Organon & Co. reports developments as a global healthcare company with portfolios in Women's Health and General Medicines, including biosimilars. Company news commonly covers operating results, product and regulatory updates, and clinical data for medicines such as VTAMA cream for atopic dermatitis and plaque psoriasis, biosimilar approvals including POHERDY, and established women's health brands and devices such as Nexplanon, Follistim, and Jada.
Updates also address capital-structure disclosures, governance matters, shareholder voting topics, and material agreements, alongside the company's commercial activity across more than 140 markets.
Organon (NYSE: OGN) reported pooled Phase 3 ADORING 1 and 2 results showing VTAMA cream 1% produced early, sustained improvements in atopic dermatitis down to age 2. Significant vIGA-AD, EASI75 and PP-NRS gains appeared by week 1 and increased through week 8 versus vehicle.
The analysis (N=813) showed EASI75 57.4% vs 22.1% at week 8 and 96.9% achieved some EASI improvement by week 8. Safety events ≥3% included folliculitis, headache, upper respiratory infection, and nasopharyngitis.
Organon (NYSE: OGN) presented a pooled Phase 3 sub-analysis from ADORING 1 and 2 showing VTAMA cream, 1% produced early and sustained improvements in patient‑reported sleep subdomains for pediatric atopic dermatitis patients down to age 2 and for affected family members through Week 8.
Key results: POEM sleep scores improved versus vehicle at Week 8: -1.9 vs -0.9 (age 2–6), -1.5 vs -1.0 (7–11), -1.2 vs -0.6 (12–17). DFI sleep subdomain also improved through Week 8. Reported common treatment‑emergent AEs (≥5%) included folliculitis, headache, and nasopharyngitis.
Organon (NYSE: OGN) entered an exclusive global license to MIUDELLA, Sebela's hormone-free copper IUD, with a $27.5 million closing payment, up to $505 million in sales-based milestones, and tiered double-digit royalties. The deal is subject to Hart-Scott-Rodino review and FDA approval of alternate supply-chain entities and other conditions.
MIUDELLA was FDA approved on February 24, 2025 for prevention of pregnancy up to three years, is not yet commercially available, and features a 3.7mm tapered inserter and a flexible frame.
Organon (NYSE: OGN) reported full year 2025 revenue of $6.2 billion (down 3% YoY) and diluted EPS of $0.72 (non-GAAP adj. EPS $3.66). Adjusted EBITDA was $1.91 billion with a 30.7% margin. Guidance for 2026 calls for ~$6.2B revenue and ~$1.9B Adjusted EBITDA, roughly in-line with 2025.
Q4 revenue fell 5% to $1.507B; Q4 net loss included a $301M goodwill impairment. The board declared a quarterly dividend of $0.02 payable March 12, 2026. Cash was $574M and debt $8.64B at year-end.
Organon (NYSE: OGN) will report fourth quarter and full year 2025 results on February 12, 2026 and host a webcast and conference call at 8:30 a.m. ET.
Organon said it does not currently expect to record any IPR&D or milestone expense in Q4 2025; results remain preliminary and are subject to quarter‑end closing procedures. A live webcast and a replay (available ~2 hours after the call) will be on the company investor website.
Organon (NYSE: OGN) announced on January 28, 2026 the closing of the sale of its JADA® System to Laborie Medical Technologies Corp.
The release reiterates JADA's intended use for control and treatment of abnormal postpartum uterine bleeding and lists contraindications, warnings, and device-use instructions. For adverse events, call 844-JADAMOM.
Organon (NYSE: OGN) announced FDA approval of a supplemental NDA extending the approved duration of use for NEXPLANON (etonogestrel implant) 68 mg from three years to up to five years for pregnancy prevention in women of reproductive potential.
In the clinical study assessing years 4–5, no pregnancies were reported and no new safety findings were observed. The study enrolled women with BMIs from 17.2 to 64.3 kg/m2, with 38.1% having BMI ≥30 kg/m2. The approval includes a new REMS to mitigate complications from improper insertion and removal and will enhance Organon’s existing Clinical Training Program and controlled distribution measures.
Organon (NYSE: OGN) entered a commercialization agreement with Daiichi Sankyo Europe to distribute and promote Nilemdo® (bempedoic acid) in France, Denmark, Iceland, Sweden, Finland and Norway, announced January 8, 2026.
Nilemdo® is described as a first‑in‑class oral treatment for patients with high cholesterol who cannot be treated effectively with statins, including statin‑intolerant patients. Under the deal, Daiichi Sankyo Europe remains the marketing authorization holder and Organon will act as the local representative and commercial partner in the six markets.
Organon (NYSE: OGN) announced that Joe Morrissey, Interim Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Wednesday, December 3, 2025 at 10:00 a.m. ET.
Investors, analysts and the public can listen to a live audio webcast at https://www.organon.com/investor-relations/events-and-presentations/. Organon is a global healthcare company with a portfolio of over 70 products across Women’s Health and General Medicines and operates in more than 140 markets, headquartered in Jersey City, New Jersey.
Organon (NYSE: OGN) and Henlius announced on November 17, 2025 that the US FDA approved POHERDY® (pertuzumab-dpzb) 420 mg/14 mL as an interchangeable biosimilar to PERJETA for all reference-product indications. POHERDY is the first pertuzumab biosimilar approved in the US and is indicated with trastuzumab and chemotherapy for metastatic and early HER2-positive breast cancer (neoadjuvant and adjuvant use).
The approval is supported by analytical, pharmacokinetic, and comparative clinical data. Organon holds exclusive global commercialization rights (except China) under a 2022 license and supply agreement with Henlius. Safety highlights include risks of left ventricular dysfunction, embryo-fetal toxicity, infusion reactions, and hypersensitivity.