- In a financial notice posted earlier today, Astellas Pharma Inc ALPMY said it was taking an impairment loss of ¥58.8 billion ($540 million) because of last year’s FDA clinical hold on Audentes’ AT132, gene therapy X-linked myotubular myopathy (XLMTM), a rare muscle-wasting disorder that is usually evident at birth.
- Last year, Audentes told patient groups that an XLMTM patient had died after receiving AT132. The patient, one of the three older children who received a higher dose in the trial, died from sepsis. The trial enrolled patients up to 5 years of age.
- Then again, Audentes shared details of a second death: The patient was another one of the three older children treated with the trial’s higher dose. The second patient who died suffered from progressive liver disease in the four to six weeks after AT132 therapy.
- Things then got worse after a third patient died in August, with early data suggesting the “immediate cause of death was gastrointestinal bleeding.” The child was the last of the three older trial participants who received the higher dose.
- At the end of the year, Audentes won a reprieve when the FDA lifted the hold to continue with the trial but with a lower dose.
- The company added: “There is no change to our plan to continue development. We will conduct future discussions with regulators on the path forward toward registration filings for AT132.”
- Astellas completed the $3 billion Audentes Therapeutics buyout last year.
- Price Action: ALPMY shares are down 3% at $14.73 during market trading hours on the last check Tuesday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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