Nasdaq

Q32 Bio Announces FDA Fast Track Designation Granted to Bempikibart (ADX-914) for the Treatment of Alopecia Areata

WALTHAM, Mass., April 30, 2025 /PRNewswire/ -- Q32 Bio Inc. (Nasdaq: QTTB) ("Q32 Bio"), a clinical stage biotechnology company focused on developing innovative therapies for alopecia areata (AA) and ...
Morningstar

MavriX Bio Receives FDA Fast Track Designation for MVX-220 for Treatment of Angelman Syndrome

MIDDLETON, Mass., Sept. 22, 2025 /PRNewswire/ -- MavriX Bio, a clinical-stage biotechnology company focused on the development of transformative genetic therapies for Angelman syndrome (AS), today ...
PharmiWeb

INTENT Biologics Receives FDA Fast Track Designation for PEP Biologic™

INTENT Biologics, a clinical-stage biotechnology company developing first-in-class exosome-based biologic therapies for ...
Nasdaq

Translate Bio Receives FDA Fast Track Designation for MRT5005 for the Treatment of Cystic Fibrosis

-- First inhaled mRNA therapeutic remains on track to report results from its ongoing multiple-ascending dose (MAD) portion of Phase 1/2 clinical trial in the third quarter of 2020 -- The FDA’s Fast ...
Seeking Alpha

Cabaletta Bio gains on FDA fast-track tags for lead asset

Cell therapy developer Cabaletta Bio (NASDAQ:CABA) traded higher on Monday after the U.S. FDA issued additional fast-track Designations for its lead candidate CABA-201 in autoimmune conditions, ...
PharmiWeb

Latus Bio Announces IND Clearance of LTS-101 for CLN2 Disease and Receipt of Fast Track, Orphan Drug, and Rare Pediatric Disease Designations

LTS-101 is a one-time AAV gene therapy candidate intended to provide durable expression of the TPP1 enzyme in the central nervous system (CNS) of children with CLN2 disease FDA designations underscore ...