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FDA recalls over 67,000 cases of Power Stick deodorant due to manufacturing violations

FDA recalls over 67,000 cases of Power Stick deodorant due to manufacturing violations

Yahoo21-07-2025
Don't stop wearing deodorant, but it might be best to consider a new antiperspirant after a recent recall on Power Stick deodorants.
On July 10, Pennsylvania-based health and beauty manufacturer A.P. Deauville announced a recall of 67,214 cases of its Power Stick roll-on deodorant due to violations of Current Good Manufacturing Practice (CGMP) standards, a set of FDA-enforced guidelines designed to ensure product safety and quality.
The recall notice does not detail any consumer remedies or identify the specific regulatory violations involved.
Here's what to know about the recalled deodorant.
What deodorant products are being recalled?
Where were the recalled products sold?
According to the recall notice, the Power Stick deodorants were sold nationwide. The deodorants are available for purchase from major retailers such as Walmart and Amazon.
What to do with the recalled Power Stick deodorant?
The FDA recommends discarding recalled products or returning them to the retailer where the products were purchased, an FDA spokesperson told USA TODAY.
-USA TODAY Network Greta Cross contributed to this report.
This article originally appeared on Austin American-Statesman: FDA recalls Power Stick deodorant due to manufacturing violations
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Sarepta will resume gene therapy shipments after FDA review of recent patient death

time2 hours ago

Sarepta will resume gene therapy shipments after FDA review of recent patient death

WASHINGTON -- Shares of beleaguered drugmaker Sarepta Therapeutics jumped in afterhours trading Monday after the company said it would resume shipping its gene therapy for some patients, following a brief pause requested by regulators. The Food and Drug Administration said it recommended lifting the hold for young patients with Duchenne's muscular dystrophy who are still able to walk. Regulators had requested the pause after the deaths of two older teenagers who were taking the therapy. The FDA also said in a statement it determined that a recently reported death of an 8-year-old boy was unrelated to the therapy. Company shares surged more than 16% after the announcement to $13.86 in afterhours trading. The jump is the latest in a series of drastic stock movements triggered by changing fortunes for the company's best-selling product. Elevidys is the first gene therapy approved in the U.S. for Duchenne's muscular dystrophy, the fatal muscle-wasting disease that affects boys and young men, resulting in early death. It received accelerated approval in 2023 for a narrow range of young patients and was expanded last year for use in older patients, including those who can no longer walk. The FDA decision Monday 'significantly improves Elevidys' sales outlook in the near-term,' Jefferies analyst Andrew Tsai told investors, in a note after the announcement. 'The street will feel relieved about the situation, suggesting meaningful stock upside potential.' Sarepta's therapy has been under scrutiny from regulators after two teenage boys died earlier this year from acute liver injury, a known side effect of the treatment. The FDA then requested a pause in shipments of the drug after the death of a third patient taking a different Sarepta therapy. FDA officials have suggested the company will need to provide new study data on safety to resume Elevidys' use in older patients. 'The FDA will continue to work with the sponsor regarding non-ambulatory patients, which remains subject to a voluntary hold, following two deaths,' FDA said in its statement. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

Cancer patients in Haiti face death sentence due to distance, gangs, lack of resources
Cancer patients in Haiti face death sentence due to distance, gangs, lack of resources

Miami Herald

time6 hours ago

  • Miami Herald

Cancer patients in Haiti face death sentence due to distance, gangs, lack of resources

