Organon halts development of endometriosis pain drug after trial failure

JERSEY CITY - Organon (NYSE:OGN), currently trading at $10.05 and showing strong profitability with a 57% gross margin according to InvestingPro data, announced Wednesday that it will discontinue development of its investigational endometriosis pain treatment OG-6219 after a Phase 2 clinical trial failed to meet its primary efficacy endpoint.

The ELENA proof-of-concept study showed the oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor did not demonstrate improvement in moderate-to-severe endometriosis-related overall pelvic pain compared to placebo.

"While these study results are disappointing, Organon remains committed to our long-term vision to create a better and healthier every day for all women including those living with endometriosis," said Juan Camilo Arjona Ferreira, Head of Research & Development and Chief Medical Officer at Organon.

The randomized, double-blind, placebo-controlled Phase 2a/b trial evaluated three dose levels of OG-6219 in pre-menopausal women aged 18 to 49 with surgically diagnosed endometriosis and moderate-to-severe pain. Participants received either one of three doses of OG-6219 or placebo orally twice daily.

Organon acquired the drug candidate through its purchase of Forendo Pharma in 2021. The global healthcare company, headquartered in Jersey City, focuses on women’s health and maintains a portfolio of over 70 products across Women’s Health and General Medicines.

The company stated in its press release that it plans to completely halt the OG-6219 clinical development program based on these results.

In other recent news, Organon & Co. announced its first-quarter 2025 earnings, revealing mixed results. The company reported earnings per share (EPS) of $1.02, exceeding analyst expectations of $0.91, but its revenue of $1.51 billion fell short of the anticipated $1.55 billion. Organon also announced a significant reduction in its dividend, a strategic decision aimed at accelerating debt reduction, which was larger than analysts had expected. BNP Paribas Exane responded by lowering its price target for Organon from $29 to $16, while maintaining an Outperform rating, citing the company’s focus on women’s health and potential strategic business developments. Additionally, the U.S. Food and Drug Administration (FDA) granted approval for HADLIMA™ as an interchangeable biosimilar to Humira®, a move expected to provide cost savings for patients. Organon also recently launched VTAMA for atopic dermatitis, which has shown promising initial success. These developments are part of Organon’s broader strategy to strengthen its financial position and expand its product offerings.

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