FibroGen's 2025 Q2: Unraveling Key Contradictions in Roxadustat and FG-3246 Clinical Trial Strategies

Phase III study design for Roxadustat, FG-3246 Phase III preparation, FG-3246 trial size and design, ESA-treated population in Phase III trial for Roxadustat, and FG-3246 development strategy are the key contradictions discussed in FibroGen, Inc.'s latest 2025Q2 earnings call.



FibroGen China Sale and Cash Runway:
- FibroGen expects to receive a total consideration of $210 million for the sale of FibroGen China, an increase of $50 million from the initial guidance.
- This increase is due to greater-than-expected net cash in China at closing, further extending the company's cash runway into 2028.

FG-3246 and FG-3180 Clinical Development:
- FibroGen is on track to initiate a Phase II monotherapy trial for FG-3246 and FG-3180 in the post-ARSI pre-chemo setting in mCRPC in the third quarter of 2025.
- The trial aims to enroll 75 patients and determine the optimal dose based on efficacy, safety, and PK parameters, with the integration of FG-3180 to correlate CD46 expression and response to the ADC.

Regulatory Progress for Roxadustat:
- FibroGen has received minutes from a positive Type-C meeting with the FDA, aligning on key elements for a pivotal Phase III trial of roxadustat for treating anemia in lower-risk MDS with high transfusion burden.
- Development is focused on patients requiring 4 or more RBC units in 2 consecutive 8-week periods prior to randomization, with a starting dose of 2.5 milligrams per kilogram.

Financial Performance and Runway Extension:
- FibroGen reported total revenue of $1.3 million for Q2, with full-year guidance raised to $6 million to $8 million.
- A decrease in total operating costs and expenses to $13.4 million, down 72% year-over-year, and a cash runway extended into 2028, supports strategic focus on U.S. development initiatives.