We are developing palovarotene, an investigational retinoic acid receptor gamma (RARγ) selective agonist, for the treatment of individuals who are affected by fibrodysplasia ossificans progressiva (FOP), multiple osteochondromas (MO) and other diseases. For FOP, we are preparing for a New Drug Application (NDA) for episodic, flare-up based palovarotene treatment, which we intend to submit to the U.S. Food and Drug Administrat...
We are developing palovarotene, an investigational retinoic acid receptor gamma (RARγ) selective agonist, for the treatment of individuals who are affected by fibrodysplasia ossificans progressiva (FOP), multiple osteochondromas (MO) and other diseases. For FOP, we are preparing for a New Drug Application (NDA) for episodic, flare-up based palovarotene treatment, which we intend to submit to the U.S. Food and Drug Administration (FDA) in the second half of 2019, and subject to approval, a U.S. commercial launch in the first half of 2020.We also completed enrollment in our Phase 3 MOVE Trial in FOP in August 2018.
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