$OGN News

Last published 4d ago

4d agoOGNNew Real-World Evidence Presented by Organon at the American College of Rheumatology (ACR) Annual Meeting Evaluated a Large-Scale Switch to HADLIMA® (adalimumab-bwwd) Across United States Veterans Affairs Healthcare SystemBusiness WireJERSEY CITY, N.J.--(BUSINESS WIRE)--Analysis of 16,000+ VA patients switching to HADLIMA from HUMIRA showed a 1.3% switchback rate and generated $132M in estimated savings.
1w agoOGNOrganon Announces Quarterly DividendBusiness WireOrganon (NYSE:OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today that the company’s Board of Directors declared a quarterly dividend
2w agoENTX OGN MRKEntera Appoints Global Research and Development Leader Dr. Juan Camilo Arjona Ferreira to Its Board of DirectorsGlobeNewswireDr. Arjona Ferreira currently serves as Head of Research and Development and Chief Medical Officer at Organon & Co. (NYSE:OGN) He joins Entera with two decades of clinical development, regulatory execution, and
3w agoOGNOrganon to Report Third Quarter 2026 Results in Its Regularly Scheduled Form 10-Q FilingBusiness WireOrganon (NYSE:OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, plans to release its third quarter 2026 financial results via its regularly
3w agoOGNOrganon Announces Positive Interim Phase 3 Study Results for MIUDELLA®, a Hormone-Free, Intrauterine Device (IUD), Through 6 Years of Use to Be Presented at the 2026 Society of Family Planning Annual MeetingBusiness WireNo new safety signals identified during additional three years of extended use Organon holds exclusive global licensing rights to MIUDELLA Organon (NYSE:OGN), a global healthcare company with a mission to
1mo agoOGNOrganon to Present New Real-World Analysis of VTAMA® (tapinarof) Cream, 1%, at the 2026 Fall Clinical Dermatology ConferenceBusiness WireNew data will represent one of the first large-scale real-world effectiveness analyses of VTAMA cream in patients with atopic dermatitis (AD) Organon (NYSE:OGN), a global healthcare company with a mission to deliver
1mo agoOGNOrganon Announces US FDA Has Accepted for Review a Supplemental New Drug Application for MIUDELLA®, a Hormone-Free Intrauterine DeviceBusiness WireSebela’s sNDA Seeks to Extend Approved Duration of Use from 3 to 6 Years Organon (NYSE:OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, today
2mo agoOGNNational Can-RISE Study to Help Close Critical Gaps in Menopause ResearchGlobeNewswireTORONTO, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Women’s Health Collective Canada (WHCC) and the Partnership for Women’s Health Research Canada (PWHR), in partnership with GreenShield and supported by a charitable grant
3mo agoOGNOrganon Opens REMS Program for MIUDELLA® Ahead of Anticipated Commercial AvailabilityBusiness WireHealthcare Providers, Healthcare Settings, and Participating Pharmacies Can Now Begin Required Training and Certification in Preparation for MIUDELLA’s Launch Later This Year Organon (NYSE:OGN), a global healthcare
3mo agoOGNOrganon Announces Quarterly DividendBusiness WireOrganon (NYSE:OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today that the company’s Board of Directors declared a quarterly dividend
3mo agoOGNNew Analysis of Phase 3 Pooled Data for Organon’s VTAMA® (tapinarof) cream, 1%, Demonstrates Early, Consistent Improvements in Atopic Dermatitis Patients Across Pediatric Age Groups and in Adults1Business WireThe presentation at the 2026 Society for Pediatric Dermatology (SPD) Annual Meeting marked the first time pooled Phase 3 data from the ADORING 1 and 2 trials on Validated Investigator Global Assessment for Atopic
