The FDA decision on Ipsen S.A.’s (IPSEY.OB) resubmitted New Drug Application for Palovarotene is expected on August 16, 2023.Palovarotene is proposed for the prevention of new bone growth (heterotopic ossification) in patients with fibrodysplasia ossificans progressiva, an ultra-rare genetic disorder.Fibrodysplasia ossificans progressiva (FOP) is characterized by bone that forms outside the normal skeleton, in muscles, tendons, or soft tissue. In June of this year, an FDA panel voted 10 to 4 that the available evidence supported the effectiveness of Palovarotene as a treatment for fibrodysplasia ossificans progressiva.Palovarotene was denied FDA approval last December and the company was asked to submit additional information on Palovarotene clinical trial data. In Canada, Palovarotene was approved under brand name Sohonos in January of 2022 to reduce the formation of heterotopic ossification in adults and children with fibrodysplasia ossificans progressiva. IPSEY.OB closed Friday’s (Jul.28, 2023) trading at $31.30, up 5.16%.