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 company's lead therapy was just approved for another indication.

Wall Street Upgraded This Stock's Price Target After a New Approval: Is It a Buy?

A highly eventful five days for the company saw bulls pile into its shares.

Why Apellis Pharmaceuticals Stock Surged This Week

WALTHAM, Mass., Feb. 22, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc., (Nasdaq:APLS), a global biopharmaceutical company and leader in complement, today announced the pricing of its underwritten public offering of 3,174,603 shares of its common stock at a public offering price of $63.00 per share and, in lieu of common stock to investors who so choose, pre-funded warrants to purchase 2,380,956 shares of its common stock at a public offering price of $62.9999 per pre-funded warrant, for total gross proceeds of approximately $350 million, before deducting underwriting discounts and commissions and offering expenses payable by Apellis. The purchase price of each pre-funded warrant equals the price per share at which the shares of common stock are being sold in the offering, minus $0.0001. All of the shares and pre-funded warrants in the offering are being sold by Apellis. The offering is expected to close on February 27, 2023, subject to customary closing conditions. In addition, Apellis has granted the underwriters a 30-day option to purchase up to 833,333 additional shares of its common stock at the public offering price, less the underwriting discounts and commissions.

Apellis Pharmaceuticals Announces Pricing of Public Offering of Common Stock and Pre-Funded Warrants

Apellis Pharmaceuticals (APLS) reports better-than-expected results, beating both earnings and revenue estimates. Empaveli sales continue to boost product revenues for the company.

Apellis' (APLS) Earnings Top, Empaveli Sales Boost Revenues

WALTHAM, Mass., Feb. 22, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc., (Nasdaq:APLS), a global biopharmaceutical company and leader in complement, today announced that it has commenced an underwritten public offering of $300 million of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof). All of the shares of common stock and pre-funded warrants are being offered by Apellis. In addition, Apellis expects to grant the underwriters a 30-day option to purchase additional shares of its common stock in an amount equal to 15% of the securities offered in the public offering.

Apellis Pharmaceuticals Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants

Apellis Pharmaceuticals, Inc. (APLS) delivered earnings and revenue surprises of 9.09% and 8.47%, respectively, for the quarter ended December 2022. Do the numbers hold clues to what lies ahead for the stock?

Apellis Pharmaceuticals, Inc. (APLS) Reports Q4 Loss, Tops Revenue Estimates

WALTHAM, Mass., Feb. 21, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced its fourth quarter and full year 2022 financial results and business highlights.

Apellis Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results

Apellis Pharmaceuticals snagged FDA approval for the first-ever geographic atrophy treatment, leading APLS stock to surge Tuesday. The post Apellis Surges To Four-Month High — Sending Rival Iveric Tumbling — On A First-Ever Approval appeared first on Investor's Business Daily.

Apellis Surges To Four-Month High — Sending Rival Iveric Tumbling — On A First-Ever Approval

Apellis Pharmaceuticals, Inc. (APLS) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Analysts Estimate Apellis Pharmaceuticals, Inc. (APLS) to Report a Decline in Earnings: What to Look Out for

A Media Snippet accompanying this announcement is available by clicking on the image or link below:

FDA Approves SYFOVRE™ (pegcetacoplan injection) as the First and Only Treatment for Geographic Atrophy (GA), a Leading Cause of Blindness

Apellis has successfully guided its C3 complement inhibitor Pegcetacoplan to an approval in paroxysmal nocturnal hemoglobinuria. In this indication the drug has outperformed multi-billion revenue per annum Soliris in head-to head studies.

Apellis: Empaveli Ought To Win Approval For Eye Disease In February - The Future Looks Bright

WALTHAM, Mass., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that leading retina specialist Caroline Baumal, M.D., has joined Apellis as chief medical officer. Dr. Baumal replaces Federico Grossi, M.D., Ph.D., who plans to remain at Apellis until February 28, 2023 to help with the transition and preparations for the potential launch of pegcetacoplan for geographic atrophy (GA).

Apellis Appoints Leading Retina Specialist Dr. Caroline Baumal as Chief Medical Officer

WALTHAM, Mass., Jan. 03, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals , Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company will present at the 41st Annual J.P. Morgan Healthcare Conference on Monday, January 9, 2023 at 9:00 a.m. PT / 12:00 p.m. ET.

Apellis Pharmaceuticals to Present at the 41st Annual J.P. Morgan Healthcare Conference

Apellis (APLS) submits a marketing authorization application for pegcetacoplan to treat geographic atrophy secondary to age-related macular degeneration to the European Medicines Agency.

