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Libtayo® (cemiplimab) Phase 3 Data in the Adjuvant Treatment of Post-Surgical High-Risk Cutaneous Squamous Cell Carcinoma (CSCC) Have Potential to Be Practice-Changing
Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death, the primary endpoint of the trial (p<0.0001) Libtayo also demonstrated 80% and 65% reductions in the risk of locoregional and distant recurrence, respectively, compared to placebo Detailed results presented in an oral session at the 2025 American Society of Clinical Oncology Annual Meeting and simultaneously published in the Regulatory applications have been submitted in the United States and European Union TARRYTOWN, N.Y., May 31, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced detailed analyses from the Phase 3 C-POST trial, which evaluated PD-1 inhibitor Libtayo® (cemiplimab) in patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery. The results, shared during an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the New England Journal of Medicine (NEJM), include additional data for the primary endpoint of disease-free survival (DFS) and the first presentation of key secondary endpoint outcomes. 'While surgery and radiotherapy remain the cornerstones of treatment for high-risk cutaneous squamous cell carcinoma, there is a critical unmet need for systemic therapies to help prevent relapse and metastasis to ultimately drive better outcomes for patients,' said Danny Rischin, M.D., M.B.B.S., F.R.A.C.P., Research Lead, Head and Neck Cancer and Cutaneous SCC, Department of Medical Oncology at the Peter MacCallum Cancer Centre in Melbourne, Australia, and lead investigator of the trial. 'The Phase 3 C-POST trial demonstrates that cemiplimab is a highly active therapy in high-risk CSCC, with clinically meaningful outcomes across primary and secondary endpoints and exceptionally low rates of locoregional and distant recurrence.' Results from the C-POST trial shared earlier this year established Libtayo as the first immunotherapy to show a statistically significant and clinically meaningful benefit in high-risk CSCC in the adjuvant setting. In contrast, negative results with another PD-1 are presented at ASCO. The data with Libtayo at this year's ASCO provide additional insights for the primary endpoint of DFS – defined as time from randomization to the first documented disease recurrence or death – as well as first results for the secondary endpoints of freedom from locoregional recurrence, freedom from distant recurrence and overall survival (OS). With a median duration of follow-up of 24 months (range: 2-64 months), efficacy results for Libtayo compared to placebo, were as follows: 68% reduction in the risk of disease recurrence or death (hazard ratio [HR]: 0.32; 95% confidence interval [CI]: 0.20-0.51; p<0.0001), with median DFS not reached for Libtayo-treated patients (versus 49 months for placebo) At two years, DFS was 87% with Libtayo versus 64% with placebo 80% reduction in the risk of locoregional recurrence (HR: 0.20; 95% CI: 0.09-0.40) 65% reduction in the risk of distant recurrence (HR: 0.35; 95% CI: 0.17-0.72) Updated OS data from a recent data cut, with approximately six months of additional follow up after the primary analysis for DFS, suggest an emerging OS benefit for Libtayo (HR: 0.78; 95% CI: 0.39-1.56) versus placebo. 'These results show the continued promise of Libtayo in non-melanoma skin cancers,' said Israel Lowy, M.D., Ph.D., Clinical Development Unit Head, Oncology, at Regeneron. 'Libtayo is the first medicine to demonstrate a statistically significant benefit in patients who have high-risk features for recurrence after resection of cutaneous squamous cell carcinoma and has the potential to become a new standard of care in the adjuvant setting. We are working with global regulatory authorities to bring this new option to patients as quickly as possible.' Additionally, an exploratory analysis of the C-POST results showed similar rates of DFS regardless of PD-L1 expression level. Specifically, Libtayo reduced the risk of disease recurrence or death by 72% in tumors with PD-L1 ≥1% (HR: 0.28; 95% CI: 0.15-0.52; n=309) and by 68% in tumors with PD-L1 <1% (HR: 0.32; 95% CI: 0.12-0.86; n=85), compared to placebo. Safety was assessed in 205 patients in the Libtayo arm and 204 patients in the placebo arm. Adverse events (AEs) of any grade occurred in 91% and 89% of patients in the Libtayo arm and the placebo arm, respectively. Grade ≥3 AEs occurred in 24% and 14% of patients in the Libtayo arm and the placebo arm, respectively. The most common AEs occurring in at least 10% of patients in the Libtayo arm were fatigue, pruritus, rash, diarrhea, arthralgia, hypothyroidism and maculo-paplar rash. The only grade ≥3 AE that occurred in more than 2% of patients in the Libtayo arm was hypertension. Treatment discontinuations due to AEs, regardless of attribution, occurred in 10% and 2% of patients in the Libtayo arm and the placebo arm, respectively. Two patients experienced an AE leading to death in each arm. The potential use of Libtayo described above is investigational, and its safety and efficacy has not been evaluated by any regulatory authority for this indication. Regulatory