Obagi Medical Announces the Launch of Latest Innovations in The SUZANOBAGIMD® Collection
Developed by Dr. Suzan Obagi, a distinguished dermatologist and the Chief Medical Director at Obagi, the powerhouse duo of skincare solutions reflects her extensive research and expertise in dermatologic surgery and skin health. Her expertise in formulation is drawn from her extensive experience treating thousands of patients each year, addressing a wide range of concerns. The most common issues she observes are hyperpigmentation and challenges with sensitive skin. Dr. Obagi's groundbreaking work, especially in understanding the unique needs of skin of color and the needs of sensitive skin types, led her to identify the five key pathways essential for optimal skin health. These pathways include reducing pigment formation and visibly improving hyperpigmentation, calming redness and reducing skin irritation, combating oxidative stress, supporting cell turnover, and restoring the skin barrier. Dr. Obagi has created effective products that do not irritate the skin while delivering results you can see in as little as a few weeks in some cases.
Dr. Suzan Obagi, Chief Medical Director at Obagi, commented, 'I am so excited to finally share these groundbreaking innovations with the world. These products are the culmination of years of research and patient testing, driven by my passion for helping patients unveil their naturally radiant skin without irritation. By incorporating cutting-edge ingredients like encapsulated silymarin to protect against oxidative stress and multi-weight hyaluronic acids for multi-layered hydration, we've developed solutions that truly push the envelope in skincare. I genuinely believe these novel formulations not only set a new standard but also reflect my unwavering commitment to treating skin holistically, ensuring health, resilience, and a luminous glow for every skin type.'
Drawing on this wealth of expertise in treating skin discoloration, Dr. Obagi formulated these latest additions to her namesake collection to transform skin health and deliver a radiant, brighter complexion. The collection includes the new Super Antioxidant Serum, providing medical-grade defense against oxidative stress for more resilient, radiant and youthful-looking skin. Super Antioxidant Serum is formulated with a potent blend of antioxidants, including encapsulated Silymarin and stabilized Vitamin C, to neutralize free radicals, combat oxidative stress, and brighten skin.
Moisture Restore Hydration Replenishing Cream is a medical-grade, multi-layered moisturizer which delivers intense, multi-layered hydration. With a blend of both low and high-molecular-weight Hyaluronic Acids this cream delivers moisture to different layers of the skin.
Delivering both immediate and long-lasting results, these products were clinically tested by Dr. Obagi and third party clinical graders. During testing of Super Antioxidant Serum and Moisture Restore Hydration Replenishing Cream, 94% of subjects felt their skin was refreshed and smoother immediately after a single application* and 97% of subjects observed an improvement in overall skin appearance after 2 weeks* including:
Visible improvement in the appearance of fine lines
Visible improvement in the appearance of hyperpigmentation
Visibly calms irritation and boosts hydration
Justin Giouzepis, Chief Marketing Officer of Obagi, added, 'We're thrilled to partner with Dr. Suzan Obagi on bringing to market Super Antioxidant Serum and Moisture Restore, products designed to address the critical needs of both skin brightening and hydration. Obagi is the leader in innovating products that defend against environmental aggressors with our vitamin C collection and products that treat hyperpigmentation with the Obagi Nu-Derm® collection. Having Super Antioxidant Serum in the Obagi portfolio provides professionals with an additional oxidative stress fighting product to recommend to their patients who may have sensitive skin but don't want to compromise on results. We know achieving radiant, healthy skin shouldn't come at the cost of irritation, which is why we've prioritized gentle yet effective formulations suitable for even the most sensitive skin types. These launches represent our commitment to providing inclusive skincare solutions for everyone."
The SUZANOBAGIMD® Super Antioxidant Serum, priced at $158, and the SUZANOBAGIMD® Moisture Restore Hydration Replenishing Cream, priced at $78, are now available through partnering professional channels. They will be available for customers to purchase on Obagi.com on 2.24.2025.
*Results are based on a 2024 2-week clinical test, with subjects using SOMD Super Antioxidant Serum & Moisture Restore Replenishing Cream (if needed) daily within protocol.
