Articles from Organon & Co.

Organon (NYSEOGN) today announced its results for the fourth quarter and full year ended December 31, 2024.

Organon (NYSEOGN), a global healthcare company with a focus on women’s health, will release its fourth quarter and full year 2024 financial results on February 13, 2025, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EST.

Organon (NYSEOGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13th, 2025, at 3:45 p.m. PT.

Organon (NYSEOGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced that the U.S. Food and Drug Administration (FDA) has approved VTAMA® (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, for an additional indication of the topical treatment of atopic dermatitis (AD) in adults and pediatric patients 2 years of age and older.1 Organon received the FDA approval prior to its extended target action date (PDUFA) of March 12, 2025.

Organon (NYSEOGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced that the U.S. Food and Drug Administration (FDA) extended by three months the target action date of its review of the supplemental New Drug Application (sNDA) for VTAMA® (tapinarof) cream, 1% as a treatment for atopic dermatitis (AD) in adults and children two years of age and older. The new target date is March 12, 2025, revised from the original target action date of December 12, 2024. The FDA has not raised any concerns regarding the safety and efficacy of VTAMA nor have they raised any concerns regarding the approvability of this indication.

Organon (NYSEOGN) today announced its results for the third quarter ended September 30, 2024.

Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSEOGN) announced that the US Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX14, an investigational biosimilar of PROLIA/XGEVA (denosumab).

Organon (NYSEOGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced the successful completion of its acquisition of Dermavant Sciences Ltd. from Roivant NASDAQ: ROIVNASDAQROIV)

Organon (NYSEOGN), a global healthcare company with a focus on women’s health, will release its third quarter 2024 financial results on October 31, 2024, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT.

Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSEOGN) announced that the phase 3 comparative clinical trial for the investigational Perjeta® (pertuzumab) biosimilar HLX11 met the primary endpoint. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX11. The agreement licenses the global commercialization rights for the product, except for China, to Organon.

Organon (NYSEOGN), a global healthcare company with a mission to improve the health of women throughout their lives, and Dermavant Sciences Ltd. announced today that they have entered into a definitive agreement, under which Organon will acquire Dermavant, a Roivant NASDAQ: ROIVNASDAQROIV)

Organon (NYSEOGN), a global healthcare company with a focus on women’s health, announced it has expanded its agreement with Eli Lilly and Company (Lilly) to become the sole distributor and promoter for the migraine medicine Emgality® (galcanezumab) in the following additional markets: Canada, Colombia, Israel, South Korea, Kuwait, Mexico, Qatar, Saudi Arabia, Taiwan, Turkey and the United Arab Emirates. This expanded partnership builds on Organon’s role as sole distributor and promoter of Emgality in Europe since February 2024.

Organon (NYSEOGN) today announced its results for the second quarter ended June 30, 2024.

Organon (NYSEOGN), a global healthcare company with a focus on women’s health, will release its second quarter 2024 financial results on August 6, 2024, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT.

Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSEOGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization applications (MAAs) for HLX14, an investigational Prolia® and Xgeva® (denosumab) biosimilar. Denosumab has been approved in various countries and regions under different trade names for a range of different indications such as for the treatment of osteoporosis in postmenopausal women at high risk for fracture, among others. In 2019, it was estimated that 32 million Europeans ages 50 or above had osteoporosis, 25.5 million of which were women.1

Organon (NYSEOGN) (“Organon”), a global healthcare company with a focus on women’s health, announced today that it, together with Organon Foreign Debt Co-Issuer B.V., a direct wholly-owned subsidiary of Organon, as co-issuer (the “Co-Issuer” and, together with Organon, the “Companies”), have priced an offering of $500 million of 6.750% senior secured notes due 2034 (the “Secured Notes”) and $500 million of 7.875% senior unsecured notes due 2034 (the “Unsecured Notes” and, together with the Secured Notes the “Notes”). Each series of notes will be guaranteed by each of the entities that guarantees the Companies’ existing senior secured credit facilities (the “Credit Facilities”).

