Synlogic Gets FDA Rare-Pediatric Designation for SYNB1934 in PKU

By Colin Kellaher

Synlogic Inc. on Thursday said the U.S. Food and Drug Administration granted rare-pediatric-disease designation to SYNB1934 for the potential treatment of phenylketonuria, a rare genetic disease more commonly known as PKU.

The Cambridge, Mass., clinical-stage biopharmaceutical company said it plans to launch a pivotal Phase 3 study of SYNB1934, its lead program, in PKU in the first half of the year.

The FDA's rare-pediatric-disease designation covers diseases with serious or life-threatening manifestations that mainly affect fewer than 200,000 people in the U.S. under the age of 18. The agency awards priority-review vouchers to drugmakers upon approval of drugs that are granted the designation, and those vouchers can be used to obtain priority review for another drug or sold to other companies.

Synlogic shares, which closed Wednesday at about 99.2 cents, were recently up 5.9%, to $1.05, in premarket trading.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

01-19-23 0809ET