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ARCT Stock Up as Updated COVID-19 Jab Betters PFE & BNTX's Comirnaty
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Arcturus Therapeutics (ARCT - Free Report) and partner CSL Seqirus, a renowned vaccine company, together reported encouraging results from a 12-month follow-up analysis of a late-stage study evaluating a booster dose of their self-amplifying (sa-mRNA) COVID-19 vaccine, ARCT-154. Following the news, the stock gained 5.4% on Monday and continued to gain another 2.5% in the after-market hours.
Superior Efficacy Observed With ARCT’s Novel COVID-19 Jab
Per the data readout, treatment with ARCT-154 showed a stronger and longer-lasting immune response compared with that achieved with the conventional mRNA vaccine, Comirnaty, developed jointly by Pfizer (PFE - Free Report) and BioNTech SE (BNTX - Free Report) , for up to a year in both younger and older adults. This effectiveness was observed against the Wuhan-Hu-1 strain, Omicron BA.4-5, and other variants, using just one-sixth of the dosage strength of PFE/BNTX’s Comirnaty (5 μg vs 30 μg).
Arcturus and CSL shared additional data demonstrating that their bivalent vaccine, ARCT-2301, built on the same platform as ARCT-154, also provides stronger and longer-lasting immune responses compared with PFE/BNTX’s Comirnaty. This enhanced immunity persists for up to six months after vaccination against key variants.
Year to date, shares of Arcturus have plunged 26.4% compared with the industry’s 1.8% decline.
Image Source: Zacks Investment Research
Management emphasized the importance of vaccines that offer longer-lasting protection, citing the recent rise in COVID-19 cases and the emergence of new variants. Per the company, these new data readouts demonstrate the potential of sa-mRNA vaccines to provide strong and extended protection against COVID-19.
Please note that in Japan, ARCT-154 first received approval in November 2023 as the first sa-mRNA COVID-19 vaccine for initial vaccination and booster for adults aged 18 years and older. Recently, the regulatory body in Japan also approved/authorized the updated formulation of the sa-mRNA COVID-19 vaccine under the brand name, Kostaive, targeting the variant JN.1 for active immunization to prevent COVID-19 in adults aged 18 years and above. A regulatory filing for Kostaive to treat the same indication is also currently under review in the EU.
Other Big Players in the COVID-19 Vaccine Market
The FDA, on Aug. 22, approved/authorized the updated mRNA-based COVID-19 vaccines of Pfizer/BioNTech and Moderna (MRNA - Free Report) that target the KP.2 strain of the virus.
While the agency approved Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax for use in individuals aged 12 years and older, it granted emergency use authorization to low-dose formulations of these vaccines for use in individuals aged six months through 11 years. These approvals/authorizations are based on a combination of manufacturing, non-clinical and real-world data, which supported the efficacy and safety of the updated Moderna and Pfizer/BioNTech vaccines.
Earlier this month, Moderna announced that the advisory committee to the European Medicines Agency (EMA) has rendered a positive opinion recommending marketing authorization for Spikevax to target the variant JN.1 for active immunization to prevent COVID-19 in individuals aged six months and above. Moderna’s Spikevax, targeting the variant JN.1, is currently approved in the United States, United Kingdom, Japan and Taiwan.
Last week, Pfizer and BioNTech also announced that EMA’s advisory committee has recommended the marketing authorization for their updated formulation of Comirnaty, which targets the currently circulating KP.2 strain of the Omicron JN.1 lineage, for individuals aged six months and above. The European Commission had earlier authorized the Omicron JN.1-adapted COVID-19 vaccine in July 2024, which is also approved in the United States, United Kingdom, Japan and Taiwan.
Arcturus Therapeutics Holdings Inc. Price and Consensus
Apart from ARCT-154 and ARCT-2301, Arcturus, in partnership with CSL, is developing innovative mRNA vaccines.
Earlier this month, the FDA cleared the company’s investigational new drug (IND) application for its product candidate, ARCT-032, which is being developed for the treatment of cystic fibrosis (CF). Following the FDA clearance of the IND, Arcturus will now begin a phase II multiple ascending dose study to evaluate the safety, tolerability and efficacy of ARCT-032 in people with CF.
ARCT-032 is developed using the company’s proprietary Lunar lipid-mediated aerosolized platform, which follows a novel mechanism of action. The FDA has previously granted an Orphan Drug designation and Rare Pediatric Disease designation to ARCT-032 for the treatment of CF.
The company is developing another pipeline candidate, ARCT-810, in a phase II study for the treatment of ornithine transcarbamylase deficiency.
Arcturus’ top line currently comprises collaboration revenues from partners and grant revenues. Successful development of these candidates should boost the company’s growth prospects.
