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.

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

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.

Aspaveli® (pegcetacoplan) receives positive CHMP opinion for treatment of PNH

WALTHAM, Mass. and STOCKHOLM, Sweden, Oct. 15, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the marketing authorization of Aspaveli® (pegcetacoplan) for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) who are anemic 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.

Apellis and Sobi Receive Positive CHMP Opinion for Aspaveli® (pegcetacoplan) for the Treatment of PNH

WALTHAM, Mass., Sept. 30, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that detailed data from the Phase 3 DERBY and OAKS studies were presented for the first time as part of two oral presentations at the Retina Society Annual Scientific Meeting in Chicago. The studies evaluated the efficacy and safety of pegcetacoplan, an investigational, targeted C3 therapy, in geographic atrophy (GA) secondary to age-related macular degeneration (AMD). GA is a leading cause of blindness that impacts more than five million people globally including one million people in the United States.1,2

Apellis Announces Detailed Results from Phase 3 DERBY and OAKS Studies Presented at Retina Society Annual Meeting

WALTHAM, Mass., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the company will present at the 2021 Cantor Virtual Global Healthcare Conference on Monday, September 27, 2021 at 8:40 a.m. ET. The conference will be held in a virtual meeting format.

Apellis Pharmaceuticals to Present at the 2021 Cantor Virtual Global Healthcare Conference

Investors were disappointed with mixed phase 3 results of intravitreal pegcetacoplan in geographic atrophy patients.

Apellis Plunges On Mixed Phase 3 Results In Geographic Atrophy

Apellis (APLS) posts mixed top-line data from the phase III DERBY and OAKS studies testing pegcetacoplan in adults with geographic atrophy secondary to age-related macular degeneration. Stock falls.

Apellis (APLS) Down on Mixed Data From Studies on GA Candidate

Here's why investors are in full selloff mode today with APLS stock on Apellis Pharmaceuticals' latest clinical trial results. The post APLS Stock: The Trial Results That Have Apellis Pharmaceuticals Plunging Today appeared first on InvestorPlace.

APLS Stock: The Trial Results That Have Apellis Pharmaceuticals Plunging Today

Apellis Pharmaceuticals Inc (NASDAQ: APLS) is trading lower Friday after the company announced its Phase 3 DERBY study in geographic atrophy did not meet the primary endpoint of GA lesion growth. DERBY did not meet the primary endpoint by itself, but the company said, in a prespecified analysis of the combined DERBY and OAKS studies, monthly and every-other-month treatment with pegcetacoplan reduced GA lesion growth by 17%.

Why Apellis Pharmaceutical Shares Are Plunging Today

Conflicting clinical trial results for the company's lead candidate are to blame.

Here's Why Apellis Pharmaceuticals Is Getting Hammered Today

Apellis Pharmaceuticals releases mixed results for its eye disease treatment and the stock falls sharply.

Apellis Stock Plunges After Its Eye Treatment Gets Mixed Results

Shares of Apellis Pharmaceuticals Inc. APLS, +0.05% plunged 31.6% toward a 10-month low to pace all premarket losers Friday, after one of the Phase 3 studies of the biopharmaceutical company's eye disease treatment failed to meet its primary endpoint. The company said late Thursday that the OAKS study for pegcetacoplan met the primary endpoint, as it significantly reduced geographic atrophy (GA) lesion growth, while the DERBY study missed its primary endpoint of GA lesion growth reduction.

Apellis Pharmaceuticals stock plunges after disappointing result from GA treatment studies

Apellis Pharmaceuticals Inc's (NASDAQ: APLS) pegcetacoplan posted mixed results in two Phase 3 trials in 1,258 geographic atrophy (GA).  Despite the mixed showing, CEO Cedric Francois thinks the candidates' performance was strong enough to warrant an FDA nod.

Apellis Unveils Mixed Results For Eye Disorder Drug, But Still Hopes To Pass FDA Finish Line

WALTHAM, Mass., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today reported top-line results from the Phase 3 DERBY and OAKS studies evaluating intravitreal pegcetacoplan, an investigational targeted C3 therapy, in 1,258 adults with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). GA is a leading cause of blindness that impacts more than five million people globally including one million people in the United States.1,2 Based on results from the studies, the company plans to submit a New Drug Application (NDA) for pegcetacoplan for GA to the U.S. Food and Drug Administration (FDA) in the first half of 2022.

