Latest news with #VX-880
Boston Globe
2 days ago
- Business
- Boston Globe
Vertex to lay off 125 employees in R.I., consolidate offices
Related : Companies are required Nina Devlin, a spokesperson for Vertex, confirmed to the Globe on Wednesday that once the positions are terminated, there will be a total of approximately 60 employees remaining in Rhode Island. Advertisement 'We value the contributions of every team member impacted, and we are committed to ensuring as smooth a transition as possible, including offering severance, outplacement support, and career counseling,' Devlin said in a statement. Get Rhode Map A weekday briefing from veteran Rhode Island reporters, focused on the things that matter most in the Ocean State. Enter Email Sign Up The layoffs come as a blow to the state's life sciences sector, which local officials Related : Vertex most recently announced it would As a result, 'certain roles related specifically to the VX-264 program have been eliminated,' according to Devlin. Advertisement 'Vertex remains committed to bringing transformative therapies to people living with [type 1 diabetes] and to progressing our cell therapy program, zimislecel (VX-880), which is in Phase 3 development,' Devlin said. The company currently operates out of three Providence buildings. Vertex plans to soon consolidate its operations into its site at 225 Carolina Ave. in Providence. A publicly traded company, Vertex's headquarters are based in both Boston and London. Outside of Rhode Island, Vertex is one of the biomedical companies seeing bright spots in a time of uncertainty as it earned Alexa Gagosz can be reached at
Yahoo
28-03-2025
- Business
- Yahoo
Vertex Announces Program Updates for Type 1 Diabetes Portfolio
- VX-264 Phase 1/2 enrollment and dosing complete in Parts A and B: VX-264 was generally safe and well tolerated; efficacy data are not supportive of further clinical advancement - - Zimislecel (VX-880) pivotal trial on track to complete enrollment and dosing in H1 2025; Vertex expects to submit marketing applications to global regulators in 2026 - - Continue to progress multiple novel, research-stage immunoprotective approaches - BOSTON, March 28, 2025--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced several updates on the Company's type 1 diabetes (T1D) portfolio. VX-264 UpdateVertex has completed enrollment and dosing in Parts A and B of the Phase 1/2 VX-264 (cells + device) study and the planned analysis at Day 90 for Part B. In Part B of the study, participants received the full dose of the investigational fully differentiated pancreatic islet cell therapy encapsulated in a proprietary immunoprotective device. There were two primary endpoints in Part B, safety and change in peak C-peptide during a mixed-meal tolerance test (MMTT) from baseline at Day 90. VX-264 was generally safe and well tolerated; however, the study did not meet the efficacy endpoint. Increases in C-peptide, a marker of insulin production, were not observed at levels necessary to deliver benefit. Therefore, VX-264 will not be advancing further in clinical trials. Vertex plans to conduct further analyses, including of explanted devices, to better understand these findings. Zimislecel UpdateZimislecel (formerly VX-880), Vertex's investigational fully differentiated islet cell therapy with standard immunosuppression, is in the Phase 3 portion of the Phase 1/2/3 study in patients with T1D with severe hypoglycemic events (SHEs) and impaired awareness of hypoglycemia. This pivotal trial is well underway and on track to complete enrollment and dosing in the first half of 2025, setting up global regulatory submissions in 2026. Zimislecel has previously 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). Consistent with this progress, Vertex is investing in expanding its manufacturing and commercial capabilities to ensure launch readiness. If approved, eligible patients across the U.S. and Europe with recurrent SHEs despite best available care could benefit from zimislecel, and Vertex anticipates that initial approval could serve approximately 60,000 people with severe T1D. T1D Research UpdateVertex is also pursuing research-stage T1D programs to evaluate additional approaches that could provide transformative benefit to people with T1D and reduce or eliminate the need for standard immunosuppressive regimens. These approaches include alternative immunosuppressive regimens, gene-edited hypoimmune stem-cell derived islet cell therapies, and novel devices to encapsulate islet cells. "We'd like to thank the patients, physicians and T1D community who participated in the VX-264 study. Today's data show that more work needs to be done to advance the 'cells plus device' program, and we are committed to doing so," said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer, Vertex Pharmaceuticals. "Equally, we are very pleased with the rapid progress of our zimislecel program, which is on track to complete enrollment and dosing in the Phase 3 study this summer, positioning us for global regulatory submissions in 2026. We're excited for the opportunity to bring the promise of zimislecel to patients as quickly as possible." 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 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, statements by Carmen Bozic, M.D., and statements regarding Vertex's plans and expectations for the clinical trial evaluating VX-264, including plans to conduct further analyses, expectations for the clinical trial evaluating zimislecel, including expectations for the trial to complete enrollment and dosing in the first half of 2025 and expectations for global regulatory submissions in 2026, plans to invest in manufacturing and commercial capabilities to ensure zimislecel launch readiness, expectations for the patient population that could benefit from zimislecel, and plans to progress multiple novel, research-stage immunoprotective approaches. 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 the company's research and development programs may not support development or registration of its compounds due to safety, efficacy or other reasons, that clinical trial data might not be available on the expected timeline, and other risks listed under Risk Factors in Vertex's most recent annual report 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. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available. (VRTX-GEN) View source version on Contacts Vertex Pharmaceuticals IncorporatedInvestors:InvestorInfo@ Media:mediainfo@ Sign in to access your portfolio
Yahoo
26-01-2025
- Business
- Yahoo
Is Vertex Pharmaceuticals Stock a Buy in 2025?
