Theratechnologies Inc.
2310 Alfred-Nobel Boulevard
Saint-Laurent
Quebec
H4S 2A4
Canada
Tel: 514-336-7800
Fax: 514-336-7242
Website: http://www.theratech.com/
Email: webinfo@theratech.com.
317 articles about Theratechnologies Inc.
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The Canadian biotech’s regulatory setbacks continued on Tuesday with an FDA Refusal to File letter for its intramuscular formulation of the humanized monoclonal antibody Trogarzo.
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Theratechnologies Receives Refusal to File Letter for Trogarzo® Intramuscular Method of Administration sBLA from FDA
2/27/2024
Theratechnologies Inc. today announced that the United States Food and Drug Administration (FDA) has issued a refusal to file letter (RTF) regarding the Company’s supplemental Biologics License Application (sBLA) for an intramuscular (IM) method of administration for the maintenance dose of Trogarzo® (ibalizumab-uiyk). The sBLA filing was announced on January 2, 2024.
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Theratechnologies Reports Financial Results for the Fourth Quarter and Full Year of Fiscal 2023 and Provides 2024 Guidance
2/21/2024
Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today reported business highlights and financial results for the fourth quarter and full year of fiscal year 2023, ended November 30, 2023.
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Theratechnologies Announces Publication in Frontiers in Immunology that Deepens Understanding of Sudocetaxel Zendusortide (TH1902) Molecular Mechanism of Action
2/20/2024
Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced the publication of a peer-reviewed article in Frontiers in Immunology that enhances understanding of the molecular mechanism of action of sudocetaxel zendusortide (also known as TH1902) as a potential anticancer treatment.
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Theratechnologies Completes Enrollment of First Six Patients in Updated Phase 1 Clinical Trial of Sudocetaxel Zendusortide in Advanced Ovarian Cancer
2/15/2024
Theratechnologies Inc. announced completion of enrollment of the first six participants in Part 3 of its Phase 1 clinical trial of sudocetaxel zendusortide in patients with advanced ovarian cancer.
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Theratechnologies to Announce Fourth Quarter and Full Year 2023 Financial Results and Provide Business Update
2/6/2024
Theratechnologies Inc. announced the Company will report financial results and provide a business update for its fourth quarter and full year fiscal 2023 ended November 30, on Wednesday, February 21, 2024, at 8:30 a.m. EDT.
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Theratechnologies Receives Complete Response Letter (CRL) from the FDA for the F8 Formulation of Tesamorelin sBLA
1/24/2024
Theratechnologies Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the Company’s supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin.
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The regulator’s Complete Response Letter flagged issues with the new formulation of tesamorelin’s chemistry, manufacturing and controls and sought more information about its immunogenicity risk.
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Theratechnologies Receives Update from FDA on Tesamorelin F8 Supplemental Biologic License Application
1/23/2024
Theratechnologies Inc. has received correspondence from the U.S. Food and Drug Administration (FDA) regarding the Company’s supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin.
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After a quiet start to 2024, the FDA is expected to decide on three applications over the next two weeks, including one for a nasal powder migraine treatment.
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Theratechnologies Submits sBLA for Trogarzo® Intramuscular (IM) Method of Administration to FDA
1/2/2024
Theratechnologies Inc today announced that the Company has filed a supplemental Biologics License Application (sBLA) for an intramuscular (IM) method of administration for the maintenance dose of Trogarzo® (ibalizumab-uiyk) to the United States Food and Drug Administration (FDA) for review.
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Theratechnologies Announces FDA Approval of Trogarzo® 90-Second Intravenous (IV) Push Loading Dose
12/13/2023
Theratechnologies Inc. today announced that the United States Food and Drug Administration (FDA) has approved the company’s Labelling Prior Approval Supplement to include a 2000-mg intravenous (IV) push loading dose for Trogarzo® (ibalizumab-uiyk).
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Theratechnologies Receives 2023 CQDM ADRIQ RSRI Innovation Award
11/24/2023
Theratechnologies Inc. today announced receipt of the 2023 Industrial Research Sectoral Group (RSRI) Innovation Award from the CQDM (formerly known as the Québec Consortium for Drug Discovery) and the Association for the Development of Research and Innovation of Québec (ADRIQ).
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Theratechnologies Announces Closing of US$25 Million Public Offering of Common Shares and Concurrent Private Placement
10/31/2023
Theratechnologies Inc. announced that it has closed its previously announced public offering of 12,500,000 common shares of the Company at a public offering price of US$1.00 per Common Share.
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Theratechnologies Announces Pricing of US$25 Million Public Offering of Common Shares and Concurrent Private Placement
10/26/2023
Theratechnologies Inc. announced that it has priced its previously announced public offering of 12,500,000 common shares of the Company at a public offering price of US$1.00 per Common Share.
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Theratechnologies Announces Operational Update
10/24/2023
Theratechnologies Inc., a biopharmaceutical company focused on the development and commercialization of innovative therapies, announced further changes to its operations that will see a tapering of R&D activities, which necessitates a reduction of up to 25 positions.
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Theratechnologies’ Ibalizumab Demonstrates Cost-Effectiveness as an Addition to Routine Clinical Care in Heavily Treatment-Experienced People with HIV
10/19/2023
Theratechnologies Inc. today shared data demonstrating the cost-effectiveness of ibalizumab, a monoclonal antibody antiretroviral therapy (ART) commercialized in the U.S. under the trade name Trogarzo®, as an addition to optimized background regimens (OBR) in heavily treatment-experienced (HTE) people with HIV.
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Theratechnologies Announces Finalization of Amendments to Some of the Terms and Conditions of its Credit Agreement with Marathon
10/16/2023
Theratechnologies Inc. announced that it has finalized all documentation giving effect to the amendments to certain of the terms and conditions of its credit agreement dated July 20, 2022, as amended from time to time, with certain funds and accounts for which Marathon Asset Management, L.P. acts as investment manager.
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Theratechnologies Presents Data at ID Week Showing Tesamorelin Reduces Visceral Adipose Tissue (VAT) and Liver Fat in People with HIV on Integrase Inhibitors (INSTIs)
10/13/2023
Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX) today presented data in a poster session at ID Week 2023 in Boston, Mass., demonstrating that treatment with tesamorelin significantly reduced visceral adipose tissue (VAT) and hepatic fat fraction (HFF, a measure of liver fat) in people with HIV treated with integrase inhibitor (INSTI) based regimens.
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Theratechnologies Announces Results from Trogarzo® (Ibalizumab-uiyk) Intramuscular Administration Study
10/13/2023
Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX) today announced results from a study evaluating an intramuscular (IM) method of administration for Trogarzo® (ibalizumab-uiyk), a monoclonal antibody antiretroviral therapy (ART) for the treatment of heavily treatment-experienced adults with multidrug-resistant (MDR) HIV-1 infection failing their current antiretroviral regimen.