Company: GLPG
Filing Date: 2025-03-27
Form Type: 20-F
Source: 0001558370-25-003806
Chunk: 4

Company: GALAPAGOS NV
Filing Date: 2025-03-27
Form: 20-F
Item: Item 3
Chunk 4
---
 trials;
-------------------------------------------------------------------------------------------------------------------------------------------------------------

●   we may be unable to demonstrate to the satisfaction of the FDA, the EMA, the MHRA, the MHLW/PMDA or other comparable regulatory authority that a product candidate is safe and effective for its proposed indication;
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

●   the results of clinical trials may not meet the level of statistical significance required by the FDA, the EMA, the MHRA, the MHLW/PMDA or other comparable regulatory authority for approval;
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

●   we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;
---------------------------------------------------------------------------------------------------------------------

●   a number of our next generation cell therapy product candidates are novel mode of action compounds, which may carry an additional risk regarding the desired level of efficacy and safety profile;
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

●   the FDA, the EMA, the MHRA, the MHLW/PMDA or other comparable regulatory authority may disagree with our interpretation of data from preclinical studies or clinical trials;
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

●   the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a new drug application, or NDA, supplemental NDA, biologics license application, or BLA, or other submission or to obtain regulatory approval in the United States, Europe or elsewhere;
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

●   the FDA, the EMA, the MHRA, the MHLW/PMDA or other comparable regulatory authorities may find deficiencies with or fail to approve the manufacturing processes, including Galapagos’ innovative decentralized cell therapy manufacturing model, or facilities of third-party manufacturers with which we contract for clinical and commercial supplies, or such processes or facilities may not pass a pre-approval inspection; and
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

●   the approval policies or regulations of the FDA, the EMA, the MHRA, the MHLW/PMDA or other comparable regulatory authority may change (in particular, the regulatory requirements and guidance with respect to cell/gene therapy products are still evolving) or differ from one another significantly in a manner rendering our clinical data insufficient for approval. For example, proposed amendments to the European Union directives and regulations related to pharmaceutical product development and marketing are currently under consideration, which, if approved, will replace the current European Union regulatory framework for medicines.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
​
This lengthy approval process as well as the unpredictability of future clinical trial results may result in our and