Updated with response from Osiris Therapeutics.
Corcept is seeking FDA approval for Korlym as a treatment for Cushing's Syndrome, a rare condition in which a tumor on an adrenal gland like the pituitary causes excess production of the hormone ACTH. Excess ACTH, in turn, causes the body to produce too much of the stress hormone cortisol.Patients with Cushing's suffer from severe cardiovascular and metabolic disease that can be fatal. No drugs are currently approved in the U.S. to treat the disorder, but Novartis (NVS) recently received approval for the first Cushing's therapy in Europe. Corcept's FDA approval decision date for Korlym is Friday, Feb. 17. I'm predicting an FDA rejection. Here's why: Corcept made a subtle but important change to the risk factor statements in its most recent 10Q filed with the Securities and Exchange Commission. The company now warns of "the possibility that the FDA may impose additional pre-approval requirements in regard to Korlym for the treatment of Cushing's Syndrome." The addition of this important risk factor is hard to find. It's a new bullet point among many older bullet points included within the context of more expansive, cautionary language about Corcept's cash resources.
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