Precision BioSciences Receives FDA Fast Track Designation for PBGENE-DMD and Announces Duchenne Muscular Dystrophy Investor Event

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases ...

Affinia receives FDA fast track designation for AFTX-201

Affinia Therapeutics has received the US Food and Drug Administration (FDA) fast track designation (FTD) for AFTX-201, a genetic medicine under investigation for treating Bcl-2-associated athanogene 3 ...
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Precision BioSciences stock jumps on FDA Fast Track status

Investing.com -- Precision BioSciences (NASDAQ:DTIL) shares rose 13% Monday following the FDA’s Fast Track designation for PBGENE-DMD, its gene editing therapy for Duchenne muscular dystrophy.

Affinia Therapeutics Granted FDA Fast Track Designation for AFTX-201 as a Treatment for People Living with BAG3-Associated Dilated Cardiomyopathy (DCM)

AFTX-201 is designed using Affinia's proprietary capsid engineered for efficient cardiac transduction at doses that are 5-10-fold lower than doses of gene therapies using conventional capsids WALTHAM, ...
PMLive

J&J’s nipocalimab gets FDA Fast Track designation for lupus

Johnson & Johnson’s (J&J) nipocalimab, a potential immunoselective investigational treatment for adults with systemic lupus ...

Johnson & Johnson Gets FDA Fast-Track Designation for Nipocalimab in Systemic Lupus Erythematosus

Johnson & Johnson has won U.S. Food and Drug Administration fast-track designation for its investigational nipocalimab drug in adults with systemic lupus erythematosus, a chronic autoimmune disease.
Cure Today

MNV-201 Secures FDA Fast Track Designation in Myelodysplastic Syndrome

MNV-201, a mitochondrial cell therapy, received FDA fast track designation for myelodysplastic syndrome, highlighting its potential to address mitochondrial dysfunction in this serious blood disorder.
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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

FDA Grants Fast Track Designation to NS-229 for the Treatment of Eosinophilic Granulomatosis with Polyangiitis

PARAMUS, NJ., Sept. 9, 2025 /PRNewswire/ -- NS Pharma, Inc. (NS Pharma) a subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku), announced today that the U.S Food & Drug Administration (FDA) has ...
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MoonLake Announces FDA Fast Track Designation for Sonelokimab Palmoplantar Pustulosis (PPP) and Provides Details on Upcoming Investor Day

The Dermatology Division of the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sonelokimab (SLK) in moderate-to-severe palmoplantar pustulosis (PPP) supported by ...
Cure Today

FDA Fast Track Designation Highlights New Option in Advanced Liver Cancer

FDA fast track designation targets advanced HCC with FGF19 overexpression after ICI and mTKI exposure, reflecting an unmet-need population with limited post-progression systemic options. Phase 1 ...