Valneva SE (VALN:NASDAQ; VLA:FRA) released the first results of its Phase 3 study in adolescents of its vaccine VLA1553 for chikungunya, a mosquito-borne viral disease, which were positive, reported H.C. Wainwright & Co. analyst Edward White in an August 28 research note.
"These initial Phase 3 safety data suggest a favorable safety profile in seropositive patients," White wrote.
Attractive Return on Investment
Accordingly, H.C. Wainwright maintained its US$22 per share price target on the France-based vaccine developer, currently trading at about US$13.50 per share. The difference between these prices suggests an attractive return for investors of 63%.
Valneva is still a Buy.
Safety Data Review
White briefly described the Phase 3 study and presented the initial results.
The VLA1553-321 trial, being carried out at multiple centers in Brazil, is double-blind, randomized, and placebo-controlled. The purpose is to evaluate the immunogenicity and safety of the adult dose of VLA1553 28 days after vaccination. These first data from VLA1553-321 include results up to Day 29, noted White.
As for the results, an independent data safety monitoring board did not find any safety issues with the vaccine.
Similarly, Valneva reported that VLA1553 was generally safe and well tolerated in adolescents between ages 12 and 17, whether or not they previously had a chikungunya infection. Most of the adverse events study participants experienced were mild or moderate and resolved within three days' time. These results were in line with those of the pivotal study in adults.
Immunogenicity data from this trial in adolescents are expected in November 2023.
Working Toward Approvals
Valneva aims to use the data from the VLA1553-321 trial to support regulatory requests in three regions.
For one, the company aims to get the vaccine licensed in Brazil.
Also, Valneva is looking to obtain a label extension to include adolescents in the U.S. after the U.S. Food and Drug Administration (FDA) approves it for adults. In the U.S., the vaccine has fast-track and breakthrough therapy designations. A biologics license application for VLA1553 is under priority review with the FDA, and the PDUFA date for it is at the end of November 2023.
"The sponsor of the first chikungunya vaccine approved in the U.S. will be eligible for a priority review voucher (PRV), which could be worth around US$100 million based on prior PRV sales," White pointed out.
Third, in the European Union, where VLA1553 has PRIME designation, Valneva intends to use these Phase 3 data to support a regulatory submission to the European Medicines Agency planned for later this year.
Valneva already filed a regulatory application with Health Canada in May of this year, seeking approval to market VLA1553 for adults.
Looking past approvals, H.C. Wainwright forecasts VLA1553 sales will reach €40 million in 2024 then increase to €350 million in 2028, White noted.
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Disclosures for H.C.Wainwright & Co., Valneva SE, August 28, 2023
H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Edward White , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of Valneva SE (including, without limitation, any option, right, warrant, future, long or short position). As of July 31, 2023 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Valneva SE. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.
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