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Investing.com - FibroGen (NASDAQ:FGEN), whose stock has surged 44% over the past six months, has initiated a Phase 2 monotherapy dose optimization trial for its FG-3246 treatment, the company announced on Tuesday. According to InvestingPro data, the company currently trades above its Fair Value, despite facing significant cash burn challenges.
The randomized, open-label trial will evaluate FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) patients who have progressed following ARSI treatment but haven’t received chemotherapy. The study plans to enroll 75 patients randomized equally across three dosage levels: 1.8, 2.4, or 2.7 mg/kg AJBW. With a current market capitalization of $50 million and significant debt burden of $93 million, this trial represents a crucial milestone for FibroGen’s future prospects.
The trial’s primary endpoint is determining the optimal dose for a future Phase 3 trial, with secondary endpoints including radiographic progression-free survival and prostate-specific antigen responses. An interim analysis is planned after 12 patients in each dose arm complete 12 weeks of treatment or discontinue.
H.C. Wainwright has reiterated its Buy rating and $43.00 price target on FibroGen following this development. The research firm views the Phase 2 trial as "a significant step forward" that builds on FG-3246’s encouraging efficacy in earlier Phase 1 testing. Discover more insights about FibroGen’s potential with InvestingPro, which offers exclusive analysis and 12 additional ProTips about the company’s financial health and market position.
The study also includes an exploratory sub-study evaluating FG-3180, a CD46 PET imaging agent, as a diagnostic radiopharmaceutical, with an interim analysis from the program planned for the second half of 2026.
In other recent news, FibroGen Inc. reported disappointing financial results for the second quarter of 2025. The company posted an earnings per share (EPS) of -$1.88, falling short of the expected -$0.09. Additionally, FibroGen’s revenue was reported at $1.3 million, significantly below the forecasted $2.88 million. In a positive development, FibroGen successfully completed the sale of its Hong Kong subsidiary to AstraZeneca for approximately $220 million, a transaction that was finalized on August 29. This sale included $85 million in enterprise value and about $135 million in net cash held in China, exceeding initial guidance by $60 million. Following this transaction, H.C. Wainwright reiterated a Buy rating for FibroGen, maintaining a price target of $43.00. Furthermore, FibroGen has initiated a Phase 2 trial of FG-3246, a potential treatment for metastatic castration-resistant prostate cancer. The trial will involve 75 patients who have not yet received chemotherapy for their condition. These developments highlight significant financial and strategic activities for FibroGen in recent times.
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