Welcome to our dedicated page for Theratechnologies news (Ticker: THTX), a resource for investors and traders seeking the latest updates and insights on Theratechnologies stock.
Overview
Theratechnologies Inc (THTX) is a specialty biopharmaceutical company known for its targeted approach in addressing unmet medical needs primarily within the HIV patient community. With a robust presence across Canada, the United States, and parts of Europe, the company has built its reputation on pioneering prescription products that focus on conditions such as HIV-associated lipodystrophy and multidrug-resistant HIV-1 infections. The company strategically integrates cutting-edge pharmaceutical research with practical treatment applications, making it a significant participant in the modern biopharmaceutical industry.
Core Business and Product Portfolio
Theratechnologies Inc has developed and marketed therapeutic solutions that are specifically designed to manage complications associated with HIV. Its approved product, EGRIFTA, is aimed at reducing excess abdominal fat in HIV-infected patients with lipodystrophy, a condition that disrupts the normal distribution of body fat. Additionally, the company offers Trogarzo, an injectable medication that represents a novel approach for patients with multidrug-resistant HIV-1 infections. These products are supported by rigorous clinical evaluations and represent an important bridge between specialized medical research and effective clinical application.
Pipeline and Research Focus
In alignment with its commitment to innovation, Theratechnologies Inc continues to expand its research pipeline. The ongoing development includes formulations that target HIV-associated lipodystrophy as well as therapeutic candidates in the field of oncology. Notably, the company is advancing candidates for the treatment of aggressive cancers, including triple negative breast cancer and ovarian cancer. This broadened focus demonstrates the company’s intent to not only solidify its niche in HIV treatment but also to explore significant opportunities in the oncology domain.
Business Model and Market Position
The company generates revenue through strategic partnerships and customer relationships, with a concentrated customer base that plays a critical role in its market operations. Its business model centers on the commercialization of niche treatments, developed based on extensive clinical research and a deep understanding of patient needs. By focusing on conditions that have historically seen limited therapeutic options, Theratechnologies has carved out a competitive niche within the broader biopharmaceutical industry.
Competitive Landscape and Strategic Value
Within the competitive landscape, Theratechnologies Inc differentiates itself through a clear focus on both specialized HIV treatments and an expanding portfolio in oncology. Investors and industry analysts value the company’s methodical approach to addressing complex health conditions. Its emphasis on clinical efficacy, combined with strategic revenue generation through established partnerships, underscores its position as a specialized player that offers unique solutions in a dynamic market environment.
Research, Regulatory, and Operational Excellence
Commitment to scientific rigor and regulatory compliance is at the heart of Theratechnologies Inc's operations. The company’s long-standing history in pharmaceutical research is reflected in its steadfast pursuit of innovation. By maintaining a strong adherence to quality standards and clinical efficacy, the company reinforces trust among healthcare providers, patients, and the wider investment community. This operational excellence is manifested in the company’s detailed research programs and its focus on developing therapies that address clear, unmet needs in patient care.
Summary
From its specialized products addressing HIV complications to its expanding pipeline in oncology, Theratechnologies Inc offers a comprehensive approach to specialized pharmaceutical care. Its strategic market position, founded on deep clinical insights and a focused business model, makes it an important entity in the biopharmaceutical industry. The company continues to exemplify how targeted research and commitment to clinical excellence can drive sustained relevance in a competitive global market.
Theratechnologies (NASDAQ: THTX) has received FDA approval for EGRIFTA WR™, an improved formulation of tesamorelin for treating excess visceral abdominal fat in adults with HIV and lipodystrophy. The new formulation requires weekly reconstitution instead of daily, with less than half the administration volume compared to the current EGRIFTA SV® version.
EGRIFTA WR™ will be supplied as four single-patient-use vials, each containing 11.6 mg of tesamorelin, sufficient for seven doses. The daily dose is 1.28 mg injected subcutaneously and can be stored at room temperature. The product is patent protected in the U.S. until 2033 and will be manufactured at a new U.S.-based contract drug manufacturing organization.
Common adverse reactions include arthralgia, injection site reactions, pain in extremity, peripheral edema, and myalgia. The new formulation has shown bioequivalence to the original F1 formulation of tesamorelin.
Theratechnologies (NASDAQ: THTX) presented significant findings at the 2025 CROI conference regarding cardiovascular risk assessment in HIV patients. The Visceral Adiposity Measurement and Observation Study (VAMOS) revealed that Body Mass Index (BMI) alone is insufficient for evaluating cardiovascular (CV) risk in people with HIV (PWH).
Key findings from the 170-participant study showed that excess visceral abdominal fat (EVAF) is a important risk factor, with high prevalence even among those with normal BMI (43%) and overweight individuals (47%). Notably, PWH with EVAF showed higher 10-year atherosclerotic cardiovascular disease risk scores regardless of BMI (p=0.0019). The study also found that visceral adipose tissue area strongly correlates with pericardial fat volume (p<0.0001).
The research suggests healthcare providers should incorporate EVAF screening, such as waist circumference measurements, alongside BMI to better identify CV risk in HIV patients on modern antiretroviral therapy.
Theratechnologies (NASDAQ: THTX) presented encouraging data from the PROMISE-US trial of ibalizumab for HIV treatment at CROI 2025. The real-world observational study demonstrated that patients receiving ibalizumab-containing regimens achieved similar viral suppression rates compared to control groups, despite having more severe baseline conditions.
The interim analysis included 112 participants (70 in control Cohort 1, 42 in ibalizumab Cohort 2). Among viremic patients, 47% in the ibalizumab group achieved undetectable viral load after 6 months, compared to 50% in controls. At 12 months, undetectable rates were 42% for ibalizumab versus 53% for controls.
Notably, ibalizumab-treated patients started with more challenging baseline characteristics, including lower CD4 counts and higher viral loads. The drug demonstrated good tolerability with no infusion reactions or treatment discontinuations due to adverse events.
Theratechnologies (NASDAQ: THTX) reported strong financial results for Q4 and FY2024, achieving record positive Adjusted EBITDA of $20 million (net loss of $8.3 million) and annual revenue of $85.9 million.
Key highlights include:
- Record quarterly revenue of $25 million in Q4 2024
- EGRIFTA SV® sales reached $60.1 million, growing 12% year-over-year
- Secured $75 million in new credit facilities with TD Bank and Investissement Québec
- In-licensed two new Ionis assets (olezarsen and donidalorsen) in Canada
- Resumed distribution of EGRIFTA SV® following temporary supply disruption
- FDA assigned March 25, 2025 PDUFA date for F8 formulation
Theratechnologies (TSX: TH) (NASDAQ: THTX), a specialty biopharmaceutical company, has scheduled its fourth quarter and full year fiscal 2024 financial results announcement and business update for February 26, 2025, at 8:30 a.m. ET.
The conference call will be led by Paul Lévesque, President and CEO, alongside other key management team members including Philippe Dubuc (CFO), Christian Marsolais (CMO), and John Leasure (Global Commercial Officer). The team will present prepared remarks followed by a Q&A session.
Participants are advised to join the call ten minutes before start time. The presentation will be accessible via webcast and telephone conference, with replay options available until March 5, 2025.
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.
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