• Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
Quantisnow Logo
  • Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
PublishDashboard
    Quantisnow Logo

    © 2025 quantisnow.com
    Democratizing insights since 2022

    Services
    Live news feedsRSS FeedsAlertsPublish with Us
    Company
    AboutQuantisnow PlusContactJobsAI employees
    Legal
    Terms of usePrivacy policyCookie policy

    May 20, 2022 - FDA Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune Disorder

    5/20/22 3:11:09 PM ET
    $REGN
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $REGN alert in real time by email
    For Immediate Release:
    May 20, 2022

    Today, the U.S. Food and Drug Administration approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in adults and pediatric patients 12 years and older weighing at least 40 kilograms (which is about 88 pounds). Today’s action marks the first FDA approval of a treatment for EoE.

    “As researchers and clinicians have gained knowledge about eosinophilic esophagitis in recent years, more cases of the disorder have been recognized and diagnosed in the U.S.,” said Jessica Lee, M.D., director of the Division of Gastroenterology in the FDA’s Center for Drug Evaluation and Research. “Today’s approval will fulfill an important unmet need for the increasing number of patients with eosinophilic esophagitis.”

    EoE is a chronic inflammatory disorder in which eosinophils, a type of white blood cell, are found in the tissue of the esophagus. In adults and adolescent patients with EoE, common symptoms include difficulty swallowing, difficulty eating, and food getting stuck in the esophagus. Dupixent is a monoclonal antibody that acts to inhibit part of the inflammatory pathway. 

    The efficacy and safety of Dupixent in EoE was studied in a randomized, double-blind, parallel-group, multicenter, placebo-controlled trial, that included two 24-week treatment periods (Part A and Part B) that were conducted independently in separate groups of patients. In Part A and Part B, patients received either placebo or 300 milligrams of Dupixent every week. The two primary measurements of efficacy were the proportion of patients who achieved a certain level of reduced eosinophils in the esophagus at week 24, as determined by assessing patients’ esophageal tissue under a microscope, and the change in the patient-reported Dysphagia Symptom Questionnaire (DSQ) score from baseline to week 24. The DSQ is a questionnaire designed to measure difficulty swallowing associated with EoE, with total scores ranging from 0 to 84; higher DSQ scores indicate worse symptoms. 

    In Part A of the trial, 60% of the 42 patients who received Dupixent achieved the pre-determined level of reduced eosinophils in the esophagus compared to 5% of the 39 patients who received a placebo. Patients in Part A who received Dupixent experienced an average improvement of 22 points in their DSQ score compared to 10 points in patients who received placebo. In Part B, 59% of the 80 patients who received Dupixent achieved the pre-determined level of reduced eosinophils in the esophagus compared to 6% of the 79 patients who received a placebo. Patients in Part B who received Dupixent experienced an average improvement of 24 points in their DSQ score compared to 14 points in patients who received placebo. Assessments incorporating the perspectives from patients with EoE supported that the DSQ score improvement in patients who received Dupixent in the clinical trial was representative of clinically meaningful improvement in dysphagia. 

    The most common side effects associated with Dupixent include injection site reactions, upper respiratory tract infections, joint pain, and herpes viral infections.

    Dupixent is contraindicated in patients with known hypersensitivity to dupilumab or any of its inactive ingredients. Dupixent carries warnings and precautions, including ones addressing potential development of allergic reactions, conjunctivitis, keratitis, or joint pain; use in patients with certain parasitic infections; and use in conjunction with live vaccinations. 

    Dupixent received priority review and breakthrough therapy designations for this indication. 

    Dupixent was originally approved in 2017. It is approved for the treatment of moderate-to-severe atopic dermatitis in adult and pediatric patients aged 6 and older whose disease is not adequately controlled by topical prescription therapies or when those therapies are not advisable. Dupixent is also approved as an add-on maintenance treatment of adults and pediatric patients aged 6 and older with certain types of moderate-to-severe asthma, as well as an add-on maintenance treatment in adults with inadequately controlled chronic rhinosinusitis with nasal polyposis. 

    The FDA granted the approval of Dupixent to Regeneron Pharmaceuticals, Inc. 
     

    Related Information

    Related Information
    • NIH: Eosinophilic Esophagitis

    ###

    Boilerplate

    The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


    Inquiries

    Media:
    Chanapa Tantibanchachai
    202-384-2219
    Consumer:
    888-INFO-FDA

    Get the next $REGN alert in real time by email

    Chat with this insight

    Save time and jump to the most important pieces.

