Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by antihistamines FDA decision expected by April 18, 2025; if approved, Dupixent would be the first targeted therapy for CSU in a decade TARRYTOWN, N.Y. and PARIS, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc.... Read More

Oral presentation shares head-to-head results for investigational combination pozelimab plus cemdisiran vs. ravulizumab in paroxysmal nocturnal hemoglobinuria Initial results for odronextamab in first-line follicular lymphoma showcase compelling monotherapy potential and progress in the confirmatory trial Additional oral presentations explore odronextamab in areas of high unmet need, including the primary analysis in diffuse... Read More

TARRYTOWN, N.Y., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) will webcast management participation as follows: • Jefferies London Healthcare Conference at 11:00 a.m. BST (6:00 a.m. ET) on Tuesday, November 19, 2024 • Piper Sandler 36th Annual Healthcare Conference at 9:30 a.m. ET on Thursday, December 5, 2024 The sessions may be accessed from the "Investors & Media" page of Regeneron's... Read More

Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on Dupixent achieved histological disease remission at 16 weeks compared to placebo, which was sustained up to one year Dupixent is the first-ever medicine in the EU indicated to treat these young patients, who persistently struggle to eat at a critical stage in life where growth is crucial TARRYTOWN, N.Y. and PARIS, Nov. 06, 2024 (GLOBE... Read More

Third quarter 2024 revenues increased 11% to $3.72 billion versus third quarter 2023 Third quarter 2024 Dupixent ® global net sales (recorded by Sanofi) increased 23% to $3.82 billion versus third quarter 2023 Third quarter 2024 U.S. net sales for EYLEA HD ® and EYLEA ® increased 3% versus third quarter 2023 to $1.54 billion, including $392 million from EYLEA HD Third quarter 2024 Libtayo ® global net sales increased 24% to... Read More

Dupixent significantly reduced itch and hive activity from baseline; 41% of patients achieved well-controlled disease status Confirmatory data to support U.S. regulatory resubmission by year-end; if approved, Dupixent would be the first new targeted treatment for people living with chronic spontaneous urticaria in more than 10 years More than 300,000 people in the U.S. suffer from chronic spontaneous urticaria that is... Read More

88% of EYLEA HD patients had a last assigned dosing interval of ≥12 weeks at week 156, while sustaining visual and anatomic improvements achieved in the first 96 weeks, in this extension study of the Phase 3 PHOTON trial presented at AAO Patients switched to EYLEA HD experienced substantially slower fluid reaccumulation, as compared to their previous rate of fluid reaccumulation with EYLEA ® (aflibercept) Injection 2 mg The... Read More

Dupixent is indicated for the approximately 300,000 adults in the U.S. with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype Following recent approvals in the EU and China , the U.S. approval is based on two landmark Phase 3 trials that showed Dupixent achieved significant reduction in exacerbations, and also showed improvements in lung function and health-related quality of... Read More

Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark Phase 3 trials showing Dupixent significantly reduced exacerbations, improved lung function and also improved health-related quality of life COPD is the most prevalent chronic respiratory disease in China, and is a priority within the government’s Healthy China 2030 public health plan Dupixent is now... Read More

TARRYTOWN, N.Y., Sept. 26, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc . (NASDAQ: REGN ) today announced that it will report its third quarter 2024 financial and operating results on Thursday, October 31, 2024, before the U.S. financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day. Conference Call Information Participants may access the conference... Read More

Recommendation based on a Phase 3 trial showing a significantly greater proportion of children on Dupixent achieved histological remission compared to placebo, consistent with improvements seen in adults and adolescents If approved, Dupixent would be the first and only medicine in the EU indicated for EoE in this age group TARRYTOWN, N.Y. and PARIS, Sept. 20, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:... Read More

Following Priority Review, Dupixent is now available to patients as young as 12 years with inadequately controlled CRSwNP Current treatment options leave many patients with uncontrolled disease and often result in the recurrence of nasal polyps Dupixent is the leading biologic medicine for all five FDA-approved indications in new-to-brand prescriptions TARRYTOWN, N.Y. and PARIS, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Regeneron... Read More