applications have been submitted for Libtayo in the treatment of adjuvant CSCC in the United States and European Union. About the Phase 3 TrialC-POST is one of several trials from Regeneron's oncology portfolio and pipeline being shared at ASCO. C-POST was a randomized, placebo-controlled, double-blind, multicenter, global Phase 3 trial investigating Libtayo versus placebo as adjuvant treatment for patients with features associated with a high-risk of CSCC recurrence and who had completed surgery and post-operative radiation therapy. Trial participants were at high risk of recurrence due to nodal features (extracapsular extension or ≥3 involved lymph nodes) and/or non-nodal features (in-transit metastases, T4 lesion, perineural invasion, or locally recurrent tumor with ≥1 additional poor prognostic features). The trial enrolled 415 patients who were randomized to receive either Libtayo (n=209) or placebo (n=206) for up to 48 weeks. For the first 12 weeks, Libtayo 350 mg or placebo was administered intravenously every three weeks, followed by Libtayo 700 mg or placebo administered intravenously every six weeks for 36 weeks. About Regeneron in Cancer We aspire to turn revolutionary discoveries into medicines that can transform the lives of those impacted by cancer. Our team around the world is driven to solve the needs and challenges of those affected by one of the most serious diseases of our time. Backed by our legacy of scientific innovation and a deep understanding of biology, genetics and the immune system, we're pursuing potential therapies across more than 30 types of solid tumors and blood cancers. Our cancer strategy is powered by cutting-edge technologies and therapies that can be flexibly combined to investigate potentially transformative treatments for patients. Oncology assets in clinical development comprise nearly half of Regeneron's pipeline, and include checkpoint inhibitors, bispecific antibodies and costimulatory bispecific antibodies. Our approved PD-1 inhibitor Libtayo serves as the backbone of many of our investigational combinations. To complement our extensive in-house capabilities, we collaborate with patients, healthcare providers, governments, biopharma companies and each other to further our shared goals. Together, we are united in the mission to serve as a beacon of transformation in cancer care. About Libtayo Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary VelocImmune® technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. Libtayo has been approved by regulatory authorities in more than 30 countries in one or more indications, including for certain adult patients with advanced basal cell carcinoma (BCC), advanced CSCC, advanced non-small cell lung cancer (NSCLC) and advanced cervical cancer. In the U.S., the generic name for Libtayo in its approved indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. FDA. Outside of the U.S., the generic name of Libtayo in its approved indications is cemiplimab. The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority. U.S. FDA-approved Indications Libtayo is a prescription medicine used to treat: People with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation. People with a type of skin cancer called basal cell carcinoma (BCC) when your BCC cannot be removed by surgery (locally advanced BCC) or when it has spread (metastatic BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with a HHI. Adults with a type of lung cancer called non-small cell lung cancer (NSCLC). LIBTAYO may be used in combination with chemotherapy that contains a platinum medicine as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor does not have an abnormal 'EGFR,' 'ALK,' or 'ROS1' gene. LIBTAYO may be used alone as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high 'PD-L1,' and your tumor does not have an abnormal 'EGFR,' 'ALK,' or 'ROS1' gene. It is not known if Libtayo is safe and effective in children. IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS What is the most important information I should know about LIBTAYO? LIBTAYO is a medicine that may treat certain cancers by working with your immune system. LIBTAYO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended. Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Lung problems: cough, shortness of breath, or chest pain Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach-area (abdomen) pain or tenderness Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach-area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than normal Hormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetite Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodes Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with LIBTAYO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruising Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: nausea, vomiting, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swelling Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with LIBTAYO. Your healthcare provider will monitor you for these complications Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with LIBTAYO. