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REDWOOD CITY, Calif. - The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to elironrasib for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received prior chemotherapy and immunotherapy but not a KRAS G12C inhibitor, Revolution Medicines, Inc. (NASDAQ:RVMD) announced today. The company, currently valued at $7.1 billion, has attracted strong analyst interest, with consensus price targets suggesting significant upside potential according to InvestingPro data.
The designation is based on data from the Phase 1 RMC-6291-001 clinical trial evaluating elironrasib monotherapy in patients with advanced KRAS G12C solid tumors, according to the company’s press release statement.
Elironrasib is a RAS(ON) G12C-selective inhibitor that binds selectively and covalently to the oncogenic form of the RAS G12C variant, which drives approximately 12% of NSCLC cases.
"There continues to be a need for new targeted therapies for patients with RAS-addicted cancers," said Mark A. Goldsmith, chief executive officer and chairman of Revolution Medicines.
NSCLC accounts for 80%-85% of all lung cancers, with most patients having advanced or metastatic disease at initial diagnosis. KRAS mutations are found in nearly 30% of NSCLC cases, with KRAS G12C being the most common variant.
The FDA’s Breakthrough Therapy Designation is intended to expedite development and review of potential new medicines for serious conditions with significant unmet medical needs. The designation requires preliminary clinical evidence demonstrating substantial improvement over available medicines.
Revolution Medicines is currently exploring elironrasib as both a monotherapy and in combinations across various treatment settings. The company is also developing other RAS(ON) inhibitors including daraxonrasib, zoldonrasib, and RMC-5127.
Currently, there are no RAS-targeted inhibitors with full FDA approval for treating patients with KRAS G12C NSCLC. With the company’s next earnings report due on August 6, investors can access comprehensive analysis and additional insights through InvestingPro’s detailed research reports, which cover over 1,400 US stocks including Revolution Medicines.
In other recent news, Revolution Medicines has secured a significant $2 billion funding agreement with Royalty Pharma. This deal is designed to support the company’s global commercialization strategy for its cancer therapies, with $1.25 billion tied to future sales of its RAS(ON) inhibitor, daraxonrasib, and an additional $750 million available as corporate debt. The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to daraxonrasib for use in patients with previously treated metastatic pancreatic ductal adenocarcinoma, based on promising early trial data. In another development, Revolution Medicines has entered a multi-year collaboration with Iambic Therapeutics to leverage artificial intelligence for drug discovery. This partnership will focus on developing new oncology drug candidates, utilizing Iambic’s AI models. Additionally, Goldman Sachs has initiated coverage of Revolution Medicines with a Buy rating and a price target of $65. Lastly, Barbara Weber, a director at Revolution Medicines, has resigned from the board ahead of the company’s annual meeting.
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