Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), September 23, 2024 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced that the European Commission has conditionally approved Iqirvo®1 (elafibranor) 80mg tablets for the treatment of Primary Biliary Cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA. This follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on July 26, 2024 and the U.S. FDA Accelerated Approval on June, 10, 2024 .

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GENFIT: Ipsen’s Iqirvo® (Elafibranor) Receives EU Approval as a First-in-Class Treatment for Primary Biliary Cholangitis following U.S. FDA...

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Nicox and Glaukos Sign Exclusive NCX 1728 Research and Global Licensing Option Agreement

Brussels, 23 September 2024 – Synergia Medical, a leader in the development of optoelectronic medical devices, is pleased to announce the successful implantation of its groundbreaking NAO.VNS system in the first two patients as part of the AURORA study. These first-in-human implantations took place on September 6, 2024, at Cliniques Universitaires Saint-Luc and UZ Gent. Two weeks after surgery, both patients have fully recovered, allowing the initiation of stimulation therapy as planned.

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Synergia Medical Successfully Implants First Patients With NAO.VNS™

SAN DIEGO, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Tr1X, Inc. (pronounced “Trix”), a biopharmaceutical company specializing in allogeneic engineered Treg and CAR-Treg cell therapies with the potential to cure autoimmune and inflammatory diseases, today announced the attendance and participation of select members of the management team at the following upcoming investor conferences:

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Tr1X to Participate at Upcoming Healthcare Investment Conferences

COPENHAGEN, Denmark, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced initial data showing signs of clinical activity in heavily pre-treated patients with platinum-resistant ovarian cancer (PROC) treated with TransCon IL-2 ?/? in combination with chemotherapy in its ongoing Phase 1/2 IL-Believe Trial of TransCon IL-2 ?/?. First results will be shared in Poster 762P at ESMO 2024, the annual meeting of the European Society of Medical Oncology being held in Barcelona from September 13-17, 2024.

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Ascendis to Present First Results from Platinum-Resistant Ovarian Cancer (PROC) Cohort of the Phase 1/2 IL-Believe Trial at ESMO 2024

BOSTON, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio Therapeutics” or “Elicio”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced upcoming presentations in September and October.

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Elicio Therapeutics Announces Three Upcoming Presentations Focused on its Lymph Node Targeted, mKRAS-Specific Amphiphile Vaccines

BERKELEY HEIGHTS, N.J., Sept. 13, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, today announced that management will be participating in a fireside chat and investor meetings at the 2024 Cantor Healthcare Conference, being held in New York, NY on September 17 – 19, 2024.

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CorMedix Inc. to Present at the Cantor Global Healthcare Conference

AMSTERDAM, Sept. 13, 2024 (GLOBE NEWSWIRE) -- (NASDAQ: RENB) RenovaroCube (Cube, the Company), a leading AI-driven innovator using multi-omics technology for cancer profiling, is pleased to announce two scientific presentations at a leading cancer conference – the European Society for Medical Oncology (ESMO) Congress – on September 15, 2024.

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RenovaroCube to Present Cutting-Edge Cancer Diagnostics Research at European Society for Medical Oncology Congress

Webcast replay of fireside chat now available

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Outlook Therapeutics® Participates in the 2nd Annual Chardan Virtual Ophthalmology Conference Series

CFT1946 Is Well-Tolerated at All Dose Levels; No Dose-Limiting Toxicities

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C4 Therapeutics Presents Monotherapy Data Demonstrating Proof of Mechanism and Early Evidence of Proof of Concept From Ongoing CFT1946 Phase 1 Trial...

-  Encouraging signs of anti-tumor activity including objective responses observed in patients with SMARCA4-mutated non-small cell lung cancer (NSCLC) and esophageal cancer in early PRT3789 monotherapy dose escalation

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Prelude Therapeutics’ SMARCA2 Degrader PRT3789 Demonstrated Promising Initial Clinical Activity and Safety Profile in Phase 1 Trial

Press Release – No. 9 / 2024

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Zealand Pharma to participate in the 2024 Cantor Global Healthcare Conference on September 18th

1adjusted current operating income corresponds to the “current operating income before amortization of assets arising from acquisitions”2growth at constant exchange rates and scope corresponds to organic growth of sales, excluding exchange rate variations, by calculating the indicator for the financial year in question and the indicator for the previous financial year on the basis of identical exchange rates (the exchange rate used is the previous financial year), and excluding material change in scope, by calculating the indicator for the financial year in question on the basis of the scope of consolidation for the previous financial year. This change is calculated on the actual scope of consolidation, including the impact of acquisitions (Globion and Sasaeah), for which the indicator in question is calculated on the basis of the previous year's exchange rate3net debt corresponds to current (€187.3 million) and non-current (€187.4 million) financial liabilities as well as a lease obligation related to the application of IFRS 16 (€37 million), less the cash position and cash equivalents (€156.8 million) as published in the statement of financial position4net cash position as of December 31, 20235operating cash flow corresponds to adjusted current operating income (€150.4 million) restated for items having no impact on the cash position as well as impact arising from asset disposal. This restates depreciation and amortization of fixed assets before acquisitions for €22.5 million (comprising €24.2 million in depreciation and amortization of fixed assets and provisions, and €-1.6 million in amortization of assets from acquisitions), as well as non-current income and expenses (€2 million), other non-cash income and expenses (€0.4 million), and impact of disposals (€1.3 million)

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Virbac 2024 half-year results

At its meeting on September 13, 2024, the board of directors acknowledged the resignation of Sébastien Huron, effective as of September 27, 2024, from his positions as chief executive officer of Virbac and director of Virbac Limited (UK).

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Virbac: Information on the departure of Sébastien Huron

Focusing on animal health, from the beginningAt Virbac, we provide innovative solutions to veterinarians, farmers and animal owners in more than 100 countries around the world. Covering more than 50 species, our range of products and services enables to diagnose, prevent and treat the majority of pathologies. Every day, we are committed to improving animals’ quality of life and to shaping together the future of animal health.

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Virbac : the board of directors announces a capital reduction through cancellation of treasury shares

Public release of the Half-Year Financial Report at 30 June 2024.

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Virbac : Public release of the Half-Year Financial Report at 30 June 2024.

Please find attached 2024 Half-yearly financial report of Virbac

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Virbac : Half-yearly financial report 2024

Following Priority Review, Dupixent is now available to patients as young as 12 years with inadequately controlled CRSwNP

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Dupixent® (dupilumab) Approved in the U.S. as First and Only Treatment for Adolescents with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

NEW YORK, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (the “Company”) (Nasdaq: PBM) announced that on September 12, 2024, the Company received a staff determination letter (the “Determination Letter”) from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it had not regained compliance with the Market Value of Listed Securities (“MVLS”) Requirement and the Market Value of Publicly Held Shares (“MVPHS”) requirement by September 9, 2024.

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Psyence Biomedical Ltd. Announces Receipt of Staff Delisting Determination from Nasdaq

MARKHAM, Ontario, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Dr. Pardeep Nijhawan (“Dr. Nijhawan”) announces that as a result of grants of restricted share units (“RSUs”) of Edesa Biotech, Inc. (“Edesa”), when combined with a series of transactions (the “Transactions”) that have occurred since the date of the most recent early warning report filed by Dr. Nijhawan on November 18, 2022 (the “Previous Report”), Dr. Nijhawan has acquired “beneficial ownership” of common shares in the capital of Edesa (“Common Shares”) in an amount equal to more than 2% of the issued and outstanding Common Shares since the date of the Previous Report.

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Pardeep Nijhawan Provides Update to Beneficial Ownership of Securities of Edesa Biotech, Inc.