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Inventiva names Jason Campagna as President of R&D and Chief Medical Officer and Martine Zimmermann as Executive Vice President of Regulatory Affairs and Quality Assurance
Globenewswire· 2025-07-09 20:05
Leadership Transition - Inventiva announced a leadership transition with the appointment of Jason Campagna, MD, PhD, as President of Research and Development and Chief Medical Officer, and Martine Zimmermann, PharmD, as Executive Vice President of Regulatory Affairs and Quality Assurance [1][2][4] - Dr. Campagna succeeds Pierre Broqua, PhD, who will transition to a consulting role as Scientific Advisor, and Michael Cooreman, MD, who is departing as CMO [2][4] Executive Experience - Dr. Campagna brings extensive expertise in the MASH field, having previously served as CMO at Q32 Bio and MASH Global Program Lead at Intercept Pharmaceuticals [2] - Dr. Zimmermann was most recently Senior Vice President, Head of Regulatory Affairs at Ipsen, where she led the approval of two liver disease drugs [3] Company Focus and Goals - Inventiva is focused on developing oral therapies for metabolic dysfunction-associated steatohepatitis (MASH) and is currently evaluating lanifibranor in the NATiV3 pivotal Phase 3 clinical trial [5][6] - The company is preparing for the readout of the NATiV3 Phase 3 study next year, with potential regulatory approval and commercialization of lanifibranor [4][6]
Inventiva receives $10 million milestone payment from CTTQ
Globenewswire· 2025-07-07 20:00
Core Viewpoint - Inventiva has received a $10 million milestone payment from Chia Tai-Tianqing Pharmaceutical Group Co., Ltd (CTTQ) as part of their collaboration to develop lanifibranor for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) [1][3] Group 1: Financial Developments - The milestone payment follows the successful settlement of the second tranche of €115.6 million in gross proceeds from a structured financing deal of up to €348 million [2] - Under the CTTQ License Agreement, Inventiva is eligible to receive up to an additional $265 million in milestone payments and royalties on annual net sales of lanifibranor if approved [3] Group 2: Clinical Development - Lanifibranor has received Breakthrough Therapy Designation for MASH from both the U.S. FDA and the Chinese NMPA, which may expedite its development and regulatory review [4] - CTTQ is participating in the ongoing NATiV3 pivotal Phase 3 clinical trial for lanifibranor, which includes over 60 sites across mainland China [4] - A Phase I bridging study by CTTQ confirmed no significant ethnic differences, facilitating the regulatory approval process in China based on NATiV3 trial results [4] Group 3: Company Overview - Inventiva is a clinical-stage biopharmaceutical company focused on developing oral therapies for MASH, with lanifibranor being a novel pan-PPAR agonist currently evaluated in the NATiV3 Phase 3 clinical trial [5]
Inventiva announces the publication in Journal of Hepatology Reports on results of lanifibranor treatment on liver sinusoidal endothelial cells in patients with MASLD/MASH and in preclinical models of the disease
Globenewswire· 2025-07-02 20:00
Core Insights - Inventiva, a clinical-stage biopharmaceutical company, announced the publication of results from the Phase 2b NATIVE clinical trial and preclinical study on lanifibranor for treating metabolic dysfunction-associated steatohepatitis (MASH) [1][10] Group 1: Clinical Trial Results - The Phase 2b NATIVE trial demonstrated that lanifibranor can reduce liver sinusoidal endothelial cell (LSEC) capillarization, which is associated with fibrosis and inflammation in patients with MASH [2][3] - CD34 staining in liver biopsies indicated a higher density in patients with MASLD or MASH compared to those without, and treatment with lanifibranor for 24 weeks resulted in a dose-dependent reduction in CD34 staining [3][6] - Histological evaluations showed that LSEC capillarization occurs early in the disease, suggesting that lanifibranor may help prevent progression to cirrhosis [6][7] Group 2: Mechanism of Action - Lanifibranor acts as a pan-PPAR agonist, targeting all three PPAR isoforms, which may contribute to its anti-fibrotic and anti-inflammatory effects [9] - Preclinical models indicated that lanifibranor not only reverses capillarization but also normalizes intrahepatic vascular resistance and portal vein pressure, outperforming single PPAR agonists [4][7] Group 3: Company Overview - Inventiva is focused on developing oral therapies for MASH and is currently evaluating lanifibranor in the pivotal Phase 3 NATiV3 clinical trial [10] - The FDA has granted Breakthrough Therapy and Fast Track designations to lanifibranor, highlighting its potential in treating MASH [9]
