Baird analyst Brian Skorney noted that AbbVie (ABBV) and Neurocrine Biosciences (NBIX) announced that the PDUFA date for elagolix in endometriosis-associated pain has been extended three months. While "a bit of a shock," Skorney does not think there has been "any hint of a liver signal for elagolix, to date," and the delay is driven more by an overabundance of caution at the FDA amid its simultaneous review of Esmya, where cases of liver failure have been seen. He recommends using the dip in Neurocrine as a buying opportunity and keeps an Outperform rating and $84 price target on the stock.

AbbVie announced positive top-line results from SELECT-GCA, a Phase 3, multicenter, randomized, double-blind, placebo-controlled study, showing upadacitinib in combination with a 26-week steroid taper regimen achieved its primary endpoint of sustained remissiona from week 12 through week 52 in adults with giant cell arteritis. In this study, 46% of patients receiving upadacitinib 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission compared to 29 percent of patients receiving placebo in combination with a 52-week steroid taper regimen. Key secondary endpoints were also met, including a higher percentage of patients receiving upadacitinib 15 mg in combination with a 26-week steroid taper regimen achieved sustained complete remissionb from week 12 through week 52 compared to patients receiving placebo in combination with a 52-week steroid taper regimen. A lower percentage of patients experienced at least one disease flare through week 52 in the upadacitinib 15 mg group versus the placebo group. The study results also showed that upadacitinib 7.5 mg did not meet the primary or any of the secondary endpoints.