SAN FRANCISCO - FibroGen, Inc. (NASDAQ: NASDAQ:FGEN) received the U.S. Food and Drug Administration (FDA) clearance for an Investigational New Drug (IND), FG-3165, a targeted therapy for solid tumors. This clearance, announced today, allows the biopharmaceutical company to proceed with a Phase 1 clinical trial to assess the safety and efficacy of the galectin-9 (Gal9) targeted monoclonal antibody.
FG-3165 is designed to treat solid tumors that exhibit high levels of Gal9 expression. Gal9 has been implicated in suppressing immune responses within tumors by signaling through various immune checkpoints on lymphocytes. By binding to Gal9, FG-3165 aims to inhibit its activity, potentially enhancing the immune system's ability to fight tumor cells.
The upcoming Phase 1 trial is expected to begin enrollment in the second half of 2024 and will evaluate FG-3165 in patients with select solid tumors. The trial's initiation follows encouraging preclinical results, where FG-3165 demonstrated anti-tumor activity and improved survival rates in mouse cancer models. Additionally, the antibody showed good tolerability in nonclinical safety studies.
FibroGen's CEO, Thane Wettig, expressed optimism about advancing FG-3165 into clinical testing, highlighting the potential impact on anti-tumor immune responses.
FibroGen is actively developing novel therapies for cancer treatment, with a portfolio that includes other clinical-stage candidates. Its product, roxadustat, is already approved in several countries for the treatment of anemia in chronic kidney disease patients, with ongoing development for chemotherapy-induced anemia.
The company's research extends to other immuno-oncology candidates targeting solid tumors, reflecting its broader commitment to addressing unmet medical needs in oncology.
The information in this article is based on a press release statement from FibroGen, Inc. The company's forward-looking statements involve risks and uncertainties, and actual results could differ materially from those projected. FibroGen does not undertake any obligation to update forward-looking statements, except as required by law. Investors and the public are advised to rely on continued progress reports and official announcements for future developments regarding FibroGen's clinical programs.
InvestingPro Insights
As FibroGen, Inc. (NASDAQ: FGEN) embarks on a promising phase in its clinical trials, a snapshot of the company's financial health and market performance is essential for investors following its journey. According to recent data from InvestingPro, FibroGen's market capitalization stands at a modest $122.85 million, reflecting the scale of the company in the biopharmaceutical landscape.
InvestingPro data also reveals a significant revenue growth of 44.31% in the last twelve months as of Q1 2024, which signals a strong upward trajectory in the company's earnings. However, it's important to note that the company's gross profit margin during the same period is notably negative at -76.43%, underscoring some of the financial challenges it faces, such as a quickly depleting cash reserve as highlighted by one of the InvestingPro Tips.
Another InvestingPro Tip worth considering is the observation that analysts do not anticipate FibroGen will be profitable this year. This aligns with the company's current negative P/E ratio of -0.5, which suggests that the market currently does not expect earnings growth in the near future. Moreover, the company's valuation implies a poor free cash flow yield, which could be a point of concern for potential investors.
For those interested in a deeper analysis, InvestingPro offers additional insights and metrics on FibroGen, with a total of 10 InvestingPro Tips available for investors looking to make a well-informed decision. To access these valuable insights, visit https://www.investing.com/pro/FGEN and consider using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription. This exclusive offer can provide investors with a more comprehensive understanding of the company's performance and future prospects.
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