Tessera Therapeutics Receives U.S. FDA Fast Track and Orphan Drug Designations for its Lead In Vivo Gene Editing Program TSRA-196 for the Treatment of Adults with AATD

TSRA-196 is designed to precisely correct the genetic mutation underlying AATD, with the goal of restoring production of functional alpha-1 antitrypsin (AAT) protein through a one-time, durable ...
CURE

FDA Grants Fast Track to ART6043 for BRCA-Mutated Advanced Breast Cancer

FDA fast track covers ART6043 plus olaparib in PARP inhibitor–naïve gBRCAm, HER2-negative locally advanced/metastatic breast ...

Armata Pharmaceuticals Receives FDA Qualified Infectious Disease Product (QIDP) Designation for AP-SA02

Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a late clinical-stage biotechnology company ...
The Manila Times

Artios Receives U.S. FDA Fast Track Designation for DNA Polymerase Theta (Polθ) Inhibitor ART6043 for Treatment of gBRCA-mutated HER2-Negative Breast Cancer

U.S. Fast Track designation of ART6043 underpinned by promising clinical data to date and high unmet need in gBRCA-mutated ...

99mTc-maraciclatide Granted FDA Fast Track Designation for the Visualization of Inflammation in Interstitial Lung Disease

Serac Healthcare Limited, a clinical radiopharmaceutical company developing an innovative molecular imaging agent, announced ...

MoonLake Announces FDA Fast Track Designation for Sonelokimab Palmoplantar Pustulosis (PPP) and Provides Details on Upcoming Investor Day

MoonLake Immunotherapeutics (NASDAQ:MLTX) ("MoonLake" or the "Company"), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announces that ...
Nasdaq

Allarity Therapeutics Granted FDA Fast Track Designation for Stenoparib for the Treatment of Advanced Ovarian Cancer

TARPON SPRINGS, Fla., August 26, 2025-- Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a ...
Stocktwits on MSN

ONCY stock rallies on second fast track designation for experimental cancer drug

The company said that the designation is supported by clinical data which demonstrates a 33% objective response rate for pelareorep-based therapy. ・According to Oncolytics, there are an estimated 2 ...
CURE

PLT012 Receives FDA Fast Track Designation for Liver Cancer Treatment

PLT012 received FDA fast track status for liver cancer, with an ongoing trial evaluating safety and early activity of the CD36-targeting immunotherapy.
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 ...
MarketWatch

Alessa Therapeutics Announces FDA Fast Track Designation for Enolen, A First-Of-Its-Kind Treatment for Localized Prostate Cancer

Alessa Therapeutics ("Alessa"), a clinical-stage biopharmaceutical company advancing novel localized drug delivery technology for the treatment of early-stage prostate cancers, today announced that ...
Nasdaq

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 ...