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Investing.com -- Revolution Medicines Inc (NASDAQ:RVMD) stock rose 5.8% on Monday after the company announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its cancer treatment daraxonrasib for pancreatic cancer.
The designation was awarded to the company’s RAS(ON) multi-selective inhibitor, which is currently being studied in a global Phase 3 clinical trial for patients with second line metastatic pancreatic ductal adenocarcinoma (PDAC).
"We are gratified the FDA has granted Orphan Drug Designation to daraxonrasib for the treatment of pancreatic cancer, a devastating disease with limited therapeutic options and representing a large unmet medical need," said Mark A. Goldsmith, CEO and chairman of Revolution Medicines.
The company noted that RAS driver mutations are present in nearly all pancreatic cancer cases, highlighting the need for targeted therapies. Revolution Medicines has also announced plans to initiate two additional Phase 3 clinical trials in pancreatic cancer: one for first line treatment in metastatic PDAC patients and another for adjuvant treatment in resectable PDAC patients.
Orphan Drug Designation provides several benefits to drug developers, including tax credits for clinical trial costs, exemption from certain FDA fees, and up to seven years of market exclusivity following approval. The designation is awarded to encourage development of treatments for rare diseases affecting fewer than 200,000 individuals in the United States.
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