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Business Wire
17 hours ago
- Business
- Business Wire
Path2College 2024 Newborn Sweepstakes Winner Announced
ATLANTA--(BUSINESS WIRE)-- Georgia's Path2College 529 Plan announced today that a Mableton baby, Sinclair Lewis, has won the 2024 Path2College Newborn Sweepstakes. Born at Northside Hospital in December 2024, Sinclair will receive a $5,529 contribution to his Path2College 529 plan. Since launching in 2011, the Newborn Sweepstakes has awarded nearly $77,000 to 14 Georgia recipients. Georgia's Path2College 529 Plan announced today that a Mableton baby, Sinclair Lewis, has won the 2024 Path2College Newborn Sweepstakes. Born at Northside Hospital in December 2024, Sinclair will receive a $5,529 contribution to his Path2College 529 plan. Share 'Sinclair has been beating odds since the day he was born. He made his entrance into the world 10 weeks early — he was small but mighty at 2.7 lbs. During his time in the Neonatal Intensive Care Unit, he surprised everyone with his strength and determination,' said Sinclair's parents, Travis and Lindsay Lewis. 'That same spirit continues to shine in everything Sinclair does today, whether it's reaching milestones ahead of schedule, or this incredible scholarship opportunity. We are so very proud of him and grateful for this moment. It's an amazing jumpstart to our child's path toward higher education.' 'We offer our congratulations to our 2024 Newborn Sweepstakes winner, Sinclair Lewis, and his family. We are proud to help contribute to his educational journey,' said Georgia State Treasurer Steve McCoy. The Path2College 529 Plan has expanded the 2025 Newborn Sweepstakes from one winner to two to help more parents, grandparents, and guardians prioritize early financial planning for college and K-12 expenses*. 2025 NEWBORN SWEEPSTAKES ENTRY NOW OPEN Sweepstakes #1: Georgia families with babies born between January 1 and June 30, 2025 have until September 30, 2025, to enter. Sweepstakes #2: Georgia families with babies born between July 1 and December 31, 2025 have until March 31, 2026, to enter. Visit for official rules and prize details. No purchase necessary, void where prohibited by law. The Newborn Sweepstakes is sponsored by the Path2College 529 Plan. For more information about the Path2College Plan or to open an account, please visit or call (877) 424-4377. *K-12 withdrawals are limited to $10,000 per year for K-12 tuition. Withdrawals for tuition expenses at a public, private or religious elementary, middle, or high school can be withdrawn free from federal and Georgia income tax. If you are not a Georgia taxpayer, these withdrawals may include recapture of tax deduction, state income tax as well as penalties. You should consult with a qualified professional about how tax provisions affect your circumstances. To learn more about Georgia's Path2College 529 Plan ('Plan'), its investment objectives, risks, charges and expenses see the Plan Description at before investing. Read it carefully. Investments in the Plan are neither insured nor guaranteed and there is the risk of investment loss. TIAA-CREF Individual & Institutional Services, LLC, Member FINRA, distributor and underwriter for the Path2College 529 Plan. 4580372.
Business Wire
20 hours ago
- Health
- Business Wire
Sarepta Therapeutics Provides Statement on ELEVIDYS
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement: Shortly after 2:30 p.m. ET today, Sarepta received an informal request from the U.S. Food and Drug Administration (FDA) to voluntarily halt shipment of ELEVIDYS (delandistrogene moxeparvovec), our gene therapy for Duchenne muscular dystrophy (Duchenne), in the U.S. We first heard of this potential request earlier in the day at the same time the public and our patient communities did, through media reports. At Sarepta, patient safety and well-being are always our top priority. We are committed to upholding the highest safety standards for all of our therapies. This guides every decision we make, as evidenced by our conservative decision to pause shipments of ELEVIDYS for non-ambulant patients while we work with the FDA to update the label and evaluate the use of an enhanced immunosuppression regimen to mitigate the risk of acute liver failure. Based on our comprehensive scientific interpretation of the data, which shows no new or changed safety signals in the ambulant patient population, we will continue to ship ELEVIDYS to the ambulant population. We look forward to continued discussions and sharing of information with FDA in order to advance our shared purpose of protecting patient safety and informed access to care. We recognize that the death of any patient is heartbreaking, including the recent death of a 51-year-old non-ambulant Limb-Girdle Muscular Dystrophy (LGMD) patient. We also want to clarify that this tragic event occurred in a Phase 1 clinical trial for an investigational gene therapy called SRP-9004. SRP-9004 is a clinical stage therapy that is intended to treat a different disease (LGMD Type 2D), is administered using a different dose, and is manufactured using a different process. The LGMD study participant who passed away was not treated with ELEVIDYS, and the