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Regeneron's BLA for Ebola Vaccine Gets FDA's Priority Review
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has accepted the biologics license application (BLA) for its investigational therapy, REGN-EB3. The company is seeking an approval for the candidate as a triple antibody cocktail treatment of the deadly Ebola virus infection.
With the FDA granting a priority review to the BLA, a decision from the regulatory body is expected on Oct 25, 2020.
The BLA was based on data from the randomized, controlled clinical study, PALM, conducted in the Democratic Republic of Congo for the given indication.
In August 2019, Regeneron announced that its study evaluating four investigational therapies for Ebola virus infection was stopped early as REGN-EB3 was found superior to Mapp Biopharmaceutical Inc.'s ZMapp (the control arm) in preventing death.
Per management, the study was concluded before time because REGN-EB3 demonstrated a highly statistically significant result compared to ZMapp, which was considered a standard-of-care treatment. REGN-EB3 showed superior efficacy across multiple measures including reduced mortality and fewer days until the Ebola virus was no longer detected in the bloodstream as compared to ZMapp.
The company is also developing REGN-EB3 as a treatment for Ebola in collaboration with HHS’ Biomedical Advanced Research and Development Authority (BARDA).
We note that REGN-EB3 was invented by Regeneron using its VelociSuite technologies. The company is now using the same approach to develop an antibody therapy that can potentially prevent and treat the novel coronavirus disease, COVID-19. Initial clinical studies for the same are expected to begin this June.
Shares of Regeneron have rallied 43.8% so far this year against the industry’s decline of 5.1%.
Ebola virus disease is rare but can become severe and prove to be fatal as well. The disease can also spread fast causing an outbreak.
We remind investors that in December 2019, the FDA granted approval to Merck’s (MRK - Free Report) vaccine for Ebola Zaire disease, Ervebo (V920). The vaccine was approved for active immunization of individuals who are 18 years of age or older. It is the first FDA-approved vaccine to prevent Ebola virus disease.
Meanwhile, last August, Glaxo (GSK - Free Report) granted an exclusive technology license to Sabin Vaccine Institute for developing its Ebola vaccine candidates. Small biotech Inovio Pharmaceuticals (INO - Free Report) is also currently developing Ebola vaccine candidate.
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
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Regeneron's BLA for Ebola Vaccine Gets FDA's Priority Review
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has accepted the biologics license application (BLA) for its investigational therapy, REGN-EB3. The company is seeking an approval for the candidate as a triple antibody cocktail treatment of the deadly Ebola virus infection.
With the FDA granting a priority review to the BLA, a decision from the regulatory body is expected on Oct 25, 2020.
The BLA was based on data from the randomized, controlled clinical study, PALM, conducted in the Democratic Republic of Congo for the given indication.
In August 2019, Regeneron announced that its study evaluating four investigational therapies for Ebola virus infection was stopped early as REGN-EB3 was found superior to Mapp Biopharmaceutical Inc.'s ZMapp (the control arm) in preventing death.
Per management, the study was concluded before time because REGN-EB3 demonstrated a highly statistically significant result compared to ZMapp, which was considered a standard-of-care treatment. REGN-EB3 showed superior efficacy across multiple measures including reduced mortality and fewer days until the Ebola virus was no longer detected in the bloodstream as compared to ZMapp.
The company is also developing REGN-EB3 as a treatment for Ebola in collaboration with HHS’ Biomedical Advanced Research and Development Authority (BARDA).
We note that REGN-EB3 was invented by Regeneron using its VelociSuite technologies. The company is now using the same approach to develop an antibody therapy that can potentially prevent and treat the novel coronavirus disease, COVID-19. Initial clinical studies for the same are expected to begin this June.
Shares of Regeneron have rallied 43.8% so far this year against the industry’s decline of 5.1%.
Ebola virus disease is rare but can become severe and prove to be fatal as well. The disease can also spread fast causing an outbreak.
We remind investors that in December 2019, the FDA granted approval to Merck’s (MRK - Free Report) vaccine for Ebola Zaire disease, Ervebo (V920). The vaccine was approved for active immunization of individuals who are 18 years of age or older. It is the first FDA-approved vaccine to prevent Ebola virus disease.
Meanwhile, last August, Glaxo (GSK - Free Report) granted an exclusive technology license to Sabin Vaccine Institute for developing its Ebola vaccine candidates. Small biotech Inovio Pharmaceuticals (INO - Free Report) is also currently developing Ebola vaccine candidate.
Zacks Rank
Regeneron currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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