Brief: Genfit Updates 2024 Outlook After Elafibranor Filings In Primary Biliary Cholangitis

Genfit SA

08/12/2023 07:05

Dec 8 (Reuters) - Genfit SA  GNFT.PA :
    * GENFIT UPDATES 2024 OUTLOOK FOLLOWING ACCEPTANCE OF
ELAFIBRANOR
FILINGS IN PRIMARY BILIARY CHOLANGITIS (PBC)
    * ACCEPTANCE TRIGGERS A FIRST MILESTONE PAYMENT. FURTHER
MILESTONES ARE EXPECTED UPON  US AND EUROPEAN LAUNCHES WHICH
COULD NOW HAPPEN IN 2Q24 IN THE US
    * THESE MILESTONES TOTAL APPROXIMATELY 89M€
    * LAUNCHES IN THE US AND EUROPE WILL ALSO MAKE GENFIT
ELIGIBLE FOR
ROYALTY PAYMENTS
    * REVENUES WILL FUND THE DEVELOPMENT OF GENFIT’S PIPELINE,
NOW
MAINLY FOCUSED ON ACUTE  ON-CHRONIC LIVER FAILURE (ACLF) WITH 5
DIFFERENTIATED ASSETS
    * VERSUS-02-HE (SMALL MOLECULE AIMING AT REDUCING
HYPERAMMONEMIA,
STABILIZING BLOOD AMMONIA AND PREVENTING HEPATIC
ENCEPHALOPATHY): IND ENABLING STUDIES STARTING IN 2024 WITH
COMPLETION EXPECTED IN 2025
    * CLM-022 (NLRP3 INFLAMMASOME INHIBITOR AIMED AT INHIBITING
SYSTEMIC INFLAMMATION AND CELL DEATH): PRECLINICAL PROOF OF
CONCEPT EXPECTED TO INITIATE IN 2024
    * VERSUS-01 (LIPOSOMAL-BASED TECHNOLOGY DESIGNED TO REMOVE
AMMONIA
AND OTHER ACLF TOXINS FROM THE BLOOD): PHASE 2 INITIATED WITH
INTERIM DATA READOUT TARGETED FOR MID-2024
    * SRT-015 (ASK1 INHIBITOR, LIVER-CENTRIC, AIMED AT
INHIBITING CELL
DEATH, INFLAMMATION AND FIBROSIS): FIRST-IN-HUMAN STUDY
INITIATION TARGETED 2H24
    * NTZ (ANTI-INFLAMMATORY AND ANTI-BACTERIAL AGENT AIMING TO
REDUCE
SYSTEMIC INFLAMMATION, AND  IMPEDE RELEASE OF PAMPS 5 AND
BACTERIAL TRANSLOCATION): REFORMULATION AND PHASE 2 UNDER 
PREPARATION IN 2024 WITH A PROOF-OF-CONCEPT STUDY INITIATION
TARGETED FOR 1H25
    * VERSUS-01 FOR UREA CYCLE DISORDERS (UCDS) AND ORGANIC
ACIDEMIAS
(OA): IND ENABLING NON CLINICAL STUDIES COMPLETION EXPECTED IN
2024
    * GNS561 FOR CHOLANGIOCARCINOMA (CCA): PHASE 1B INTERIM
BIOMARKER
DATA TARGETED AS EARLY AS 1H24

Source text for Eikon:  urn:newsml:reuters.com:*:nGNE6s5xBm
Further company coverage:  GNFT.PA 

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