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EBS Stock Rises on FDA Nod for ACAM2000 in Mpox Indication
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Emergent BioSolutions Inc. (EBS - Free Report) announced that the FDA has approved its supplemental biologics license application (sBLA) seeking a label expansion for ACAM2000 (Smallpox and Mpox (Vaccinia) Vaccine, Live) to include prevention of mpox disease in individuals who are at increased risk of the disease.
Shares of the company were up in pre-market trading on Friday following the announcement of the news.
ACAM2000 is currently approved by the FDA as a single dose for active immunization against smallpox disease in individuals who stand at high risk of smallpox infection.
The latest approval for the mpox indication was based on previously available human safety data and data from an animal study, which demonstrated that the ACAM2000 vaccine was effective in protecting against the mpox virus, previously called monkeypox.
EBS Stock Outperforming Industry
Shares of Emergent have skyrocketed 271.3% so far this year compared with the industry’s 0.2% rise.
Image Source: Zacks Investment Research
Mpox is a disease similar to smallpox, although it is usually less severe. The World Health Organization (WHO) has declared mpox as a Global Health Emergency.
Though the outbreak is mainly centered in central and west Africa, the virus has also been observed in other parts of the world.
Earlier this month, EBS filed an Expression of Interest (EOI) with the WHO for its evaluation of the ACAM2000 vaccine to be given an Emergency Use Listing related to the mpox outbreak.
The company is looking to donate 50,000 doses of ACAM2000 across impacted countries in central Africa.
EBS’ Smallpox Vaccine Portfolio
Emergent’s smallpox vaccines portfolio comprises sales from ACAM2000, VIGIV and Tembexa.
In the first six months of 2024, sales of smallpox vaccine totaled $68.1 million, down 48% on a year-over-year basis. This decrease was primarily due to the timing of USG purchases of ACAM2000.
Now that ACAM2000 is also approved for mpox disease, it remains to be seen whether it is able to drive sales for Emergent’s smallpox vaccine portfolio. The FDA approval for the ACAM2000 vaccine in mpox indication should provide an edge for Emergent over its competitors who are developing mpox vaccine.
Zacks Rank & Stocks to Consider
Emergent currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.18 to $3.62. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 3.9%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.98 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 57.4%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have jumped 29.2%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
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EBS Stock Rises on FDA Nod for ACAM2000 in Mpox Indication
Emergent BioSolutions Inc. (EBS - Free Report) announced that the FDA has approved its supplemental biologics license application (sBLA) seeking a label expansion for ACAM2000 (Smallpox and Mpox (Vaccinia) Vaccine, Live) to include prevention of mpox disease in individuals who are at increased risk of the disease.
Shares of the company were up in pre-market trading on Friday following the announcement of the news.
ACAM2000 is currently approved by the FDA as a single dose for active immunization against smallpox disease in individuals who stand at high risk of smallpox infection.
The latest approval for the mpox indication was based on previously available human safety data and data from an animal study, which demonstrated that the ACAM2000 vaccine was effective in protecting against the mpox virus, previously called monkeypox.
EBS Stock Outperforming Industry
Shares of Emergent have skyrocketed 271.3% so far this year compared with the industry’s 0.2% rise.
Image Source: Zacks Investment Research
Mpox is a disease similar to smallpox, although it is usually less severe. The World Health Organization (WHO) has declared mpox as a Global Health Emergency.
Though the outbreak is mainly centered in central and west Africa, the virus has also been observed in other parts of the world.
Earlier this month, EBS filed an Expression of Interest (EOI) with the WHO for its evaluation of the ACAM2000 vaccine to be given an Emergency Use Listing related to the mpox outbreak.
The company is looking to donate 50,000 doses of ACAM2000 across impacted countries in central Africa.
EBS’ Smallpox Vaccine Portfolio
Emergent’s smallpox vaccines portfolio comprises sales from ACAM2000, VIGIV and Tembexa.
In the first six months of 2024, sales of smallpox vaccine totaled $68.1 million, down 48% on a year-over-year basis. This decrease was primarily due to the timing of USG purchases of ACAM2000.
Now that ACAM2000 is also approved for mpox disease, it remains to be seen whether it is able to drive sales for Emergent’s smallpox vaccine portfolio. The FDA approval for the ACAM2000 vaccine in mpox indication should provide an edge for Emergent over its competitors who are developing mpox vaccine.
Zacks Rank & Stocks to Consider
Emergent currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Illumina, Inc. (ILMN - Free Report) , Krystal Biotech, Inc. (KRYS - Free Report) and Fulcrum Therapeutics, Inc. (FULC - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.18 to $3.62. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 3.9%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.98 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 57.4%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have jumped 29.2%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.