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SAB (SABS) Abandons COVID-19 Treatment Study, Stock Plummets
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Shares of SAB Biotherapeutics (SABS - Free Report) plunged almost 40% on Wednesday after SABS announced discontinuing enrollment in the phase III ACTIV-2 study, which is evaluating its investigational antibody SAB-185 for the treatment of COVID-19.
The ACTIV-2 study was sponsored and conducted by the U.S. National Institutes of Health (NIH). The primary endpoints of the study comprised reductions in hospitalization and death rates.
The discontinuation of the study was decided by NIH after it observed a decline in Omicron-related hospitalization and death rates in the United States. Per SAB Biotherapeutics, the fall in these two endpoints made it difficult to determine statistically significant clinical efficacy of SAB-185 since the study could only manage to enroll limited COVID-19 patients with an observable study endpoint event.
Following the suspension of the study, SAB Biotherapeutics is evaluating plans for the antibody treatment and utilize its potential for prophylactic or therapeutic use in high-risk populations.
In the trailing 12 months, shares of SAB Biotherapeutics have plunged 64.7% compared with the industry’s 15.9% decline.
Image Source: Zacks Investment Research
We note that SAB Biotherapeutics had advanced SAB-185 to the ACTIV-2 study, following a positive review of the interim phase II data by the Data Safety Monitoring Board last September. SABS’ antibody treatment demonstrated neutralization in viral COVID-19 variants, including the Delta and Omicron variants. The phase II study was also sponsored and conducted by NIH.
SAB-185 was being developed by SAB Biotherapeutics with direct support from the U.S. government.
Apart from SAB-185, SABS has only one candidate in clinical development, which is SAB-176. It is an investigational therapeutic for the treatment of seasonal influenza. SAB Biotherapeutics plans to evaluate the candidate in phase II study, which is expected to start in second-quarter 2022.
GlaxoSmithKline (GSK - Free Report) and partner Vir Biotechnology (VIR - Free Report) developed their own monoclonal antibody sotrovimab, which GSK markets under the trade name Xevudy. Glaxo and Vir Biotechnology’s Xevudy was granted an emergency use authorization (EUA) by the FDA last May to treat mild-to-moderate COVID-19 in high-risk adults and pediatric patients (aged at least 12 years and weighing at least 40 kg).
Both Glaxo and Vir Biotechnology plan to file a biologics license application for Xevudy to the FDA in the second half of 2022.
The FDA also granted EUA to Regeneron (REGN - Free Report) and Eli Lilly for their respective antibody cocktails to treat COVID-19. However, in January, both RGEN and Lilly faced a setback when the regulatory body revised the EUA granted to the antibody cocktails that they developed, thereby limiting their use to treat COVID-19 variants with these effective cocktail treatments.
The regulatory agency cited that the antibody cocktails of Lilly and Regeneron are unlikely to be effective against the Omicron variant, which is currently the dominating variant in the country.
Image: Bigstock
SAB (SABS) Abandons COVID-19 Treatment Study, Stock Plummets
Shares of SAB Biotherapeutics (SABS - Free Report) plunged almost 40% on Wednesday after SABS announced discontinuing enrollment in the phase III ACTIV-2 study, which is evaluating its investigational antibody SAB-185 for the treatment of COVID-19.
The ACTIV-2 study was sponsored and conducted by the U.S. National Institutes of Health (NIH). The primary endpoints of the study comprised reductions in hospitalization and death rates.
The discontinuation of the study was decided by NIH after it observed a decline in Omicron-related hospitalization and death rates in the United States. Per SAB Biotherapeutics, the fall in these two endpoints made it difficult to determine statistically significant clinical efficacy of SAB-185 since the study could only manage to enroll limited COVID-19 patients with an observable study endpoint event.
Following the suspension of the study, SAB Biotherapeutics is evaluating plans for the antibody treatment and utilize its potential for prophylactic or therapeutic use in high-risk populations.
In the trailing 12 months, shares of SAB Biotherapeutics have plunged 64.7% compared with the industry’s 15.9% decline.
Image Source: Zacks Investment Research
We note that SAB Biotherapeutics had advanced SAB-185 to the ACTIV-2 study, following a positive review of the interim phase II data by the Data Safety Monitoring Board last September. SABS’ antibody treatment demonstrated neutralization in viral COVID-19 variants, including the Delta and Omicron variants. The phase II study was also sponsored and conducted by NIH.
SAB-185 was being developed by SAB Biotherapeutics with direct support from the U.S. government.
Apart from SAB-185, SABS has only one candidate in clinical development, which is SAB-176. It is an investigational therapeutic for the treatment of seasonal influenza. SAB Biotherapeutics plans to evaluate the candidate in phase II study, which is expected to start in second-quarter 2022.
GlaxoSmithKline (GSK - Free Report) and partner Vir Biotechnology (VIR - Free Report) developed their own monoclonal antibody sotrovimab, which GSK markets under the trade name Xevudy. Glaxo and Vir Biotechnology’s Xevudy was granted an emergency use authorization (EUA) by the FDA last May to treat mild-to-moderate COVID-19 in high-risk adults and pediatric patients (aged at least 12 years and weighing at least 40 kg).
Both Glaxo and Vir Biotechnology plan to file a biologics license application for Xevudy to the FDA in the second half of 2022.
The FDA also granted EUA to Regeneron (REGN - Free Report) and Eli Lilly for their respective antibody cocktails to treat COVID-19. However, in January, both RGEN and Lilly faced a setback when the regulatory body revised the EUA granted to the antibody cocktails that they developed, thereby limiting their use to treat COVID-19 variants with these effective cocktail treatments.
The regulatory agency cited that the antibody cocktails of Lilly and Regeneron are unlikely to be effective against the Omicron variant, which is currently the dominating variant in the country.
SAB Biotherapeutics, Inc. Price
SAB Biotherapeutics, Inc. price | SAB Biotherapeutics, Inc. Quote
Zacks Rank
SAB Biotherapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here