Organon (NYSEOGN) (“Organon”), a global healthcare company with a focus on women’s health, announced today that it, together with Organon Foreign Debt Co-Issuer B.V., a direct wholly-owned subsidiary of Organon, as co-issuer (the “Co-Issuer” and, together with Organon, the “Companies”), plan to offer, subject to market conditions, $500 million of senior secured notes due 2034 (the “secured notes”) and $500 million of senior unsecured notes due 2034 (the “unsecured notes” and, together with the Secured Notes the “notes”). Each series of notes will be guaranteed by each of the entities that guarantees the Companies’ existing senior secured credit facilities (the “Credit Facilities”). The notes offering is expected to be a leverage-neutral transaction.

Organon (NYSEOGN) today announced its results for the first quarter ended March 31, 2024.

Organon (NYSEOGN), a global healthcare company with a focus on women’s health, will release its first quarter 2024 financial results on May 2, 2024, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT.

Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSEOGN) announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® (denosumab) biosimilar HLX14 met the primary endpoints. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the United States, the European Union, and Canada. An exception to the agreement is China.

Organon (NYSEOGN), a global healthcare company with a dedicated commitment to biosimilars, announced that the US Department of Veterans Affairs (VA) has exclusively selected HADLIMA in replacement of HUMIRA (adalimumab) for the VA National Formulary. HADLIMA is an FDA-approved biosimilar to HUMIRA for the treatment of specific autoimmune or autoinflammatory conditions such as rheumatoid arthritis, Crohn’s disease, hidradenitis suppurativa, and plaque psoriasis (see full indications below).

Organon (NYSEOGN) today announced its results for the fourth quarter and full year ended December 31, 2023.

Organon (NYSEOGN), a global healthcare company with a focus on women’s health, will release its fourth quarter and full year 2023 financial results on February 15, 2024, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EST.

Organon (NYSEOGN), a global healthcare company with a focus on women’s health, announced that XACIATO™ (clindamycin phosphate) vaginal gel 2% is available by prescription to treat bacterial vaginosis (BV). BV results from an overgrowth of certain bacteria, which upsets the balance of the natural vaginal microbiome (environment) and can lead to symptoms of odor and discharge.3 BV has also been shown to disproportionately affect non-Hispanic Black and Mexican American women.4,5

Organon (NYSEOGN) today affirmed prior revenue and Adjusted EBITDA guidance, indicated that free cash flow before one-time spin-related costs is expected to be above the high end of the previous guidance range, and provided high-level financial objectives for 2024. Kevin Ali, Organon’s Chief Executive Officer and Matthew Walsh, Organon’s Chief Financial Officer, will discuss these updates as part of a webcast presentation at the 42nd Annual J.P. Morgan Healthcare Conference to be held tomorrow, January 9, 2024, at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time.

Organon (NYSEOGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9th, 2024, at 1:30 p.m. PT.

Organon (NYSEOGN), a global healthcare company with a focus on women’s health, announced an agreement with Eli Lilly and Company (Lilly) to become the sole distributor and promoter for the migraine medicines Emgality® (galcanezumab) and RAYVOW™ (lasmiditan) in Europe.1

Organon (NYSEOGN), a global healthcare company with a focus on women’s health, announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the Piper Sandler 35th Annual Healthcare Conference on Wednesday, November 29, 2023 at 11:00 a.m. EST.

Organon (NYSEOGN) today announced its results for the third quarter ended September 30, 2023.

Organon (NYSEOGN) and Sempre Health today announced a strategic partnership designed to motivate eligible patients to refill their prescriptions on time and improve adherence through an innovative pricing program that offers personalized support.

Organon (NYSEOGN), a global healthcare company with a focus on women’s health, will release its third quarter 2023 financial results on November 2, 2023, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EST. Interested parties may access the live call via webcast on the Organon website at https://www.organon.com/investor-relations/events-and-presentations/. A replay of the webcast will be available approximately two hours after the conclusion of the live event on the company’s website.