For four years Jean Fritz Dieu fought to stay alive, traveling by motorbike over rugged mountains and through gang-controlled streets to get treatment for an aggressive tumor. When the armed gangs took over the final open road, he used a barge on the bay to reach Haiti's capital. On Saturday, Dieu, known as 'Presnel' to family and friends, lost his years-long battle with cancer. He died in the neighboring Dominican Republic, where he had been receiving radiation treatment with the help of a South Florida-based charity, Flying High 4 Haiti. 'Presnel risked his life just to stay alive,' said Ines Lozano, a Miami resident and founder of Flying High 4 Haiti. 'He clung to hope, attending Mass every Sunday to pray for healing and give thanks to those who supported him. I hope we continue to dream of a future where all cancer patients in Haiti have access to essential treatments like radiotherapy. His legacy lives on through the compassion of all those who donated for his treatment.' While Dieu, 42, didn't survive his fight, his journey is serving as a stark reminder of the roadblocks and immense challenges Haitians with cancer and other chronic illnesses face amid the country's widespread gang violence and crumbling healthcare infrastructure. It's also underscoring the need for access to better care. While radiation therapy remans an important part of cancer treatment, there is not a single machine in Haiti, where the last clinic with a gamma radiation device closed more than 20 years ago. 'You should have one radiation machine for every 2 million inhabitants and you have 12 million people in Haiti and we don't even have one machine,' said Dr. Oriol Jn Baptiste, director of the SESHAD Services de Santé Haitiano-Dominicaine, in Santiago de los Caballeros in the northern Dominican Republic, where Dieu was being treated. 'A public health system in charge of a country cannot afford to not be thinking about the treatments for cancer.' Dieu was 38 and working at a school Flying High 4 Haiti supports in Ille-a-Vache, an island off Haiti's southwestern coast, when he first discovered he had a tumor. In the last few months, Haitians have not only seen the further collapse of their already fragile healthcare system, but for those with cancer, life-saving treatment has become even harder to obtain. In March, gangs attacked the city of Mirebalais, forcing the evacuation of the 35-bed University Hospital of Mirebalais. Haiti's most modern health facility, the hospital offered free cancer care and was featured in the Miami Herald's 2019 series 'Cancer in Haiti.' The series explored how deaths from preventable diseases like cervical cancer were growing due to limited early detection programs and a lack of radiation treatment. The series also explored the lack of public health priority to pediatric cancer cases. The attack on Mirebalais was among several on hospitals that has stopped 40% of health facilities in the capital from operating. Among them is the St. Francis de Sales Hospital, which treated hundreds of cancer patients annually. 'It has been very rough,' said Dr. Joseph Bernard, an oncologist who worked at the Catholic hospital and has since opened his own private cancer clinic, Clinique de Cancer St Francois de Sales, in the capital. Dr. Bernard was Dieu's doctor before he was forced to seek care in the Dominican Republic because the chemotherapy had run its course. Dr. Bernard said since the closure of Mirebalais and St. Francis, demand for care has gone up and many patients are at advanced stages. of the disease. In addition to having to pay for previously free care, patients from Mirebalais face another complication: The cancer specialist hasn't been able to get access to their charts. Then, there is the lack of treatment equipment. 'We still have limitations regarding radiation therapy,' Dr. Bernard said. In the past, patients had the possibility of traveling to the Dominican Republic or Cuba if they had the financial means. However both have become nearly impossible to get to because of medication shortages and a lack of direct flights in the case of Cuba, and border closures with the Dominican Republic. As a result, patients, including children in need of radiation therapy, have had difficulties getting humanitarian visas to seek treatment. 'I've been fighting for two years for a humanitarian visas for Haitians who need treatment; I've written to the Dominican consulate and they never answered me,' said Dr. Baptiste, who added he was working with Nos Petits Frères et Sœurs in Port-au-Prince, which offers the only juvenile cancer program in Haiti, to transfer cases to the Dominican Republic for radiation treatment before the border closed. In 2021, Dieu spent six months undergoing radiotherapy in the Dominican Republic for his cancer. He was doing well until a small tumor was detected behind the right ear, Dr. Bernard said. 'We tried to shrink it with chemo. It did not work. The tumor started to bleed a lot and it became very infected.' 'When cancer reoccurs, it's very aggressive,' said Dr. Bernard, noting that radiotherapy is one of the three main components of cancer care, which also includes surgery as well as chemo. 