Inventiva(IVA)

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Inventiva announces the publication in Clinical Gastroenterology and Hepatology of its analysis of new biomarker signatures predictive of histological response in patients with MASH treated with lanifibranor
GlobeNewswire News Room· 2025-04-24 20:01
► Biomarker signatures were developed to predict histological treatment response to lanifibranor treatment in patients with MASH and fibrosis ► The biomarker signatures developed for fibrosis improvement, MASH resolution and composite histological endpoints, suggested better predictive accuracy than other diagnostic scores available including FIB4, FIBC3, ABC3D, NFS, ELF and MACK-3 ► The biomarker signatures suggested strong predictive accuracy, with AUROC values above 0.80 that may indicate high reliabilit ...
Inventiva(IVA) - 2024 Q4 - Annual Report
2025-04-15 20:07
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ...
Inventiva announces filing of its 2024 Universal Registration Document and 2024 Annual Report on Form 20-F
Newsfilter· 2025-04-15 20:00
Core Viewpoint - Inventiva, a clinical-stage biopharmaceutical company, has filed its 2024 Universal Registration Document and Annual Report for the year ended December 31, 2024, with relevant regulatory authorities in France and the United States, highlighting its focus on developing therapies for metabolic dysfunction-associated steatohepatitis (MASH) and other unmet medical needs [1][9]. Company Overview - Inventiva specializes in the development of oral small molecule therapies targeting MASH and other diseases with significant unmet medical needs [3]. - The company is currently conducting the NATiV3 pivotal Phase 3 clinical trial for lanifibranor, a novel pan-PPAR agonist aimed at treating adult patients with MASH [3]. - Inventiva has a scientific team of approximately 90 professionals with expertise in various fields, including biology, medicinal chemistry, and clinical development [4]. Financial Reporting - The 2024 Universal Registration Document and the 2024 Annual Report on Form 20-F are accessible on the company's website and the websites of the French Autorité des Marchés Financiers and the U.S. Securities and Exchange Commission [2][9]. - The filings include management reports and annual financial reports, which provide insights into the company's performance and future outlook [1].
Inventiva announces completion of enrollment in the Phase 3 NATiV3 clinical trial of lanifibranor in patients with MASH and advanced fibrosis
Newsfilter· 2025-04-01 21:00
Daix (France), New York City (New York, United States), April 1, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) ("Inventiva" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of metabolic dysfunction-associated steatohepatitis ("MASH") and other diseases with significant unmet medical needs, today announced the completion of patient enrollment in its NATiV3 Phase 3 clinical trial with the randomization of the last p ...
Inventiva(IVA) - 2024 Q4 - Earnings Call Transcript
2025-03-27 14:50
Inventiva S.A. (NASDAQ:IVA) Q4 2024 Earnings Call March 27, 2025 8:00 AM ET Company Participants Fr??d??ric Cren - CEO Jean Volatier - CFO Pierre Broqua - CSO Conference Call Participants Unidentified Analyst - TD Cowen Unidentified Analyst - Jefferies & Co. Annabel Samimy - Stifel Ed Arce - HC Wainwright Jacob Mekhael - KBC Securities Rami Katkhuda - LifeSci Capital Unidentified Analyst - UBS Operator Good day and thank you for standing by. Welcome to the Inventiva Full Year 2024 Financial Results Webcast ...
Inventiva reports its 2024 full year results and provides a business update
GlobeNewswire· 2025-03-26 20:00
Revenues of €9.2 million for the full year of 2024Cash and cash equivalents at €96.6 million as of December 31, 2024 First tranche of up to €348 million Structured Financing closed with aggregate gross proceeds of €116 millionLast patient screened in the NATiV3 Phase 3 clinical trial of lanifibranor in MASH early in January 2025 Pipeline prioritization plan presented to the workers council to focus exclusively on the development of lanifibranor, stopping all preclinical research activities and reducing the ...
Inventiva announces the schedule of publication and presentation of its 2024 Full-Year Financial Results
GlobeNewswire· 2025-03-19 20:00
Daix (France), New York City (New York, United States), March 19, 2025 – Inventiva (Euronext Paris and NASDAQ: IVA) ("Inventiva" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of metabolic dysfunction-associated steatohepatitis ("MASH") and other diseases with significant unmet medical needs, today announced that its management team will host a webcast to present the Company's 2024 full-year financial results on Thu ...
