Articles from Theratechnologies

Results show similar levels of virus undetectability in patients on ibalizumab-containing regimens as in controls, despite greater baseline severity of HIV

Study Demonstrates Excess Visceral Abdominal Fat Drives CV Risk

MONTREAL, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care, today reported business highlights and financial results for the fourth quarter and full year of fiscal year 2024, ended November 30, 2024. All figures are in U.S. dollars unless otherwise stated.

MONTREAL, Feb. 14, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care, today announced the Company will report financial results and provide a business update for its fourth quarter and full year fiscal 2024 ended November 30 on Wednesday, February 26, 2025, at 8:30 a.m. ET.

MONTREAL, Feb. 13, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care, today announced that it has resumed distribution of EGRIFTA SV® (tesamorelin for injection), following correspondence from the U.S. Food and Drug Administration (FDA) that allows the Company to release two recently manufactured batches of EGRIFTA SV®. The product is ready for immediate shipment to network pharmacies.

MONTREAL, Jan. 09, 2025 (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 a shortage of EGRIFTA SV® (tesamorelin for injection) will occur at the patient level in mid-January 2025, following a voluntary shutdown of the contract manufacturing facility in 2024. While the Company is aware of remaining inventory of EGRIFTA SV® in certain pharmacies throughout the United States, several pharmacies have reported stockouts.

MONTREAL, Dec. 18, 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 has submitted a Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration (FDA) describing the changes made to the manufacturing environment of the facility where EGRIFTA SV® is produced. A PAS is reviewed by the FDA within four months of receipt and an approval is needed prior to the distribution of the recently manufactured batches of EGRIFTA SV®.

MONTREAL, Dec. 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 announced that the United States Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 25, 2025 to the Company’s recently submitted supplemental Biologics License Application for the F8 formulation of tesamorelin.

No dose-limiting toxicities reported in two different weekly doses in heavily pre-treated patients

Addition of investigational RNA-targeted medicines build upon Theratechnologies’ foundational HIV portfolio

MONTREAL, Dec. 03, 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 production of EGRIFTA SV® has resumed following a voluntary shutdown of the Company’s contract manufacturer’s facility to address observations from an inspection by the US Food and Drug Administration (FDA).

MONTREAL, Dec. 02, 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 it has closed on a $40 million three-year non-dilutive, senior secured syndicated financing with TD Bank, as agent (TD Bank Financing). The new credit facilities include a $20 million accordion feature, which could expand total commitments up to $60 million. Investissement Québec (IQ), the Company’s largest shareholder, has also agreed to provide a $15 million second ranking secured subordinated term loan (IQ Subordinated Loan). Net proceeds from the new loans together with cash on hand will be used to repay all obligations including prepayment penalties under the Company’s existing facility with affiliates of Marathon Asset Management, L.P. (Marathon) pursuant to the credit agreement entered into with Marathon in July 2022, and to fund business development activities. All amounts are in US dollars unless otherwise stated.

Resubmission addresses questions raised in January 2024 Complete Response Letter

Data Show Tesamorelin May Reduce CVD Risk by Reducing EVAF

Baseline Data Show More Frequent Selection of Ibalizumab in Patients with Lower CD4 Counts and Higher Viral Loads, Compared to Other Regimens

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.

MONTREAL, June 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 second quarter ended May 31, 2024, on Wednesday, July 10 at 8:30 a.m. ET.

MONTREAL, May 23, 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 Phase 1 data demonstrating signs of long-term efficacy and a manageable safety profile of its lead investigational peptide drug conjugate (PDC) candidate, sudocetaxel zendusortide (TH1902), in patients with solid tumors. The data will be presented in a poster session on June 1, 9:00 AM-12:00 PM CDT (abstract #3081, poster board #226) at the 2024 American Society of Clinical Oncology (ASCO) annual meeting, which is taking place May 31-June 4, 2024, in Chicago, IL.

MONTREAL, May 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, reported the voting results from its annual meeting of shareholders held today in a virtual-only setting.

