04:59 PM EDT, 06/03/2024 (MT Newswires) -- FibroGen ( FGEN ) was up 26% in recent after-hours activity Monday after the US Food and Drug Administration accepted its investigational new drug application for FG-3165 to treat solid tumors characterized by high levels of protein Galectin-9.

The investigational new drug clearance authorizes FibroGen ( FGEN ) to start phase 1 safety and efficacy study of the drug, according to the company.

FibroGen ( FGEN ) expects to start enrollment for the trial in H2.

The company separately said that it agreed to a clinical trial supply agreement with Regeneron Pharmaceuticals ( REGN ) to evaluate FG-3165 and FG-3175 in combination with Libtayo.

Under the collaboration, Regeneron will provide drug supply to FibroGen ( FGEN ) and both companies will retain all rights to their compounds.

Price: 1.5500, Change: +0.32, Percent Change: +26.02