FDA Fast Track for Quince Therapeutics EryDex System for Rare Disease

Shares in biotechnology company, Quince Therapeutics (Nasdaq: QNCX), climbed on Monday morning before settling up +5.66% at the close of trading, and rising an additional 3.80% after the market close. The company announced that the FDA has granted Fast Track designation for its EryDex System for the treatment of patients with Ataxia-Telangiectasia (A-T).

A-T is a rare, inherited disorder that affects the nervous and immune systems and is characterized by abnormal movements, dilated blood vessels in the eyes and skin, a weakened immune system and an increased risk of developing leukemia. There are currently no approved therapeutic treatments in any global market for this rare pediatric disease.

Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, commented on the news, saying, “The granting of Fast Track status for EryDex System marks another important milestone in our endeavor to identify a beneficial therapeutic solution for patients with A-T. We have initiated our pivotal Phase 3 NEAT clinical trial, which is being conducted in the U.S., U.K., and the European Union.”

Quince’s EryDex System is comprised of dexamethasone sodium phosphate (DSP) encapsulated in a patient’s own red blood cells utilizing Quince’s proprietary Autologous Intracellular Drug Encapsulation (AIDE) technology platform. EryDex is designed to provide the efficacy of corticosteroids and to reduce or eliminate the significant adverse effects that accompany chronic corticosteroid treatment.

About Quince Therapeutics

Quince Therapeutics (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the potential of a patient’s own biology to deliver innovative and life-changing therapeutics to those living with rare diseases. For more information on the company and its latest news, visit www.quincetx.com and follow Quince Therapeutics on social media platforms LinkedIn, Facebook, and Twitter/X.