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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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.
5 Stocks Set to Double
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.
Today, See These 5 Potential Home Runs >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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