Latest news with #Stamford
Bloomberg
3 days ago
- Business
- Bloomberg
Freepoint Commodities Ex-Analyst Claims Illegal Retaliation
A former senior analyst with Freepoint Commodities LLC claims he was fired from the energy-trading firm for resisting pressure to cooperate with executives in illegal insider trading, market manipulation and trade-theft schemes. The analyst, Andrew Martin, sued May 14 in Manhattan federal court claiming wrongful termination and retaliation by Freepoint, where he had worked for a decade. Martin claimed he was fired to prevent him from reporting alleged violations during a planned visit by the Federal Bureau of Investigation to Freepoint's Stamford, Connecticut, headquarters.
Associated Press
3 days ago
- Business
- Associated Press
Synchrony and Jewelers Mutual® Collaborate on Innovative New Sponsorship Agreement, Combining Finance and Insurance Marketing Efforts
Synchrony Financing Solutions Will Be Offered in Jewelers Mutual Marketing Materials and in Zing Marketplace STAMFORD, Conn., May 28, 2025 /PRNewswire/ -- Synchrony (NYSE: SYF), a premier consumer financial services company, and Jewelers Mutual ®, an insurer dedicated to protecting jewelry and jewelry businesses for over a century, today announced a new sponsorship agreement to co-market both services to jewelry merchants looking to make customers aware of both financing and insurance coverage options. 'Through this new sponsorship agreement with Jewelers Mutual, we are extending the value Synchrony brings to retailers around the country,' said Darrell Owens, CEO, Lifestyle, Synchrony. 'Jewelry merchants can now present their customers with financing options that make purchases more affordable, while making their customers aware of the option to protect their jewelry, which is often among a customer's most cherished possessions.' As part of the agreement, Jewelers Mutual will showcase Synchrony financing solutions in its marketing materials as well as Zing® Marketplace, a comprehensive online platform created for its member retailers. Zing Marketplace features essential tools to help merchants best serve their customers, including jeweler web pages, diamond marketplace, a jewelry appraisal solution and, now, financing offerings from Synchrony. Synchrony will also feature offers directly from Jewelers Mutual to merchants and consumers through select marketing materials as well as on Synchrony Marketplace, a shopping destination for consumers to find special offers from Synchrony partners. As a result, Synchrony will help elevate awareness of Jewelers Mutual and its insurance services, which are used by over one million customers throughout the United States and Canada. 'As a leader in consumer financing, we're excited about the added value our collaboration with Synchrony will bring to jewelers and their customers,' said Mike Alexander, Chief Operating Officer, Jewelers Mutual. 'Together, we are committed to supporting jewelers in delivering seamless customer experiences while helping protect the pieces they will treasure for a lifetime.' Synchrony financing is currently used by more than 4,000 jewelry retailers nationwide. Synchrony is committed to offering financing options for small and medium-sized businesses across the country to help them grow their business and offer customers greater purchasing power to meet their needs. About Jewelers Mutual Group Jewelers Mutual® was founded in 1913 by a group of Wisconsin jewelers to meet their unique insurance needs. Later, consumers began putting their trust in Jewelers Mutual to protect their jewelry and the special memories each piece holds. Today, Jewelers Mutual continues to support and move the industry forward by listening to jewelers and consumers and offering products and services to meet their evolving needs. Beyond insurance, Jewelers Mutual's powerful suite of innovative solutions and digital technology offerings help jewelers strengthen and grow their businesses, mitigate risk, and bring them closer to their customers. The Group insurers' strong financial position is reflected in their 38 consecutive 'A+ Superior' ratings from AM Best Company, as of November 2024. Policyholders of the Group insurers are members of Jewelers Mutual Holding Company. Jewelers Mutual is headquartered in Neenah, Wisconsin, with other Group offices in Dallas, Texas, Miami, Florida and Raleigh, North Carolina. To learn more, visit About Synchrony Synchrony (NYSE: SYF) is a leading consumer financing company at the heart of American commerce and opportunity. From health to home, auto to retail, our Synchrony products have been serving the needs of people and businesses for nearly 100 