US LNG exports surge but will buyers in China turn up?
SAN FRANCISCO - FibroGen, Inc. (NASDAQ: FGEN), a biopharmaceutical company currently valued at $33.1 million and showing signs of undervaluation according to InvestingPro Fair Value metrics, announced the publication of a study in the Journal of Clinical Oncology detailing the results of a Phase 1 trial for FG-3246, a potential new treatment for metastatic castration-resistant prostate cancer (mCRPC). The study, sponsored by Fortis Therapeutics, showed that FG-3246 demonstrated encouraging anti-cancer activity and an acceptable safety profile in heavily pre-treated patients.
The trial, which included 56 patients, identified the maximally tolerated dose of FG-3246 at 2.7 mg/kg adjusted body weight every three weeks. The most common adverse events were similar to those seen with other MMAE-based antibody-drug conjugates (ADCs), such as infusion-related reactions and neutropenia. Notably, ocular adverse events were infrequent, which may distinguish FG-3246 from other MMAE-based ADCs.
Efficacy results from the trial were promising. The confirmed objective response rate was 20%, with a median duration of response of 7.5 months. The disease control rate stood at 80%, with 12 patients maintaining treatment for over 24 weeks. Additionally, a PSA50 response rate of 36% was observed in 39 evaluable patients, and the median radiographic progression-free survival was 8.7 months across all 40 subjects in the efficacy analysis set.
Dr. Rahul Aggarwal, Principal Investigator of the study, expressed optimism about FG-3246’s potential, highlighting the significance of targeting CD46 in the treatment of mCRPC. Thane Wettig, CEO of FibroGen, echoed this sentiment and noted that the company remains on track to initiate a Phase 2 monotherapy dose optimization study by mid-2025. InvestingPro data reveals the company faces significant financial challenges, with an EBITDA of -$128.27 million and a revenue decline of 36.71% in the last twelve months. Topline results from a combination trial of FG-3246 and enzalutamide are also anticipated in the second half of 2025.
FG-3246, an investigational drug not yet approved for marketing by any regulatory authority, is being developed by FibroGen for mCRPC and other tumor types. It consists of an anti-CD46 antibody linked to the anti-mitotic agent MMAE.
FibroGen, a biopharmaceutical company, is also known for its development of roxadustat, a treatment for anemia in chronic kidney disease patients, which is approved in multiple countries.
The information reported is based on a press release statement from FibroGen, Inc.
In other recent news, FibroGen Inc. reported its fourth-quarter 2024 earnings, showcasing an earnings per share (EPS) of $0.18, which exceeded analyst expectations of -$0.17. Despite this positive earnings surprise, the company faced a revenue decline, with fourth-quarter revenue dropping to $3.1 million from $3.6 million the previous year. For the full year 2024, FibroGen’s revenue fell to $29.6 million from $46.8 million in 2023, highlighting ongoing challenges in sales generation. Additionally, FibroGen announced the sale of its China operations to AstraZeneca for approximately $160 million, a move expected to simplify operations and extend the company’s cash runway into 2027. The company is also focusing on advancing its oncology pipeline, particularly FG3246 and FG3180, which are in development for metastatic castration-resistant prostate cancer. Looking ahead, FibroGen projects its 2025 revenue to be between $4 million and $8 million, with a significant reduction in operating costs. Analyst feedback from firms like William Blair and H.C. Wainwright has been cautiously optimistic, with a focus on the company’s strategic shift and cost-saving measures.
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