Taysha Gene Therapies And Catalent Expand Strategic Partnership To Include Future Commercial Manufacturing Support Of TSHA-102 Gene Therapy For Rett Syndrome

Taysha Gene Therapies, Inc.,(Taysha),a clinical-stage biotechnology company focused on developing adeno-associated virus (AAV)-based gene therapies for rare, monogenic diseases of the central nervous system, and Catalent, Inc.,(Catalent), the leading global contract development and manufacturing organization (CDMO) dedicated to helping people live better and healthier lives, today announced a commercial supply agreement for TSHA-102, Taysha’s investigational gene therapy in pivotal development for Rett syndrome, under which Catalent will serve as Taysha’s primary commercial manufacturer following potential U.S. Food and Drug Administration (FDA) approval.

Building on a partnership that has supported the development of TSHA-102 since 2020, the agreement secures long-term commercial manufacturing capacity and a scalable supply framework to support a potential commercial launch and future demand. Catalent will provide GMP manufacturing and commercial supply of TSHA-102 at its FDA-licensed commercial gene therapy facility in Harmans, Maryland, leveraging its experience across more than 90 gene therapy programs, including multiple commercial products.

“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. “Catalent's deep gene therapy expertise and proven commercial manufacturing capabilities make them an ideal partner as we expand our partnership to further strengthen our commercial infrastructure with a reliable, scalable supply framework. With BLA-enabling Process Performance Qualification activities underway, we believe we have established the manufacturing foundation necessary to support the strong demand we expect following the potential launch and commercialization of TSHA-102.”

“At Catalent, our priority is to support innovators who are redefining what’s possible for patients with rare diseases,” said David McErlane, Biologics Group President for Catalent. “Our partnership with Taysha brings together deep AAV expertise and a shared commitment to advancing a potential therapy for Rett syndrome—a condition with significant unmet need. We are proud to help enable the development and future supply of therapies that have the potential to make a meaningful difference for patients and their families.”

This partnership reflects Catalent’s continued commitment to supporting innovators across the cell and gene therapy landscape, providing end-to-end solutions from development through commercialization to help bring transformative therapies to patients.

About Rett Syndrome
Rett syndrome is a rare neurodevelopmental disorder caused by mutations in the X-linked MECP2 gene encoding methyl CpG-binding protein 2 (MeCP2), which is essential for regulating neuronal and synaptic function in the brain. The disorder is characterized by loss of communication and hand function, slowing and/or regression of development, motor and respiratory impairment, seizures, intellectual disabilities and shortened life expectancy. Rett syndrome progression is divided into four key stages, beginning with early onset stagnation at 6 to 18 months of age followed by rapid regression, plateau and late motor deterioration. Rett syndrome primarily occurs in females and is one of the most common genetic causes of severe intellectual disability. Currently, there are no approved disease-modifying therapies that treat the genetic root cause of the disease. Rett syndrome caused by a pathogenic/likely pathogenic MECP2 mutation is estimated to affect between 15,000 and 20,000 patients in the U.S., EU, and U.K.

About Taysha Gene Therapies
Taysha Gene Therapies (Nasdaq: TSHA) is a clinical-stage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system. Its lead clinical program TSHA-102 is in development for Rett syndrome, a rare neurodevelopmental disorder with no approved disease-modifying therapies that address the genetic root cause of the disease. With a singular focus on developing transformative medicines, Taysha aims to address severe unmet medical needs and dramatically improve the lives of patients and their caregivers. The Company’s management team has proven experience in gene therapy development and commercialization. Taysha leverages this experience, its manufacturing process and a clinically and commercially proven AAV9 capsid in an effort to rapidly translate treatments from bench to bedside. For more information, visit www.tayshagtx.com.

About Catalent
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) championing the missions that help people live better and healthier lives. Every product that Catalent helps develop, manufacture and launch reflects its commitment to improve health outcomes around the world through its Patient First approach. Catalent provides unparalleled service to pharma, biotech and consumer health customers, delivering on their missions to transform lives. Catalent tailors end-to-end solutions to meet customers’ needs in all phases of development and manufacturing. With thousands of scientists and technicians and the latest technology platforms at nearly 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. For more information, visit www.catalent.com.