Latest news with #STAAR
Business Wire
25-06-2025
- Business
- Business Wire
STAAR Surgical Announces Appointment of Deborah Andrews as Chief Financial Officer, Forms Capital Stewardship Committee of the Board of Directors
LAKE FOREST, Calif.--(BUSINESS WIRE)--STAAR Surgical Company (NASDAQ: STAA), the global leader in phakic IOLs with the EVO family of Implantable Collamer® Lenses (EVO ICL™) for vision correction, today announced that Deborah Andrews has been appointed Chief Financial Officer, effective June 25, 2025. Ms. Andrews has served as Interim CFO since March 2025, and she previously served as STAAR's CFO from 2007-2013 and 2017-2020. 'Deborah has blended seamlessly with the leadership team, and we quickly realized that her deep knowledge of STAAR and her skills, abilities, and approach made her the perfect choice to be STAAR's next CFO,' said the Company's CEO and Board member, Stephen Farrell. 'In the last few months, Deborah has already driven greater financial and operating rigor across the organization, and, as a result, we are on track to achieve our targeted $225 million annual SG&A run rate ahead of schedule. I look forward to working with Deborah, and I know she will serve the Company well as CFO.' 'I am honored to once again step into the role of CFO,' said Ms. Andrews. 'STAAR is a great company with great people and great technology. I am excited to work with Steve and the leadership team to drive sustainable growth while we continue to improve our cost structure to increase shareholder value.' Separately, STAAR announced the formation of a new committee of its Board of Directors, the Capital Stewardship Committee, which will be chaired by Board member Lilian Y. Zhou. The Board determined to establish this new committee to help guide the Company's financial strategies, including the responsible allocation, management and oversight of capital. Ms. Zhou brings extensive experience in institutional investing and investment banking to chair this new committee. 'Capital allocation is a key focus for STAAR given our growth prospects, strong cash flow generation, and opportunities to drive long-term value from our propriety Collamer ® material,' said Ms. Zhou. 'STAAR is dedicated to enhancing long-term shareholder returns, and I am excited to work with Steve and Deborah to drive STAAR's financial strategies and help build trust and credibility with investors.' In connection with the appointment of Ms. Andrews as CFO, the establishment of the Capital Stewardship Committee, and the Company's broader effort to reduce costs, the Company restructured its investor relations function. As a result, Brian Moore, Vice President, Investor Relations and Corporate Development, will be leaving STAAR, effective June 27, 2025. About STAAR Surgical STAAR Surgical (NASDAQ: STAA) is the global leader in implantable phakic intraocular lenses, a vision correction solution that reduces or eliminates the need for glasses or contact lenses. Since 1982, STAAR has been dedicated solely to ophthalmic surgery, and for 30 years, STAAR has been designing, developing, manufacturing, and marketing advanced Implantable Collamer® Lenses (ICLs), using its proprietary biocompatible Collamer material. STAAR ICL's are clinically-proven to deliver safe long-term vision correction without removing corneal tissue or the eye's natural crystalline lens. Its EVO ICL™ product line provides visual freedom through a quick, minimally invasive procedure. STAAR has sold more than 3 million ICLs in over 75 countries. Headquartered in Lake Forest, California, the company operates research, development, manufacturing, and packaging facilities in California and Switzerland. For more information about ICL, visit To learn more about STAAR, visit Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements in this press release that are not statements of historical fact are forward-looking statements, including statements about any of the following: the ability to achieve and anticipated success of efforts to improve the Company's cost structure, reduce the annual SG&A run rate, drive sustainable growth, allocate capital, generate cash flows, drive value from Collamer, and increase shareholder value. These forward-looking statements are neither promises nor guarantees and involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from what is expressed or implied by the forward-looking statements, including, but not limited to: our ability to continue our growth and profitability trajectory; our reliance on independent distributors in international markets; a slowdown or disruption to the Chinese economy; global economic conditions; disruptions in our supply chain; fluctuations in foreign currency exchange rates; international trade disputes (including involving tariffs) and substantial dependence on demand from Asia; changes in effective tax rate or tax laws; any loss of use of our principal manufacturing facility; competition; potential losses due to product liability claims; our exposure to environmental liability; data