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REGENERON PHARMACEUTICALS (NASDAQ: REGN) STOCK QUOTE

Last Trade: US$966.30 2.75 0.29
Volume: 292,236
5-Day Change: 0.27%
YTD Change: 10.02%
Market Cap: US$104.300B

LATEST NEWS FROM REGENERON PHARMACEUTICALS

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... 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
Collaboration combines Intellia’s leading genome editing platform, including its proprietary Nme2Cas9 technology, with Regeneron’s proprietary antibody-targeted viral vector delivery technologies to jointly advance in vivo programs outside of the liver for neurological and muscular diseases TARRYTOWN, N.Y. and CAMBRIDGE, Mass., Oct. 03, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Intellia... 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
TORONTO, Sept. 25, 2023 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for rare and ultrarare genetic diseases, today announced the approval of Evkeeza ® (evinacumab) in Canada. Evkeeza ® was approved by Health Canada as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies... 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 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., 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., 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
89% of all aflibercept 8 mg patients maintained ≥12-week dosing intervals through two years Of those assigned to a 16-week dosing regimen at baseline, 83% maintained ≥16-week dosing intervals through two years Many patients met the extension criteria for even longer dosing intervals, including 43% for ≥20-week intervals and 27% for 24-week intervals Visual gains and safety of aflibercept 8 mg remained consistent with the... 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
71% objective response rate, with 59% of patients achieving a very good partial response or better at the recommended 200 mg dose, per new data to be shared in an oral session at ASCO Benefit also observed across prespecified subgroups, including patients with high disease burden and aggressive disease Data from this trial to form the basis of planned regulatory submissions, starting with the FDA in 2023 TARRYTOWN, N.Y., May... Read More
Data demonstrate objective response rates from 56% to 63% across three independent cohorts of advanced melanoma patients – about double the rate historically seen with anti-PD-1 alone in similar settings – per trial results to be presented in an oral session at ASCO Clinically meaningful responses observed in post hoc analyses of populations of interest, including patients with poor prognosis factors, prior anti-PD-1 therapy... Read More
Dupixent is the first and only investigational biologic for COPD that has demonstrated a significant reduction in moderate or severe acute exacerbations by 30% compared to placebo Dupixent is the first and only investigational biologic for COPD that has significantly improved lung function at 12 and 52 weeks, with numerical improvements seen as early as 2 weeks Dupixent significantly improved quality of life, with numerical... Read More
TARRYTOWN, N.Y. and WASHINGTON, D.C., May 19, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) and Society for Science (the Society) announced that Kaitlyn Wang, 17, of San José, CA, won the $75,000 top award in the 2023 Regeneron International Science and Engineering Fair (Regeneron ISEF), the world’s largest global pre-college science and engineering competition, for a project that explored planets... Read More
TARRYTOWN, N.Y., May 18, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) will webcast management participation as follows: TD Cowen 4 th Annual Oncology Innovation Summit at 12:30 p.m. ET on Tuesday, May 30, 2023 Jefferies Healthcare Conference at 8:30 a.m. ET on Wednesday, June 7, 2023 Goldman Sachs 44 th Annual Global Healthcare Conference at 8:40 a.m. PT (11:40 a.m. ET) on Wednesday, June 14, 2023... Read More
Decision ends nearly decade-long patent dispute related to Regeneron-invented Praluent ® (alirocumab) TARRYTOWN, N.Y., May 18, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) applauds the United States Supreme Court’s unanimous opinion 1 ending a nearly decade-long patent dispute related to the Regeneron-invented PCSK9 inhibitor, Praluent ® (alirocumab). The decision affirms the United States Court... Read More
First quarter 2023 revenues increased 7% to $3.16 billion versus first quarter 2022 First quarter 2023 Dupixent ® global net sales (recorded by Sanofi) increased 37% to $2.49 billion versus first quarter 2022 First quarter 2023 EYLEA ® U.S. net sales were $1.43 billion First quarter 2023 GAAP diluted EPS of $7.17 and non-GAAP diluted EPS (a) of $10.09; includes unfavorable $0.42 impact from acquired IPR&D charge European... Read More
