Revolution Medicines Inc (NASDAQ:RVMD) shares gained 5.8% on Monday after the company announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its investigational therapy daraxonrasib for the treatment of pancreatic cancer.
The designation applies to the company’s RAS(ON) multi-selective inhibitor, which is currently being evaluated in a global Phase 3 study 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 emphasized that RAS driver mutations are present in nearly all pancreatic cancer cases, reinforcing the need for more targeted therapeutic options. Revolution Medicines also plans to launch two additional Phase 3 trials — one for first-line treatment in metastatic PDAC and another for adjuvant use in resectable PDAC.
Orphan Drug Designation offers developers several incentives, including tax credits for clinical trial expenses, exemption from certain FDA fees, and up to seven years of market exclusivity upon approval. The program aims to encourage the development of therapies for rare diseases affecting fewer than 200,000 people in the U.S.