Company: AGIO
Filing Date: 2025-07-31
Form Type: 10-Q
Source: 0001439222-25-000089
Chunk: 89

Company: AGIOS PHARMACEUTICALS, INC.
Filing Date: 2025-07-31
Form: 10-Q
Item: Part II, Item 1A
Chunk 89
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In addition, foreign regulatory authorities may change their approval policies and new regulations may be enacted. For instance, EU pharmaceutical legislation is currently undergoing a complete review process.  The proposed revisions remain to be agreed and adopted by the European Parliament and European Council and the proposals may be substantially revised before adoption, which is not anticipated before early 2026. The revisions may have a significant impact on the EU pharmaceutical industry and our business in the long term. 

We expect that we will be subject to additional risks in commercializing any of our product candidates that receive marketing approval outside the United States, including tariffs and trade barriers; economic weakness, including inflation, or political instability in particular foreign economies and markets; compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; foreign currency fluctuations, which could result in increased operating expenses and reduced revenue; and workforce uncertainty in countries where labor unrest is more common than in the United States. In addition, we do not have direct experience commercializing products outside of the United States and such efforts may depend on our ability to find a suitable collaborator. For example, we have entered into the NewBridge Agreement and the Avanzanite Agreement for the commercialization of PYRUKYND® in certain jurisdictions outside of the United States. 

Fast track designation and/or priority review designation by the FDA or PRIME designation in the EU may not actually lead to a faster development or regulatory review or approval process, nor does it ensure approval of the product candidate. 

We may in the future seek fast track designation or priority review designation for our product candidates.The FDA has broad discretion on whether to grant fast track designation and/or priority review designation to a product candidate, so even if we believe a particular product candidate is eligible for such designation or status, the FDA may decide not to grant it. Even if our product candidates receive fast track designation and/or priority review designation, we may not experience a faster development process, review or approval, if at all, compared to conventional FDA procedures. The FDA may withdraw fast track designation if it believes that the designation is no longer supported by data from our clinical development program. 

In addition, we may seek PRIME designation in the EU for our product candidates. The benefits of a PRIME designation include, among other things, the potential to qualify product for accelerated review. Even if our product candidates receive PRIME designation, we may not experience a faster development process, review or approval compared to conventional EMA procedures and it does not ensure or increase the likelihood of the