years. We provide responsible access to credit and banking products to support healthier financial lives for tens of millions of people, enabling them to access the things that matter to them. Additionally, through our innovative products and experiences, we support the growth and operations of some of the country's most respected brands, as well as more than 400,000 small and midsize businesses and health and wellness providers that Americans rely on. Synchrony is proud to be ranked as the country's #2 Best Company to Work For® by Fortune magazine and Great Place to Work®. For more information, visit Contact: Lauren Devilbiss Synchrony [email protected] 240-814-5825 View original content to download multimedia: SOURCE Synchrony
The Guardian
4 days ago
- Business
- The Guardian
They sued after their medical devices failed. But billionaire bankruptcy moves could mean they get nothing
Gene Davis was in his 50s when he could no longer ignore the pain in his knee. He worked two jobs he loved in Stamford, Connecticut – he and his brothers were all firefighters, and they also ran a real estate business together. It meant a lot of walking up stairs. Finally, in July 2019, Davis got his knee replaced with an implant. At first, he was recovering fine. Then, the pain got worse. An X-ray revealed that bits of the implant had begun to splinter into his leg. He assumed it was bad luck. After a second surgery to get a new version of the same device, manufactured by a Florida-based company called Exactech, things just got worse. 'Here we go again,' he thought, 'I'm haemorrhaging a lot of blood … and I'm wondering why.' Eventually, Davis, who had always been conscientious about his health and, at 60, still fit into his Marine uniform, had to leave his job at the fire department. In April 2022, less than a year after his second surgery, Davis received a letter from his surgeon, saying that pieces of both implants had been recalled. Problems with the way the implants were packaged left components vulnerable to oxidation, potentially causing them to fragment after surgery, the Food and Drug Administration (FDA) said in a statement about the recall. Davis was actually relieved. 'I'm finally going to get better, and it isn't my fault,' he thought. But after receiving his third implant in August 2022, Davis woke up in the night to find his leg had swollen to double the size. He had to drag himself to the bathroom. His doctor said the leg was infected. It was now scarred and damaged beyond repair. In 2023, Davis sued the two companies he believed were responsible for his pain, Exactech and the multi-billion dollar firm that owned the company, a publicly listed private equity behemoth, which currently has $251bn in assets, called TPG. The firm, founded in Texas, was famous for its 2002 acquisition of Burger King and other high-profile Wall Street deals. Davis's claim was one of more than 2,500 personal injury lawsuits against Exactech which, by 2024, had recalled over 650,000 devices due to the defective packaging that could cause potential oxidation and fragmentation. But Davis's legal pursuits faced significant hurdles. In March 2024, a New York district judge dismissed TPG, the private equity firm Davis had sued alongside Exactech, from personal injury lawsuits related to the alleged defects in Exactech's implants. Plaintiffs who had sued TPG had not adequately shown, the judge found, that TPG had 'requisite control' over Exactech. 'TPG plausibly had a large influence in Exactech's business strategy, including surrounding the decision to recall its products.' But, he said, 'that is not enough' to show that TPG had the 'dominance and control' over Exactech legally required to pursue litigation against them. In July 2024, a special committee formed by Exactech began evaluating possible restructuring options, including bankruptcy. Then in October 2024, just weeks before Davis and other plaintiffs' cases were scheduled for trial, Exactech filed for bankruptcy, essentially freezing thousands of lawsuits against it. It was another blow to Davis's pursuit of legal claims. He was not alone. A Guardian investigation found that legal claims like those brought by Davis against private-equity backed healthcare companies are increasingly being delayed or obstructed in bankruptcy court. Bankruptcies among private-equity backed healthcare companies have spiked in recent years. As a result, experts say, private equity firms may be able to avoid liability for healthcare investments. TPG Capital is one of the 10 richest private equity firms in the world. After Exactech filed for bankruptcy in Delaware, a committee of unsecured creditors (UCC), which represents everyone who is owed money by Exactech, including personal injury claims like Davis's, filed a motion that, if granted, would allow personal injury claimants and other creditors to pursue their claims in any forum, despite the bankruptcy freeze. The UCC's legal filings contain allegations against both TPG and Exactech, including claims that TPG was seeking to 'bury' and 'undermine' the lawsuits in the bankruptcy court. In their objection to the UCC's fillings, TPG has disputed the claim, saying in court documents that the UCC has not shown that claimants would have a better outcome outside the bankruptcy court. In a statement to the Guardian, Ellen Relkin, a partner at Weitz & Luxenberg who is representing claimants against TPG and Exactech, pointed a finger of blame at TPG, which she alleges had control over Exactech's actions sufficient to make it responsible for them. They deny that claim, referencing the judge's dismissal of the suits against TPG. Plaintiffs, Relkin said, were prepared to ask that judge to essentially correct his ruling dismissing TPG from Exactech personal injury claims. In her statement, Relkin said: 'The trial court dismissed TPG without affording the Plaintiffs any discovery from TPG,' and that she believes the trial court will reverse TPG's dismissal once the judge has seen the new evidence. What Gene Davis did not know back in 2019, as he headed into the operating room to have his first knee replacement surgery, was that questions about Exactech's products had allegedly been flagged at Exactech years before. TPG acquired Exactech in 2018, which added the Florida company to TPG's existing portfolio of healthcare companies. Reuters reported at the time that TPG would play an 'advisory role' to the company. Three TPG employees were appointed to Exactech's board after the deal. TPG also appointed Jeffrey Binder, one of its own advisers, as co-executive chairman of Exactech, according to court documents filed by the UCC. Binder would later go on to become CEO of Exactech. In legal documents, the UCC has claimed that 'Exactech and certain officers and directors' had allegedly been made aware of product defects since 2005. The creditors allege Exactech 'engaged in a pattern of practices designed to hide the defects', including by 'providing inaccurate and misleading information to the FDA'. The UCC has also alleged in court documents that 'TPG and Mr Binder became aware of the full scope of product defect issues with the Exactech devices and the regulatory issues facing the company' after the 2018 acquisition closed. They alleged Binder received 'multiple warnings' about Exactech's device problems in March 2019. The UCC also alleged in court documents that a surgeon advised Exactech in April 2019 about 'device failures for at least 17 surgeries he had performed using an Exactech product'. An August 2019 performance report described Binder as having 'day-to-day control of all commercial activities at Exactech', according to a UCC court motion. 'TPG's motivation was apparent: to protect the TPG investment at all costs … all at the expense of the ultimate victims of such a scheme,' according to a UCC motion in the bankruptcy case. Those allegations are disputed. In responses filed in the bankruptcy court, Exactech and its TPG affiliates said the UCC was merely speculating that directors and officers had acted 'with an actual intent to violate law or act in dereliction of their duties'. TPG said in a statement to the Guardian that it is 'categorically false' that the private equity firm had any 'prior knowledge of the packaging nonconformance'. Further details about those alleged warnings, and who sent them, have been redacted by the court. The question over who knew what – and when – is a central issue in the ongoing legal proceedings, because creditors have argued that TPG itself ought to be on the hook for some personal injury claims. TPG and its affiliates have said in legal filings that Exactech and TPG maintained 'clearly separate businesses' and that Exactech is just one of 300-plus companies in TPG's portfolio. The Guardian reached out to Binder, who served as chairman of Exactech from 2018 to 2024, as chief executive officer from 2022-2023, and has had a consulting relationship with TPG from 2015 to present. In an emailed statement, Binder said orthopaedic medical device makers 'regularly receive product complaints, including reports of revision surgeries, and conduct investigations into these complaints so that we may take appropriate corrective action'. 