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Theratechnologies Inc Stock Price, News & Analysis

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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.

Theratechnologies Inc (NASDAQ: THTX) is a specialty biopharmaceutical company advancing therapies for HIV complications and oncology conditions. This news hub provides investors and medical professionals with essential updates on clinical developments, regulatory milestones, and strategic initiatives.

Access timely information about FDA-approved HIV treatments like EGRIFTA for lipodystrophy and Trogarzo for multidrug-resistant infections, alongside emerging oncology candidates targeting aggressive cancers. Our curated news collection includes earnings reports, partnership announcements, and research breakthroughs.

Key updates cover three focus areas: commercialized HIV therapies, pipeline progress in oncology, and operational developments across North American/European markets. Content types include clinical trial results, regulatory filings, and executive commentary.

Bookmark this page for structured access to Theratechnologies' latest advancements in niche biopharmaceutical solutions. Verify information directly through company filings and press releases for informed decision-making.

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Theratechnologies (NASDAQ: THTX) has received FDA approval for its Prior Approval Supplement (PAS) to the supplemental biologics license application (sBLA) for EGRIFTA SV®. This approval enables unrestricted distribution of EGRIFTA SV®, eliminating previous discretionary product release requirements.

EGRIFTA SV® is currently the only FDA-approved treatment for reducing excess abdominal fat in adults with HIV and lipodystrophy. The FDA has also recently approved a new F8 formulation, EGRIFTA WR™, which will replace EGRIFTA SV® and offers improved patient convenience.

The medication works as a growth hormone-releasing factor (GHRF) analog, stimulating the production and release of endogenous growth hormone. Common side effects include arthralgia, injection site reactions, pain in extremity, peripheral edema, and myalgia.

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Theratechnologies (NASDAQ: THTX) has scheduled its first quarter 2025 financial results announcement and business update for April 9, 2025, at 8:30 a.m. ET. The conference call will feature key executives including CEO Paul Lévesque, CFO Philippe Dubuc, Chief Medical Officer Christian Marsolais, and Global Commercial Officer John Leasure.

The management team will present the Q1 2025 results for the period ended February 28 and will be available for a Q&A session following their prepared remarks. The presentation will be accessible via webcast and telephone conference, with replay available until April 16, 2025.

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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.

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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.

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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.

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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

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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.

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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.

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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.

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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.

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FAQ

What is the current stock price of Theratechnologies (THTX)?

The current stock price of Theratechnologies (THTX) is $3.15 as of July 14, 2025.

What is the market cap of Theratechnologies (THTX)?

The market cap of Theratechnologies (THTX) is approximately 145.8M.
Theratechnologies Inc

Nasdaq:THTX

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145.76M
34.58M
1.15%
50.11%
0.11%
Biotechnology
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