About Obagi MedicalObagi Medical is an industry-leading, advanced skincare line rooted in research and skin biology, refined with a legacy of 35 years' experience. First known as leaders in the treatment of hyperpigmentation with the Obagi Nu-Derm® System, Obagi products are designed to diminish the appearance of premature aging, photodamage, skin discoloration, acne, and sun damage. Backed by science and trusted by professionals, Obagi empowers individuals to achieve healthy, beautiful skin.
More information about Obagi is available on the brand's website, https://www.obagi.com.
About WaldencastFounded by Michel Brousset and Hind Sebti, Waldencast's ambition is to build a global best-in-class beauty and wellness operating platform by developing, acquiring, accelerating, and scaling conscious, high-growth purpose-driven brands. Waldencast's vision is fundamentally underpinned by its brand-led business model that ensures proximity to its customers, business agility, and market responsiveness, while maintaining each brand's distinct DNA. The first step in realizing its vision was the business combination with Obagi Cosmeceuticals and Milk Makeup. As part of the Waldencast platform, its brands will benefit from the operational scale of a multi-brand platform; the expertise in managing global beauty brands at scale; a balanced portfolio to mitigate category fluctuations; asset-light efficiency; and the market responsiveness and speed of entrepreneurial indie brands. For more information please visit: https://ir.waldencast.com/.
Media Contact:obagi@purplepr.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2e3ff584-7c90-4039-9b0e-ab93ef0fcf5aSign in to access your portfolio
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Upturn
2 hours ago
- Business Upturn
Regional Health Properties, Inc. Outlines Reasons for Regional Shareholders to Vote YES for Proposed Merger with SunLink Health Systems, Inc.
By GlobeNewswire Published on July 29, 2025, 03:42 IST ATLANTA, GA, July 28, 2025 (GLOBE NEWSWIRE) — Regional Health Properties, Inc. ('Regional') (OTCBQ: RHEP) (OTCQB: RHEPA) (OTCQB: RHEPB), a self-managed healthcare real estate investment company that invests primarily in real estate purposed for senior living and long-term care, today issues the following statement to its common stock shareholders. Shareholders recently may have received or seen communication from two of Regional's shareholders, Ken Grossman and Charlie Frischer, opposing the pending merger (the 'merger') of Regional and SunLink Health Systems, Inc. ('SunLink'). Please do not be confused by these shareholders. Regional does not believe that Messrs. Grossman and Frischer have the Regional common shareholders' best interests in mind. Mr. Grossman is the owner of approximately 6% of Regional's Series B preferred stock, but owns only approximately 1% of Regional's common stock. Lisewise, Mr. Frischer owns approximately 21% of the Regional's Series B preferred stock, but owns only approximately 7% of Regional's common stock. Mr. Morrison's communications with Messrs. Grossman and Frischer over the years have been primarily related to their Series B preferred stock. Regional's belief is that their interest is in advancing the interests of the Series B preferred shareholders, not those of the common shareholders. Specifically, please be aware that: 1. The purported 'two detailed written offers' are not entirely as described by both gentlemen. There were many conditions and uncertainties to those 'offers' with no certainty of satisfaction or accomplishment – one actually has been superseded by an offer for fewer shares – whereas the merger is well documented and agreed. Mr. Morrison's personal belief is that they may be working in concert to push to liquidate Regional Health, in which event the Series B preferred shareholders would receive much, if not all, of the proceeds. Regional encourages you to read Regional's Form 8-K filing with the SEC on July 18, 2025, July 24, 2025 and July 28, 2025 for additional disclosures as well as the tender offer that was filed on July 18, 2025. The tender offer is only for a control position – but not all or even a majority of the Regional common shares. 2. It is not at all clear to Regional how Mr. Grossman derives the $4.00 share value as mentioned in his letter. As noted, Mr. Morrison believes his intent is likely to proceed with the liquidation with the proceeds flowing first to the Series B preferred shareholders and then the Series A preferred shareholders, until they are fully redeemed. Mr. Morrison believes there would be little, if any, proceeds left for your common shares. 3. Both Regional's and SunLink's common shares have traded higher since the merger announcement on January 6, 2025. Regional is approximately 120% higher, and Sunlink is approximately 30% higher. Regional believes the SunLink merger is positive for ALL shareholders because: 1. The merger brings capital to the combined company (approximately $6,000,000). This will improve Regional's balance sheet, and, Regional believes, substantially aid operations. This is intended to, among other things, give the combined company greater access to capital for the benefit of all shareholders as well as Regional's patients, dedicated employees and its portfolio of facilities. 