'Exactech's investigation of product complaints led us to discover in 2021 a packaging non-conformity that had been undetected since 2008, many years prior to TPG's ownership of Exactech and to my tenure with the company,' he said. 'When we at Exactech discovered the non conformance we reported it to FDA in a timely fashion and initiated a product recall.' The Guardian sent both Exactech and TPG questions about allegations that Exactech and TPG were aware of defects with Exactech's products before 2019. Exactech did not respond to the Guardian's request for comment. TPG also said the packaging issues at the company predated its ownership of Exactech, and that they had only learned about the issues in 2021. 'TPG supported the company as it immediately launched an investigation, initiated a voluntary recall, and provided support programs for physicians and patients,' TPG said. Exactech has also said in court disclosures that it initiated recalls 'in an abundance of caution' but that the faulty packaging did not lead to overall higher rates of what is called revision surgeries – when patients have to repeat surgeries – beyond industry averages. The company claims its position is supported by scientific and clinical data. In its recall notice, the FDA said some of the recalled devices were associated with an 'increased risk of revision surgeries and bone loss related to excessive device wear/failure'. In addition, annual reports from the Australian Orthopedics Association National Joint Replacement Registry between 2011-2018 identified Exactech devices – which were made in US facilities – as having 'higher than anticipated' revision rates. For example, their 2016 annual report found that the Optetrak Ps prosthesis had a 10 year revision rate over four times higher than overall industry rates. Mass lawsuits are more or less inevitable when private equity and healthcare mix, according to Martin Kenney, a distinguished professor at UC Davis's department of human ecology and author of Private Equity and the Demise of the Local. The private equity playbook, he says, revolves around cutting costs as much as possible, which can be dangerous when it comes to healthcare. 'They push these companies so close to the margin,' Kenney suggested. The Guardian's investigation found that an increasing number of bankruptcy filings are coming from private-equity backed healthcare companies facing lawsuits. Bankruptcies automatically freeze all lawsuits against the defendant filing for bankruptcy protection, and can also limit how much money goes to settle legal claims. Between 2023 and 2024, at least 25 private-equity backed health companies filed for bankruptcy in the US while facing lawsuits in federal court, according to the Guardian's analysis of S&P Global data and federal court records. That was more than such filings from 2010 to 2022 combined. Some of the lawsuits were filed by investors over misleading medical claims, while others, like Davis's, involved products and services that ultimately endangered patients. Relkin, who is representing claimants against TPG and Exactech, said she believes it is a 'travesty' that private equity giants can 'misuse the bankruptcy system' so that companies they own can avoid liability, to the detriment of thousands of people who have received recalled devices. 'Many lives have been devastated, some clients now need to use assistive devices to walk and many can no longer do their jobs,' Relkin said. TPG said in a statement to the Guardian that it is 'categorically false' to allege that TPG 'encouraged or engineered a bankruptcy filing to protect itself from liability'. In a media report about the bankruptcy published in October 2024, Reuters reported that Exactech said that high interest payments and litigation expenses began cutting into the company's cash flow in mid-2023, threatening to derail an otherwise-strong business. It said it had spent $20m on recalls and litigation expenses in the previous year. A proposal by debtors including TPG in the bankruptcy court, would allow TPG to dispense with its liabilities, including personal injury claims, for $10m. The proposal cites a special committee investigation which found $10m to be a fair price for the release. The proposal by debtors also includes a plan to sell Exactech's assets for an undisclosed amount. The UCC has criticized the special committee report, alleging that critical issues 'do not appear to have been investigated' and that 'key witnesses were not interviewed'. The UCC has claimed in legal documents that the full value of personal injury claims against Exactech likely amount to more than $1bn. TPG declined to comment on the Guardian's questions about the special committee investigation. In their objection to the