- Valneva SE (NASDAQ:VALN) warned it might have to reconsider its FY22 financial guidance after the European Commission informed the company of its intent to terminate an advance purchase agreement (APA) for its VLA2001 COVID-19 candidate vaccine.
- In November, the company signed the APA with the European Commission to supply up to 60 million doses of its COVID-19 vaccine candidate VLA2001 over two years.
- The EC decision is regrettable, especially as we continue to receive messages from Europeans who are looking for a more traditional vaccine solution," CEO Thomas Lingelbach said.
- That advance purchase agreement provided the European Commission the right to cancel the deal if Valneva's VLA2001 had not received marketing authorization from the European Medicines Agency (EMA) by April 30, 2022.
- "Based on the terms of the APA, Valneva has 30 days from May 13, 2022, to obtain marketing authorization or propose an acceptable remediation plan," Valneva said, adding it had submitted its response to the EMA's latest request on May 2.
- Related: Valneva Receives More Questions From European Regulator For Its COVID-19 Vaccine, Shares Fall.
- "The company will work with the European Commission and the participating EC member states to agree to a remediation plan and to make VLA2001 available to those member states who still wish to receive it.
- In April, the U.K. granted conditional approval to Valneva's COVID-19 vaccine.
- Concurrent with the European setback, Valneva's COVID-19 shot has received emergency use authorization in the United Arab Emirates.
- Price Action: VALN shares are down 22% at $19.43 premarket on the last check Monday.
- Photo by hakan german from Pixabay
