Apellis Pharma

Apellis Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company, which develops novel therapeutic and complement immunotherapies for the treatment of complement-dependent autoimmune and inflammatory diseases through APL-2 product. The company was founded by Candace Rose Depp, Pascal Deschatelets, Cedric Francois, Alec Machiels on September 25, 2009 and is headquartered in Waltham, MA.

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Apellis Pharma reports strong Q1 revenue, eyes U.S. expansion

Apellis Pharma's Q1 2023 performance showcased strong revenue from SYFOVRE and EMPAVELI, with positive feedback and demand in the market.
While facing challenges like safety concerns and European commercialization, the company is focused on expanding market reach and driving awareness.
Opportunities lie in making SYFOVRE widely available, promoting patient education, and potential approval in Europe for further growth.

Apellis Pharma reports robust Q2 sales amidst safety event challenges

Apellis Pharma's Q2 performance highlighted strong sales, positive product efficacy, and proactive response to safety events
Despite challenges with rare safety events, the company's strengths in product credibility, manufacturing quality, and market acceptance shine through
Opportunities lie in enhancing physician education, exploring financing options, and leveraging positive efficacy evolution for market growth
Overall, Apellis Pharma's strategic measures position it well to navigate challenges, capitalize on opportunities, and maintain market confidence

Apellis Pharma reports mixed Q3 results, eyes European expansion

Apellis Pharma's Q3 performance showed strong revenue from key products but also highlighted the need for cost-saving measures. The company's focus on global expansion and product launches in Europe presents growth opportunities amidst market challenges.

Apellis Pharma reports strong Q4 earnings amidst market challenges

Apellis Pharma delivered strong financial results in Q4 2023, driven by the success of SYFOVRE and EMPAVELI in the U.S., while navigating challenges in the EU market and competitive landscape.
The company's strategic focus on patient access, market leadership, and R&D advancement positions it for continued growth and innovation in precision medicine, supported by robust engagement with medical communities.
Opportunities lie in expanding market share through bilateral treatments, advancing pipeline programs, and leveraging compliance and real-world data to strengthen Apellis Pharma's position as a leading provider of GA therapies.
Addressing challenges such as market competition, regulatory processes, and financial performance will be crucial for Apellis Pharma to sustain growth, optimize revenue, and drive profitability in the future.

Apellis Pharma reports robust Q1 performance and eyes expansion

Apellis Pharma (APLS) showcased strong financial performance and product success in Q1 2024, with plans for expansion and upcoming study data.
Despite challenges like a negative CHMP opinion and safety concerns, opportunities in education, expansion, and market penetration are on the horizon.
The company's commitment to shareholder value, financial stability, and milestone achievements sets a positive outlook for the future.

Apellis Pharma reports robust Q2 earnings, eyes market expansion

Apellis Pharma's Q2 performance reflects strong revenue growth and market leadership, supported by successful product sales and strategic initiatives.
While facing competition and challenges in market share retention, the company's focus on expansion and financial strength bode well for future growth.
Opportunities in new indications, market expansion, and pipeline development position Apellis Pharma for continued value creation for patients and shareholders.

Apellis Pharma reports robust Q3 performance amidst market challenges

Apellis Pharma's Q3 performance reflects strong demand for SYFOVRE and strategic initiatives to drive market share.
While facing challenges such as gross to net adjustments and market dynamics, the company remains optimistic about future growth opportunities.
By leveraging strengths in product efficacy and real-world data, Apellis Pharma aims to expand globally and enhance profitability.

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Apellis Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company, which engages in the discovery, development, and commercialization of novel therapeutic compounds to treat diseases with high unmet needs. Its products include EMPAVELI and SYFOVRE. The company was founded by Candace Rose Depp, Pascal Deschatelets, Cedric Francois, and Alec Machiels on September 25, 2009 and is headquartered in Waltham, MA.

Shares of Apellis Pharmaceuticals Inc. APLS, +1.55% gained 6.1% in premarket trading on Wednesday after the company shared longer-term clinical data demonstrating that intravitreal pegcetacoplan reduced geographic atrophy lesion growth at 18 months. The data, culled from two clinical trials, will be used in the new drug application that is expected to be submitted to the Food and Drug Administration in the second quarter of this year.

Apellis shares jump 6% after the company announces new new data for its geographic atrophy drug

WALTHAM, Mass., March 16, 2022 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced longer-term data from the Phase 3 DERBY and OAKS studies, which showed that intravitreal pegcetacoplan, an investigational, targeted C3 therapy, continued to reduce geographic atrophy (GA) lesion growth and demonstrate a favorable safety profile at month 18 for the treatment of GA secondary to age-related macular degeneration (AMD). These data will be included in the New Drug Application (NDA) that the company plans to submit to the U.S. Food and Drug Administration (FDA) in the second quarter of 2022.

Apellis Announces Pegcetacoplan Showed Continuous and Clinically Meaningful Effects at Month 18 in Phase 3 DERBY and OAKS Studies for Geographic Atrophy (GA)

Apellis' (APLS) earnings miss estimates in the fourth quarter of 2021, while revenues surpass expectations.

Apellis (APLS) Q4 Loss Widens, Revenues Surpass Estimates

Apellis Pharmaceuticals, Inc. (APLS) CEO Cedric Francois on Q4 2021 Results - Earnings Call Transcript

WALTHAM, Mass., Feb. 28, 2022 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced its fourth quarter and full year 2021 financial results and business highlights.

Apellis Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results

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Apellis made a lot of progress in the last few months. The launch of Empaveli is progressing well and partner Sobi secured EMA approval for Aspaveli.

The Situation Has Improved At Apellis Pharmaceuticals In Recent Months

WALTHAM, Mass., Feb. 22, 2022 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company will host a conference call and webcast to discuss its fourth quarter and full year 2021 financial results on Monday, February 28, 2022 at 4:30 p.m. ET.