UCC's complaint, the debtors including TPG say the UCC 'has offered no cost-benefit analysis of any kind, let alone one demonstrating that continued litigation would produce greater recoveries and otherwise better results' than 'those provided under the plan'. On 28 May, a hearing will begin to determine whether the bankruptcy court will approve TPG's plan to sell Exactech and obtain a release from liability for $10m. If that plan is approved, Relkin fears claimants like Davis will likely get nothing. Meanwhile, TPG could still get some money back from Exactech, as repayments for loans they leveraged to help fund restructuring. TPG declined to comment on the Guardian's questions about those loans. Samir Parikh, a Wake Forest University law professor who specializes in bankruptcy, said loans like this are commonly seen in private equity bankruptcy proceedings. 'It's frustrating,' he said. Kenney, the UC professor, compared it to a 'Heads I win, tails you lose,' coin toss. According to Parikh, it is common for private equity investors to acquire portfolio companies and immediately layer them with debt so they can start earning money on their investments right away in the form of loan interest and fees – while also ensuring that the portfolio company operates on as slim a margin as possible. That also means the companies have fewer assets left to pay off legal liabilities. Courts can't force companies to pay settlements with money they don't have. Parikh said it was 'somewhat palatable' for a variety of industries to adopt such business practices, 'but in healthcare, it's just not right'. When investors take on life and death responsibilities, 'it's no longer acceptable to just say 'oh, sorry, this entity is now bankrupt'.' Cynthia Camp, a 66-year-old resident of Supply, North Carolina, hopes she won't need her recalled hip implant removed – again. Like Davis, she had one faulty Exactech device replaced with another, and the damage of both has permanently disabled her – she sued Exactech in 2022. 'My husband and I do not make love,' she said. When she recently learned a part of her replacement device had also been recalled, 'I almost died on the table,' she said, 'Y'all done been in there twice. God, don't tell me they got to go in there again.' Davis finds it especially infuriating that he received not one but three Exactech implants, each one putting more money in the company's pocket, as they were all covered by Davis's insurance. Because his bone had been shaped to conform to Exactech devices, Davis says he could only receive Exactech devices in revision surgeries. For this reason, Davis will always have a body part manufactured by the company he claims is responsible for his injury. 'I'm in bed with my abuser,' he said.
Yahoo
23-05-2025
- Business
- Yahoo
SpringWorks Therapeutics Receives Positive CHMP Opinion for Mirdametinib for the Treatment of Adult and Pediatric Patients with NF1-PN
– If approved, mirdametinib is expected to be the first and only therapy in the European Union with marketing authorization for both adults and children with NF1-PN – – Decision from European Commission expected in the third quarter of 2025 – STAMFORD, Conn., May 23, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a conditional marketing authorization for mirdametinib, a MEK inhibitor, for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in pediatric and adult patients with neurofibromatosis type 1 (NF1) aged 2 years and above. The European Commission (EC) will review the CHMP opinion and is expected to make a final decision regarding the approval in the third quarter of 2025. If approved, mirdametinib will be available in 1 and 2 mg capsules and in a 1 mg dispersible tablet, which dissolves easily in water. 'The positive opinion from the CHMP brings us one step closer to delivering our medicine to both children and adults with NF1-PN in Europe, who we believe are in need of new therapeutic advances,' said Saqib Islam, Chief Executive Officer of SpringWorks. 'Upon approval, we look forward to bringing mirdametinib to appropriate patients in Europe as quickly as possible.' NF1 is a genetic disorder that affects approximately 3 in 10,000 people in the EU, or an estimated 135,000 people.1,2 Patients with NF1 have approximately a 30 to 50% lifetime risk of developing plexiform neurofibromas, which are tumors that grow in an infiltrative pattern along the peripheral nerve sheath and that can cause severe disfigurement, pain and functional impairment.3,4 Plexiform neurofibromas can transform into malignant peripheral nerve sheath tumors, an aggressive and potentially fatal disease.5 Surgical removal can be challenging due to the infiltrative tumor growth pattern of plexiform neurofibromas along nerves, and up to approximately 85% of plexiform neurofibromas are considered not amenable to complete resection.6,7,8 'NF1-PN is a genetic disorder that can be highly morbid and unpredictable. It takes a significant physical and emotional toll on patients and their caregivers, and there have been limited treatment options available,' said Ignacio Blanco, MD, PhD, Chairman of the National Reference Center for Adult Patients with Neurofibromatosis at Hospital Universitari Germans Trias i Pujol, Spain. 