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with LIBTAYO if you have severe side effects. Before you receive LIBTAYO, tell your healthcare provider about all your medical conditions, including if you: have immune system problems such as Crohn's disease, ulcerative colitis, or lupus have received an organ transplant have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic) have received radiation treatment to your chest area have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome are pregnant or plan to become pregnant. LIBTAYO can harm your unborn baby Females who are able to become pregnant: Your healthcare provider will give you a pregnancy test before you start treatment You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of LIBTAYO. Talk to your healthcare provider about birth control methods that you can use during this time Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LIBTAYO are breastfeeding or plan to breastfeed. It is not known if LIBTAYO passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of LIBTAYO when used alone include tiredness, muscle or bone pain, rash, diarrhea, and low levels of red blood cells (anemia). The most common side effects of LIBTAYO when used in combination with platinum-containing chemotherapy include hair loss, muscle or bone pain, nausea, tiredness, numbness, pain, tingling, or burning in your hands or feet, and decreased appetite. These are not all the possible side effects of LIBTAYO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals at 1-877-542-8296. Please see full Prescribing Information, including Medication Guide. About Regeneron's Technology Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spend decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo, Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). In addition, REGEN-COV® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit or follow Regeneron on LinkedIn, Instagram, Facebook or X. Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ('Regeneron' or the 'Company'), and actual events or results may differ materially from these forward-looking statements. Words such as 'anticipate,' 'expect,' 'intend,' 'plan,' 'believe,' 'seek,' 'estimate,' variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, 'Regeneron's Products') and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, 'Regeneron's Product Candidates') and research and clinical programs now underway or planned, including without limitation Libtayo® (cemiplimab); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, such as Libtayo as an adjuvant treatment for patients with high-risk cutaneous squamous cell carcinoma following surgery as discussed in this press release as well as Libtayo as a monotherapy or in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron's Products (such as Libtayo) and Regeneron's Product Candidates; the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron's Products (such as Libtayo) and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron's Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates (including biosimilar versions of Regeneron's Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2024 and its Form 10-Q for the quarterly period ended March 31, 2025. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website ( and its LinkedIn page ( Contacts: Media Relations Investor Relations Taylor Ramsey Skott Mark Hudson Tel: +1 914-409-2381 Tel: +1 914-847-3482 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
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2 days ago
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Press Release: Itepekimab met the primary endpoint in one of two COPD phase 3 studies
Itepekimab met the primary endpoint in one of two COPD phase 3 studies AERIFY-1 study met its primary endpoint of a statistically significant reduction in moderate or severe exacerbations in former smokers regardless of eosinophilic phenotype and provided a clinically meaningful benefit AERIFY-2 study, a second Phase 3 study, did not meet the primary endpoint despite a benefit seen earlier in the study Itepekimab was generally well tolerated in both AERIFY-1 and AERIFY-2 Sanofi and Regeneron are assessing the data and will discuss with regulatory authorities to evaluate next steps Paris and Tarrytown, NY, May 30, 2025. The AERIFY-1 phase 3 study evaluating itepekimab in former smokers with inadequately controlled chronic obstructive pulmonary disease (COPD) met the primary endpoint of a statistically significant reduction in moderate or severe acute exacerbations compared to placebo of 27% at week 52, a clinically meaningful benefit. The AERIFY-2 phase 3 study did not meet the same primary endpoint, although a benefit was seen earlier in the trial. In the studies, patients were randomized to receive itepekimab every two weeks (AERIFY-1: n=375; AERIFY-2: n=326), every four weeks (AERIFY-1: n=377; AERIFY-2: n=303), or placebo (AERIFY-1: n=375; AERIFY-2: n=324), which was added to inhaled triple or double standard-of-care therapy. The primary endpoint analysis for AERIFY-1 and AERIFY-2 was the reduction in the annualized rate of acute moderate or severe COPD exacerbations with itepekimab treatment. The table below summarizes the reductions in moderate or severe exacerbations (itepekimab compared to placebo) through weeks 24 and 52: AERIFY-1 AERIFY-2 Week 24 Week 52 