Inventiva Announces the Appointment of Renée Aguiar-Lucander to its Board of Directors
Globenewswire· 2025-06-10 20:00
Core Insights - Inventiva, a clinical-stage biopharmaceutical company, has appointed Renée Aguiar-Lucander to its Board of Directors, a decision approved by shareholders at the recent Annual General Meeting [1][2] - The company is focused on developing oral therapies for metabolic dysfunction-associated steatohepatitis (MASH) and is currently in the final stages of clinical development for its drug lanifibranor [1][3] Company Overview - Inventiva specializes in the research and development of oral small molecule therapies aimed at treating MASH and other diseases with significant unmet medical needs [3] - The company is evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for adult patients with MASH, a progressive chronic liver disease [3] Leadership Background - Renée Aguiar-Lucander, the newly appointed board member, has a strong background in the biopharmaceutical industry, having served as CEO of Hansa Biopharma and Calliditas Therapeutics, where she led the latter to a $1.1 billion acquisition by Asahi Kasei in 2024 [2] - Under her leadership, Calliditas achieved the first-ever FDA approval for a treatment in IgA nephropathy and successfully launched the product in the U.S. [2] Strategic Importance - The appointment of Aguiar-Lucander is seen as pivotal for Inventiva as it prepares for the potential approval and launch of lanifibranor [2] - The NATiV3 Phase 3 trial is fully enrolled, indicating progress towards bringing lanifibranor to patients with MASH [2]
Inventiva (IVA) Upgraded to Buy: What Does It Mean for the Stock?
ZACKS· 2025-06-03 17:01
Core Viewpoint - Inventiva S.A. Sponsored ADR (IVA) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Revisions - The Zacks Consensus Estimate for Inventiva indicates that for the fiscal year ending December 2025, the company is expected to earn -$1.30 per share, reflecting a 61% change from the previous year's reported number [8]. - Over the past three months, the Zacks Consensus Estimate for Inventiva has increased by 20.7%, indicating a positive trend in earnings estimates [8]. Zacks Rating System - The Zacks rating system is based on changes in a company's earnings picture, which is crucial for predicting near-term stock price movements [2][4]. - The system classifies stocks into five groups, with Zacks Rank 1 (Strong Buy) stocks generating an average annual return of +25% since 1988, showcasing its effectiveness [7]. - The upgrade of Inventiva to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for higher stock movement in the near term [10].
Inventiva to Participate in the Upcoming Jefferies Global Healthcare Conference and UBS Spring Biotech Conference
GlobeNewswire News Room· 2025-05-27 20:00
Group 1 - The core focus of Inventiva is the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) [4] - Inventiva will participate in two investor conferences in June 2025, including the Jefferies Global Healthcare Conference and the UBS Spring Biotech Conference [2][3] - Frédéric Cren, CEO of Inventiva, will present a corporate overview during a fireside chat at the Jefferies Global Healthcare Conference on June 4, 2025 [2] Group 2 - Inventiva is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for MASH treatment [4] - The company is publicly listed on Euronext Paris and NASDAQ, with the ticker symbol IVA [5]
Inventiva reports 2025 First Quarter Financial Information¹
Globenewswire· 2025-05-23 06:30
Core Insights - Inventiva reported a decrease in cash and cash equivalents to €67.9 million as of March 31, 2025, down from €96.6 million at the end of 2024, primarily due to cash used in operating activities for the lanifibranor development program [2][3] - The company anticipates that its current cash resources, along with gross proceeds of €115.6 million from structured financing and a $10 million milestone payment from Chia Tai Tianqing Pharmaceutical Group, will fund operations until the end of Q3 2026 [3] - Inventiva did not recognize any revenues in Q1 2025, consistent with Q1 2024 [5] Financial Results - Cash and cash equivalents as of March 31, 2025: €67.9 million, a decrease of €28.7 million from €96.6 million on December 31, 2024 [2] - Gross proceeds from structured financing: €115.6 million, with net proceeds of €108.5 million [3] - Anticipated milestone payment from CTTQ: $10 million [3] Research