'Surgical removal of plexiform neurofibromas can be challenging and is often not possible, so if approved, mirdametinib could be an important treatment option for children and adult patients in Europe.' The CHMP opinion was based on the Marketing Authorization Application (MAA) for mirdametinib, which was validated by the EMA in August 2024. The MAA centered on the primary results from the Phase 2b ReNeu trial, which enrolled 114 patients with NF1-PN age 2 years or older (58 adults and 56 pediatric patients). The study met the primary endpoint of confirmed objective response rate (ORR), as assessed by blinded independent central review, demonstrating an ORR of 41% (N= 24/58) in adults and 52% in children (N=29/56). The median best percentage change in target PN volume was -41% (range: -90 to 13%) in adults and -42% (range: -91 to 48%) in children. Among those with a confirmed response, 88% percent of adults and 90% of children had a response of at least 12 months duration, and 50% and 48%, respectively, had a response of at least 24 months duration. Both adults and children also experienced early and sustained significant improvements from baseline in pain and quality of life as assessed across multiple patient-reported outcome tools.9 Mirdametinib demonstrated a manageable safety and tolerability profile. The most common adverse events (>25%) reported in adults receiving mirdametinib were rash, diarrhea, nausea, musculoskeletal pain, vomiting and fatigue. The most common adverse events (>25%) occurring in children were rash, diarrhea, musculoskeletal pain, abdominal pain, vomiting, headache, paronychia, left ventricular dysfunction and nausea.9 Mirdametinib is approved in the U.S. for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. About the ReNeu TrialReNeu (NCT03962543) is an ongoing, multi-center, open-label, single arm, Phase 2b trial evaluating the efficacy, safety and tolerability of mirdametinib in patients ≥2 years of age with an inoperable NF1-associated PN causing significant morbidity. The study enrolled 114 patients to receive mirdametinib at a dose of 2 mg/m2 twice daily (maximum dose of 4 mg twice daily) without regard to food. Mirdametinib was administered orally in a 3-week on, 1-week off dosing schedule as either a capsule or dispersible tablet. The primary endpoint is confirmed objective response rate (ORR) defined as the proportion of patients with a ≥20% reduction in target tumor volume on consecutive scans during the 24-cycle treatment phase, as measured by MRI and assessed by blinded independent central review. Secondary endpoints include safety and tolerability, duration of response, and changes in patient-reported outcomes from baseline to Cycle 13. The treatment phase of the trial is complete, and results were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Patients who completed the treatment phase were eligible to continue receiving treatment in the optional long-term follow-up portion of the study, which is ongoing. About NF1-PNNeurofibromatosis type 1 (NF1) is a rare genetic disorder that arises from mutations in the NF1 gene, which encodes for neurofibromin, a key suppressor of the MAPK pathway.10,11 NF1 is the most common form of neurofibromatosis, with an estimated global birth incidence of approximately 1 in 2,500 individuals.3,12 In the EU, NF1 affects approximately 3 in 10,000 people, or an estimated 135,000 people.1,2 The clinical course of NF1 is heterogeneous and manifests in a variety of symptoms across numerous organ systems, including abnormal pigmentation, skeletal deformities, tumor growth and neurological complications, such as cognitive impairment.13 Patients with NF1 have an 8 to 15-year mean reduction in their life expectancy compared to the general population.1 NF patients have approximately a 30%-50% lifetime risk of developing plexiform neurofibromas, or PN, which are tumors that grow in an infiltrative pattern along the peripheral nerve sheath and that can cause severe disfigurement, pain and functional impairment; in rare cases, NF1-PN may be fatal.3,4,5 NF1-PNs