Mirare

Astellas and Taysha Gene Therapies Announce Strategic Investment to Support Development of Taysha’s AAV-based Gene Therapy Programs

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Tuesday, October 25, 2022
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TOKYO and DALLAS, Oct. 24, 2022 (GLOBE NEWSWIRE) -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Taysha Gene Therapies, Inc. (NASDAQ: TSHA, CEO: RA Session II, “Taysha”) today announced a strategic investment to support the advancement of Taysha’s adeno-associated virus (AAV) gene therapy development programs for the treatment of Rett syndrome and GAN. The future options to potentially apply Astellas’ global R&D, manufacturing and commercialization capabilities in gene therapy to Taysha’s innovative AAV gene therapy development programs for genetic diseases of the central nervous system (CNS) create the opportunity for the two companies to enhance the development of novel treatment options for patients with Rett syndrome and GAN, who have serious unmet medical needs.

Key Points: 
  • Taysha is engaged in the development of intrathecally-delivered AAV gene therapies for monogenic CNS diseases.
  • To further strategically align Astellas and Taysha, in connection with its equity investment, Astellas will receive one Board observer seat on Tayshas Board of Directors, enabling Taysha to leverage Astellas gene therapy clinical and commercial expertise as Taysha advances TSHA-120 and TSHA-102.
  • Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines with the potential to deliver transformative value for patients.
  • Astellas Gene Therapies will also be advancing additional Astellas gene therapy programs toward clinical investigation.

Taysha Gene Therapies Reports Second Quarter 2022 Financial Results and Provides Corporate Update

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Thursday, August 11, 2022
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We look forward to reporting preliminary Phase 1/2 clinical data in adult females with Rett syndrome by year-end 2022.

Key Points: 
  • We look forward to reporting preliminary Phase 1/2 clinical data in adult females with Rett syndrome by year-end 2022.
  • TSHA-120 for giant axonal neuropathy (GAN): an intrathecally dosed AAV9 gene therapy in clinical development for the rare inherited genetic disorder GAN.
  • Taysha management will hold a conference call and webcast with slides today at8:00 am ET/7:00 am CTto review its financial and operating results and to provide a corporate update.
  • Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease.

Taysha Gene Therapies Reports First Quarter 2022 Financial Results and Provides Corporate Update

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Monday, May 16, 2022
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DALLAS, May 16, 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 first quarter ended March 31, 2022 and provided a corporate update.“In 2022, we are focused on advancing our key programs in Rett syndrome and GAN. We initiated clinical development of TSHA-102 in Rett syndrome and expect preliminary clinical data from the REVEAL study by year-end,” said RA Session II, President, Founder and CEO of Taysha. “Recently, the European Commission granted orphan drug designation for TSHA-120 for GAN, further highlighting the unmet need for treatment options for these patients and the important potential of TSHA-120. We have completed a commercially representative GMP batch for TSHA-120 with release testing currently underway. Our existing capital resources, along with full access to the term loan facility, should fund operating expenses and capital requirements into the fourth quarter of 2023.”   

Key Points: 
  • TSHA-120 is designed to deliver a functional copy of the GAN gene to the CNS and PNS.
  • TSHA-102 in Rett syndrome: a self-complementary intrathecally delivered AAV9 gene replacement therapy under development for the treatment of Rett syndrome.
  • Taysha management will hold a conference call and webcast today at8:00 am ET/7:00 am CTto review its financial and operating results and to provide a corporate update.
  • Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease.

Taysha Gene Therapies Announces Initiation of Clinical Development of TSHA-102 in Rett Syndrome

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Tuesday, March 29, 2022
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Initiation of clinical development is a significant milestone for the TSHA-102 program and Rett syndrome community, said Suyash Prasad, MBBS, M.Sc., MRCP, MRCPCH, FFPM, Chief Medical Officer and Head of Research and Development of Taysha.

Key Points: 
  • Initiation of clinical development is a significant milestone for the TSHA-102 program and Rett syndrome community, said Suyash Prasad, MBBS, M.Sc., MRCP, MRCPCH, FFPM, Chief Medical Officer and Head of Research and Development of Taysha.
  • Dr. Prasad added, There are no disease-modifying therapies to treat over 350,000 patients estimated to suffer from Rett syndrome worldwide2.
  • These preclinical safety and efficacy data will be presented at the International Rett Syndrome Foundation (IRSF) Rett Syndrome Scientific Meeting taking place April 26-27, 2022 in Nashville, Tennessee.
  • TSHA-102 is a self-complementary intrathecally delivered AAV9 gene replacement therapy under development for the treatment of Rett syndrome.

Taysha Receives Orphan Drug Designation from the European Commission for TSHA-102 for the Treatment of Rett Syndrome

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Wednesday, September 22, 2021
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TSHA-102 is a self-complementary intrathecally delivered AAV9 gene replacement therapy under development for the treatment of Rett syndrome.

Key Points: 
  • TSHA-102 is a self-complementary intrathecally delivered AAV9 gene replacement therapy under development for the treatment of Rett syndrome.
  • TSHA-102 has previously received rare pediatric disease designation and orphan drug designation from the U.S. Food and Drug Administration (FDA).
  • The European Commission grants orphan drug designation for medicines being developed for the diagnosis, prevention or treatment of treat life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 people in the European Union.
  • Orphan designation in the European Union includes benefits such as protocol assistance, reduced regulatory fees and market exclusivity.

Taysha Gene Therapies to Host Key Opinion Leader Webinar on TSHA-102 for the Treatment of Rett Syndrome

Retrieved on: 
Wednesday, September 8, 2021
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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 announced it will host a virtual key opinion leader (KOL) webinar on TSHA-102 for the treatment of Rett syndrome on Wednesday, September 22, 2021, from 10:00 a.m. to 12:30 p.m.

Key Points: 
  • 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 announced it will host a virtual key opinion leader (KOL) webinar on TSHA-102 for the treatment of Rett syndrome on Wednesday, September 22, 2021, from 10:00 a.m. to 12:30 p.m.
  • A live video webcast will be available in the Events & Media section of the Taysha corporate website.
  • Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease.
  • With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside.