logo
Navigating ADA Requests In The Era Of Return-To-Office Mandates

Navigating ADA Requests In The Era Of Return-To-Office Mandates

Forbes25-04-2025

Seth Turner is the Founder and Senior Advisor of AbsenceSoft . getty
Since companies started pushing return-to-office mandates, we've seen a significant uptick in employees submitting reasonable accommodation requests under the Americans with Disabilities Act (ADA). Why? Not everyone is willing or able to go back to the office, and employees are pulling the ADA into play in a completely new way. This massive shift in the use of the ADA requests started during Covid-19, when we learned that so many jobs could be done at home.
The problem: Not all requests for accommodations fall within the purview of the ADA. As such, employers are struggling to balance their employees' needs with their operational needs and legal obligations. This deluge of requests has placed a significant burden on human resource managers as they try to navigate the intricacies of the accommodations.
The ADA requires employers to provide reasonable accommodations unless it creates an undue hardship . The challenge is defining what's 'reasonable' in this new work environment. Before the pandemic, remote work was sometimes seen as an undue hardship. However, after it was proven possible during the pandemic, employers have to ensure their RTO plans are justifiable, clear and consistently applied. You can't tell someone they have to work in the office if five of their peers in the same job are remote.
Keep in mind that to be eligible for a reasonable accommodation under the ADA, the employee must:
• Have a disability or impairment that substantially limits a major life activity; and
• Be qualified to perform the essential functions of the role with or without a reasonable accommodation.
The ADA guidance can be vague, making it hard to determine what constitutes an undue hardship. The EEOC notes that employers should not deny a remote work accommodation 'solely because a job involves some contact and coordination with other employees.'
In AbsenceSoft's 2025 State of Leave and Accommodations , we found that remote work made up 51% of accommodation requests and was the most requested accommodation under the ADA. The second most frequently requested accommodation was intermittent leave or reduced schedules, which accounted for 46% of requests. And, for the second year in a row, the majority of HR managers we surveyed (60%) reported an increase in requests. Of those who saw an increase, 62% saw requests rise by 21% or more.
Mental health conditions like anxiety and PTSD are among the most common reasons for remote work requests. Autoimmune disorders and mobility impairments are also coming up frequently, with employees stating that commuting poses a health risk.
However, not all requests for reasonable accommodations fall under the ADA. We're hearing from HR managers that people are asking for an accommodation because they don't have child care, which is not a disability and, therefore, not a valid request under the ADA. Do employers need to allow remote work as a reasonable accommodation?
When it comes to reasonable accommodations, employers must conduct an individualized assessment rather than applying blanket policies. Remote work may not always be feasible; employers need clear justifications for in-office requirements. It's in everybody's best interest to make an accommodation where it makes sense. But if it doesn't make sense, then it's okay to say no.
Some accommodations can be alternatives to remote work. Maybe a neurodiverse employee needs to be at home for quiet time, or maybe they just need a quieter office or noise-canceling headphones instead. The Interactive Process: Engaging In Good-Faith Discussions
The interactive process involves gathering information, evaluating alternatives and implementing accommodations. It's a back-and-forth discussion where both the employer and employee explore possible accommodations. Employers must engage in a structured, documented dialogue with employees, and training managers to properly handle accommodation requests is crucial. Simply denying a request without considering alternatives can lead to legal trouble.
When an employer gets a request, they can use the interactive process to determine whether the employee's condition rises to the level of disability under the ADA, determine why the disability might necessitate working from home and offer other types of accommodations that would allow the person to remain in the workplace. Legal Risks Of Mishandling ADA Requests
Mishandling ADA requests can lead to legal action and reputational damage for the employer. As such, employers must be cautious about rejecting remote work requests without justification. Companies that outright reject remote work requests without considering alternatives are at risk of ADA lawsuits.
We've already seen litigation where employees claim they were unfairly denied accommodations that were granted during the pandemic. One example is the EEOC v. FedEx case that is currently pending litigation. In this case, a FedEx dispatcher worked remotely from 2020 to 2023 and asked to continue after FedEx required employees to return to the office, but the request was denied.
Conversely, not all accommodation requests based on what was allowed during COVID are reasonable. There was an EEOC case ( Jordan v. Norfolk Public School board ) where a school principal requested remote work because it was allowed at the beginning of the pandemic when schools switched to virtual learning environments. The court ruled the request was an undue hardship because principals need to be physically present to perform the essential duties of their job. Best Practices For HR And Legal Teams
First, employers should proactively define job roles and expectations to avoid legal gray areas and update job descriptions to clearly state which roles are remote, hybrid or in-office. HR teams should document every step of the interactive process and provide clear reasons if a request is denied.
Employers should embrace flexibility while maintaining legal compliance. That said, consistency is key—employees in the same role should be treated equally.
Update policies and train staff on ADA accommodations to minimize risks and prevent compliance issues. Training managers to handle accommodation discussions sensitively is critical because missteps can escalate into formal complaints. Engage in the interactive process for every request and present a menu of alternative accommodation options as part of the process. And, while you're at it, document everything in case a complaint arises.
With all of the policies, processes and documentation required to maintain compliance, many businesses find it useful to utilize technology to help them keep track of everything. Housing information, like when a process was kicked off, the decision criteria for denial or approval, records of supporting medical documentation and other pertinent information within a software platform, allows for easier access and reporting. Audit trails are very important, and if you're not leveraging automation and tracking, you're going to spend a lot of time on administration instead of focusing on the negotiation process.
At the end of the day, it's about balancing business needs with fairness to employees. The business value is clear: 56% of accommodations cost zero dollars and boost retention. When handled correctly, these accommodations increase productivity, morale, and employee loyalty.
The information provided here is not legal advice and does not purport to be a substitute for advice of counsel on any specific matter. For legal advice, you should consult with an attorney concerning your specific situation.
Forbes Human Resources Council is an invitation-only organization for HR executives across all industries. Do I qualify?

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Vertex Presents Positive Data for Zimislecel in Type 1 Diabetes at the American Diabetes Association 85th Scientific Sessions
Vertex Presents Positive Data for Zimislecel in Type 1 Diabetes at the American Diabetes Association 85th Scientific Sessions

Yahoo

time33 minutes ago

  • Yahoo

Vertex Presents Positive Data for Zimislecel in Type 1 Diabetes at the American Diabetes Association 85th Scientific Sessions

– Results from the study continue to demonstrate the transformative potential of zimislecel with consistent and durable patient benefit – – All 12 patients with at least one year of follow-up who received a full dose of zimislecel as a single infusion achieved ADA-recommended target HbA1c levels <7% and >70% time-in-range (70-180 mg/dL), and 10/12 patients were insulin free – – Data presented at ADA simultaneously published in the New England Journal of Medicine – – Vertex to host investor webcast tonight, June 20, 2025, at 7:15 p.m. CT / 8:15 p.m. ET – BOSTON, June 20, 2025--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced simultaneous presentation and publication of updated data from the Phase 1/2 portion of the Phase 1/2/3 FORWARD-101 clinical trial of zimislecel (VX-880), an investigational stem cell-derived, fully differentiated islet cell therapy, in people with type 1 diabetes (T1D) with impaired hypoglycemic awareness and severe hypoglycemic events (SHEs). The data were featured in an oral presentation at the American Diabetes Association (ADA) annual conference in Chicago as part of the symposium, "Innovation and Progress in Stem Cell-Derived Islet-Cell Replacement Therapy," from 6:15-6:30 p.m. CT (abstract 2025-A-1921) and published online by the New England Journal of Medicine. The data are from 12 patients who received the full dose of zimislecel as a single infusion and were followed for at least one year, as of October 2024. Results from the study to date continue to demonstrate the transformative potential of zimislecel with consistent and durable patient benefit with longer follow-up. All 12 participants: Demonstrated engraftment with glucose-responsive endogenous C-peptide production, which was durable through one year of follow-up. Achieved the ADA targets of HbA1c <7% and time in range of >70%. Were free of SHEs from day 90 onwards. Had a reduction in exogenous insulin use (mean reduction in daily insulin dose: 92%). 10/12 (83%) no longer required exogenous insulin at Month 12. Achieved the Phase 1/2 primary endpoint of elimination of SHEs with HbA1c <7%. Zimislecel continues to be generally well tolerated. Most adverse events (AEs) were mild or moderate, and there were no serious AEs related to zimislecel treatment. As previously reported, two patient deaths occurred, both unrelated to treatment with zimislecel. The safety profile is generally consistent with the immunosuppressive regimen used in the study, the infusion procedure, and complications from long-standing diabetes. "These data on the first fully differentiated, stem cell-derived, off-the-shelf islet cell therapy continue to be unprecedented. The magnitude, consistency and durability of the results from all 12 patients with more than one year of follow-up reinforce the transformative potential of zimislecel for people living with T1D complicated by severe hypoglycemia," said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. "We are excited to complete enrollment and dosing in the Phase 1/2/3 Program and look forward to potential regulatory submissions next year." "It's remarkable to see 12 out of 12 patients with baseline HbA1c above 7% and multiple severe hypoglycemic events reach consensus targets for glycemic control by both HbA1c and time in range as well as elimination of severe hypoglycemic events," said Michael R. Rickels, M.D., M.S., Medical Director, Pancreatic Islet Cell Transplant Program, Willard and Rhoda Ware Professor in Diabetes and Metabolic Diseases, Presenting Author and Steering Committee Co-Chair for the zimislecel clinical program, and author on the New England Journal of Medicine paper. "As I think about my patients and the unmet need in the type 1 diabetes community, the results we've seen so far for restoring endogenous insulin secretion with a stem cell-derived islet therapy bring me hope and confidence for a transformative treatment option for individuals with type 1 diabetes in the not-so-distant future." About Type 1 DiabetesT1D results from the autoimmune destruction of insulin-producing beta cells in