Organon & Co.
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See all $OGN insider activity →Organon reported positive 6-year Phase 3 results for MIUDELLA, a hormone-free copper IUD, with a Pearl Index of 0.93 and a pregnancy rate of 3.9%. The FDA is reviewing an sNDA for extended use, with a decision expected in Q2 2027.
AbbVie (ABBV) hit a 52-week high of $274.94 after receiving FDA Breakthrough Therapy designations for Temab-A. HealthStream (HSTM) rose 2% to $32.42, reporting Q2 revenue growth of 12.5%. Organon (OGN) reached $13.79, with FDA review of MIUDELLA expected by Q2 2027. All three companies hit 52-week highs on October 6, 2026.
Organon Canada, a subsidiary of Organon & Co. (OGN), announced approval of NDUVRA 1% cream for atopic dermatitis in patients aged 2+. The steroid-free treatment was previously approved for plaque psoriasis. Atopic dermatitis affects up to 20% of children and 3% of adults globally. OGN shares closed at $13.73, up 0.07% on Friday.
Recent OGN coverage spans regulation, corporate actions and financial news.
Positive trial data may lift Organon's valuation as investors anticipate FDA approval and commercial rollout.
Regulatory progress could lift the stock.
Positive regulatory approval expands Organon's dermatology pipeline and may boost sales.
No new product news; mention reinforces existing market position.
The FDA acceptance could lead to a longer‑duration product, expanding Organon's women's health portfolio and supporting the stock.
AlphAI scores every news story that mentions OGN with an AI model for sentiment and relevance, and aggregates insider trades from Organon & Co.'s SEC EDGAR Form 4 filings. Figures refresh continuously.
Organon reported positive 6-year Phase 3 results for MIUDELLA, a hormone-free copper IUD, with a Pearl Index of 0.93 and a pregnancy rate of 3.9%. The FDA is reviewing an sNDA for extended use, with a decision expected in Q2 2027.
2 min readAbbVie (ABBV) hit a 52-week high of $274.94 after receiving FDA Breakthrough Therapy designations for Temab-A. HealthStream (HSTM) rose 2% to $32.42, reporting Q2 revenue growth of 12.5%. Organon (OGN) reached $13.79, with FDA review of MIUDELLA expected by Q2 2027. All three companies hit 52-week highs on October 6, 2026.
2 min readOrganon Canada, a subsidiary of Organon & Co. (OGN), announced approval of NDUVRA 1% cream for atopic dermatitis in patients aged 2+. The steroid-free treatment was previously approved for plaque psoriasis. Atopic dermatitis affects up to 20% of children and 3% of adults globally. OGN shares closed at $13.73, up 0.07% on Friday.
2 min readKelsey Norman, PharmD, discussed new data and guidelines reshaping hyperlipidemia management at the NEIAP 2026 Annual Forum. She highlighted the role of pharmacists in optimizing lipid-lowering therapies, including PCSK9 inhibitors, ezetimibe, and bempedoic acid. Norman noted the FDA's expanded indication for evolocumab (Repatha; Amgen) based on the VESALIUS-CV trial, and the missed primary endpoint in the Lp(a)HORIZON trial (NCT04023552) for pelacarsen (Novartis).
3 min readOrganon (OGN) announced FDA acceptance of a supplemental New Drug Application for MIUDELLA, seeking to extend its use from 3 to 6 years. The FDA decision is expected in Q2 2027. MIUDELLA is currently approved for 3-year use and is anticipated to launch commercially in late 2026. Clinical trials showed 99% contraceptive effectiveness. Organon licensed MIUDELLA from Sebela Women's Health in June 2026.
2 min readOrigin Enterprises plc transferred 15,349 treasury shares to satisfy share options under its Savings Related Share Option Scheme (UK). The number of treasury shares decreased from 12,050,357 to 12,035,008, with 107,706,523 ordinary shares in issue. The company is listed on Euronext Growth Dublin and the AIM market of the London Stock Exchange.
1 min readOrganon (NYSE: OGN) said its MIUDELLA copper IUD REMS program is open for enrollment via www.miudellarems.com. The REMS requires individual provider and separate healthcare setting certifications to support dispensing and insertion, aiming to reduce complications from improper insertion. MIUDELLA is indicated for up to three years of pregnancy prevention.
2 min readDrinane Juliana Papa (Head of Mfg & Supply) sold 14,761 shares of Organon & Co. (OGN) at $13.57 ($0.20M total) on 2026-08-05.
2 min readOrganon & Co. (OGN) filed an SEC Form 8-K — Submission of Matters to a Vote of Security Holders. 8-K false 0001821825 0001821825 2026-07-23 2026-07-23 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 23,
3 min readOTC Markets Group said Orogen Royalties Inc (TSX-V: OGN, OTCQX: OGNNF) qualified to trade on OTCQX Best Market, upgrading from OTCQB. It will trade on OTCQX under symbol OGNNF, with U.S. investors able to access disclosures and Level 2 quotes on OTCMarkets.com. Orogen focuses on precious and base metal royalties in North America.
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