Theratechnologies Faces Potential Supply Disruption For Its Top Selling Drug, Warns of Revenue Impact Due To Manufacturing Delays
Theratechnologies Faces Potential Supply Disruption For Its Top Selling Drug, Warns of Revenue Impact Due To Manufacturing Delays
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.On Tuesday, Theratechnologies Inc. (NASDAQ:THTX) warned of a potential temporary supply disruption of Egrifta SV (tesamorelin for injection) in early 2025.
週二，Theratechnologies Inc.（納斯達克股票代碼：THTX）警告說，2025年初，Egrifta SV（注射用替薩莫瑞林）的供應可能會暫時中斷。
The FDA has approved Egrifta SV as the only treatment for HIV-related excess visceral abdominal fat.
美國食品藥品管理局已批准Egrifta SV作爲唯一治療與艾滋病毒相關的腹部內臟脂肪過多的方法。
The interruption is linked to an unexpected voluntary shutdown of the contract manufacturer's facility following an FDA inspection.
中斷與合同製造商的設施在FDA檢查後意外自願關閉有關。
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.
美國食品藥品管理局的審查時間表可能會推遲產品分銷的恢復，但該公司正在積極與製造商和美國食品藥品管理局合作，以最大限度地減少對患者的影響。
Also Read: HIV Medicine Maker Theratechnologies' Wraps Up Strong Second Quarter,' Stock Soars
另請閱讀：HIV藥物製造商Theratechnologies第二季度表現強勁，'股價飆升
Paul Lévesque, President and CEO of Theratechnologies, expressed confidence that patient needs in 2025 will be met despite this disruption.
Theratechnologies總裁兼首席執行官保羅·萊維斯克表示相信，儘管出現了這種干擾，但2025年的患者需求仍將得到滿足。
To mitigate the risk of shortages, Theratechnologies plans to implement measures to manage Egrifta SV inventory levels through early January 2025.
爲了降低短缺風險，Theratechnologies計劃在2025年1月初之前採取措施管理Egrifta SV的庫存水平。
However, due to the supply challenges, the company anticipates a revenue shortfall of approximately $1.6 million for its fiscal year 2024.
但是，由於供應挑戰，該公司預計其2024財年的收入缺口約爲160萬美元。
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.
該合同製造商的工廠自願關閉了三個月，以回應美國食品和藥物管理局合規辦公室的觀察，這些觀察與Egrifta SV的製造過程無關，但涉及該設施的環境。
The manufacturer aims to resume operations by mid-October, with the first batch of Egrifta SV slated for production on October 21.
該製造商的目標是在10月中旬之前恢復運營，第一批Egrifta SV定於10月21日投產。
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.
Theratechnologies必須向美國食品藥品管理局提交事先批准補充文件（PAS），詳細說明該設施所做的更改，預計將在生產日期前後進行。美國食品和藥物管理局通常會在四個月內審查PAS申報的文件。
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.
根據該公司的年度申報，它不擁有或運營其製造設施，而是依賴第三方供應商，例如Bachem、Jubilant和新英格蘭凍幹服務公司來生產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.
該公司沒有合格的替代製造商，新供應商的驗證過程可能需要長達三年的時間，這會使任何潛在的過渡變得複雜。
Price Action: THTX Stock is up 4.16% at $1.25 at the last check on Thursday.
價格走勢：在週四的最後一次支票中，THTX股價上漲4.16％，至1.25美元。
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