Week 24 Week 52 Itepekimab every two weeks 30% 27%a 18% 2% Itepekimab every four weeks 34% 21%a 21% 12% a Formal significance testing was only performed at 52 weeks in the Phase 3 trials, with significance achieved for both the every two-week arm and every four-week arm in AERIFY-1 The total number of exacerbations were lower than prospectively anticipated, decreasing the power of both trials. Enrollment largely occurred during the time of the global COVID pandemic, which could have contributed to the overall lower exacerbation rates. Executive Vice President, Head of Research and Development at Sanofi'While we are encouraged by the results of AERIFY-1, the results of both studies merit further exploration to have a full understanding of the data and the role that IL33 plays in this complex disease. Certain people with COPD are in desperate need of new treatment options, especially those who continue to experience exacerbations despite being on maximal therapy, and we remain committed to discussing these data with regulatory agencies to evaluate our path forward.' The safety profile of itepekimab was consistent across dosing regimens, and adverse events (AEs) were generally comparable between treatment and placebo groups. In AERIFY-1, the overall rates of AEs were 67% and 68% for itepekimab every two weeks and every four weeks, respectively, compared to 68% for placebo. In AERIFY-2, the overall rates of AEs were 64% and 71% for itepekimab every two weeks and every four weeks, respectively, compared to 64% for placebo. In AERIFY-1, the rate of serious infections was 7% for each itepekimab arm, compared to 10% for placebo. In AERIFY-2, the rate of serious infections was 10% and 7% for itepekimab every two weeks and every four weeks, respectively, compared to 7% for placebo. AEs leading to death were 1% for each itepekimab arm compared to 2% for placebo in AERIFY-1, and 3% for each itepekimab arm compared to 2% for placebo in AERIFY-2. Anti-drug antibodies were rare and had no apparent impact on itepekimab drug levels. Sanofi and Regeneron are reviewing the data and will discuss with regulatory authorities to evaluate next steps. Detailed results from these studies will be presented at a future medical meeting. Itepekimab is currently being evaluated in other studies, including chronic rhinosinusitis with nasal polyps (CRSwNP), chronic rhinosinusitis without nasal polyps (CRSsNP), and bronchiectasis. Board co-Chair, President and Chief Scientific Officer at Regeneron'COPD is a particularly complex disease, and novel approaches are needed to address the multiple underlying biological disease driver. We are proud of our work in this challenging treatment landscape, bringing Dupixent – the first-ever biologic medicine for COPD – to certain patients who previously had very limited options remaining. We are encouraged by the initial results from AERIFY-1 and are carefully reviewing the results from both itepekimab trials to inform next steps. We remain committed to our broader itepekimab development program. The learnings will be invaluable as we continue to advance itepekimab in respiratory diseases with unmet need.' The safety and efficacy of itepekimab are currently under clinical investigation and have not been fully evaluated by any regulatory authority. About itepekimabItepekimab is a fully human monoclonal antibody that binds to and inhibits interleukin-33 (IL33), an initiator and amplifier of broad inflammation in COPD. IL33 is thought to be involved in different types of inflammation and is particularly elevated in the lungs of former smokers. Itepekimab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement and is currently in clinical development programs for CRSwNP (phase 3), non-cystic fibrosis bronchiectasis (phase 2), and CRSsNP (phase 2). About the AERIFY clinical study programAERIFY-1 and AERIFY-2 phase 3 studies were randomized, Phase 3, double-blind, placebo-controlled studies that evaluated the efficacy and safety of itepekimab in 1,127 (AERIFY-1) and 953 (AERIFY-2) adults aged 40-85 years who were former smokers with moderate-to-severe COPD. Former smokers were defined as those who have not smoked for at least six months. Treatments were administered subcutaneously and added to double therapy (inhaled corticosteroid [ICS] plus long-acting beta2-agonist [LABA] or long-acting muscarinic antagonist [LAMA] plus LABA) or a maximal standard-of-care inhaled triple therapy (ICS, LABA and LAMA). The primary endpoint for AERIFY-1 and AERIFY-2 was the annualized rate of acute moderate or severe COPD exacerbations. Moderate exacerbations were defined as those requiring systemic steroids and/or antibiotics. Severe exacerbations, also assessed separately as a pre-specified endpoint, were defined as those: requiring hospitalization; more than 24 hours of observation in an emergency department or urgent care facility; or resulting in death. The AERIFY program includes two additional ongoing trials: AERIFY-3, a Phase 2 mechanistic study assessing the impact of itepekimab on airway inflammation in patients with COPD, and AERIFY-4, a Phase 3 study assessing the long-term safety of itepekimab in patients with COPD. About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and