Three new post-hoc analyses highlight EYLEA HD rapid and sustained fluid control and consistent safety profile over two years in patients with wet age-related macular degeneration (wAMD) New indirect comparison evaluates disease control of EYLEA HD and faricimab across different pivotal Phase 3 trials in wAMD TARRYTOWN, N.Y., Sept. 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced... Read More

Confirming the results of Study A, this second pivotal trial in biologic-naïve patients met primary and key secondary endpoints, showing treatment with Dupixent resulted in a nearly 50% reduction in itch and urticaria activity scores compared to placebo More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by antihistamines Data will support regulatory resubmission in the U.S. by year-end; if... Read More

Trial met the primary and all key secondary endpoints in adults with moderate-to-severe disease; five times more patients achieved sustained disease remission with Dupixent than placebo Dupixent is the first medicine to show significant steroid-sparing effect in this debilitating and life-threatening disease If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S. and European Union... Read More

Late-breaking data at WCLC show Libtayo monotherapy nearly doubled median overall survival and reduced the risks of death and disease progression by 41% and 50%, respectively, compared to chemotherapy WCLC presentation also reviews data on overall survival, progression-free survival and response rate among patients who added chemotherapy to Libtayo following disease progression TARRYTOWN, N.Y., Sept. 09, 2024 (GLOBE... Read More

At WCLC, five-year survival data to be presented on Libtayo (PD-1 inhibitor) first-line monotherapy in advanced non-small cell lung cancer At ESMO, l onger-term results with investigational fianlimab (LAG-3 inhibitor) plus Libtayo from initial trial in advanced melanoma show high clinical activity, including deepening responses, per blinded independent central review Regeneron to host virtual investor event to discuss... Read More

Approval of Ordspono is based on data demonstrating robust and durable responses in both relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma, including in the post-CAR-T setting Ordspono is Regeneron’s first approved bispecific antibody and will provide an off-the-shelf option that can be administered in the out-patient setting, with hope for complete remission TARRYTOWN, N.Y., Aug. 26, 2024 (GLOBE... Read More

20 abstracts, including 4 oral presentations, offer new treatment insights for chronic obstructive pulmonary disease (COPD), asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) Data from landmark Phase 3 trials for Dupixent in COPD reinforce exacerbation reduction and improvement in lung function compared to placebo, and provide new assessments on health-related quality of life across patient subgroups Additional... Read More

TARRYTOWN, N.Y., Aug. 20, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for linvoseltamab in relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies. This anticipated outcome was previously disclosed... Read More

TARRYTOWN, N.Y., Aug. 07, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) announces the following September 2024 investor events: Investor Conference Presentations • Morgan Stanley 22 nd Annual Global Healthcare Conference at 11:30 a.m. ET on Wednesday, September 4, 2024 • 2024 Wells Fargo Healthcare Conference at 12:45 p.m. ET on Thursday, September 5, 2024 The sessions may be accessed from the... Read More

Second quarter 2024 revenues increased 12% to $3.55 billion versus second quarter 2023 Second quarter 2024 Dupixent ® global net sales (recorded by Sanofi) increased 27% to $3.56 billion versus second quarter 2023 Second quarter 2024 U.S. net sales for EYLEA ® HD and EYLEA ® increased 2% to $1.53 billion versus second quarter 2023, including $304 million from EYLEA HD Second quarter 2024 Libtayo ® global net sales increased... Read More

TARRYTOWN, N.Y., July 31, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the winners of the 12th annual Regeneron Prize for Creative Innovation (the Regeneron Prize), an award that recognizes, celebrates and rewards outstanding talent and creativity from early-career scientists in biomedical research. Each year, Regeneron asks leading research universities across the United States to... Read More

First-in-world approval of Dupixent for adults with uncontrolled COPD with raised blood eosinophils based on two landmark Phase 3 trials showing Dupixent significantly reduced exacerbations, improved lung function and also improved health-related quality of life Dupixent is the first new treatment approach for COPD in more than a decade and a new option for approximately 220,000 adults in the European Union (EU) Approval... Read More

TARRYTOWN, N.Y., June 28, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL),... Read More

TARRYTOWN, N.Y., June 27, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) today announced that it will report its second quarter 2024 financial and operating results on Thursday, August 1, 2024, before the U.S. financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day. Conference Call Information Participants may access the conference... Read More

