- Breakthrough Designations: Daraxonrasib and elironrasib received Breakthrough Therapy designations for pancreatic cancer and NSCLC, respectively, accelerating regulatory pathways.
- $2 Billion Funding Partnership: Royalty Pharma provided $2B in funding, including $1.25B synthetic royalty on daraxonrasib sales and $750M corporate debt, ensuring financial stability.
- Phase III Trial Timeline: Full data from RASolute 302 (daraxonrasib) expected by 2026, with no definitive approval timeline but readiness for rapid regulatory submissions.
- 2025 Financial Outlook: Anticipated GAAP net loss of $1.03–$1.09 billion in 2025, reflecting strategic investments in R&D and commercialization.
Daraxonrasib: Breakthrough Therapy Designation and Strategic Partnerships
Daraxonrasib, RevMed's lead candidate, received Breakthrough Therapy designation from the FDA for previously treated metastatic pancreatic cancer. This designation signifies the drug's potential to address an urgent medical need and could expedite regulatory review. The company is actively enrolling patients in its Phase III trial, RASolute 302, with data expected in 2026. To support its development and commercialization efforts, RevMed recently secured a $2 billion funding partnership with Royalty Pharma, which includes a $1.25 billion synthetic royalty on future daraxonrasib sales and $750 million in corporate debt.
Elironrasib and Zoldonrasib: Expanding the RAS(ON) Inhibitor Portfolio
Elironrasib, another RAS(ON) inhibitor, received Breakthrough Therapy designation for locally advanced or metastatic KRAS G12C NSCLC following prior systemic therapy. Preclinical data and early clinical evidence suggest promising results for elironrasib in combination with other therapies, including daraxonrasib and pembrolizumab. Zoldonrasib, meanwhile, demonstrated encouraging clinical activity and tolerability in patients with KRAS G12D non-small cell lung cancer.
Future Trials and Strategic Collaborations
RevMed is actively exploring combinations of its RAS(ON) inhibitors with other therapies. A partnership with Summit Therapeutics aims to investigate the combination of their RAS(ON) inhibitors with the ivonescimab bispecific antibody. They are also exploring the potential of combining their RAS inhibitors with a PRMT5 inhibitor, focusing initially on pancreatic cancer. Additional promising data from ongoing studies on zoldonrasib and elironrasib will inform future clinical trial decisions.