creating compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. About RegeneronRegeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit or follow Regeneron on LinkedIn, Instagram, Facebook or X. Sanofi Media RelationsSandrine Guendoul | +33 6 25 09 14 25 | Evan Berland | +1 215 432 0234 | Le Bourhis | +33 6 75 06 43 81 | Rouault | +33 6 70 93 71 40 | Gilbert | +1 516 521 2929 | Ubaldi | +33 6 30 19 66 46 | Sanofi Investor RelationsThomas Kudsk Larsen |+44 7545 513 693 | Kaisserian | +33 6 47 04 12 11 | Lauscher | +1 908 612 7239 | Browne | +1 781 249 1766 | Pham | +33 7 85 93 30 17 | Elgoutni | +1 617 710 3587 | Châtelet | +33 6 80 80 89 90 | Li | +33 6 84 00 90 72 | Regeneron Media RelationsHannah Kwagh | +1 914-847-6314| Regeneron Investor RelationsMark Hudson | +1 914-847-3482 | Sanofi forward-looking statementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words 'expects', 'anticipates', 'believes', 'intends', 'estimates', 'plans', and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under 'Risk Factors' and 'Cautionary Statement Regarding Forward-Looking Statements' in Sanofi's annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi group except for VelociSuite and Regeneron Genetics Center. Regeneron forward-looking statements and use of digital media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ('Regeneron' or the 'Company'), and actual events or results may differ materially from these forward-looking statements. Words such as 'anticipate,' 'expect,' 'intend,' 'plan,' 'believe,' 'seek,' 'estimate,' variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, 'Regeneron's Products') and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, 'Regeneron's Product Candidates') and research and clinical programs now underway or planned, including without limitation itepekimab in adults who were former smokers with inadequately controlled chronic obstructive pulmonary disease ('COPD') and other potential indications; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, such as itepekimab for the treatment of COPD as discussed in this press release as well as itepekimab for the treatment of chronic rhinosinusitis with nasal polyps, non-cystic fibrosis bronchiectasis, and chronic rhinosinusitis without nasal polyps; any feedback that may be provided by regulatory authorities on the results from the AERIFY-1 and AERIFY-2 trials discussed in this press release, including the impact of any such feedback on any potential regulatory approval of itepekimab; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron's Products and Regeneron's Product Candidates (such as itepekimab); the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; 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the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2024 and its Form 10-Q for the quarterly period ended March 31, 2025. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website ( and its LinkedIn page ( Attachment Press ReleaseError 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
News.com.au
6 days ago
- Entertainment
- News.com.au
Inside Emma Stone's $41 million renovated estate
Emma Stone has listed her newly renovated Texas estate for a hefty $US26.5 million ($A41.1 million). Located in the upscale Tarrytown neighbourhood, the 1.25-acre property will be among the most expensive on the market in Austin, Realtor reports. According to Eric Moreland of Moreland Properties/Forbes Global Properties, one of the listing agents, the actress and her husband, comedy writer Dave McCary spent more than three years renovating and restoring the home. Moreland said the couple's New York business interests have expanded since they started the remodel, and while they hope to live in Austin eventually, it doesn't make sense for now. The couple, who are co-founders of the production company Fruit Tree, own a roughly $US12 million ($A18 million) apartment in lower Manhattan, according to property records. Stone is slated to star in the upcoming contemporary Western film 'Eddington.' It's unclear what Stone and McCary paid for the Austin property, since Texas is a nondisclosure state. The Georgian-style brick house dates to around 1940, making it one of the oldest estates in the area. The roughly 10,000-square-foot estate includes a main house with four bedrooms and a two-bedroom guesthouse. The property also has a pool, a hot tub, and a garage with a screening room and entertaining space above. As part of the renovation, the couple removed, cleaned and reused all the exterior brick. The pair also reconfigured some of the living spaces, opening the kitchen to the living room for a more modern layout. It took more than a year just to install the millwork in the screening room, said Moreland. The contractors are now putting the finishing touches on the property, he said. The 'La La Land' actress has a track record of buying and selling her homes for significantly more than she paid. In 2022, she sold her blufftop Malibu, Calififornia, home for $US4.425 million after buying it for $US3.25 million in 2018, according to property records. Last year, she sold her home in L.A.'s Comstock Hills neighbourhood for $US4.3 million, significantly more than the $US2.3 million she paid in 2019.
