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New Vaccine for Chikungunya Shown To Be Safe in Youths
Research Report

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The company behind the vaccine plans to use the safety data to support approvals in the U.S., European Union and Brazil, noted an H.C. Wainwright & Co. report.

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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Important Disclosures:

  1. Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor.
  2. The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
  3. This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

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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.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The Firm or its affiliates did not receive compensation from Valneva SE for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in Valneva SE as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request.

H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report. H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report. H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice. Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.

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