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GENFIT

Regulatory Filings Jun 2, 2015

1362_iss_2015-06-02_a6963e12-8bb6-4f8a-987d-49a9ae9c4193.pdf

Regulatory Filings

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2015 Press release

GENFIT: ELAFIBRANOR ACCEPTED AS THE GENERIC NAME FOR GFT505 BY THE WHO

Elafibranor is unique and represents a new pharmacological class (first-in-class)

Lille (France), Boston (Massachusetts, United States), June 2nd , 2015 – GENFIT (Euronext: GNFT; ISIN: FR0004163111), a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, today announces that the World Health Organization (WHO) has accepted the international non-proprietary name (INN, or generic name) Elafibranor for its leading drug candidate previously referred to as GFT505. w w w . g

The aim of the INN system is to provide health professionals with a unique and universal designated name for each pharmaceutical substance. This is important for the clear identification, safe prescription and dispensing of medicines to patients. In the INN system, the names of pharmacologically-related substances have a common "stem", enabling health professionals to recognize substances having similar pharmacological activity. n f i t .

The new non-proprietary name, Elafibranor, reflects the first-in-class nature of the drug candidate, since it does not contain a pre-existing INN stem. The novel pre-stem "-fibranor" may thus become an established stem over time, as other later developed drugs are recognized to be related in structure or activity. r

Jean-François MOUNEY, Chairman & Chief Executive Officer of GENFIT,

declared: "We are very pleased that the INN division of WHO recognized the unique nature of Elafibranor/GFT505 by accepting the proposed generic name for our leading drug candidate. Moreover, their acceptance of the novel pre-stem "-fibranor" reflects the innovative nature of the drug candidate, and marks a new step in our overall development strategy in the run-up to the market launch of this first-in-class product."

GENFIT | 885 Avenue Eugène Avinée, 59120 Loos, France | +333 2016 4000 | www.genfit.com

Items in this press release may contain forward-looking statements involving risks and uncertainties. The Company's actual results could differ substantially from those anticipated in these statements owing to various risk factors which are described in the Company's prospectus. This press release has been prepared in both French and English. In the event of any differences between the two texts, the French language version shall supersede.

About Elafibranor/GFT505:

Elafibranor is being developed for the treatment of NASH, and has recently completed a major international Phase 2b study in 274 NASH patients in Europe and the United States. Elafibranor showed significant activity on both NASH regression and liver fibrosis scores, as well as a significant improvement in cardiometabolic risk factors and an excellent safety profile. Elafibranor is expected to enter Phase 3 clinical trials in NASH at the end of the year.

About GENFIT:

GENFIT is a biopharmaceutical company focused on the Discovery and Development of drug candidates in fields of high medical need due to a lack of suitable treatment and an increasing number of patients worldwide. GENFIT's R&D efforts are focused on contributing to bringing new medicines to market for patients with metabolic, inflammatory, autoimmune and fibrotic diseases, that affect the liver (such as NASH - Nonalcoholic steatohepatitis) or the bowel (such as the inflammatory bowel disease). GENFIT implements mutually beneficial approaches that combine novel treatments and biomarkers; its research programs have resulted in the creation of a rich and diversified pipeline of drug candidates, including GENFIT's lead proprietary compound, GFT505/Elafibranor, that has completed a positive Phase 2b study in NASH and is currently launching a Phase 3 study.

With facilities in Lille, France, and Boston, MA (USA), the Company has approximately 90 employees. GENFIT is a public company listed in compartment B of Euronext's regulated market in Paris (Euronext: GNFT; ISIN: FR0004163111). www.genfit.com

Disclaimer:

This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. For a discussion of risks and uncertainties which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the Listing Prospectus upon the admission of Company's shares for trading on the regulated market Euronext of Euronext Paris filed with the AMF, which is available on the AMF website (www.amf-france.org) or on GENFIT's website (www.genfit.com).

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in GENFIT in any country.

Contacts

GENFIT | Jean-François Mouney - CEO & Chairman of the Management Board | Ph. +333 2016 4000

MILESTONES – Relation Presse | Bruno Arabian | Ph. +331 8362 3484 / +336 8788 4726 – [email protected]

Items in this press release may contain forward-looking statements involving risks and uncertainties. The Company's actual results could differ substantially from those anticipated in these statements owing to various risk factors which are described in the Company's prospectus. This press release has been prepared in both French and English. In the event of any differences between the two texts, the French language version shall supersede.

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