Oral presentations include interim results from pivotal trial of linvoseltamab (BCMAxCD3) in relapsed/refractory multiple myeloma and three cohorts of fianlimab (LAG-3 inhibitor) combined with Libtayo ® (cemiplimab-rwlc) in advanced melanoma Ten total presentations to cover clinical research across six solid tumors and blood cancers TARRYTOWN, N.Y., May 02, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc . (NASDAQ:... Read More
Single Doses of ALN-APP Demonstrated Dose-Dependent, Rapid and Sustained Reduction of sAPPα and sAPPβ in Cerebrospinal Fluid, with Up to 90% at Highest Dose to Date Encouraging Clinical Safety and Tolerability Profile Observed with Single Dosing to Date Results Provide First Demonstration of Gene Silencing by RNAi Therapeutics in the Human Brain Using Alnylam's Proprietary C16 Platform Alnylam to Host Conference Call Today... Read More
Single Doses of ALN-APP Demonstrated Dose-Dependent, Rapid and Sustained Reduction of sAPPα and sAPPβ in Cerebrospinal Fluid, with Up to 90% at Highest Dose to Date Encouraging Clinical Safety and Tolerability Profile Observed with Single Dosing to Date Results Provide First Demonstration of Gene Silencing by RNAi Therapeutics in the Human Brain Using Alnylam's Proprietary C16 Platform TARRYTOWN, N.Y. and CAMBRIDGE, Mass.,... Read More
TARRYTOWN, N.Y., April 17, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) today announced that P. Roy Vagelos, M.D., will retire from his role as Chair of the Company’s Board of Directors and will not stand for reelection at the Company’s 2023 Annual Meeting of Shareholders. Dr. Vagelos has served as Chair since January 1995 and will complete his current term through the conclusion of the Annual... Read More
New subgroup data and further analyses of the aflibercept 8 mg clinical trial program to highlight durability results of extended dosing intervals, patient characteristics, and efficacy and safety in wet age-related macular degeneration and diabetic macular edema 18 presentations reinforce Regeneron’s commitment to patients with serious retinal diseases TARRYTOWN, N.Y., April 17, 2023 (GLOBE NEWSWIRE) -- Regeneron... Read More
TARRYTOWN, N.Y., April 11, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) will webcast management participation as follows: BofA Securities 2023 Health Care Conference at 1:40 p.m. PT (4:40 p.m. ET) on Tuesday, May 9, 2023 2023 RBC Capital Markets Global Healthcare Conference at 9:30 a.m. ET on Tuesday, May 16, 2023 The sessions may be accessed from the "Investors & Media" page of Regeneron's... Read More
TARRYTOWN, N.Y., April 03, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) today announced that it will report its first quarter 2023 financial and operating results on Thursday, May 4, 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 call... Read More
Libtayo-based combination demonstrated superior survival outcomes compared to chemotherapy alone in Phase 3 trial designed to include patients with varied disease presentations seen in everyday clinical practice Approval marks second first-line indication in NSCLC and fifth indication for Libtayo in the European Union (EU) TARRYTOWN, N.Y., March 29, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)... Read More
TARRYTOWN, N.Y., and SOUTH SAN FRANCISCO, Calif., March 28, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sonoma Biotherapeutics, Inc. today announced a collaboration to apply their scientific and clinical expertise and respective technology platforms to the discovery, development and commercialization of novel regulatory T cell (T reg ) therapies for autoimmune diseases. The collaboration will... Read More
First and only biologic to demonstrate clinically meaningful and statistically significant reduction (30%) in exacerbations compared to placebo First and only biologic to show rapid and significant improvement in lung function (160 mL in FEV 1 ) compared to placebo (77 mL in FEV 1 ) First and only biologic to demonstrate significant improvements in quality of life and respiratory symptoms COPD is the third leading cause of... Read More
Approval extends Evkeeza to children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH), an inherited condition characterized by extremely high low-density lipoprotein cholesterol (LDL-C) 48% reduction in LDL-C from baseline at week 24 when Evkeeza was added to other lipid-lowering therapies in the pivotal trial TARRYTOWN, N.Y., March 22, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)... Read More