pancreatic islets. Insulin deficiency results in hyperglycemia and can lead to acute life-threatening complications such as diabetic ketoacidosis. People with T1D are reliant on lifelong treatment with exogenous insulin that requires careful monitoring of blood glucose levels. Even with the availability of advanced exogenous insulin delivery and glucose monitoring systems, people with T1D can have periods of very low and very high blood sugar levels. Exogenous insulin has a narrow therapeutic range and carries an inherent risk of causing low blood sugar levels or hypoglycemic events, which can potentially result in arrhythmias, seizures, coma and even death. Due to the limitations and complexities of exogenous insulin treatment, it can be difficult for people with T1D to achieve and maintain good glucose control. Exposure to prolonged periods of high blood glucose levels, or hyperglycemia, can lead to long-term complications such as nerve damage, kidney disease/failure, eye disease (including vision loss), cardiovascular disease, stroke and even death. HbA1c is a measure of average blood glucose over the most recent ~2-3 months, and the consensus guidance is to maintain an HbA1c of <7% to reduce the risk of long-term complications; only ~1 in 4 people with T1D globally meet this clinical target. Current standards of care do not address the underlying cause of the disease and leave people with T1D susceptible to both hypo- and hyperglycemia and their associated morbidity and mortality. There is no cure for T1D. About ZimislecelZimislecel (VX-880) is an investigational allogeneic stem cell-derived, fully differentiated, insulin-producing islet cell therapy manufactured using proprietary technology. Zimislecel is being evaluated for patients who have T1D with impaired hypoglycemic awareness and severe hypoglycemia. Zimislecel has the potential to restore the body's ability to regulate glucose levels by restoring pancreatic islet cell function, including glucose-responsive insulin production. Zimislecel is delivered by an infusion into the hepatic portal vein and requires chronic immunosuppressive therapy to protect the islet cells from immune rejection. The zimislecel trial has expanded to additional sites that are currently active and enrolling in the U.S., Canada and Europe. Zimislecel has been granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration, Priority Medicines (PRIME) designation from the European Medicines Agency (EMA), and has secured an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) from the UK Medicines and Healthcare products Regulatory Agency (MHRA). Zimislecel is investigational and has not been approved by health authorities globally. About VertexVertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 15 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on LinkedIn, Facebook, Instagram, YouTube and X. Special Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, (i) statements by Carmen Bozic, M.D., and Michael R. Rickels, M.D., M.S., in this press release, (ii) plans, expectations for, and the potential benefits of zimislecel, (iii) expectations for the Phase 1/2/3 clinical trial for zimislecel, including expectations for the trial to complete enrollment and dosing, and (iv) plans for potential regulatory submissions next year. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from a limited number of patients may not be indicative of final clinical trial results, that data from the company's research and development programs may not support registration or further development of its potential medicines in a timely manner, or at all, due to safety, efficacy, that timelines for regulatory submissions may be longer than anticipated, and other risks listed under the heading "Risk Factors" in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission at and available through the company's website at You should not place undue reliance on these statements, or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available. (VRTX-GEN) Investor Event and Webcast Vertex will host an investor event on Friday, June 20, 2025, at 7:15 p.m. CT/8:15 p.m. ET, in Chicago, to discuss the positive zimislecel data in type 1 diabetes. A live webcast of the presentation and Q&A portions can be accessed through the Investor Relations section of Vertex's website at An archived webcast will be available on the company's website. View source version on Contacts Vertex Pharmaceuticals IncorporatedInvestors: InvestorInfo@ Media: mediainfo@ orInternational: +44 20 3204 5275

