Catalyst Biosciences Shares Rise Premarket After Key FDA Designation

CBIO

By Colin Kellaher

Shares of Catalyst Biosciences Inc. rose almost 20% in premarket trading Tuesday after the biopharmaceutical company said the U.S. Food and Drug Administration granted rare-pediatric-disease designation to CB 4332, its lead pipeline candidate, for the treatment of the genetic disorder complement factor I deficiency.

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.

The South San Francisco, Calif., company said it is focused on efficiently advancing the development of CB 4332 and its complement medicines portfolio in a number of complement-driven diseases in hematology, nephrology and ophthalmology.

Catalyst shares, which closed Monday at 63 cents, were recently up 19% in premarket trading at 75 cents. The stock is down roughly 90% from its 52-week high of $7.55 reached last February.

Write to Colin Kellaher at [email protected]

(END) Dow Jones Newswires

01-25-22 0840ET