Approximately seven times as many patients aged 6 months to 5 years with severe atopic dermatitis treated with Dupixent experienced clear or almost clear skin and reduced overall disease severity compared to placebo Patients treated with Dupixent achieved rapid itch reduction as early as three weeks after start of therapy, with significant improvements at 16 weeks sustained through one year Dupixent is now a treatment option... Read More
More than twice as many patients on Dupixent achieved clear or almost clear skin compared to placebo at 16 weeks Nearly four times as many patients on Dupixent saw a clinically meaningful reduction of itch, with improvements seen as early as one week TARRYTOWN, N.Y. and PARIS, March 18, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today presented positive results from the clinical trial... Read More
TARRYTOWN, N.Y. and WASHINGTON, D.C., March 14, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Society for Science (the Society) announced that Neel Moudgal, 17, of Saline, Mich., won the top $250,000 award in the 2023 Regeneron Science Talent Search , the nation’s oldest and most prestigious science and math competition for high school seniors. The competition, now in its 82nd year, celebrates... Read More
TARRYTOWN, N.Y. and PARIS, March 07, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) that is not adequately controlled with... Read More
Three times more patients treated with Kevzara achieved sustained remission compared to placebo in Phase 3 trial Kevzara now approved to treat two chronic inflammatory disorders TARRYTOWN, N.Y. and CAMBRIDGE, Mass., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Kevzara ® (sarilumab) for the treatment of... Read More
TARRYTOWN, N.Y., Feb. 24, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Libtayo ® (cemiplimab) in combination with platinum-based chemotherapy. Specifically, the CHMP recommended the Libtayo combination be approved in the European Union (EU) for first-line... Read More
BLA supported by two pivotal trials demonstrating non-inferior vision gains to EYLEA ® (aflibercept) Injection, with vast majority of patients maintaining extended dosing regimens through 48 weeks If approved, aflibercept 8 mg will be second ophthalmology medicine developed by Regeneron TARRYTOWN, N.Y., Feb. 23, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and... Read More
If approved, pozelimab would be the first and only treatment for those living with CHAPLE CHAPLE is an ultra-rare hereditary immune disease that causes overactivation of the complement system, leading to potentially life-threatening abdominal and cardiovascular symptoms TARRYTOWN, N.Y., Feb. 21, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA)... Read More
ROP is a leading cause of childhood blindness worldwide EYLEA now approved to treat five retinal conditions caused by ocular angiogenesis TARRYTOWN, N.Y., Feb. 08, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA ® (aflibercept) Injection to treat preterm infants with retinopathy of prematurity (ROP). Following this... Read More
Fourth quarter 2022 revenues decreased 31% to $3.41 billion versus fourth quarter 2021; excluding REGEN-COV ® and Ronapreve TM (a)(b) , revenues increased 14% Full year 2022 revenues decreased 24% to $12.17 billion versus full year 2021; excluding REGEN-COV and Ronapreve (a)(b) , revenues increased 17% Fourth quarter 2022 EYLEA ® U.S. net sales decreased 3% to $1.50 billion versus fourth quarter 2021; full year 2022 EYLEA... Read More
TARRYTON, N.Y., Jan. 31, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) will webcast management participation as follows: SVB Securities Global Biopharma Conference at 9:20 a.m. ET on Tuesday, February 14, 2023 Cowen 43 rd Annual Health Care Conference at 12:50 p.m. ET on Monday, March 6, 2023 Oppenheimer 33 rd Annual Healthcare Conference at 9:20 a.m. ET on Monday, March 13, 2023 Barclays Global... Read More
A pproximately 60% of patients aged 12 years and older treated with Dupixent 300 mg weekly in the pivotal trial experienced histological disease remission; patients also significantly improved their ability to swallow compared to placebo Dupixent is now an option for the approximately 50,000 adults and adolescents living with severe uncontrolled eosinophilic esophagitis in the European Union (EU) Dupixent now approved to... Read More
If approved, Dupixent would be the first and only targeted medicine in the EU for these young children Recommendation based on a Phase 3 trial in children 6 months to 5 years old showing Dupixent improved skin clearance, reduced overall disease severity and improved health-related quality of life In Europe, about 80,000 children aged 6 months to 5 years with uncontrolled severe atopic dermatitis are candidates for systemic... Read More
Nation’s Most Innovative Teens will Showcase Research with Prizes of Over $1.8 million TARRYTOWN, N.Y. and WASHINGTON, D.C., Jan. 24, 2023 (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... Read More
