Taysha Gene Therapies (Nasdaq: TSHA) and Catalent have signed a commercial supply agreement for TSHA-102, Taysha's investigational gene therapy for Rett syndrome, under which Catalent will serve as the primary commercial manufacturer if the therapy receives U.S. Food and Drug Administration approval.

The agreement builds on a development partnership between the two companies that began in 2020. Under the new terms, Catalent will provide GMP manufacturing and commercial supply of TSHA-102 at its FDA-licensed gene therapy facility in Harmans, Maryland.

Taysha said BLA-enabling Process Performance Qualification activities are currently underway. The company described the manufacturing agreement as part of its launch readiness strategy.

"As we continue to advance TSHA-102, establishing long-term commercial manufacturing capacity is a critical component of our launch readiness strategy," said Sean P. Nolan, Chairman and Chief Executive Officer of Taysha.

Rett syndrome is a rare neurodevelopmental disorder caused by mutations in the MECP2 gene. It primarily affects females and is estimated to affect between 15,000 and 20,000 patients in the U.S., EU, and U.K. There are currently no approved disease-modifying therapies that address the genetic root cause of the condition.

The information in this article is based on a press release issued by Taysha Gene Therapies.