Image: Bigstock
ARCT Stock Up as Updated COVID-19 Jab Betters PFE & BNTX's Comirnaty
Arcturus Therapeutics (ARCT - Free Report) and partner CSL Seqirus, a renowned vaccine company, together reported encouraging results from a 12-month follow-up analysis of a late-stage study evaluating a booster dose of their self-amplifying (sa-mRNA) COVID-19 vaccine, ARCT-154. Following the news, the stock gained 5.4% on Monday and continued to gain another 2.5% in the after-market hours.
Superior Efficacy Observed With ARCT’s Novel COVID-19 Jab
Per the data readout, treatment with ARCT-154 showed a stronger and longer-lasting immune response compared with that achieved with the conventional mRNA vaccine, Comirnaty, developed jointly by Pfizer (PFE - Free Report) and BioNTech SE (BNTX - Free Report) , for up to a year in both younger and older adults. This effectiveness was observed against the Wuhan-Hu-1 strain, Omicron BA.4-5, and other variants, using just one-sixth of the dosage strength of PFE/BNTX’s Comirnaty (5 μg vs 30 μg).
Arcturus and CSL shared additional data demonstrating that their bivalent vaccine, ARCT-2301, built on the same platform as ARCT-154, also provides stronger and longer-lasting immune responses compared with PFE/BNTX’s Comirnaty. This enhanced immunity persists for up to six months after vaccination against key variants.
Year to date, shares of Arcturus have plunged 26.4% compared with the industry’s 1.8% decline.
Image Source: Zacks Investment Research
Management emphasized the importance of vaccines that offer longer-lasting protection, citing the recent rise in COVID-19 cases and the emergence of new variants. Per the company, these new data readouts demonstrate the potential of sa-mRNA vaccines to provide strong and extended protection against COVID-19.
Please note that in Japan, ARCT-154 first received approval in November 2023 as the first sa-mRNA COVID-19 vaccine for initial vaccination and booster for adults aged 18 years and older. Recently, the regulatory body in Japan also approved/authorized the updated formulation of the sa-mRNA COVID-19 vaccine under the brand name, Kostaive, targeting the variant JN.1 for active immunization to prevent COVID-19 in adults aged 18 years and above. A regulatory filing for Kostaive to treat the same indication is also currently under review in the EU.
Other Big Players in the COVID-19 Vaccine Market
The FDA, on Aug. 22, approved/authorized the updated mRNA-based COVID-19 vaccines of Pfizer/BioNTech and Moderna (MRNA - Free Report) that target the KP.2 strain of the virus.
While the agency approved Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax for use in individuals aged 12 years and older, it granted emergency use authorization to low-dose formulations of these vaccines for use in individuals aged six months through 11 years. These approvals/authorizations are based on a combination of manufacturing, non-clinical and real-world data, which supported the efficacy and safety of the updated Moderna and Pfizer/BioNTech vaccines.
Earlier this month, Moderna announced that the advisory committee to the European Medicines Agency (EMA) has rendered a positive opinion recommending marketing authorization for Spikevax to target the variant JN.1 for active immunization to prevent COVID-19 in individuals aged six months and above. Moderna’s Spikevax, targeting the variant JN.1, is currently approved in the United States, United Kingdom, Japan and Taiwan.
Last week, Pfizer and BioNTech also announced that EMA’s advisory committee has recommended the marketing authorization for their updated formulation of Comirnaty, which targets the currently circulating KP.2 strain of the Omicron JN.1 lineage, for individuals aged six months and above. The European Commission had earlier authorized the Omicron JN.1-adapted COVID-19 vaccine in July 2024, which is also approved in the United States, United Kingdom, Japan and Taiwan.
Arcturus Therapeutics Holdings Inc. Price and Consensus
Arcturus Therapeutics Holdings Inc. price-consensus-chart | Arcturus Therapeutics Holdings Inc. Quote
ARCT’s Other Pipeline Development Activities
Apart from ARCT-154 and ARCT-2301, Arcturus, in partnership with CSL, is developing innovative mRNA vaccines.
Earlier this month, the FDA cleared the company’s investigational new drug (IND) application for its product candidate, ARCT-032, which is being developed for the treatment of cystic fibrosis (CF). Following the FDA clearance of the IND, Arcturus will now begin a phase II multiple ascending dose study to evaluate the safety, tolerability and efficacy of ARCT-032 in people with CF.
ARCT-032 is developed using the company’s proprietary Lunar lipid-mediated aerosolized platform, which follows a novel mechanism of action. The FDA has previously granted an Orphan Drug designation and Rare Pediatric Disease designation to ARCT-032 for the treatment of CF.
The company is developing another pipeline candidate, ARCT-810, in a phase II study for the treatment of ornithine transcarbamylase deficiency.
Arcturus’ top line currently comprises collaboration revenues from partners and grant revenues. Successful development of these candidates should boost the company’s growth prospects.
ARCT’s Zacks Rank
Arcturus currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.