Apellis Announces Top-Line Results from Phase 3 DERBY and OAKS Studies in Geographic Atrophy (GA) and Plans to Submit NDA to FDA in the First Half of 2022

Apellis Pharmaceuticals, Inc. (APLS) reported earnings 30 days ago. What's next for the stock?

Apellis Pharmaceuticals, Inc. (APLS) Down 6.8% Since Last Earnings Report: Can It Rebound?

WALTHAM, Mass., Sept. 03, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the company approved the grant of equity awards to its newly appointed VP, Corporate Controller / Chief Accounting Officer, Jim Chopas, with a grant date of August 30, 2021, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2021 Inducement Stock Incentive Plan) and material to Mr. Chopas entering into employment with the company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

Apellis Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) to New VP, Corporate Controller / Chief Accounting Officer

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With the trading day more than halfway over, the broad markets made another comeback from the open, similar to Wednesday, but can they hold it today?

Thursday Afternoon Analyst Upgrades and Downgrades: Apple, AutoDesk and More

Investors need to pay close attention to Apellis (APLS) stock based on the movements in the options market lately.

Is the Options Market Predicting a Spike in Apellis (APLS) Stock?

Apellis (APLS) reports a wider-than-expected loss for the second quarter of 2021. Revenues too miss expectations.

Apellis' (APLS) Q2 Earnings & Revenues Fall Shy of Estimates

Apellis Pharmaceuticals, Inc. (APLS) CEO Cedric Francois on Q2 2021 Results - Earnings Call Transcript

Shares of Apellis Pharmaceuticals (NASDAQ:APLS) fell in after-market trading after the company reported Q2 results. Quarterly Results Earnings per share decreased 73.25% year over year to ($2.72), which missed the estimate of ($1.70).

Recap: Apellis Pharmaceuticals Q2 Earnings

WALTHAM, Mass., Aug. 09, 2021 (GLOBE NEWSWIRE) --  Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced its second quarter 2021 financial results and business highlights.

Apellis Pharmaceuticals Reports Second Quarter 2021 Financial Results

WALTHAM, Mass., July 26, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq:APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced the closing of its previously announced privately negotiated exchange transactions (the “Exchange Transactions”) with certain holders of its 3.500% Convertible Senior Notes due 2026 (the “Notes”). In the Exchange Transactions, the holders exchanged approximately $201.1 million in aggregate principal amount of Notes and Apellis issued an aggregate of 5,992,217 shares of its common stock.

Apellis Announces Closing of Previously Announced Exchanges of Approximately $201.1 Million in Principal Amount of Its 3.500% Convertible Senior Notes Due 2026 for Common Stock

WALTHAM, Mass., July 07, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq:APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that it has entered into separate, privately negotiated exchange agreements with certain holders of its 3.500% Convertible Senior Notes due 2026 (the “Notes”). Under the terms of these exchange agreements, the holders have agreed to exchange with Apellis approximately $198.6 million in aggregate principal amount of Notes held by them for (i) 4,530,431 shares of Apellis' common stock, which is equal to 22.8065 shares per $1,000 principal amount of Notes exchanged plus (ii) an additional number of shares of Apellis' common stock per $1,000 principal amount of Notes exchanged equal to the quotient of (a) $449.64 divided by (b) the average of the daily volume-weighted average prices of Apellis' common stock over the 10 consecutive trading days commencing on July 8, 2021. The exchange transactions are expected to close on July 23, 2021, subject to the satisfaction of customary closing conditions.

Apellis Announces Agreements to Exchange Approximately $198.6 Million in Principal Amount of Its 3.500% Convertible Senior Notes Due 2026 for Common Stock

Apellis (APLS) signs a collaboration deal with Beam Therapeutics to develop new treatments for complement-driven diseases. Shares rise.

News for Apellis Pharma Stock (APLS)