MONTREAL, May 02, 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 it will present long-term efficacy, safety and pharmacokinetic (PK) data on the use of its lead investigational peptide-drug conjugate (PDC) candidate, TH1902 (sudocetaxel zendusortide), in patients with solid tumors. The Company will present the long-term data in a poster session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, which takes place May 31-June 4, 2024, in Chicago, IL.

MONTREAL, April 15, 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 has mailed its 2024 management proxy circular to shareholders in connection with its virtual annual meeting of shareholders to be held on May 9, 2024, at 10:00 a.m. ET.

MONTREAL, April 11, 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 the 2024 Bloom Burton & Co. Healthcare Investor Conference, which is taking place April 16-17 in Toronto, Canada.

MONTREAL, April 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 first quarter of fiscal year 2024 ended February 29, 2024 (Q1 2024). All figures are in US dollars unless otherwise stated.

MONTREAL, April 08, 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 presented preclinical data that highlight the versatility and flexibility of the Company’s SORT1+ Technology™ platform. In a poster session at the 2024 annual meeting of the American Association for Cancer Research (AACR) in San Diego, Calif., researchers reported that Theratechnologies’ investigational camptothecin-peptide conjugates are well tolerated and associated with significant tumor regression in colorectal cancer (CRC) and triple-negative breast cancer (TNBC) xenograft models. The study also demonstrated synergistic anti-tumor efficacy and good tolerability with the combination of two peptide drug conjugates with different payloads.

MONTREAL, April 05, 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 appointment of Elina Tea, Chief Financial Officer at GLS North America, to its Board of Directors and as a member of the Company’s Audit Committee. Ms. Tea will be Investissement Québec’s designee pursuant to its investor rights agreement with the Company.

MONTREAL, April 03, 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 first quarter ended February 29, 2024, on Wednesday, April 10 at 8:30 a.m. ET.

MONTREAL, March 28, 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 two posters will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2024, demonstrating the potential of its SORT1+ Technology™ platform – including novel camptothecin-peptide conjugates and its lead investigational peptide drug conjugate (PDC) candidate, sudocetaxel zendusortide (TH1902), as anticancer treatments. The AACR meeting is taking place April 5-10 in San Diego, CA.

Company continues to shift to commercial focus as it seeks partners to advance R&D

MONTREAL, March 21, 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 appointment of Jordan Zwick, Chief Business Officer at Mirador Therapeutics Inc., to its Board of Directors and as a member of the Company’s Audit Committee.

MONTREAL, March 21, 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 moving to the next dose level in Part 3 of its Phase 1 clinical trial of sudocetaxel zendusortide in patients with advanced ovarian cancer. The study’s Medical Review Committee (MRC) has deemed the dose level in the first cohort of patients safe and has approved initiation of the next cohort with an increased dose, in accordance with the updated dose optimization protocol. Study centers are now actively recruiting patients for the second cohort, with one patient already enrolled and treated with the higher dose.

MONTREAL, Feb. 29, 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 Mr. Alain Trudeau has resigned from the Board of Directors of Theratechnologies and as a member of its Audit Committee, effective immediately.

MONTREAL, Feb. 27, 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 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.

MONTREAL, Feb. 21, 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 fourth quarter and full year of fiscal year 2023, ended November 30, 2023. All figures are in U.S. dollars unless otherwise stated.

MONTREAL, Feb. 20, 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 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. Sudocetaxel zendusortide is an investigational, first-in-class peptide-drug conjugate (PDC) that targets the sortilin receptor (SORT1) and expedites the internalization and delivery of the cytotoxic payload (docetaxel) directly into cancer cells.

MONTREAL, Feb. 15, 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 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. Sudocetaxel zendusortide, also known as TH1902, is an investigational, first-in-class peptide-drug conjugate (PDC) that targets the sortilin receptor (SORT1) and aims to expedite the internalization and delivery of the cytotoxic payload (docetaxel) directly into cancer cells.

