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Valneva (VALN) Gets EC's Approval on Chikungunya Vaccine
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Valneva SE (VALN - Free Report) recently announced that the European Commission (EC) has given it the marketing authorization for Valneva’s single-dose Chikungunya vaccine, IXCHIQ, in Europe. This approval followed the FDA's nod for IXCHIQ in November 2023.
The approval was unanimously endorsed by Member States, followed by a rigorous assessment by the European Medicines Agency.It positions Valneva to protect the lives of European populations against Chikungunya outbreaks and make a significant impact on the Chikungunya vaccine market globally.
Significance of the IXCHIQ Vaccine
In recent years, climate change has caused the Aedes mosquito, a known carrier of chikungunya and dengue viruses, to spread to areas in Europe that were previously unaffected. It is critical to provide a vaccine solution not only to European travelers going to endemic chikungunya areas, such as South America or Africa, but also to the local European populations experiencing invasive mosquito attacks.
IXCHIQ is the world’s first vaccine offering protection against the debilitating Chikungunya virus. The vaccine prevents diseases caused by the chikungunya virus in individuals aged 18 years and above.
Expanding Market Potential
With the latest approval of IXCHIQ, Valneva is expected to deliver the first dose of vaccine in Europe in the fourth quarter of 2024.
Per the International Recognition Procedure, Valneva has also submitted a marketing authorization application to the UK Medicines and Healthcare products Regulatory Agency.
An additional marketing authorization application is under review by the Brazilian Health Regulatory Agency to make the vaccine available in certain low- and middle-income countries, with a potential approval in 2024.
Image Source: Zacks Investment Research
Industry Prospects
Per the Brainy Insights report, the global chikungunya vaccine market was valued at $264 million in 2022 and is expected to reach $624.98 million by 2032, at a CAGR of 9% during the period. Primary factors such as the rising and unmet medical needs of the low-and-middle-income countries, along with the increasing vaccine research and development, should drive the market growth.
Valneva’s latest approval from the EC turns out to be in favor of market growth.
Other Notable Developments
In June 2024, Valneva received Health Canada’s approval for IXCHIQ. This approval was based on a Phase 3 study published in The Lancet in May 2024. The study demonstrated a 98.9% zero response rate, 28 days post-vaccination. This strong immune response was sustained for six months by 96.3% of the participants, showcasing the vaccine’s efficacy and durability.
Price Performance
Year to date, shares of VALN have lost 32% against the industry’s 1.7 % growth.
The Hims & Hers Heath stock has surged 141.3% in the past year. Estimates for the company’s earnings have moved north 10% to 20 cents for 2024 in the past 30 days.
HIMS’ earnings beat estimates in three of the trailing four quarters and missed in one, delivering an average surprise of 79.2%. In the last reported quarter, it posted an earnings surprise of a staggering 150%.
Estimates for The Joint’s 2024 earnings per share (EPS) have remained constant at 21 cents in the past 60 days. Shares of JYNT have surged 37.4% year to date compared with the industry’s 4.1% growth.
In the last reported quarter, JYNT delivered an earnings surprise of 300%. It has a trailing four-quarter average earnings surprise of 18.75%.
Estimates for Medpace’s 2024 EPS have remained unchanged at $11.29 in the past 30 days. Shares of the company have soared 66.4% in the past year compared with the industry’s 2.2% growth.
MEDP’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 12.8%. In the last reported quarter, it delivered an earnings surprise of 30.6%.
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Valneva (VALN) Gets EC's Approval on Chikungunya Vaccine
Valneva SE (VALN - Free Report) recently announced that the European Commission (EC) has given it the marketing authorization for Valneva’s single-dose Chikungunya vaccine, IXCHIQ, in Europe. This approval followed the FDA's nod for IXCHIQ in November 2023.
The approval was unanimously endorsed by Member States, followed by a rigorous assessment by the European Medicines Agency.It positions Valneva to protect the lives of European populations against Chikungunya outbreaks and make a significant impact on the Chikungunya vaccine market globally.
Significance of the IXCHIQ Vaccine
In recent years, climate change has caused the Aedes mosquito, a known carrier of chikungunya and dengue viruses, to spread to areas in Europe that were previously unaffected. It is critical to provide a vaccine solution not only to European travelers going to endemic chikungunya areas, such as South America or Africa, but also to the local European populations experiencing invasive mosquito attacks.
IXCHIQ is the world’s first vaccine offering protection against the debilitating Chikungunya virus. The vaccine prevents diseases caused by the chikungunya virus in individuals aged 18 years and above.
Expanding Market Potential
With the latest approval of IXCHIQ, Valneva is expected to deliver the first dose of vaccine in Europe in the fourth quarter of 2024.
Per the International Recognition Procedure, Valneva has also submitted a marketing authorization application to the UK Medicines and Healthcare products Regulatory Agency.
An additional marketing authorization application is under review by the Brazilian Health Regulatory Agency to make the vaccine available in certain low- and middle-income countries, with a potential approval in 2024.
Image Source: Zacks Investment Research
Industry Prospects
Per the Brainy Insights report, the global chikungunya vaccine market was valued at $264 million in 2022 and is expected to reach $624.98 million by 2032, at a CAGR of 9% during the period. Primary factors such as the rising and unmet medical needs of the low-and-middle-income countries, along with the increasing vaccine research and development, should drive the market growth.
Valneva’s latest approval from the EC turns out to be in favor of market growth.
Other Notable Developments
In June 2024, Valneva received Health Canada’s approval for IXCHIQ. This approval was based on a Phase 3 study published in The Lancet in May 2024. The study demonstrated a 98.9% zero response rate, 28 days post-vaccination. This strong immune response was sustained for six months by 96.3% of the participants, showcasing the vaccine’s efficacy and durability.
Price Performance
Year to date, shares of VALN have lost 32% against the industry’s 1.7 % growth.
Zacks Rank and Key Picks
Valneva currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Hims & Hers Health, Inc. (HIMS - Free Report) , The Joint Corp. (JYNT - Free Report) and Medpace Holdings (MEDP - Free Report) . While Hims & Hers and The Joint currently sport a Zacks Rank #1 (Strong Buy) each, Medpace Holdings carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
The Hims & Hers Heath stock has surged 141.3% in the past year. Estimates for the company’s earnings have moved north 10% to 20 cents for 2024 in the past 30 days.
HIMS’ earnings beat estimates in three of the trailing four quarters and missed in one, delivering an average surprise of 79.2%. In the last reported quarter, it posted an earnings surprise of a staggering 150%.
Estimates for The Joint’s 2024 earnings per share (EPS) have remained constant at 21 cents in the past 60 days. Shares of JYNT have surged 37.4% year to date compared with the industry’s 4.1% growth.
In the last reported quarter, JYNT delivered an earnings surprise of 300%. It has a trailing four-quarter average earnings surprise of 18.75%.
Estimates for Medpace’s 2024 EPS have remained unchanged at $11.29 in the past 30 days. Shares of the company have soared 66.4% in the past year compared with the industry’s 2.2% growth.
MEDP’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 12.8%. In the last reported quarter, it delivered an earnings surprise of 30.6%.