Majority of patients in this age group with eosinophilic esophagitis (EoE) receiving Dupixent achieved histologic remission, with improvements sustained up to one year Dupixent is the first and only treatment indicated for EoE in the U.S. for this age group TARRYTOWN, N.Y. and PARIS, June 26, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the New England Journal of Medicine... Read More

At 14-months median follow-up in the pivotal trial, 50% of patients achieved a complete response or better and a 71% overall response rate, as presented in an EHA oral presentation and simultaneously published in the Journal of Clinical Oncology Also presented at EHA, a retrospective study of patient outcomes that compared investigational linvoseltamab to real-world standard-of-care treatment in clinical practice TARRYTOWN,... Read More

Approval in patients with pJIA weighing 63kg or greater adds to Kevzara’s position in treating adult chronic inflammatory conditions of moderately to severely active rheumatoid arthritis and polymyalgia rheumatica TARRYTOWN, N.Y. and CAMBRIDGE, MA, June 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration has approved Kevzara ®... Read More

Recommendation for adults with uncontrolled COPD with raised blood eosinophils based on data from two landmark Phase 3 trials demonstrating Dupixent significantly reduced exacerbations and improved lung function If approved, Dupixent would be the first-ever targeted therapy for COPD in the EU and the first new treatment approach for this disease in more than a decade TARRYTOWN, N.Y. and PARIS, May 31, 2024 (GLOBE NEWSWIRE)... Read More

TARRYTOWN, N.Y. and PARIS, May 31, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic... Read More

Oral presentation to highlight activity of REGN7075 in combination with Libtayo from dose-escalation portion of trial in patients with microsatellite stable colorectal cancer, which has historically proven unresponsive to immunotherapy Ongoing REGN7075 Phase 1/2 trial is investigating a potentially first-in-class combination across a range of advanced solid tumors TARRYTOWN, N.Y., May 23, 2024 (GLOBE NEWSWIRE) -- Regeneron... Read More

NOTUS results confirm landmark data from the Phase 3 BOREAS trial and show Dupixent significantly reduced exacerbations by 34% and improved lung function, compared to placebo, in uncontrolled chronic obstructive pulmonary disease (COPD) with evidence of type 2 inflammation Data support the potential of Dupixent as the first new treatment approach in more than a decade and first-ever targeted therapy for COPD TARRYTOWN, N.Y.... Read More

TARRYTOWN, N.Y. and WASHINGTON, D.C., May 17, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Society for Science (the Society) announced that Grace Sun, 16, of Lexington, Kentucky, won the $75,000 top award, the George D. Yancopoulos Innovator Award, named in honor of the pioneering drug researcher and Regeneron co-Founder, Board co-Chair, President and Chief Scientific Officer, in the 2024... Read More

If approved, Dupixent would be the first treatment in the U.S. indicated for adolescents aged 12-17 years with inadequately controlled CRSwNP, a condition driven in part by underlying type 2 inflammation that obstructs the sinuses and nasal passages and can lead to a loss of sense of smell Current treatment options for adolescents with CRSwNP leave many patients with uncontrolled disease and often result in the recurrence of... Read More

Preliminary data detailed in an ASGCT oral presentation include results for one of the youngest children in the world to receive a gene therapy for genetic deafness Ongoing Phase 1/2 CHORD trial is currently enrolling infants and children in the U.S., UK and Spain TARRYTOWN, N.Y., May 08, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the investigational gene therapy DB-OTO... Read More

TARRYTOWN, N.Y., May 06, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) will webcast management participation as follows: RBC Capital Markets Global Healthcare Conference at 9:00 a.m. ET on Tuesday, May 14, 2024 Jefferies Global Healthcare Conference at 8:30 a.m. ET on Wednesday, June 5, 2024 Goldman Sachs 45 th Annual Global Healthcare Conference at 8:00 a.m. ET on Tuesday, June 11, 2024 The... Read More

First quarter 2024 revenues decreased 1% to $3.15 billion versus first quarter 2023; excluding Ronapreve TM (a)(b) , revenues increased 7% First quarter 2024 Dupixent ® global net sales (recorded by Sanofi) increased 24% to $3.08 billion versus first quarter 2023 First quarter 2024 U.S. net sales for EYLEA ® HD and EYLEA ® were $1.40 billion, including $200 million from EYLEA HD First quarter 2024 Libtayo ® global net sales... Read More

