FDA clears Theratechnologies' EGRIFTA SV for unrestricted distribution

MONTREAL - Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company with annual revenues of $85.87 million and an impressive 76% gross profit margin, today announced that the U.S. Food and Drug Administration (FDA) has approved unrestricted distribution of its product EGRIFTA SV® (tesamorelin for injection), a treatment for reducing excess abdominal fat in HIV-infected adults with lipodystrophy. This approval follows the recent FDA nod for a new formulation, EGRIFTA WR™, which will soon replace EGRIFTA SV® in the U.S. market. According to InvestingPro analysis, the company is currently trading at Fair Value.

With the FDA's Prior Approval Supplement (PAS) to the supplemental biologics license application (sBLA) for EGRIFTA SV®, Theratechnologies can now resume regular distribution of the drug without any regulatory constraints that previously affected the release of manufactured batches. This development is expected to close a period of supply uncertainty for the company.

Paul Lévesque, President and CEO of Theratechnologies, expressed satisfaction with the FDA's decision, stating that the company is looking forward to transitioning patients to EGRIFTA WR™, which has been designed to offer a more convenient treatment experience. The market has responded positively to recent developments, with the stock showing a significant 17% gain over the past week and a 35% increase over the last six months.

EGRIFTA SV® and the upcoming EGRIFTA WR™ are growth hormone-releasing factor (GHRF) analogs that stimulate the production and release of endogenous growth hormone to target visceral adipose tissue. However, the long-term cardiovascular safety of tesamorelin for injection has not been established, and its use is not indicated for weight loss management or for improving compliance with anti-retroviral therapies in HIV-positive patients.

The most common adverse reactions reported for tesamorelin for injection include joint pain, reactions at the injection site, pain in extremity, swelling of the extremities, and muscle pain. Healthcare providers and patients are advised to report any adverse events.

Theratechnologies is a specialty biopharmaceutical company focused on bringing innovative therapies to market. With the latest FDA action, the company aims to redefine standards of care in its specialty areas. InvestingPro analysts project the company will achieve profitability this year, with additional insights and detailed financial analysis available in the comprehensive Pro Research Report, which covers over 1,400 US equities.

This news is based on a press release statement from Theratechnologies Inc. and has not been independently verified.

In other recent news, Theratechnologies Inc. has announced the approval from the U.S. Food and Drug Administration for its new formulation of tesamorelin, marketed as EGRIFTA WR™. This new formulation requires weekly reconstitution, offering a more convenient dosing schedule compared to the current daily requirement for EGRIFTA SV®. EGRIFTA WR™ is intended for reducing excess abdominal fat in adults with HIV who have lipodystrophy and is expected to enhance patient experience due to its bioequivalence to the original formulation. The product will be manufactured in the United States and is patent protected until 2033, set to replace EGRIFTA SV®. Additionally, Theratechnologies has presented promising results for ibalizumab, used in combination antiretroviral therapy, for patients with multidrug-resistant HIV. The PROMISE-US study, presented at the 2025 Conference on Retroviruses and Opportunistic Infections, showed that ibalizumab-containing regimens achieved similar rates of viral suppression compared to non-ibalizumab regimens. Interim analysis indicated that nearly half of the patients achieved undetectable viral loads at six months, with no reported infusion reactions or treatment discontinuations among ibalizumab users. Theratechnologies continues to monitor patients in this ongoing study, highlighting its focus on innovative therapies for challenging conditions.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.