2. The merger brings additional, experienced management to the combined company. 3. The merger brings a solid level of industry and public-company Board expertise to the combined company, expertise which Regional believes is much greater than usual for companies the size of the combined company. 4. The merger has the potential to improve shareholder value for both the common and preferred holders, whereas a liquidation would primarily benefit the preferred holders. 5. The merger provides a path to produce internally generated free cash flow which can be used to redeem the Series B preferred over time. 6. The merger allows for an improved trading market and the potential to re-list your common shares on a national market, which an 'orderly liquidation' may not. Time is very critical. Please vote your shares FOR the merger today. About Regional Health Properties Regional Health Properties, Inc., a Georgia corporation, is a self-managed healthcare real estate investment company that invests primarily in real estate purposed for senior living and long-term care. For more information, visit NO OFFER OR SOLICITATION Communications in this press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any proxy vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended (the 'Securities Act'). ADDITIONAL INFORMATION The proposed merger will be submitted to both the Regional and SunLink shareholders for their consideration. In connection with the proposed merger, Regional filed a Registration Statement on Form S-4 (File No. 333-286975) (the 'Registration Statement') with SEC that includes a joint proxy statement/prospectus for Regional and SunLink, which was sent to common stock shareholders of Regional and common stock shareholders of SunLink on or about June 30, 2025. INVESTORS ARE URGED TO READ THE REGISTRATION STATEMENT AND THE CORRESPONDING JOINT PROXY STATEMENT/PROSPECTUS REGARDING THE PROPOSED MERGER, AS WELL AS ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, TOGETHER WITH ALL AMENDMENTS AND SUPPLEMENTS TO THOSE DOCUMENTS, AS THEY WILL CONTAIN IMPORTANT INFORMATION. IN ADDITION, INVESTORS ARE URGED TO READ THE TENDER OFFER STATEMENT ON SCHEDULE TO FILED WITH THE SEC ON JULY 18, 2025 REGARDING A PROPOSED TENDER OFFER, AS WELL AS ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, TOGETHER WITH ALL AMENDMENTS AND SUPPLEMENTS TO THOSE DOCUMENTS, AS THEY WILL CONTAIN IMPORTANT INFORMATION. You are able to obtain a copy of the joint proxy statement/prospectus, as well as other filings containing information about Regional and SunLink, without charge, at the SEC's website ( or by accessing Regional's website ( under the tab 'Investor Relations' or by accessing SunLink's website ( under the tab 'Investors.' Copies of the joint proxy statement/prospectus can also be obtained, without charge, by directing a request to Investor Relations, Regional Health Properties, Inc., 1050 Crown Pointe Parkway, Suite 720, Atlanta, Georgia, 30338, telephone 678-869-5116 or to Investor Relations, SunLink Health Systems, Inc., 900 Circle 75 Parkway, Suite 690, Atlanta, Georgia, 30339, telephone 770-933-7004. Regional and SunLink and certain of their directors and executive officers may be deemed to be participants in the solicitation of proxies from the shareholders of Regional and SunLink in connection with the proposed merger. Information about the directors and executive officers of Regional is set forth in the proxy statement for Regional's Annual Report on Form 10-K for the year ended December 31, 2024 (the 'Regional Annual Report'), as filed with the SEC on March 31, 2025, which information may be updated by Regional from time to time in subsequent filings with the SEC. Information about the directors and executive officers of SunLink is set forth in the proxy statement for SunLink's Amendment No. 1 to Annual Report on Form 10-K/, as filed with the SEC on October 25, 2024, which information may be updated by SunLink from time to time in subsequent filings with the SEC. Additional information about the interests of those participants and other persons who may be deemed participants in the transaction may also be obtained by reading the joint proxy statement/prospectus relating to the proposed merger when it becomes available. Free copies of this document may be obtained as described above. