Company: GLPG
Filing Date: 2025-03-27
Form Type: 20-F
Source: 0001558370-25-003806
Chunk: 9

Company: GALAPAGOS NV
Filing Date: 2025-03-27
Form: 20-F
Item: Item 3
Chunk 9
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 less severe patient populations with longer life expectancies compared to heavily pretreated patients with cancer. 
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The FDA or any other regulatory authority may approve different labels, including for whom the drug is indicated or require different warnings or precautions, or impose dosing restrictions that differ from the approved dosing regimen in other jurisdictions, and these differences could have a material adverse effect on our ability to commercialize our products in these jurisdictions. There can be no assurance that the FDA, EMA, the MHRA, the MHLW/PMDA or any other regulatory authority will accept data from trials conducted outside of their jurisdictions as adequate support of a marketing application. If the FDA, EMA, MHRA, the MHLW/PMDA or any comparable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which could be costly and time-consuming, and which may result in current or future product candidates that we may develop not receiving approval for commercialization in the applicable jurisdiction. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted, which may increase costs or time required to complete the clinical trial. Regulatory authorities could also not approve our applications, which would adversely affect our business prospects and ability to achieve or sustain profitability.
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Conducting multinational clinical trials exposes us to additional risks, including risks associated with:
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• additional foreign regulatory requirements;
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• foreign exchange fluctuations;
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• compliance with foreign manufacturing, customs, shipment and storage requirements;
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• inconsistent standards for reporting and evaluating clinical data and adverse events;
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• varying standards or availability of care, resulting in data that may differ from patients who have received the standard of care therapy;
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• any pandemic, epidemic or public health emergencies;
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• diminished protection of intellectual property in some countries; and
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• political instability, civil unrest, war or similar events that may jeopardize our ability to commence, conduct or complete a clinical trial and evaluate resulting data.
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Even if we receive regulatory approval for any of our product candidates, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.
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Any regulatory approvals that we receive for our product candidates may also be subject to limitations on