Verdiva Bio to Present New Data Highlighting Once-Weekly Potential of Its Investigational Oral Obesity Candidates at the ADA 85th Scientific Sessions
Verdiva Bio to Present New Data Highlighting Once-Weekly Potential of Its Investigational Oral Obesity Candidates at the ADA 85th Scientific Sessions

Business Wire

time2 hours ago

  • Business Wire

Verdiva Bio to Present New Data Highlighting Once-Weekly Potential of Its Investigational Oral Obesity Candidates at the ADA 85th Scientific Sessions

LONDON & SAN FRANCISCO--(BUSINESS WIRE)--Verdiva Bio Limited ('Verdiva' or 'the Company') a clinical-stage biopharmaceutical company focused on developing innovative therapies for obesity and cardiometabolic disorders, will present new data showcasing the once-weekly potential of Verdiva's investigational oral GLP-1RA and amylin analog peptide candidates at the American Diabetes Association (ADA) 85th Scientific Sessions. 'These presentations underscore the potential value of our compounds as the only once-weekly oral amylin and oral GLP-1 receptor agonist (RA) candidates known to be advancing into clinical studies," said Dr. Mohamed Eid, CMO, Verdiva Bio Share 'Our first data presentation as Verdiva Bio at the prestigious ADA meeting marks a key milestone for our team. These presentations underscore the potential value of our compounds as the only once-weekly oral amylin and oral GLP-1 receptor agonist (RA) candidates known to be advancing into clinical studies,' stated Dr. Mohamed Eid, CMO at Verdiva. 'The early clinical and preclinical data not only show the potential of these compounds individually, but also the additive effect they may have in combination, highlighting the flexibility of our modular portfolio approach. At Verdiva Bio, we are committed to developing convenient, patient-friendly and commercially scalable therapeutic options for obesity, cardiometabolic disorders and related complications. We're excited about the potential of our once-weekly oral peptide candidates to help address this global health challenge.' VRB-101: An investigational once-weekly oral GLP-1 analog This presentation highlights new clinical pharmacokinetic data for VRB-101, an investigational, once-weekly, cAMP-biased oral GLP-1RA formulated with Verdiva's clinically validated, proprietary oral delivery technology T2026. Phase 1 results demonstrated that oral VRB-101 achieved drug levels comparable to, or exceeding, those of currently available once-weekly injectable GLP-1RA therapies. These findings support continued investigation of VRB-101 as a potential once-weekly, scalable oral therapeutic option for both weight reduction and long-term weight maintenance, with the potential to exert potent weight reduction and may improve adherence via a more patient-friendly dosing regimen. Poster Presentation #069 Title: VRB-101 is a potent oral GLP-1 tablet with once-weekly dosing potential Date/Time: June 21, 2025, 12:30–1:30 p.m. Central Time Location: Poster Hall (Hall F1) 068, McCormick Place Convention Center VRB-103: Efficacy of novel once-weekly oral amylin analog as a monotherapy, and in combination with VRB-101 in vivo A second presentation will share novel preclinical data on VRB-103, an investigational potentially once-weekly oral amylin analog, tested alone and in combination with VRB-101. In preclinical models, the rationally designed peptide combination showed an additive effect on body weight reduction. Additionally, co-formulation of these peptides in a single tablet with T2026 maintained comparable plasma exposure for both compounds. These data support continued development of VRB-103 as both a monotherapy and in combination with VRB-101. Poster Presentation #068 Title: Efficacy of a novel oral amylin analog and the development of an oral GLP-1/amylin co-formulated tablet to produce high in vivo plasma exposures Date/Time: June 21, 2025, 12:30–1:30 p.m. Central Time Location: Poster Hall (Hall F1) 068, McCormick Place Convention Center About Verdiva Bio Verdiva Bio is committed to developing next-generation therapies to help people living with obesity, cardiometabolic disorders, and related complications achieve better outcomes via more patient-friendly therapeutic options. Verdiva's most advanced product candidate is VRB-101, an oral GLP-1 peptide in clinical development that has demonstrated potential efficacy in a phase 1 study in Australia, which also confirmed the viability of once-weekly dosing potential. The Company is also developing a portfolio of amylin molecules, including oral and subcutaneous agonists, and other undisclosed programs that offer the potential for enhanced efficacy and improved tolerability. The Verdiva team will harness the emerging science in gut-brain biology and leverage their history of successful drug development to advance novel therapeutic options aiming to transform the lives of millions living with obesity worldwide. For more information, please visit