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements can often, but not always, be identified by the use of words like 'believe', 'continue', 'pattern', 'estimate', 'project', 'intend', 'anticipate', 'expect' and similar expressions or future or conditional verbs such as 'will', 'would', 'should', 'could', 'might', 'can', 'may', or similar expressions. These forward-looking statements include, but are not limited to, statements with respect to the impact of the proposed merger and expectations with respect to Mr. Grossman's and Mr. Frischer's plans. These forward-looking statements are subject to significant risks, assumptions and uncertainties that may cause results to differ materially from those set forth in forward-looking statements, including, among other things: the risk that the businesses of Regional and SunLink will not be integrated successfully or such integration may be more difficult, time-consuming or costly than expected; expected revenue synergies and cost savings from the merger may not be fully realized or realized within the expected time frame; revenues following the merger may be lower than expected; customer, vendor and employee relationships and business operations may be disrupted by the merger; the ability to obtain required regulatory approvals or the approvals of Regional's or SunLink's shareholders, and the ability to complete the merger on the expected timeframe; the costs and effects of litigation and the possible unexpected or adverse outcomes of such litigation; the ability of Regional and SunLink to meet the initial or continued listing requirements or rules of the NYSE American LLC or the OTCQB, as applicable, and to maintain the listing or trading, as applicable, of securities thereon; possible changes in economic and business conditions; the impacts of epidemics, pandemics or other infectious disease outbreaks; the existence or exacerbation of general geopolitical instability and uncertainty; possible changes in monetary and fiscal policies, and laws and regulations; competitive factors in the healthcare industry; Regional's dependence on the operating success of its operators; the amount of, and Regional's ability to service, its indebtedness; covenants in Regional's debt agreements that may restrict its ability to make investments, incur additional indebtedness and refinance indebtedness on favorable terms; the effect of increasing healthcare regulation and enforcement on Regional's operators and the dependence of Regional's operators on reimbursement from governmental and other third-party payors; the relatively illiquid nature of real estate investments; the impact of litigation and rising insurance costs on the business of Regional's operators; the effect of Regional's operators declaring bankruptcy, becoming insolvent or failing to pay rent as due; the ability of any of Regional's operators in bankruptcy to reject unexpired lease obligations and to impede its ability to collect unpaid rent or interest during the pendency of a bankruptcy proceeding and retain security deposits for the debtor's obligations; Regional's ability to find replacement operators and the impact of unforeseen costs in acquiring new properties; and other risks and factors identified in (i) Regional's cautionary language included under the headings 'Statement Regarding Forward-Looking Statements' and 'Risk Factors' in the Regional Annual Report, and other documents subsequently filed by Regional with the SEC and (ii) SunLink's cautionary language included under the headings 'Forward-Looking Statements' and 'Risk Factors' in SunLink's Annual Report on Form 10-K for the year ended June 30, 2024, and other documents subsequently filed by SunLink with the SEC. Neither Regional nor SunLink undertake any obligation to update any forward-looking statement, whether written or oral, relating to the matters discussed in this press release. In addition, Regional's and SunLink's past results of operations do not necessarily indicate either of their anticipated future results, whether the merger is effectuated or not. Regional Contact Brent Morrison, CFAChief Executive Officer & PresidentRegional Health Properties, (404) 823-2359 [email protected] Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
Business Upturn
2 hours ago
- Business Upturn
North Park Nursing Student Receives Prestigious Schweitzer Fellowship
Chicago, July 28, 2025 (GLOBE NEWSWIRE) — Victoria Roehl, a student in the Master of Nursing Leadership program at North Park University (NPU), has been named a 2025–26 Schweitzer Fellow, a prestigious honor given to graduate students to lead innovative, service-driven projects that address health inequities in Chicago's underserved communities. Named in honor of Nobel laureate Dr. Albert Schweitzer, the yearlong program uses an interdisciplinary approach to address unmet health needs in Chicago's underserved neighborhoods. Roehl's project will focus on improving quality of life for cancer survivors through mindfulness-based self-care planning. In partnership with the University of Illinois Chicago Cancer Center, she will lead educational classes and provide participants with digital tools to set meaningful, personalized goals as they navigate survivorship. She plans to graduate from NPU in 2026. 