Theratechnologies, Inc.

Theratechnologies submitted a Prior Approval Supplement to the FDA for changes in EGRIFTA SV® manufacturing environment. Existing inventory is expected to meet demand until mid-January 2025, with ongoing discussions to avoid shortages.

Theratechnologies submitted a Prior Approval Supplement (PAS) to the FDA for EGRIFTA SV® manufacturing environment changes, with a 4-month review period. Current inventory is expected to last until mid-January 2025, and the company is discussing with FDA to expedite release to prevent shortages.

Theratechnologies submitted a Prior Approval Supplement to the FDA for changes in the manufacturing environment of EGRIFTA SV®. Existing inventory is expected to meet demand until mid-January 2025, with ongoing discussions to accelerate FDA approval and prevent shortages.

Theratechnologies reports favorable tolerability and efficacy signals for sudocetaxel zendusortide in Phase 1b trial for advanced ovarian cancer, with no dose-limiting toxicities and significant tumor shrinkage observed.

Theratechnologies Inc. partners with Ionis Pharmaceuticals to license olezarsen for familial chylomicronemia syndrome and severe hypertriglyceridemia, and donidalorsen for hereditary angioedema, with submissions to Health Canada planned for 2025.

Theratechnologies announced the resumption of EGRIFTA SV® production after a voluntary shutdown at their contract manufacturer's facility due to FDA inspection observations. One new batch has completed quality control and awaits FDA approval through a Prior Approval Supplement, expected to be filed mid-December 2024. Two additional batches are in production. The company has managed existing inventory to meet patient demand until mid-January 2025 and is working with FDA divisions to prevent potential shortages in 2025. EGRIFTA SV® is exclusively distributed in the United States.

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