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Theratechnologies Inc. (symbol: THTX) is a biopharmaceutical company that markets prescription products across the United States, Europe, and Canada. Founded in 1993 and headquartered in Montreal, Canada, the company is dedicated to addressing the unmet medical needs of patients living with HIV and other serious health conditions.
Core Products:
- EGRIFTA and EGRIFTA SV: These products help reduce excess abdominal fat in HIV-infected patients with lipodystrophy, improving their quality of life.
- Trogarzo: A vital injection treatment for multidrug-resistant HIV-1 infected patients, offering hope to those who have limited treatment options.
Pipeline Products:
- F8 Formulation: A promising treatment for HIV-associated lipodystrophy, currently in development.
- TH-1902: A potential breakthrough in the treatment of triple-negative breast cancer.
- TH-1904: Targeting ovarian cancer, another pipeline product with significant potential.
Theratechnologies generates significant revenue from its relationship with RxCrossroads, a major customer based in the United States. The company's strategic partnerships and innovative products showcase its commitment to improving patient outcomes in serious medical conditions. With a dedicated focus on research and development, Theratechnologies continues to make strides in the biopharmaceutical industry.
MONTREAL, May 10, 2022 - Theratechnologies (TSX: TH, NASDAQ: THTX) held its annual meeting where shareholders elected Board candidates and appointed KPMG as auditors. Resolutions for a shareholder rights plan and amendments to the share option plan were approved. The company reported successful revenue growth and is building a research pipeline in oncology, aiming for strong returns for shareholders. Chair Dawn Svoronos emphasized the need for a balanced approach between commercial operations and research development for maximizing shareholder value.
Theratechnologies announced the initiation of patient enrollment in a basket trial for TH1902, its investigational peptide drug conjugate aimed at treating solid tumors expressing Sortilin. The established dose for this phase 1b study is 300 mg/m2, which is 1.5 times the therapeutic dose of docetaxel, without dose-limiting toxicities observed. The study will assess the efficacy and safety of TH1902 in various cancers including HR+ Breast Cancer and Melanoma. This development follows promising pre-clinical results suggesting TH1902 could significantly enhance docetaxel delivery into cancer cells.
Theratechnologies (THTX) has announced it will cease commercialization of Trogarzo® in Europe due to unsatisfactory pricing and reimbursement conditions. The company will focus on the North American market and return European rights to TaiMed Biologics within 180 days. This decision involves restructuring its Dublin subsidiary, resulting in an estimated cash charge of US$1.5 to US$2 million and non-cash charges of about US$6.5 million. European sales, which represented less than 2% of overall revenues, will not impact the company's revenue guidance for fiscal year 2022.
Theratechnologies Inc. (NASDAQ: THTX) will present at the Bloom Burton & Co.’s Healthcare Investor Conference 2022 on Tuesday, May 3, 2022, starting at 1:30 PM ET. The event will take place at the Metro Toronto Convention Centre, Track B, featuring 66 leading healthcare companies.
Investors can receive corporate updates and engage in one-on-one meetings with company management. Registration is mandatory for participation. More details are available on Theratechnologies' official website.
Theratechnologies (THTX) reported a 20% increase in consolidated sales for Q1 2022, driven by a 34.7% rise in EGRIFTA SV® sales, totaling $11.7 million. Overall revenues reached $18.6 million, up from $15.4 million in Q1 2021. R&D expenses surged by 64.6% to $8 million due to oncology program investments. The company is advancing its TH1902 clinical trial and aims for a basket study enrollment in 2022. However, delays in filing an sBLA for the F8 formulation due to supply issues were noted, alongside a net loss of $9 million, worsening from $5.9 million the prior year.
Theratechnologies (THTX) announced three poster presentations at the 2022 AACR Annual Meeting, highlighting promising preclinical data for its lead product TH1902. This drug targets sortilin-expressing cancers, showing significant tumor growth inhibition in triple-negative breast and ovarian cancer models. Key findings demonstrated an 80% reduction in tumor growth compared to standard treatments. Additionally, TH1902 exhibited superior efficacy in melanoma and endometrial cancer models. The company anticipates moving forward with further clinical trials, pending positive results.
Theratechnologies has announced it will report its first quarter financial results for fiscal 2022, ending February 28, 2022, on April 13, 2022. A conference call will follow at 8:30 a.m. (ET) to discuss the results and provide business updates. The call will feature Paul Lévesque, President & CEO, with a Q&A session for participants. Access details include a toll-free dial-in number and a webcast link. Audio replay options will be available for later listening.
Theratechnologies (THTX) announced acceptance of three poster abstracts for the 2022 AACR Annual Meeting, showcasing TH1902 preclinical data. These studies reveal the drug's ability to inhibit tumor growth in human cancer stem-like cells (CD133+) in triple-negative breast and ovarian cancers. Additional findings demonstrate TH1902's efficacy against ovarian and endometrial cancer xenografts and its inhibitory effects on melanoma growth and lung metastasis in syngeneic mice. Presentations will take place on April 11, 2022, in New Orleans.
Theratechnologies (THTX) reported a 5.7% increase in FY2021 consolidated sales, totaling $69.8 million, driven primarily by strong EGRIFTA SV® performance. Revenue guidance for FY2022 is projected between $79 million and $84 million, indicating growth of 13%-20% compared to FY2021. New patient enrollments surged 24%. The company is advancing its lead oncology asset, TH1902, towards Phase 1/Part B expansion, as it seeks out-licensing partners in Greater China. However, Trogarzo® sales declined 28.3% in Q4 2021 due to reimbursement issues in France.
Theratechnologies (THTX) announced positive results from a Phase 3 study of Trogarzo®'s IV Push method for HIV-1 treatment, presented at the virtual CROI on February 12-16, 2022. Key findings include:
- No significant pharmacokinetic differences between IV Push and IV Infusion.
- 94.7% of subjects achieved target drug concentration for both methods.
- No serious adverse events reported, with only one mild treatment-related adverse event noted.
- No difference in HIV-1 viral load or detection of anti-drug antibodies.
The FDA has accepted the supplemental Biologics License Application, with a target action date of October 3, 2022.
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