Corcept Resubmits NDA for Relacorilant in Cushing's Syndrome, Expects 6-Month FDA Review
CORT has more than doubled off its 52-week low of $28.66.
Summary
Corcept Therapeutics has officially resubmitted its New Drug Application for relacorilant for Cushing's syndrome to the FDA, initiating a six-month review period.
Key Events · Product Development and Regulatory · CORT
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NDA Resubmission for Relacorilant
Corcept Therapeutics officially resubmitted its New Drug Application (NDA) to the FDA for relacorilant as a treatment for patients with Cushing's syndrome.
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Six-Month FDA Review Expected
The company anticipates a six-month review period for the resubmission, providing a clear timeline for a potential regulatory decision.
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Addresses Prior Setback
This resubmission follows a previous Complete Response Letter for relacorilant in hypercortisolism, marking a significant step forward for a key drug candidate.
Analysis · CORT · Life Sciences
This 8-K confirms the official resubmission of the New Drug Application for relacorilant to treat Cushing's syndrome, a key pipeline candidate that previously received a Complete Response Letter. The FDA's acceptance of the resubmission and the expected six-month review period provide a clear timeline for a potential approval decision, addressing a significant prior setback for the company.
At the time of this filing, CORT was trading at $81.75 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $8.8B. The 52-week trading range was $28.66 to $91.00. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.