Should FDA Approval of Lasix ONYU Prompt a Closer Look at Gerresheimer’s (XTRA:GXI) Growth Path?

• On October 13, 2025, SQ Innovation received FDA approval for Lasix ONYU, a combination product featuring Gerresheimer’s proprietary on-body infusor for at-home subcutaneous drug delivery in select congestive heart failure patients.
• This milestone showcases Gerresheimer’s technological capabilities in advanced drug delivery devices and highlights its growing position as a full-service partner to pharmaceutical companies embracing home-based care.
• Next, we’ll explore how the FDA-backed rollout of Gerresheimer’s infusor technology could influence its longer-term outlook and growth assumptions.

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Gerresheimer Investment Narrative Recap

To own Gerresheimer stock, you need to believe in its transformation into a full-service partner for pharma companies, capitalizing on demand for advanced drug delivery devices and high-value packaging. While the FDA approval of Lasix ONYU confirms Gerresheimer’s technical capabilities, in the short term the most important catalyst, successful integration and ramp-up of new product lines, remains unchanged, and the main risk continues to be execution challenges in integrating Bormioli Pharma and managing associated costs. The approval serves as encouraging validation, but does not fundamentally alter the immediate operational or financial risk profile.

One of the most relevant recent announcements was the October 8, 2025 adjustment to Gerresheimer’s full-year 2025 guidance, now expecting an organic revenue decline of 2–4%. This revision coincided with ongoing integration activities and headwinds in traditional packaging segments, adding context to the significance of new product wins like Lasix ONYU as potential offsets to near-term softness.

By contrast, investors should be aware of the ongoing integration risks tied to the Bormioli Pharma acquisition, particularly as Gerresheimer balances production ramp-ups and cost control ...

Read the full narrative on Gerresheimer (it's free!)

Gerresheimer's outlook anticipates €2.9 billion in revenue and €197.3 million in earnings by 2028. This is based on a projected 9.5% annual revenue growth rate and an increase in earnings of €134 million from the current €63.3 million.

Uncover how Gerresheimer's forecasts yield a €56.36 fair value, a 101% upside to its current price.

Exploring Other Perspectives

Fair value estimates from 10 Simply Wall St Community members range from €37.84 to €221.45 per share. As you review these opinions, keep in mind that integration risks could have broad implications for Gerresheimer’s earnings and profitability, suggesting reasons for differing outlooks.

Explore 10 other fair value estimates on Gerresheimer - why the stock might be worth over 7x more than the current price!

Build Your Own Gerresheimer Narrative

Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

• A great starting point for your Gerresheimer research is our analysis highlighting 2 key rewards and 4 important warning signs that could impact your investment decision.
• Our free Gerresheimer research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Gerresheimer's overall financial health at a glance.

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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.

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