corruption, cyber-based attacks or network security breaches and/or noncompliance with data protection and privacy regulations; acquisitions of new technologies; climate changes; the willingness of surgeons and patients to adopt a new or improved product and procedure; extensive clinical trials and resources devoted to research and development; compliance with government regulations; the discretion of regulatory agencies to approve or reject existing, new or improved products, or to require additional actions before or after approval, or to take enforcement action; laws pertaining to healthcare fraud and abuse; changes in FDA or international regulations related to product approval; product recalls or failures; and other important factors set forth in the Company's Annual Report on Form 10-K for the year ended December 27, 2024 under the caption 'Risk Factors,' which is on file with the Securities and Exchange Commission (the 'SEC') and available in the 'Investor Information' section of the Company's website under the heading 'SEC Filings,' as any such factors may be updated from time to time in the Company's other filings with the SEC. Forward-looking statements speak only as of the date they are made and, except as may be required under applicable law, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Yahoo
24-06-2025
- Business
- Yahoo
Sangamo Therapeutics Announces Positive Topline Results From Registrational STAAR Study in Fabry Disease
STAAR study demonstrated positive mean annualized estimated glomerular filtration rate (eGFR) slope at 52-weeks across all dosed patients in the study, which U.S. Food and Drug Administration (FDA) has agreed will serve as primary basis of approval Isaralgagene civaparvovec showed a favorable safety and tolerability profile Sangamo intends to submit a Biologics License Application (BLA) in 2026 RICHMOND, Calif., June 24, 2025--(BUSINESS WIRE)--Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced positive topline results from the registrational Phase 1/2 STAAR study evaluating isaralgagene civaparvovec, or ST-920, a wholly owned investigational gene therapy for the treatment of adults with Fabry disease. Following a single dose of isaralgagene civoparvovec, a positive mean annualized eGFR slope of 1.965 mL/min/1.73m2/year (95% confidence interval (CI): -0.153, 4.083) at 52-weeks was observed across all 32 dosed patients in the study, which the FDA has agreed will serve as an intermediate clinical endpoint under the Accelerated Approval pathway. Furthermore, a mean annualized eGFR slope of 1.747 mL/min/1.73m2/year (95% CI: -0.106, 3.601) was observed for the 19 patients who have achieved 104-weeks of follow-up. As recommended by the FDA, Sangamo plans to compare the annualized mean eGFR slope of isaralgagene civaparvovec with approved treatments for Fabry disease by performing a meta-analysis of published studies. According to observational studies, estimated mean annualized eGFR slopes for other marketed treatment options range from -2.2 to -0.4 mL/min/1.73m2/year for treatments such as Replagal (agalsidase alfa)1, Fabrazyme (agalsidase beta)2 and Galafold (migalastat)3. We believe these data support the potential for isaralgagene civaparvovec as a one-time, durable treatment for Fabry disease that can improve patient outcomes and will form the basis for an anticipated BLA submission under the Accelerated Approval pathway as early as the first quarter of 2026. The STAAR study enrolled male and female patients who were either on enzyme replacement therapy (ERT), were ERT pseudo-naïve (defined as having been off ERT for six or more months), or were ERT-naïve. The median age of patients enrolled in the study was 42, with a median duration of follow-up of 24 months and the longest treated patient having achieved 4.5 years of follow-up. Key secondary endpoints in the study were also positive. Elevated expression of alpha-galactosidase A (α-Gal A) activity was maintained for up to 4.5 years for the longest treated patient. All 18 patients who began the study on ERT have been withdrawn from ERT and all remain off ERT as of today. Plasma lyso-Gb3 levels in these patients remained generally stable following ERT withdrawal. A stabilization in cardiac endpoints was also observed. Patients demonstrated a range of other clinical benefits, including improvements in disease severity reported in the Fabry Outcome Survey adaptation of the Mainz Severity Score Index (FOS-MSSI) age-adjusted score and statistically and clinically significant improvements in the short form-36 (SF-36) quality of life scores, including role-physical +14.8 (95% CI: 7.3, 22.4, p=0.0003), vitality +9.6 (95% CI: 3.9, 15.2, p=0.0017), bodily pain +9.0 (95% CI: 2.3, 15.7, p=0.0104), social functioning +7.8 (95% CI: 2.0, 13.6, p=0.0100), general health +7.4 (95% CI: 2.0, 12.8, p=0.0091), and physical component scores +4.2 (95% CI: 1.8, 6.6, p=0.0014), at week 52 compared to baseline. Statistically significant improvements in the gastrointestinal symptoms rating scale (GSRS) compared to baseline were