Replies to post #96282 on Biotech Values

[alertmeipp]

NBIX: this should lead to significant partnership. stay tuned.

[mcbio]

Re: NBIX elagolix program

NBIX is UP ~50% in AH.


Neurocrine Biosciences Announces Positive Results in Daisy PETAL Study
PHASE II STUDY MEETS ALL EFFICACY ENDPOINTS

SAN DIEGO, May 24 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq:NBIX - News) today announced statistically significant and clinically meaningful top-line efficacy results from its Phase II Daisy PETAL study (901 study) using its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis.

“The Daisy PETAL study was successful, all primary and secondary efficacy endpoints were met, and provided exactly the information we need to move this program forward,” said Chris O’Brien, M.D., Chief Medical Officer at Neurocrine. “We now have confirmation that the daily scales for menstrual and non-menstrual pelvic pain, developed with extensive input from the FDA and patients, function well in a clinical trial setting. These daily endpoints reflect the way women with endometriosis experience their symptoms and also demonstrate improvement with elagolix.”

Notwithstanding what clearly appears to be good Phase 2 data today for elagolix, I have some concerns now about the elagolix program as a whole given that the FDA is taking a closer look at the safety of GnRH agonists. See: #msg-49736609 . Also, see Dub Narcotic's bearish concerns as well here: #msg-49739987. All told, I think NBIX would be wise to do an offering if these gains hold up. Also, I think any prospective elagolix partner would want to wait until the results of NBIX's end of Phase 2 meeting with the FDA to get some comfort around the size and scope of the Phase 3 trials given the aforementioned concerns.