Apellis Pharmaceuticals, Inc. - APLS STOCK NEWS

On June 28, 2024, Apellis Pharmaceuticals (Nasdaq: APLS) announced that the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on the marketing authorization application for pegcetacoplan, a treatment for geographic atrophy (GA). Despite this, Apellis plans to seek a re-examination with a final decision expected in Q4 2024. The expert group confirmed that GA lesion size is a suitable trial outcome measure and microperimetry is the best functional measure. Pegcetacoplan is already approved in the US for GA secondary to age-related macular degeneration. GA affects over 5 million people globally and leads to irreversible vision loss.

Apellis Pharmaceuticals announced that their SYFOVRE® (pegcetacoplan injection) has shown to preserve visual function for 36 months in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD), as revealed in the GALE long-term extension study.

The findings were presented at the Clinical Trials at the Summit Meeting. SYFOVRE is the only approved GA treatment to show a visual function benefit in a prespecified endpoint, reducing the development of new scotomatous points compared to a sham crossover group.

The GALE study, consisting of 792 participants, evaluates the long-term efficacy and safety of SYFOVRE. The Phase 3 OAKS and DERBY studies supporting these results showed that both monthly and every-other-month doses reduced GA lesion growth and maintained a favorable safety profile.

However, SYFOVRE is associated with risks such as endophthalmitis, retinal detachments, and increased intraocular pressure.

Apellis Pharmaceuticals (Nasdaq: APLS) will host a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference.

The event is scheduled for June 12, 2024, at 4:00 p.m. ET.

A live webcast will be accessible via the company's website on the 'Events and Presentations' page under the 'Investors and Media' section.

A replay of the webcast will be available for 90 days post-event.

Apellis Pharmaceuticals and Sobi have announced positive one-year results from the Phase 2 NOBLE study on systemic pegcetacoplan for treating post-transplant recurrence of C3 glomerulopathy (C3G) and IC-MPGN. The study, presented at the ERA Congress, showed rapid reduction of disease activity at 12 weeks, sustained over a year.

Of the 11 patients treated, 55% showed zero C3c staining intensity, indicating clearance of C3c deposits, and 64% showed zero inflammation. Additionally, the treatment led to sustained improvements in proteinuria and kidney function stabilization. Pegcetacoplan was generally well-tolerated with mostly mild to moderate adverse events. The ongoing Phase 3 VALIANT study will further evaluate pegcetacoplan’s potential, with results expected later this year.

Apellis Pharmaceuticals announced a new non-dilutive senior secured credit facility with Sixth Street for up to $475 million, with $375 million received at closing. Apellis can access an additional $100 million before September 2025 under certain conditions and another $100 million through a third-party working capital facility. The majority of the proceeds will buy out a $326 million development liability to SFJ Pharmaceuticals, eliminating $366 million in payments through 2027. This improves Apellis' liquidity without needing additional capital markets funding. The credit facility matures in 2030 with a 3-month SOFR + 5.75% interest rate and is secured by Apellis' assets. As of March 31, 2024, Apellis had $325.9 million in cash and equivalents.

Apellis Pharmaceuticals reported strong financial results for the first quarter of 2024, with $172.3 million in revenues, driven by SYFOVRE and EMPAVELI sales. The company anticipates a CHMP opinion for pegcetacoplan by July 2024 and plans to report Phase 3 data in mid-2024. Cash and cash equivalents stood at $325.9 million, supporting future operations. Dr. Francois highlighted the positive performance of SYFOVRE and EMPAVELI, emphasizing the progress made in the treatment of challenging diseases.

Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) will host a fireside chat at the Bank of America Securities Healthcare Conference on May 14, 2024. The webcast will be available on the company's website.

Apellis Pharmaceuticals, Inc. announced 11 oral presentations at the ARVO Annual Meeting, showcasing the efficacy and safety profile of SYFOVRE® for geographic atrophy secondary to AMD. The data presented highlight the potential of SYFOVRE to slow disease progression and preserve visual function over time.

Apellis Pharmaceuticals, Inc. announced that the European Medicines Agency (EMA) has reset the review of the marketing authorization application for intravitreal pegcetacoplan, following a recent judgment by the Court of Justice of the European Union. The decision by EMA is procedural and not related to the pegcetacoplan data package. An opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected no later than July 2024.