The FDA's ODD award is based on the positive findings from the phase 2 TouCAHn trial, which also support Crinetics' robust phase 3 pivotal clinical trial program for the novel agent.
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A new analysis of the CAHtalog phase 3 study showed approximately 95% of participants experienced either high glucocorticoid exposure or elevated androstenedione levels during treatment.
Lundbeck announced the designation today and said it is expanding an ongoing phase I/II clinical open label trial of the investigational mAb in adults with classic CAH.
An oral antibiotic for drug-resistant UTIs, a long-awaited therapy for congenital adrenal hyperplasia, and more.