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Taysha Gene Therapies Reports Second Quarter 2022 Financial Results and Provides Corporate Update
TSHA-120 treated patients in GAN demonstrated durable improvement and recoverability of sensory nerve amplitude potential (SNAP), a definitive clinical
About this update from Taysha Gene Therapies, Inc.
[{"type":"text","content":"TSHA-120 treated patients in GAN demonstrated durable improvement and recoverability of sensory nerve amplitude potential (SNAP), a definitive clinical endpoint, compared to natural history TSHA-120 commercial grade and clinical trial material considered comparable across all key quality attributes as assessed by an extensive panel of release assays and next-generation sequencing Positive feedback from MHRA supports regulatory strategy and manufacturing approach including potency assay matrix; additional regulatory feedback, including from FDA, expected by year-end 2022 Preclinical data for TSHA-102 in Rett syndrome demonstrated near normalization of survival as well as normalization of behavior in neonatal knockout Rett mice; clinical data expected by year-end 2022 Conference call and live webcast today at 8:00 AM Eastern Time DALLAS, Aug. 11, 2022 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric, pivotal-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS) in both rare and large patient populations, today reported financial results for the second quarter ended June 30, 2022, and provided a corporate update. “We are excited to announce important progress in giant axonal neuropathy (GAN) including stabilization and improvement of sensory nerve function, a definitive clinical endpoint, in patients with GAN following treatment with TSHA-120,” said RA Session II, President, Founder and CEO of Taysha. “In addition, we now have positive comparability data demonstrating that our commercial grade and clinical trial material are comparable across all key quality attributes. Importantly, we believe positive feedback received from the MHRA, in conjunction with robust comparability data for TSHA-120 and comprehensive clinical data generated to date, further support our ongoing regulatory engagement. We expect additional regulatory feedback, including from the FDA, by year-end. In Rett syndrome, we are highly encouraged by late-breaking neonatal data in preclinical mouse models demonstrating near normalization of survival and normalization of behavior. We look forward to reporting preliminary Phase 1/2 clinical data in adult females with Rett syndrome by year-end 2022.” Recent Corporate Highli...