and Development Updates - The company completed enrollment for its pivotal Phase 3 clinical trial, NATiV3, evaluating lanifibranor in patients with MASH [10] - The company initiated a clinical development program for lanifibranor in Japan with the first participant dosed in a Phase 1 trial [10] - Recent publications include findings on non-invasive biomarker signatures and improvements in portal hypertension with lanifibranor treatment [10] Future Outlook - The company plans to raise additional funds for the long-term development and commercialization of lanifibranor through public offerings, private placements, and strategic partnerships [4] - Topline results from the NATiV3 trial are expected in the second half of 2026 [8]
Results of the Votes of the Combined Shareholders' General Meeting of May 22, 2025
GlobeNewswire News Room· 2025-05-23 06:00
Core Points - Inventiva, a clinical-stage biopharmaceutical company, focuses on developing oral therapies for metabolic dysfunction-associated steatohepatitis (MASH) and announced the results of its Combined Shareholders' Meeting [1][12] - The meeting took place on May 22, 2025, in Paris, chaired by CEO Frédéric Cren [2] - All resolutions were adopted except for the 33rd resolution, which was negatively recommended by the Board of Directors [3] Voting Results - The shareholders present included 245 participants, representing a total of 90,772,892 shares and 102,984,957 votes, achieving a quorum of 65.264% [5] - Ordinary resolutions were overwhelmingly adopted, with the first resolution receiving 99.98% approval [6][10] - The 33rd resolution, which would have allowed the Board to decide on share capital increases for a company savings plan, was rejected with 90.58% against [10][11] Company Overview - Inventiva is publicly listed on Euronext Paris and Nasdaq, focusing on the research and development of oral small molecule therapies for MASH and other unmet medical needs [12][13] - The company is currently evaluating lanifibranor in a pivotal Phase 3 clinical trial for MASH treatment [12]
Results of the Votes of the Combined Shareholders’ General Meeting of May 22, 2025
Globenewswire· 2025-05-23 06:00
Core Points - Inventiva, a clinical-stage biopharmaceutical company, focuses on developing oral therapies for metabolic dysfunction-associated steatohepatitis (MASH) [1][11] - The Combined Shareholders' Meeting took place on May 22, 2025, where all resolutions were adopted except for one [2][3] - The compensation policy for corporate officers was approved as presented in the 2024 Universal Registration Document [4] Voting Results - A total of 245 shareholders participated in the voting, representing 90,772,892 shares, which is 65.264% of the voting rights [5][7] - The majority of ordinary resolutions were adopted with over 99% approval, while the only rejected resolution was the 33rd, which aimed to empower the Board of Directors for share capital increases [3][10] - The voting results showed a high level of shareholder engagement, with a quorum of 65.264% achieved [5][10] Company Overview - Inventiva is publicly listed on Euronext Paris and Nasdaq, focusing on unmet medical needs in liver diseases [11][12] - The company is currently evaluating lanifibranor in a pivotal Phase 3 clinical trial for MASH [11]
Description of the Share Repurchase Program Covered by the Liquidity Agreement with Kepler Chevreux
Globenewswire· 2025-05-22 12:00
Core Viewpoint - The company Inventiva has approved a share repurchase program aimed at enhancing market liquidity, with a maximum purchase limit of 10% of its capital over the next 18 months [1][4]. Group 1: Share Repurchase Program - The share repurchase program was approved during the Ordinary General Meeting on May 22, 2025, with the primary objective of animating the market under a liquidity agreement [1][2]. - The maximum number of shares that can be acquired is 13,869,673, considering the 45,454 shares already held in treasury as of May 19, 2025 [4]. - The maximum price per share for the repurchase is set at 40 euros [4]. Group 2: Company Overview - Inventiva is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for MASH and other diseases with significant unmet medical needs [2]. - The company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the pivotal Phase 3 clinical trial for treating adult patients with MASH [2]. Group 3: Market Information - Inventiva is publicly listed on Euronext Paris (ticker: IVA) and the Nasdaq Global Market in the United States [3]. - The company has a total of 13,915,127 shares in its capital structure as of May 19, 2025 [4].