3mo agoOGNOrganon to Report Second Quarter 2026 Results in Its Regularly Scheduled Form 10-Q FilingBusiness WireOrganon (NYSE:OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, plans to release its second quarter 2026 financial results via its regularly
4mo agoOGNOrganon to Present New Analysis on VTAMA® (tapinarof) cream, 1%, at the 2026 Society for Pediatric Dermatology Annual MeetingBusiness WireNew analysis of pooled Phase 3 data will evaluate efficacy and safety of VTAMA cream across age groups in pediatric and adult patients with atopic dermatitis (AD) Organon (NYSE:OGN), a global healthcare company with
4mo agoOGNOrganon Canada and Henlius Expand Access to Denosumab Treatments With Launch of BILDYOS® (denosumab injection) and TUZEMTY® (denosumab injection), Biosimilars to PROLIA and XGEVABusiness WireThe launch expands Organon’s biosimilars portfolio in Canada to eight products spanning five therapeutic areas Organon Canada and Shanghai Henlius Biotech, Inc. (2696.HK) today announced that BILDYOS® (denosumab
4mo agoOGNOrganon Completes Agreement to License MIUDELLA®, Sebela Pharmaceuticals’ Hormone-Free Intrauterine DeviceBusiness WireThis transaction strengthens Organon’s contraception portfolio and expands long-acting reversible options for women Organon (NYSE:OGN), a global healthcare company with a mission to deliver impactful medicines and
4mo agoOGNOrganon and Samsung Bioepis Expand Agreement to Commercialize PYZCHIVA® (ustekinumab), a Biosimilar Referencing STELARA® (ustekinumab) in CanadaBusiness WireThe amended agreement deepens Organon and Samsung Bioepis's collaboration to six biosimilars in Canada across multiple therapeutic areas, including immunology, oncology and dermatology. To be launched in Canada in
5mo agoOGNOrganon Secures US Food and Drug Administration Approval Expanding Indications for TOFIDENCE® (tocilizumab-bavi) in Cytokine Release Syndrome (CRS) and Pediatric COVID-19Business WireOrganon (NYSE:OGN) today announced the US Food and Drug Administration (FDA) approval of the supplemental Biologics License Application (sBLA) for TOFIDENCE® (tocilizumab-bavi) injection, for intravenous use, a
5mo agoOGNANNUAL MEETING OF SHAREHOLDERS - ORGANON & CO.Earnings Call TranscriptsThis is Organon and Co.'s 2026 Annual Meeting of Shareholders. My name is Paul, and I will be the operator of the meeting and will be assisting the speakers this morning. I will now turn the meeting over to Kirk Weaver,
5mo agoOGNANNUAL MEETING OF SHAREHOLDERS - ORGANON & COEarnings Call TranscriptsThis is Organon and Co.'s 2026 Annual Meeting of Shareholders. My name is Paul, and I will be the operator of the meeting and will be assisting the speakers this morning. I will now turn the meeting over to Kirk Weaver,
6mo agoOGNOrganon to Present New Research on Access and Value at ISPOR 2026Business WireNew findings will highlight contraception affordability, biosimilar adoption, and access-focused analyses across the women's health and general medicines portfolio Organon (NYSE:OGN), a global healthcare company with
6mo agoOGNOrganon Reports Results for the First Quarter Ended March 31, 2026Business WireFirst quarter 2026 revenue of $1.460 billion, down 4% as-reported and down 9% excluding the impact of foreign currency. First quarter 2026 diluted earnings per share of $0.55 and non-GAAP Adjusted diluted earnings
6mo agoOGNEuropean Commission (EC) Approves Henlius and Organon's POHERDY® (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in EuropePR NewswireShanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the European Commission (EC) has granted marketing authorization...
