NextCure Receives Fast Track Designation for SIM0505 (CDH6 ADC) in Ovarian Cancer

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SIM0505 for the treatment of women with platinum resistant ...

Climb Bio Announces FDA Fast Track Designation for Budoprutug for the Treatment of Primary Membranous Nephropathy

Fast Track Designation recognizes both the urgent need for new therapies in pMN and the compelling early clinical activity generated to date with budoprutug,” said Edgar Charles, M.D., Chief Medical ...
MPR

FDA Grants Budoprutug Fast Track Status for Primary Membranous Nephropathy

Budoprutug is an investigational, humanized monoclonal antibody designed to selectively target and bind to CD19 antigen on B cells.

Climb Bio Gets FDA Fast-Track Designation for Budoprutug in Rare Kidney Disease

Climb Bio on Tuesday said there are currently no FDA-approved treatments for pMN, which affects about 75,000 people in the U.S. and can lead to chronic or end-stage kidney disease, requiring dialysis ...
Seeking Alpha

Werewolf Therapeutics Receives Fast Track Designation from the U.S. FDA for WTX-124, an Investigational Therapy for the Treatment of Cancer

WATERTOWN, Mass., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (HOWL), pioneering the development of therapeutics engineered to stimulate the body’s immune system for the treatment of ...
Seeking Alpha

Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Severe-to-Very Severe Alopecia Areata

SAN FRANCISCO, July 29, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ...
Targeted Oncology

FDA Grants Fast Track Designation to CTIM-76 for Platinum-Resistant Ovarian Cancer

The FDA has granted Fast Track Designation to CTIM-76, a claudin-6 (CLDN6) x CD3 T cell engaging bispecific antibody, for the ...

Cocrystal Pharma Receives FDA Fast Track Designation for CDI-988 for Norovirus Infection Treatment and Preventive

FDA Fast Track designation supports accelerated development and expedites regulatory reviewNorovirus is responsible for an estimated 685 million global cases each year and approximately $60 billion in ...

Cocrystal Pharma shares soar after FDA grants fast track status to CDI-988

Cocrystal Pharma, Inc. COCP shares are trading higher Thursday after the company announced that it has received Fast Track ...
Targeted Oncology

FDA Grants Fast Track Designation to PAS-004 for NF1-Associated Plexiform Neurofibromas

The FDA granted fast track designation to PAS-004, a macrocyclic MEK inhibitor, for NF1-associated plexiform neurofibromas ...
Business Wire

Avenzo Therapeutics Granted Fast Track Designation for AVZO-103, a Potential Best-in-Class Nectin4/TROP2 Bispecific Antibody-Drug Conjugate, for the Treatment of Patients with ...

SAN DIEGO--(BUSINESS WIRE)--Avenzo Therapeutics, Inc. (“Avenzo”), a clinical-stage biotechnology company developing next-generation oncology therapies, today announced the U.S. Food and Drug ...

TRIANA Biomedicines’ TRI-611 Granted U.S. FDA Fast Track Designation for Treatment of ALK Positive Non-small Cell Lung Cancer

TRIANA Biomedicines, Inc. (TRIANA), a leading biopharmaceutical company focused on advancing a target-first and proximity-first molecular glue discovery platform to address difficult to drug disease ...