Inventiva Builds Commercial Infrastructure Ahead of MASH Phase 3 Readout

Inventiva is assembling the financial, legal, and organizational infrastructure typically associated with a company preparing for regulatory submission and commercial launch, appointing three senior executives as it awaits top-line data from the NATiV3 Phase 3 trial evaluating lanifibranor in MASH, expected in Q4 2026. For regulatory affairs and QA professionals tracking the MASH pipeline, the move signals that Inventiva is treating the data readout not as a milestone in isolation but as the opening of a compressed regulatory and commercialization sequence that demands institutional readiness well in advance.

The company named Axel-Sven Malkomes as Chief Financial Officer, Susan Coles as Chief Legal Officer, and Pamela Herbster as Chief People Officer. Malkomes brings more than 30 years of experience across investment banking, corporate leadership, and private equity in life sciences and healthcare. He most recently served as CFO at CureVac, an mRNA company focused on oncology and infectious diseases, and previously held CFO roles at Cardior, where he co-led the company's acquisition by Novo Nordisk, and at Medigene, a publicly listed immuno-oncology company. Earlier in his career, Malkomes held roles at Merck KGaA in mergers, acquisitions, and business development, and served as CEO of a Merck KGaA Group company. His investment banking background includes Lehman Brothers, Barclays, and 3i Group plc. Coles brings more than 25 years of experience guiding life science companies through growth and transformation. Herbster brings over 25 years of biopharmaceutical experience in human resource strategy and organizational development.

The appointments follow a structured leadership transition rather than a wholesale replacement. Jean Volatier, who has served as CFO since the company's inception, moves to a newly created EVP Finance and Corporate Social Responsibility role, retaining involvement in key strategic priorities. Nathalie Harroy, who has led human resources since the company's founding, also remains with Inventiva. Retaining institutional knowledge from founding-era executives while layering in commercially experienced leadership is a pattern consistent with companies managing the operational inflection point between late-stage clinical development and potential NDA or MAA submission.

For plant heads and QA directors monitoring the MASH competitive landscape, Inventiva's organizational posture reflects the broader industry recognition that regulatory submissions for complex metabolic indications require cross-functional readiness, spanning clinical data packages, CMC documentation, legal and compliance infrastructure, and the workforce capacity to sustain post-approval commitments. The NATiV3 trial evaluates lanifibranor, an oral therapy for MASH, and its anticipated Q4 2026 readout will determine whether Inventiva advances into the regulatory submission phase. CEO Andrew Obenshain described the readout as a defining moment, citing the need for speed from pivotal data to potential regulatory submissions and commercialization.

Source: Inventiva press release via GlobeNewswire, April 22, 2026.