also observed. Furthermore, following a single administration of isaralgagene civaparvovec, additional clinical benefits were observed in some patients, such as the reduction or elimination in pain medication usage and the resumption of sweating, that has enabled these patients to perform physical tasks and exercise. Isaralgagene civaparvovec demonstrated a favorable safety and tolerability profile in the study, without the requirement for preconditioning. The majority of adverse events were grade 1-2 in nature. The most common treatment-emergent adverse events (TEAEs) were pyrexia (60.6% of participants), COVID-19 (36.4%), headache (33.3%) and nasopharyngitis (33.3%). All TEAEs resolved in response to clinical management and there were no safety-related study discontinuations. "Fabry disease is a debilitating and multifaceted condition, for which there is a serious unmet medical need," said Nathalie Dubois-Stringfellow, Ph. D, Chief Development Officer at Sangamo. "We are thrilled to see these compelling topline STAAR study results, including the positive mean annualized eGFR slope at both 52 and 104 weeks, alongside notable improvements in a range of secondary endpoints. Taken together these data demonstrate the potential for a single dose of ST-920 to provide meaningful clinical benefits above current standards of care and to treat the underlying pathology of Fabry disease. We want to thank the patients and investigators who participated in this study and look forward to sharing these data with health authorities." Isaralgagene civaparvovec has been granted Orphan Drug, Fast Track and RMAT designations from the FDA, Orphan Medicinal Product designation and PRIME eligibility from the European Medicines Agency and Innovative Licensing and Access Pathway from U.K. Medicines and Healthcare products Regulatory Agency. Analyses of the full dataset from the STAAR study are ongoing and additional data will be presented at an upcoming medical meeting. Sangamo is advancing BLA preparation activities for isaralgagene civaparvovec, while continuing to engage in business development negotiations for a potential Fabry commercialization agreement. About the STAAR Study The Phase 1/2 STAAR study is a global open-label, single-dose, dose-ranging, multicenter clinical study designed to evaluate isaralgagene civaparvovec, or ST-920, a gene therapy product candidate in patients with Fabry disease. Isaralgagene civaparvovec requires a one-time infusion without preconditioning. About Fabry Disease Fabry disease is a lysosomal storage disorder caused by mutations in the galactosidase alpha gene (GLA), which leads to deficient alpha-galactosidase A (α-Gal A) enzyme activity, which is necessary for metabolizing globotriaosylceramide (Gb3). The buildup of Gb3 in the cells can cause serious damage to vital organs, including the kidney, heart, nerves, eyes, gut and skin. Symptoms of Fabry disease can include decreased or absent sweat production, heat intolerance, angiokeratoma (skin blemishes), vision problems, kidney disease, heart failure, gastrointestinal disturbance, mood disorders, neuropathic pain and tingling in the extremities. About Sangamo Therapeutics Sangamo Therapeutics is a genomic medicine company dedicated to translating ground-breaking science into medicines that transform the lives of patients and families afflicted with serious neurological diseases who do not have adequate or any treatment options. Sangamo believes that its zinc finger epigenetic regulators are ideally suited to potentially address devastating neurological disorders and that its capsid discovery platform can expand delivery beyond currently available intrathecal delivery capsids, including the central nervous system. Sangamo's pipeline also includes multiple partnered programs and programs with opportunities for partnership and investment. To learn more, visit and connect with us on LinkedIn and X. 1 Replagal (agalsidase alfa) estimated mean annualized eGFR slope: -2.2 mL/min/1.73m2/year (95% CI: -2.8, -1.7) in male patients and -0.7 mL/min/1.73m2/year (95% CI: -1.4, 0) in female patients (Source: Feriozzi, 2012: The effectiveness of long-term agalsidase alfa therapy in the treatment of Fabry nephropathy)2 Fabrazyme (agalsidase beta) estimated mean annualized eGFR slope: -1.5 mL/min/1.73m2/year (Source: Fabrazyme Package Insert: Galafold (migalastat) estimated mean annualized eGFR slope: -0.4 mL/min/1.73m2/year (95% CI: -2.27, 1.48) (Source: Hughes, 2016: Oral pharmacological chaperone migalastat compared with enzyme replacement therapy in Fabry disease: 18-month results from the randomized phase III ATTRACT study) Forward-Looking Statements This press release contains forward-looking statements regarding Sangamo's current expectations. These forward-looking statements include, without limitation, statements relating to: the safety and efficacy and therapeutic potential of isaralgagene civaparvovec, including the potential for it to be a one-time, durable treatment option for Fabry disease that can improve patient outcomes and treat the underlying pathology of Fabry disease; the presentation of clinical data from the Phase 1/2 STAAR study; the potential for isaralgagene civaparvovec to qualify for the FDA's Accelerated Approval program, including the adequacy of data generated in the Phase 1/2 STAAR study to support any such approval; expectations concerning the availability of additional data to support a potential BLA submission for isaralgagene civaparvovec, and the timing of such submission; the potential to accelerate the expected timeline to approval of isaralgagene civaparvovec; Sangamo's plans to seek a potential collaboration partner for ST-920; and other statements that are not historical fact. