On Tuesday, Theratechnologies Inc. THTX warned of a possible momentary provide disruption of Egrifta SV (tesamorelin for injection) in early 2025.
The FDA has accepted Egrifta SV as the one therapy for HIV-related extra visceral belly fats.
The interruption is linked to an surprising voluntary shutdown of the contract producer’s facility following an FDA inspection.
The FDA evaluate timeline might delay the resumption of product distribution, however the firm is actively working with its producer and the FDA to attenuate affected person impression.
Additionally Learn: HIV Medication Maker Theratechnologies’ Wraps Up Robust Second Quarter,’ Inventory Soars
Paul Lévesque, President and CEO of Theratechnologies, expressed confidence that affected person wants in 2025 might be met regardless of this disruption.
To mitigate the chance of shortages, Theratechnologies plans to implement measures to handle Egrifta SV stock ranges via early January 2025.
Nevertheless, as a result of provide challenges, the corporate anticipates a income shortfall of roughly $1.6 million for its fiscal 12 months 2024.
The contract producer’s facility underwent a voluntary three-month shutdown to handle observations made by the FDA’s Workplace of Compliance, which have been unrelated to the Egrifta SV manufacturing course of however involved the ability’s setting.
The producer goals to renew operations by mid-October, with the primary batch of Egrifta SV slated for manufacturing on October 21.
Theratechnologies should file a Prior Approval Complement (PAS) with the FDA detailing modifications made on the facility, which is anticipated across the manufacturing date. The FDA usually opinions PAS filings inside 4 months.
As the corporate’s annual filing, it doesn’t personal or function its manufacturing amenities and depends on third-party suppliers, resembling Bachem, Jubilant, and Lyophilization Providers of New England, to provide Egrifta SV.
The corporate has not certified different producers, and the validation course of for brand spanking new suppliers might take as much as three years, complicating any potential transition.
Worth Motion: THTX Inventory is up 4.16% at $1.25 on the final test on Thursday.
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