Neurocrine Biosciences Inc Stock Price, News & Analysis

Neurocrine Biosciences reported fourth quarter net product sales of $399 million for INGREZZA, contributing to full-year sales of $1.44 billion. The company projects net product sales guidance for 2023 between $1.67 - $1.77 billion. Key developments include the completion of enrollment in registrational studies for crinecerfont, aimed at treating congenital adrenal hyperplasia, with top-line results expected in the second half of 2023. Financial highlights show a GAAP net income of $89 million for Q4 2022, a significant improvement over the $7 million loss in Q4 2021. Total cash and marketable securities stood at $1.29 billion as of December 31, 2022.

Neurocrine Biosciences (Nasdaq: NBIX) has scheduled its fourth quarter and year-end 2022 financial results conference call and webcast for February 6, 2023. The press release will be issued at 4:30 a.m. PT and the call will begin at 5:00 a.m. PT (8:00 a.m. ET). The conference call can be accessed domestically at 866-952-8559 and internationally at 785-424-1743, using conference ID NBIX. A replay will be available approximately an hour after the event and archived for a month. Neurocrine focuses on developing treatments for neurological and endocrine disorders, with several FDA-approved therapies in its portfolio.

Neurocrine Biosciences (Nasdaq: NBIX) will present at the 41st Annual J.P. Morgan Healthcare Conference on January 9, 2023, at 11:15 a.m. PT in San Francisco. CEO Kevin Gorman will lead the presentation, which can be accessed via a live webcast on the company's website, www.neurocrine.com. A replay will be available approximately one hour post-event and archived for a month. Neurocrine focuses on developing treatments for neurological and neuroendocrine disorders, with FDA-approved therapies for tardive dyskinesia, Parkinson's disease, endometriosis, and uterine fibroids in its portfolio.

Neurocrine Biosciences (Nasdaq: NBIX) has announced that the FDA has accepted its supplemental New Drug Application for valbenazine, targeting chorea associated with Huntington disease, with a PDUFA action date set for August 20, 2023. This sNDA includes data from the KINECT-HD Phase 3 study and ongoing KINECT-HD2 study, involving over 150 patients. Valbenazine aims to provide a new treatment option for the estimated 40,000 adults in the U.S. affected by Huntington disease, characterized by abnormal involuntary movements.

Neurocrine Biosciences (Nasdaq: NBIX) announced that its investigational drug NBI-827104 did not achieve its primary endpoint in the Phase 2 STEAMBOAT study for treating pediatric patients with epileptic encephalopathy characterized by continuous spike-and-wave during sleep. The study aimed to measure the drug's efficacy against placebo in reducing the spike-wave index after 6 weeks. Despite the setback, the drug was well tolerated, and the company plans to analyze the data for future steps in development.

Neurocrine Biosciences (NBIX) reported data from a genetic screening study involving over 17,000 children with SCN8A-related epilepsies, highlighting the phenotypic spectrum and seizure burden experienced. The findings were shared at the AES 2022 Annual Meeting in Nashville. The study revealed that 0.2% of patients had pathogenic SCN8A variants, with a mean seizure onset age of 1.4 years. Neurocrine is conducting a Phase 2 clinical trial for NBI-921352, aimed at treating SCN8A developmental and epileptic encephalopathy. The company has received FDA designations for this investigational therapy.

On November 8, 2022, Neurocrine Biosciences (Nasdaq: NBIX) announced participation in two investor conferences. The management team, including CEO Kevin Gorman, CFO Matt Abernethy, and Kyle Gano, will present at the Jefferies London Healthcare Conference on November 15 at 1:30 PM GMT. Additionally, Gorman and Abernethy will speak at the 5th Annual Evercore HealthCONx Virtual Conference on December 1 at 12:35 PM ET. Both events will be webcasted and are accessible on the company's website.

On November 3, 2022, Neurocrine Biosciences (Nasdaq: NBIX) presented findings at the ASCP 2022 Annual Meeting regarding the in vitro dissolution performance of INGREZZA (valbenazine) capsules. The study revealed that crushing the capsule contents, irrespective of the strength (40 mg or 80 mg), did not affect dissolution performance, showcasing rapid drug release. This data supports the medication's accessibility for patients with tardive dyskinesia who face difficulties swallowing capsules. Additionally, the company will share long-term data on valbenazine's effectiveness in elderly patients.

Neurocrine Biosciences (NASDAQ: NBIX) reported significant additional results from the Phase 3 KINECT-HD study on valbenazine for treating chorea associated with Huntington Disease. The study met its primary endpoint with a marked improvement in chorea severity, evidenced by a 3.2 unit reduction in the TMC score (p<0.0001) compared to placebo. Secondary endpoints also favored valbenazine significantly. Treatment-emergent adverse events were mild to moderate, aligning with known safety profiles. The findings were presented at the Huntington Study Group meeting in Tampa, Florida.