Theratechnologies issues update on Egrifta SV shortage

More on Theratechnologies

• Theratechnologies resumes production of EGRIFTA SV
• Theratechnologies resubmits BLA for new tesamorelin formulation
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  Seeking Alpha | January 9, 2025

Theratechnologies Provides Update on EGRIFTA SV® Supply

MONTREAL, Jan. 09, 2025 (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 a shortage of EGRIFTA SV® (tesamorelin for injection) will occur at the patient level in mid-January 2025, following a voluntary shutdown of the contract manufacturing facility in 2024. While the Company is aware of remaining inventory of EGRIFT

Yahoo | January 9, 2025

Theratechnologies Announces Filing of FDA Prior Approval Supplement for EGRIFTA SV® Manufacturing Environment

MONTREAL, Dec. 18, 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 Company has submitted a Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration (FDA) describing the changes made to the manufacturing environment of the facility where EGRIFTA SV® is produced. A PAS is reviewed by the FDA w

Yahoo | December 18, 2024

Theratechnologies Receives March 2025 PDUFA Goal Date for Updated Tesamorelin F8 Formulation sBLA

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 tesam

Yahoo | December 10, 2024

Theratechnologies Announces Preliminary Tolerability and Efficacy Data from Phase 1b, Dose-Ranging Trial of Sudocetaxel Zendusortide in Patients with Advanced Ovarian Cancer

No dose-limiting toxicities reported in two different weekly doses in heavily pre-treated patients Preliminary evidence of dose response includes significant tumor shrinkage and one patient with complete resolution of a liver lesion MONTREAL, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Thera technologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced data from Part 3

Yahoo | December 9, 2024

Theratechnologies enters exclusive licensing agreement with Ionis

Theratechnologies (THTX) announced it has entered into an agreement with Ionis Pharmaceuticals (IONS) to license two investigational RNA-targeted medicines developed by Ionis. Under the agreement, Theratechnologies receives exclusive rights in Canada for olezarsen, which is being evaluated for familial chylomicronemia syndrome and severe hypertriglyceridemia, and for donidalorsen, which is being evaluated for the treatment of hereditary angioedema. All figures are in U.S. dollars unless otherwis

Yahoo | December 5, 2024

Theratechnologies Announces Exclusive Licensing Agreement with Ionis to Commercialize Olezarsen and Donidalorsen in Canada

Addition of investigational RNA-targeted medicines build upon Theratechnologies’ foundational HIV portfolio Submissions to Health Canada planned for 2025 MONTREAL, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a pharmaceutical company focused on the development and commercialization of innovative therapies, today announced it has entered into an agreement with Ionis Pharmaceuticals, Inc. (Ionis) to license two investigat

Yahoo | December 4, 2024

Theratechnologies Announces Resumed Production of EGRIFTA SV®

MONTREAL, Dec. 03, 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 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 E

Yahoo | December 3, 2024

Theratechnologies secures up to $75M in new credit facilities

Theratechnologies (THTX) announced that it has closed on a $40 million three-year non-dilutive, senior secured syndicated financing with TD Bank, as agent. The new credit facilities include a $20 million accordion feature, which could expand total commitments up to $60 million. Investissement Quebec, the Company’s largest shareholder, has also agreed to provide a $15 million second ranking secured subordinated term loan. Net proceeds from the new loans together with cash on hand will be used to

Yahoo | December 3, 2024

Theratechnologies Secures up to $75 Million in New Credit Facilities with TD Bank and Investissement Québec

New financing replaces existing credit facility to optimize Company’s capital structureFavorable interest rates and amortization schedules to free up approximately $19 million in cash in 2025 to support business development strategy MONTREAL, Dec. 02, 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 it has close

Yahoo | December 2, 2024