are most often diagnosed in the first two decades of life.3 These tumors can be aggressive and are associated with clinically significant morbidities; typically, they grow more rapidly during childhood.14,15 Surgical removal of these tumors can be challenging due to the infiltrative tumor growth pattern along nerves and can lead to permanent nerve damage and disfigurement.5 Up to approximately 85% of plexiform neurofibromas are considered not amenable to complete resection.6,7,8 About MirdametinibMirdametinib is an oral, small molecule MEK inhibitor approved in the United States for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. The FDA and the European Commission have granted Orphan Drug designation for mirdametinib for the treatment of NF1. About SpringWorks TherapeuticsSpringWorks is a commercial-stage biopharmaceutical company dedicated to improving the lives of patients with severe rare diseases and cancer. We developed and are commercializing the first and only FDA-approved medicine for adults with desmoid tumors and the first and only FDA-approved medicine for both adults and children with neurofibromatosis type 1 associated plexiform neurofibromas (NF1-PN). We are also advancing a diverse portfolio of novel targeted therapy product candidates for patients with both solid tumors and hematological cancers. For more information, visit and follow @SpringWorksTx on X, LinkedIn, Facebook, Instagram and YouTube. Forward-Looking Statements This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, relating to our business, operations, and financial conditions, including but not limited to current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our development and commercialization plans, our preclinical and clinical results, our expectations regarding the timing and results of the EMA's review of our MAA for mirdametinib and our plans to begin its initial launch in the European Union in 2025, our plans to continue to study mirdametinib in pediatric and young adult patients with low-grade gliomas in a Phase 2 study, as well as relating to other future conditions. Words such as, but not limited to, 'look forward to,' 'believe,' 'expect,' 'anticipate,' 'estimate,' 'intend,' 'plan,' 'would,' 'should' and 'could,' and similar expressions or words, identify forward-looking statements. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks relating to: (i) the fact that topline or interim data from clinical studies may not be predictive of the final or more detailed results of such study or the results of other ongoing or future studies, (ii) the success and timing of our collaboration partners' ongoing and planned clinical trials, (iii) the timing of our planned regulatory submissions and interactions, including the timing and outcome of decisions made by the FDA, EMA, and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, (iv) whether EMA or other regulatory authorities will require additional information or further studies, or may fail or refuse to approve or may delay approval of our product candidates, including mirdametinib, (v) our ability to obtain regulatory approval of any of our product candidates or maintain regulatory approvals granted for our products, (vi) our plans to research, discover and develop additional product candidates, (vii) our ability to enter into collaborations for the development of new product candidates and our ability to realize the benefits expected from such collaborations, (viii) our ability to maintain adequate patent protection and successfully enforce patent claims against third parties, (ix) the adequacy of our cash position to fund our operations through any time period indicated herein, (x) our ability to establish manufacturing capabilities, and our collaboration partners' abilities to manufacture our product candidates and scale production, and (xi) our ability to meet any specific milestones set forth herein. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. For further information regarding the risks, uncertainties and other factors that may cause differences between SpringWorks' expectations and actual results, you should review the 'Risk Factors' in Item 1A of Part II of SpringWorks' Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 as well as discussions of potential risks, uncertainties and other important factors in SpringWorks' subsequent filings. Contacts: MediaMedia@ InvestorsInvestors@ References Lee TJ, et al. Incidence and prevalence of neurofibromatosis type 1 and 2: a systematic review and meta-analysis. Orphanet J Rare Dis. 2023;18(1):292. doi:10.1186/s13023-023-02911-2. Eurostat. Population and population change statistics. Eurostat Statistics Explained. 