Apellis Pharmaceuticals shares surge following Astellas Pharma’s FDA setback

Investing.com - Shares of biopharmaceutical firm Apellis Pharmaceuticals Inc (NASDAQ:APLS ) surged 16.44% to $31 on Tuesday after the FDA delayed the approval of a drug from rival Astellas Pharma.

The FDA issued a Complete Response Letter (CRL) for Astellas' Izervay, which is intended to treat geographic atrophy (GA), a form of macular degeneration. The CRL means that the drug’s approval process has been delayed, with a key issue being the rejection of the every-other-month dosing regimen for Izervay, limiting its use to a 12-month dosing schedule.

JPMorgan analysts pointed out that this setback offers a clear competitive advantage for Apellis’ Syfovre, which has already been approved for every-other-month dosing. This feature, combined with Syfovre’s flexible dosing schedule (no fixed duration), provides it with a distinct label advantage that Apellis can use to promote its benefits to physicians.

Syfovre is used to treat geographic atrophy (GA), a condition that causes vision loss in patients with macular degeneration. With the advantage in dosing flexibility, Apellis is well-positioned to capitalize on this market opportunity.

Source: Investing.com