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Valneva (VALN) Begins Submission for COVID-19 Vaccine in UK
Valneva SE (VALN - Free Report) announced that it has commenced the rolling submission for initial approval of its COVID-19 vaccine candidate, VLA2001, with the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”).
The vaccine candidate is currently being evaluated in the phase III Cov-Compare study in the United Kingdom, with top-line results expected early in fourth-quarter 2021. If data from the Cov-Compare study is found to be positive, and upon successful MHRA review of said data, Valneva plans to get initial approval for VLA2001 before the end of the year.
Per the company, VLA2001 is currently the only whole-virus, inactivated, adjuvanted vaccine candidate that is being evaluated in clinical studies for treating COVID-19 in Europe.
Shares of Valneva were up in pre-market trading on Monday following the announcement of the news. The stock has rallied 9.8% in the past three months while the industry remained flat.
Image Source: Zacks Investment Research
Earlier this month, Valneva initiated a further phase III study (VLA2001-304) on VLA2001.
We remind investors that Valneva started trading on the NASDAQ stock exchange following its initial public offering on May 6, 2021.
We note that several big companies have already launched vaccines for fighting the COVID-19 virus.
AstraZeneca’s (AZN - Free Report) adenovirus-based coronavirus vaccine (called Vaxzevria in EU) is approved for emergency use in Europe and several other countries, including India. The company expects to file a biologics license application for its COVID-19 vaccine in the United States in the second half of 2021.
This apart, Pfizer/BioNTech’s (BNTX - Free Report) mRNA-based COVID-19 vaccine, BNT162b2, is approved for emergency/temporary/conditional use in several countries. Another mRNA-based COVID-19 vaccine c, mRNA-1273, developed by Moderna, Inc. (MRNA - Free Report) , has also been approved for emergency/temporary use in various countries. J&J’s single-shot COVID-19 vaccine is also available in the United States and some other countries for emergency use.
Zacks Rank
Valneva currently carries a Zacks Rank #5 (Strong Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.