dosing for the SRP-9004 trial had concluded at the time of his death. Additionally, in a timely manner, Sarepta reported this ALF event as a life-threatening case to FDA on June 20, 2025, and further followed up with notification to FDA of the death on July 3, 2025, in accordance with applicable law and our commitment to full regulatory transparency. ELEVIDYS is the only approved gene therapy for individuals devastated by Duchenne, a rare, progressive and ultimately fatal disease. We are committed to working closely with the FDA to ensure that all decisions are grounded in science and the best interests of patients, considering the compelling need of these families to access disease-modifying therapy. About ELEVIDYS (delandistrogene moxeparvovec-rokl) ELEVIDYS (delandistrogene moxeparvovec-rokl) is a single-dose, adeno-associated virus (AAV)-based gene transfer therapy for intravenous infusion designed to address the underlying genetic cause of Duchenne muscular dystrophy – mutations or changes in the DMD gene that result in the lack of dystrophin protein – through the delivery of a transgene that codes for the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle. ELEVIDYS is indicated for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age. For patients who are ambulatory and have a confirmed mutation in the DMD gene For patients who are non-ambulatory and have a confirmed mutation in the DMD gene. The DMD indication in non-ambulatory patients is approved under accelerated approval based on expression of ELEVIDYS micro-dystrophin in skeletal muscle. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). IMPORTANT SAFETY INFORMATION CONTRAINDICATION: ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene. WARNINGS AND PRECAUTIONS: Infusion-related Reactions: Infusion-related reactions, including hypersensitivity reactions and anaphylaxis, have occurred during or up to several hours following ELEVIDYS administration. Closely monitor patients during administration and for at least 3 hours after the end of infusion. If symptoms of infusion-related reactions occur, slow, or stop the infusion and give appropriate treatment. Once symptoms resolve, the infusion may be restarted at a lower rate. ELEVIDYS should be administered in a setting where treatment for infusion-related reactions is immediately available. Discontinue infusion for anaphylaxis. Acute Serious Liver Injury: Acute serious liver injury has been observed with ELEVIDYS, and administration may result in elevations of liver enzymes (such as GGT, GLDH, ALT, AST) or total bilirubin, typically seen within 8 weeks. Patients with preexisting liver impairment, chronic hepatic condition, or acute liver disease (e.g., acute hepatic viral infection) may be at higher risk of acute serious liver injury. Postpone ELEVIDYS administration in patients with acute liver disease until resolved or controlled. Prior to ELEVIDYS administration, perform liver enzyme test and monitor liver function (clinical exam, GGT, and total bilirubin) weekly for the first 3 months following ELEVIDYS infusion. Continue monitoring if clinically indicated, until results are unremarkable (normal clinical exam, GGT, and total bilirubin levels return to near baseline levels). Systemic corticosteroid treatment is recommended for patients before and after ELEVIDYS infusion. Adjust corticosteroid regimen when indicated. If acute serious liver injury is suspected, consultation with a specialist is recommended. Immune-mediated Myositis: In clinical trials, immune-mediated myositis has been observed approximately 1 month following ELEVIDYS infusion in patients with deletion mutations involving exon 8 and/or exon 9 in the DMD gene. Symptoms of severe muscle weakness, including dysphagia, dyspnea, and hypophonia, were observed. Limited data are available for ELEVIDYS treatment in patients with mutations in the DMD gene in exons 1 to 17 and/or exons 59 to 71. Patients with deletions in these regions may be at risk for a severe immune-mediated myositis reaction. Advise patients to contact a physician immediately if they experience any unexplained increased muscle pain, tenderness, or weakness, including dysphagia, dyspnea, or hypophonia, as these may be symptoms of myositis. Consider additional immunomodulatory treatment (immunosuppressants [e.g., calcineurin-inhibitor] in addition to corticosteroids) based on patient's clinical presentation and medical history if these symptoms occur. Myocarditis: Acute serious myocarditis and troponin-I elevations have been observed following ELEVIDYS infusion in clinical trials. If a patient experiences myocarditis, those with pre-existing left ventricle ejection fraction (LVEF) impairment may be at higher risk of adverse outcomes. Monitor troponin-I before ELEVIDYS infusion and weekly for the first month following infusion and continue monitoring if clinically indicated. More frequent monitoring may be warranted in the presence of cardiac symptoms, such as chest pain or shortness of breath. Advise patients to contact a physician immediately if they experience cardiac symptoms. Preexisting Immunity against AAVrh74: In AAV-vector based gene therapies, preexisting anti-AAV antibodies may impede