TARRYTOWN, N.Y., Jan. 03, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) today announced that it will report its fourth quarter and full year 2022 financial and operating results on Friday, February 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... Read More
TARRYTOWN, N.Y. , Dec. 23, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals (NASDAQ: REGN) today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Libtayo ® (cemiplimab) as monotherapy to treat patients with advanced or recurrent cervical cancer whose disease progressed after chemotherapy. "In recent years, the incidence of cervical cancer has... Read More
Dupixent 300 mg weekly showed significant histological disease remission and improvement in symptoms of the disease compared to placebo Improvements were sustained for up to one year in patients aged 12 years and older with eosinophilic esophagitis (EoE) Dupixent is the first and only targeted medicine indicated in the U.S. to treat EoE patients aged 12 and older weighing at least 40 kg TARRYTOWN, N.Y. and PARIS , Dec. 21,... Read More
TARRYTOWN, N.Y. , Dec. 19, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will webcast its presentation at the 41 st Annual J.P. Morgan Healthcare Conference on Monday, January 9, 2023 . The presentation is scheduled for 9:00 a.m. Pacific Time ( 12:00 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
If approved, Dupixent would be the first and only targeted medicine specifically indicated for people aged 12 years and older with eosinophilic esophagitis in the European Union In the U.S., Dupixent is currently the only medicine indicated to treat eosinophilic esophagitis Approval recommendation based on pivotal trial data demonstrating patients on Dupixent 300 mg weekly experienced significantly improved ability to... Read More
Approval based on direct-to-Phase 3 program showing more than three times as many Dupixent patients (60% and 58%) experienced clinically meaningful itch reduction at 24 weeks compared to placebo (18% and 20%) Dupixent also significantly reduced skin lesions and improved health-related quality of life compared to placebo In Europe , about 70,000 adults living with prurigo nodularis are most in need of new treatment options... Read More
First Phase 2 data presented at ASH showed an 82% response rate in patients with grades 1 to 3a disease, with 75% of the overall population achieving a complete response 20-month median progression-free survival, with median overall survival not reached Data will form the basis of regulatory submissions planned for 2023 TARRYTOWN, N.Y. , Dec. 12, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today... Read More
As presented at ASH, recommended 200 mg dose of linvoseltamab demonstrated a 64% response rate, with 45% of responders achieving a very good partial response or better; responses may further improve with longer follow-up Trial enrolled patients with particularly high disease burden, with 37% having bone marrow plasma cells ≥50% and the median soluble BCMA being 0.43 mg/L Data represent initial efficacy results from first 58... Read More
DJSI World recognizes the top 10 percent of most sustainable companies by industry; Regeneron ranked among top three biotechnology companies 1 TARRYTOWN, N.Y. , Dec. 12, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals , Inc. (NASDAQ: REGN ) today announced that the company has been included on the Dow Jones Sustainability World Index (DJSI World) for the fourth consecutive year and on the Dow Jones Sustainability North... Read More
49% objective response rate ( ORR ) in heavily pre-treated patients who were naïve to prior CAR-T, with 31% achieving a complete response (CR) Even in patients who received prior CAR-T, 48% ORR and 32% CR observed in a dose expansion cohort from a Phase 1 trial Data will form the basis of regulatory submissions planned for 2023 TARRYTOWN, N.Y. , Dec. 11, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)... Read More
Presentations include initial results for an investigational combination of fianlimab (LAG-3 inhibitor) and Libtayo (PD-1 inhibitor) in advanced non-small cell lung cancer TARRYTOWN, N.Y. , Dec. 1, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data across its oncology pipeline will be presented at the European Society for Medical Oncology Immuno-Oncology (ESMO IO)... Read More
If approved, Evkeeza would be the first and only treatment of its kind to help children as young as 5 years old control dangerously high levels of LDL cholesterol caused by homozygous familial hypercholesterolemia TARRYTOWN, N.Y. , Nov. 30, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics... Read More
