Welcome to our dedicated page for Apellis Pharmace news (Ticker: APLS), a resource for investors and traders seeking the latest updates and insights on Apellis Pharmace stock.
Apellis Pharmaceuticals (APLS) operates in the biotechnology sector, where news typically centers on clinical trial results, regulatory decisions, product approvals, and commercial performance updates. As a company focused on complement immunotherapy for ophthalmology and hematology indications, developments in these areas drive significant investor attention.
Clinical trial data represents a major news category for Apellis. Biotechnology companies regularly report results from Phase 2 and Phase 3 trials evaluating safety and efficacy in various patient populations. For complement-targeted therapies, trial outcomes include measurements of disease progression, biomarker changes, and adverse event profiles. Positive data can support regulatory filings and label expansions, while unexpected safety signals or efficacy failures can substantially impact development programs.
Regulatory announcements constitute another critical news stream. FDA decisions on new drug applications, supplemental applications for additional indications, and priority review designations directly affect commercial opportunities. The agency may also issue complete response letters requiring additional data or post-marketing study commitments. International regulatory decisions from the EMA and other agencies similarly influence market access in specific territories.
Commercial performance updates provide insight into product adoption and revenue trajectory. Quarterly earnings reports disclose sales figures, prescriber trends, and market penetration metrics. For rare disease treatments, commercial success depends on physician awareness, patient identification, reimbursement access, and competitive positioning against alternative therapies. Conference presentations often detail promotional strategies and market development initiatives.
Partnership announcements and licensing agreements represent significant value-creation events. Apellis has established collaborations for international commercialization, where regional partners contribute local market expertise in exchange for milestone payments and royalties. These arrangements extend the company's geographic reach without requiring substantial infrastructure investment in every market.
This news resource provides comprehensive coverage of Apellis developments across clinical, regulatory, and commercial domains. Stay informed about the company's progress in complement-targeted therapies and their impact on patients with serious retinal and hematological diseases.
Apellis Pharmaceuticals (APLS) presented Phase 3 study results for pegcetacoplan, a targeted C3 therapy, at the Retina Society Annual Scientific Meeting. The OAKS trial showed significant reduction in geographic atrophy (GA) lesion growth with monthly (p=0.0003) and every-other-month (p=0.0052) treatments. The DERBY trial showed a reduction in lesion growth but narrowly missed the primary endpoint. Pegcetacoplan could become the first treatment for GA, which affects over five million globally. An NDA is planned for submission in H1 2022.
Apellis Pharmaceuticals (Nasdaq: APLS) announced its participation in the 2021 Cantor Virtual Global Healthcare Conference, scheduled for September 27, 2021, at 8:40 a.m. ET. The conference will be conducted virtually and accessible via a live webcast on the company’s website. A replay will be available for 90 days post-event. Apellis, a leader in targeted C3 therapies, focuses on transformative solutions for diseases caused by complement cascade activation.
Apellis Pharmaceuticals, Inc. (APLS) announced positive results from the Phase 3 DERBY and OAKS studies evaluating intravitreal pegcetacoplan for geographic atrophy (GA) due to age-related macular degeneration (AMD). In the OAKS study, pegcetacoplan achieved its primary endpoint, reducing GA lesion growth by 22% (p=0.0003) monthly and 16% (p=0.0052) every-other-month. Conversely, DERBY did not meet its primary endpoint, exhibiting lesser reductions. Overall, pegcetacoplan demonstrated a 26% reduction in lesion growth among patients with extrafoveal lesions. Aiming for FDA approval, Apellis plans to submit a New Drug Application in early 2022.
Apellis Pharmaceuticals (Nasdaq: APLS) announced the grant of equity awards to a new employee effective September 1, 2021, as part of their 2021 Inducement Stock Incentive Plan. The awarded equity includes options to purchase 1,000 shares at an exercise price of $64.73, the closing price on the grant date, and 500 restricted stock units (RSUs). The options will vest over four years, while the RSUs will vest annually over four years, contingent on continued employment. This move aims to incentivize talent acquisition in line with Nasdaq Listing Rule 5635(c)(4).
On September 3, 2021, Apellis Pharmaceuticals (Nasdaq: APLS) announced the approval of equity awards for Jim Chopas, its newly appointed VP, Corporate Controller / Chief Accounting Officer. The award includes options to purchase 21,750 shares at an exercise price of $65.41, equal to the stock's closing price on the grant date. Additionally, 7,600 restricted stock units (RSUs) were granted. The vesting schedule for both options and RSUs is contingent on Chopas' continued employment with the company. This appointment aligns with Nasdaq Listing Rule 5635(c)(4).
Apellis Pharmaceuticals (APLS) received FDA approval for EMPAVELI™, the first targeted C3 therapy for adults with paroxysmal nocturnal hemoglobinuria (PNH), and initiated a U.S. commercial launch. The company reported $0.6 million in net product revenue for Q2 2021, marking its first sales since EMPAVELI's approval. Additionally, positive results were announced from the Phase 3 PRINCE study, indicating statistical superiority in key endpoints. Apellis continues to expand its pipeline and has entered into a collaboration with Beam Therapeutics for new therapies.
Apellis Pharmaceuticals (Nasdaq: APLS) announced on August 6, 2021, that it approved equity awards for three new employees. The awards consist of options to purchase 75,100 shares and 5,050 restricted stock units (RSUs), granted under the 2021 Inducement Stock Incentive Plan. The options have an exercise price of $63.25, equal to the stock's closing price on the grant date. The vesting schedule includes a one-year cliff and monthly vesting thereafter for options, while RSUs vest 25% annually. This move aims to attract talent to support growth and innovation.
Apellis Pharmaceuticals (Nasdaq: APLS) plans to host a conference call and webcast on August 9, 2021, at 4:30 p.m. ET to discuss its second quarter 2021 financial results. Participants can join via phone or through the company’s website. A 90-day replay of the webcast will be accessible post-event. Apellis focuses on targeted C3 therapies and aims to develop transformative treatments for diseases driven by excessive complement activation. More information is available at www.apellis.com.
Apellis Pharmaceuticals (Nasdaq: APLS) has successfully closed privately negotiated exchange transactions for its 3.500% Convertible Senior Notes due 2026. Approximately $201.1 million of these notes were exchanged, resulting in the issuance of 5,992,217 shares of common stock. The shares are unregistered under current securities laws and cannot be sold in the U.S. without proper registration or exemption. This strategic move aims to strengthen the company's financial position and support its ongoing commitment to developing targeted C3 therapies for various debilitating diseases.
Apellis Pharmaceuticals (Nasdaq:APLS) announced it has engaged in privately negotiated exchange agreements with holders of its 3.500% Convertible Senior Notes due 2026. The holders have agreed to exchange approximately $198.6 million of the Notes for 4,530,431 shares of common stock, equating to 22.8065 shares per $1,000 of Notes. An additional number of shares will be issued based on the average stock price over a specified period. The exchange transactions are expected to close by July 23, 2021, pending customary closing conditions.
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