Riding a PhII success, a small French biotech lands a rare 'breakthrough' status in NASH
For all the hype NASH drugs have received, the FDA has not been quick to roll out the red carpet for the most talked-about compounds. The agency gave breakthrough designation to Intercept’s obeticholic acid in 2015 but, since then, have declined to offer that seal to other late-stage drugs, including those from Gilead or Genfit.
On Monday afternoon, though, the French biotech Inventiva announced that they had won breakthrough status, becoming — by their count — the first company to receive the designation for a NASH drug since Intercept did 5 years ago. It was enough to send the company’s stock up 6%, from $13.65 to $14.50 pre-market.
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