6mo agoOGNOrganon Cancels First Quarter Earnings CallBusiness WireOrganon (NYSE:OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today that it has canceled its first quarter 2026 earnings conference call
6mo agoOGNEuropean Commission (EC) Approves Henlius and Organon's POHERDY® (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in EuropeBusiness WireShanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE:OGN) today announced the European Commission (EC) has granted marketing authorization for POHERDY® (pertuzumab) 420 mg/14 mL injection for intravenous
6mo agoOGNSun Pharma signs Definitive Agreement to Acquire OrganonBusiness WireOrganon stockholders to receive US$ 14.00 per share in cash The deal values Organon at EV of US$ 11.75 billion Combined Business leverages complementary portfolios and global scale for sustained long‑term value
6mo agoOGNOrganon To Report First Quarter 2026 Results and Host Conference Call on May 7, 2026Business WireOrganon (NYSE:OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, will release its first quarter 2026 financial results on May 7, 2026, prior to the
7mo agoOGNOrganon's VTAMA® (tapinarof) cream, 1%, Granted Strong Recommendation in the 2026 American Academy of Dermatology Guidelines for Pediatric Atopic DermatitisBusiness WireThe American Academy of Dermatology (AAD) provided a strong, evidence-based recommendation for the use of VTAMA cream, the only steroid-free topical treatment the AAD found to be supported by a high certainty of
7mo agoOGNOrganon Debuts New Analysis of VTAMA® (tapinarof) cream, 1%, Phase 3 Pooled Data Demonstrating Early and Consistent Skin Clearance and Itch Improvement in Atopic Dermatitis Patients Down to 2 Years of AgeBusiness WireVTAMA demonstrated early and consistent response rates in disease severity and itch improvements, measured by the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) and Peak
8mo agoOGNNew Analysis of Organon's VTAMA® (tapinarof) cream, 1%, Phase 3 Data Showed Early and Consistent Improvement in Patient-Reported Sleep Subdomains in Pediatric Patients Down to 2 Years of Age with Atopic DermatitisBusiness WireClinically meaningful improvements in sleep scores, as measured by subdomains of the Patient-Oriented Eczema Measure (POEM) and Dermatitis Family Impact (DFI) assessments, were observed as early as week 1 and continued
8mo agoOGNOrganon Enters into Agreement to License MIUDELLA®, Sebela Pharmaceuticals' Hormone-Free Intrauterine DeviceBusiness WireMIUDELLA® is a strategic addition to Organon's portfolio, strengthening its long‑term commitment to advancing women's health Organon (NYSE:OGN), a global healthcare company with a mission to deliver impactful
8mo agoAMGN CNTB NKTR APGE+6Atopic Dermatitis Market to Accelerate at a Rapid Pace by 2034 with Advancements in Biologics and JAK Inhibitors | DelveInsightPR NewswireRecently published Atopic Dermatitis Market Insights report includes a comprehensive understanding of current treatment practices, atopic dermatitis...
9mo agoOGNOrganon and Co., Q4 and FY 2025 Earnings Call and Webcast - Organon and Co.Earnings Call TranscriptsHello, and welcome to the Organon 4th Quarter and Full Year 2025 Earnings Call and Webcast. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and an
9mo agoOGNOrganon Reports Results for the Fourth Quarter and Full Year Ended December 31, 2025Business WireFull year 2025 revenue of $6.2 billion, down 3% on both an as-reported basis and at constant currency Full year 2025 diluted earnings per share of $0.72 and non-GAAP Adjusted diluted earnings per share of
9mo agoOGNOrganon To Report Fourth Quarter and Full Year 2025 Results and Host Conference Call on February 12, 2026Business WireOrganon (NYSE:OGN), a global healthcare company with a primary focus on women's health, will release its fourth quarter and full year 2025 financial results on February 12, 2026, prior to the company's webcast and
9mo agoOGNOrganon Completes Divestiture of JADA® System to LaborieBusiness WireOrganon (NYSE:OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today the successful closing of the sale of its JADA® System to
