Astellas Ditches Gene Therapies, with Losses Exceeding $390 Million

Faced with safety issues, Astellas has decided to terminate multiple projects, and redraw plans for its gene therapy for X-linked Myotubular Myopathy (XLMTM) a.k.a. AT132. The Japanese company has marked impairment losses in Q4 of 2021 and Q1 of 2022, with losses exceeding $390 million.

An impairment loss is a reduction in the fair value of an asset held by a company, and is recorded in the company’s financial statements.

Astellas Reassesses Gene Therapies

Astellas has recorded four patient deaths during the ASPIRO trial of AT132. Complications linked to the AAV gene therapy include sepsis, bleeding in the gut, and liver failure. Following the deaths, Astellas suspended screening and dosing in September 2021. The company received a clinical hold from the FDA soon after. 

It seems unlikely that AT132 will get a product launch, and if it did, its treatment population would be different from Astellas’ original assessment. Astellas chose to book an impairment loss of intangible assets as other expenses. 

Astellas has decided to terminate the development of ASP2390, a Phase 1 DNA vaccine against house dust mite-induced allergic rhinitis, and the GITR agonistic antibody ASP1951, which is in Phase 1 for cancer patients. 

These losses amount to around $390 million and will be listed in Astellas’ financial statement for Q4 of the fiscal year 2021. 

Furthermore, Astellas is cancelling development on three more gene therapies for Duchenne muscular dystrophy, AT702, AT751, and AT753, based on “recent preclinical study data”. The company will book another impairment loss of intangible assets of $170 million for Q1 of fiscal year 2022. 

Astellas is expected to give further details of the financial impact of its project changes along with the announcement of its financial results on April 27, 2022.

Author

Joy Lin

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