FibroGen slips as late-stage trial for Duchenne candidate fails

• FibroGen (NASDAQ:FGEN) shares lost ~7% pre-market Wednesday after the biotech said that its Phase 3 trial for pamrevlumab, a candidate targeted at neuromuscular disorder Duchenne Muscular Dystrophy (DMD) did not reach the main goal.
• The 99-subject trial called LELANTOS-1 was designed to evaluate the antibody therapy in non-ambulatory patients aged 12 years and above with DMD who were on systemic corticosteroids.
• The company said that the trial did not meet the primary endpoint for the change of Performance of the Upper Limb 2.0 (PUL 2.0) score from baseline at Week 52. However, the study drug was safe and well tolerated in LELANTOS-1, the San Francisco, California-based biotech added.
• FibroGen’s (FGEN) LELANTOS-2 clinical trial for pamrevlumab in ambulatory DMD patients is currently underway, with topline data expected in Q3 2023.

More on FibroGen

• FibroGen raised to buy by Stifel ahead of Phase 3 data for pamrevlumab
• FibroGen: Several Pamrevlumab Data Releases Could Change Scope Of Biotech