'In the end, he needed radiation therapy.' During a visit to the Dominican Republic, Lozano, who had arranged for Dieu's prior treatment with the help of Nuestros Pequeños Hermanos, a Catholic children's charity with programs in Latin America and the Caribbean, approached officials about getting a humanitarian visa for Dieu and his wife. It came a few weeks later. With Dieu too weak to make the journey by road, Lozanao arranged for him to fly from Les Cayes to Cap-Haïtien, the country's second largest city in the north. He then traveled to the border, where an ambulance transported him to the clinic in Santiago, three hours away. Radiation treatment is expensive and most of the patients never finish the course, said Baptiste, who noted that the stay in the Dominican Republic also adds up the costs. He determined that Dieu would need at least 33 rounds of radiotherapy over 10 weeks. The cost was $19,000, which Lozano had hoped to absorb with the help of a GoFundme effort that remains open. On Saturday, Dieu collapsed. It's unclear what went wrong, though he arrived for treatment needing six rounds of blood transfusions with his head severely infected. Dr. Bernard said most people don't realize the psychological toll Haiti's present gang crisis poses for cancer patients. 'There are a lot of things we really cannot evaluate, like the impact of stress, for example, on treatment outcomes' he said. 'These are things that are tough to evaluate but we need to consider them seriously.' In the case of Dieu, he faced a perilous journey trying to get to treatment in Haiti before he went to the Dominican Republic. What previously consisted of a boat ride from Ille-a-Vache and then a bus ride into the capital along a main highway suddenly became an arduous journey through gang tolls, shootouts and police blockades. After temporarily moving to Port-au-Prince to get to his treatments he sent a voice message one day, over the sound of gunfire, explaining that he could not get there because the capital had become a war zone. Lozano began to fear that if the cancer didn't kill Dieu the gangs would. She hired a driver to transport him overnight on the back of a motorbike. He made the seven-hour journey every 21 days to get to his chemo treatments. When traveling 5,000 feet high along a mountain range, no longer became an option this year after gangs seized control of the last open road in the hills above the capital in Kenscoff, Dieu, with his head wrapped in bandages, texted to say that he had found another way: via barge through the bay of Port-au-Prince. Dr. Bernard will be expanding his services next month to Les Cayes at the private Caramel Hospital. It will be the first oncology unit in the coastal southwestern city where many cancer patients from the south are diagnosed too late or not at all. 'Too many Haitian women are dying from cancers that are treatable, simply because there is no access to care in the south,' said Skyler Badenoch, who runs Hope for Haiti, a Naples-based nonprofit that provides health care access in southwest Haiti. 'Dr. Bernard's plan to open a cancer treatment facility in this region could be transformational. Together, we can bring early detection, treatment and dignity within reach, and ensure that where someone lives no longer determines whether they live.' Lozano says the expansion of cancer care to the south is good news. 'There are a large number of patients in the south who haven't been able to go chemo or anything, and they're dying,' she said, adding that Bernard's clinic opening will bring a lot of hope. 'In spite of all the problems that exist in Haiti, there's a lot of acts of hope that people don't know.' On Sunday, an ambulance, paid for by Lozano, transported Dieu's body in a casket back across the Haitian-Dominican border so. his four children could say goodbye. 'We had high hopes for a better outcome, but at least he died with dignity and receiving the kind of care every Haitian deserves,' said Lozano. 'That is his legacy. I hope that Presnel's battle serves as an example of the urgent need for radiotherapy in Haiti to save other lives.'

FDA Approves Apellis' EMPAVELI® (pegcetacoplan) as the First C3G and Primary IC-MPGN Treatment for Patients 12 and Older
FDA Approves Apellis' EMPAVELI® (pegcetacoplan) as the First C3G and Primary IC-MPGN Treatment for Patients 12 and Older

Yahoo

time9 hours ago

  • Yahoo

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. ETWALTHAM, 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. 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). 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 WebcastApellis 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 StudyThe 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 , , and 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 , including Boxed WARNING regarding serious infections caused by encapsulated bacteria, and . 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 Vineismedia@ Investors: Neil Carnahan, References1. Data on file using literature consensus. 2. Smith RJH, et al. Nat Rev Nephrol. 2019;15(3):129-143.3. Servais A, et al. Kidney Int. 2012;82(4):454-464.4. Zand L, et al. J Am Soc Nephrol. 2014;25(5):1110-1117.5. Tarragón, B, et al. C3 Glomerulopathy Recurs Early after Kidney Transplantation in Serial Biopsies Performed within the First 2 Years after Transplantation. Clinical Journal of the American Society of Nephrology. August 2024; 19(8)1005-1015. doi: 10.2215/CJN.0000000000000474. A photo accompanying this announcement is available at

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