'I chose to focus on a project that would strengthen cancer survivors' sense of well-being to help create personalized roadmaps for self-care in conjunction with mindfulness,' Roehl said, adding that lifelong emotional stress is part of any cancer diagnosis. 'The consequence of psychological stress negatively impacts survivorship, and this is magnified in communities with high socioeconomic deficits.' 'North Park University's mission is to prepare students for lives of significance and service,' said Mary Shehan, NPU's graduate nursing programs director. 'The Schweitzer Fellowship is an exceptional opportunity for Victoria to utilize the city of Chicago as a platform for learning and service.' Shannon Sweetnam, spokeswoman for the Schweitzer Program, said Roehl was selected from a competitive pool of 100 applicants with backgrounds including art therapy and public health. For 29 years, the Chicago Area Schweitzer Fellows Program has provided a platform for graduate students in health-related fields. The program has provided more than 130,000 hours of community service to more than 150 Chicagoland community service organizations. North Park University is city-centered, intercultural, and emerging as the model for Christian higher education in 21st-century America. Follow us on Instagram, Facebook, and LinkedIn. Ellen Almer, (773) 244-5747, [email protected] Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
Business Upturn
2 hours ago
- Business Upturn
FDA Approves Apellis' EMPAVELI® (pegcetacoplan) as the First C3G and Primary IC-MPGN Treatment for Patients 12 and Older
Proven efficacy across all three key markers of disease—68% reduction in proteinuria, stabilization of kidney function, and substantial clearance of C3 deposits Broad label includes adults and adolescents with C3G or primary IC-MPGN, and post-transplant C3G disease recurrence Well-established safety profile, consistent across >2,200 patient years in approved indications C3G and primary IC-MPGN are rare kidney diseases with high risk of kidney failure Conference call tomorrow at 8:00 a.m. ET WALTHAM, Mass., July 28, 2025 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the U.S. Food and Drug Administration (FDA) has approved EMPAVELI® (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older, to reduce proteinuria. C3G and primary IC-MPGN are rare kidney diseases, affecting 5,000 people in the United States.1 'I'm excited to now have a highly effective therapy for a broad range of patients living with C3G and primary IC-MPGN,' said Carla Nester, M.D., MSA, FASN, lead principal investigator for the VALIANT study, professor of internal medicine and pediatrics and director of pediatric nephrology, University of Iowa Stead Family Children's Hospital. 'With standard of care, patients living with these rare and severe diseases frequently progress to kidney failure, necessitating lifelong dialysis and/or a kidney transplant. Given the urgent need, particularly in children, the approval of EMPAVELI marks a pivotal moment in the treatment of rare kidney diseases.' In the Phase 3 VALIANT study, EMPAVELI demonstrated an unprecedented 68% reduction in proteinuria, stabilization of kidney function, and substantial clearance of C3 deposits as measured by C3 staining, compared to placebo. The positive results were consistent across adolescent and adult patients with C3G and primary IC-MPGN, and in C3G patients with post-transplant disease recurrence. 'EMPAVELI has the potential to be truly transformational for patients with C3G and primary IC-MPGN, who until now have had very few treatment options. In the largest pivotal study of these diseases, EMPAVELI demonstrated its potential to preserve kidney function by controlling all three key markers of disease,' said Cedric Francois, M.D., Ph.D., co-founder and chief executive officer, Apellis. 'As Apellis' third approval in four years, this milestone underscores the unique ability of targeting C3 to improve patients' lives. We are deeply grateful to everyone who made this approval possible and look forward to building on this momentum as we advance pivotal studies of EMPAVELI in other rare kidney diseases.' 'The approval of EMPAVELI is a historic milestone for people living with C3G and primary IC-MPGN, many of whom are adolescents or young adults,' said Josh Tarnoff, chief executive officer, NephCure. 'We recognize Apellis' commitment to these patients and their families, and to the research and innovation that will bring this life-changing treatment into the hands of patients that need it most.' The approval of EMPAVELI is based on positive six-month results from the VALIANT study, demonstrating benefits across all three key markers of disease: Proteinuria reduction: The study met its primary endpoint, demonstrating a statistically significant 68% (p<0.0001) proteinuria reduction in EMPAVELI-treated patients compared to placebo. The study met its primary endpoint, demonstrating a statistically significant 68% (p<0.0001) proteinuria reduction in EMPAVELI-treated patients compared to placebo. Stabilization of kidney function: EMPAVELI-treated patients achieved stabilization of kidney function compared to placebo (nominal p=0.03) as measured by estimated glomerular filtration rate (eGFR). EMPAVELI-treated patients achieved stabilization of kidney function compared to placebo (nominal p=0.03) as measured by estimated glomerular filtration rate (eGFR). Reduction of C3 staining: A majority of EMPAVELI-treated patients achieved a reduction in C3 staining intensity (nominal p<0.0001) compared to placebo. 