Ipsen Withdraws Palovarotene NDA, To Re-submit Following Additional Data Analysis; Stock Down

(RTTNews) - Shares of Ipsen SA (IPSEY) were losing around 11 percent in the morning trading in Paris after the French pharmaceutical company announced Friday the withdrawal of the New Drug Application or NDA for palovarotene following very recent discussions with the U.S. Food and Drug Administration.

Ipsen plans to resubmit to the FDA upon completion of the additional data analysis.

Palovarotene is an oral, investigational, selective RARy agonist for the prevention of heterotropic ossification (new bone formation) as a potential treatment for people living with fibrodysplasia ossificans progressiva or FOP.

FOP is an ultra-rare genetic disorder with an estimated prevalence of 1.36 per million individuals globally; however, the number of confirmed cases varies by country.

The target regulatory action date assigned by the FDA under a Priority Review status for palovarotene was November 30.

The withdrawal of the palovarotene NDA follows ongoing dialogue with the FDA following the acceptance of the NDA for Priority Review which was announced on May 28. During the review and ongoing dialogue between Ipsen and the FDA, it was recognized that additional analysis and evaluation of data collected from Ipsen's Phase III MOVE and FOP program would be required to progress and complete the review process.

It was agreed between Ipsen and the FDA that it would not be possible to complete this within the current NDA review cycle.

Howard Mayer, Executive Vice President and Head of Research and Development, Ipsen, said, "Unfortunately, as there is no regulatory mechanism to "pause" the current ongoing review process, we have taken the decision to withdraw the NDA for palovarotene to undertake the additional analyses and evaluation needed, with plans to resubmit the data for palovarotene as soon as possible."

In Paris, Ipsen shares were trading 81.86 euros, down 11.23 percent.