TARRYTOWN, N.Y., April 29, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the presentation of positive long-term results and subgroup analyses from the pivotal clinical program of EYLEA ® HD (aflibercept) Injection 8 mg. The presentations are part of 14 accepted abstracts on EYLEA HD and EYLEA ® (aflibercept) Injection 2 mg that will be shared at the Association for Research in Vision... Read More

Mammoth’s proprietary ultracompact CRISPR-based gene editing platform and Regeneron’s proprietary delivery technologies set to advance in vivo programs in multiple tissue and cell types Mammoth to receive $100 million total upfront payment and equity investment from Regeneron at signing TARRYTOWN, N.Y., April 25, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) and Mammoth Biosciences, Inc., today... Read More

Oral presentation will feature new data for investigational REGN7075, an EGFRxCD28 costimulatory bispecific with the potential to enhance the treatment of certain advanced solid tumors in combination with Libtayo ® (cemiplimab-rwlc) 17 presentations to highlight Regeneron's investigational pipeline including checkpoint inhibitors, CD3 bispecifics and CD28 costimulatory bispecifics TARRYTOWN, N.Y., April 24, 2024 (GLOBE... Read More

Oral presentations include updated results from clinical study of otoferlin gene therapy DB-OTO demonstrating restoration in children with profound genetic hearing loss Additional presentations cover progress in novel genetic medicine delivery systems and immune response modulation TARRYTOWN, N.Y., April 22, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that new and updated data... Read More

TARRYTOWN, N.Y., April 07, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the oral plenary session presentation of positive pivotal data from the Phase 1/2 LINKER-MM1 trial of linvoseltamab in patients with relapsed/refractory (R/R) multiple myeloma (MM) at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego. Linvoseltamab is an investigational... Read More

TARRYTOWN, N.Y., April 01, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) today announced that it will report its first quarter 2024 financial and operating results on Thursday, May 2, 2024, before the U.S. financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day. Conference Call Information Participants may access the conference call... Read More

TARRYTOWN, N.Y., March 25, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued Complete Response Letters (CRLs) for the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) and in R/R diffuse large B-cell lymphoma (DLBCL), each after two or more lines of systemic therapy. The... Read More

TARRYTOWN, N.Y. and WASHINGTON, D.C., March 12, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) and Society for Science (the Society) announced that Achyuta Rajaram, 17, of Exeter, NH, won the top award in the Regeneron Science Talent Search (STS) 2024, America’s oldest and most prestigious science and math competition for high school seniors. The competition, now in its 83rd year, has consistently... Read More

TARRYTOWN, N.Y., March 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the U.S. Food & Drug Administration (FDA) has extended the approval of Praluent ® (alirocumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies to include pediatric patients aged 8 and older with heterozygous familial hypercholesterolemia (HeFH). “Many children with... Read More

Published results show EYLEA HD with extended 12- or 16-week dosing regimens demonstrated non-inferior vision gains to standard of care EYLEA ® (aflibercept) Injection 2 mg with fixed 8-week dosing in patients with wAMD and DME in the first year EYLEA HD has shown impressive durable visual improvements and rapid and resilient fluid control with a safety profile comparable to EYLEA Extended dosing intervals with EYLEA HD have... Read More

Priority Review granted based on positive results from two Phase 3 trials; i f approved, Dupixent would be the only biologic therapy for COPD and the first new treatment approach for this disease in more than a decade Regulatory submissions are also under review in China and Europe Dupixent is the leading biologic treatment for all five of its FDA-approved indications in new-to-brand prescriptions in the U.S. TARRYTOWN, N.Y.... Read More

TARRYTOWN, N.Y., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies. The target action date for the FDA... Read More

Approval based on results from Phase 3 trial showing Dupixent significantly reduced itch compared to placebo CSU is the fifth approved indication for Dupixent in Japan and the sixth indication for Dupixent globally TARRYTOWN, N.Y. and PARIS, Feb. 16, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted... Read More

