ORGANON & CO Stock Price, News & Analysis

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.

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#.