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Valneva (VALN) Down as EU Considers Ending COVID-Vaccine Deal
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Shares of Valneva (VALN - Free Report) fell 20.6% on May 16, after management announced that the European Commission (EC) has communicated its intent to terminate the advance purchase agreement (APA) for VALN’s inactivated COVID-19 vaccine, VLA2001.
We note that VLA2001 is yet to receive a marketing authorization in the European Union (EU).
Following the receipt of the above notice of intent, Valneva has 30 days from May 13, 2022, to either secure a marketing authorization for VLA2001 from the European Medicines Agency (EMA) or propose an acceptable remediation plan.
While a final decision by the EC is yet to be made, Valneva started discussions with the member states of the EU, which are still interested in receiving its COVID-19 vaccine.
This intent to terminate is a right granted to EC, per the APA terms. The APA allows EC to exercise this right if Valneva is unable to secure a marketing authorization for VLA2001 from the European Medicines Agency (EMA) by Apr 30, 2022.
In the year so far, Valneva’s shares have plunged 61.6% compared with the industry’s 20.3% fall.
Image Source: Zacks Investment Research
Last month, Valneva announced that it had received a further List of Questions (LoQ) from the EMA’s Committee for Medicinal Products for Human Use (CHMP), which requested additional data to support the marketing authorization for VLA2001. Management already submitted its responses to the LoQ on May 2, expecting the responses to satisfy CHMP’s queries. A positive recommendation can be expected next month, provided the CHMP accepts VALN’s responses.
In a separate press release, management announced that Valneva’s COVID vaccine received authorization for emergency use in the United Arab Emirates (UAE). VLA2001 is already authorized for use in the United Kingdom (U.K.) and Bahrain.
The authorizations in Bahrian, the U.K. and the UAE granted to VLA2001 are based on positive top-line data from the pivotal phase III Cov-Compare study that Valneva had announced last October. The Cov-Compare study compared VLA2001 to AstraZeneca’s (AZN - Free Report) COVID vaccine AZD1222. Data from the study demonstrated the superiority of VLA2001 over the AstraZeneca vaccine.
The study achieved both co-primary endpoints two weeks after the second dose of vaccination. VLA2001 produced superior neutralizing antibody titer levels to AstraZeneca’s AZD1222. Further, VLA2001 demonstrated the same effectiveness as AZD1222 in neutralizing antibody seroconversion rates above 95%.
Apart from VLA2001, Valneva is evaluating other vaccines in its pipeline for Lyme disease and chikungunya.
VLA15, Valneva’s vaccine candidate for Lyme disease, is being prepared in collaboration with Pfizer (PFE - Free Report) . Both Valneva and Pfizer successfully completed phase II studies, evaluating VLA15 in both adults (aged 18 years and above) and pediatric participants (from 5 years to 17 years). Based on data from these phase II studies, both Pfizer and Valneva plan to proceed with a phase III study of the vaccine in both pediatric and adult participants, which is expected to start in third-quarter 2022.
We remind investors that Valneva entered into collaboration with Pfizer in 2020 to develop and commercialize VLA15.
Alkermes’ loss per share estimates for 2022 have narrowed from 13 cents to 3 cents in the past 30 days. Shares of ALKS have risen 24.4% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.5%. In the last reported quarter, Alkermes delivered an earnings surprise of 1,100%.
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Valneva (VALN) Down as EU Considers Ending COVID-Vaccine Deal
Shares of Valneva (VALN - Free Report) fell 20.6% on May 16, after management announced that the European Commission (EC) has communicated its intent to terminate the advance purchase agreement (APA) for VALN’s inactivated COVID-19 vaccine, VLA2001.
We note that VLA2001 is yet to receive a marketing authorization in the European Union (EU).
Following the receipt of the above notice of intent, Valneva has 30 days from May 13, 2022, to either secure a marketing authorization for VLA2001 from the European Medicines Agency (EMA) or propose an acceptable remediation plan.
While a final decision by the EC is yet to be made, Valneva started discussions with the member states of the EU, which are still interested in receiving its COVID-19 vaccine.
This intent to terminate is a right granted to EC, per the APA terms. The APA allows EC to exercise this right if Valneva is unable to secure a marketing authorization for VLA2001 from the European Medicines Agency (EMA) by Apr 30, 2022.
In the year so far, Valneva’s shares have plunged 61.6% compared with the industry’s 20.3% fall.
Image Source: Zacks Investment Research
Last month, Valneva announced that it had received a further List of Questions (LoQ) from the EMA’s Committee for Medicinal Products for Human Use (CHMP), which requested additional data to support the marketing authorization for VLA2001. Management already submitted its responses to the LoQ on May 2, expecting the responses to satisfy CHMP’s queries. A positive recommendation can be expected next month, provided the CHMP accepts VALN’s responses.
In a separate press release, management announced that Valneva’s COVID vaccine received authorization for emergency use in the United Arab Emirates (UAE). VLA2001 is already authorized for use in the United Kingdom (U.K.) and Bahrain.
The authorizations in Bahrian, the U.K. and the UAE granted to VLA2001 are based on positive top-line data from the pivotal phase III Cov-Compare study that Valneva had announced last October. The Cov-Compare study compared VLA2001 to AstraZeneca’s (AZN - Free Report) COVID vaccine AZD1222. Data from the study demonstrated the superiority of VLA2001 over the AstraZeneca vaccine.
The study achieved both co-primary endpoints two weeks after the second dose of vaccination. VLA2001 produced superior neutralizing antibody titer levels to AstraZeneca’s AZD1222. Further, VLA2001 demonstrated the same effectiveness as AZD1222 in neutralizing antibody seroconversion rates above 95%.
Apart from VLA2001, Valneva is evaluating other vaccines in its pipeline for Lyme disease and chikungunya.
VLA15, Valneva’s vaccine candidate for Lyme disease, is being prepared in collaboration with Pfizer (PFE - Free Report) . Both Valneva and Pfizer successfully completed phase II studies, evaluating VLA15 in both adults (aged 18 years and above) and pediatric participants (from 5 years to 17 years). Based on data from these phase II studies, both Pfizer and Valneva plan to proceed with a phase III study of the vaccine in both pediatric and adult participants, which is expected to start in third-quarter 2022.
We remind investors that Valneva entered into collaboration with Pfizer in 2020 to develop and commercialize VLA15.
Valneva SE Sponsored ADR Price
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Zacks Rank & Stock to Consider
Valnevacurrently carries a Zacks Rank #4 (Sell).
A better-ranked stock in the overall healthcare sector is Alkermes (ALKS - Free Report) , which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Alkermes’ loss per share estimates for 2022 have narrowed from 13 cents to 3 cents in the past 30 days. Shares of ALKS have risen 24.4% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.5%. In the last reported quarter, Alkermes delivered an earnings surprise of 1,100%.