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VALN Doses First Infant With Shigella Vaccine in Mid-Stage Study
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Shares of Valneva (VALN - Free Report) rose 12% on Wednesday after the company announced that it has vaccinated the first participant in a phase II study evaluating its investigational Shigella vaccine, Shigella4V2 (S4V2).
This study will test the safety and immunogenicity of S4V2 in about 110 infants to identify the best vaccine dose for a late-stage study. The study participants will receive a two-dose regimen with either one of two different vaccine dose levels of S4V2 or a control vaccine.
The safety of the vaccine will be closely monitored throughout the study, which will run for six months after the final dose. Results from the study are expected in the second half of 2025.
Shigella is a bacterium that causes shigellosis, the second leading cause of fatal diarrheal disease globally. It significantly contributes to pediatric illness and mortality, especially in low and middle-income countries. Valneva estimates that Shigella is responsible for up to 165 million infections, out of which more than 62 million occur in children younger than five years.
VALN Stock’s Performance
The rise in share price is likely driven by growing investor optimism surrounding the commercial potential of S4V2. With no approved vaccine currently available, shigellosis remains a major global health concern, creating a sizable unmet market opportunity. Adding to the positive sentiment is the FDA’s fast track designation for S4V2 last year, reflecting increased regulatory support and potentially expediting the vaccine’s development and review timeline.
Year to date, shares of Valneva have surged 55% against the industry’s 4% decline.
Image Source: Zacks Investment Research
More on VALN’s Shigella Vaccine
This is the second mid-stage study initiated by Valneva on S4V2. Last year, Valneva started a phase IIb controlled human infection model (CHIM) study, which is evaluating the vaccine in nearly 120 healthy Shigella-naïve participants aged 18 to 50 years.
Both the ongoing mid-stage studies are supported by positive data from a phase I/II study, which showed that S4V2 exhibited a favorable safety and tolerability profile, along with robust immunogenicity against the four most common Shigella serotypes — S. flexneri 2a, 3a, 6 and S. sonnei.
The vaccine is being developed as part of an exclusive licensing agreement with LimmaTech Biologics, signed last year. While LimmaTech remains responsible for conducting both the above-mentioned mid-stage studies, Valneva will be accountable for the vaccine’s further development, regulatory filings and commercialization activities.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have risen from $5.54 to $6.35. EPS estimates for 2026 have increased from $6.75 to $7.21 during the same period.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 17.32%.
In the past 60 days, estimates for CytomX Therapeutics’ 2025 EPS have improved from a loss of 31 cents to a profit of 25 cents. During the same timeframe, estimates for 2026 loss per share have narrowed from 65 cents to 31 cents.
CytomX Therapeutics’ earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 180.70%.
Estimates for 89bio’s loss per share have narrowed from $2.51 to $1.98 for 2025 in the past 60 days. During the same time frame, estimates for 2026 loss per share have improved from $2.94 to $2.15.
89bio’s earnings missed estimates in three of the trailing four quarters and beat the mark on one occasion, delivering an average negative surprise of 46.18%.
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VALN Doses First Infant With Shigella Vaccine in Mid-Stage Study
Shares of Valneva (VALN - Free Report) rose 12% on Wednesday after the company announced that it has vaccinated the first participant in a phase II study evaluating its investigational Shigella vaccine, Shigella4V2 (S4V2).
This study will test the safety and immunogenicity of S4V2 in about 110 infants to identify the best vaccine dose for a late-stage study. The study participants will receive a two-dose regimen with either one of two different vaccine dose levels of S4V2 or a control vaccine.
The safety of the vaccine will be closely monitored throughout the study, which will run for six months after the final dose. Results from the study are expected in the second half of 2025.
Shigella is a bacterium that causes shigellosis, the second leading cause of fatal diarrheal disease globally. It significantly contributes to pediatric illness and mortality, especially in low and middle-income countries. Valneva estimates that Shigella is responsible for up to 165 million infections, out of which more than 62 million occur in children younger than five years.
VALN Stock’s Performance
The rise in share price is likely driven by growing investor optimism surrounding the commercial potential of S4V2. With no approved vaccine currently available, shigellosis remains a major global health concern, creating a sizable unmet market opportunity. Adding to the positive sentiment is the FDA’s fast track designation for S4V2 last year, reflecting increased regulatory support and potentially expediting the vaccine’s development and review timeline.
Year to date, shares of Valneva have surged 55% against the industry’s 4% decline.
Image Source: Zacks Investment Research
More on VALN’s Shigella Vaccine
This is the second mid-stage study initiated by Valneva on S4V2. Last year, Valneva started a phase IIb controlled human infection model (CHIM) study, which is evaluating the vaccine in nearly 120 healthy Shigella-naïve participants aged 18 to 50 years.
Both the ongoing mid-stage studies are supported by positive data from a phase I/II study, which showed that S4V2 exhibited a favorable safety and tolerability profile, along with robust immunogenicity against the four most common Shigella serotypes — S. flexneri 2a, 3a, 6 and S. sonnei.
The vaccine is being developed as part of an exclusive licensing agreement with LimmaTech Biologics, signed last year. While LimmaTech remains responsible for conducting both the above-mentioned mid-stage studies, Valneva will be accountable for the vaccine’s further development, regulatory filings and commercialization activities.
VALN’s Zacks Ranks
Valneva currently carries a Zacks Rank #4 (Sell).
Valneva SE Sponsored ADR Price
Valneva SE Sponsored ADR price | Valneva SE Sponsored ADR Quote
Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are ANI Pharmaceuticals (ANIP - Free Report) , CytomX Therapeutics (CTMX - Free Report) and 89bio (ETNB - Free Report) . While ANIP and CTMX sport a Zacks Rank #1 (Strong Buy) each at present, ETNB carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have risen from $5.54 to $6.35. EPS estimates for 2026 have increased from $6.75 to $7.21 during the same period.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 17.32%.
In the past 60 days, estimates for CytomX Therapeutics’ 2025 EPS have improved from a loss of 31 cents to a profit of 25 cents. During the same timeframe, estimates for 2026 loss per share have narrowed from 65 cents to 31 cents.
CytomX Therapeutics’ earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 180.70%.
Estimates for 89bio’s loss per share have narrowed from $2.51 to $1.98 for 2025 in the past 60 days. During the same time frame, estimates for 2026 loss per share have improved from $2.94 to $2.15.
89bio’s earnings missed estimates in three of the trailing four quarters and beat the mark on one occasion, delivering an average negative surprise of 46.18%.