transgene expression at desired therapeutic levels. Following treatment with ELEVIDYS, all patients developed anti-AAVrh74 antibodies. Perform baseline testing for presence of anti-AAVrh74 total binding antibodies prior to ELEVIDYS administration. ELEVIDYS administration is not recommended in patients with elevated anti-AAVrh74 total binding antibody titers greater than or equal to 1:400. Adverse Reactions: The most common adverse reactions (incidence ≥5%) reported in clinical studies were vomiting, nausea, liver injury, pyrexia, and thrombocytopenia. Report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics at 1-888-SAREPTA (1-888-727-3782). For further information, please see the full Prescribing Information. About Sarepta Therapeutics Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. For more information, please visit or follow us on LinkedIn, X, Instagram and Facebook. Forward-Looking Statements This statement contains 'forward-looking statements.' Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as 'believe,' 'anticipate,' 'plan,' 'expect,' 'will,' 'may,' 'intend,' 'prepare,' 'look,' 'potential,' 'possible' and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to our future operations, research and development programs, clinical trials, ELEVIDYS, and expected plans, including our plan to continue to ship ELEVIDYS to the ambulant population and continued discussions and sharing of information with FDA in order to advance our shared purpose of protecting patient safety and informed access to care. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: our products or product candidates may be perceived as insufficiently effective, unsafe or may result in unforeseen adverse events; our products or product candidates may cause undesirable side effects that result in significant negative consequences following any marketing approval; different methodologies, assumptions and applications we use to assess particular safety or efficacy parameters may yield different statistical results, and even if we believe the data collected from clinical trials are positive, these data may not be sufficient to support approval by the FDA or other global regulatory authorities; success in clinical trials, especially if based on a small patient sample, does not ensure that later clinical trials will be successful, and the results of future research may not be consistent with past positive results or with advisory committee recommendations, or may fail to meet regulatory approval requirements for the safety and efficacy of product candidates; we may not be able to comply with all FDA requests in a timely manner or at all; the possible impact of regulations and regulatory decisions by the FDA and other regulatory agencies on our business; and those risks identified under the heading 'Risk Factors' in our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company, which you are encouraged to review. Any of the foregoing risks could materially and adversely affect the Company's business, results of operations and the trading price of Sarepta's common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained herein. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by law. Internet Posting of Information We routinely post information that may be important to investors in the 'For Investors' section of our website at We encourage investors and potential investors to consult our website regularly for important information about us. Source: Sarepta Therapeutics, Inc.
Business Wire
20 hours ago
- Business Wire
Keller Rohrback LLP: Labor Day 2020 Fire Survivors Awarded $56M
PORTLAND, Ore.--(BUSINESS WIRE)--In the ninth jury trial for wildfire survivors against PacifiCorp following the 2020 Labor Day Fires, a jury has awarded eleven plaintiffs a total of $56.1 million. This verdict follows a landmark class action verdict in 2023 that held PacifiCorp liable to the entire class of wildfire survivors who suffered losses. The sole question in the trials that have followed is survivors' damages. The damages trials will continue for the remainder of 2025 and likely 2026. Counsel for the class have asked the Court to schedule five trials per month in 2026. Under the law, the individuals are awarded economic damages (which are doubled) and noneconomic damages, which the 2023 verdict automatically increases by 25% for punitive damages against PacifiCorp. The plaintiffs are: Plaintiff Jerome Kosel and his wife Michelle Kosel lost their home and decades of cherished possessions in the Santiam Canyon Fire. Mr. Kosel and his family have spent the last five years rebuilding their home themselves. Plaintiff Richard Little and his wife Patti Little lost their riverfront retirement home, historic family photos, a loved one's ashes, and countless family heirlooms in the Santiam Canyon Fire. They were subsequently forced to move outside of the river canyon they called home. Plaintiff Amaya Ramsey was only 16 years old when the Santiam Canyon Fire burned her family's home—her 'safe place,' adjacent to the wooded forest where her young imagination ran wild. The ensuing displacement separated her family and has had long-lasting impacts on Ms. Ramsey. Plaintiff Lillie Harvison was living