regulatory
confidence high
sentiment positive
materiality 0.90
FDA approves Phathom's VOQUEZNA for Erosive GERD; triggers $175M payment
Phathom Pharmaceuticals, Inc.
- FDA approved VOQUEZNA (vonoprazan) for healing, maintenance, and heartburn relief in Erosive GERD.
- Phase 3 PHALCON-EE trial showed 93% healing rate at Week 8 for VOQUEZNA 20mg vs 85% for lansoprazole.
- VOQUEZNA demonstrated superiority in moderate-to-severe patients (70% vs 53% at Week 2).
- Approval triggers a $175M non-dilutive payment from Revenue Interest Financing Agreement.
- VOQUEZNA expected to launch in US in December 2023; marketed exclusively by Phathom.