Organon (NYSEOGN), a global healthcare company with a focus on women’s health, has been named to Fortune’s 2023 Change the World list for its leadership in helping women and girls around the world take control of their reproductive health. Organon has a portfolio of programs, collaborations, and investments designed to lift women for generations to come through family planning education and contraceptive access. Fortune’s annual list recognizes companies that have had a positive social impact through activities that are part of their core business strategy.

Organon (NYSEOGN), a global healthcare company focused on improving women’s health, today announced that Obstetrics & Gynecology (“The Green Journal”), the peer-reviewed journal of the American College of Obstetrics and Gynecology (ACOG), published the results of the RUBY study (NCT04995887) which reached its primary effectiveness outcome of successfully treating abnormal postpartum uterine bleeding and postpartum hemorrhage (PPH) with the JADA® System.1 JADA is an intrauterine vacuum-induced hemorrhage control device intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.1

Organon (NYSEOGN), a global healthcare company with a focus on women’s health, today announced the appointment of Juan Camilo Arjona Ferreira, M.D., as Chief Medical Officer (CMO) and Charlotte Owens, M.D., as Head of Medical Affairs and Outcomes Research, strengthening the company’s global clinical and medical capabilities, advancing external relationships and fueling efforts to bring forward innovations to solve unmet health needs. Both positions report directly to Sandra Milligan, M.D., J.D., Head of Research and Development.

Organon (NYSEOGN) today announced its results for the second quarter ended June 30, 2023.

Organon (NYSEOGN), a global women’s healthcare company will release its second quarter 2023 financial results on August 8, 2023, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT.

Organon & Co. (NYSEOGN) & Samsung Bioepis Co., Ltd. today announced that HADLIMA™ (adalimumab-bwwd), a biosimilar referencing Humira (adalimumab), is now available to patients in the United States. Consistent with Humira, HADLIMA is available in both citrate-free high concentration (100 mg/mL) and citrate-containing low concentration (50 mg/mL) to provide patients with seamless continuity of care.

Organon (NYSEOGN), a global healthcare company focused on women’s health, today released its 2022-2023 Environmental, Social, and Governance (ESG) Report. The report highlights the company’s progress on its comprehensive ESG platform, Her Promise, and its related goals, which are in line with the United Nations Sustainable Development Goals (SDGs).

Today, Organon (NYSEOGN), a global healthcare company focused on women’s health, and CAF, Development Bank of Latin America, signed a memorandum of understanding (MOU) to contribute to the United Nations Sustainable Development Goals through the design, structure and implementation of sustainable programs that promote and improve equity, health and autonomy of girls and women in Latin America and the Caribbean. Across the globe, tremendous gaps exist in women’s health that can potentially prevent women and thus economies from achieving their full potential. Sustainable financing can advance progress in women’s health by mobilizing capital towards initiatives that might not otherwise receive adequate support like increasing access to sexual and reproductive health education and healthcare services.

Organon (NYSEOGN) today announced its results for the first quarter ended March 31, 2023.

Organon (NYSEOGN), a global women’s healthcare company will release its first quarter 2023 financial results on May 4, 2023, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT.

Organon (NYSEOGN), a global healthcare company focused on improving women’s health, today announced the launch of a new global initiative, “Her Plan is Her Power,” to accelerate progress toward addressing the public health crisis of unplanned pregnancy. Annually, nearly 50% of pregnancies (approximately 121 million) around the world are estimated to be unplanned, leading to health risks and reduced educational and employment opportunities for mother and child – challenges which can span generations.

Organon (NYSEOGN), a global women’s healthcare company will release its fourth quarter and full year 2022 financial results on February 16, 2023, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EST.

Organon (NYSEOGN), a global women’s healthcare company, today announced a strategic investment in Claria Medical, Inc. a privately-held company developing an investigational medical device being studied for use during minimally invasive laparoscopic hysterectomy. The agreement also grants Organon the option to acquire Claria Medical.

