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Favorable VLA1553-321 Phase 3 Study Results Boost VALN Stock
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Valneva SE (VALN - Free Report) , a specialty vaccine company, recently reported positive Phase 3 - VLA1553-321 data in adolescents (12 to 17 years old) for its single-shot chikungunya virus (CHIKV) vaccine, IXCHIQ. For investors’ note, IXCHIQ is the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need.
The trial data supports and strengthens the pivotal data previously reported for adolescents in the United States, Europe and Canada. Data from this trial are also expected to support the licensure of IXCHIQ in Brazil.
The new favorable data from the Phase 3 trial helped Valneva advance the furthest along the clinical development timeline.
Impact of the News on VALN Stock
Subsequent to the news, the share price of VALN jumped 1.4% to $4.37 yesterday.
The latest development is capable of generating positive market sentiment, considering the rising number of chikungunya cases in select geographies. We therefore expect market sentiment toward VALN stock to be positive surrounding this news.
Valneva boasts a market capitalization of $346.6 million. The company is estimated to report 8.3% earnings growth in 2024.
About VALN’s Favorable Phase 3 Trial Data
The one-year VLA1553-321 data showed that a single-dose vaccination induced a high, sustained immune response in an immunogenicity subset of participants who were CHIKV negative at baseline, with a seroresponse rate of 98.3% one year after vaccination. The results complement the long-term persistence data previously reported for adults, confirming a strong and long-lasting antibody response to the vaccine.
Additionally, the one-year data confirmed that a single dose of the vaccine was generally well tolerated in adolescents. Throughout the trial, an Independent Data Safety Monitoring Board consistently assessed safety data and found no safety issues.
About Phase 3 Study VLA1553-321
VLA1553-321 is a prospective, double-blinded, multicenter, randomized, placebo-controlled pivotal Phase 3 trial conducted in 754 adolescents in Brazil.
The trial was conducted in collaboration with Instituto Butantan in Brazil and funded by the Coalition for Epidemic Preparedness Innovations (CEPI) with support from the European Union (EU)’s Horizon 2020 program, the VLA1553-321 trial, which represents the first clinical trial conducted in an endemic area and upon individuals previously infected with CHIKV.
Recent Global Expansion of VALN
The FDA application complements the recent label extension submissions to the European Medicines Agency and Health Canada, highlighting Valneva’s strategic push to enhance IXCHIQ’s global reach.
Image Source: Zacks Investment Research
Additionally, the company is actively pursuing marketing authorization in Brazil and expanding collaborations with CEPI to improve vaccine access in low and middle-income countries. Data from the Phase 3 trial may support regulatory approval of the vaccine in Brazil and other countries in Latin America.
Addressing a Growing Public Health Threat
Chikungunya’s geographical spread, exacerbated by climate change, underscores the urgency of accessible vaccines. With more than 3.7 million cases reported in the Americas alone over the past decade, the disease imposes significant medical and economic burdens. Valneva’s advancements with IXCHIQ reinforce its leadership in specialty vaccines, offering hope for mitigating this escalating global health challenge.
By expanding IXCHIQ’s reach and demonstrating its long-term efficacy, Valneva solidifies its position as a key player in combating emerging infectious diseases.
Share Price Performance of VALN
Over the past three years, shares of VALN have plummeted 42.3% against the industry’s 9.5% growth.
VCYT’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 520.58%. Veracyte’s shares have risen 49.2% in the past year compared with the industry’s 5.5% growth.
ResMed, carrying a Zacks Rank #2 (Buy) at present, has an estimated growth rate of 21.1% for 2025. RMD’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 6.41%. Its shares have risen 34.1% compared with the industry’s 7.7% growth in the past year.
Omnicell, carrying a Zacks Rank #2 at present, has an estimated earnings growth rate of 72.7% for fourth-quarter 2024. Its earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 121.74%. OMCL’s shares have risen 26.4% against the industry’s 15.7% decline in the past year.
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Favorable VLA1553-321 Phase 3 Study Results Boost VALN Stock
Valneva SE (VALN - Free Report) , a specialty vaccine company, recently reported positive Phase 3 - VLA1553-321 data in adolescents (12 to 17 years old) for its single-shot chikungunya virus (CHIKV) vaccine, IXCHIQ. For investors’ note, IXCHIQ is the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need.
