Genfit wins BTD status at FDA for its lead drug for liver disease; Idorsia outlines $530M '19 spending plans on late-stage R&D
→ Genfit $GNFT is getting a helping hand from the FDA with its lead drug elafibranor, in development for primary biliary cholangitis, a liver disease often referred to as PBC. The agency has handed over its breakthrough therapy designation for the drug, aiming at keeping the regulatory doors open as researchers look to hustle it through development. “The FDA’s decision to grant elafibranor the Breakthrough Therapy Designation on the basis of our Phase II data, is of course a milestone that will allow us to accelerate elafibranor’s development,” noted deputy CMO Pascal Birman.
→ Swiss biotech Idorsia says it plans to spend about $530 million this year as it concentrates on 4 late-stage development projects. “Our focus in 2019 must be on delivering on our strategic priorities by advancing at full steam with our key clinical activities,” noted CEO Jean-Paul Clozel. “This will enable us to begin reading out late stage clinical trials next year. Keep in mind that for every Phase III program, there are activities ongoing across the whole company to prepare the comprehensive dossier required by the health authorities.”
→ Evotec has repaid a €140 million bridge loan it took out in 2017 for the Aptuit acquisition.