    Recent Analyst Ratings for
    $REGN

    DatePrice TargetRatingAnalyst
    5/30/2025$662.00Outperform → Sector Perform
    RBC Capital Mkts
    5/30/2025$580.00Overweight → Equal Weight
    Wells Fargo
    5/14/2025$700.00Neutral → Buy
    Citigroup
    4/22/2025$695.00Overweight
    Cantor Fitzgerald
    2/5/2025$762.00 → $834.00Market Perform → Outperform
    Leerink Partners
    1/16/2025$1130.00 → $738.00Buy → Neutral
    UBS
    12/10/2024$565.00Underperform
    BofA Securities
    11/15/2024$1150.00Outperform
    Wolfe Research
    More analyst ratings

    $REGN
    SEC Filings

    See more
    • SEC Form 13F-HR filed by Regeneron Pharmaceuticals Inc.

      13F-HR - REGENERON PHARMACEUTICALS, INC. (0000872589) (Filer)

      5/2/25 4:15:32 PM ET
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form 10-Q filed by Regeneron Pharmaceuticals Inc.

      10-Q - REGENERON PHARMACEUTICALS, INC. (0000872589) (Filer)

      4/29/25 6:51:48 AM ET
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Regeneron Pharmaceuticals Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits

      8-K - REGENERON PHARMACEUTICALS, INC. (0000872589) (Filer)

      4/29/25 6:37:44 AM ET
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $REGN
    Large Ownership Changes

    This live feed shows all institutional transactions in real time.

    See more
    • SEC Form SC 13G/A filed by Regeneron Pharmaceuticals Inc. (Amendment)

      SC 13G/A - REGENERON PHARMACEUTICALS, INC. (0000872589) (Subject)

      2/13/24 5:12:22 PM ET
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form SC 13G/A filed by Regeneron Pharmaceuticals Inc. (Amendment)

      SC 13G/A - REGENERON PHARMACEUTICALS, INC. (0000872589) (Subject)

      2/9/24 6:19:03 PM ET
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form SC 13G/A filed by Regeneron Pharmaceuticals Inc. (Amendment)

      SC 13G/A - REGENERON PHARMACEUTICALS, INC. (0000872589) (Subject)

      2/9/24 9:49:31 AM ET
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $REGN
    Financials

    Live finance-specific insights

    See more
    • Regeneron to Report First Quarter 2025 Financial and Operating Results and Host Conference Call and Webcast on April 29, 2025

      TARRYTOWN, N.Y., March 25, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its first quarter 2025 financial and operating results on Tuesday, April 29, 2025, 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' page of Regeneron's website at https://investor.regeneron.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detai

      3/25/25 4:05:00 PM ET
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Regeneron to Report Fourth Quarter and Full Year 2024 Financial and Operating Results and Host Conference Call and Webcast on February 4, 2025

      TARRYTOWN, N.Y., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its fourth quarter and full year 2024 financial and operating results on Tuesday, February 4, 2025, 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' page of Regeneron's website at https://investor.regeneron.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmati

      1/7/25 4:05:00 PM ET
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Regeneron to Report Third Quarter 2024 Financial and Operating Results and Host Conference Call and Webcast on October 31, 2024

      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 call live via webcast on the 'Investors and Media' page of Regeneron's website at https://investor.regeneron.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email deta

      9/26/24 4:05:00 PM ET
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $REGN
    Analyst Ratings

    Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

    See more

    $REGN
    Insider Trading

    Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

    See more
    • Regeneron Pharma downgraded by RBC Capital Mkts with a new price target

      RBC Capital Mkts downgraded Regeneron Pharma from Outperform to Sector Perform and set a new price target of $662.00

      5/30/25 12:22:00 PM ET
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Regeneron Pharma downgraded by Wells Fargo with a new price target

      Wells Fargo downgraded Regeneron Pharma from Overweight to Equal Weight and set a new price target of $580.00

      5/30/25 9:03:41 AM ET
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Regeneron Pharma upgraded by Citigroup with a new price target

      Citigroup upgraded Regeneron Pharma from Neutral to Buy and set a new price target of $700.00

      5/14/25 8:51:04 AM ET
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Director Schenkein David P was granted 166 shares, increasing direct ownership by 59% to 448 units (SEC Form 4)

      4 - REGENERON PHARMACEUTICALS, INC. (0000872589) (Issuer)

      1/6/25 5:42:19 PM ET
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Director Thompson Craig B. was granted 166 shares, increasing direct ownership by 37% to 620 units (SEC Form 4)

      4 - REGENERON PHARMACEUTICALS, INC. (0000872589) (Issuer)

      1/6/25 4:13:03 PM ET
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Director Coles N Anthony was granted 166 shares, increasing direct ownership by 12% to 1,559 units (SEC Form 4)

      4 - REGENERON PHARMACEUTICALS, INC. (0000872589) (Issuer)

      1/6/25 4:12:14 PM ET
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $REGN
    Leadership Updates

