Revolution Medicines, Inc. has disclosed preliminary data from its first-in-human study of RMC-9805, an investigational drug targeting solid tumors with specific mutations. The company, based in Redwood (NYSE:RWT) City, California, shared these findings in a recent SEC filing dated October 25, 2024.
The study evaluated the safety, tolerability, and activity of RMC-9805 in 179 patients with previously treated solid tumors harboring KRAS G12D mutations. Patients were administered doses ranging from 150 mg to 1,200 mg once daily and 300 mg to 600 mg twice daily.
Notably, treatment-related adverse events were predominantly gastrointestinal, with only 3% of patients requiring dose reductions. No adverse events led to treatment discontinuation, and no Grade 4 or 5 events or serious adverse events were reported.
For a subset of 99 patients receiving the highest daily dose of 1,200 mg, the observed adverse events were consistent with the larger group, including gastrointestinal issues and rash. Again, these events did not lead to treatment discontinuation.
In patients with pancreatic ductal adenocarcinoma in the second-line or later setting, the objective response rate was 30%, and the disease control rate was 80% among those who had been treated for at least 14 weeks before the data cutoff date.
Revolution Medicines stated that these preliminary results support the ongoing development of RMC-9805, both as a monotherapy and in combination with other treatments, such as the company's multi-selective inhibitor RMC-6236.
This news is based on the company's SEC filing.
In other recent news, Revolution Medicines has made significant strides with its Phase 1 study of RMC-6236. The treatment, aimed at pancreatic ductal adenocarcinoma (PDAC) patients, showed encouraging progression-free survival rates and manageable side effects.
Furthermore, the company reported a loss of $0.81 per share, closely aligning with the consensus estimate of a $0.77 loss. For the full year 2024, Revolution anticipates a net loss between $560 million and $600 million, an increase from previous estimates due to the acceleration of the Phase 2 trial for PDAC.
Firms such as Oppenheimer, Piper Sandler, and Needham have maintained positive ratings on Revolution, with price targets of $55.00, $57.00, and $61.00 respectively, influenced by the promising results of RMC-6236. Revolution is also expected to provide multiple updates at an upcoming conference, highlighting data from studies on '6236 and '9805 monotherapy treatments.
These recent developments underline Revolution Medicine's ongoing pursuit of effective treatments for challenging cancer types. The company's progress in developing treatments for non-small cell lung cancer (NSCLC) continues to be a point of interest for investors.
The forthcoming Phase I data for RMC-6236 is anticipated to provide an initial view of the progression-free survival of patients treated in the second-line setting for NSCLC.
InvestingPro Insights
Revolution Medicines' promising preliminary data for RMC-9805 aligns with the company's strong market performance. InvestingPro data shows that RVMD's stock has seen a remarkable 136.13% price total return over the past year, with a 33.74% increase in the last six months alone. This surge has brought the stock price to 92.65% of its 52-week high, reflecting investor optimism about the company's pipeline.
Despite the positive clinical developments, InvestingPro Tips highlight that Revolution Medicines is not currently profitable and suffers from weak gross profit margins. This is typical for biotech companies in the development stage, as reflected in the company's -56,628.03% gross profit margin for the last twelve months. However, the company's strong cash position, with more cash than debt on its balance sheet, provides financial flexibility to continue its research and development efforts.
For investors considering RVMD, it's worth noting that analysts do not anticipate the company to be profitable this year, according to InvestingPro Tips. This underscores the importance of the company's pipeline progress, including RMC-9805, in driving future value. InvestingPro offers 7 additional tips for RVMD, providing deeper insights for those interested in the company's financial health and market position.
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