in a home she considered 'the last place she would ever live' before it was burned in the Santiam Canyon Fire. Ms. Harvison was forced to flee the approaching wildfire in the middle of the night, through encroaching flames. She lost the tranquility of her garden and hummingbirds, the canopied swing she always dreamt of, and dozens of collected, inherited, or handmade housewares. Plaintiff Melissa Marr lost her home in the Santiam Canyon Fire. After the traumatic loss, Ms. Marr and her family worked hard to rebuild the life they had before the fire, but tragically, Ms. Marr passed away before her case went to trial. Plaintiff Beverly Unruh, a cancer survivor, and her husband, Don Unruh lost their custom-built retirement home in the Echo Mountain Complex Fire. They left home early to help evacuees at their church and later learned that their property and the scenic environment were destroyed. Ms. Unruh lost deeply significant family heirlooms, such as war memorabilia, love letters, and handmade items from past generations. Plaintiffs Bruce and Connie McGowan 's home was already on fire by the time they narrowly escaped the Echo Mountain Complex Fire; Mr. McGowan had to push a flaming tree out of the road in order to escape. In the fire, the McGowans lost the home they had built from the ground up and priceless family antiques, including an original seventeenth-century grandfather clock. The McGowans were displaced to smaller homes until they each passed away prior to trial. Plaintiff Gerald Wescott and his wife Norma Wescott's house suffered significant smoke and ash damage in the Santiam Canyon Fire, which also burned down several structures and the lush forest on their property. They lost cherished family heirlooms and Mr. Wescott's musical equipment. Mr. Wescott has spent the last five years cleaning up the charred remains and replanting thousands of trees in an effort to restore some of the natural beauty to his property. Plaintiff Glen Kent escaped the Santiam Canyon Fire in the middle of the night, with nothing but the clothes on his back and slippers on his feet. Mr. Kent and his wife were surrounded by flames as they drove to their daughter's house in Salem. Mr. Kent lost his family's riverfront retirement home, his wife's wedding band, his military medals, and countless family heirlooms in the fire. Plaintiff Rick Allen also escaped the Echo Mountain Complex Fire in the middle of the night, with only his dog and a framed photo of his late wife. Mr. Allen lost deeply cherished belongings and irreplaceable mementos from his lifetime. 'Once again, a jury of Oregon citizens has returned a verdict many multiples greater than the low-ball compensation numbers proposed by PacifiCorp at trial. It is unfortunate that PacifiCorp continues to sink significant financial resources into a losing court fight against these survivors' claims instead of simply paying them what jury after jury has concluded they are owed,' said Keller Rohrback partner Will Dreher. 'For the ninth time, an Oregon jury has held PacifiCorp accountable for its reckless and willful misconduct during the Labor Day 2020 storm. It's long past time for Berkshire Hathaway and PacifiCorp to take responsibility. Fire survivors and their families deserve justice for what these giant corporations have done,' said Cody Berne, a partner at Stoll Berne. 'Verdict after verdict, juries are returning consistent, substantial awards to survivors of PacifiCorp's fires," said Nicholas Rosinia, partner at Edelson PC. "Each verdict is a powerful affirmation of what our clients have known all along: PacifiCorp's recklessness and gross negligence turned their lives upside down, for which the company must be held accountable." There have been eight damages trials so far, with three more set in 2025. The Court is expected to soon issue a trial schedule for 2026. There are thousands of members of the class who, under the classwide liability finding, are entitled to damages against PacifiCorp. About the Firms EDELSON PC is a nationally recognized leader in high-stakes plaintiff's litigation, including class actions, mass torts, and government enforcement actions. The firm is litigating wildfire cases in Oregon, Colorado, and now in Los Angeles arising from the Eaton Fire. As lead counsel, the firm has recovered over $5 billion in settlements and judgments. Edelson PC has offices in Chicago, San Francisco, Los Angeles, Boulder, and Washington, D.C. KELLER ROHRBACK L.L.P., with offices in Seattle, Denver, Portland, Phoenix, Oakland, Missoula, New York, and Santa Barbara, serves as lead and Co-Lead Counsel in class actions throughout the country. The team of environmental litigators has a long history of successful representation in a wide range of important environmental litigation. The firm has helped protect people and the environment across the country, with judgments and settlements on behalf of clients exceeding $93 billion. STOLL BERNE, based in Portland, Oregon, represents plaintiffs nationwide in complex environmental, securities, and other class action lawsuits. Recently, Stoll Berne represented the State of Oregon in obtaining a $698 million settlement in a PCB contamination lawsuit against Monsanto.
