#Priority review

4 stories

Regulatory August 27, 2026 · View digest

FDA Approves Revolution Medicines Rasonque (Daraxonrasib) for Metastatic Pancreatic Adenocarcinoma

The FDA on Wednesday August 26, 2026 approved Rasonque (daraxonrasib, a once-daily oral pan-RAS inhibitor developed by Revolution Medicines) for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multi-agent chemotherapy. Approval was based on the Phase 3 RASolute 302 trial across 500 previously-treated patients showing median overall survival of 13.2 months on Rasonque versus 6.7 months on standard chemotherapy. The drug does not require a companion diagnostic and is approved for patients with or without an identifiable RAS tumor mutation. FDA granted Breakthrough Therapy and Orphan Drug designations plus Priority Review. Daraxonrasib is a small molecule and not a peptide; the approval matters to peptide-relevant readers because it hardens the oncology backdrop the neoantigen peptide vaccine class (Merck-Moderna intismeran, individualized long-peptide programs) is entering, and because it validates a new mechanism class in a tumor where five-year survival has stalled near 13% for two decades.

Clinical Trials June 13, 2026 · View digest

Protagonist and Takeda Bring Phase 3 VERIFY and Long-Term Rusfertide Data to EHA 2026 in Stockholm Through June 14

Protagonist Therapeutics (Nasdaq: PTGX) and Takeda are presenting four rusfertide abstracts at the 2026 European Hematology Association Congress in Stockholm (June 11-14), including analyses from the Phase 3 VERIFY study and long-term results from the Phase 2 REVIVE and THRIVE open-label extensions. The 32-week VERIFY primary analysis showed 76.9% of patients on rusfertide achieved a clinical response versus 32.9% on placebo; the 52-week dataset met the primary endpoint and all four key secondary endpoints. Rusfertide is a first-in-class subcutaneous hepcidin-mimetic peptide for polycythemia vera. The FDA accepted the rusfertide NDA in early 2026 with priority review and set a Q3 2026 PDUFA target action date.

Regulatory April 4, 2026 · View digest

Rusfertide Receives FDA Priority Review for Polycythemia Vera

Takeda/Protagonist Therapeutics' rusfertide, a first-in-class hepcidin mimetic peptide, received NDA acceptance and priority review. The Phase 3 VERIFY study showed it more than doubled clinical response rates.

Regulatory April 3, 2026 · View digest

FDA Approves Foundayo Under National Priority Voucher Program in Record 50 Days

Foundayo became the first new molecular entity cleared under the Commissioner's National Priority Voucher Program, with review completed 294 days before the PDUFA date. Commercial pricing set at $25/month insured and $149/month self-pay at the lowest dose.