Organon Secures FDA Approval Extending NEXPLANON Use to Five Years

Organon & Co. OGN recently announced that the FDA has approved a supplemental New Drug Application, extending the duration of use of NEXPLANON (etonogestrel implant) 68 mg Radiopaque to up to five years, from the previous three-year indication. NEXPLANON is indicated for pregnancy prevention in women of reproductive potential.

The approval is supported by clinical trial data demonstrating sustained contraceptive efficacy through years four and five, with no reported pregnancies and no new safety issues. The study included women with different body weights, including those with higher body mass index (BMI). About 38.1% of participants had a BMI of 30 or higher, showing that the implant worked well across a wide range of body types.

Management highlighted that the approval marks an important step forward for women who want reliable, highly effective and long-lasting reversible contraception. The extended use of NEXPLANON up to five years, along with study results showing it works for women with different body weights, including those who are overweight or obese, shows Organon’s commitment to providing inclusive and complete healthcare for women.

OGN Stock’s Trend Following the News

Shares of Organon traded flat since the announcement on Friday. Over the past six months, the stock has declined 7.3% against the industry’s 19.7% growth and the S&P 500’s 12.8% gain.

In the long run, the five-year indication enhances NEXPLANON’s competitive positioning versus other long-acting contraceptive options by improving convenience, reducing replacement frequency and increasing long-term adoption. Strong clinical results showing no pregnancies during years four and five, along with effectiveness across a wide range of body weights, reinforce confidence among healthcare providers and patients. The introduction of an enhanced Risk Evaluation and Mitigation Strategy (REMS) program further supports patient safety and provider training, helping maintain high clinical standards and reduce risks. Overall, this approval is likely to support Organon’s reputation, expand its market reach and drive sustained revenue growth in the women’s health segment.

OGN currently has a market capitalization of $2.28 billion.

More on the Extended Use for NEXPLANON

The FDA approval introduces a new REMS program in the United States to address risks associated with the incorrect insertion or removal of NEXPLANON. Built on Organon’s long-standing Clinical Training Program and controlled distribution model, the REMS framework is designed to ensure healthcare providers are trained and certified for proper insertion and removal of the implant.

According to Anita Nelson, MD, Obstetrics and Gynecology at Western University of Health Sciences, the updated information for NEXPLANON reflects the wide variety of women who use it every day. It includes women of different ages and BMIs who want birth control that lasts up to five years and prefer an implant in the arm instead of the uterus. Further, the REMS program will ensure provider certification and maintain high standards of clinical practice.

For Organon, extending NEXPLANON’s duration of use to five years boosts the product’s clinical and economic value. Longer duration reduces the need for repeat procedures, enhances patient adherence and lowers the total cost of contraception over time, making NEXPLANON more attractive to patients and providers. The REMS may add patient safety and provider confidence, supporting the long-term sustainability of NEXPLANON’s expanded use and Organon’s leadership in women’s health.

Industry Prospects Favoring the Market

Going by data provided by Precedence Research, the women's health therapeutics market is valued at $48.57 billion in 2026 and is expected to witness a CAGR of 4% through 2035. Factors like the increase in women's health issues, such as osteoporosis, endometriosis, gynecological cancers and PCOS, boosting the need for targeted therapies, are driving the growth of the market.

Other News

Organon recently announced an agreement with Daiichi Sankyo Europe to market Nilemdo (bempedoic acid) in France and several other countries. Nilemdo is a new drug for patients at risk of heart disease and high cholesterol and those who cannot tolerate statins. This partnership strengthens Organon’s cardiovascular portfolio and helps expand access to new treatment options for dyslipidemia. The collaboration also addresses an important healthcare gap, as women are more likely to experience statin intolerance than men, making alternative therapies like Nilemdo valuable.

In November, Organon and Shanghai Henlius Biotech announced that the FDA had approved POHERDY, a biosimilar to the cancer drug PERJETA. POHERDY is given by intravenous injection and is used to treat certain HER2-positive breast cancers. It is the first and only pertuzumab biosimilar approved in the United States. This approval marks an important step toward increasing patient access to high-quality and potentially more affordable biologic cancer treatments.

Organon & Co. Price

Organon & Co. price | Organon & Co. Quote

OGN’s Zacks Rank & Stocks to Consider

Currently, OGN carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are AtriCure ATRC, Charles River Laboratories International CRL and Pediatrix Medical Group, Inc. MD.

AtriCure, currently flaunting a Zacks Rank #1 (Strong Buy), reported a third-quarter 2025 adjusted loss per share of 1 cent, 90.9% narrower than the Zacks Consensus Estimate. Revenues of $134.3 million beat the Zacks Consensus Estimate by 2.1%. You can see the complete list of today’s Zacks #1 Rank stocks here.

ATRC has an estimated earnings growth rate of 91.7% for 2026 compared with the industry’s 17.3% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 67.1%.

Charles River Laboratories International, currently carrying a Zacks Rank #2 (Buy), reported a third-quarter 2025 adjusted EPS of $2.43, which surpassed the Zacks Consensus Estimate by 4.7%. Revenues of $1.0 billion beat the Zacks Consensus Estimate by 2.1%.

CRL has an estimated long-term earnings growth rate of 3.1% compared with the industry’s 15.5% growth. The company’s earnings beat estimates in the trailing four quarters, the average surprise being 12.4%.

Pediatrix Medical Group, currently carrying a Zacks Rank #2, reported a third-quarter 2025 adjusted EPS of 67 cents, which surpassed the Zacks Consensus Estimate by 45.7%. Revenues of $492.8 million beat the Zacks Consensus Estimate by 1.8%.

MD has an estimated earnings growth rate of 0.9% for 2026 compared with the industry’s 19.4% growth. The company beat earnings estimates in the trailing four quarters, the average surprise being 35.4%.

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