Valneva Shares Fall After EMA Requested More Data on Covid-19 Vaccine

- Advertisement -


By Cecilia Butini
- Advertisement -

Shares in French pharmaceutical company Valneva SE fell sharply in opening trade Monday after the company said the European Medicines Agency has asked for more data about its Covid-19 vaccine candidate.

- Advertisement -

According to Valneva, the EMA’s Committee for Medicinal Products for Human Use has provided a list of questions requiring more data and a justification of a conditional marketing authorization for the vaccine. Valneva had submitted data to start a rolling review of its vaccine with the European Medicines Agency last December, and had already been asked to provide additional data in March.

At 0730 GMT, Valneva shares traded 12.7% down at 13.44 euros ($14.43).

- Advertisement -

Analysts at Dutch merchant bank Kempen & Co. said in a note that the regulatory delay was not entirely surprising, given Valneva’s vaccine wasn’t on the committee’s agenda for the adoption of an opinion as of last week. “With the process dragging on, we expect pressure on the shares with the delay,” the analysts said.

Valneva Chief Executive Thomas Lingelbach said that the company is disappointed that the EMA hasn’t considered its submission to be sufficient, and that it remains fully committed and dedicated to working with regulators toward the vaccine’s approval.

Write to Cecilia Butini at [email protected]

,

Credit: www.marketwatch.com /

- Advertisement -

Stay on top - Get the daily news in your inbox

DMCA / Correction Notice

Recent Articles

Related Stories

Stay on top - Get the daily news in your inbox