The healthcare sector has struggled to deliver worthwhile returns for investors since 2021, weighed down by several headwinds. Rising interest rates, challenges in the U.S. healthcare system, and the inherent risks of drug development have contributed to the sector's underperformance relative to the broader markets during this period. However, some healthcare companies have bucked this downward trend in the post-pandemic era. Notably, Vertex Pharmaceuticals (NASDAQ: VRTX), which focuses on developing treatments for rare diseases, has significantly outpaced both its biotechnology peers and the S&P 500 since early 2022. With the biotech company's stock already posting impressive gains of over 9% in early 2025, it's worth examining whether Vertex stock remains a compelling buy right now. Vertex has built an empire in cystic fibrosis (CF) treatment, recently crowning its dominance with Alyftrek's approval last month. This latest CF drug adds even more firepower to a franchise already set to rake in approximately $10.9 billion last year. With patents locked up into the 2030s and rivals nowhere in sight, Vertex's CF fortress looks impregnable. The company has methodically built this position through years of innovation, leaving would-be competitors in the dust. But the real excitement lies in Vertex's push beyond CF, where years of investment are finally bearing fruit. All eyes are on Jan. 30, when the FDA weighs in on suzetrigine -- a potential game-changer for pain treatment that could offer an alternative to addictive opioids. If approved, Wall Street analysts think suzetrigine will eventually generate blockbuster-level sales (greater than $1 billion annually). The core reason is the drug's novel mechanism of action and potential to be a viable alternative to highly addictive opioids. The biotech also has a burgeoning gene therapy portfolio and pipeline. Working with CRISPR Therapeutics, Vertex has hit the ground running with Casgevy, its gene therapy for blood disorders. Moreover, its experimental cell therapy for type 1 diabetes, Zimislecel (formerly VX-880), has shown remarkable early results, setting the stage for the therapy to enter a pivotal-stage trial. At 23.8 times forward earnings, Vertex stock trades in line with the broader S&P 500 index, which is at 23.6 times earnings -- a surprising valuation for a company with a dominant market share and high barriers to entry. Wall Street sees plenty of growth ahead, projecting an 8.2% jump in sales for 2025 as new products gain traction. The balance sheet tells an equally compelling story: Vertex has $11.2 billion in cash and minimal debt, under $2 billion. This financial strength gives management ample room to pursue strategic deals or accelerate pipeline development as opportunities arise. The company's modest market multiple, combined with robust growth prospects and a fortress-like balance sheet, reflects management's disciplined approach to building long-term value. Few biotechs can match Vertex's combination of growth potential and financial stability. Vertex stands at an inflection point, with its CF franchise providing a rock-solid foundation while multiple late-stage programs could dramatically expand its reach. The next 12 months look particularly eventful, with decisions due on suzetrigine in acute pain, upcoming readouts in diabetes, and the continued rollout of Casgevy with partner CRISPR Therapeutics. This wouldn't be Vertex's first successful reinvention, having already transformed from a hepatitis C player into the dominant force in CF treatment. The company's methodical expansion into pain, diabetes, and kidney disease follows this proven playbook of tackling complex diseases with high unmet needs. With a bulletproof CF business generating a mountain of cash, minimal competition on the horizon in this key area, and multiple shots at billion-dollar markets, Vertex offers a compelling mix of stability and upside potential. The bottom line is few companies can match its combination of established leadership in rare diseases and realistic pathways to significant market expansion, making Vertex stock a worthwhile buy in 2025. Before you buy stock in Vertex Pharmaceuticals, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Vertex Pharmaceuticals wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $874,051!* Now, it's worth noting Stock Advisor's total average return is 937% — a market-crushing outperformance compared to 178% for the S&P 500. Don't miss out on the latest top 10 list. Learn more » *Stock Advisor returns as of January 21, 2025 George Budwell has positions in CRISPR Therapeutics. The Motley Fool has positions in and recommends CRISPR Therapeutics and Vertex Pharmaceuticals. The Motley Fool has a disclosure policy. Is Vertex Pharmaceuticals Stock a Buy in 2025? was originally published by The Motley Fool Sign in to access your portfolio
