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Arcturus (ARCT) to Begin Phase II COVID-19 Vaccine Study
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Arcturus Therapeutics Holdings Inc. (ARCT - Free Report) announced that it has received allowance for the investigational new drug application from the FDA to begin a phase II study on its COVID-19 vaccine candidate, ARCT-021 in the United States.
Shares of Arcturus were up 12.7% following the announcement of the news on Monday. In fact, the stock has skyrocketed 367.5% in the past year compared with the industry’s increase of 5.6%.
The FDA’s nod to begin a phase II study on ARCT-021 in the United States came following review of data from the phase I/II study. Data from the phase I/II study showed that treatment with ARCT-021 led to favorable tolerability and both humoral and cellular immunogenicity against COVID-19.
In December 2020, Arcturus received approval from the Singapore Health Sciences Authority to proceed with a phase II study of ARCT-021.
The phase II study in the United States and Singapore will evaluate both single-dose and two-dose priming regimens of ARCT-021 in 600 participants out of which 450 will receive ARCT-021 while the rest will be given placebo.
Interim data from the phase II study is expected early this year, and if successful, the company plans to begin a phase III study ARCT-021 in the second quarter of 2021, which could help in filing for an emergency use authorization (“EUA”) or a conditional approval for ARCT-021 in the second half of this year.
We note that several companies have already received EUA from the FDA for their respective coronavirus vaccine.
Pfizer Inc. (PFE - Free Report) and BioNTech’s mRNA-based coronavirus vaccine candidate, BNT162b2, was granted EUA by the FDA in December 2020. The vaccine is now approved for emergency/temporary use in more than 40 countries including the United Kingdom, Bahrain, Mexico, Singapore, Switzerland and Canada. Also, Moderna’s (MRNA - Free Report) coronavirus vaccine, mRNA-1273, has been approved for emergency use in the United States and Canada.
AstraZeneca’s (AZN - Free Report) adenovirus-based coronavirus vaccine candidate, AZD1222, has also received an authorization for emergency use in the United Kingdom and India.
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Image: Bigstock
Arcturus (ARCT) to Begin Phase II COVID-19 Vaccine Study
Arcturus Therapeutics Holdings Inc. (ARCT - Free Report) announced that it has received allowance for the investigational new drug application from the FDA to begin a phase II study on its COVID-19 vaccine candidate, ARCT-021 in the United States.
Shares of Arcturus were up 12.7% following the announcement of the news on Monday. In fact, the stock has skyrocketed 367.5% in the past year compared with the industry’s increase of 5.6%.
The FDA’s nod to begin a phase II study on ARCT-021 in the United States came following review of data from the phase I/II study. Data from the phase I/II study showed that treatment with ARCT-021 led to favorable tolerability and both humoral and cellular immunogenicity against COVID-19.
In December 2020, Arcturus received approval from the Singapore Health Sciences Authority to proceed with a phase II study of ARCT-021.
The phase II study in the United States and Singapore will evaluate both single-dose and two-dose priming regimens of ARCT-021 in 600 participants out of which 450 will receive ARCT-021 while the rest will be given placebo.
Interim data from the phase II study is expected early this year, and if successful, the company plans to begin a phase III study ARCT-021 in the second quarter of 2021, which could help in filing for an emergency use authorization (“EUA”) or a conditional approval for ARCT-021 in the second half of this year.
We note that several companies have already received EUA from the FDA for their respective coronavirus vaccine.
Pfizer Inc. (PFE - Free Report) and BioNTech’s mRNA-based coronavirus vaccine candidate, BNT162b2, was granted EUA by the FDA in December 2020. The vaccine is now approved for emergency/temporary use in more than 40 countries including the United Kingdom, Bahrain, Mexico, Singapore, Switzerland and Canada. Also, Moderna’s (MRNA - Free Report) coronavirus vaccine, mRNA-1273, has been approved for emergency use in the United States and Canada.
AstraZeneca’s (AZN - Free Report) adenovirus-based coronavirus vaccine candidate, AZD1222, has also received an authorization for emergency use in the United Kingdom and India.
Zacks Rank
Arcturus currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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