other material
confidence high
sentiment positive
materiality 0.70
Processa Pharma: Phase 1b interim data show NGC-Cap improved safety with 10x higher 5-FU exposure than capecitabine
Processa Pharmaceuticals, Inc.
- NGC-Cap doses: 75-225 mg twice daily vs capecitabine's 1600-2500 mg twice daily; 5-FU exposure up to 10x greater.
- Anabolite side effect profile similar to capecitabine; FBAL-related side effects (hand-foot syndrome) almost absent; FBAL exposure ~1% of capecitabine.
- FDA acknowledges NGC-Cap as a New Chemical Entity based on altered metabolism and distribution of 5-FU.
- Fireside chat scheduled Dec 20 at 4:30 PM ET to discuss data and corporate strategy; results require further studies.