France-based healthcare stock Valneva SE (NASDAQ: VALN) has revealed positive data related to its inactivated COVID-19 vaccine candidate, VLA2001. Shares of the company closed 45% higher at $47.52 on Wednesday.
The specialty vaccine company said that in preliminary laboratory studies, data demonstrated that three doses of VLA2001 neutralize the Omicron variant. At present, VLA2001 is the only whole virus, inactivated vaccine candidate in clinical trials in Europe that’s intended to fight COVID-19.
Supporting Data
The Phase 1/2 trial VLA2001-201 was designed to evaluate the neutralization of the SARS-CoV-2 virus as well as the Delta and Omicron variants by using serum samples of 30 individuals. Results showed 100% efficacy of tested serum samples in presenting neutralizing antibodies against the SARS-CoV-2 virus and Delta variant, and 87% against the Omicron variant.
Official Comments
CMO of Valneva, Juan Carlos Jaramillo, said, “These results add to earlier findings from our Cov-Compare Phase 3 trial, in which two doses of VLA2001 given as a primary vaccination were shown to induce superior neutralizing antibody levels and a broad T-cell response. We continue to believe that VLA2001 could be an important component of the fight against COVID-19, and Valneva remains fully committed to bringing VLA2001 to people who need it as soon as we can.”
Approvals
Valneva is seeking initial approval of VLA2001 from various regulatory authorities, including the European Medicines Agency (EMA), the U.K. Medicines and Healthcare products Regulatory Agency, and the National Health Regulatory Authority in Bahrain (NHRA). The company expects potential regulatory approvals in the first quarter of 2022, with timely submission of applications.
Wall Street’s Take
Last month, Kempen & Co. analyst Suzanne van Voorthuizen downgraded Valneva to a Sell from a Hold, but maintained a price target of $31 (34.76% downside potential).
Turning to Wall Street, the stock has a Hold consensus rating based on 1 Buy and 1 Sell. The average Valneva price target of $50.50 implies 6.27% upside potential to current levels. That’s after a 61% rise in Valneva’s share price over the past year.
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