Approval based on a Phase 3 trial that demonstrated significant survival benefit in patients with recurrent or metastatic cervical cancer, with Libtayo reducing the risk of death by 31% compared to chemotherapy during the study Libtayo now approved to treat four cancer types in the European Union TARRYTOWN, N.Y. , Nov. 22, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European... Read More
Collaboration will enable the development of investigational next-generation bispecific immunotherapies using CytomX's Probody ® and Regeneron's Veloci-Bi ® platforms CytomX to receive $30 million upfront payment with the potential for up to $2 billion in research, development, regulatory and sales-based milestones TARRYTOWN, N.Y. and SOUTH SAN FRANCISCO, Calif. , Nov. 17, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.... Read More
Collaboration will enable the development of investigational next-generation bispecific immunotherapies using CytomX’s Probody ® and Regeneron's Veloci-Bi ® platforms CytomX to receive $30 million upfront payment with the potential for up to $2 billion in research, development, regulatory and sales-based milestones SOUTH SAN FRANCISCO, Calif. and TARRYTOWN, N.Y., Nov. 17, 2022 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc.... Read More
Recommendation is based on data from two pivotal trials showing Dupixent significantly improved itch, skin lesions and health-related quality of life in adults with prurigo nodularis If approved, Dupixent would be the first and only targeted medicine specifically indicated for prurigo nodularis in the European Union TARRYTOWN, N.Y. and PARIS , Nov. 11, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and... Read More
Approval based on superior survival outcomes of Libtayo plus chemotherapy, compared to chemotherapy alone, in a patient population with a wide range of disease characteristics Second advanced NSCLC indication expands patient population eligible for a Libtayo-based regimen to include combination treatment with chemotherapy irrespective of PD-L1 expression levels TARRYTOWN, N.Y. , Nov. 8, 2022 /PRNewswire/ -- Regeneron... Read More
Presentations reinforce that aflibercept 8 mg demonstrated non-inferior vision gains to EYLEA at 48 weeks, with 93% and 83% of patients in PHOTON and PULSAR, respectively, maintaining dosing intervals of 12 weeks or longer after initial monthly doses Additional new pre-specified and exploratory analyses showed aflibercept 8 mg led to sustained improvements in certain anatomical measures during the 48-week treatment period... Read More
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) will webcast management participation as follows: Jefferies London Healthcare Conference at 3:15 p.m. GMT ( 10:15 a.m. ET ) on Wednesday, November 16, 2022 5th Annual Evercore ISI HealthCONx Conference at 11:45 a.m. ET on Tuesday, November 29, 2022 Piper Sandler 34th Annual Healthcare Conference at 8:00 a.m. ET on Wednesday, November 30, 2022 The sessions may be accessed from... Read More
First Phase 2 data for odronextamab (CD20xCD3) in diffuse large B-cell lymphoma and follicular lymphoma to be presented in two oral sessions Additional presentations include new data on linvoseltamab (REGN5458; BCMAxCD3) in multiple myeloma Regeneron will host an investor webcast on Wednesday, December 14 at 8:30 AM ET to provide updates across its hematology portfolio Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today... Read More
Third quarter 2022 revenues decreased 15% to $2.94 billion versus third quarter 2021; excluding REGEN-COV ® (a)(b) , revenues increased 11% Third quarter 2022 EYLEA ® U.S. net sales increased 11% versus third quarter 2021 to a record $1.63 billion Third quarter 2022 Dupixent ® global net sales (c) (recorded by Sanofi) increased 40% to $2.33 billion versus third quarter 2021 Third quarter 2022 GAAP diluted EPS of $11.66;... Read More
Inmazeb is the first FDA-approved treatment for Zaire ebolavirus Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that Inmazeb™ (atoltivimab, maftivimab, and odesivimab-ebgn) has been recognized as the "Best Biotechnology Product" of 2022 by the Galien Foundation, which acknowledges extraordinary scientific innovations that improve the human condition. The Prix Galien USA Award was presented in a ceremony in... Read More
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for EYLEA ® (aflibercept) Injection. This grant extends the period of U.S. market exclusivity for EYLEA by an additional six months through May 17, 2024 . The pediatric exclusivity determination is based on data from two Phase 3 trials – BUTTERFLEYE and FIREFLEYE – which were submitted... Read More
Recommendation based on a Phase 3 Libtayo trial that was first and only to demonstrate significantly improved survival compared to chemotherapy in the second-line setting irrespective of PD-L1 expression status or tumor histology Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Libtayo... Read More
