Theratechnologies Inc - THTX STOCK NEWS

Theratechnologies (NASDAQ: THTX) has announced the resumption of EGRIFTA SV® distribution following FDA approval to release two recently manufactured batches. The treatment, exclusively distributed in the United States, is now ready for immediate shipment to network pharmacies.

The FDA's review of the Company's Prior Approval Supplement continues with an action goal date of April 18, 2025. EGRIFTA SV® (tesamorelin for injection) is designed for people with HIV, representing an important treatment option for this patient population.

Theratechnologies (TSX: TH) (NASDAQ: THTX) announced an upcoming shortage of EGRIFTA SV® (tesamorelin for injection) expected to affect patients by mid-January 2025. The shortage follows a voluntary shutdown of the contract manufacturing facility in 2024, with several pharmacies already reporting stockouts despite remaining inventory in certain U.S. locations.

The company filed a Prior Approval Supplement to the FDA on December 18, 2024, and submitted additional questions through a Type D meeting request regarding two recently manufactured batches awaiting release. The FDA has committed to responding in writing by February 8, 2025. EGRIFTA SV®, exclusively distributed in the United States, is the only FDA-approved medicine of its kind for people with HIV.

Theratechnologies (TSX: TH, NASDAQ: THTX) has submitted a Prior Approval Supplement (PAS) to the FDA regarding changes in the manufacturing environment for EGRIFTA SV®. The FDA's review process typically takes four months, and approval is required before distributing recently manufactured batches. Current inventory is expected to last until mid-January 2025. The company is in discussions with FDA divisions to expedite the release of EGRIFTA SV® to prevent potential patient-level shortages. The product is exclusively distributed in the United States.

Theratechnologies (NASDAQ: THTX) announced that the FDA has set a PDUFA goal date of March 25, 2025 for its supplemental Biologics License Application for the F8 formulation of tesamorelin. If approved, the F8 formulation will replace the current F4 formulation (EGRIFTA SV®) in the U.S. market. The new formulation is protected by patent until 2033.

Theratechnologies announced preliminary data from Part 3 of its Phase 1b trial of sudocetaxel zendusortide in advanced ovarian cancer patients. The trial, involving 13 heavily pre-treated patients, tested two weekly doses: 1.75-mg/kg/week (Arm A, 7 patients) and 2.5-mg/kg/week (Arm B, 6 patients).

Key findings include no dose-limiting toxicities in either arm and encouraging activity in Arm B, where three patients showed significant tumor shrinkage, including one with complete liver lesion resolution. Arm B patients received longer treatment duration (mean 10.25 weeks) compared to Arm A (mean 7.6 weeks).

The Medical Review Committee unanimously recommended continued evaluation at higher doses. The company plans to accelerate its search for a partner to advance its oncology program.

Theratechnologies (THTX) has entered into an exclusive licensing agreement with Ionis Pharmaceuticals to commercialize two investigational RNA-targeted medicines in Canada: olezarsen and donidalorsen. Olezarsen is being evaluated for familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (sHTG), while donidalorsen targets hereditary angioedema (HAE).

Under the agreement, Theratechnologies will pay Ionis a $10 million upfront payment and up to $12.75 million in milestone payments. Ionis will receive tiered double-digit royalties on annual net sales. Both drugs are pending FDA approval, with submissions to Health Canada planned for 2025. The agreement expands Theratechnologies' portfolio beyond its HIV business in the U.S.

Theratechnologies announced the resumption of EGRIFTA SV® production following 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.

Theratechnologies has secured up to $75 million in new credit facilities through agreements with TD Bank and Investissement Québec (IQ). The financing includes a $40 million three-year senior secured syndicated financing from TD Bank, with a $20 million accordion feature, and a $15 million subordinated loan from IQ. The new financing, featuring more favorable interest rates, replaces the existing Marathon Asset Management facility. The TD Bank financing includes a $25 million secured term loan and $15 million revolving facility at SOFR plus 2.75%, while the IQ loan carries an 11.45% interest rate. This restructuring is expected to free up approximately $19 million in cash in 2025 for business development initiatives.

Theratechnologies has resubmitted its supplemental Biologics License Application (sBLA) to the FDA for the F8 formulation of tesamorelin, addressing concerns raised in January 2024's Complete Response Letter. The F8 formulation aims to replace EGRIFTA SV® with simplified dosing for treating excess abdominal fat in HIV patients with lipodystrophy. The FDA's previous concerns focused on chemistry, manufacturing and controls, and immunogenicity risk information. The FDA will review the updated application within four months, with a decision expected around March 2025. The new formulation is patent protected until 2033.