Vertex Presents Positive Data for Zimislecel in Type 1 Diabetes at the American Diabetes Association 85th Scientific Sessions
Vertex Presents Positive Data for Zimislecel in Type 1 Diabetes at the American Diabetes Association 85th Scientific Sessions

Business Wire

time3 hours ago

  • Business Wire

Vertex Presents Positive Data for Zimislecel in Type 1 Diabetes at the American Diabetes Association 85th Scientific Sessions

BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced simultaneous presentation and publication of updated data from the Phase 1/2 portion of the Phase 1/2/3 FORWARD-101 clinical trial of zimislecel (VX-880), an investigational stem cell-derived, fully differentiated islet cell therapy, in people with type 1 diabetes (T1D) with impaired hypoglycemic awareness and severe hypoglycemic events (SHEs). The data were featured in an oral presentation at the American Diabetes Association (ADA) annual conference in Chicago as part of the symposium, 'Innovation and Progress in Stem Cell-Derived Islet-Cell Replacement Therapy,' from 6:15-6:30 p.m. CT (abstract 2025-A-1921) and published online by the New England Journal of Medicine. The data are from 12 patients who received the full dose of zimislecel as a single infusion and were followed for at least one year, as of October 2024. Results from the study to date continue to demonstrate the transformative potential of zimislecel with consistent and durable patient benefit with longer follow-up. All 12 participants: Demonstrated engraftment with glucose-responsive endogenous C-peptide production, which was durable through one year of follow-up. Achieved the ADA targets of HbA1c <7% and time in range of >70%. Were free of SHEs from day 90 onwards. Had a reduction in exogenous insulin use (mean reduction in daily insulin dose: 92%). 10/12 (83%) no longer required exogenous insulin at Month 12. Achieved the Phase 1/2 primary endpoint of elimination of SHEs with HbA1c <7%. Zimislecel continues to be generally well tolerated. Most adverse events (AEs) were mild or moderate, and there were no serious AEs related to zimislecel treatment. As previously reported, two patient deaths occurred, both unrelated to treatment with zimislecel. The safety profile is generally consistent with the immunosuppressive regimen used in the study, the infusion procedure, and complications from long-standing diabetes. 'These data on the first fully differentiated, stem cell-derived, off-the-shelf islet cell therapy continue to be unprecedented. The magnitude, consistency and durability of the results from all 12 patients with more than one year of follow-up reinforce the transformative potential of zimislecel for people living with T1D complicated by severe hypoglycemia,' said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. 'We are excited to complete enrollment and dosing in the Phase 1/2/3 Program and look forward to potential regulatory submissions next year.' 'It's remarkable to see 12 out of 12 patients with baseline HbA1c above 7% and multiple severe hypoglycemic events reach consensus targets for glycemic control by both HbA1c and time in range as well as elimination of severe hypoglycemic events,' said Michael R. Rickels, M.D., M.S., Medical Director, Pancreatic Islet Cell Transplant Program, Willard and Rhoda Ware Professor in Diabetes and Metabolic Diseases, Presenting Author and Steering Committee Co-Chair for the zimislecel clinical program, and author on the New England Journal of Medicine paper. 'As I think about my patients and the unmet need in the type 1 diabetes community, the results we've seen so far for restoring endogenous insulin secretion with a stem cell-derived islet therapy bring me hope and confidence for a transformative treatment option for individuals with type 1 diabetes in the not-so-distant future.' About Type 1 Diabetes T1D results from the autoimmune destruction of insulin-producing beta cells in pancreatic islets. Insulin deficiency results in hyperglycemia and can lead to acute life-threatening complications such as diabetic ketoacidosis. People with T1D are reliant on lifelong treatment with exogenous insulin that requires careful monitoring of