Piper Jaffray Comments On Corlux NDA Announcement (CORT)

Corcept Therapeutics Inc. CORT has announced plans to file their NDA for Corlux for the treatment of Cushing's syndrome during the week of April 11th, “in line with expectations,” Piper Jaffray reports. “The company plans to request a priority review, which could allow for a 4Q11 PDUFA. We continue to expect approval of Corlux in Cushing's syndrome, potentially a $500mn opportunity, and shares to be driven in the medium term by presentation of detailed Phase III data at ENDO (June 4th -7th),” Piper Jaffray writes. “Importantly, the Phase III trial produced compelling secondary endpoint results. For the secondary endpoint of global clinical improvement (fasting plasma glucose, hemoglobin A1c, change in glucose lowering medications, systolic blood pressure, change in antihypertensive medications, body composition, weight, bone turnover and bone density, cognitive/psychiatric assessments, metabolic functions, Quality of Life (SF-36 questionnaire), muscle strength and physical function), a response rate of 87% was achieved, meeting the requirement of >30% with high statistical significance (p<0.0001) and suggesting that a vast majority of the Cushing's syndrome patients in the trial saw a broad clinical benefit from Corlux use. “Though we should get more color on Phase III adverse events at ENDO, top-line results suggest that they are in-line with expectations and all controlled by dose reduction or drug holiday. There were no discontinuations related to Corlux AEs and the most common AEs were hypokalemia, adrenal insufficiency (n=2), and endometrial thickening. We believe that Corlux's risk/benefit profile remains superior to Novartis's SOM230, which normalized cortisol levels in 26% of its Phase III trial's patients but also increased the rate of diabetes (17.9%), fatigue (11.7%), diarrhea (58%), nausea (46.9%), hyperglycemia (38.9%), and cholelithiasis (29.6%).” Corcept Therapeutics closed Thursday at $7.27.