The trial data supports and strengthens the pivotal data previously reported for adolescents in the United States, Europe and Canada. Data from this trial are also expected to support the licensure of IXCHIQ in Brazil.
The new favorable data from the Phase 3 trial helped Valneva advance the furthest along the clinical development timeline.
Impact of the News on VALN Stock
Subsequent to the news, the share price of VALN jumped 1.4% to $4.37 yesterday.
The latest development is capable of generating positive market sentiment, considering the rising number of chikungunya cases in select geographies. We therefore expect market sentiment toward VALN stock to be positive surrounding this news.
Valneva boasts a market capitalization of $346.6 million. The company is estimated to report 8.3% earnings growth in 2024.
About VALN’s Favorable Phase 3 Trial Data
The one-year VLA1553-321 data showed that a single-dose vaccination induced a high, sustained immune response in an immunogenicity subset of participants who were CHIKV negative at baseline, with a seroresponse rate of 98.3% one year after vaccination. The results complement the long-term persistence data previously reported for adults, confirming a strong and long-lasting antibody response to the vaccine.
Additionally, the one-year data confirmed that a single dose of the vaccine was generally well tolerated in adolescents. Throughout the trial, an Independent Data Safety Monitoring Board consistently assessed safety data and found no safety issues.
About Phase 3 Study VLA1553-321
VLA1553-321 is a prospective, double-blinded, multicenter, randomized, placebo-controlled pivotal Phase 3 trial conducted in 754 adolescents in Brazil.
The trial was conducted in collaboration with Instituto Butantan in Brazil and funded by the Coalition for Epidemic Preparedness Innovations (CEPI) with support from the European Union (EU)’s Horizon 2020 program, the VLA1553-321 trial, which represents the first clinical trial conducted in an endemic area and upon individuals previously infected with CHIKV.
Recent Global Expansion of VALN
The FDA application complements the recent label extension submissions to the European Medicines Agency and Health Canada, highlighting Valneva’s strategic push to enhance IXCHIQ’s global reach.
Image Source: Zacks Investment Research
Additionally, the company is actively pursuing marketing authorization in Brazil and expanding collaborations with CEPI to improve vaccine access in low and middle-income countries. Data from the Phase 3 trial may support regulatory approval of the vaccine in Brazil and other countries in Latin America.
Addressing a Growing Public Health Threat
Chikungunya’s geographical spread, exacerbated by climate change, underscores the urgency of accessible vaccines. With more than 3.7 million cases reported in the Americas alone over the past decade, the disease imposes significant medical and economic burdens. Valneva’s advancements with IXCHIQ reinforce its leadership in specialty vaccines, offering hope for mitigating this escalating global health challenge.
By expanding IXCHIQ’s reach and demonstrating its long-term efficacy, Valneva solidifies its position as a key player in combating emerging infectious diseases.
Share Price Performance of VALN
Over the past three years, shares of VALN have plummeted 42.3% against the industry’s 9.5% growth.
Zacks Rank of Valneva and Key Picks
Valneva currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Veracyte (VCYT - Free Report) , ResMed (RMD - Free Report) and Omnicell (OMCL - Free Report) .
Veracyte, carrying a Zacks Rank #1 (Strong Buy) at present, has an estimated earnings growth rate of 65.8% for 2025. You can see the complete list of today’s Zacks #1 Rank stocks here.
VCYT’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 520.58%. Veracyte’s shares have risen 49.2% in the past year compared with the industry’s 5.5% growth.
ResMed, carrying a Zacks Rank #2 (Buy) at present, has an estimated growth rate of 21.1% for 2025. RMD’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 6.41%. Its shares have risen 34.1% compared with the industry’s 7.7% growth in the past year.
Omnicell, carrying a Zacks Rank #2 at present, has an estimated earnings growth rate of 72.7% for fourth-quarter 2024. Its earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 121.74%. OMCL’s shares have risen 26.4% against the industry’s 15.7% decline in the past year.