Quince Therapeutics Plummets After Late-Stage Trial of A-T Therapy Fails to Hit Targets
Shares of Quince Therapeutics (NASDAQ: QNCX) were decimated on Tuesday, plunging over 90% in pre-market trading after the biotech announced its flagship therapy for a rare genetic disorder failed a crucial late-stage study.
The company reported that its investigational drug, eDSP (dexamethasone sodium phosphate encapsulated in autologous erythrocytes), did not achieve statistical significance on the primary endpoint in the Phase III NEAT trial. The study aimed to treat patients with Ataxia-Telangiectasia (A-T), a progressive condition with no approved therapies that causes severe neurological impairment. The primary measure was change from baseline on a modified ataxia rating scale after six months.
"While we are deeply disappointed, we extend our heartfelt thanks to the patients, families, and investigators involved in the NEAT trial," said Quince CEO Dr. Dirk Thye in a statement. "Our focus now shifts to a thorough analysis of the full data set."
The news wiped out nearly all of Quince's market value, sending its capitalization to a mere $9.5 million. The failure is a stark setback not only for the company but also for the A-T patient community, which has been eagerly awaiting a breakthrough treatment.
Background & Analysis: A-T is caused by mutations in the ATM gene, leading to degeneration in the cerebellum, immune deficiencies, and a high cancer risk. The failure of eDSP, previously known as EryDex, highlights the immense challenge of developing treatments for complex neurological disorders. The drug's mechanism aimed to use a patient's own red blood cells to deliver a steroid directly to target cells, hoping to mitigate neuroinflammation.
The sting of Quince's failure is sharpened by recent news from a competitor. Just last week, IntraBio reported positive Phase III results for its A-T candidate, levacetylleucine, setting it on a path toward regulatory submissions. This contrast underscores the high-risk, high-reward nature of biotech investing in rare diseases.
Expert & Investor Reactions:
Dr. Anya Sharma, Neurologist at Boston Children's Hospital: "This is a devastating outcome for families. The NEAT trial was designed with input from the community, and the unmet need is enormous. We must continue to support basic research to understand A-T's pathways better."
Michael Torres, Portfolio Manager at LifeSci Capital: "The data are unequivocal. This failure likely necessitates a strategic pivot for Quince. Their cash runway and remaining pipeline will be under intense scrutiny. It's a sobering reminder of binary event risk in micro-cap biotech."
David Chen, Patient Advocate and Father of a child with A-T: "It's a crushing blow. We pin our hopes on these trials for years. To see it fail while another succeeds is a brutal emotional rollercoaster. It feels like the community's fate is just a coin toss for investors."
Lisa Park, Biotech Analyst: "The safety profile was clean, which is a silver lining, but efficacy is king. The trial's outcome questions the fundamental hypothesis behind targeted steroid delivery in A-T. The field will now look intently at IntraBio's data for validation."