Top News

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

July 10, 2023 ( Newswire) 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 US$51 per share target price on Arcturus.

Currently, the company is trading at about US$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.

More Info:

This news is published on the Newswire – a global digital news source for investors and business leaders

Disclaimer/Disclosure: is a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investing involves risk and possible losses. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers. Contact management and IR of each company directly regarding specific questions.

More disclaimer info: Learn more about publishing your news release and our other news services on the newswire

Global investors must adhere to regulations of each country. Please read privacy policy:

That’s all it takes to get an article published on Investor Ideas – Learn More – investing ideas in biotechnology stocks, medical technology and life sciences

Like Biotech Stocks? View our Biotech Stocks Directory

Buy a biotech guest post on

You may also like

Leave a reply

Your email address will not be published. Required fields are marked *

More in Top News