11mo agoOGNOrganon To Present at the Piper Sandler 37th Annual Healthcare ConferenceBusiness WireOrganon (NYSE:OGN), announced today that Joe Morrissey, Interim Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the Piper Sandler 37th Annual
11mo agoOGNHenlius and Organon Announce US FDA Approval of POHERDY® (pertuzumab-dpzb), the First PERJETA (pertuzumab) Biosimilar in the USBusiness WireShanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE:OGN) today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for POHERDY® (pertuzumab-dpzb)
1y agoOGNOrganon Reports Results for the Third Quarter Ended September 30, 2025Business WireThird quarter 2025 revenue of $1.602 billion, up 1% as-reported and down 1% excluding the impact of foreign currency Third quarter 2025 diluted earnings per share of $0.61 and non-GAAP Adjusted diluted earnings per
1y agoOGNNew Data Show Early and Consistent Response to VTAMA® (tapinarof) Cream, 1%, in Children Aged 2+ with Atopic Dermatitis, Including Those With Associated ComorbiditiesBusiness WireSub-analysis of children with atopic dermatitis aged 2-17 in pivotal Phase 3 trials revealed early and clinically meaningful improvements in vIGA-AD™ and EASI-75 (skin clearance and severity), POEM
1y agoOGNOrganon Announces Agreement to Divest its JADA® System for Up to $465 Million to LaborieBusiness WireNet proceeds will be applied to debt reduction, advancing Organon's ongoing deleveraging efforts Positions Organon for future investment in growth opportunities with a focus on women's health biopharma and other
1y agoOGNOrganon To Report Third Quarter 2025 Results and Host Conference Call on November 10, 2025Business WireOrganon (NYSE:OGN), a global healthcare company with a primary focus on women's health, will release its third quarter 2025 financial results on November 10, 2025, prior to the company's webcast and conference call
1y agoOGNOrganon Appoints Company Executive Joseph Morrissey as Interim CEO and Board Chair Carrie Cox as Executive Chair; Announces Results of Audit Committee InvestigationBusiness WireOrganon (NYSE:OGN) ("Organon" or "the company") today announced that its Board of Directors has appointed the Company's Executive Vice President and Head of Manufacturing & Supply, Joseph Morrissey, Interim Chief
1y agoOGNKuehn Law Encourages Investors of Organon & Co. to Contact Law FirmPR NewswireKuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of Organon & Co. (NYSE: OGN) breached...
1y agoOGNUS Food and Drug Administration (FDA) Approves Henlius and Organon's BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), RespectivelyBusiness WireShanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE:OGN) today announced the US Food and Drug Administration (FDA) has approved BILDYOS® (denosumab-nxxp) injection 60 mg/mL and BILPREVDA®
1y agoOGNOrganon & Co. (OGN) Q2 2025 Earnings Call TranscriptEarnings Call Transcripts
1y agoOGNOrganon Reports Results for the Second Quarter Ended June 30, 2025Business WireSecond quarter 2025 revenue of $1.594 billion Second quarter 2025 diluted earnings per share of $0.56 and non-GAAP Adjusted diluted earnings per share of $1.00; GAAP diluted earnings per share includes a $46 million
1y agoOGNOrganon To Report Second Quarter 2025 Results and Host Conference Call on August 5, 2025Business WireOrganon (NYSE:OGN), a global healthcare company with a primary focus on women's health, will release its second quarter 2025 financial results on August 5, 2025, prior to the company's webcast and conference call
1y agoOGNINVESTOR DEADLINE APPROACHING: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of OrganonGlobeNewswireFaruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses In Organon To Contact Him Directly To Discuss Their Options If you purchased or acquired securities in
1y agoOGNOrganon & Co. Sued for Securities Law Violations – Investors Should Contact The Gross Law Firm Before July 22, 2025 to Discuss Your Rights – OGNGlobeNewswireNEW YORK, July 16, 2025 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Organon & Co. (NYSE:OGN). Shareholders who purchased shares of OGN during the class period listed are
1y agoOGNOGN Investors Have the Opportunity to Lead the Organon Securities Fraud Lawsuit with Faruqi & Faruqi, LLPPR NewswireFaruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Organon & Co. ("Organon" or the "Company")...