- The FDA approved Apellis Pharmaceuticals Inc’s (NASDAQ:APLS) Syfovre (pegcetacoplan injection) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
- Syfovre is the first and only FDA-approved treatment for GA.
- The approval of SYFOVRE is based on positive results from the Phase 3 OAKS and DERBY studies at 24 months across a broad and representative population of patients.
- Related: Apellis’s Pegcetacoplan Shows Increased Effects In Geographic Atrophy At Two Years.
- Syfovre is approved for GA patients with or without subfoveal involvement and provides dosing flexibility for patients and physicians with a dosing regimen of every 25 to 60 days.
- In the OAKS and DERBY studies, SYFOVRE reduced the rate of GA lesion growth compared to sham and demonstrated increasing treatment effects over time, with the greatest benefit (up to 36% reduction in lesion growth with monthly treatment in DERBY) occurring between months 18-24.
- Syfovre is expected to be available by the beginning of March. A European marketing application for Syfovre is under review, with a decision expected in early 2024.
- Price Action: APLS shares are up 11.70% at $62 on the last check Tuesday.
McKesson Q1 EPS $5.83 Beats $5.27 Estimate, Sales $67.15B Beat $65.14B Estimate
McKesson (NYSE:MCK) reported quarterly earnings of $5.83 per share which beat the analyst consensus estimate of $5.27 by 10.63 percent. This is a 4.86 percent increase over earnings of $5.56 per share from the same