MONTREAL, Feb. 06, 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 fourth quarter and full year fiscal 2023 ended November 30, on Wednesday, February 21, 2024, at 8:30 a.m. EDT.

MONTREAL, Jan. 24, 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 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. The Company will address the FDA’s request and intends to pursue approval of this newer formulation of tesamorelin.

MONTREAL, Jan. 23, 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, 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. The FDA has notified the Company that it is continuing its review of the application beyond the Prescription Drug User Fee Act (PDUFA) goal date of January 22, 2024.   Further information will be provided in due course.

MONTREAL, Jan. 02, 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 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. In the U.S., Trogarzo®, in combination with other antiretrovirals (ARVs), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current ARV regimen.

MONTREAL, Dec. 13, 2023 (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 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). IV push is a method by which the undiluted medication is “pushed” by syringe for faster administration into the body’s circulation and is designed to make Trogarzo® administration easier and more convenient for people with HIV and their health care providers. As a result, more clinics will be able to initiate new patients and provide ongoing treatment.

Honor awarded last night recognizes Theratechnologies and Prof. Borhane Annabi for advancing preclinical development of sudocetaxel zendusortide for treatment of triple-negative breast cancer

MONTREAL, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (Nasdaq: THTX; TSX: TH), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that it has closed its previously announced public offering (the “Public Offering”) of 12,500,000 common shares of the Company (the “Common Shares”) at a public offering price of US$1.00 per Common Share (the “Offering Price”). The gross proceeds of the Public Offering are US$12,500,000, before deducting the underwriting discounts and commissions and other estimated offering expenses. Pursuant to the underwriting agreement dated October 25, 2023, the Company has also granted the underwriter a 30-day option (the “Option”) to purchase up to 1,875,000 Common Shares at the Offering Price, less underwriting discounts and commissions.

Common shares priced at US$1.00 per share

This news release constitutes a “designated news release” for the purposes of the Company’s prospectus supplement dated December 16, 2021 to its short form base shelf prospectus dated December 14, 2021.

MONTREAL, Oct. 24, 2023 (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 further changes to its operations that will see a tapering of R&D activities, which necessitates a reduction of up to 25 positions. The Company expects to realize recurring yearly savings of approximately US$3.5 million resulting from this reorganization and will record a restructuring charge of approximately US$1.5 million in its fourth quarter of 2023.

MONTREAL, Oct. 19, 2023 (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 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. The analysis, which was presented at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023 conference in Orlando, Fla., suggests that adding ibalizumab to routine clinical care may provide payers with a cost-effective treatment option that can substantially improve outcomes for HTE individuals with HIV.

- Revised the Minimum Liquidity Covenant for All Times Following October 31, 2023 to be Between US$15 Million and US$20 Million

This news release constitutes a “designated news release” for the purposes of the Company’s prospectus supplement dated December 16, 2021 to its short form base shelf prospectus dated December 14, 2021.

This news release constitutes a “designated news release” for the purposes of the Company’s prospectus supplement dated December 16, 2021 to its short form base shelf prospectus dated December 14, 2021.

MONTREAL, Oct. 12, 2023 (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 dosing of the first participant in Part 3 of its Phase 1 clinical trial of sudocetaxel zendusortide in patients with advanced ovarian cancer. Sudocetaxel zendusortide is an investigational, first-in-class peptide-drug conjugate (PDC) that targets the sortilin (SORT1) receptor and expedites the internalization and delivery of a cytotoxic payload directly into cancer cells.

This news release constitutes a “designated news release” for the purposes of the Company’s prospectus supplement dated December 16, 2021 to its short form base shelf prospectus dated December 14, 2021.

MONTREAL, Sept. 26, 2023 (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 and first nine months of fiscal year 2023, ended August 31, 2023. All figures are in U.S. dollars unless otherwise stated.

- Removal of Minimum Liquidity Covenant of US$30 Million if F8 Formulation of Tesamorelin is Not Approved by the FDA by March 31, 2024

MONTREAL, Sept. 25, 2023 (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 has filed a supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin to the U.S. Food and Drug Administration (FDA) for review. Tesamorelin is the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy.

