GENFIT Reaches Historic FDA Approval with Ipsen's Iqirvo® for Primary Biliary Cholangitis

GENFIT GNFT, a leading late-stage biopharmaceutical company specializing in the development of treatments for rare and severe liver conditions, has recently achieved a significant milestone. The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Iqirvo®, a new therapy for patients with Primary Biliary Cholangitis (PBC), developed in collaboration with Ipsen. This pivotal development took place on June 10, 2024, marking a momentous occasion for the France-based company with operational facilities in Cambridge, Massachusetts, and Zurich, Switzerland.

A Momentous Achievement for GENFIT

GENFIT's commitment to addressing unmet medical needs in the domain of liver diseases has propelled the company to the forefront of the biopharmaceutical industry. The FDA's decision to grant accelerated approval for Iqirvo® underscores the potential of the drug to provide much-needed relief to patients suffering from PBC, a chronic liver disease that can lead to life-threatening consequences if left untreated.

The Significance of Accelerated Approval

The FDA's accelerated approval program enables early access to medications for severe conditions upon demonstration of a drug's potential benefit over existing treatments. For GENFIT, this translates to an expedited path toward delivering Iqirvo® to patients in dire need of innovative therapeutic solutions. Moreover, this milestone is anticipated to positively influence GENFIT's market positioning and investor confidence, as seen by its presence on both Nasdaq and Euronext stock exchanges under the ticker GNFT.

About GENFIT and its Expanding Portfolio

Genfit SA, headquartered in Loossa, France, is a renowned entity in the biopharmaceutical landscape. The company's mission is to combat metabolic and liver diseases through the discovery and development of effective drug candidates and diagnostic solutions. With the FDA's nod for Iqirvo®, GENFIT solidifies its reputation as an innovator in the field, offering new hope to patients and healthcare providers alike.

GENFIT, FDA, Ipsen, Accelerated, Approval, PBC, Iqirvo, Therapy, Biopharmaceutical, Liver