Organon (NYSEOGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10th, 2023 at 7:30 a.m. PT.

Organon (NYSEOGN), a global women’s healthcare company, today announced that Kirke Weaver has been appointed General Counsel and Corporate Secretary, and will continue as a member of Organon’s executive leadership team, effective January 1, 2023. Mr. Weaver was named as the interim head of the Office of General Counsel and Corporate Secretary in July 2022.

Organon (NYSEOGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the Piper Sandler 34th Annual Healthcare Conference on Tuesday, November 29th, 2022 at 9:00 a.m. EST.

Organon (NYSEOGN) (the “company”), today announced its results for the third quarter ended September 30, 2022.

Organon (NYSEOGN), a global women’s healthcare company will release its third quarter 2022 financial results on November 3, 2022, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT.

Samsung Bioepis Co., Ltd. and Organon & Co. (NYSEOGN) today announced the U.S. Food and Drug Administration (FDA) has approved the citrate-free, high-concentration (100 mg/mL) formulation of HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® (adalimumab). HADLIMA will be available in pre-filled syringe and autoinjector options, and the autoinjector was specifically designed with the patient in mind. HADLIMA was previously approved by the FDA as a low-concentration (50 mg/mL) formulation in July 2019 and outside the US that formulation has been available in various markets globally under different brand names, with over 5 million doses sold since 2018.1,2

Organon (NYSEOGN) (the “company”), today announced its results for the second quarter ended June 30, 2022.

Organon (NYSEOGN), a global women’s healthcare company, and Cirqle Biomedical today announced they have entered into a research collaboration and exclusive license agreement for a novel investigational non-hormonal, on-demand contraceptive candidate.

Organon (NYSEOGN), a global women’s healthcare company will release its second quarter 2022 financial results on August 4, 2022, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT.

Organon (NYSEOGN), a global women’s health company with deep expertise in biosimilar commercialization, today announced that it has entered into an agreement with Shanghai Henlius Biotech, Inc. (2696.HK), whereby Organon will license commercialization rights for biosimilar candidates referencing Perjeta® (pertuzumab, HLX11) and Prolia®/Xgeva® (denosumab, HLX14). Organon will acquire exclusive global commercialization rights except for China; including Hong Kong, Macau and Taiwan.

Organon (NYSEOGN), a global women’s healthcare company, today announced the publication of its inaugural Environmental, Social, and Governance (ESG) Report for 2021. The ESG Report introduces Organon’s ESG platform, known as Her Promise, and details how the company is working to help women and girls achieve the full potential of their promise through better health. The publication of the ESG Report and launch of Her Promise coincides with Organon’s one year anniversary and reflects the company’s vision to create a better and healthier every day for every woman around the world.

Organon (NYSEOGN) (the “company”), today announced its results for the first quarter ended March 31, 2022.

Organon (NYSEOGN), will release its first quarter 2022 financial results on May 5, 2022, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT.

Organon (NYSEOGN), a global women’s healthcare company, and Daré Bioscience, Inc. NASDAQ: DARENASDAQDARE)

Organon (NYSEOGN) today announced its results for the fourth quarter and full year ended December 31, 2021.

Organon (NYSEOGN) today announced that it has acquired the rights from Bayer AG to Marvelon® and Mercilon®, combined oral hormonal daily contraceptive pills, in the People’s Republic of China, including Hong Kong and Macau, and has entered into an agreement to acquire the rights to these products in Vietnam. Marvelon and Mercilon are already owned, manufactured, and marketed by Organon as prescription oral contraceptives in 20 other markets. This acquisition gives Organon full global ownership of these brands (except in South Korea) by reacquiring the rights to them in these markets. The agreement to acquire the rights in Vietnam is expected to close in the first half of 2022 and is subject to customary closing conditions, including regulatory approval.