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to Sangamo's lack of capital resources to obtain regulatory approval for and commercialize its product candidates in a timely manner or at all, including the ability to secure a collaboration partner for ST-920; the uncertain timing and unpredictable nature of clinical trial results, including the risk that preliminary or topline data is not indicative of final results, that the therapeutic effects observed in the latest clinical data from the Phase 1/2 STAAR study will not be durable in patients and that final clinical trial data from the study will not validate the safety and efficacy of isaralgagene civaparvovec, including that the 52-week data from the Phase 1/2 STAAR study will not support a BLA submission and/or that the 104-week data from such study will not verify the clinical benefit of isaralgagene civaparvovec or support FDA approval, and that the patients withdrawn from ERT will remain off ERT; Sangamo's need for substantial additional funding to execute its operating plan and to continue to operate as a going concern; the effects of macroeconomic factors or financial challenges on the global business environment, healthcare systems and Sangamo's business and operations; the research and development process; the unpredictable regulatory approval process for product candidates across multiple regulatory authorities; the potential for technological developments that obviate technologies used by Sangamo; Sangamo's reliance on collaborators and the potential inability to secure additional collaborations; and Sangamo's ability to achieve expected future financial performance. All forward-looking statements about Sangamo's future plans and expectations, including Sangamo's development plans for its product candidates, are subject to Sangamo's ability to secure adequate additional funding. There can be no assurance that Sangamo and its current or potential future partners will be able to develop commercially viable products. Actual results may differ materially from those projected in these forward-looking statements due to the risks and uncertainties described above and other risks and uncertainties that exist in the operations and business environments of Sangamo and its collaborators. These risks and uncertainties are described more fully in Sangamo's Securities and Exchange Commission, or SEC, filings and reports, including in Sangamo's Annual Report on Form 10-K for the year ended December 31, 2024, as supplemented by its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, each filed with the SEC, and future filings and reports that Sangamo makes from time to time with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Sangamo undertakes no duty to update such information except as required under applicable law. View source version on Contacts Investor Relations Louise Wilkieir@ Media Inquiries Melinda Hutcheonmedia@
CBS News
18-06-2025
- Science
- CBS News
STAAR test results are out. Here's how to look up your student's scores.
Results for the State of Texas Assessments of Academic Readiness exams were released this week, showing improvement in certain areas across the state. Results for math, reading language arts, science and social studies STAAR exams that were taken this spring were released on June 17. Results for exams taken in June will be released on July 31, according to the Texas Education Agency How to look up your student's STAAR test results Log on to and enter your student's unique six-character code, date of birth and legal first name. Your student's unique code should be the same every year. If you don't know your student's code, you can look it up under "Information and Support" and entering their first name and Social Security number. 2025 STAAR test results show slight improvement across Texas Students across Texas continue to show growth in reading, but more than half remain below grade level in math, a concern for long-term academic success, test results show. Despite the positive momentum, some experts remain cautious. "It was really encouraging to see continued growth in reading," said Gabe Grantham, policy advisor for the nonprofit Texas 2036. "But more than half our students are below grade level in math, which is just not okay when we're thinking about how core those skills are for academic and post-academic success."
