Welcome to our dedicated page for Apellis Pharmaceuticals news (Ticker: APLS), a resource for investors and traders seeking the latest updates and insights on Apellis Pharmaceuticals stock.
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) is a commercial-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapeutic compounds. The company's primary focus is on treating diseases with high unmet medical needs through the inhibition of the complement system, a crucial part of the immune system. Apellis targets the complement system at the level of C3, aiming to provide comprehensive disease control.
Apellis's flagship products include SYFOVRE® (pegcetacoplan injection) and EMPAVELI® (pegcetacoplan). SYFOVRE is the first-ever approved therapy for geographic atrophy (GA), a leading cause of blindness, while EMPAVELI is approved for treating paroxysmal nocturnal hemoglobinuria (PNH), a rare hematological disease. Both medicines reflect the company's innovative approach to complement immunotherapy.
In 2023, Apellis achieved significant milestones, including generating $397 million in revenue, with substantial contributions from SYFOVRE and EMPAVELI. The company has also presented positive data from its Phase 2 NOBLE study for systemic pegcetacoplan in rare kidney diseases at the European Renal Association Congress, highlighting the potential of pegcetacoplan to address complex medical conditions.
Looking ahead, Apellis anticipates regulatory developments, including the European Medicines Agency’s (EMA) review of the marketing authorization application (MAA) for SYFOVRE and the expected topline data from the Phase 3 VALIANT study of systemic pegcetacoplan in mid-2024. Financially robust, Apellis recently closed a $375 million funding deal with Sixth Street to buy out existing liabilities, significantly improving its liquidity profile and positioning the company for sustainable growth.
Apellis's commitment to advancing science is evident through its extensive pipeline and collaborations, such as its partnership with Sobi for systemic pegcetacoplan. The company's approach combines bold scientific endeavors with compassionate patient care, continually striving to bring life-changing therapies to those in need.
Apellis Pharmaceuticals (APLS) announced the approval of equity inducement awards for a new employee, effective January 3, 2022. The award consists of options to purchase 60,000 shares at an exercise price of $48.77 and 20,000 restricted stock units (RSUs). The options will vest over four years, with 25% vesting on the first anniversary. This action is aligned with Nasdaq Listing Rule 5635(c)(4) and aims to attract talent by providing long-term incentive compensation.
Apellis Pharmaceuticals (Nasdaq: APLS) will present virtually at the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022, at 8:15 a.m. ET. The presentation will include a live Q&A session and will be accessible via a webcast on the company’s website. A replay will be available for 30 days post-event, along with the presentation slides posted online at 8:00 a.m. ET on the same day. Apellis is focused on developing transformative therapies targeting the complement system for various debilitating diseases.
Apellis Pharmaceuticals announced that the European Commission has approved Aspaveli (pegcetacoplan), the first targeted C3 therapy for paroxysmal nocturnal hemoglobinuria (PNH), aimed at adults who remain anemic after C5 inhibitor treatment. This approval is based on the PEGASUS Phase 3 study showing Aspaveli's effectiveness over eculizumab in improving hemoglobin levels. Aspaveli will enjoy market exclusivity in the EU due to its orphan drug designation, supporting its potential to enhance patient care for PNH.
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.
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