Company: GLPG
Filing Date: 2025-03-27
Form Type: 20-F
Source: 0001558370-25-003806
Chunk: 20

Company: GALAPAGOS NV
Filing Date: 2025-03-27
Form: 20-F
Item: Item 3
Chunk 20
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iological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing. 
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If competitors are able to obtain marketing approval for biosimilars referencing any of our product candidates, our products may become subject to competition from such biosimilars, which would impair our ability to successfully commercialize and generate revenues from sales of such products. 
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15

Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
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Undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, the EMA, the MHRA, the MHLW/PMDA, or any other comparable regulatory authority. Results of our trials could reveal a high and unacceptable severity and prevalence of certain side effects. In such an event, our trials could be suspended or terminated and the FDA, the EMA, the MHRA, the MHLW/PMDA, or any comparable regulatory authority could order us to cease further development of approval of our product candidates for any or all targeted indications could not be obtained. The drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences may harm our business, financial condition and prospects significantly.
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For example (without any limitation), the ISABELA Phase 3 trial of ziritaxestat in idiopathic pulmonary fibrosis (IPF) was discontinued in February 2021, prior to completion of patient enrollment. The decision was based on the recommendations of the Independent Data Monitoring Committee (the “IDMC”) which, following a regular review of unblinded data, concluded that ziritaxestat’s benefit-risk profile no longer supported continuing the Phase 3 trial.
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If one or more of our products or product candidates receive marketing approval, and we or others identify undesirable side effects later caused by such products, a number of potentially significant negative consequences could result, including:
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●   regulatory authorities may withdraw approvals of such product;
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●   regulatory authorities may require additional warnings on the label or impose updates to the label;
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●   we may be required to create a medication guide outlining the risks of such side effects