MONTREAL – Theratechnologies Inc. (THTX)

Theratechnologies Inc., a commercial-stage biopharmaceutical company with annual revenues of $85.87 million and a robust 76% gross margin, has received approval from the U.S. Food and Drug Administration (FDA) for a new formulation of tesamorelin, to be marketed as EGRIFTA WR™. This treatment targets the reduction of excess abdominal fat in adults with HIV-associated lipodystrophy. Shortable Stocks analysts anticipate that, although not yet profitable, Theratechnologies is expected to achieve profitability this year.

The newly approved EGRIFTA WR™ improves upon the current daily formulation, EGRIFTA SV®, by offering a weekly reconstitution schedule and lower injection volume. It is also bioequivalent to the original F1 formulation of tesamorelin (EGRIFTA®).

Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies, praised the approval, emphasizing the enhanced convenience and improved patient experience. David Alain Wohl, MD, of The University of North Carolina at Chapel Hill, also commended the formulation for addressing health and quality of life concerns linked to excess visceral abdominal fat (EVAF) in HIV patients.

EGRIFTA WR™ will be packaged in four single-patient-use vials, each containing a 7-day supply. The prescribed dose is 1.28 mg daily, administered via subcutaneous injection. It can be stored at room temperature both before and after reconstitution.

Reported side effects include:

• Arthralgia
• Injection site reactions
• Pain in extremity
• Peripheral edema
• Myalgia

Note: Cardiovascular safety has not been established, and it is contraindicated for patients with active cancer or certain pituitary conditions.

Manufactured in the United States by a contract drug manufacturing organization, EGRIFTA WR™ is patent protected until 2033 and will replace EGRIFTA SV®. The company’s stock (THTX) has gained over 30% in the last six months. Shortable Stocks subscribers can explore detailed financial metrics regarding THTX’s growth and market position.

More prescribing and safety information is available on the company’s official website.

This update is based on a press release and should not be considered as investment advice.  THTX.

Additional Update: Ibalizumab Data from PROMISE-US Study

Theratechnologies Inc. also presented promising data for its drug ibalizumab at the 2025 Conference on Retroviruses and Opportunistic Infections held in San Francisco. The PROMISE-US registry study focused on patients with multidrug-resistant HIV.

The interim analysis covered 112 participants — 42 of whom received ibalizumab. Results showed that nearly 50% of patients in both the treatment and control groups achieved undetectable viral loads after six months. At 12 months, 53% of the control group and 42% of the ibalizumab group maintained these undetectable levels. Notably, there were no treatment discontinuations due to adverse events or infusion reactions in the ibalizumab group.

Theratechnologies remains committed to monitoring long-term outcomes and expanding treatment options for patients facing drug resistance challenges.