Theratechnologies Inc., a biopharmaceutical company, focuses on the development and commercialization of various therapies to address the unmet medical needs in the United States, Canada, and Europe. The company offers EGRIFTA and EGRIFTA SV for the reduction of excess abdominal fat in human immunodeficiency virus (HIV)-infected patients with lipodystrophy; and Trogarzo, a recombinant humanized monoclonal antibody, which is an injection for the treatment of multidrug resistant HIV-1 infected patients. Its pipeline products include F8 Formulation for the treatment of lipodystrophy in people living with HIV; and TH1902, which is in Phase 1 clinical trials for the treatment of various solid tumors, including HR+ breast cancer, triple negative breast cancer, ovarian cancer, endometrial cancer, melanoma, thyroid cancer, small cell lung cancer, and prostate cancer. The company was incorporated in 1993 and is headquartered in Montreal, Canada.

Theratechnologies Inc.

(RTTNews) - Theratechnologies (TH.TO, THTX) announced the FDA has approved the company's Prior Approval Supplement to the supplemental biologics license application for EGRIFTA SV, or tesamorelin for injection. Tesamorelin for injection is the only treatment approved in the U.S. to reduce excess abdominal fat in adults with HIV and lipodystrophy. Approval of the PAS removes any regulatory requirement for discretionary product release, thereby allowing the company to resume regular distribution of EGRIFTA SV.
"Securing FDA approval of the Prior Approval Supplement for the EGRIFTA SV sBLA closes a chapter of supply uncertainty and we are pleased to return to normal supply conditions," said Paul Lvesque, President and CEO of Theratechnologies.
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Theratechnologies Gets FDA Approval Of Prior Approval Supplement For EGRIFTA SV SBLA

(RTTNews) - Theratechnologies (THTX) has entered into an agreement with Ionis Pharmaceuticals to license two investigational RNA-targeted medicines developed by Ionis. 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.
Ionis will receive a $10 million upfront payment upon execution of the agreement as well as milestone payments up to $12.75 million based on the achievement of regulatory milestones, public reimbursement, and annual sales targets. Ionis will be entitled to receive tiered double-digit royalties on annual net sales of each medicine. Theratechnologies will be responsible for filing, obtaining and maintaining regulatory approval for olezarsen and donidalorsen in Canada.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Ionis Grants Theratechnologies License To Commercialize Olezarsen And Donidalorsen For Use In Canada

(RTTNews) - Biopharmaceutical company Theratechnologies Inc. (THTX, TH.TO) announced Tuesday the filing of a supplemental Biologics License Application (sBLA) for an intramuscular (IM) method of administration for the maintenance dose of Trogarzo (ibalizumab-uiyk) to the U.S. Food and Drug Administration (FDA) for review.
Trogarzo, in combination with other antiretrovirals (ARVs), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current ARV regimen.
The Trogarzo IM sBLA submission follows the recent FDA approval of the Company's Labelling Prior Approval Supplement to include a 2,000-mg intravenous (IV) push loading dose, which can now be delivered in as little as 90 seconds and no longer requires treatment to be initiated in specialized infusion clinics.
The potential addition of an entirely new method of administration for the maintenance dose via a rapid IM injection every two weeks could further simplify the Trogarzo treatment regimen.
In accordance with the FDA's filing review period, Theratechnologies expects to receive an acknowledgment letter of the sBLA application within 30 days along with a Prescription Drug User Fee Act (PDUFA) goal date.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Theratechnologies Files SBLA For Trogarzo Intramuscular Method Of Administration With FDA

(RTTNews) - Biopharmaceutical company Theratechnologies Inc. (THTX, TH.TO) announced it has filed a supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin to the U.S. Food and Drug Administration (FDA) for review.
Tesamorelin is the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy.
Pharmacokinetic studies have shown bioequivalence of the F8 formulation to the original F1 formulation of tesamorelin (EGRIFTA).
The F8 formulation is eight times more concentrated than EGRIFTA and two times more concentrated than the F4 formulation sold in the U.S. under the trade name EGRIFTA SV. This enables a smaller volume of administration as well as a new product presentation in a multiple-dose vial (MDV) that is reconstituted only once per week. The new formulation is patent protected in the U.S. until 2033.
In accordance with the FDA's filing review period, Theratechnologies expects to receive an acknowledgment letter of the sBLA application within 30 days along with a Prescription Drug User Fee Act (PDUFA) goal date. The proposed proprietary name for the F8 formulation, EGRIFTA MDVTM, is already under review by the FDA.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.