Theratechnologies Announces Resumed Production of EGRIFTA SV® [Yahoo! Finance]
Theratechnologies Inc. - Common Shares (THTX)
Company Research
Source: Yahoo! Finance
company focused on the development and commercialization of innovative therapies, today announced that the production of EGRIFTA SV ® has resumed following a voluntary shutdown of the Company's contract manufacturer's facility to address observations from an inspection by the US Food and Drug Administration (FDA). One newly manufactured batch of EGRIFTA SV ® has completed standard quality control and will be available for release to the market upon approval from the FDA of a Prior Approval Supplement, which the Company is expected to file around mid-December 2024. The manufacturing of two additional batches of EGRIFTA SV ® is currently underway. The Company implemented measures to carefully manage existing inventory levels of EGRIFTA SV ® to meet patient demand until mid-January 2025. Theratechnologies continues to collaborate closely with the relevant divisions of the FDA and other key stakeholders to avoid a shortage at the patient level in 2025. The Company will update the ma
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THTX
News
- Theratechnologies Announces Filing of FDA Prior Approval Supplement for EGRIFTA SV® Manufacturing Environment [Canadian Business Journal (Canada)]Canadian Business Journal
- Theratechnologies Announces Filing of FDA Prior Approval Supplement for EGRIFTA SV® Manufacturing EnvironmentGlobeNewswire
- Theratechnologies Receives March 2025 PDUFA Goal Date for Updated Tesamorelin F8 Formulation sBLA [Canadian Business Journal (Canada)]Canadian Business Journal
- Theratechnologies Receives March 2025 PDUFA Goal Date for Updated Tesamorelin F8 Formulation sBLAGlobeNewswire
- Theratechnologies Announces Preliminary Tolerability and Efficacy Data from Phase 1b, Dose-Ranging Trial of Sudocetaxel Zendusortide in Patients with Advanced Ovarian Cancer [Yahoo! Finance]Yahoo! Finance
THTX
Sec Filings
- 12/19/24 - Form 6-K
- 12/12/24 - Form 6-K
- 12/11/24 - Form 6-K
- THTX's page on the SEC website