blood glucose levels. Even with the availability of advanced exogenous insulin delivery and glucose monitoring systems, people with T1D can have periods of very low and very high blood sugar levels. Exogenous insulin has a narrow therapeutic range and carries an inherent risk of causing low blood sugar levels or hypoglycemic events, which can potentially result in arrhythmias, seizures, coma and even death. Due to the limitations and complexities of exogenous insulin treatment, it can be difficult for people with T1D to achieve and maintain good glucose control. Exposure to prolonged periods of high blood glucose levels, or hyperglycemia, can lead to long-term complications such as nerve damage, kidney disease/failure, eye disease (including vision loss), cardiovascular disease, stroke and even death. HbA1c is a measure of average blood glucose over the most recent ~2-3 months, and the consensus guidance is to maintain an HbA1c of <7% to reduce the risk of long-term complications; only ~1 in 4 people with T1D globally meet this clinical target. Current standards of care do not address the underlying cause of the disease and leave people with T1D susceptible to both hypo- and hyperglycemia and their associated morbidity and mortality. There is no cure for T1D. About Zimislecel Zimislecel (VX-880) is an investigational allogeneic stem cell-derived, fully differentiated, insulin-producing islet cell therapy manufactured using proprietary technology. Zimislecel is being evaluated for patients who have T1D with impaired hypoglycemic awareness and severe hypoglycemia. Zimislecel has the potential to restore the body's ability to regulate glucose levels by restoring pancreatic islet cell function, including glucose-responsive insulin production. Zimislecel is delivered by an infusion into the hepatic portal vein and requires chronic immunosuppressive therapy to protect the islet cells from immune rejection. The zimislecel trial has expanded to additional sites that are currently active and enrolling in the U.S., Canada and Europe. Zimislecel has been granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration, Priority Medicines (PRIME) designation from the European Medicines Agency (EMA), and has secured an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) from the UK Medicines and Healthcare products Regulatory Agency (MHRA). Zimislecel is investigational and has not been approved by health authorities globally. About Vertex Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 15 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on LinkedIn, Facebook, Instagram, YouTube and X. Special Note Regarding Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, (i) statements by Carmen Bozic, M.D., and Michael R. Rickels, M.D., M.S., in this press release, (ii) plans, expectations for, and the potential benefits of zimislecel, (iii) expectations for the Phase 1/2/3 clinical trial for zimislecel, including expectations for the trial to complete enrollment and dosing, and (iv) plans for potential regulatory submissions next year. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from a limited number of patients may not be indicative of final clinical trial results, that data from the company's research and development programs may not support registration or further development of its potential medicines in a timely manner, or at all, due to safety, efficacy, that timelines for regulatory submissions may be longer than anticipated, and other risks listed under the heading 'Risk Factors' in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission at and available through the company's website at You should not place undue reliance on these statements, or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available. (VRTX-GEN) Vertex will host an investor event on Friday, June 20, 2025, at 7:15 p.m. CT/8:15 p.m. ET, in Chicago, to discuss the positive zimislecel data in type 1 diabetes. A live webcast of the presentation and Q&A portions can be accessed through the Investor Relations section of Vertex's website at An archived webcast will be available on the company's website.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store