    Live Leadership Updates

    See more
    • Regeneron Announces Formation of Regeneron Cell Medicines with the Acquisition of 2seventy bio Platforms and Preclinical and Clinical Programs

      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 acquired programs will join Regeneron Cell Medicines, a newly formed research & development (R&D) unit to advance cell therapies and combination approaches in oncology and immunology. "Regeneron and 2seventy share a relentless commitment to push the boundaries of scie

      1/30/24 7:00:41 AM ET
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Together for CHANGE Genomics and Equity Initiative Launched by a Coalition of Meharry Medical College, Regeneron Genetics Center, AstraZeneca, Novo Nordisk, and Roche to Improve Health Outcomes for People of African Ancestry

      NIH data show that globally less than 2% of genetic information being studied today originates from people of African ancestry1 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 BAGSVAERD, Denmark and BASEL, Switzerland, Oct. 18, 2023 (GLOBE NEWSWIRE) -- Meharry Medical College, along with partners Regeneron Genetics Center® (RGC™), AstraZeneca, Novo Nordisk, and Roche, today announced the launch of the Together for CHANGE™ ("Changing Healthcare for

      10/18/23 9:00:00 AM ET
      $AZN
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Regeneron Announces Retirement of Board Chair, Dr. P. Roy Vagelos, Accomplished Physician-Businessman and Industry Luminary

      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 Meeting on June 9, 2023. Effective upon the conclusion of that meeting, the Board plans to appoint Leonard S. Schleifer, M.D., Ph.D., and George D. Yancopoulos, M.D., Ph.D., as Co-Chairs of the Board, in addition to their roles as President and Chief Executive Officer and P

      4/17/23 7:30:00 AM ET
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $REGN
    Press Releases

    Fastest customizable press release news feed in the world

    See more
    • Libtayo® (cemiplimab) Phase 3 Data in the Adjuvant Treatment of Post-Surgical High-Risk Cutaneous Squamous Cell Carcinoma (CSCC) Have Potential to Be Practice-Changing

      Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death, the primary endpoint of the trial (p<0.0001) Libtayo also demonstrated 80% and 65% reductions in the risk of locoregional and distant recurrence, respectively, compared to placebo   Detailed results presented in an oral session at the 2025 American Society of Clinical Oncology Annual Meeting and simultaneously published in the New England Journal of Medicine Regulatory applications have been submitted in the United States and European Union TARRYTOWN, N.Y., May 31, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) today announced detailed analyses from the Phase 3 C-POST trial, which

      5/31/25 8:04:38 AM ET
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Press Release: Itepekimab met the primary endpoint in one of two COPD phase 3 studies

      Itepekimab met the primary endpoint in one of two COPD phase 3 studies AERIFY-1 study met its primary endpoint of a statistically significant reduction in moderate or severe exacerbations in former smokers regardless of eosinophilic phenotype and provided a clinically meaningful benefitAERIFY-2 study, a second Phase 3 study, did not meet the primary endpoint despite a benefit seen earlier in the studyItepekimab was generally well tolerated in both AERIFY-1 and AERIFY-2Sanofi and Regeneron are assessing the data and will discuss with regulatory authorities to evaluate next steps Paris and Tarrytown, NY, May 30, 2025. The AERIFY-1 phase 3 study evaluating itepekimab in former smokers with in

      5/30/25 1:00:00 AM ET
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Itepekimab Met Primary Endpoint in One of Two Chronic Obstructive Pulmonary Disease (COPD) Phase 3 Trials

      AERIFY-1 trial met the primary endpoint of a statistically significant reduction in moderate or severe exacerbations in former smokers regardless of eosinophilic phenotype and provided a clinically meaningful benefit AERIFY-2, a second Phase 3 trial, did not meet the primary endpoint despite a benefit seen earlier in the trial Itepekimab was generally well tolerated in both AERIFY-1 and AERIFY-2, with safety consistent with prior clinical trials Regeneron and Sanofi are assessing the data and will discuss next steps with regulatory authorities TARRYTOWN, N.Y. and PARIS, May 30, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi today anno

      5/30/25 1:00:00 AM ET
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $REGN
    FDA approvals

    Live FDA approvals issued by the Food and Drug Administration and FDA breaking news

    See more
    • May 20, 2022 - FDA Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune Disorder

      For Immediate Release: May 20, 2022 Today, the U.S. Food and Drug Administration approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in adults and pediatric patients 12 years and older weighing at least 40 kilograms (which is about 88 pounds). Today’s action marks the first FDA approval of a treatment for EoE. “As researchers and clinicians have gained knowledge about eosinophilic esophagitis

      5/20/22 3:11:09 PM ET
      $REGN
      Biotechnology: Pharmaceutical Preparations
      Health Care