ROP is a leading cause of childhood blindness worldwide Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for EYLEA ® (aflibercept) Injection to treat Retinopathy of Prematurity (ROP) in preterm infants. The target action date for the FDA decision is February 11, 2023. ROP is a... Read More
A majority of children on Dupixent (up to 68% on a higher dose) achieved histological disease remission at week 16 First and only Phase 3 trial to show positive results in this patient population; there are currently no approved treatments specifically indicated for children under 12 years of age with EoE Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today presented late-breaking positive results from a Phase 3... Read More
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its third quarter 2022 financial and operating results on Thursday, November 3, 2022 , 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 live via webcast on the 'Investors and Media'... Read More
Former President and CEO of Memorial Sloan Kettering Cancer Center brings a unique combination of business and scientific leadership, with exceptional experience in immuno-oncology, translational research and precision medicine Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) today announced that Craig B. Thompson , M.D., has been elected to the Board of Directors, effective immediately. Dr. Thompson has also been appointed... Read More
PHOTON and PULSAR data presentations demonstrate aflibercept 8 mg led to sustained improvements in vision and anatomic measures of retinal fluid across the 48-week treatment period in both 12- and 16-week dosing regimens Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the first presentations of positive detailed results from two pivotal trials investigating novel aflibercept 8 mg with 12- and 16-week dosing... Read More
Dupixent significantly reduced itch and skin lesions compared to placebo in direct-to-Phase 3 program consisting of two pivotal trials About 75,000 adults in the U.S. living with prurigo nodularis are most in need of new treatment options Approval represents the second dermatology indication for Dupixent and fifth disease indication overall in the U.S. Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced... Read More
Interim data from the cardiomyopathy arm of the Phase 1 study of NTLA-2001 showed deep and sustained mean serum transthyretin (TTR) reductions of 93% and 92% at 0.7 mg/kg and 1.0 mg/kg doses, respectively, at day 28 NTLA-2001 was generally well-tolerated at both dose levels Intellia to discuss data at investor event today, Friday, September 16 , at 8:00 a.m. ET Intellia Therapeutics, Inc. (NASDAQ: NTLA ) and Regeneron... Read More
Dupixent is the first and only biologic that significantly improved skin clearance, and reduced itch and overall disease severity in children as young as 6 months old in a Phase 3 trial Published results reinforce well-established efficacy and safety profile of Dupixent across age groups Regeneron Pharmaceuticals, Inc . (NASDAQ: REGN) and Sanofi today announced that The Lancet has published positive results from a Phase 3... Read More
Target knockdown and safety results support continued clinical development Regeneron and Alnylam intend to initiate a Phase 2 study in late 2022 Detailed results to be presented at an upcoming medical congress Regeneron Pharmaceuticals (Nasdaq: REGN ) and Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY ) announced today preliminary Phase 1 data supporting the clinical advancement of ALN-HSD, an investigational RNAi therapeutic... Read More
63% combined pathologic response rate for neoadjuvant Libtayo monotherapy in stage II to IV resectable CSCC per primary analysis of a confirmatory Phase 2 trial Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive clinical data for an investigational regimen of PD-1 inhibitor Libtayo ® (cemiplimab) as neoadjuvant monotherapy in stage II to IV resectable cutaneous squamous cell carcinoma (CSCC). The data,... Read More
Positive clinical data presented in a mini-oral session at ESMO Safety profile of the combination was generally similar to Libtayo monotherapy Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the presentation of positive data from multiple expansion cohorts of an initial Phase 1 trial for an investigational combination of LAG-3 inhibitor fianlimab and PD-1 inhibitor Libtayo ® (cemiplimab) in advanced melanoma.... Read More
First-in-class Phase 1 data presented at ESMO for ubamatamab (REGN4018; MUC16xCD3) in recurrent ovarian cancer and REGN5093 (METxMET) in MET-altered advanced non-small cell lung cancer Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive early data for two novel and investigational bispecific antibodies – ubamatamab (REGN4018; MUC16xCD3) in recurrent ovarian cancer and REGN5093 (METxMET) in MET-altered... Read More
