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Vir Biotechnology (VIR) Down on Influenza Study Failure
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Shares of Vir Biotechnology (VIR - Free Report) plunged 44.90% after the company announced that the mid-stage PENINSULA (PrevEntioN of IllNesS DUe to InfLuenza A) study evaluating VIR-2482 for the prevention of symptomatic influenza A was unsuccessful.
VIR-2482 is an investigational hemagglutinin targeting, intramuscularly administered influenza A-neutralizing monoclonal antibody.
The phase II dose-ranging proof-of-concept study PENINSULA is the first outpatient study to evaluate the role of a monoclonal antibody in the prevention of influenza A illness. The study (n=3000) enrolled men and women in the age group 18 to 64 without serious risk factors for complications from an influenza infection who did not receive an influenza vaccination for the flu season.
The primary efficacy endpoint was the proportion of trial participants with protocol-defined influenza-like-illness1 with Protocol-defined Influenza-Like-Illness (PCR)-confirmed influenza A infection compared with placebo. Secondary endpoints included the proportion of participants with CDC-defined influenza-like-illness with PCR-confirmed influenza A infection and the proportion of participants with WHO-defined influenza-like-illness with PCR-confirmed influenza A infection.
The study did not meet primary or secondary efficacy endpoints. Investors were disappointed with the outcome and shares were down on the same.
Data showed that the participants who received the highest dose of VIR-2482 (1,200 mg) experienced a reduction of approximately 16% in influenza A protocol-defined illness, which was statistically insignificant.
Participants who received the highest dose showed an approximately 57% reduction in symptomatic influenza A illness. Nevertheless, the candidate was generally well tolerated and no safety signals were identified.
Shares of Vir have plunged 47.7% year to date compared with the industry's 8.5% decline.
Image Source: Zacks Investment Research
The study was supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR) and Biomedical Advanced Research and Development Authority (BARDA).
Vir Biotech has a collaboration agreement with GSK plc (GSK - Free Report) . Per the agreement signed in 2021, GSK has the option to lead post-phase II development and commercialization of VIR-2482.
Following the outcome of this study, VIR will now focus on VIR-2981, an investigational neuraminidase-targeting monoclonal antibody against both influenza A and B viruses.
Zacks Rank & Stocks to Consider
Vir currently carries a Zacks Rank #5 (Strong Sell).
The Zacks Consensus Estimate for Alkermes’ 2023 earnings increased from 20 cents to $1.02 in the past 60 days. Earnings estimates for 2024 increased from $1.73 to $2.08 in the past 60 days. ALKS beat estimates in three of the last four quarters and met the mark on one occasion, the average surprise being 90.83%.
In the past 90 days, the Zacks Consensus Estimate for Anixa Biosciences 2023 loss per share has narrowed from 43 cents to 39 cents. During the same period, the estimate for 2024 loss per share has narrowed from 46 cents to 38 cents. ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 31.21%.
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Vir Biotechnology (VIR) Down on Influenza Study Failure
Shares of Vir Biotechnology (VIR - Free Report) plunged 44.90% after the company announced that the mid-stage PENINSULA (PrevEntioN of IllNesS DUe to InfLuenza A) study evaluating VIR-2482 for the prevention of symptomatic influenza A was unsuccessful.
VIR-2482 is an investigational hemagglutinin targeting, intramuscularly administered influenza A-neutralizing monoclonal antibody.
The phase II dose-ranging proof-of-concept study PENINSULA is the first outpatient study to evaluate the role of a monoclonal antibody in the prevention of influenza A illness. The study (n=3000) enrolled men and women in the age group 18 to 64 without serious risk factors for complications from an influenza infection who did not receive an influenza vaccination for the flu season.
The primary efficacy endpoint was the proportion of trial participants with protocol-defined influenza-like-illness1 with Protocol-defined Influenza-Like-Illness (PCR)-confirmed influenza A infection compared with placebo. Secondary endpoints included the proportion of participants with CDC-defined influenza-like-illness with PCR-confirmed influenza A infection and the proportion of participants with WHO-defined influenza-like-illness with PCR-confirmed influenza A infection.
The study did not meet primary or secondary efficacy endpoints. Investors were disappointed with the outcome and shares were down on the same.
Data showed that the participants who received the highest dose of VIR-2482 (1,200 mg) experienced a reduction of approximately 16% in influenza A protocol-defined illness, which was statistically insignificant.
Participants who received the highest dose showed an approximately 57% reduction in symptomatic influenza A illness. Nevertheless, the candidate was generally well tolerated and no safety signals were identified.
Shares of Vir have plunged 47.7% year to date compared with the industry's 8.5% decline.
Image Source: Zacks Investment Research
The study was supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR) and Biomedical Advanced Research and Development Authority (BARDA).
Vir Biotech has a collaboration agreement with GSK plc (GSK - Free Report) . Per the agreement signed in 2021, GSK has the option to lead post-phase II development and commercialization of VIR-2482.
Following the outcome of this study, VIR will now focus on VIR-2981, an investigational neuraminidase-targeting monoclonal antibody against both influenza A and B viruses.
Zacks Rank & Stocks to Consider
Vir currently carries a Zacks Rank #5 (Strong Sell).
Some better-ranked stocks in the healthcare sector are Alkermes (ALKS - Free Report) and Anixa Biosciences (ANIX - Free Report) . Alkermes sports a Zacks Rank #1 (Strong Buy), Anixa carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
The Zacks Consensus Estimate for Alkermes’ 2023 earnings increased from 20 cents to $1.02 in the past 60 days. Earnings estimates for 2024 increased from $1.73 to $2.08 in the past 60 days. ALKS beat estimates in three of the last four quarters and met the mark on one occasion, the average surprise being 90.83%.
In the past 90 days, the Zacks Consensus Estimate for Anixa Biosciences 2023 loss per share has narrowed from 43 cents to 39 cents. During the same period, the estimate for 2024 loss per share has narrowed from 46 cents to 38 cents. ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 31.21%.