71% of EMPAVELI-treated patients achieved zero C3 staining intensity, demonstrating complete clearance of C3 deposits. The safety profile of EMPAVELI is well-established, with >2,200 patient years across all approved indications. The most common adverse reactions in the VALIANT study (≥10%) were infusion site reactions, pyrexia, nasopharyngitis, influenza, cough, and nausea. Apellis is committed to helping patients with treatment access and support. ApellisAssist® is a program designed to help EMPAVELI patients along their treatment journey by providing a comprehensive system of support including help navigating insurance coverage, financial assistance for eligible patients, disease education, and ongoing product support. Patients and healthcare providers can call 1-888-273-5547 for more information. Conference Call and Webcast Apellis will host a conference call and webcast to discuss the FDA's approval of EMPAVELI tomorrow, July 29, 2025 at 8:00 a.m. ET. To access the live call by phone, please pre-register for the call here. A live audio webcast of the event and accompanying slides may also be accessed through the 'Events and Presentations' page of the 'Investors and Media' section of the company's website. A replay of the webcast will be available for 30 days following the event. About C3 Glomerulopathy (C3G) and Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) C3G and primary IC-MPGN are rare and debilitating kidney diseases that can lead to kidney failure. Excessive C3 deposits are a key marker of disease activity, which can lead to kidney inflammation, damage, and failure. Approximately 50% of people living with C3G and primary IC-MPGN suffer from kidney failure within five to 10 years of diagnosis, requiring a burdensome kidney transplant or lifelong dialysis therapy.2-4 Additionally, approximately 90% of patients who previously received a kidney transplant will experience disease recurrence.5 The diseases are estimated to affect 5,000 people in the United States and up to 8,000 in Europe.1 About the VALIANT Study The VALIANT Phase 3 study (NCT05067127) was a randomized, placebo-controlled, double-blinded, multi-center study that evaluated EMPAVELI® (pegcetacoplan) efficacy and safety in 124 patients who were 12 years of age and older with C3G or primary IC-MPGN. It is the largest single trial conducted in these populations and the only study to include pediatric and adult patients, with native and post-transplant kidneys. Study participants were randomized to receive EMPAVELI or placebo twice weekly for 26 weeks. Following this 26-week randomized controlled period, patients were able to proceed to a 26-week open-label phase in which all patients received EMPAVELI. The primary endpoint of the study was the log transformed ratio of urine protein-to-creatinine ratio (UPCR) at Week 26 compared to baseline. About EMPAVELI ® /Aspaveli ® (pegcetacoplan) EMPAVELI®/Aspaveli® (pegcetacoplan) is a targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body's immune system, which can lead to the onset and progression of many serious diseases. It is approved for the treatment of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in the United States and paroxysmal nocturnal hemoglobinuria (PNH) in the United States, European Union, and other countries globally. The therapy is also under investigation for other rare diseases. U.S. Important Safety Information for EMPAVELI BOXED WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA EMPAVELI, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae , Neisseria meningitidis , and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, unless the risks of delaying therapy with EMPAVELI outweigh the risks of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor. Patients receiving EMPAVELI are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected. Because of the risk of serious infections caused by encapsulated bacteria, EMPAVELI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the EMPAVELI REMS. CONTRAINDICATIONS Hypersensitivity to pegcetacoplan or to any of the excipients For initiation in patients with unresolved serious infection caused by encapsulated bacteria including Streptococcus pneumoniae , Neisseria meningitidis , and Haemophilus influenzae type B WARNINGS AND PRECAUTIONS Serious Infections Caused by Encapsulated Bacteria EMPAVELI, a complement inhibitor, increases a patient's susceptibility to serious, life-threatening, or fatal infections caused by encapsulated bacteria including Streptococcus pneumoniae , Neisseria meningitidis (caused by any serogroup, including non-groupable strains), and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initiation of EMPAVELI treatment is contraindicated in patients with unresolved serious infection caused by encapsulated bacteria. Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of EMPAVELI, according to the most current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with EMPAVELI. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent EMPAVELI therapy is indicated in a patient who is not up to date with vaccines against encapsulated bacteria according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible. The benefits and risks of treatment with EMPAVELI, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by encapsulated bacteria. Vaccination does not eliminate the risk of serious encapsulated bacterial infections, despite development of antibodies following vaccination. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. Promptly treat known infections. Serious infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of EMPAVELI in patients who are undergoing treatment for serious infections. EMPAVELI is available only through a restricted program under a REMS. EMPAVELI REMS EMPAVELI is available only through a restricted program under a REMS called EMPAVELI REMS, because of the risk of serious infections caused by encapsulated bacteria. Notable requirements of the EMPAVELI REMS include the following: Under the EMPAVELI REMS, prescribers must enroll in the program. Prescribers must counsel patients about the risks, signs, and symptoms of serious infections caused by encapsulated bacteria, provide patients with the REMS educational materials, ensure patients are vaccinated against encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, prescribe antibacterial drug prophylaxis if patients' vaccine status is not up to date and treatment must be started urgently, and provide instructions to always carry the Patient Safety Card both during treatment, as well as for 2 months following last dose of EMPAVELI. Pharmacies that dispense EMPAVELI must be certified in the EMPAVELI REMS and must verify prescribers are certified. Further information is available at or 1-888-343-7073. Infusion-Related Reactions Systemic hypersensitivity reactions (eg, facial swelling, rash, urticaria, pyrexia) have occurred in patients treated with EMPAVELI, which may resolve after treatment with antihistamines. Cases of anaphylaxis leading to treatment discontinuation have been reported. If a severe hypersensitivity reaction (including anaphylaxis) occurs, discontinue EMPAVELI infusion immediately, institute appropriate treatment, per standard of care, and monitor until signs and symptoms are resolved. Interference with Laboratory Tests There may be interference between silica reagents in coagulation panels and EMPAVELI that results in artificially prolonged activated partial thromboplastin time (aPTT); therefore, avoid the use of silica reagents in coagulation panels. ADVERSE REACTIONS Most common adverse reactions in adult and pediatric patients 12 years of age and older with C3G or primary IC-MPGN (incidence ≥10%) were infusion-site reactions, pyrexia, nasopharyngitis, influenza, cough, and nausea. USE IN SPECIFIC POPULATIONS Females of Reproductive Potential EMPAVELI may cause embryo-fetal harm when administered to pregnant women. Pregnancy testing is recommended for females of reproductive potential prior to treatment with EMPAVELI. Advise female patients of reproductive potential to use effective contraception during treatment with EMPAVELI and for 40 days after the last dose. Please see full Prescribing Information, including Boxed WARNING regarding serious infections caused by encapsulated bacteria, and Medication Guide. About Apellis Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company leading the way in complement science to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two C3-targeting medicines approved to treat four serious diseases. Breakthroughs for patients include the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients 12 and older with C3G or primary IC-MPGN, two severe, rare kidney diseases. We believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit or follow us on LinkedIn and X. Apellis Forward-Looking Statement Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute 'forward-looking statements' within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the potential market opportunity of EMPAVELI for C3G and IC-MPGN. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether the clinical trial results of EMPAVELI for C3G and IC-MPGN indicate an effect that is greater than the actual positive effect; and any other factors discussed in the 'Risk Factors' section of Apellis' Annual Report on Form 10-K with the Securities and Exchange Commission on February 28, 2025 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Media:Tracy Vineis [email protected] 617.420.4839
