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公司（納斯達克股票代碼：THTX）警告稱，Egrifta SV（注射用特薩莫瑞林）可能在2025年初出現暫時的供應中斷。
The FDA has approved Egrifta SV as the only treatment for HIV-related excess visceral abdominal fat.
FDA已批准Egrifta SV作爲治療艾滋病相關過多內臟腹部脂肪的唯一療法。
The interruption is linked to an unexpected voluntary shutdown of the contract manufacturer's facility following an FDA inspection.
供應中斷與合同製造商的設施由於FDA的檢查而意外自願停產有關。
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.
FDA的審核時間表可能會延遲產品的再分發，但公司正在積極與其製造商和FDA合作，以最小化對患者的影響。
Also Read: HIV Medicine Maker Theratechnologies' Wraps Up Strong Second Quarter,' Stock Soars
同時閱讀：艾滋病藥物製造商Theratechnologies強勁收官第二季度，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的總裁兼首席執行官Paul Lévesque表示，儘管出現這種中斷，2025年患者的需求仍將得到滿足，並對此表示信心。
To mitigate the risk of shortages, Theratechnologies plans to implement measures to manage Egrifta SV inventory levels through early January 2025.
爲了減少短缺的風險，Theratechnologies計劃通過2025年1月初採取措施來管理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.
然而，由於供應挑戰，該公司預計其2024財年的營業收入將出現約160萬美元的差額。
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.
該代工廠自願關閉了三個月，以解決FDA合規辦公室提出的觀察結果，與Egrifta SV製造過程無關，但與工廠環境有關。
The manufacturer aims to resume operations by mid-October, with the first batch of Egrifta SV slated for production on October 21.
該製造商計劃在10月中旬恢復運營，首批Egrifta SV的生產預計於10月21日開始。
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FDA提交一份先前批准補充申請（PAS），詳細說明工廠所做的更改，預計將在製造日期附近進行。FDA通常在四個月內審查PAS申請。
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.
作爲公司的年度申報文件，其不擁有或經營製造設施，而是依賴第三方供應商（如Bachem、Jubilant和Lyophilization Services of New England）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.
公司尚未對備選製造商進行評估，而向新供應商的驗證過程可能需要長達三年的時間，從而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：THTX股票上漲4.16%，報價爲$1.25（最後一次查詢爲週四）。
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譯文內容由第三人軟體翻譯。