Forbes
22-05-2025
- Entertainment
- Forbes
Emma Stone's $26.5 Million Austin Estate Lists After Four-Year Renovation
Hidden behind high walls yet only minutes from downtown Austin, Emma Stone's Tarrytown estate blends seclusion and convenience. Renovation is a slow burn. For multi award-winning actor Emma Stone and comedy-writer and producer Dave McCary, that burn lasted four years—long enough for the pair to carve deeper roots in New York, long enough for a project once intimate to become impossibly remote. The couple's unfinished Austin sanctuary is now on the market at $26.5 million, offering a new steward the rare chance to direct its dazzling finale. The address is 2109 Rockmoor Avenue, a leafy corner of Tarrytown where magnolia leaves blanket the streets and celebrity sightings prompt more knowing nods than star-struck squeals. Privacy, yes, but conversely a sense of quiet community. Streets remain walkable. Schools rank highly. Lake Austin sits minutes away for a paddle or a dusk cruise. The 1.24-acre grounds read like a country estate: water features, a cutting garden, fairy garden and broad lawn space. In that context, a discreet iron gate and a brick drive feel less like luxury than necessary etiquette. That said, listing agent Eric Moreland notes the walled, 1.24-acre parcel is a rare pocket of private breathing-room—hard to come by in Tarrytown and harder still across Austin. Stone and McCary bought the 1940s manor in 2021, seeing potential in its dignified brick and the guardian oaks that flank the plot. They then set about coaxing it into the 21st century without silencing its past. Brick in the Georgian-style façade was removed, cleaned and re-used, a meticulous process that allowed steel skeletons and poured concrete to slip behind the home's historic skin. Glass walls followed, pulling Hill Country sunlight deep into rooms that had once squeezed rays in through small windows. Eighty percent of the work is finished, according to Moreland. The remaining finishing touches are set to wrap by summer. Every installed element of the near-complete renovation of Emma Stone and Dave McCary's 1940s-era property is squarely top-tier. Inside, craftsmanship channels old-world flourish. Herringbone oak clashes playfully with reclaimed brick, a syncopated conversation in wood and clay. Fireplaces and countertops wear thick, cream-toned marble. Leaded-glass panes peek through arched openings, winking at the past. Heritage, rewritten. 'The goal from day one was to craft a modern estate that still feels anchored to Tarrytown,' notes Moreland, who shares the listing with fellow Moreland Properties agent Diane Humphreys. 'Rooted in tradition yet forward-thinking in design and livability.' Structural bones aside, architects Cuppett Kilpatrick preserved the original footprint where they could, bending additions around venerable oaks. Outdoor rooms unfurl beside their canopy—terraces for twilight suppers, a future pool deck pitched toward the lake breeze. Nearby, an auxiliary two-bedroom cottage seals the estate status. Handsome millwork imbues the four-bedroom main house with an old-world glamour. Fitting for an actor, the house hides a cinematic lair. Walnut-clad cabinetry conceals secret doors, a full bar waits in the wings, and double insulation teams with acoustic fabric overhead to uncork genuine theater hush. Elsewhere, a glass-wrapped solarium absorbs the day's full rays, while a wood-paneled library keeps counsel. Historic homes like 2109 Rockmoor Avenue can be found in steady supply across Austin, yet the city's future-leaning ethos spills into its rooftops, where new construction steers much of the market's current momentum. Still, discerning buyers are in search of soul without inheriting every squeaky joist. Rockmoor Avenue threads that needle. Though the famous couple may have never officially lived in the estate, their imprint lingers in bespoke flourishes and highly considered materials. Of course, craft never comes cheap. But, according to Moreland, starting over from scratch would cost more than money—it would cost narrative. 'In today's market, new construction feels prescriptive and often like a sterile blank canvas. A project like this offers a refreshing and completely elevated residence without starting from scratch.' Moreland Properties is a member of Forbes Global Properties, an invitation-only network of top-tier brokerages worldwide and the exclusive real estate partner of Forbes.
Wall Street Journal
20-05-2025
- Entertainment
- Wall Street Journal
Emma Stone Asks $26.5 Million for Freshly Renovated Austin Home
In 2021, actress Emma Stone purchased a historic estate in Austin, Texas, with a plan to move her family there. Four years later, she has instead decided to put the property on the market. The actress and her husband, comedy writer Dave McCary, are asking $26.5 million for the newly renovated estate, according to Eric Moreland of Moreland Properties/Forbes Global Properties, one of the listing agents. The 1.25-acre property, located in the upscale Tarrytown neighborhood, will be among the most expensive on the market in Austin.
