Organon (OGN): Exploring Valuation Following FDA Approval of First US Pertuzumab Biosimilar

Organon (OGN) and Shanghai Henlius just received a green light from the FDA for POHERDY, the first pertuzumab biosimilar approved in the US. This move expands their reach in oncology therapies and opens the door for broader access in treating HER2-positive breast cancer.

See our latest analysis for Organon.

Organon’s latest FDA win arrives after a year of challenging share price momentum, with a 1-year total shareholder return of -50.17% and a steep year-to-date share price return of -48.46%. While the recent approval for POHERDY provides a fresh narrative for growth potential, the company’s long-term performance highlights the need for sustained execution to restore investor confidence.

If you want to explore other healthcare names driving innovation and making headlines, check out our handpicked See the full list for free..

With the FDA approval in hand and a decade-low valuation by several metrics, investors are left to weigh whether Organon's current price reflects an overlooked opportunity or if Wall Street has already anticipated future growth in advance.

Most Popular Narrative: 20% Undervalued

At $7.71, Organon’s share price sits considerably below the most widely followed narrative fair value of $9.67. This has sparked debate about whether the discount reflects opportunity or heightened caution. The situation invites a closer look at the assumptions that shape this price disconnect.

The biosimilars portfolio is outperforming expectations, underpinned by accelerating adoption (for example, Hadlima's growth, new launches like Tofidence, and a strong pipeline including Henlius denosumab). This provides a sustainable pathway to top-line expansion while benefiting from industry-wide momentum toward biosimilars as key biologics lose exclusivity.

Read the complete narrative.

What’s the math behind the bullish backdrop? The narrative outlines a future built on margin expansion, global market momentum, and surprising earnings power. Curious how analyst forecasts envision such a jump despite recent stumbles? Dive in and discover what’s fueling this forward-looking valuation.

Result: Fair Value of $9.67 (UNDERVALUED)

Have a read of the narrative in full and understand what's behind the forecasts.

However, persistent pressure on legacy brands and delays in delivering operational efficiencies could significantly challenge the optimistic outlook for Organon's recovery.

Find out about the key risks to this Organon narrative.

Build Your Own Organon Narrative

If you see things differently or want to dig into the numbers yourself, it’s quick and simple to build your own perspective in just minutes. Do it your way.

A great starting point for your Organon research is our analysis highlighting 3 key rewards and 2 important warning signs that could impact your investment decision.

Ready to Level Up Your Portfolio?

Thousands of investors are finding smart opportunities before the crowd by using specialized screeners on Simply Wall Street. Target your next move, grow your knowledge, and never let a good idea slip by.

• Unlock fresh potential for growth and income by checking out these 15 dividend stocks with yields > 3% with above-average yields and robust fundamentals.
• Ride the momentum of artificial intelligence with these 25 AI penny stocks that are capturing real breakthroughs and innovation across industries.
• Aim for true bargains by sifting through these 920 undervalued stocks based on cash flows where some of the market's strongest cash flow stories remain overlooked.

This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com