Inventiva SA
F:6IV
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Inventiva SA
F:6IV
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Inventiva SA
Inventiva SA is a French biopharmaceutical company that develops oral drug candidates for serious liver and metabolic diseases, with a main focus on MASH, the fatty liver disease that can progress to inflammation and scarring. It also has work in rare diseases. The company is not a drug store or generic manufacturer; it is a research-and-development business that takes compounds through lab testing and clinical trials. Its main product candidate is lanifibranor, a small-molecule medicine designed to act on several biological pathways at once. Inventiva’s customers are not patients today but future ones, along with hospitals and doctors if a drug wins approval. For now, the company makes money mainly through research funding, partnerships, and any licensing or milestone payments tied to its programs, rather than from product sales. What makes Inventiva different is its focus on a hard-to-treat disease area where there are still few approved medicines, and on medicines that are taken by mouth instead of given by injection. That makes the company more like a specialist drug developer than a broad pharmaceutical company: its value depends on whether its clinical programs can prove safe and effective enough to become approved treatments.
Inventiva SA is a French biopharmaceutical company that develops oral drug candidates for serious liver and metabolic diseases, with a main focus on MASH, the fatty liver disease that can progress to inflammation and scarring. It also has work in rare diseases. The company is not a drug store or generic manufacturer; it is a research-and-development business that takes compounds through lab testing and clinical trials.
Its main product candidate is lanifibranor, a small-molecule medicine designed to act on several biological pathways at once. Inventiva’s customers are not patients today but future ones, along with hospitals and doctors if a drug wins approval. For now, the company makes money mainly through research funding, partnerships, and any licensing or milestone payments tied to its programs, rather than from product sales.
What makes Inventiva different is its focus on a hard-to-treat disease area where there are still few approved medicines, and on medicines that are taken by mouth instead of given by injection. That makes the company more like a specialist drug developer than a broad pharmaceutical company: its value depends on whether its clinical programs can prove safe and effective enough to become approved treatments.
Lanifibranor Progress: Phase III pivotal study for lanifibranor in NASH was initiated, and trial design for the LEGEND combination study with empagliflozin was announced and received FDA IND acceptance.
Regulatory Milestones: Lanifibranor received extended Fast Track designation from the FDA and confirmation that its toxicology package is adequate for NDA filing.
Cedirogant Momentum: AbbVie successfully advanced cedirogant into Phase IIb for psoriasis after promising Phase Ib results, triggering a EUR 4 million milestone payment.
Financial Position: Cash balance is approximately EUR 95.4 million (close to $100 million), with a runway through Q1 2023; an at-the-market (ATM) program raised about $32 million.
R&D Spending: R&D expenses roughly doubled in 2021, driven by Phase III activities.
Site Impact: Phase III recruitment in Ukraine and Russia was paused due to the crisis, but additional sites are being activated to mitigate delays.
Upcoming Data: Key clinical readouts expected in the second half of 2022 (lanifibranor diabetes study), early 2023 (cedirogant Phase IIb), and second half of 2024 (lanifibranor Phase III).
