Organon Receives FDA Approval for NEXPLANON Extended Use
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 17 2026
0mins
Should l Buy OGN?
Source: Businesswire
Organon & Co. shares rose 5.71% as the stock reached a 20-day high amid a challenging market environment where the Nasdaq-100 and S&P 500 are down 1.61% and 1.52%, respectively.
The core catalyst for this price movement is the FDA's approval for Organon's NEXPLANON to extend its use from three to five years. This approval is expected to significantly enhance the product's market competitiveness, as clinical trials showed no pregnancies among 399 participants during the extended use period, confirming its efficacy. Additionally, the FDA has mandated a new Risk Evaluation and Mitigation Strategy (REMS) to ensure proper insertion and removal, which will further boost patient confidence and safety.
This FDA approval positions NEXPLANON favorably in the long-acting contraception market, potentially increasing its adoption among women. The company's proactive measures in promoting the product and ensuring safety through the REMS program indicate a strong commitment to enhancing user experience and expanding market share.
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Analyst Views on OGN
Wall Street analysts forecast OGN stock price to rise
5 Analyst Rating
0 Buy
1 Hold
4 Sell
Strong Sell
Current: 7.920
Low
5.00
Averages
8.50
High
12.00
Current: 7.920
Low
5.00
Averages
8.50
High
12.00
About OGN
Organon & Co. is a global healthcare company. The Company is engaged in developing and delivering health solutions through a portfolio of prescription therapies and medical devices within women's health, biosimilars and a franchise of established medicines across a range of therapeutic areas. It has a portfolio of approximately 70 medicines and products across a range of therapeutic areas. It has a portfolio of contraception and fertility brands, including Nexplanon, NuvaRing, and Follistim AQ. Its Biosimilars portfolio spans across immunology and oncology treatments. It also has a portfolio of established brands, including brands in cardiovascular, dermatology and non-opioid pain management. It sells these products through various channels, including drug wholesalers and retailers, hospitals, government agencies and managed health care providers, such as pharmacy benefit managers and other institutions.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Russia's Declining Birth Rate: Russia's fertility rate has also decreased from 1.51 in 2021 to 1.37 in 2025, and despite the Kremlin's initiatives to encourage larger families, the lack of effective results reflects a broader societal insecurity affecting women's decisions to have children.
- Long-term Demographic Consequences of War: The four-year conflict has deterred women in both Ukraine and Russia from having children, leading to greater economic and social pressures in the future, particularly as an aging population increases and the labor market faces significant challenges.
- Resistance to Putin's Birth Policies: Despite various incentives introduced by the Russian government, including cash rewards and tax breaks, the low birth rates persist due to women's feelings of insecurity, raising questions about the effectiveness of these policies in addressing demographic concerns.
See More
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- Financial Commitment: Under the agreement, Organon will pay $27.5 million at closing, with potential sales-based milestone payments of up to $505 million, demonstrating the company's confidence in MIUDELLA®'s future market potential.
- FDA Approval Requirements: As the first hormone-free copper IUD approved in the U.S. in 40 years, MIUDELLA® is subject to FDA review of its alternate supply chain, which will impact its market launch timeline and ensure product safety and efficacy.
- Innovation in Women's Health: MIUDELLA® offers a long-acting, reversible, hormone-free contraceptive option that meets diverse reproductive health needs, likely attracting women seeking new contraceptive methods and further driving Organon's growth in this niche market.
See More
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- Introduction of New Therapies: The launch of new therapies such as Rocatinlimab and Amlitelimab is anticipated to transform the market landscape by providing more effective treatment options to meet the increasing patient demand.
- Rising Patient Numbers: In 2024, approximately 53 million diagnosed cases of atopic dermatitis are expected in the 7MM, with the increase in patient numbers directly fueling the demand for advanced treatment options and promoting market growth.
- Changing Competitive Landscape: As new drugs undergo clinical trials and enter the market, competition will intensify, particularly with companies like Eli Lilly leveraging their product portfolios to capture significant market share in the EU4 and Japan, showcasing strong market potential.
See More
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- Financial Performance Overview: In 2025, Organon reported $6.2 billion in revenue and $1.9 billion in adjusted EBITDA, despite a 3% year-over-year revenue decline, indicating pressure in a competitive market landscape.
- Product Line Challenges: Sales of Nexplanon decreased by 20% in Q4 and 4% for the full year, reflecting the impact of U.S. policy changes and competitive pressures on women's health products, leading to an overall business downturn.
- Strategic Adjustments: The company opted to lower its dividend payout ratio, reallocating funds for debt reduction, and generated approximately $390 million in net proceeds from the divestiture of the Jada system to enhance financial flexibility.
- Future Outlook: Management anticipates that revenue and adjusted EBITDA for 2026 will align with 2025 figures at $6.2 billion and $1.9 billion, respectively, despite ongoing market challenges and margin pressures.
See More
Organon Stock Drops 13% Following Disappointing Q4 Earnings
- Organon Shares Fall: Organon shares experienced a 13% decline following the announcement of a profit miss in the fourth quarter.
- Impact of Earnings Report: The disappointing earnings report has raised concerns among investors regarding the company's financial performance and future outlook.
- Market Reaction: The significant drop in share price reflects investor sentiment and market reaction to the missed profit expectations.
- Future Projections: Analysts are now closely monitoring Organon's strategies and projections to assess potential recovery and growth opportunities.
See More
Organon Q4 Financials Miss Expectations, Shares Drop
- Disappointing Financials: Organon's Q4 adjusted EPS of $0.63 and revenue of $1.5B represent approximately 30% and 5% year-over-year declines, respectively, missing consensus estimates of $0.73 and $1.53B, indicating significant financial pressure on the company.
- Women's Health Segment Decline: The Women's Health unit generated $398M in revenue, reflecting a 15% drop year-over-year, marking the second consecutive quarter of decline, primarily due to policy-related demand headwinds in the U.S. and a $17M sales hit from Nexplanon contraceptive implant.
- Biosimilars Growth: Despite overall poor performance, Organon's biosimilar segment expanded by approximately 11% year-over-year, contributing $181M to the topline, showcasing growth potential in this area amidst broader challenges.
- Cautious Future Outlook: The company projects $6.2B in revenue for 2026, slightly below last year's $6.22B but above analysts' expectations of $6.11B, with adjusted EBITDA expected to reach nearly $1.9B, indicating some growth expectations despite ongoing challenges.
See More
