Neurocrine Biosciences, Inc. and Diurnal Ltd., a Neurocrine Biosciences company, presented baseline data from the CAHtalyst?? Phase 3 studies of crinecerfont in adult and pediatric patients with congenital adrenal hyperplasia (CAH), and modified-release hydrocortisone (Chronocort®?) data for a Phase 2 clinical study (CHAMPAIN) in participants with primary adrenal insufficiency and in a Phase 3 extension study in CAH. In the study, twice daily MRHC developed by Diurnal was compared with once-daily Plenadren (modified-release hydrocortis one) in patients aged 18 years with confirmed primary adrenal insufficiency (defined as morning pre-dose cortisol.

Baseline Characteristics of Adults with Classic Congenital Adrenal Hyperplasia Enrolled in CAHtalyst Adult, a Phase 3 Study of Crinecerfont, a Corticotropin-Releasing Factor Type 1 Receptor Antagonist (Poster #P423). CHAMPAIN study: Initial Results from a Phase II Study of Efficacy, Safety and Tolerability of Modified-Release Hydrocortisone (CHAMPAIN) versus Plenadren, in Primary Adrenal Insufficiency (Abstract #4275, Rapid Communication #RC3.4); Biochemical Control with Dose Reduction in Chronic Glucocorticoid Therapy over 4 Years: A Phase III Extension Study of Chronocort (Efmody®?) in the Treatment of Congenital Adrenal Hyper Plasia (CAH) (Abstract #4271, Rapid Communications #RC3.1); Incidence of Adrenal Crisis in Congenital Adrenal Hyper plasia (CAH) Patients During a Prospective Monitored Long-Term study of Modified-Release Hydrocortsisone (MRHC) Capsules, (Efmody) (Poster #P215). A new drug application for the modified-release hydrocort is not been submitted to the U.S. Food and Drug Administration.

The CHAMPAIN Phase 2 clinical study compared the efficacy, safety and tolerability of twice daily DNL0200 (Chronocort), a modified-release hydrocortISone, with once daily Plenadren, a combination of immediate- and delayed-release hydrocortis One (authorized for use in the European Union), over a treatment period of up to 2 months in participants 18 years of age and diagnosed with primary adrenal insuffiencies. Among the factors that could cause actual results to difference materially from those indicated in the forward-looking statements include: risks that regulatory submissions for products and/or product candidates may not occur or be submitted in a timely manner, or accepted for filing; products and/or product candidates will not obtain regulatory approvals; or that the U.S. Food & Drug Administration or regulatory authorities outside the U.S. may make adverse decisions regarding products and/or product candidates; products and/or product candidate will not be found to be safe and/or effective or may not prove to be beneficial to patients; that development activities for products and/or product candidate may not be completed on time or at all; that clinical development activities may be delayed for regulatory or other reasons, may not be successful or replicate previous and/or interim clinical trial results, or may not be predictive of real-world results or of results in results in the U.S.