Moderna, Inc. (NASDAQ: MRNA) shares jumped late on Monday after the firm announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its investigational Zika vaccine (mRNA-1893) currently being evaluated in a Phase 1 study for the prevention of Zika virus infection in healthy adults.
This Fast Track designation is meant to facilitate the development and expedite the review of therapies and vaccines for serious conditions and fill an unmet medical need.
Moderna previously received Fast Track designation for its methylmalonic acidemia (MMA) program (mRNA-3704), which is now recruiting patients for a Phase 1/2 clinical study.
This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services (HHS).
Tal Zaks, M.D., Ph.D., chief medical officer at Moderna, commented:
Protecting against Zika virus transmission, particularly in women during pregnancy, continues to be an area of high unmet need. Fast Track designation supports our belief in the clinical potential of mRNA-1893 and the importance of developing an effective vaccine that can be rapidly developed and deployed. Our Zika program is part of Moderna’s broader commitment to improving global public health through developing mRNA vaccines to prevent the spread of infectious diseases.
Shares of Moderna closed Monday at $13.40, with a 52-week range of $11.54 to $29.79. The consensus analyst price target is $30.31. Following the announcement, the stock was up about 6% at $14.25 in the after-hours session.