MONTREAL, Sept. 20, 2023 (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 Mr. Paul Lévesque, President and Chief Executive Officer, will participate in a panel presentation at the Cantor Fitzgerald Global Healthcare Conference 2023 being held September 26-28 in New York City.

MONTREAL, Sept. 18, 2023 (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, 2023, on Tuesday, September 26 at 8:30 a.m. EDT.

MONTREAL, Sept. 07, 2023 (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 Paul Lévesque, President and Chief Executive Officer, will present at the H.C. Wainwright 25th Annual Global Investment Conference, to be held virtually and in person on September 11-13, 2023, in New York City at the Lotte New York Palace Hotel.

- 2023 Q3 positive adjusted EBITDA to be achieved

MONTREAL, Aug. 30, 2023 (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 all five of the U.S.-based clinical sites participating in the conduct of the Phase 1 clinical trial of the Company’s lead investigational peptide drug conjugate, sudocetaxel zendusortide, are now activated to screen, enroll and dose advanced ovarian cancer patients. A sixth site based in Canada is finalizing its start-up activity.

MONTREAL, July 31, 2023 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies”, the “Company”, or “we”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that it has completed the previously announced consolidation of the issued and outstanding common shares of the Company’s share capital on the basis of one (1) post- consolidation share for each four (4) pre-consolidation shares issued and outstanding (the “Consolidation”).

Amendments Allow Theratechnologies to Maintain Minimum Liquidity of US$15 Million up to and until October 31, 2023

MONTREAL, July 21, 2023 (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 Mr. Gary Littlejohn has resigned from the Board of Directors of Theratechnologies and as a member of its Audit Committee, effective immediately.

- Issued and outstanding common shares to be consolidated on the basis of 1 post-consolidation share for each 4 pre-consolidation shares issued and outstanding, to regain compliance with NASDAQ listing requirements

MONTREAL, July 12, 2023 (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 and first half of fiscal year 2023 ended May 31, 2023 (Q2 2023). All figures are in US dollars unless otherwise stated.

MONTREAL, June 29, 2023 (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 it will report financial results and provide a business update for its second quarter ended May 31, 2023, on Wednesday, July 12 at 8:30 a.m. EDT.

Proceeds to Be Used to Redeem All of the Outstanding 5.75% Convertible Unsecured Senior Notes

MONTREAL, June 12, 2023 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, will hold a video conference call on Tuesday, June 13, 2023, to update investors and analysts on the Phase 1 trial of its lead peptide-drug conjugate (PDC) candidate, sudocetaxel zendusortide (formerly TH1902), for the treatment of solid tumors.

MONTREAL, June 02, 2023 (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 U.S. Food and Drug Administration (FDA) has agreed to the Company’s amended protocol for the Phase 1 clinical trial of sudocetaxel zendusortide, an investigational, first-in-class peptide-drug conjugate (PDC) that targets the sortilin (SORT1) receptor and expedites the internalization and delivery of a cytotoxic payload directly into cancer cells. Today’s announcement also marks the lifting of the FDA’s partial clinical hold on the Phase 1 trial, following the Company’s voluntary pause of patient recruitment in December 2022.

MONTREAL, May 25, 2023 (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 preliminary efficacy data from a Phase 1 study of its lead investigational peptide-drug conjugate (PDC) candidate, sudocetaxel zendusortide (formerly TH1902), in patients with advanced solid tumors. In a June 3 poster session at the 2023 annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, researchers will present early results from Part 1 (dose escalation) and Part 2 (dose expansion) of the multicenter, open-label trial of sudocetaxel zendusortide, in which 36% of heavily pretreated participants experienced a clinical benefit, including two patients with partial responses (PR) and seven achieving prolonged stable disease (SD).

MONTREAL, May 09, 2023 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported the voting results from its annual meeting of shareholders held today in a virtual-only setting.