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VALN Stock Nosedives on Mixed Results From Lyme Disease Vaccine Study
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Key Takeaways
VALN stock dropped 37% after its Lyme vaccine missed a key statistical benchmark in a phase III study.
Valneva reported 73.2% efficacy at 28 days, but the confidence interval fell below the required threshold.
PF-07307405 showed 74.8% efficacy in a second analysis, supporting planned global filings.
Shares of Valneva (VALN - Free Report) tanked 37% on Monday after the company reported top-line results from the phase III VALOR study, which evaluated its experimental Lyme disease vaccine, PF-07307405 (formerly VLA15). The vaccine is being developed in collaboration with pharma giant Pfizer (PFE - Free Report) .
Though the vaccine showed an efficacy rate of more than 70%, the results fell short of a pre-specified statistical criterion.
Breaking Down Valneva/Pfizer’s VALOR Study Results
The companies conducted two pre-specified analyses — one conducted 28 days after receiving the fourth and final dose, and another conducted just a day after receiving this dose.
Data from the first analysis showed that PF-07307405 was 73.2% effective compared to placebo in preventing Lyme disease 28 days after the final dose. The lower bound of the 95% confidence interval was 15.8%, below the pre-defined 20% threshold, resulting in a miss on the primary endpoint.
Per Valneva and Pfizer, this shortfall was attributed to “fewer than anticipated Lyme disease cases being accrued over the study period,” which limited the statistical power of the analysis.
In the second pre-specified analysis, conducted one day after the fourth dose, the vaccine demonstrated efficacy of 74.8%, with the lower bound of the confidence interval meeting the statistical requirement. Based on this analysis, Valneva and Pfizer are willing to move forward with regulatory submissions worldwide for the vaccine.
The companies pointed out that there are currently no approved vaccines for Lyme disease globally, underscoring a significant unmet medical need. Despite the primary endpoint miss in the first analysis, Pfizer and Valneva noted that the overall data package supports the PF-07307405’s clinical benefit and expressed confidence in the vaccine’s potential, positioning it as a potentially first-in-class preventive option for Lyme disease.
VALN Stock’s Performance
Shares of Valneva were down yesterday as investors remain focused on the miss in the primary endpoint, which they perceive could introduce regulatory uncertainty.
Year to date, the stock has lost 26% compared with the industry’s 12.5% decline.
Image Source: Zacks Investment Research
More on VALN/PFE’s Lyme Disease Vaccine
PF-07307405 is being developed as part of a collaboration agreement between the company and Pfizer, signed in 2022. Per the deal terms, Pfizer has exclusive rights to manufacture and market the vaccine.
In return, Valneva received an upfront payment of $130 million and is eligible to receive milestone payments worth $178 million. The company is required to fund 30% of all development costs through completion of the development program.
VALN is eligible to receive tiered royalties from Pfizer on future sales of the vaccine.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have risen from $2.55 to $2.87, while those for 2027 have increased from $2.85 to $3.25. CPRX shares have registered breakeven growth year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 EPS have increased from $8.28 to $8.99, while the same for 2027 have risen from $9.25 to $10.10. The stock has declined 6% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
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VALN Stock Nosedives on Mixed Results From Lyme Disease Vaccine Study
Key Takeaways
Shares of Valneva (VALN - Free Report) tanked 37% on Monday after the company reported top-line results from the phase III VALOR study, which evaluated its experimental Lyme disease vaccine, PF-07307405 (formerly VLA15). The vaccine is being developed in collaboration with pharma giant Pfizer (PFE - Free Report) .
Though the vaccine showed an efficacy rate of more than 70%, the results fell short of a pre-specified statistical criterion.
Breaking Down Valneva/Pfizer’s VALOR Study Results
The companies conducted two pre-specified analyses — one conducted 28 days after receiving the fourth and final dose, and another conducted just a day after receiving this dose.
Data from the first analysis showed that PF-07307405 was 73.2% effective compared to placebo in preventing Lyme disease 28 days after the final dose. The lower bound of the 95% confidence interval was 15.8%, below the pre-defined 20% threshold, resulting in a miss on the primary endpoint.
Per Valneva and Pfizer, this shortfall was attributed to “fewer than anticipated Lyme disease cases being accrued over the study period,” which limited the statistical power of the analysis.
In the second pre-specified analysis, conducted one day after the fourth dose, the vaccine demonstrated efficacy of 74.8%, with the lower bound of the confidence interval meeting the statistical requirement. Based on this analysis, Valneva and Pfizer are willing to move forward with regulatory submissions worldwide for the vaccine.
The companies pointed out that there are currently no approved vaccines for Lyme disease globally, underscoring a significant unmet medical need. Despite the primary endpoint miss in the first analysis, Pfizer and Valneva noted that the overall data package supports the PF-07307405’s clinical benefit and expressed confidence in the vaccine’s potential, positioning it as a potentially first-in-class preventive option for Lyme disease.
VALN Stock’s Performance
Shares of Valneva were down yesterday as investors remain focused on the miss in the primary endpoint, which they perceive could introduce regulatory uncertainty.
Year to date, the stock has lost 26% compared with the industry’s 12.5% decline.
Image Source: Zacks Investment Research
More on VALN/PFE’s Lyme Disease Vaccine
PF-07307405 is being developed as part of a collaboration agreement between the company and Pfizer, signed in 2022. Per the deal terms, Pfizer has exclusive rights to manufacture and market the vaccine.
In return, Valneva received an upfront payment of $130 million and is eligible to receive milestone payments worth $178 million. The company is required to fund 30% of all development costs through completion of the development program.
VALN is eligible to receive tiered royalties from Pfizer on future sales of the vaccine.
VALN’s Zacks Rank
Valneva currently carries a Zacks Rank #3 (Hold).
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 Catalyst Pharmaceuticals (CPRX - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) . While CPRX sports a Zacks Rank #1 (Strong Buy) at present, ANIP carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have risen from $2.55 to $2.87, while those for 2027 have increased from $2.85 to $3.25. CPRX shares have registered breakeven growth year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 EPS have increased from $8.28 to $8.99, while the same for 2027 have risen from $9.25 to $10.10. The stock has declined 6% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.