Organon Nexplanon Approved by FDA for Extended Use Up to Five Years
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 19 2026
0mins
Should l Buy OGN?
Organon announced that the US Food and Drug Administration, FDA, has approved a supplemental New Drug Application, sNDA, for Nexplanon, which is indicated for use by women of reproductive potential to prevent pregnancy. The sNDA extends the duration of use of Nexplanon for up to five years, an extension of the previous three-year indication. "Today marks an important milestone for women seeking a highly effective long-acting reversible contraceptive option, as well as another advancement in Organon's women's health franchise," said Organon's Head of Research and Development and Chief Medical Officer, Juan Camilo Arjona Ferreira, MD. "The sNDA approval of an extended duration up to five years, along with data about the use of Nexplanon in women with varying BMIs, including women with overweight or obesity, is a testament to Organon's commitment to inclusive and comprehensive women's healthcare."
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Analyst Views on OGN
Wall Street analysts forecast OGN stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for OGN is 8.50 USD with a low forecast of 5.00 USD and a high forecast of 12.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
5 Analyst Rating
0 Buy
1 Hold
4 Sell
Strong Sell
Current: 8.000
Low
5.00
Averages
8.50
High
12.00
Current: 8.000
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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- Financial Result Uncertainty: While preliminary financial estimates have been provided, actual results are subject to the quarter-end closing procedures, highlighting potential volatility in financial outcomes that could affect market reactions.
- Investor Participation Options: Interested institutional investors and analysts can join the call by dialing specified numbers, demonstrating the company's openness and accessibility in investor communications.
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- Investor Participation Options: Interested institutional investors and analysts can join the call by dialing specified numbers, demonstrating the company's openness and accessibility in investor communications.
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- Milestone Expense Outlook: The company does not expect to record any milestone expenses in Q4 2025, indicating a cautious approach to cost management that supports financial stability.
- Financial Result Uncertainty: The Q4 and full year 2025 results are not yet finalized and may differ due to the quarter-end closing procedures, reflecting the company's prudence in financial reporting.
- Investor Participation Options: Interested investors can join the earnings call via specified phone numbers or the company website, enhancing engagement and communication with stakeholders.
See More
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- Safety Warnings: Caution is advised during the use of JADA to avoid excessive force that could lead to uterine wall perforation, highlighting safety and efficacy concerns that may influence physician adoption of the product.
- Future Outlook: The transaction includes a potential payment of up to $25 million contingent on achieving 2026 revenue targets, demonstrating Organon's confidence in future growth potential while reflecting its keen awareness of market dynamics.
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