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MONTREAL - Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company with annual revenues of $85.87 million and an impressive 76% gross margin, has received approval from the U.S. Food and Drug Administration (FDA) for its new formulation of tesamorelin, now to be marketed as EGRIFTA WR™. This product is intended for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy. According to InvestingPro analysis, while the company isn’t currently profitable, analysts expect it to turn profitable this year.
The newly approved EGRIFTA WR™ requires weekly reconstitution, as opposed to the current daily requirement for the F4 formulation, EGRIFTA SV®, and is administered in a lower volume. It has been shown to be bioequivalent to the original F1 formulation of tesamorelin (EGRIFTA®).
Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies, expressed satisfaction with the FDA’s approval, underscoring the benefits of the more convenient dosing schedule and improved patient experience. David Alain Wohl, MD, of The University of North Carolina at Chapel Hill, noted the significant health and quality of life implications of excess visceral abdominal fat (EVAF) in patients with HIV, and welcomed the new formulation as an important advancement.
EGRIFTA WR™ will be available in packages of four single-patient-use vials, with each vial containing enough tesamorelin for seven doses. The daily dose is 1.28 mg, injected subcutaneously, and can be stored at room temperature both before and after reconstitution.
The most commonly reported adverse reactions include arthralgia, injection site reactions, pain in extremity, peripheral edema, and myalgia. The product’s long-term cardiovascular safety has not been established, and it is contraindicated in patients with certain conditions such as active cancer or a history of hypothalamic-pituitary axis disruption.
Theratechnologies has announced that EGRIFTA WR™ will be manufactured in the United States by a contract drug manufacturing organization and is patent protected in the U.S. until 2033, set to replace EGRIFTA SV®. The company’s stock has shown strong momentum, gaining over 30% in the past six months. InvestingPro subscribers can access detailed financial health scores and 6 additional exclusive ProTips about THTX’s growth prospects and market position. The company has provided full prescribing information, instructions for use, and safety information on its website.
This news is based on a press release statement and includes no endorsement of the claims. With the company’s next earnings report due in 15 days, investors can access comprehensive analysis and Fair Value estimates through InvestingPro’s detailed research reports, available for over 1,400 US stocks including THTX.
In other recent news, Theratechnologies Inc. has presented promising data regarding its drug, ibalizumab, at the 2025 Conference on Retroviruses and Opportunistic Infections in San Francisco. The observational registry study, PROMISE-US, evaluated the efficacy of ibalizumab for patients with multidrug-resistant HIV. The interim analysis included 112 participants, with 42 receiving ibalizumab, and showed that nearly half of the patients in both the ibalizumab and control cohorts achieved undetectable viral loads after six months. At the 12-month mark, 53% of the control group and 42% of the ibalizumab group maintained undetectable viral loads. Importantly, no infusion reactions or treatment discontinuations due to adverse events were reported among ibalizumab users. Theratechnologies continues to monitor patients in the ongoing study, with a focus on the commercialization of innovative therapies. These developments reflect the company’s commitment to advancing treatment options for patients with limited options due to drug resistance.
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