Why Is Apellis Pharmaceuticals Stock Trading Lower Today?

Shares of Apellis Pharmaceuticals Inc APLS declined following a report by Citron Research casting doubts on the company's prospects and the safety of its recently approved treatment for Geographic Atrophy, Syfovre. 

The report anticipates an FDA warning letter and criticizes the lack of transparency surrounding the drug's approval process and side effect reports. 

Apellis is under scrutiny after alleged underreporting of retinal vasculitis cases associated with Syfovre use, a serious concern echoed by healthcare professionals despite the company's defense of its product's safety.

Cedric Francois, CEO of Apellis, faces skepticism over his disclosures to Wall Street, as the Citron report aligns with the findings of Favus Research and Wolfe, suggesting the company's communication about the vasculitis cases may have been inadequate. 

Earlier in the year, Apellis welcomed the launch of Syfovre, making it the first FDA-approved treatment for this debilitating eye condition without the advisory committee's usual vetting process. However, the decision has been controversial since then.

The criticism intensified in July when the ASRS linked Syfovre with reports of retinal vasculitis, leading to a significant drop in Apellis stock. 

The company maintained that the issues stemmed from the application device rather than the drug itself, an assertion met with skepticism. 

In August, in response to the growing concerns, Apellis announced a strategic restructuring plan, aiming to refocus on its main products, including Syfovre and Empaveli.

Citron Research, citing Favus Research, noted that Apellis trials didn't sufficiently report 14 cases of retinal vasculitis, an inflammatory condition that kills blood vessels in patients receiving the therapy. The media covered this as a "short seller attack." 

According to Citron, Apellis's clinical trial reports are allegedly inconsistent with real-world data regarding safety and efficacy, a discrepancy that the research firm suggests warrants at least an FDA-imposed warning on Syfovre. 

Price Action: APLS stock is down 5.68% at $44.17 on the last check Monday.