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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) reported Q3 2025 revenue of $1.602 billion, up 1% as-reported and down 1% ex-FX. GAAP diluted EPS was $0.61 and non-GAAP adjusted diluted EPS was $1.01. Net income was $160 million; Adjusted EBITDA was $518 million with an Adjusted EBITDA margin of 32.3%. Reported gross margin fell to 53.5% from 58.3% year-over-year. Full-year revenue guidance was lowered to $6.20–$6.25 billion and Adjusted EBITDA margin guidance was lowered to ~31.0%. The board declared a $0.02 quarterly dividend payable December 11, 2025. Cash was $672 million and debt totaled $8.83 billion as of September 30, 2025.
Organon (NYSE: OGN) presented pooled Phase 3 sub-analysis data (ADORING 1 & 2) on November 8, 2025 showing VTAMA cream 1% gave early, clinically meaningful improvement in children 2–17 with atopic dermatitis, both with and without atopic comorbidities.
Key results through week 8: vIGA-AD response as early as week 1 (with comorbidities: 42.3% vs 11.8%; without: 49.5% vs 14.8%), EASI improvements from week 2 (with: 54.5% vs 21.8%; without: 63.1% vs 20.4%), POEM and POEM sleep improved by week 1, and PP-NRS itch ≥4-point response by week 2. Most common TEAEs in children were folliculitis (7.8%), upper respiratory infection (4.6%) and headache (3.7%).
Organon (NYSE: OGN) agreed to sell the JADA System to Laborie for up to $465 million — $440 million at closing plus up to $25 million contingent on 2026 revenue targets. Approximately 100 employees are expected to transfer to Laborie. The 6.5x multiple reflects JADA’s trailing 12-month revenues and U.S. expansion since Organon’s 2021 acquisition. Net proceeds will be applied to debt reduction to support the company’s objective to lower Net Debt to Adjusted EBITDA. Closing is expected in Q1 2026, subject to regulatory approvals and customary conditions.
Organon (NYSE: OGN) will report third quarter 2025 financial results on November 10, 2025 prior to a webcast and conference call at 8:30 a.m. ET. The call will be hosted by Carrie Cox (Executive Board Chair), Joe Morrissey (Interim CEO) and Matt Walsh (CFO). The company said it will not record any milestone expense in Q3 2025.
Investors can join the live webcast at https://www.organon.com/investor-relations/events-and-presentations/; a replay will be available about two hours after the live event. Dial-in for U.S./Canada is (888) 596-4144 or (646) 968-2525 with Conference ID 1036555#.
Organon (NYSE: OGN) appointed Joseph Morrissey as Interim CEO and Carrie S. Cox as Executive Chair following Kevin Ali’s resignation connected to an Audit Committee investigation into wholesaler sales practices for Nexplanon.
The internal investigation found certain U.S. wholesaler purchases at year-end 2022, Q3–Q4 2024 and Q1–Q3 2025 that represented less than 1% of consolidated revenue in the applicable years but helped the company meet guidance or external revenue expectations. The Board found the practices improper, identified inaccurate or incomplete prior statements, is taking remedial actions on controls, and does not currently expect financial restatements. The company intends to timely file its Form 10-Q for Q3 2025.
Organon (NYSE: OGN) and Shanghai Henlius Biotech (2696.HK) have received European Commission (EC) approval for two biosimilars: BILDYOS® (denosumab 60 mg/mL) and BILPREVDA® (denosumab 120 mg/1.7 mL), which reference PROLIA and XGEVA respectively.
BILDYOS is approved for treating osteoporosis in postmenopausal women and men at increased fracture risk, bone loss in prostate cancer patients, and glucocorticoid-induced bone loss. BILPREVDA is indicated for preventing skeletal events in advanced bone malignancies and treating giant cell tumors of bone.
The approvals follow successful U.S. FDA authorizations and are based on comprehensive data demonstrating biosimilarity to the reference products. This expansion stems from a 2022 agreement granting Organon exclusive global commercialization rights, except for China.
Organon (NYSE: OGN) and Shanghai Henlius Biotech announced FDA approval of two biosimilars: BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), which are biosimilar versions of PROLIA and XGEVA, respectively.
BILDYOS is indicated for treating various conditions including postmenopausal osteoporosis, increasing bone mass in men with osteoporosis, treating glucocorticoid-induced osteoporosis, and increasing bone mass in patients receiving specific cancer therapies. BILPREVDA is approved for preventing skeletal-related events in patients with multiple myeloma, bone metastases, giant cell tumor of bone, and hypercalcemia of malignancy.
The approvals were based on comprehensive data demonstrating that both biosimilars are highly similar to their reference products with no clinically meaningful differences in safety, purity, and potency.
Organon (NYSE: OGN) reported Q2 2025 financial results with revenue of $1.594 billion, down 1% year-over-year. The company posted diluted EPS of $0.56 and non-GAAP Adjusted EPS of $1.00, including a $46 million gain from debt extinguishment.
Key segment performance showed Women's Health revenue up 3%, Biosimilars revenue increased 5%, while Established Brands declined 3%. The company achieved an Adjusted EBITDA of $522 million with a 32.7% margin. During the quarter, Organon repaid $345 million of long-term debt and is on track to achieve a net debt to Adjusted EBITDA ratio below 4.0x by year-end.
The company raised its full-year 2025 revenue guidance to $6.275-$6.375 billion while maintaining its Adjusted EBITDA margin guidance at 31.0-32.0%.
Organon (NYSE: OGN), a global healthcare company focused on women's health, has scheduled its second quarter 2025 financial results announcement for August 5, 2025. The company will release results before market open, followed by a webcast and conference call at 8:30 a.m. EDT.
Investors can access the live webcast through Organon's investor relations website, with a replay available approximately two hours after the event. Institutional investors and analysts can participate via phone using the toll-free numbers (888) 596-4144 for U.S. and Canada, or (646) 968-2525 with Conference ID: 1036555#.
Organon (NYSE: OGN) announced that VTAMA® (tapinarof) cream, 1% received a strong recommendation from the American Academy of Dermatology (AAD) in their 2025 guidelines for treating adult atopic dermatitis (AD).
The recommendation is based on the ADORING clinical trials, highlighting VTAMA as an effective steroid-free treatment option with no label restrictions on use. The Phase 3 ADORING 3 study demonstrated a potential treatment-free interval averaging 80 days after treatment success.
VTAMA cream was FDA-approved in December 2024 for AD treatment in adults and children aged 2 and older. The treatment addresses a significant market, as 26 million Americans are affected by AD, including 16.5 million adults, with 6.6 million having moderate to severe cases.