ABBV - Neurocrine's Pipeline Including Crinecerfont's Priority Review Drives Long-Term Growth
2024-07-09 10:32:15 ET
Summary
- Ingrezza Sprinkle, granules, has been recently granted with the FDA approval. Supporting $2.1-2.2 billion in 2024 sales for the whole Ingrezza franchise guided by Neurocrine’s management.
- Neurocrine Biosciences, Inc. has two new drug applications for Crinecerfont accepted by the FDA with a priority review, potentially leading to regulatory approval by the end of 2024.
- Positive results from Crinecerfont trials show efficacy in controlling androgen hormones in patients with congenital adrenal hyperplasia, supporting potential regulatory approval.
- Neurocrine's strong financial performance, diverse pipeline, and upcoming 2024 catalysts make it a promising investment with long-term growth potential.
Thesis
Neurocrine Biosciences, Inc. ( NBIX ) has recently announced the FDA accepted the two new drug applications (NDA) associated with Crinecerfont with a priority review, setting PDUFA dates for late December 2024. In addition, the company mentioned that, at the moment, the FDA is not planning to hold an advisory committee meeting for the assessment of the application. Thus, suggesting the assessment of the NDAs might be smooth.
Crinecerfont’s NDAs are supported on data from the CAHtalysts Phase 2 clinical trials in adults and paediatric patients, which I will be describing in the following sections of this article. In summary, Crinecerfont, reported good tolerability, no major adverse events, and it was efficient at controlling the androgen hormone excess in patients suffering with congenital adrenal hyperplasia ( CAH ) while enabling the dose reduction of glucocorticoids to physiological levels....
Neurocrine's Pipeline, Including Crinecerfont's Priority Review, Drives Long-Term Growth