On Tuesday, Theratechnologies Inc. (NASDAQ:THTX) warned of a potential temporary supply disruption of Egrifta SV (tesamorelin for injection) in early 2025.
The FDA has approved Egrifta SV as the only treatment for HIV-related excess visceral abdominal fat.
The interruption is linked to an unexpected voluntary shutdown of the contract manufacturer's facility following an FDA inspection.
The FDA review timeline could delay the resumption of product distribution, but the company is actively working with its manufacturer and the FDA to minimize patient impact.
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Paul Lévesque, President and CEO of Theratechnologies, expressed confidence that patient needs in 2025 will be met despite this disruption.
To mitigate the risk of shortages, Theratechnologies plans to implement measures to manage Egrifta SV inventory levels through early January 2025.
However, due to the supply challenges, the company anticipates a revenue shortfall of approximately $1.6 million for its fiscal year 2024.
The contract manufacturer's facility underwent a voluntary three-month shutdown to address observations made by the FDA's Office of Compliance, which were unrelated to the Egrifta SV manufacturing process but concerned the facility's environment.
The manufacturer aims to resume operations by mid-October, with the first batch of Egrifta SV slated for production on October 21.
Theratechnologies must file a Prior Approval Supplement (PAS) with the FDA detailing changes made at the facility, which is expected around the manufacturing date. The FDA typically reviews PAS filings within four months.
As the company's annual filing, it does not own or operate its manufacturing facilities and relies on third-party suppliers, such as Bachem, Jubilant, and Lyophilization Services of New England, to produce Egrifta SV.
The company has not qualified alternative manufacturers, and the validation process for new suppliers could take up to three years, complicating any potential transition.
Price Action: THTX Stock is up 4.16% at $1.25 at the last check on Thursday.
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