Neurocrine Biosciences Inc - NBIX STOCK NEWS

Neurocrine Biosciences announced that valbenazine met its primary endpoint in the Phase 3 KINECT-HD study, showing a significant improvement in chorea severity in Huntington disease patients compared to placebo (p<0.0001). Improvements were evident as early as Week 2. Response rates for clinical and patient global impressions also favored valbenazine. The company plans to submit a supplemental new drug application to the FDA in 2022. The safety profile was consistent with prior studies, with no serious adverse events reported.

Neurocrine Biosciences (Nasdaq: NBIX) announced on March 28, 2022, that its collaboration partner, Mitsubishi Tanabe Pharma Corporation, received regulatory approval from the Japanese Ministry of Health for DYSVAL® (valbenazine) capsules 40 mg, aimed at treating tardive dyskinesia (TD). This approval signifies a key milestone in their partnership established in March 2015, under which MTPC covers all costs related to development and commercialization in Japan and select Asian markets. Neurocrine will earn tiered royalties on future sales, bolstering its financial outlook.

Neurocrine Biosciences (Nasdaq: NBIX) will present new research on treatment patterns and unmet needs for congenital adrenal hyperplasia (CAH) at the AMCP 2022 annual meeting in Chicago from March 29 to April 1. The studies highlight the challenges in managing classic CAH, for which no non-steroidal FDA-approved treatments exist. Current treatment relies on glucocorticoids, posing risks of complications. The company is developing crinecerfont, a non-steroidal CRF₁ receptor antagonist, advancing two Phase 3 studies for both adults and children with classic CAH.

Neurocrine Biosciences (Nasdaq: NBIX) announced the presentation of its movement disorders program and telemedicine research at the AAN Annual Meeting from April 2-7, 2022, in Seattle. The research reveals a significant gap in evidence regarding telemedicine's effects on individuals with serious mental illnesses and movement disorders, indicating the need for further studies. The company will also showcase data on INGREZZA (valbenazine) and ONGENTYS (opicapone) in treating tardive dyskinesia and Parkinson's disease, respectively, highlighting ongoing commitments to patient care and treatment outcomes.

Neurocrine Biosciences will present at the Stifel 2022 CNS Days virtual conference on March 28, 2022, at 3:30 p.m. Eastern Time. The presentation will be led by Eiry Roberts, Chief Medical Officer, and Kyle Gano, Chief Business Development and Strategy Officer. Attendees can access the live webcast on the company's website under the Investors section. A replay will be available about one hour post-event and archived for a month. Neurocrine specializes in therapies for neurological and neuroendocrine disorders, with an array of FDA-approved treatments and clinical programs.

Neurocrine Biosciences (Nasdaq: NBIX) announced participation in upcoming investor conferences. CEO Kevin Gorman will present at the Cowen 42nd Annual Virtual Health Care Conference on March 8, 2022, at 9:10 a.m. ET. He and CFO Matt Abernethy will also present at the Barclays Global Healthcare Conference on March 16, 2022, at 3:50 p.m. ET in Miami. Additionally, Kyle Gano will speak at the 1st Annual Needham Virtual Neuroscience Forum on the same day at 1:50 p.m. ET. Webcasts will be available on the company's website.

Neurocrine Biosciences (NBIX) reported strong financial results for Q4 and fiscal year 2021, with total revenues of $1.133 billion, up from $1.046 billion in 2020. The company achieved net product sales of $1.1 billion for INGREZZA, reflecting 25% growth in Q4 year-over-year. Despite a GAAP net loss of $7 million in Q4, its non-GAAP net income was $4.3 million. For 2022, NBIX guided INGREZZA sales between $1.25 billion and $1.35 billion, indicating approximately 20% growth. The firm is advancing a diverse pipeline with 12 mid-to-late-stage clinical programs.

Neurocrine Biosciences (Nasdaq: NBIX) announced a conference call to discuss its 2021 fourth quarter and year-end financial results on February 11, 2022, at 5:00 a.m. PT (8:00 a.m. ET). The press release will precede this at 4:30 a.m. PT. Investors can access the call via domestic (800-895-3361) and international (785-424-1062) dial-in numbers, using Conference ID: NBIX. A replay will be available on Neurocrine's website following the event, highlighting the company's commitment to addressing neurological and psychiatric disorders through its diverse portfolio and ongoing clinical programs.

Neurocrine Biosciences (NBIX) reported preliminary net product sales of INGREZZA (valbenazine) for Q4 2021, totaling approximately $301 million, showing a 25% increase year-over-year. Total prescriptions rose by 32%. The company is on track to complete its commercial expansion by Q1 2022 and will provide full-year 2022 sales guidance on February 11, 2022. CEO Kevin Gorman highlighted the company's dedication to advancing a broad pipeline with 13 clinical programs expected to yield significant data in the next two years.