TARRYTOWN, N.Y., Feb. 06, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) will webcast management participation as follows: Oppenheimer 34 th Annual Healthcare Life Sciences Conference at 1:20 p.m. ET on Wednesday, February 14, 2024 TD Cowen 44 th Annual Health Care Conference at 11:10 a.m. ET on Wednesday, March 6, 2024 Barclays 26 th Annual Global Healthcare Conference at 11:15 a.m. ET on Tuesday,... Read More

Fourth quarter 2023 revenues increased 1% to $3.43 billion versus fourth quarter 2022; excluding Ronapreve TM (a)(b) , revenues increased 14% Full year 2023 revenues increased 8% to $13.12 billion versus full year 2022; excluding Ronapreve (a) , revenues increased 12% Fourth quarter 2023 Dupixent ® global net sales (recorded by Sanofi) increased 31% to $3.22 billion versus fourth quarter 2022; full year 2023 Dupixent global... Read More

TARRYTOWN, N.Y., Feb. 02, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have progressed after at least three prior therapies. Linvoseltamab is an investigational bispecific... Read More

TARRYTOWN, N.Y., Jan. 30, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the formation of Regeneron Cell Medicines based on an agreement with 2seventy bio, Inc. to acquire full development and commercialization rights to its pipeline of investigational novel immune cell therapies, along with its discovery and clinical manufacturing capabilities. 2seventy bio employees who support the... Read More

Approval based on Phase 3 EoE KIDS trial showing a greater proportion of children taking Dupixent achieved histological remission compared to placebo Expanded indication marks second disease for which Dupixent is approved in children this young, underscoring the commitment to bringing therapies to young patients with significant unmet needs EoE is one of five FDA-approved indications for Dupixent in the U.S. for which type 2... Read More

TARRYTOWN, N.Y. and WASHINGTON, D.C., Jan. 24, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Society for Science (the Society) today announced the top 40 finalists in this year’s Regeneron Science Talent Search , the nation’s oldest and most prestigious science and math competition for high school seniors. The competition, now in its 83 rd year, has consistently identified young innovators who... Read More

Data included from first and only Phase 3 trial specifically evaluating a biologic in this difficult-to-treat population Phase 3 trial showed more than twice as many patients treated with Dupixent achieved clear or almost clear skin and nearly four times as many had improvement in itch, compared with placebo TARRYTOWN, N.Y. and PARIS, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi... Read More

Libtayo (cemiplimab) is a leading PD-1 inhibitor that has shown efficacy in the treatment of certain patients with cutaneous squamous cell carcinoma, advanced basal cell carcinoma, advanced non-small cell lung cancer and advanced cervical cancer, and is approved by regulatory authorities in more than two dozen countries for various indications Medison and Regeneron will work together to continue patient access to this... Read More

TARRYTOWN, N.Y., Jan. 05, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) today announced that it will report its fourth quarter and full year 2023 financial and operating results on Friday, February 2, 2024, before the U.S. financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day. Conference Call Information Participants may access the... Read More

TARRYTOWN, N.Y., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) will webcast its presentation at the 42 nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024. The presentation is scheduled for 2:15 p.m. Pacific Time (5:15 p.m. Eastern Time) and may be accessed from the "Investors & Media" page of Regeneron's website at http://investor.regeneron.com/events-and-presentations... Read More

TARRYTOWN, N.Y., Dec. 11, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced its inclusion on the Dow Jones Sustainability World Index (DJSI World) for the fifth consecutive year, alongside its fourth consecutive inclusion on the Dow Jones Sustainability North America Index (DJSI North America). These consistent rankings reflect the company's continued dedication to sustainability and... Read More

Updated results presented at ASH demonstrated an 80% objective response rate and a 73% complete response (CR), with a 23-month median duration of response and 24-month median duration of CR Oral presentation showcased overall maintenance of patient-reported outcomes from baseline to 50 weeks during investigational odronextamab treatment, complementing the overall efficacy and safety profile in this heavily pretreated and... Read More

Phase 2 primary analysis results presented in ASH oral session demonstrated a 52% objective response rate (ORR), with 31% achieving a complete response (CR) Results from a Phase 1 expansion cohort showed a 48% ORR and 30% CR in patients who had progressed on CAR-T Additional exploratory data from the Phase 2 trial presented in an oral session showed an association between circulating tumor DNA (ctDNA) negativity and... Read More