Apellis (APLS) Files MAA for Pegcetacoplan in GA in Europe

WALTHAM, Mass., Dec. 16, 2022 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for intravitreal pegcetacoplan, an investigational, targeted C3 therapy, for the treatment of 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.1,2

Apellis Submits Marketing Authorization Application to the European Medicines Agency for Pegcetacoplan for Geographic Atrophy

Apellis Pharmaceuticals, Inc. has an upcoming PDUFA. Data is mixed.

Apellis Pharmaceuticals: Approval Is Baked Into Valuation

The FDA accepts Apellis' (APLS) major amendment to the NDA for pegcetacoplan to treat geographic atrophy secondary to age-related macular degeneration. A decision is now due on Feb 26, 2023.

Apellis (APLS) Rises on FDA Acceptance of NDA Amendment for GA

Apellis Pharmaceuticals Inc (NASDAQ:APLS) shares surged in pre-market deals after the Nasdaq-listed global biopharma announced that the US regulator had accepted the company's amendment to its new drug application (NDA) for a therapy for geographic atrophy (GA) - an advanced form of age-related macular degeneration (AMD). GA is a leading cause of blindness that impacts more than five million people worldwide, including one million in the US.

Apellis Pharmaceuticals advances as US regulator approves new drug application (NDA) amendment for geographic atrophy (GA) therapy

Apellis Pharmaceuticals said Friday the Food and Drug Administration will review its new eye-disease drug in February, and APLS stock surged. The post Apellis Pharmaceuticals Surges On New Review Date For Eye-Disease Treatment appeared first on Investor's Business Daily.

Apellis Pharmaceuticals Surges On New Review Date For Eye-Disease Treatment

Shares of Apellis Pharmaceuticals Inc. APLS, -1.21% jumped 16.8% in premarket trading on Friday after the company said the Food and Drug Administration accepted an amendment to its drug-approval submission for a geographic atrophy therapy. The FDA is expected to make a decision on the drug by Feb. 26, and the company said the regulator does not plan to hold an advisory committee meeting to discuss the new drug application for pegcetacoplan.

Apellis shares gain 16% after FDA accepts new data for drug submission

WALTHAM, Mass., Nov. 18, 2022 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the U.S. Food and Drug Administration (FDA) has accepted Apellis' unsolicited major amendment to the New Drug Application (NDA) for intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The updated Prescription Drug User Fee Act (PDUFA) goal date is February 26, 2023. The FDA also restated that they do not plan to hold an advisory committee meeting to discuss the application.

Apellis Announces FDA Acceptance of NDA Amendment and New PDUFA Date of February 26, 2023 for Pegcetacoplan for Geographic Atrophy (GA)

Apellis' (APLS) earnings miss estimates in the third quarter of 2022 while revenues beat the same.

Apellis' (APLS) Q3 Earnings Miss Estimates, Revenues Top Mark

Apellis Pharmaceuticals, Inc. (NASDAQ:APLS ) Q3 2022 Earnings Conference Call November 7, 2022 4:30 PM ET Company Participants Adam Townsend - Chief Commercial Officer Cedric Francois - Co-Founder, President & Chief Executive Officer Federico Grossi - Co-Founder & Chief Medical Officer Meredith Kaya - Senior Vice President, Investor Relations & Strategic Finance Timothy Sullivan - Chief Financial Officer Conference Call Participants Tazeen Ahmad - BAML Jon Miller - Evercore Anupam Rama - JPMorgan Philip Nadeau - Cowen Steven Seedhouse - Raymond James Chris Howerton - Jefferies Colleen Kusy - Baird Justin Kim - Oppenheimer Yigal Nochomovitz - Citi Ellie Merle - UBS Annabel Samimy - Stifel Douglas Tsao - H.C. Wainwright Operator Hello, and thank you for standing by.

Apellis Pharmaceuticals, Inc. (APLS) Q3 2022 Earnings Call Transcript

IVERIC bio Inc

Apellis reported an unexpected delay for its eye-disease treatment, leading APLS stock to crash as shares of rival Iveric Bio inched higher. The post Apellis Pharma Crashes On Unexpected Delay For Eye Drug — A Boon For Iveric Bio appeared first on Investor's Business Daily.

Apellis Pharma Crashes On Unexpected Delay For Eye Drug — A Boon For Iveric Bio

WALTHAM, Mass., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today provided an update on its New Drug Application (NDA) for intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

News for Apellis Pharma Stock (APLS)