to 16 pence, matching a record low first hit on May 18. The shares, which were trading down 12 percent at 0750 GMT, have fallen 82 percent from their 2015 peak of more than 88.

The FDA blow follows a similar CRL for the company's sister product CCP-07 in April.

"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," Chief Executive Ian Garland said.

Garland said both drugs were "of the utmost importance to Vernalis" and the company was working with its partner Tris and the FDA to resubmit both applications as quickly as possible. It expects to provide an update on progress "in the coming months".

Rx Securities analyst Joseph Hedden said the latest setback was disappointing but not a significant surprise, given the earlier problems with CCP-07.

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.