Organon (NYSEOGN), a global women’s health company, is designating International Women’s Day (IWD) on March 8 as a day to recognize the growing health disparities women face that have been exacerbated by the COVID-19 pandemic. Since its inception, IWD has focused on accelerating gender parity. Organon recognizes the need for a global effort to address her health and is starting with its own employees by providing paid time off this year for all employees to attend to their own health needs. The company invites organizations across the globe to join in raising awareness of the inequity in women’s health and to adopt initiatives that help women prioritize their health.

Organon (NYSEOGN), will release its fourth quarter and full year 2021 financial results on February 17, 2022, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EST.

Samsung Bioepis Co., Ltd. and Organon & Co. (NYSEOGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for a citrate-free, high-concentration (100 mg/mL) formulation of SB5 (adalimumab-bwwd), a biosimilar candidate referencing HUMIRA® (adalimumab).1 SB5 was previously approved by the FDA under the brand name HADLIMA™ as a low-concentration (50 mg/mL) formulation in July 2019. The low concentration and high concentration forms of the reference product are both marketed in the United States (U.S.) today.

Organon (NYSEOGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the 40th Annual J.P. Morgan Healthcare Virtual Conference on Monday, January 10, 2022 at 2:15 p.m. ET.

Organon (NYSEOGN), a global women’s healthcare company, today announced the completion of its acquisition of Forendo Pharma, a clinical-stage drug development company focused on novel treatments in women’s health. Forendo’s lead candidate, FOR-6219, is an investigational, potentially first-in-class oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor entering Phase 2 clinical development for endometriosis. Forendo’s pipeline also includes a preclinical program targeting polycystic ovarian syndrome (PCOS).

Organon (NYSEOGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the Evercore ISI 4th Annual HealthCONx Conference on Wednesday, December 1, 2021 at 1:50 p.m. ET.

Organon (NYSEOGN) (the “company”), today announced its results for the third quarter and year to date ended September 30, 2021.

Organon (NYSEOGN), and Forendo Pharma today announced that the companies have entered into a definitive agreement, under which Organon will acquire Forendo, a clinical-stage drug development company focused on novel treatments in women’s health. Forendo is pioneering the science of intracrinology, addressing disease through a novel, tissue-specific approach. Its lead clinical compound is an investigational, potentially first-in-class oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor in early clinical development for endometriosis, being evaluated for its potential effect on endometriotic lesions. Endometriosis is a common and chronic condition that affects up to 1 in 10 women of reproductive age, causes abdominal pain and is associated with infertility.

Organon (NYSEOGN), will release its third quarter 2021 financial results on November 11, 2021, prior to the company’s webcast and conference call scheduled for 8:30 a.m. ET.

Organon (NYSEOGN) today announced the launch of a new website – Fertility Journey – that helps inform and empower people with resources and information needed to navigate the process of fertility care. The website aims to meet people wherever they are on their fertility journey and equip them with knowledge and questions for consideration to feel prepared and empowered throughout their journey.

Organon (NYSEOGN), a global women’s health company, today announced clearance by the U.S. Food and Drug Administration (FDA) of the Special 510(k) for technological updates to the Jada® System, intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. The incidence of postpartum hemorrhage due to uterine atony has increased significantly in the United States during the past decade.ii The product updates include a new kit configuration with updated packaging, as well as a streamlined design to help improve the device’s ease of use.

Organon (NYSEOGN), a global women’s health company, is launching a Public Service Announcement (PSA) that aims to raise awareness and ignite a worldwide conversation about the staggering rates of unplanned pregnancy around the world.

Organon (NYSEOGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at Morgan Stanley’s 19th Annual Global Healthcare Virtual Conference on Monday, September 13, 2021 at 9:30 a.m. EDT.

Organon (NYSEOGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at Citi’s 16th Annual BioPharma Virtual Conference on Friday, September 10, 2021 at 9:45 a.m. EDT.

Organon (NYSEOGN) (the “company”), today announced its results for the second quarter and year to date ended June 30, 2021 and affirmed its full year 2021 financial guidance.