Business Wire
20 hours ago
- Business
- Business Wire
FCPT Announces Acquisition of Six Novant Health Urgent Care Properties for $12.0 Million
MILL VALLEY, Calif.--(BUSINESS WIRE)--Four Corners Property Trust (NYSE:FCPT), a real estate investment trust primarily engaged in the ownership and acquisition of high-quality, net-leased restaurant and retail properties ('FCPT' or the 'Company'), is pleased to announce the acquisition of six Novant Health Urgent Care properties for $12.0 million. The properties are located in highly trafficked corridors in South Carolina and are corporate operated under long-term, triple net leases. The transaction was priced at a cap rate in range with previous FCPT transactions. Novant Health is an integrated network of more than 900 locations, including 19 hospitals, more than 750 physician clinics and urgent care centers, outpatient facilities, and imaging and pharmacy services. About FCPT FCPT, headquartered in Mill Valley, CA, is a real estate investment trust primarily engaged in the ownership, acquisition and leasing of restaurant and retail properties. The Company seeks to grow its portfolio by acquiring additional real estate to lease, on a net basis, for use in the restaurant and retail industries. Additional information about FCPT can be found on the website at Category: Acquisition
Business Wire
21 hours ago
- Business
- Business Wire
KBRA Assigns Preliminary Ratings to GS Mortgage-Backed Securities Trust 2025-HE1 (GSMBS 2025-HE1)
NEW YORK--(BUSINESS WIRE)--KBRA assigns preliminary ratings to 6 classes of mortgage-backed notes from GS Mortgage-Backed Securities Trust 2025-HE1 (GSMBS 2025-HE1), a $282.0 million RMBS transaction sponsored by Goldman Sachs Mortgage Company. GSMBS 2025-HE1 consists of first lien (7.1%) and second lien (92.9%) home equity line of credit (HELOC) loans. The underlying pool is seasoned approximately seven months and comprises 2,904 loans, with United Wholesale Mortgage, LLC (54.5%) as the largest contributing originator. The HELOCs are interest-only (IO) adjustable-rate mortgages, with initial draw windows of three (50.9%), five (18.7%) or ten (30.4%) years. Most loans feature 10-year or 20-year amortization terms after the IO period. IO periods range from 3 to 10 years and loan maturity terms range from 10 to 30 years. As of the June 30, 2025 cut-off date, the borrowers in the pool have drawn $282.0 million from a combined credit limit of $318.0 million for an aggregate utilization rate of 88.7%. KBRA's rating approach incorporated loan-level analysis of the mortgage pool through its Residential Asset Loss Model (REALM), an examination of the results from third-party loan file due diligence, cash flow modeling analysis of the transaction's payment structure, reviews of key transaction parties and an assessment of the transaction's legal structure and documentation. This analysis is further described in our U.S. RMBS Rating Methodology. To access ratings and relevant documents, click here. Click here to view the report. Methodologies Disclosures Further information on key credit considerations, sensitivity analyses that consider what factors can affect these credit ratings and how they could lead to an upgrade or a downgrade, and ESG factors (where they are a key driver behind the change to the credit rating or rating outlook) can be found in the full rating report referenced above. A description of all substantially material sources that were used to prepare the credit rating and information on the methodology(ies) (inclusive of any material models and sensitivity analyses of the relevant key rating assumptions, as applicable) used in determining the credit rating is available in the Information Disclosure Form(s) located here. Information on the meaning of each rating category can be located here. Further disclosures relating to this rating action are available in the Information Disclosure Form(s) referenced above. Additional information regarding KBRA policies, methodologies, rating scales and disclosures are available at About KBRA Kroll Bond Rating Agency, LLC (KBRA), one of the major credit rating agencies (CRA), is a full-service CRA registered with the U.S. Securities and Exchange Commission as an NRSRO. Kroll Bond Rating Agency Europe Limited is registered as a CRA with the European Securities and Markets Authority. Kroll Bond Rating Agency UK Limited is registered as a CRA with the UK Financial Conduct Authority. In addition, KBRA is designated as a Designated Rating Organization (DRO) by the Ontario Securities Commission for issuers of asset-backed securities to file a short form prospectus or shelf prospectus. KBRA is also recognized as a Qualified Rating Agency by Taiwan's Financial Supervisory Commission and is recognized by the National Association of Insurance Commissioners as a Credit Rating Provider (CRP) in the U.S. Doc ID: 1010465
