secwatch.observer — SEC 8-K summary
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Issuer:     Revolution Medicines, Inc. (RVMD)
CIK:        0001628171
Form:       8-K
Filed at:   2026-08-26T17:33:35+00:00
Accession:  0001193125-26-366931
Event type: regulatory
Sentiment:  positive
Materiality: 1.00
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA approves Revolution Medicines' RASONQUE for metastatic pancreatic adenocarcinoma
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- FDA approved RASONQUE (daraxonrasib) on Aug 26, 2026 for adult patients with metastatic pancreatic adenocarcinoma after prior systemic therapy or ineligible for multiagent therapy.
- Approval based on RASolute 302, a global randomized Phase 3 trial vs investigator's choice of cytotoxic chemotherapy in previously treated patients.
- Once-daily oral RASONQUE tablets now available in the U.S. for eligible patients; wholesale acquisition cost $39,800 for 30-day supply.
- This is the first FDA approval for Revolution Medicines' RAS inhibitor, marking a major commercial milestone.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1628171/000119312526366931/0001193125-26-366931-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1628171/000119312526366931/rvmd-20260826.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-366931

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer