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Emergent's (EBS) Cyfendus Anthrax Vaccine Gets FDA Nod
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Emergent’s (EBS - Free Report) shares were up more than 16% in after-market hours on Thursday, as the FDA approved Cyfendus, its anthrax vaccine for people aged between 18 and 65, who may have been exposed to bacillus anthracis, a harmful germ.
The vaccine, previously known as AV7909, has been approved for post-exposure prophylaxis of disease following suspected or confirmed exposure to the germ, Bacillus anthracis. It is taken with recommended antibacterial medications.
Since 2019, Emergent has been supplying AV7909 to the U.S. Department of Health and Human Services with pre-emergency use authorization status. The company plans to maintain its collaboration with the U.S. government to facilitate the shift toward post-approval procurement.
The biologics license application seeking approval for AV7909 was accepted for review by the FDA in April 2022. The regulatory approval of the Cyfendus vaccine was based on comprehensive data gathered from a couple of mid-late-stage studies conducted by EBS, supported and funded by the U.S. government.
A non-clinical study was also conducted to assess the vaccine's protective efficacy against lethal anthrax spore challenges and identify neutralizing antibody levels associated with disease protection.
Shares of Emergent have nosedived 40.2% year to date compared with the industry’s 8.6% decline.
Image Source: Zacks Investment Research
Cyfendus vaccine consists of anthrax vaccine, adsorbed along with an additional adjuvant, which has been shown to elicit protective levels of immune response when administered in two doses over 14 days. This rapid immune response can be particularly crucial in addressing large-scale public health emergencies involving anthrax.
In addition to Cyfendus, Emergent's anthrax franchise includes the BioThrax vaccine, licensed by the FDA for the general use prophylaxis and post-exposure prophylaxis of anthrax disease, and two treatments — Anthrasil (anthrax immune globulin intravenous - human), a polyclonal antibody therapeutic, and Raxibacumab, a monoclonal antibody therapeutic.
In May, the company completed the sale of its travel health business to Denmark’s biotechnology company, Bavarian Nordic. Per the agreement, Bavarian Nordic acquired rights to the drugs, Vaxchora and Vivotif, and the development-stage chikungunya vaccine candidate, CHIKV VLP, for a cash purchase price of $270 million.
In the past 90 days, the Zacks Consensus Estimate for ADC Therapeutics has widened from a loss of $2.58 per share to a loss of $2.61 for 2023. The consensus estimate has narrowed from a loss of $2.72 per share to a loss of $2.45 for 2024 during the same time frame. Shares of the company have lost 60.9% year to date.
ADCT’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 10.70%.
In the past 90 days, the Zacks Consensus Estimate for Acadia Pharmaceuticals has narrowed from a loss of 58 cents per share to a loss of 31 cents for 2023. Shares of the company have rallied 96.4% year to date.
ACAD’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average negative earnings surprise of 2.75%.
In the past 90 days, the Zacks Consensus Estimate for Akoya Biosciences has narrowed from a loss of $1.80 per share to a loss of $1.71 for 2023. The consensus estimate for Akoya Biosciences has narrowed from a loss of $1.57 per share to a loss of $1.33 for 2024 during the same time frame. Shares of the company have lost 27% year to date.
AKYA’s earnings missed estimates in each of the trailing four quarters, delivering an average negative surprise of 21.05%.
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Emergent's (EBS) Cyfendus Anthrax Vaccine Gets FDA Nod
Emergent’s (EBS - Free Report) shares were up more than 16% in after-market hours on Thursday, as the FDA approved Cyfendus, its anthrax vaccine for people aged between 18 and 65, who may have been exposed to bacillus anthracis, a harmful germ.
The vaccine, previously known as AV7909, has been approved for post-exposure prophylaxis of disease following suspected or confirmed exposure to the germ, Bacillus anthracis. It is taken with recommended antibacterial medications.
Since 2019, Emergent has been supplying AV7909 to the U.S. Department of Health and Human Services with pre-emergency use authorization status. The company plans to maintain its collaboration with the U.S. government to facilitate the shift toward post-approval procurement.
The biologics license application seeking approval for AV7909 was accepted for review by the FDA in April 2022. The regulatory approval of the Cyfendus vaccine was based on comprehensive data gathered from a couple of mid-late-stage studies conducted by EBS, supported and funded by the U.S. government.
A non-clinical study was also conducted to assess the vaccine's protective efficacy against lethal anthrax spore challenges and identify neutralizing antibody levels associated with disease protection.
Shares of Emergent have nosedived 40.2% year to date compared with the industry’s 8.6% decline.
Image Source: Zacks Investment Research
Cyfendus vaccine consists of anthrax vaccine, adsorbed along with an additional adjuvant, which has been shown to elicit protective levels of immune response when administered in two doses over 14 days. This rapid immune response can be particularly crucial in addressing large-scale public health emergencies involving anthrax.
In addition to Cyfendus, Emergent's anthrax franchise includes the BioThrax vaccine, licensed by the FDA for the general use prophylaxis and post-exposure prophylaxis of anthrax disease, and two treatments — Anthrasil (anthrax immune globulin intravenous - human), a polyclonal antibody therapeutic, and Raxibacumab, a monoclonal antibody therapeutic.
In May, the company completed the sale of its travel health business to Denmark’s biotechnology company, Bavarian Nordic. Per the agreement, Bavarian Nordic acquired rights to the drugs, Vaxchora and Vivotif, and the development-stage chikungunya vaccine candidate, CHIKV VLP, for a cash purchase price of $270 million.
Emergent Biosolutions Inc. Price and Consensus
Emergent Biosolutions Inc. price-consensus-chart | Emergent Biosolutions Inc. Quote
Zacks Rank and Stocks to Consider
Emergent currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same industry are ADC Therapeutics (ADCT - Free Report) , Acadia Pharmaceuticals (ACAD - Free Report) and Akoya Biosciences (AKYA - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for ADC Therapeutics has widened from a loss of $2.58 per share to a loss of $2.61 for 2023. The consensus estimate has narrowed from a loss of $2.72 per share to a loss of $2.45 for 2024 during the same time frame. Shares of the company have lost 60.9% year to date.
ADCT’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 10.70%.
In the past 90 days, the Zacks Consensus Estimate for Acadia Pharmaceuticals has narrowed from a loss of 58 cents per share to a loss of 31 cents for 2023. Shares of the company have rallied 96.4% year to date.
ACAD’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average negative earnings surprise of 2.75%.
In the past 90 days, the Zacks Consensus Estimate for Akoya Biosciences has narrowed from a loss of $1.80 per share to a loss of $1.71 for 2023. The consensus estimate for Akoya Biosciences has narrowed from a loss of $1.57 per share to a loss of $1.33 for 2024 during the same time frame. Shares of the company have lost 27% year to date.
AKYA’s earnings missed estimates in each of the trailing four quarters, delivering an average negative surprise of 21.05%.