Shares of drugmaker Genfit SA (GNFT) soared after the ring of the bell on Tuesday. In the after-market session, the stock added more than 145% to its value reaching $13.00.
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Shares of the company gained by 0.95% during the regular session on Tuesday trading as high as $5.38 while $5.13 remained the day’s low. During the trading session, a total of 0.97 million shares were traded which represents a 1214.53% rise from the average session volume which is 73.63K shares. GNFT had ended its last session trading at $5.29.
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What the company do?
GENFIT is a late-stage biopharmaceutical firm devoted to changing the life of cholestatic and metabolic chronic liver disease patients. With a long tradition and deep research legacy spanning more than two decades, GENFIT is a leader in the area of nuclear receptor-based drug development. GENFIT is currently participating in ELATIVE, a Phase 3 clinical trial in patients with primary biliary cholangitis testing elafibranor (PBC). Elafibranor is an investigational drug that has not yet been reviewed by any regulatory body and has not obtained clearance.
Recent Developments:
Yesterday, the company announced the publication of positive Phase 2 clinical results of elafibranor in the Journal of Hepatology in patients with Primary Biliary Cholangitis (PBC) who did not respond to ursodeoxycholic acid.
These results confirm our rationale for looking at elafibranor as a novel treatment for PBC and convince us that a pivotal Phase 3 trial is imperative, said CMO of Genfit, Dr. Carol Addy. PBC remains a disease with unmet medical needs, partly because a substantial number of patients have inadequate responses to existing treatments or cannot benefit from them, she added.
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What’s next for elafibranor?
The Food and Drug Administration (FDA) categorized elafibranor as Breakthrough Therapy based on the Phase 2 data. Additionally, the European Medicines Agency (EMA) classified it as an Orphan Drug. GENFIT has begun recruiting patients for the pivotal Phase 3 clinical trial ELATIVE to investigate the safety and effectiveness of elafibranor among patients with PBC and insufficient response to UDCA.