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will host a conference call and simultaneous webcast to share updates on the company's oncology portfolio in conjunction with the European Society for Medical Oncology (ESMO) Annual Congress on Monday, September 12, 2022 . The webcast is scheduled for 8:00 AM ET ( 2:00 PM CEST ) and may be accessed from the "Investors & Media" page of Regeneron's website at... Read More
Nearly three times as many Dupixent patients experienced clinically meaningful reductions in itch and skin lesions at 24 weeks compared to placebo There are currently no approved medicines specifically indicated to treat prurigo nodularis; regulatory submissions for Dupixent are under Priority Review in the U.S. and under review in the European Union 22 Dupixent abstracts are being presented at the EADV 2022 Congress across... Read More
91% and 89% of diabetic macular edema (DME) patients were rapidly initiated and maintained on 12- and 16-week dosing intervals (without need for regimen modification) through week 48, respectively 79% and 77% of wet age-related macular degeneration (wAMD) patients were rapidly initiated and maintained on 12- and 16-week dosing intervals (without need for regimen modification) through week 48, respectively Safety of... Read More
Results from the longest global Phase 3 open-label extension trial in this age group in asthma show sustained improvement in lung function, low rate of asthma attacks and a consistent safety profile for up to two years Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced results from a Phase 3 open-label extension trial demonstrating the efficacy and safety profile of Dupixent ® (dupilumab) as a... Read More
First-in-class Phase 1 data for two investigational bispecifics in advanced ovarian cancer and advanced MET-altered non-small cell lung cancer (NSCLC) to be presented Additional presentations include new data for investigational Libtayo monotherapy and combination therapies in advanced melanoma, NSCLC and cervical cancer, as well as neoadjuvant cutaneous squamous cell carcinoma Regeneron will host an investor webcast on... Read More
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will webcast management participation as follows: 2022 Wells Fargo Healthcare Conference at 11:00 a.m. ET on Thursday, September 8, 2022 Morgan Stanley 20 th Annual Global Healthcare Conference at 11:05 a.m. ET on Monday, September 12, 2022 The sessions may be accessed from the "Investors & Media" page of Regeneron's website at... Read More
Second quarter 2022 revenues decreased 44% to $2.86 billion versus second quarter 2021; excluding REGEN-COV ® (a)(b) , revenues increased 20% Second quarter 2022 EYLEA ® U.S. net sales increased 14% versus second quarter 2021 to a record $1.62 billion Second quarter 2022 Dupixent ® global net sales (c) (recorded by Sanofi) increased 40% to $2.09 billion versus second quarter 2021 Second quarter 2022 GAAP diluted EPS of... Read More
First clinical data from ongoing Phase 1/2 trial show dose-dependent anti-tumor activity for investigational REGN5678 (PSMAxCD28) when combined with standard dose Libtayo, suggesting potential to overcome mCRPC resistance to PD-1 inhibition Anti-cancer activity correlated with immune-related adverse events These data provide early evidence and proof of principle for Regeneron's broader costimulatory bispecific platform,... Read More
New research published in The New England Journal of Medicine reveals that people with certain genetic loss-of-function mutations have more than 50% lower risk of nonalcoholic liver disease and nonalcoholic cirrhosis Regeneron and Alnylam have developed an siRNA therapeutic candidate targeting CIDEB that could enter clinical stages of development in the next year Unprecedented size of Regeneron Genetics Center human sequence... Read More
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the winners of the 10th annual Regeneron Prize for Creative Innovation, a competition designed to recognize excellence and creativity in biomedical research conducted by postdoctoral fellows and graduate students. Each year, Regeneron invites the country's leading research universities to nominate early career scientists. Applicants present their "dream projects"... Read More
First and only investigational Phase 3 trial to show positive results in these young children; results follow recent approval of Dupixent in people with eosinophilic esophagitis aged 12 years and older who weigh at least 40 kilograms Trial met its primary endpoint, with 68% of patients on higher dose Dupixent and 58% on lower dose Dupixent achieving histological disease remission at 16 weeks Fifth pediatric pivotal trial... Read More
