Moderna Stock Pushes To New Record On Fast Track Designation For Coronavirus Vaccine

Moderna Inc MRNA, which is developing an mRNA vaccine codenamed mRNA-1273 for the coronavirus, announced an incremental update concerning its vaccine program Tuesday, sending its shares further into record territory.

FDA Grants Fast Track Status For Vaccine Candidate 

The Cambridge, Massachusetts-based company said the FDA has granted Fast Track designation for mRNA-1273.

"Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus," Moderna Chief Medical Officer Tal Zaks said in a statement. 

The Fast Track designation comes close on heels of the FDA vetting Moderna's IND for initiating a Phase 2 study.

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Why It Matters For Moderna 

Fast Track designation is accorded to facilitate the development and expedite the review of therapies and vaccines for serious conditions that fill an unmet need. This would provide benefits such as early and frequent communication with the FDA, in addition to allowing the rolling submission of the marketing application. 

Moderna previously received Fast Track designation for its investigational Zika vaccine mRNA-1893 as well as its methylmalonic acidemia and propionic acidemia programs.

What's Next For Moderna 

Moderna said it is actively preparing for its Phase 2 and 3 studies even as it awaits full set of clinical data from the NIAID-sponsored Phase 1 study.

Revealing the design of the Phase 2 study, the company said it plans to enroll 600 healthy volunteers across two cohorts of adults: ages 18-55 and older adults ages 55 and above, with each participant receiving a placebo; a 50 microgram; or a 250 microgram dose of two vaccinations given 28 days apart.

The study will evaluate the safety, reactogenicity and immunogenicity of the vaccine, Moderna said.

In premarket trading Tuesday, Moderna shares were rising 2.12% to $68.32. 

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