Inventiva announces the publication in Biomedicine & Pharmacotherapy of the results from a preclinical study showing improvement of portal hypertension with lanifibranor treatment
GlobeNewswire News Room· 2025-02-26 21:00
The study demonstrated that lanifibranor improved Portal Hypertension (PH) in mouse models of fibrotic PH and prehepatic non-fibrotic PHLanifibranor was observed to decrease portal pressure by improving Liver Sinusoidal Endothelial Cell (LSEC) dysfunction and fibrosis, and by directly targeting the splanchnic vasculature through its anti-angiogenetic effectsThese findings suggest that lanifibranor may be a promising therapeutic candidate that could potentially address PH-related complications typically asso ...
Inventiva and Hepalys Pharma, Inc. announce the initiation of the clinical development program of lanifibranor in Japan with the dosing of the first participant in Phase 1 trial
GlobeNewswire News Room· 2025-02-20 21:00
Core Viewpoint - The initiation of the clinical development program for lanifibranor in Japan marks a significant step for Inventiva and Hepalys in addressing metabolic dysfunction-associated steatohepatitis (MASH) in a market where approximately 2.7% of the population is affected by this condition [4][9]. Company Overview - Inventiva is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for MASH and other diseases with unmet medical needs. The company is currently evaluating lanifibranor in a pivotal Phase 3 clinical trial [11]. - Hepalys Pharma, Inc. is a private biopharmaceutical company dedicated to developing novel therapeutics for liver disease, with a focus on lanifibranor and other compounds for Asian markets [6]. Clinical Development - The Phase 1 clinical trial for lanifibranor in Japan involves 32 subjects who will be randomly assigned to four cohorts, receiving the drug once daily for 14 days [2]. - The trial is part of an exclusive licensing agreement between Inventiva and Hepalys, which outlines that Hepalys will conduct and finance all necessary trials in Japan and South Korea for new drug applications [3]. Market Potential - The partnership aims to introduce lanifibranor to the Japanese market, where there is a significant patient population suffering from MASH, thus presenting a potential opportunity for the companies if the drug is approved [4][5]. Product Information - Lanifibranor is a pan-PPAR agonist designed to induce antifibrotic, anti-inflammatory, and beneficial metabolic changes by activating all three PPAR isoforms. It is the only pan-PPAR agonist in clinical development for MASH [10]. - The FDA has granted Breakthrough Therapy and Fast Track designations to lanifibranor, indicating its potential therapeutic benefits for MASH [10].
Inventiva reports preliminary 2024 fiscal year financial results¹ and provides a business update
GlobeNewswire· 2025-02-10 21:00
Core Viewpoint - Inventiva reported preliminary unaudited financial results for the year ended December 31, 2024, highlighting significant changes in cash position, revenues, and operational activities related to its clinical development of lanifibranor for MASH [1][6]. Financial Results - As of December 31, 2024, the company's cash and cash equivalents were €96.6 million, a substantial increase from €26.9 million in 2023 [2]. - Net cash used in operating activities was (€85.9) million in 2024, up 5.3% from (€81.6) million in 2023 [3]. - R&D expenses decreased by 17% to €90.9 million in 2024 from €110.0 million in 2023, primarily due to a temporary pause in patient recruitment for the NATiV3 trial [3]. - Revenues for 2024 were €9.2 million, down from €17.5 million in 2023, mainly due to milestone payments from CTTQ [11][12]. Business Update - The NATiV3 Phase 3 clinical trial screening was completed in early January 2025, with over 95% of the target patients randomized [13]. - The company plans to focus exclusively on the development of lanifibranor, halting all preclinical research activities and reducing its workforce by approximately 50% [14][15]. Financing Activities - The company generated €145.6 million from financing activities in 2024, a significant increase from €29.1 million in 2023, due to various financing agreements [5]. - The first tranche of structured financing closed with gross proceeds of €116 million, with expectations for additional funding in 2025 [9]. Future Outlook - The company estimates that its current cash position and expected funding will allow it to finance operations until the end of the third quarter of 2026 [9]. - Key upcoming milestones include the randomization of the last patient in the NATiV3 trial and participation in several investor and scientific conferences [17].