GreenStockNews
Ultima Genomics, Inc. (the Company) has signed an agreement with Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) to further advance Ultima Genomics' sequencing architecture. Under the terms of the agreement, Regeneron will collaborate with Ultima on the development and testing of Ultima's second-generation sequencing platform,... Read More
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its second quarter 2022 financial and operating results on Wednesday, August 3, 2022 , 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 live via webcast on the 'Investors and Media'... Read More
Company provides anticipated impact to second quarter 2022 financial results due to recently completed business development transactions Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it has completed the acquisition of Sanofi's stake in Libtayo ® (cemiplimab), providing Regeneron with exclusive worldwide development, commercialization, and manufacturing rights to the medicine originally discovered in... Read More
If approved, extended regimen would provide a longer treatment interval and additional dosing flexibility, alongside approved every 4- and 8-week dosing regimens Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the EYLEA ® (aflibercept) Injection supplemental Biologics License Application (sBLA) for an every 16-week 2 mg dosing regimen (after... Read More
Serum TTR reductions were sustained at all doses tested with follow-up now reaching 12 months in the 0.1 and 0.3 mg/kg and six months in the 0.7 and 1.0 mg/kg cohorts Pharmacokinetic modeling and simulation indicated that an 80 mg fixed dose provides similar exposure to the 1.0 mg/kg dose, where treatment with NTLA-2001 resulted in 93% mean and 98% maximum serum TTR reduction by day 28 Intellia to host investor event to... Read More
Children treated with Dupixent and topical corticosteroids (TCS) achieved clearer skin, experienced significantly improved overall disease severity and significantly reduced itch compared to TCS alone at week 16 in a Phase 3 trial Long-term safety data from a 52-week open-label extension trial in this age group reinforce the well-established safety profile of Dupixent observed across all other approved age groups Dupixent is... Read More
Regeneron will secure global rights to Libtayo from Sanofi in exchange for upfront payment of $900 million , plus royalties and potential future milestone payments 18 different investigational treatment combinations with Libtayo currently being evaluated in 22 clinical trials Regeneron will host an investor conference call today at 8:30 am ET ; dial-in details are available below Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN... Read More
Ad-hoc announcement pursuant to Article 53 of the SIX listing rules $2.5 million of milestone to be paid to XOMA Corporation under royalty agreement Kuros Biosciences AG (“Kuros” or the “Company”), a leader in next generation bone graft technologies, notes the completion of the acquisition of Checkmate Pharmaceuticals (NASDAQ: CMPI) by Regeneron Pharmaceuticals (NASDAQ: REGN). The completion triggers a $5 million milestone... Read More
Acquisition strengthens Regeneron's innovative portfolio of immuno-oncology candidates and diversified approach to cancer treatment Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) today announced that it has successfully acquired Checkmate Pharmaceuticals, Inc., deepening its commitment to immuno-oncology and adding a new modality to the company's portfolio of potential combination-ready approaches for difficult-to-treat... Read More
Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent ® Medical (dupilumab) to treat adults with prurigo nodularis, a chronic skin disease... Read More
Children already on other lipid-lowering therapies entered the trial with dangerously high LDL-C (264 mg/dL on average), and 79% saw their LDL-C reduced by at least half at 24 weeks FDA submission planned by end of 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) today announced positive results from a Phase 3 trial evaluating Evkeeza ® (evinacumab) in children aged 5 to 11 with homozygous familial hypercholesterolemia... Read More
Dupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United States ; approval granted more than two months ahead of FDA's Priority Review action date Dupixent 300 mg weekly significantly improved signs and symptoms of eosinophilic esophagitis compared to placebo in a Phase 3 trial, underscoring the role of type 2 inflammation in this complex disease Eosinophilic esophagitis is a chronic,... Read More

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