2024. Available at: Accessed May 8, 2025. Prada C, Rangwala F, Martin L, et al. Pediatric Plexiform Neurofibromas: Impact on Morbidity and Mortality in Neurofibromatosis Type 1. J Pediatr. 2012;160(3):461-467. doi:10.1016/ Miller DT, et al. Health supervision for children with neurofibromatosis Type 1. Pediatrics. 2019;143(5):e20190660. Kamaludin, Siti Nurhazwani, et al. 'Plexiform neurofibromatosis with peripheral malignant nerve sheath tumor and scoliosis - more surveillance imaging needed?' Radiology case reports vol. 17,7 2388-2393. 6 May. 2022, doi:10.1016/ Needle M, Cnaan A, Dattilo J, et al. Prognostic signs in the surgical management of plexiform neurofibroma: The Children's Hospital of Philadelphia experience, 1974-1994. J Pediatr. 1997;131(5):678-682. doi:10.1016/s0022-3476(97)70092-1. Ejerskov, C., Farholt, S., Nielsen, F.S.K. et al. Clinical Characteristics and Management of Children and Adults with Neurofibromatosis Type 1 and Plexiform Neurofibromas in Denmark: A Nationwide Study. Oncol Ther 11, 97–110 (2023). doi:10.1007/s40487-022-00213-4. Wolkenstein, P. et al. (2023) 'French cohort of children and adolescents with neurofibromatosis type 1 and symptomatic inoperable plexiform neurofibromas: Cassiopea study', European Journal of Medical Genetics, 66(5), p. 104734. doi:10.1016/ Moertel CL, Fisher MJ, Weiss BD, et al. ReNeu: A pivotal, Phase IIb trial of mirdametinib in adults and children with symptomatic neurofibromatosis type 1-associated plexiform neurofibroma. J Clin Oncol. 2024;JCO.24.01034. doi:10.1200/JCO.24.01034. Yap YS, McPherson JR, Ong CK, et al. The NF1 gene revisited - from bench to bedside. Oncotarget. 2014;5(15):5873-5892. doi:10.18632/oncotarget.2194. Rasmussen S, Friedman J. NF1 Gene and Neurofibromatosis 1. Am J Epidemiol. 2000;151(1):33-40. doi:10.1093/ Ferner R. Neurofibromatosis 1 and neurofibromatosis 2: a twenty first century perspective. The Lancet Neurology. 2007;6(4):340-351. doi:10.1016/s1474-4422(07)70075-3. Weiss, Brian D et al. 'NF106: A Neurofibromatosis Clinical Trials Consortium Phase II Trial of the MEK Inhibitor Mirdametinib (PD-0325901) in Adolescents and Adults with NF1-Related Plexiform Neurofibromas.' Journal of clinical oncology: official journal of the American Society of Clinical Oncology vol. 39,7 (2021):797-806. doi:10.1200/JCO.20.02220. Gross A, Singh G, Akshintala S, et al. Association of plexiform neurofibroma volume changes and development of clinical morbidities in neurofibromatosis 1. Neuro Oncol. 2018;20(12):1643-1651. doi:10.1093/neuonc/noy067. Nguyen R, Dombi E, Widemann B, et al. Growth dynamics of plexiform neurofibromas: a retrospective cohort study of 201 patients with neurofibromatosis 1. Orphanet J Rare Dis. 2012;7(1):75. doi:10.1186/ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
22-05-2025
- Business
- Yahoo
Land & Buildings Comments on Preliminary Results of National Health Investors Annual Meeting
STAMFORD, Conn., May 22, 2025--(BUSINESS WIRE)--Land & Buildings Investment Management, LLC (together with its affiliates, "Land & Buildings"), a significant stockholder of National Health Investors, Inc. (NYSE: NHI) ("NHI" or the "Company"), issued the following statement in connection with the Company's 2025 Annual Meeting of Stockholders (the "2025 Annual Meeting"). "We want to thank our fellow stockholders and the leading proxy advisory firms for their support and dialogue throughout this campaign. Based on preliminary results, Land & Buildings fell just short of gaining a board seat for its nominees, with a margin of about 1% of the outstanding shares. While we are disappointed with the outcome, we recognize the Company has made improvements in direct response to our engagement. However, we continue to believe further change is warranted – underscored by the fact that our nominees received the support of at least 60% of unaffiliated stockholders of NHI and National Healthcare Corp. (NHC) who voted at the 2025 Annual Meeting. Land & Buildings is hopeful that the message has been received, and that we will see further improvements to NHI's governance and performance. We will be keeping a close eye on the NHC lease renewal negotiation and future capital allocation decisions to ensure management is empowered to maximize value. We will not hesitate to hold the Company accountable moving forward, including, if necessary, by taking our concerns directly to stockholders again." View source version on Contacts Media ContactLongacre Square PartnersDan Zacchei / Miller Winstondzacchei@ / mwinston@ Investor ContactSaratoga Proxy ConsultingJohn Ferguson(212) 257-1311 Sign in to access your portfolio
