Valneva Receives More Questions From European Regulator For Its COVID-19 Vaccine, Shares Fall

Valneva SE VALN has provided an update on the rolling review process of its inactivated COVID-19 vaccine candidate, VLA2001, with the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).
Following last week's meeting, the CHMP provided another List of Questions that includes requests for additional data and further justification of a Conditional Marketing Authorization.
Valneva will respond to these requests in the coming days. If the CHMP accepts the submissions, the company expects a Conditional Marketing Authorization this quarter.
In February, Valneva received a list of questions as part of the CHMP's initial assessment, which pushed the recommendation into April.
Related: Valneva Shares Jump As Its COVID-19 Vaccine Receives Conditional Approval In UK.
Thomas Lingelbach, CEO of Valneva, commented, "We are disappointed that the EMA has not considered our submissions sufficient to date. We remain fully committed and dedicated to working jointly with the regulators toward product approval."
In its Phase 3 pivotal trial, Valneva demonstrated that two doses of VLA2001 induced superior neutralizing antibody levels and a significantly better tolerability profile than AstraZeneca Plc's AZN vaccine (AZD1222).
Price Action: VALN shares are down 14.4% at $28.00 during the premarket session on the last check Monday.