SAN FRANCISCO - FibroGen Inc . (NASDAQ: NASDAQ:FGEN) has announced a partnership with Regeneron (NASDAQ:REGN) Pharmaceuticals to test two of its experimental cancer drugs in combination with Regeneron's LIBTAYO® therapy. The clinical trial will focus on assessing the efficacy of FibroGen's FG-3165 and FG-3175 as both standalone treatments and in conjunction with LIBTAYO® in patients with certain solid tumors.
The two drugs, FG-3165 and FG-3175, have shown promising results in preclinical studies, suggesting they may work well with PD-1 inhibitors like LIBTAYO®. FG-3165, an anti-galectin 9 antibody, is designed to prevent lymphocyte cell death, potentially enhancing the immune system's ability to fight tumors. FG-3175 targets CCR8, a receptor found on T regulatory cells within tumors, and is intended to improve immune response by depleting these cells and disrupting their signaling.
FibroGen will lead the Phase 1 trials for both monotherapy and combination therapies, with Regeneron supplying the drugs. The U.S. Food and Drug Administration (FDA) has already cleared an Investigational New Drug (IND) application for FG-3165, with plans to initiate a trial in the second half of 2024. An IND submission for FG-3175 is expected in 2025.
Deyaa Adib, M.D., Chief Medical Officer at FibroGen, expressed optimism about the collaboration, highlighting the potential for improved clinical outcomes for patients. The two companies will retain all rights to their respective compounds.
FibroGen is a biopharmaceutical company known for its work in cancer biology and the development of novel therapies. The company's portfolio includes treatments for various conditions, including pancreatic cancer, chronic kidney disease, and metastatic castration-resistant prostate cancer.
InvestingPro Insights
As FibroGen Inc. (NASDAQ: FGEN) embarks on its latest venture with Regeneron Pharmaceuticals, the company's financial data and market behavior present a mixed picture. According to InvestingPro data, FibroGen has a market capitalization of $122.85 million, reflecting its standing in the biopharmaceutical industry. Despite a significant revenue growth of 44.31% over the last twelve months as of Q1 2024, the company's gross profit margin stands at a concerning -76.43%, indicating substantial costs relative to revenue.
Investors and analysts alike are keeping a close eye on the company's stock performance, especially given that the price has seen a dramatic fluctuation over the last year, with a 90.96% uptick in the last six months, yet still down -93.29% from the previous year. This volatility is a crucial factor for potential investors to consider, especially in the context of the company's latest clinical trials and partnerships.
Two critical InvestingPro Tips for FibroGen highlight the company's challenges: it has been quickly burning through cash and analysts do not anticipate the company will be profitable this year. These insights suggest that while the partnership with Regeneron could be a positive development, the financial stability and profitability of FibroGen remain areas of concern.
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