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Resubmission addresses questions raised in January 2024 Complete Response Letter F8 formulation intended to replace EGRIFTA SV ® with simplified dosing for the treatment of excess abdominal fat in adults with HIV and lipodystrophy MONTREAL, Nov. 26, 2024 (GLOBE NEWSWIRE) -- 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 resubmission of its supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the F8 formulation of tesamorelin, the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy. Theratechnologies has filed the resubmission to address concerns raised in the FDA's Complete Response Letter (CRL) to the initial F8 formulation sBLA filing.
MONTREAL, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on development and commercialization of innovative therapies, today announced data from two poster presentations, focusing on the association between excess visceral abdominal fat (EVAF) and cardiovascular disease (CVD) risk in people with HIV (PWH), and on the use of tesamorelin to reduce such risk. In a poster presentation at IDWeek 2024 in Los Angeles, Calif.
Baseline Data Show More Frequent Selection of Ibalizumab in Patients with Lower CD4 Counts and Higher Viral Loads, Compared to Other Regimens Baseline Data Show More Frequent Selection of Ibalizumab in Patients with Lower CD4 Counts and Higher Viral Loads, Compared to Other Regimens
Theratechnologies Inc. (NASDAQ:THTX ) Q2 2024 Earnings Conference Call October 10, 2024 8:30 AM ET Company Participants Julie Schneiderman - Senior Director, Communications & Corporate Affairs Paul Levesque - President & CEO Philippe Dubuc - SVP & CFO John Leasure - Global Commercial Officer Christian Marsolais - SVP & Chief Medical Officer Conference Call Participants Justin Walsh - JonesTrading Andre Uddin - Research Capital Carvey Leung - Cantor Fitzgerald Operator Good morning, ladies and gentlemen, and thank you for standing by. Welcome to Theratechnologies Third Quarter 2024 Earnings Call.
MONTREAL, Oct. 10, 2024 (GLOBE NEWSWIRE) -- 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 third quarter of fiscal year 2024 ended August 31, 2024 (Q3 2024). All figures are in US dollars unless otherwise stated.
MONTREAL, Oct. 09, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on development and commercialization of innovative therapies, today announced three upcoming poster presentations at IDWeek 2024, taking place October 16-19 in Los Angeles, Calif.
MONTREAL, Sept. 26, 2024 (GLOBE NEWSWIRE) -- 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 Company will report financial results and provide a business update for its third quarter ended August 31, 2024, on Thursday, October 10 at 8:30 a.m. ET.
MONTREAL, Sept. 17, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced a risk of a temporary supply disruption for EGRIFTA SV ® (tesamorelin for injection) in early 2025 caused by an unexpected voluntary shutdown of the Company's contract manufacturer's facility following an inspection by the US Food and Drug Administration (FDA), as well as the FDA review timeline to resume distribution of the product.
MONTREAL, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that the Company's President and CEO, Paul Lévesque will be presenting at two investor conferences in September. Members of the Theratechnologies management team will also be available for one-on-one meetings throughout the conferences.
MONTREAL, July 10, 2024 (GLOBE NEWSWIRE) -- 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 second quarter of fiscal year 2024 ended May 31, 2024 (Q2 2024). All figures are in US dollars unless otherwise stated.
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