New Vaccine for Chikungunya Shown To Be Safe in Youths
Source: Edward White
September 5, 2023 (Investorideas.com Newswire) 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.
More Info:
This news is published on the Investorideas.com Newswire - a global digital news source for investors and business leaders
Disclaimer/Disclosure: Investorideas.com is a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investing involves risk and possible losses. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers. Contact management and IR of each company directly regarding specific questions.
More disclaimer info: https://www.investorideas.com/About/Disclaimer.asp Learn more about publishing your news release and our other news services on the Investorideas.com newswire https://www.investorideas.com/News-Upload/
Global investors must adhere to regulations of each country. Please read Investorideas.com privacy policy: https://www.investorideas.com/About/Private_Policy.asp
That's all it takes to get an article published on Investor Ideas - Learn More
