Curis, Inc. (NASDAQ: CRIS), a biotechnology firm trading near its 52-week low with a market capitalization of $19.64 million, has concluded discussions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding the accelerated approval pathway for its drug candidate emavusertib in treating primary central nervous system lymphoma (PCNSL). According to InvestingPro analysis, the stock appears undervalued based on its Fair Value metrics, despite falling nearly 79% over the past year. The company also announced the Orphan Drug Designation for emavusertib in both the US and EU.
The discussions focused on the potential use of data from the ongoing TakeAim Lymphoma study to support a regulatory filing for accelerated approval. The study has enrolled 27 patients with relapsed/refractory PCNSL, showing promising results, including reductions in tumor burden and objective responses in patients previously treated with BTK inhibitors.
In addition to its PCNSL trial, Curis provided an update on its TakeAim Leukemia study, which reported objective responses in patients with relapsed/refractory Acute Myeloid Leukemia (AML) harboring a FLT3 mutation. The company also initiated a Phase 1 study of emavusertib in combination with venetoclax and azacitidine for frontline AML treatment.
Financially, Curis reported a net loss of $43.4 million for the year ended December 31, 2024, with a reduced net loss in the fourth quarter compared to the same period in 2023. Revenue grew 8.83% year-over-year to $10.91 million, primarily consisting of royalty revenues from Erivedge®, a treatment for advanced basal cell carcinoma commercialized by Genentech and Roche. InvestingPro data reveals the company maintains a healthy current ratio of 2.85, indicating strong short-term liquidity. Subscribers can access 10+ additional ProTips and comprehensive financial metrics in the Pro Research Report.
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