71% objective response rate, with 46% achieving a complete response or better after 11 months of median follow-up Data to be submitted to regulatory authorities, with Biologics License Application on track to be submitted to the FDA this year Regeneron to host virtual investor event to discuss results alongside updates across its hematology portfolio on Thursday, December 14 at 8:30 a.m. ET TARRYTOWN, N.Y., Dec. 07, 2023... Read More

First dose-escalation results for REGN5668 (MUC16xCD28), a costimulatory bispecific, in combination with Libtayo ® (cemiplimab) showed encouraging initial activity in patients with recurrent ovarian cancer Additional data include a late-breaking oral presentation of first results for neoadjuvant Libtayo in combination with low-dose stereotactic body radiotherapy in early-stage hepatocellular carcinoma TARRYTOWN, N.Y., Dec.... Read More

TARRYTOWN, N.Y., Nov. 30, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) will host a conference call and simultaneous webcast to provide an update on the company's hematology portfolio on Thursday, December 14, 2023 at 8:30 AM ET. This investor call follows Regeneron data updates presented at the 65 th American Society of Hematology (ASH) Annual Meeting and Exposition, from December 9-12, 2023. The... Read More

NOTUS trial met its primary endpoint with overwhelming efficacy, showing Dupixent significantly reduced exacerbations by 34% compared to placebo in patients with moderate-to-severe COPD with evidence of type 2 inflammation (i.e., blood eosinophils ≥300 cells per μL), confirming results from the landmark BOREAS pivotal trial Dupixent rapidly and significantly improved lung function (139 mL in FEV 1 ) compared to placebo (57... Read More

TARRYTOWN, N.Y., Nov. 15, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) will webcast management participation as follows: Piper Sandler 35th Annual Healthcare Conference at 8:30 a.m. ET on Tuesday, November 28, 2023 The session may be accessed from the "Investors & Media" page of Regeneron's website at https://investor.regeneron.com/events-and-presentations . A replay and transcript of the webcast... Read More

Regeneron has sponsored ISEF - the world’s largest high school science and engineering competition, and a program of Society for Science (Society) - since 2019 Each year, over 175,000 students participate in the Society’s affiliated high school science fairs around the world to earn the right to compete in Regeneron ISEF, where 1,600 finalists vie for almost $8 million in awards, prizes and scholarships Regeneron is also... Read More

Ten abstracts, including three oral presentations, spotlight the expanding body of evidence supporting odronextamab in follicular lymphoma and diffuse large B-cell lymphoma Additional presentations include the first review of primary endpoint results with longer follow-up from the pivotal trial for linvoseltamab in heavily pre-treated patients with multiple myeloma TARRYTOWN, N.Y., Nov. 03, 2023 (GLOBE NEWSWIRE) -- Regeneron... Read More

Third quarter 2023 revenues increased 15% to $3.36 billion versus third quarter 2022 Third quarter 2023 Dupixent ® global net sales (recorded by Sanofi) increased 33% to $3.10 billion versus third quarter 2022 Third quarter 2023 U.S. net sales for EYLEA ® and EYLEA HD were $1.49 billion, including $43 million from EYLEA HD Third quarter 2023 Libtayo ® global net sales increased 62% to $232 million versus third quarter 2022... Read More

TARRYTOWN, N.Y., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced long-term outcomes and new analyses of pivotal clinical data for EYLEA ® HD (aflibercept) Injection 8 mg will be presented at the American Academy of Ophthalmology (AAO) annual meeting in San Francisco from November 3 to 6. “Following the approval of EYLEA HD, we have continued to evaluate data from the pivotal... Read More

Global Phase 1/2 CHORD trial investigating otoferlin gene therapy (DB-OTO) represents Regeneron’s first auditory program and is currently enrolling patients DB-OTO is part of a growing pipeline of genetic medicines for hearing loss and other therapeutic areas that are being advanced by the company TARRYTOWN, N.Y., Oct. 26, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced preliminary,... Read More

TARRYTOWN, N.Y., Oct. 25, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) will webcast management participation as follows: BMO Biopharma Spotlight Series: Oncology at 9:30 a.m. ET on Wednesday, November 8, 2023 Truist Securities BioPharma Symposium at 3:20 p.m. ET on Wednesday, November 8, 2023 UBS Biopharma Conference at 11:00 a.m. ET on Thursday, November 9, 2023 Jefferies London Healthcare... Read More

