Astellas warns of impairment losses due to development setbacks

Japanese drugmaker Astellas Pharma (TSE: 4503) has announced that it will book an impairment loss in both the fourth quarter of the fiscal year ended on March 31, 2022, and in the subsequent quarter.

One of the reasons for the unforeseen fourth-quarter impairment loss of approximately 50 billion yen ($390 million) is the receipt of serious adverse events in patients who participated in the ASPIRO trial evaluating investigational gene therapy AT132 in patients with X-linked myotubular myopathy.

As a result, Astellas voluntarily suspended screening and dosing in September, 2021. After that, the firm received the clinical hold for the ASPIRO clinical trial from the US Food and Drug Administration (FDA). The company then reassessed the development plan and recognized a delay in approval timing, as well as revising the eligible treatment population based upon an anticipated future product label compared to the initial assessment. Following re-evaluation of the intangible asset based on the updated assumptions, Astellas will book an impairment loss of intangible assets as other expenses.