Ipsen’s rare bone disease asset, Palovarotene, has hit yet another regulatory setback – filing has been withdrawn after US FDA demanded additional phase III data. Although the group plans to re-submit the filing, Palovarotene’s US launch is pushed back into 2022 and, considering that the high-margin drug was partially expected to fill the revenue hole due to the upcoming generic erosion of Somatuline, the news has not been taken well by the markets. A value-accretive deal could reignite investor ....

16 Aug 2021
Another setback for Palovarotene

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Another setback for Palovarotene
Ipsen’s rare bone disease asset, Palovarotene, has hit yet another regulatory setback – filing has been withdrawn after US FDA demanded additional phase III data. Although the group plans to re-submit the filing, Palovarotene’s US launch is pushed back into 2022 and, considering that the high-margin drug was partially expected to fill the revenue hole due to the upcoming generic erosion of Somatuline, the news has not been taken well by the markets. A value-accretive deal could reignite investor ....