TooNiceStocks Initiates Coverage on Corcept Therapeutics Inc. Evaluating the Benefits of Corlux
Corcept Therapeutics (NASDAQ: CORT) released their final Phase 3 data for Corlux in mid-January, concluding a successful clinical trial. The next anticipated milestone is submission of the New Drug Application to the U.S. Food and Drug Administration. Corcept Therapeutics plans to submit, with a priority review (6-months), end of first quarter. The FDA determines within 45 days after submission to grant priority review.
New York, NY (Vocus/PRWEB) March 22, 2011
After Corcept Therapeutics released their final Phase 3 data for Corlux in mid-January and concluding a successful clinical trial. TooNiceStocks research has uncovered that the next anticipated milestone is submission of the New Drug Application to the U.S. Food and Drug Administration. Corcept Therapeutics plans to submit, with a priority review (6-months), end of first quarter. The FDA determines within 45 days after submission to grant priority review. Corlux is the first and only glucocorticoid receptor antagonist for treatment of endogenous Cushing’s syndrome. Cushing’s syndrome is a hormone disorder that can be caused by adrenal, pituitary or ectopic tumors constitutively stimulating cortisol production. Corlux’s risk-benefit analysis compared to already limited treatments leads TooNiceStocks to believe priority review will be granted and eventual filing.
Digging Deeper into the Benefits of Corlux.
TooNiceStocks research found that the medical treatment for Cushing’s syndrome is needed when surgery or radiation becomes ineffectual. However, current medical treatments come with high risk relative to efficacy. Majority of treatments consist of anticortisol drugs which has an advantage of direct measurement of cortisol levels. But the tolerability and risk of anticortisol drugs have to be taken into consideration. There have been reports of serious adverse side effects, heptotoxicity, gastrointestinal, and neurotoxic effects to name a few. Besides the adverse effects, the time it takes for therapeutic benefits to take into effect lags behind Corlux. Corlux yields both superior efficacies with minimal side effects.
TooNiceStocks research also found that in late December and early January, Corcept Therapetics released results for Corlux’s Phase III primary and secondary endpoints. Both end points have achieved statistically significant results. The primary endpoint demonstrated Corlux improved symptoms for both patients groups. Also the drug was well tolerated in the trial; however, adrenal insufficiency, endometrial thickening and hypokalemia were reported, these symptoms can be ameliorated by clinical management. Although the secondary endpoint was not necessary, including and meeting its endpoint leads more credence to Corlux. Due to the fact its endpoint “global clinical improvement” assessment was by an independent three-member group, experienced in evaluating and treating patients with Cushing’ Syndrome. Statistical significant improvement with minimal side effects, as well as, rapidly effective treatment in controlling hypercorticolism puts Corlux to be a superior drug.
TooNiceStocks believes with Corcept Therapeutics planning to submit the NDA at the end of first quarter and present detailed Phase III data at the Endocrine Society Annual Meeting (ENDO) on June 4-7 in Boston, these two catalysts will garner more attention to Corcept Therapeutics. If and when FDA approves the NDA, Corcept Therapeutics can see peak sales of Curlux upwards of $300M. TooNiceStocks sees more Smallcap investors eying Corcept, especially with its NDA submission coming soon. However, this is the market and anything is possible.
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For the original version on PRWeb visit: http://www.prweb.com/releases/prweb2011/3/prweb8225993.htm