$heff's $tation of $tocks & $olid DD

[jrbritt]

Corcept Therapeutics Inc. (CORT) DD

Just some basic DD of what CORT is all about – I’m not advocating anyone to buy/sell. Disclaimer: I did buy a starter position @ $4.00 last Friday.

Stock Data
• Shares Outstanding – 72.38 M
• Float – 37.44 M
• Held By Insiders – 58.90%
• Held By Institutions – 20.10%
• Shares Short ~ 2.69 M
• Short % of Float – 8.10%

Financial Data
• Debt – None
• Cash – Roughly $25 M
• Revenue – None

Analyst Targets (Note: I typically put little faith into analyst targets)
• Piper Jaffray - $7.40
• Stifel Nicolaus - $7.00
• JMP Securities - $7.00

Catalyst
-Filing of NDA by end of 1st QTR


Corcept’s product pipeline is centered around the development of CORLUX. CORLUX is designed for the treatment of Cushing’s Syndrome.

----A little background on Cushing’s Syndrome----
Cushing’s syndrome is a hormone disorder that develops because of high levels of cortisol in the blood. Cushing’s Sydrome is caused by taking glucocorticoid drugs(hormone, think steroids) or by tumors. Typically it is caused from hormones that come from outside the body (exogenous), typically from glucocorticoids prescribed by doctors for other diseases. Symptoms include weight gain, excess sweating, thinning of the skin and hemorrhage due to the stretching from weight gain, sore joints, easy bruising, etc. Treatment usually is to reduce the source of the outside source to the lowest amount possible.

As for endogenous Cushing’s Syndrome, which is caused by tumors that secrete excess cortisol, there are limited treatment options. Treatment options may include surgery, radiation, chemotherapy, or cortisol-inhibiting drugs. 80% of patients have surgery to have the tumors removed – but nearly half fail the surgery or have a lapse at a later date.

If surgery or radiation is unsuccessful, there are no FDA approved treatments available – most just take drugs to address symptoms.

CORLUX has been granted Orphan Drug Designation by the FDA for the treatment of endogenous Cushing’s syndrome.

----Phase 3 Study----
Phase 3 Data was announced in December of 2010. The study was a 50-patient open-label study with Cushing’s syndrome patients who were not elgible, failed, or relapsed from surgery. The study evaluated the response of two patient groups to CORLUX treatment, one included patients who were (1)glucose intolerant and one included patients who were (2)hypertensive. Statistically significant improvement in the primary endpoint was achieved for both groups: with 60% and 38% responding in the glucose intolerant group and hypertensive group, respectively. Statistically significant benefit was also achieved in the key secondary endpoint of global clinical improvement, with 87% of patients responding. An initial review of safety data indicates that CORLUX was well tolerated by Cushing’s Syndrome patients in this Phase 3 study. The protocol for the trial dictates that if a sufficient number of patients in either the glucose intolerant group or the hypertension group are responders, such that the lower limit of the exact one-sided 95% binomial confidence interval (CI) for the responder rate is greater than 20%, then the trial will have demonstrated efficacy for the treatment of Cushing's Syndrome.

Corcept Therapeutics is planning on filing a NDA to the FDA for Corlux by the end of the first quarter of 2011.

You can read more about the phase 3 results here http://www.corcept.com/news_events/pr_1292984884