The description of Elagolix's MOO appears to indicate that the FDA review shouldn't affect Elagolix since it is the opposite of a GnRH agonist though it appears to produce the same end result. I think the initial spurt produced by an agonist is the problem but i'm a layman.
"Gonadotropin-releasing hormone, or GnRH, is a peptide that stimulates the secretion of the pituitary hormones that are responsible for sex steroid production and normal reproductive function. Researchers have found that chronic administration of GnRH agonists, after initial stimulation, reversibly shuts down this transmitter pathway and is clinically useful in treating hormone-dependent diseases such as endometriosis and uterine fibroids. "
"Orally active, nonpeptide GnRH antagonists potentially offer several advantages over injectable GnRH peptide drugs, including rapid onset of hormone suppression without a hormonal flare."
The GnRH agonists have the same MOA as the antagonists after an initial treatment period. I think the FDA is going to want to see a lot of long-term studies from Neurocrine that they have not run and don't have the money to run. I would take this spike in the price as an opportunity to get out of the stock.
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