ARCT Stock Up as Updated COVID-19 Jab Betters PFE & BNTX's Comirnaty
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Arcturus Therapeutics ARCT 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 and BioNTech SE BNTX, 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 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.