• Daiichi Sankyo (OTC: DSKYF) (OTC: DSNKY) has filed for marketing approval of DS-5670 to the regulatory authorities in Japan. DS-5670 is an mRNA COVID-19 vaccine proposed as a booster vaccine to prevent COVID-19.

• The application is based on the results of a phase 1/2/3 trial (original strain) in approximately 5,000 healthy adult and elderly subjects who received the primary series (two doses) of an mRNA vaccine approved in Japan.

• Daiichi Sankyo started prior assessment consultations for drugs with the Pharmaceuticals and Medical Devices Agency in September 2022 based on non-clinical, clinical, and quality data available to obtain marketing approval earlier.

• In addition, Daiichi Sankyo plans to develop DS-5670 for the Omicron strain to respond to new variants of the coronavirus in parallel with the development for the original strain.

• DS-5670 uses a novel nucleic acid delivery technology discovered by Daiichi Sankyo, designed to produce antibodies against the receptor binding domain (RBD) of the spike protein of the novel coronavirus.

• Furthermore, Daiichi Sankyo aims for mRNA vaccines that can be distributed in refrigerated temperatures (2-8°C).

• Price Action: DSNKY shares are trading higher by 4.41% at $32.68 on the last check Friday.

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