Yahoo
17-06-2025
- Politics
- Yahoo
Texas students make gains in reading but struggle with math, STAAR scores show
Texas' students saw some wins in reading but continued to struggle to bounce back from pandemic-related learning losses in math, state testing results released Tuesday showed. Elementary students who took the State of Texas Assessments of Academic Readiness exam this year made the biggest gains in reading across grade levels. Third graders saw a three percentage point increase in reading, a milestone because early literacy is a strong indicator of future academic success. Progress among middle students in the subject, meanwhile, slowed. 'These results are encouraging and reflect the impact of the strategic supports we've implemented in recent years,' said Texas Education Agency Commissioner Mike Morath. 'We are seeing meaningful signs of academic recovery and progress.' Morath also acknowledged students needed more help to make similar gains in math. Five years after pandemic-related school closures, students are still struggling to catch up in that subject, the results showed. About 43% of students met grade-level standards for math, compared to 50% in 2019. The STAAR exam tests all Texas public school students in third through eighth grade in math and reading. A science test is also administered for third and eighth graders, as well as a social studies test for eighth graders. The test scores give families a snapshot of how Texas students are learning. School accountability ratings — which the Texas Education Agency gives out to each district and campus on an A through F scale as a score for their performance — are also largely based on how students do on the standardized tests. The test often casts a shadow over classrooms at the end of the year, with teachers across the state saying they lose weeks of valuable instructional time preparing children to take the test. Parents also don't like the test because of its high-stakes nature and the enormous pressure it puts on students. A bill that would have scrapped the STAAR test died in the last days of the 2025 legislative session. Both Republican and Democratic legislators expressed a desire to overhaul STAAR, but in the end, the House and Senate could not align on what they wanted out of an alternative test. Legislators this session did expand support for the state's youngest students to help them catch up before they first take their STAAR test in third grade. A sweeping school finance package also included new statewide assessment tools in early childhood learning, and targeted academic intervention for students who are struggling. This is a developing story; check back for details. Big news: 20 more speakers join the TribFest lineup! New additions include Margaret Spellings, former U.S. secretary of education and CEO of the Bipartisan Policy Center; Michael Curry, former presiding bishop and primate of The Episcopal Church; Beto O'Rourke, former U.S. Representative, D-El Paso; Joe Lonsdale, entrepreneur, founder and managing partner at 8VC; and Katie Phang, journalist and trial lawyer. Get tickets. TribFest 2025 is presented by JPMorganChase.
Yahoo
13-06-2025
- General
- Yahoo
Fort Worth ISD reports 2024 STAAR results, prioritizes literacy in ongoing overhaul
The Brief Fort Worth ISD announced preliminary 2024 STAAR results showing gains in reading and most subjects across grades 3-8. The district surpassed its strategic plan literacy goal and saw improvements in 4th and 5th-grade reading and math, and US History and Biology EOCs. FWISD acknowledges challenges in English I and II and plans a full curriculum redesign and new literacy/math frameworks for the 2025-26 school year. FORT WORTH, Texas - Fort Worth ISD (FWISD) announced their preliminary 2024 STAAR results on Tuesday and states their intentional focus on literacy is already resulting in gains for students across the district. Big picture view On Tuesday, during the regularly scheduled Board of Trustees meeting included FWISD Superintendent Dr. Karen Molinar. Dr. Molinar presented preliminary STAAR scores from spring testing. The preliminary data showed reading performance scores are on the rise. FWISD not only met its strategic plan literacy goal but surpassed it by four percentage points. What they're saying "Beyond third grade reading, we are also seeing gains in nearly every tested subject in third through eighth grades, a strong signal that our instructional strategies and support systems are driving meaningful outcomes for students across the district," Superintendent Dr. Karen Molinar said. "Our work does not stop here. In fact, it's only just begun. Moving forward, we have to remain focused on literacy and be willing to make changes in areas we are not performing as we should be," Molinar added. By the numbers Results for the grades 3-8 STAAR showed no decreases in reading scores for all grades, with gains ranging from 2-7%. Preliminary scores also show: • 4th grade reading and math scores went up at all levels – Approaches, Meets, and Masters. • 5th grade reading scores improved at the Meets and Masters levels, while the Approaches level stayed the same. The biggest gain was at the Meets level, with a 5% increase. • The percentage of students achieving the Masters level in US History increased to 25%, reflecting growth among our highest-performing students. • 85% of students taking the Biology EOC scored at Approaches Grade Level or higher, and the percentage meeting or exceeding grade level expectations rose significantly. Dig deeper FWISD says they recognize the challenges in English I and II performance and are diving deeper into the data to act with urgency to address performance challenges. Superintendent Dr. Molinar is putting new measures in place to address these deficiencies, such as demo classrooms with instructional modeling, and a full curriculum redesign with tiered support tailored to student needs. What's next As FWISD moves into the 2025-26 school year and implements the District Wide Strategic Plan, every decision Fort Worth ISD makes will focus on what truly drives student success. The district is already launching a bold and aggressive redesign of literacy and math frameworks. This includes more instructional time in middle schools, a new phonics program for kindergarten through second grade, and enhanced dyslexia tools. "We will continue to work to give every student in Fort Worth ISD the tools they need to succeed. I am proud of our teachers and students and what they accomplished this year, but we will hit the ground running in August and continue to improve. Every second and every student counts", said Molinar. The Source Information in this article was provided by the Fort Worth Independent School District.
