Why Is Apellis Pharmaceuticals Stock Shooting Higher Today?

Apellis Pharmaceuticals Inc APLS released a comprehensive update regarding its Syfovre (pegcetacoplan injection) treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). 

The update covers crucial information about injection kits and the occurrence of rare events of retinal vasculitis associated with the treatment.

In July, Apellis shares came under pressure after disclosing safety events connected to Syfovre. 

Six cases of occlusive retinal vasculitis were observed since Syfovre's launch in March this year.

The company has identified internal structural variations in a specific component of the injection kits - the 19-gauge x 1½-inch filter needle, used to withdraw treatment from vials when preparing for injection. 

However, no direct link has been established between these structural variations and the rare retinal vasculitis reported in real-world use.

To ensure patient safety, Apellis Pharmaceuticals advises practitioners to discontinue using any injection kits containing the 19-gauge filter needle. 

Instead, the company recommends using injection kits with the 18-gauge filter needle already in distribution. Due to these findings, Apellis has transitioned exclusively to distributing kits with the 18-gauge filter needle.

Apellis says that despite over 100,000 vials being distributed for commercial use and clinical trials, the incidence of these events remains very low, estimated at 0.01% per injection in the real world.

The distribution breakdown includes over 78,000 vials since launch and over 26,000 vials in the current quarter. Additionally, approximately 24,000 Syfovre injections have been administered in clinical trials.

Confirmed cases of retinal vasculitis, both occlusive and non-occlusive, stand at eight. These cases occurred after the first injection of Syfovre, with patients receiving injections in April, May, or June. Patient outcomes vary; some show stable or improved vision, while others have experienced severe vision impairment.

Price Action: APLS shares are up 29.40% at $39.82 on the last check Wednesday.