Apellis Pharmace Stock Price, News & Analysis

Apellis Pharmaceuticals (Nasdaq: APLS) and Sobi™ announced positive data for Empaveli™ (pegcetacoplan) in treating paroxysmal nocturnal hemoglobinuria (PNH) at the ASH Annual Meeting. Results from the Phase 3 PRINCE study revealed significant improvements in treatment-naïve patients: 46% achieved hemoglobin normalization without transfusions, with a mean hemoglobin rise from 9.4 g/dL to 12.8 g/dL. The treatment also resulted in rapid reductions in lactate dehydrogenase (LDH) levels. The safety profile was consistent, with lower serious adverse events compared to standard care.

Apellis Pharmaceuticals (Nasdaq: APLS) will present at the 4th Annual Evercore ISI HealthCONx Conference on December 2, 2021, at 8:00 a.m. ET. The presentation will be conducted in a virtual format and can be accessed via a live webcast on the company’s website. A replay of the event will be available for 90 days post-conference. Apellis is a global leader in complement therapies, focusing on innovative treatments for diseases related to the complement cascade in various fields, including hematology and neurology.

Apellis Pharmaceuticals (APLS) announced the closing of its underwritten public offering, selling a total of 10,062,500 shares at $40.00 each. This offering generated gross proceeds of approximately $402.5 million before expenses. The underwriters fully exercised their option to purchase an additional 1,312,500 shares. The offering was conducted under an effective shelf registration statement filed with the SEC.

Apellis focuses on developing therapies for diseases linked to the complement system, emphasizing innovation and patient care in various medical fields.

Apellis Pharmaceuticals announced the pricing of its underwritten public offering of 8,750,000 shares at $40.00 per share, totaling $350 million in gross proceeds. The offering aims to enhance the company's financial position and support further development in targeted C3 therapies. A 30-day option for underwriters to purchase an additional 1,312,500 shares is also available. The offering is set to close on November 18, 2021, pending customary conditions. J.P. Morgan, Goldman Sachs, and Evercore are leading the offering, emphasizing the company's focus on innovative therapeutics.

Apellis Pharmaceuticals (Nasdaq:APLS) has initiated a public offering of $300 million in common stock, all of which is being offered by the company. There is also an option for underwriters to purchase an additional 15% of the shares sold. The offering is subject to market conditions, and there are no guarantees regarding its completion. The shares are part of an automatically effective shelf registration statement filed with the SEC on January 7, 2020. Details will be provided in a preliminary prospectus supplement to be filed with the SEC.

Apellis Pharmaceuticals (Nasdaq: APLS) announced it received formal FDA feedback supporting its plans to submit a New Drug Application (NDA) for intravitreal pegcetacoplan aimed at treating geographic atrophy (GA) due to age-related macular degeneration. The NDA will utilize data from the Phase 3 DERBY and OAKS studies, alongside the Phase 2 FILLY study, all deemed adequate by the FDA. Apellis aims to submit the NDA in H1 2022 without needing additional trials. Over 1,500 patients participated in these studies, highlighting the company's commitment to addressing GA, a leading cause of blindness.

Apellis Pharmaceuticals (APLS) announced the presentation of Phase 3 DERBY and OAKS trial data for pegcetacoplan at the AAO Annual Meeting from Nov 12-15, 2021. Pegcetacoplan, an investigational C3 therapy, demonstrated clinically meaningful reductions in geographic atrophy (GA) lesion growth in patients with age-related macular degeneration. While achieving the primary endpoint in OAKS, it narrowly missed in DERBY. The company plans to file a New Drug Application with the FDA in the first half of 2022, marking a significant step toward addressing a condition with no approved treatments worldwide.

Apellis Pharmaceuticals reported $5.3 million in net product revenues from EMPAVELI in Q3 2021, contributing to total revenues of $5.7 million. The company received a positive opinion from the CHMP for pegcetacoplan in PNH and anticipates a decision by the European Commission by year-end. Apellis is on track to submit a New Drug Application for pegcetacoplan for geographic atrophy by mid-2022, with promising trial results indicating significant GA lesion growth reduction. However, net loss increased to $195.6 million, up from $135.7 million a year prior.

Apellis Pharmaceuticals announced the acceptance of five abstracts for the upcoming American Society of Hematology (ASH) Annual Meeting, including the positive Phase 3 PRINCE study of EMPAVELI in treatment-naïve patients with paroxysmal nocturnal hemoglobinuria (PNH). Results indicated EMPAVELI’s superiority in hemoglobin stabilization and LDH reduction at Week 26 compared to standard care. The study assessed 53 adults, showcasing EMPAVELI's potential to enhance treatment for all PNH patients, regardless of prior hemoglobin levels. The oral presentation is scheduled for December 13, 2021.