CORT :CORT Completes Enrollment In First Pivotal Trial
2006-05-03 02:31 (New York)
Piper Jaffray & Co. Hot Comment
May 3, 2006
Corcept Therapeutics Incorporated (CORT - $5.24)
Market Perform Volatility: Medium
Health Care
CORT Completes Enrollment In First Pivotal Trial
Thomas Wei, Senior Research Analyst
212 284-9305, thomas.a.wei@pjc.com
Gur A. Roshwalb, M.D., Research Analyst
212-284-9314, gur.a.roshwalb@pjc.com
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KEY POINTS:
* Data From First Pivotal Trial Of Corlux In PMD Expected in August. CORT
announced the completion of enrollment of the 07 trial, one of three pivotal
trials testing Corlux in psychotic major depression (PMD). As a reminder,
Corcept is running two U.S.-based trials (known as 06 and 07) for Corlux in
PMD and one in Europe (known as 09) and, if successful, we continue to
project a launch in 2008. Both the 06 and 07 trials are under special
protocol assessment (SPA) with the FDA for the statistical analysis used, a
responder analysis, and the efficacy endpoint, the positive symptom subscale
of the Brief Psychiatric Rating Scale (BPRS PSS) that specifically measures
symptoms of psychosis. CORT expects topline data from the 07 trial in
August, and continues to expect data from the 09 trial in 3Q06 and the 06
trial in 4Q06. We continue to view the trials as high risk and remain on the
sidelines.
PRICE TARGET AND JUSTIFICATION:
Our $6 price target is based on a 25x 2010E EPS, discounted at 45%.
RISKS TO ACHIEVEMENT OF TARGET PRICE:
Risks include but are not limited to: 1) negative data from Phase III trials
of Corlux in psychotic major depression; and 2) financing risk prior to
profitability.
Related Companies:
CORT: 5.24 |
