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Valneva's (VALN) CHIKV Vaccine Gets Health Canada's Approval
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Valneva SE (VALN - Free Report) , a specialty vaccine company, has achieved a significant milestone with the approval of its single-dose chikungunya vaccine, IXCHIQ, by Health Canada. This approval follows the FDA's nod in November 2023 as well as the European Medicines Agency's recent recommendation for marketing authorization in Europe.
This latest endorsement positions Valneva to significantly impact the chikungunya vaccine market globally.
A Few Words on Chikungunya
Also known as CHIKV, Chikungunya is a mosquito-borne viral disease spread by the bites of infected female Aedes mosquitoes. It commonly causes fever, severe joint pain, muscle pain, headache, nausea, fatigue and rash.
Impact of Climate Change
As climate change drives the spread of the Aedes mosquito, the carrier of the chikungunya virus, the need for effective vaccines has risen manifold. Valneva’s IXCHIQ, the world’s only licensed chikungunya vaccine, is a critical tool in combating this public health threat. Dr. Richard Hatchett, CEO of CEPI, emphasized the importance of expanding access to the vaccine to control the growing number and severity of chikungunya outbreaks worldwide.
Expanding Market Potential
The latest Health Canada approval of IXCHIQ is set to broaden Valneva’s market presence significantly. The company plans to launch the vaccine in Canada in the fourth quarter of 2024, following its U.S. commercialization earlier this year.
Health Canada's approval was based on robust data from a pivotal Phase 3 study published in The Lancet, which demonstrated a 98.9% seroresponse 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.
According to Valenva, over 50 million North Americans, including approximately 7 million Canadians, travel to chikungunya-endemic regions annually. Accordingly, the potential market for IXCHIQ is substantial. The vaccine's approval positions Valneva to address this unmet medical need and mitigate the impact of chikungunya on travelers.
Image Source: Zacks Investment Research
Addressing Global Health Challenges
Valneva's global strategy includes collaborations with the Coalition for Epidemic Preparedness Innovations (CEPI) and Instituto Butantan in Brazil to enhance vaccine accessibility in low- and middle-income countries. This effort is backed by a funding agreement with CEPI, which aims to make the vaccine available to vulnerable populations. The Brazilian Health Regulatory Agency is also reviewing a marketing authorization application, with potential approval expected in 2024.
Share Price Performance
Over the past year, shares of VALN have plunged 30.8% against the industry’s 3.9% growth.
Hims & Hers Heath stock has surged 169.4% in the past year. Estimates for the company’s earnings have increased from 18 cents to 19 cents for 2024 and from 33 cents to 35 cents for 2025 in the past seven 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 ResMed’s fiscal 2024 earnings per share have remained constant at $7.70 in the past 30 days. Shares of the company have declined 4% in the past year compared with the industry’s fall of 0.7%.
RMD’s earnings surpassed estimates in three of the trailing four quarters and missed in one, the average surprise being 2.8%. In the last reported quarter, it delivered an earnings surprise of 10.9%.
Estimates for Medpace’s 2024 earnings per share have remained constant at $11.29 in the past 30 days. Shares of the company have surged 79.4% in the past year compared with the industry’s 5.4% 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's (VALN) CHIKV Vaccine Gets Health Canada's Approval
Valneva SE (VALN - Free Report) , a specialty vaccine company, has achieved a significant milestone with the approval of its single-dose chikungunya vaccine, IXCHIQ, by Health Canada. This approval follows the FDA's nod in November 2023 as well as the European Medicines Agency's recent recommendation for marketing authorization in Europe.
This latest endorsement positions Valneva to significantly impact the chikungunya vaccine market globally.
A Few Words on Chikungunya
Also known as CHIKV, Chikungunya is a mosquito-borne viral disease spread by the bites of infected female Aedes mosquitoes. It commonly causes fever, severe joint pain, muscle pain, headache, nausea, fatigue and rash.
Impact of Climate Change
As climate change drives the spread of the Aedes mosquito, the carrier of the chikungunya virus, the need for effective vaccines has risen manifold. Valneva’s IXCHIQ, the world’s only licensed chikungunya vaccine, is a critical tool in combating this public health threat. Dr. Richard Hatchett, CEO of CEPI, emphasized the importance of expanding access to the vaccine to control the growing number and severity of chikungunya outbreaks worldwide.
Expanding Market Potential
The latest Health Canada approval of IXCHIQ is set to broaden Valneva’s market presence significantly. The company plans to launch the vaccine in Canada in the fourth quarter of 2024, following its U.S. commercialization earlier this year.
Health Canada's approval was based on robust data from a pivotal Phase 3 study published in The Lancet, which demonstrated a 98.9% seroresponse 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.
According to Valenva, over 50 million North Americans, including approximately 7 million Canadians, travel to chikungunya-endemic regions annually. Accordingly, the potential market for IXCHIQ is substantial. The vaccine's approval positions Valneva to address this unmet medical need and mitigate the impact of chikungunya on travelers.
Image Source: Zacks Investment Research
Addressing Global Health Challenges
Valneva's global strategy includes collaborations with the Coalition for Epidemic Preparedness Innovations (CEPI) and Instituto Butantan in Brazil to enhance vaccine accessibility in low- and middle-income countries. This effort is backed by a funding agreement with CEPI, which aims to make the vaccine available to vulnerable populations. The Brazilian Health Regulatory Agency is also reviewing a marketing authorization application, with potential approval expected in 2024.
Share Price Performance
Over the past year, shares of VALN have plunged 30.8% against the industry’s 3.9% 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 (HIMS - Free Report) , ResMed (RMD - Free Report) and Medpace (MEDP - Free Report) . While Hims & Hers Health and ResMed each sport a Zacks Rank #1 (Strong Buy), Medpace carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks Rank #1 stocks here.
Hims & Hers Heath stock has surged 169.4% in the past year. Estimates for the company’s earnings have increased from 18 cents to 19 cents for 2024 and from 33 cents to 35 cents for 2025 in the past seven 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 ResMed’s fiscal 2024 earnings per share have remained constant at $7.70 in the past 30 days. Shares of the company have declined 4% in the past year compared with the industry’s fall of 0.7%.
RMD’s earnings surpassed estimates in three of the trailing four quarters and missed in one, the average surprise being 2.8%. In the last reported quarter, it delivered an earnings surprise of 10.9%.
Estimates for Medpace’s 2024 earnings per share have remained constant at $11.29 in the past 30 days. Shares of the company have surged 79.4% in the past year compared with the industry’s 5.4% 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%.