Apellis Pharmaceuticals to Host Conference Call on February 28, 2022 to Discuss Fourth Quarter and Full Year 2021 Financial Results

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Approval of Apellis' (APLS) Empaveli for treating paroxysmal nocturnal hemoglobinuria lends a significant boost to the company's growth prospects. The drug's label expansion studies also hold promise.

Apellis (APLS) Up More Than 40% in Past 3 Months: Here's Why

WALTHAM, Mass., Jan. 03, 2022 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company will present virtually at the 40th Annual J.P. Morgan Healthcare Conference on Monday, January 10, 2022 at 8:15 a.m. ET.

Apellis Pharmaceuticals to Present at the 40th Annual J.P. Morgan Healthcare Conference

The European Commission approves Apellis (APLS) and Sobi's Aspaveli for the treatment of paroxysmal nocturnal hemoglobinuria in adult patients. Shares rise.

Apellis (APLS), Sobi Get EU Nod for Rare Blood Disorder Drug

The European Commission has approved Swedish Orphan Biovitrum AB (OTC: BIOVF) - Apellis Pharmaceuticals Inc's (NASDAQ: APLS) Aspaveli (pegcetacoplan) for paroxysmal nocturnal hemoglobinuria (PNH). The approval covers anemic patients after treatment with a C5 inhibitor for at least three months.

Apellis - Sobi's Pegcetacoplan Wins European Approval For Rare Blood Disorder

STOCKHOLM, Dec. 15, 2021 /PRNewswire/ -- The first targeted C3 therapy approved in the EU Approval based on results from head-to-head PEGASUS phase 3 study where Aspaveli demonstrated superiority to eculizumab in improving haemoglobin levels1 Aspaveli will have market exclusivity for paroxysmal nocturnal haemoglobinuria (PNH) based on orphan drug designation Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) and Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced today that the European Commission (EC) has approved Aspaveli® (pegcetacoplan), the first and only targeted C3 therapy, for the treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least three months. Based on the recommendation from the European Medicines Agency's Committee for Orphan Medicinal Products, the EC determined that pegcetacoplan continues to meet the criteria for the orphan drug designation status granted in 2017 for the treatment of PNH.

Aspaveli® (pegcetacoplan) approved in EU as orphan drug for treatment of PNH

WALTHAM, Mass. and STOCKHOLM, Sweden, Dec. 13, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) announced today new data demonstrating that Empaveli™/Aspaveli® (pegcetacoplan) provides consistent, sustained normalization of clinical measures across patients with paroxysmal nocturnal hemoglobinuria (PNH) who are treatment-naïve and patients with baseline hemoglobin levels greater than or equal to 10.0 g/dL. The data were presented at the American Society of Hematology Annual Meeting (ASH) taking place December 11 - 14, 2021.

Apellis and Sobi Report Empaveli™ (pegcetacoplan) Demonstrated Sustained Normalization of Clinical Measures in a Broad PNH Patient Population

WALTHAM, Mass., Nov. 29, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company will present at the 4th Annual Evercore ISI HealthCONx Conference on Thursday, December 2, 2021 at 8:00 a.m. ET. The conference will be held in a virtual meeting format.

Apellis Pharmaceuticals to Present at the 4th Annual Evercore ISI HealthCONx Conference

WALTHAM, Mass., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that it received formal, written feedback from the U.S. Food and Drug Administration (FDA) that further reinforces the company's plans to submit a New Drug Application (NDA) for intravitreal pegcetacoplan for geographic atrophy (GA) secondary to age-related macular degeneration. The NDA will be supported by efficacy and safety data from the Phase 3 DERBY and OAKS studies and the Phase 2 FILLY study.

Apellis Reiterates Plans to Submit a New Drug Application in the First Half of 2022 for Pegcetacoplan for Geographic Atrophy Following FDA Feedback

Apellis (APLS) reports wider-than-expected loss for the third quarter of 2021 while revenues surpass expectations.

Apellis' (APLS) Q3 Loss Widens, Revenues Surpass Estimates

Apellis Pharmaceuticals, Inc. (APLS) CEO Cedric Francois on Q3 2021 Results - Earnings Call Transcript

WALTHAM, Mass., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced its third quarter 2021 financial results and business highlights.

Apellis Pharmaceuticals Reports Third Quarter 2021 Financial Results

WALTHAM, Mass., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that five abstracts were accepted for presentation at the American Society of Hematology (ASH) Annual Meeting to be held December 11-14, 2021. The new data further support the positive efficacy and safety profile of EMPAVELI, the first and only targeted C3 therapy, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

Apellis to Present New Data Reinforcing EMPAVELI™ (pegcetacoplan) Efficacy and Safety in Patients with PNH at the 2021 ASH Annual Meeting

WALTHAM, Mass., Nov. 01, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the company will host a conference call and webcast to discuss its third quarter 2021 financial results on Monday, November 8, 2021 at 4:30 p.m. ET.

Apellis Pharmaceuticals to Host Conference Call on November 8, 2021 to Discuss Third Quarter 2021 Financial Results

The CHMP gives a positive opinion on and recommends granting marketing authorization to Apellis' (APLS) Aspaveli for the treatment of adults with paroxysmal nocturnal hemoglobinuria.

Apellis (APLS) Gets CHMP Nod for Rare Blood Disorder Drug (Revised)

Apellis (APLS) Gets CHMP Nod for Rare Blood Disorder Drug

STOCKHOLM, Oct. 15, 2021 /PRNewswire/ -- Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) and Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announce today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the marketing authorisation of Aspaveli® (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least three months. The positive opinion from the CHMP is now referred to the European Commission for an approval decision.

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