Alkermes plc (ALKS) has disclosed a new risk, in the Regulation category.
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Alkermes plc faces significant business risks associated with the stringent regulatory approval processes required for its products. The company must navigate complex and evolving requirements from agencies like the FDA and their international counterparts, which can be time-consuming and costly. Differences in regulatory interpretations, evolving guidelines, and external disruptions such as government shutdowns can further delay or hinder approval. Any failure or delay in securing regulatory approval could materially impact Alkermes’ business operations, financial health, and investor confidence, leading to potential declines in share value.
Overall, Wall Street has a Strong Buy consensus rating on ALKS stock based on 8 Buys and 2 Holds.
To learn more about Alkermes plc’s risk factors, click here.