By Chris Wack
Ayala Pharmaceuticals Inc. said Tuesday that the U.S. Food and Drug Administration has granted fast-track designation for AL102 for the treatment of progressing desmoid tumors.
AL102 is a potent, selective, oral gamma-secretase inhibitor.
The FDA grants fast track to facilitate development and expedite the review of therapies with the potential to treat a serious condition where there is an unmet medical need. A therapeutic that receives the designation can benefit from early and frequent communication with the agency, in addition to a rolling submission of the marketing application.
AL102 is being evaluated in a Phase 2/3 clinical trial in desmoid tumors. AL102 was well-tolerated, Ayala said. The company has initiated Part B of the trial and is enrolling patients in an open label extension study.
Desmoid tumors are rare connective tissue tumors that don't metastasize but often aggressively infiltrate neurovascular structures and vital organs, Ayala said. Desmoid tumors are found in about 1,700 patients a year in the U.S., the company said.
Ayala shares were up 22% to $1.28 in premarket trading.
Write to Chris Wack at email@example.com
(END) Dow Jones Newswires
September 27, 2022 08:43 ET (12:43 GMT)Copyright (c) 2022 Dow Jones & Company, Inc.