Theratechnologies Receives March 2025 PDUFA Goal Date for Updated Tesamorelin F8 Formulation sBLA
Theratechnologies Inc. - Common Shares (THTX)
Company Research
Source: GlobeNewswire
MONTREAL, Dec. 10, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that the United States Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 25, 2025 to the Company’s recently submitted supplemental Biologics License Application for the F8 formulation of tesamorelin. If approved by the FDA, the F8 formulation is intended to replace the F4 formulation, which is sold in the U.S. under the trade name EGRIFTA SV®. The new formulation is patent protected in the U.S. until 2033. About Theratechnologies Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. Further information about Theratechnologies is available on the Company's
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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 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
- Theratechnologies Announces Preliminary Tolerability and Efficacy Data from Phase 1b, Dose-Ranging Trial of Sudocetaxel Zendusortide in Patients with Advanced Ovarian CancerGlobeNewswire
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