VALN - Valneva slips as EU regulators request more data on COVID-19 shot

The ADRs of Valneva (NASDAQ:VALN) have lost ~17% in the premarket Monday after the French biotech announced on Monday that the European Medicines Agency (“EMA”) requested additional data to support the marketing authorization for the company’s COVID-19 vaccine VLA2001. EMA’s Committee for Medicinal Products for Human Use (“CHMP”) has issued a List of Questions (“LoQ”) following its last week’s meeting, the company said, adding that it will send responses in the coming days. Valneva (VALN) expects the EMA to issue a Conditional Marketing Authorization for VLA2001 in this quarter. The inactivated vaccine candidate is designed using the CpG 1018 adjuvant of Dynavax Technologies (DVAX), which is currently trading ~2% lower in the premarket. “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 towards a product approval,” Valneva (VALN) Chief Executive Thomas Lingelbach remarked. Read more on

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Valneva slips as EU regulators request more data on COVID-19 shot