Genfit readies its $120M IPO; Karyopharm shares boosted after an FDA delay for selinexor
→ Weeks after officially unveiling its plan to list on the Nasdaq, Lille-based liver drug developer Genfit on Thursday said it would offer 5,000,000 shares in the offering, but is still determining the price (per ADS) range for the offering, having just begun the book building process. In a filing posted separately, the company said it expected to generate net proceeds of about €106.0 million ($119.2 million), assuming an offering price of $26.33 per ADS in the US offering. The future of the company — which is already listed on Euronext Paris under the symbol $GNFT — hinges on the regulatory fate of its drug elafibranor for two main liver disorders — NASH and primary biliary cholangitis (PBC). Genfit is expected to come out with its Phase III interim NASH results by the end of 2019, while positive mid-stage data on the use of the drug in PBC was announced last December.
→ Maybe all isn’t lost for Karyopharm $KPTI after all. The biotech reported Friday morning that the FDA has extended its review of selinexor by 3 months. Normally that doesn’t amount to more than a speed bump for a company. But after the FDA insider review offered some heavy criticism of the drug and an FDA panel weighed in against it — with some notable support nevertheless in a fairly close vote — investors liked the implications that the agency had some thinking to do. Its shares shot up 20% this morning. The new PDUFA date is July 6.
→ Norway’s Targovax has set up a new collaboration with two prestigious research groups. The Parker Institute for Cancer Immunotherapy and the Cancer Research Institute are both signing on to work on Targovax’s TG mutant RAS vaccine. They’ll be working on combo studies for pancreatic cancer.