Late-breaking presentation at ACG 2023 showed histologic and endoscopic improvements were maintained with no new safety signals to week 52 with higher dose Dupixent in these children Data reinforce the role of type 2 inflammation in EoE and the importance of targeting both IL-4 and IL-13 pathways sBLA for Dupixent to treat children aged 1 to 11 years with EoE is under Priority Review in the U.S.; if approved, Dupixent would... Read More

89% estimated event-free survival at one year among patients with stage II to IV resectable CSCC who received Libtayo prior to surgery in a Phase 2 trial No disease recurrence among the 51% of patients who experienced a pathologic complete response in the primary analysis TARRYTOWN, N.Y., Oct. 21, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the first presentation of key secondary... Read More

TARRYTOWN, N.Y. and PARIS, Oct. 20, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) in chronic spontaneous urticaria (CSU). CSU is an inflammatory skin condition, which causes sudden and debilitating... Read More

Commitment builds on Regeneron’s longstanding efforts to develop the STEM talent pipeline as lead sponsor of the premier high school competitions, the Regeneron Science Talent Search (STS) and Regeneron International Science and Engineering Fair (ISEF) Regeneron will adapt successful initiatives it co-created in its local New York-based community to Nashville’s unique STEM ecosystem, helping to advance students to these... Read More

NIH data show that globally less than 2% of genetic information being studied today originates from people of African ancestry 1 The newly established Diaspora Human Genomics Institute (DHGI) will manage the Together for CHANGE initiative, which aims to increase available genomic data for people of African ancestry and enhance representation in STEM careers NASHVILLE, Tenn. and TARRYTOWN, N.Y. and WILMINGTON, Del. and... Read More

Event-free survival of investigational use of Libtayo ® (cemiplimab) in neoadjuvant cutaneous squamous cell carcinoma (CSCC) from Phase 2 trial to be featured in oral presentation First data for the investigational combination of Libtayo and ubamatamab (MUC16xCD3) in recurrent ovarian cancer also to be presented Additional presentations on outcomes of Libtayo-based therapy in advanced non-small cell lung cancer, including... Read More

TARRYTOWN, N.Y., Oct. 05, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the first presentation of positive two-year (96 weeks) results from the pivotal PULSAR trial investigating EYLEA ® HD (aflibercept) Injection 8 mg with 12- and 16-week dosing regimens, compared to EYLEA ® (aflibercept) Injection, in patients with wet age-related macular degeneration (wAMD). The results were... Read More

If approved, odronextamab would be the first and only bispecific antibody approved in both FL and DLBCL – the two most common subtypes of non-Hodgkin lymphoma European Medicines Agency also reviewing odronextamab Marketing Authorization Application TARRYTOWN, N.Y., Sept. 29, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted... Read More

TARRYTOWN, N.Y., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) today announced that it will report its third quarter 2023 financial and operating results on Thursday, November 2, 2023, before the U.S. financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day. Conference Call Information Participants may access the conference... Read More

If approved, Dupixent would be the first and only treatment in the U.S. indicated for children aged 1 to 11 with EoE, a disease driven by type 2 inflammation that impacts the ability to eat Of the approximately 21,000 children under the age of 12 in the U.S. currently being treated for EoE, about 9,000 do not satisfactorily respond to the unapproved therapies they have been treated with and potentially require advanced... Read More

TARRYTOWN, N.Y., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) today announced that it has successfully completed its acquisition of Decibel Therapeutics, Inc., strengthening the company’s gene therapy and auditory programs. The acquisition of Decibel builds on prior collaboration between the companies and includes three ongoing gene therapy programs targeting different forms of... Read More

TARRYTOWN, N.Y., Sept. 08, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) today announced that Kathryn Guarini, Ph.D., and David P. Schenkein, M.D., have joined Regeneron’s Board of Directors effective September 8, 2023. “Today’s announcement demonstrates our strong commitment to strategic refreshment of the Board, a focus on the recruitment of new directors to complement the overall mix of skills,... Read More

