Baris-Ozer
FibroGen (NASDAQ:FGEN) shares dropped sharply on Wednesday after the company announced initial results from a Phase 1 study for its prostate cancer therapy, FG-3246, developed in partnership with immune-oncology biotech Fortis Therapeutics.
The study enrolled more than 50 patients with a severe form of prostate cancer called metastatic castration-resistant prostate cancer (mCRPC) whose tumors have progressed despite prior therapy.
Citing data from its dose-escalation and dose-expansion cohorts, FibroGen (FGEN) said FG-3246, an antibody-drug conjugate, led to a median progression-free survival of 8.7 months based on radiographic evidence.
Meanwhile, 36% of patients witnessed a ≥ 50% decline in the disease biomarker, prostate-specific antigen (PSA50).
The safety profile was manageable, the company added, noting its plans to meet with the FDA to discuss future R&D strategies for FG-3246 and start a mid-stage trial in H2 2024.
William Blair said results were “encouraging" and “appear to offer numerically improved efficacy metrics relative to alternate novel hormone therapy.”
“We believe the heavily pretreated nature of the study population, coupled with enrolling an unselected population, warrants further investigation of FG-3246 in prostate cancer,” the firm argued, according to industry publication Fierce Biotech.
However, the readout failed to convince investors, with FibroGen (FGEN) losing nearly a third of its market value at the end of regular trading on Wednesday.