Revolution Medicines Inc

Pancreatic cancer: daraxonrasib “transformational” Phase III + rapid access and regulators moving - RASolute 302 (completed global Phase III) data presented at ASCO and published in *NEJM*: reported statistically significant OS and PFS improvements vs chemotherapy and improved patient-reported quality of life, with a manageable safety profile. - FDA NDA accepted for review (potential path to approval; company is actively engaging the FDA). - Expanded access program (EAP) ramp-up: >90% of reviewed requests approved; >2,000 eligible patients treated; sites now in almost all 50 states + Puerto Rico. - EMA acceleration: daraxonrasib designated high priority under Cancer Medicines Pathfinder; EMA has started a phase review with potential to expedite assessment. - Surprising/good: extremely fast operational scale-up (EAP + global Phase III “catapult” into access/launch readiness) immediately after Phase III results.

Regulatory/launch readiness: strong commercialization preparedness, but success hinges on approval timing - Company says it is prepared to launch from day one in the U.S. (sales force in place, field access operational, patient services, commercial supply/distribution ready). - Internationally building launch capabilities to support future commercialization “at an accelerating pace.” - Key outlook: relies on “subject to regulatory approvals,” so approval timelines and labeling details are material near-term uncertainties.

Pancreatic cancer pipeline: multiple Phase III efforts across RAS genotypes and combinations - Continuing enrollment and progress in RASolute 303 (1L metastatic) and RASolute 304 (adjuvant) for daraxonrasib. - Zoldonrasib: RASolute 305 (Phase III, 1L metastatic, RAS G12D) enrolling. - Combination strategy: RASolute 309 (daraxonrasib + zoldonrasib) initiated for first-line RAS G12D. - New supportive clinical readouts (ESMO GI): zoldonrasib+chemo showed high early response/DC rates (e.g., ORR 82% with modified FOLFIRINOX; 61% with gemcitabine+nab-paclitaxel); the combination daraxonrasib+zoldonrasib showed ORR ~50% and PFS medians ~9.6 months (2nd line) / ~7.6 months (3rd+ line) in early data—intended to support pivotal program rationale. - Opportunity: potential to redefine standard of care across the disease continuum (early/adjuvant + metastatic; multiple RAS genotypes).