Welcome to our dedicated page for ORGANON & CO news (Ticker: OGN), a resource for investors and traders seeking the latest updates and insights on ORGANON & CO stock.
News about Organon & Co. (NYSE: OGN) centers on its activities as a global healthcare company focused on Women’s Health, General Medicines and biosimilars. Company press releases repeatedly describe a portfolio of over 70 products and a mission to deliver impactful medicines and solutions for a healthier every day, with particular emphasis on health needs that uniquely, disproportionately or differently affect women.
Visitors to this news page will find updates on Organon’s product and portfolio developments, including regulatory milestones, commercialization agreements and clinical data presentations. Recent announcements feature US Food and Drug Administration approvals of biosimilars such as BILDYOS and BILPREVDA for all indications of their reference products, and POHERDY as an interchangeable biosimilar to PERJETA for HER2-positive breast cancer. Organon also reports European Commission approvals for BILDYOS and BILPREVDA, expanding access to bone health treatments across the EU.
Organon’s news flow also covers women’s health and dermatology data, such as Phase 3 ADORING program results for VTAMA cream in children with atopic dermatitis, and agreements like the planned divestiture of the JADA System to Laborie and the commercialization of Nilemdo in selected European markets. Financial and corporate governance updates appear through quarterly earnings releases, capital allocation decisions, leadership changes and disclosures related to the Audit Committee investigation into Nexplanon wholesaler sales practices.
For investors, analysts and healthcare observers, the Organon news stream provides insight into how the company manages its women’s health, biosimilars and established brands portfolios, responds to regulatory developments and adjusts its leadership and balance sheet. Regularly reviewing these updates can help readers follow Organon’s evolving product mix, geographic reach and governance actions over time.
Organon (NYSE: OGN) will announce its Q2 2024 financial results on August 6, 2024. The company's webcast and conference call are scheduled for 8:30 a.m. EDT. Organon estimates a $15 million milestone expense in the second quarter, impacting both GAAP and non-GAAP EPS by approximately $0.05. These expenses stem from collaborations with Cirqle Biomedical and Shanghai Henlius Biotech. The company notes that these milestones are not included in their May 2, 2024, financial guidance due to forecasting uncertainties. Final results are pending and may differ from estimates.
Interested parties can access the live webcast on Organon's website, with a replay available two hours post-event. Institutional investors and analysts need to pre-register to participate in the call.
Shanghai Henlius Biotech and Organon announced that the European Medicines Agency (EMA) has validated the marketing authorization applications for HLX14. HLX14 is a biosimilar candidate for Prolia® and Xgeva® (denosumab), used primarily to treat osteoporosis in postmenopausal women at high risk for fractures. The applications are based on a comprehensive phase 3 clinical study comparing HLX14 with EU-sourced reference denosumab. In 2022, Henlius granted Organon exclusive commercialization rights for HLX14 in the EU, US, and Canada, excluding China. Notably, 32 million Europeans aged 50 or above suffer from osteoporosis, highlighting the market potential for HLX14.
Organon, a global healthcare company focusing on women's health, announced the pricing of $1.0 billion Senior Notes Offering, consisting of $500 million of 6.750% senior secured notes and $500 million of 7.875% senior unsecured notes. The proceeds will be used to repay borrowings and cover related expenses. The offering is expected to close on May 17, 2024.
Organon, a global healthcare company focusing on women's health, plans to offer $1.0 billion in senior notes, consisting of $500 million in secured notes and $500 million in unsecured notes. The proceeds will be used to repay borrowings and cover related expenses. The offering is not registered under the U.S. Securities Act and is targeted at qualified institutional buyers and non-U.S. persons.
Organon (NYSE: OGN) reported impressive first-quarter 2024 results, with revenue reaching $1,622 million, up 5% on an as-reported basis and 7% at constant currency. Diluted earnings per share were $0.78, with non-GAAP adjusted earnings per share at $1.22. The company reaffirmed its full-year 2024 financial guidance. Women's Health revenue grew by 11%, Biosimilars revenue by 46%, and Established Brands revenue remained flat. Overall, Organon had a solid start to the year, focusing on growth while maintaining its commitment to improving women's health.
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