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Adagio's (ADGI) COVID-19 Antibody Meets Goals in Studies
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Adagio Therapeutics announced positive preliminary data from two phase II/II studies that are evaluating its monoclonal antibody, adintrevimab (ADG20), for the prevention and treatment of COVID-19 infections.
Adagio is evaluating a 300mg dose of adintrevimab versus placebo across two ongoing phase II/III studies, EVADE and STAMP. While the EVADE study is evaluating the candidate as pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) for the prevention of COVID-19 in two independent cohorts, the STAMP study is evaluating the antibody for the treatment of mild-to-moderate COVID-19 who are at high risk for disease progression.
Based on preliminary data, both the EVADE and STAMP studies achieved primary endpoints with statistical significance and clinically meaningful reduction. The primary efficacy analysis of the data from the EVADE study demonstrated that a reduction in the risk of symptomatic COVID-19 was observed in patients who were administered adintrevimab in comparison to those administered placebo. Relative risk reductions by 71% and 75% were observed in the PrEP and PEP cohorts, respectively.
Conversely, the primary efficacy analysis of the data from the STAMP study demonstrated a reduction in the risk of COVID-19 hospitalization or death by 66% compared to placebo. Further, participants who received antibody treatment within three days of symptom onset experienced a relative risk reduction in COVID-19 hospitalization or death by 77% compared to placebo.
Based on the above data, Adagio intends to discuss these results with the FDA and subsequently submit a regulatory application seeking emergency use authorization (EUA) for adintrevimab as both treatment and prevention of COVID-19.
ADGI’s shares surged 30.4% following the news, as investors were most likely impressed with the results. The company also announced financial results for fourth-quarter 2021. Adagio posted a net loss per share of 77 cents, which beat the Zacks Consensus Estimate of a loss of $1. This may also be attributed to the price rise.
In the year so far, Adagio Therapeutics’ stock price has declined 30.9% in comparison with the industry’s 11.2% decline.
Image Source: Zacks Investment Research
It is to be noted that the FDA has granted EUA to multiple monoclonal antibodies for COVID-19 prevention and treatment. While Eli Lilly’s (LLY - Free Report) bebtelovimab and GlaxoSmithKline’s (GSK - Free Report) /Vir’s sotrovimab are authorized for treating mild-to-moderate COVID-19 patients who are at a high risk of disease progression, AstraZeneca’s (AZN - Free Report) Evusheld is authorized for PrEP (prevention) of COVID-19. If authorized, Adagio’s adintrevimab will face stiff competition from these pharma giants.
AstraZeneca’s Evusheld is the first and currently the only monoclonal antibody cocktail authorized by the FDA to prevent COVID-19 symptoms before virus exposure. Earlier this week, AZN also announced that the therapy has also received marketing authorization in the European Union.
We remind investors that the FDA had authorized Eli Lilly’s bebtelovimab last month. This approval was also a needed win for LLY. Earlier this January, Eli Lilly faced a setback when the FDA revised the EUA granted to its antibody cocktail for COVID-19 treatment. The FDA’s decision was based on data that showed that Lilly’s cocktail therapy was unlikely to be effective against the Omicron variant.
A similar setback was faced by Glaxo earlier this month when the the FDA revised the EUA granted to sotrovimab. The revised EUA restricts the use of GSK’s sotrovimab in certain U.S. regions where the COVID-19 infection is likely to have been caused by a non-susceptible variant of the virus. The decision was based on data that showed that Glaxo’s treatment option was not effective against the Omicron BA.2 subvariant.
Image: Bigstock
Adagio's (ADGI) COVID-19 Antibody Meets Goals in Studies
Adagio Therapeutics announced positive preliminary data from two phase II/II studies that are evaluating its monoclonal antibody, adintrevimab (ADG20), for the prevention and treatment of COVID-19 infections.
Adagio is evaluating a 300mg dose of adintrevimab versus placebo across two ongoing phase II/III studies, EVADE and STAMP. While the EVADE study is evaluating the candidate as pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) for the prevention of COVID-19 in two independent cohorts, the STAMP study is evaluating the antibody for the treatment of mild-to-moderate COVID-19 who are at high risk for disease progression.
Based on preliminary data, both the EVADE and STAMP studies achieved primary endpoints with statistical significance and clinically meaningful reduction. The primary efficacy analysis of the data from the EVADE study demonstrated that a reduction in the risk of symptomatic COVID-19 was observed in patients who were administered adintrevimab in comparison to those administered placebo. Relative risk reductions by 71% and 75% were observed in the PrEP and PEP cohorts, respectively.
Conversely, the primary efficacy analysis of the data from the STAMP study demonstrated a reduction in the risk of COVID-19 hospitalization or death by 66% compared to placebo. Further, participants who received antibody treatment within three days of symptom onset experienced a relative risk reduction in COVID-19 hospitalization or death by 77% compared to placebo.
Based on the above data, Adagio intends to discuss these results with the FDA and subsequently submit a regulatory application seeking emergency use authorization (EUA) for adintrevimab as both treatment and prevention of COVID-19.
ADGI’s shares surged 30.4% following the news, as investors were most likely impressed with the results. The company also announced financial results for fourth-quarter 2021. Adagio posted a net loss per share of 77 cents, which beat the Zacks Consensus Estimate of a loss of $1. This may also be attributed to the price rise.
In the year so far, Adagio Therapeutics’ stock price has declined 30.9% in comparison with the industry’s 11.2% decline.
Image Source: Zacks Investment Research
It is to be noted that the FDA has granted EUA to multiple monoclonal antibodies for COVID-19 prevention and treatment. While Eli Lilly’s (LLY - Free Report) bebtelovimab and GlaxoSmithKline’s (GSK - Free Report) /Vir’s sotrovimab are authorized for treating mild-to-moderate COVID-19 patients who are at a high risk of disease progression, AstraZeneca’s (AZN - Free Report) Evusheld is authorized for PrEP (prevention) of COVID-19. If authorized, Adagio’s adintrevimab will face stiff competition from these pharma giants.
AstraZeneca’s Evusheld is the first and currently the only monoclonal antibody cocktail authorized by the FDA to prevent COVID-19 symptoms before virus exposure. Earlier this week, AZN also announced that the therapy has also received marketing authorization in the European Union.
We remind investors that the FDA had authorized Eli Lilly’s bebtelovimab last month. This approval was also a needed win for LLY. Earlier this January, Eli Lilly faced a setback when the FDA revised the EUA granted to its antibody cocktail for COVID-19 treatment. The FDA’s decision was based on data that showed that Lilly’s cocktail therapy was unlikely to be effective against the Omicron variant.
A similar setback was faced by Glaxo earlier this month when the the FDA revised the EUA granted to sotrovimab. The revised EUA restricts the use of GSK’s sotrovimab in certain U.S. regions where the COVID-19 infection is likely to have been caused by a non-susceptible variant of the virus. The decision was based on data that showed that Glaxo’s treatment option was not effective against the Omicron BA.2 subvariant.
Adagio Therapeutics, Inc. Price
Adagio Therapeutics, Inc. price | Adagio Therapeutics, Inc. Quote
Zacks Rank
Adagio currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.