TICKERS: ARCT

Approval Sought in Japan for New SARS-CoV-2 Vaccine
Research Report

Source: Ed Arce (7/6/23)

The vaccine developer's partner in Japan is already working on getting a manufacturing facility built there, noted an H.C. Wainwright & Co. report.

Arcturus Therapeutics Holdings Inc.'s (ARCT:NASDAQ) self-amplifying messenger RNA (mRNA) vaccine candidate ARCT-154 "could enter the Japanese market as a COVID-19 primary vaccine course and as a booster dose in 2023," reported H.C. Wainwright & Co. analyst Ed Arce in a July 3 research note. Applications for both uses were submitted by Arcturus' Japanese partner, Meiji Seika Pharma, tasked with obtaining regulatory approval, distribution, sales and marketing of the vaccine in Japan.

"We expect Meiji to begin marketing ARCT-154 shortly after its approval," Arce wrote.

Attractive gain potential

H.C. Wainwright reiterated its Buy rating and $51 per share target price on Arcturus. Currently, the company is trading at about $28.68 per share. The difference between these prices implies a significant return for investors, of 78%.

Supportive Phase 3 data

Meiji Seika filed the application, asking for ARCT-154 to be approved as a COVID-19 vaccine booster in adults in Japan, on June 30, 2023. This request was based on recent positive results of the Phase 3 noninferiority immunogenicity vaccine trial in Japan, jRCT2071220080.

In the study, the vaccine met the primary efficacy endpoint of "geometric mean titers and seroconversion rates of neutralizing antibodies against SARS-CoV-2," the Wuhan strain, on day 29 after a booster shot of ARCT-154 or Pfizer's COMIRNATY. Also, ARCT-154 exhibited a favorable safety profile.

NDA filed earlier

Previously, in late April, Meiji Seika filed a new drug application in Japan for ARCT-154 as a primary immunization against COVID-19 in adults.

Arcturus' management team expects to receive a decision on both applications this year, Arce wrote.

Manufacturing being addressed

In anticipation of and preparation for ARCT-154's approval, Meiji is working with ARCALIS, a joint venture company between Arcturus and Axcelead Inc., the latter a drug discovery services provider in Japan, to establish an mRNA vaccine manufacturing facility in the Japanese city of Minamisoma.

"This facility would enable Meiji to supply ARCT-154 in Japan as soon as possible following its potential approval," wrote Arce.

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