TARRYTOWN, N.Y., Sept. 08, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) today announced that Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron, will retire in February 2024. Christopher Fenimore, current Senior Vice President, Head of Accounting and Controller at Regeneron, will succeed Mr. Landry as CFO upon his retirement. “Bob has been an invaluable... Read More

TARRYTOWN, N.Y., Aug. 23, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) will webcast management participation as follows: • 2023 Wells Fargo Healthcare Conference at 8:45 a.m. ET on Wednesday, September 6, 2023 • Morgan Stanley 21 st Annual Global Healthcare Conference at 9:20 a.m. ET on Monday, September 11, 2023 The sessions may be accessed from the "Investors & Media" page of Regeneron's website... Read More

TARRYTOWN, N.Y., Aug. 22, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) today announced that the Biomedical Advanced Research and Development Authority (BARDA) has entered into an agreement with Regeneron to support clinical development, clinical manufacturing and the regulatory licensure process of a next-generation COVID-19 monoclonal antibody therapy for the prevention of SARS-CoV-2 infection.... Read More

Approval based on the pivotal PULSAR and PHOTON trials in which EYLEA ® HD demonstrated clinically equivalent vision gains to EYLEA (aflibercept) Injection 2 mg that were maintained with fewer injections First and only treatment approved in wAMD and DME for immediate dosing at 8-week and up to 16-week intervals following three initial monthly doses TARRYTOWN, N.Y., Aug. 18, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals,... Read More

CHAPLE is an ultra-rare hereditary disease that can cause potentially life-threatening gastrointestinal and cardiovascular symptoms Approval represents 10 th FDA-approved medicine invented by Regeneron With the approval of Veopoz, the pre-approval inspection issues related to the aflibercept 8 mg biologics license application (BLA) have been addressed FDA action on the aflibercept 8 mg BLA is expected in the next few weeks... Read More

TARRYTOWN, N.Y., Aug. 17, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic... Read More

88% of all aflibercept 8 mg patients were on a ≥12-week dosing interval at the end of two years 78% of all aflibercept 8 mg patients maintained ≥12-week dosing intervals throughout the two-year study period 71% met the extension criteria for even longer dosing intervals, including 47% for ≥20-week intervals and 28% for 24-week intervals Visual gains and safety of aflibercept 8 mg remained consistent with the established... Read More

Proposed acquisition builds on existing collaboration between Decibel and Regeneron, will accelerate and further resource key gene therapy programs for hearing loss Decibel’s lead investigational gene therapy DB-OTO, designed to provide hearing to people with otoferlin-related hearing loss, is in its first clinical trial TARRYTOWN, N.Y. and BOSTON, Aug. 09, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:... Read More

Second quarter 2023 revenues increased 11% to $3.16 billion versus second quarter 2022 Second quarter 2023 Dupixent ® global net sales (recorded by Sanofi) increased 33% to $2.79 billion versus second quarter 2022 Second quarter 2023 EYLEA ® U.S. net sales were $1.50 billion Second quarter 2023 GAAP diluted EPS of $8.50 and non-GAAP diluted EPS (a) of $10.24 Two-year results reported for aflibercept 8 mg from pivotal PHOTON... Read More

TARRYTOWN, N.Y., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the winners of the 11th annual Regeneron Prize for Creative Innovation, a competition designed to honor exceptional talent and originality in biomedical research. Each year, Regeneron invites the nation’s top research universities to nominate up-and-coming postdoctoral fellows and graduate students to pitch their... Read More

89% and 84% of patients were maintained on ≥12- and ≥16-week dosing intervals, respectively, throughout the two-year period, while sustaining their vision and anatomic improvements At two years, 44% of patients met the criteria for ≥20-week dosing intervals, including 27% who were eligible for 24-week dosing intervals TARRYTOWN, N.Y., July 29, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today... Read More

TARRYTOWN, N.Y., June 29, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) today announced that it will report its second quarter 2023 financial and operating results on Thursday, August 3, 2023, before the U.S. financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day. Conference Call Information Participants may access the conference... Read More

No issues with clinical efficacy or safety, trial design, labeling or drug substance manufacturing were identified in the CRL No additional clinical data or trials have been requested TARRYTOWN, N.Y., June 27, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application... Read More