Neurocrine Biosciences (NBIX) Stock News

Neurocrine Biosciences (NASDAQ: NBIX) reported publication of Phase 4 KINECT-PRO™ data showing once-daily INGREZZA (valbenazine) improved patient-reported quality of life and functioning in adults with tardive dyskinesia over 24 weeks. The open-label study (n=59; 45 in efficacy analyses) used multiple validated patient-reported outcomes, including the Tardive Dyskinesia Impact Scale (TDIS™), EQ-VAS and Sheehan Disability Scale, plus clinician-rated AIMS.

Mean improvements in TD impact (TDIS) and movement severity (AIMS) exceeded minimal clinically important difference thresholds and were sustained to Week 24 across psychiatric diagnoses and baseline severities. About 58% of patients met a clinician-defined symptomatic remission threshold at Week 24, and safety and tolerability were reported as consistent with the known INGREZZA profile, with no new concerns identified.

Neurocrine Biosciences (Nasdaq: NBIX) announced the initiation of a Phase 1 first-in-human clinical study of NBIP-'1968, an investigational GLP-1/GIP/glucagon receptor triple agonist being developed as a therapy for obesity. The trial will initially assess safety and tolerability of single ascending doses in adults across overweight and obese body mass index categories.

NBIP-'1968 is an internally discovered, long-acting candidate designed for once-weekly subcutaneous administration, with balanced glucagon receptor activity to support tolerability while targeting appetite regulation, energy balance and glycemic control. It is intended for fixed-dose combination use with NBIP-'2118, a corticotropin-releasing factor type 2 receptor agonist also in Phase 1 development, within Neurocrine’s broader obesity portfolio.

Neurocrine Biosciences (Nasdaq: NBIX) reported second-quarter 2026 total revenue of $959 million, up 39% year-over-year, with net product sales of INGREZZA at $716 million (+15%), CRENESSITY at $184 million (+247%), and VYKAT XR at $54 million from the May 18 Soleno acquisition close. Unaudited pro-forma total revenue including a full quarter of VYKAT XR was $998 million.

GAAP net income was $144 million (diluted EPS $1.39) versus $108 million ($1.06) a year ago; Non-GAAP net income was $297 million (EPS $2.85) versus $166 million ($1.65). Cash, cash equivalents, and marketable securities were $482 million at June 30, 2026, compared with $2.543 billion at year-end 2025. Full-year 2026 INGREZZA net sales guidance increased to $2.825–$2.875 billion, while GAAP R&D, GAAP SG&A, and amortization guidance rose, reflecting portfolio investment and Soleno-related intangible amortization.

Neurocrine Biosciences (Nasdaq: NBIX) appointed three new Senior Vice Presidents as it advances its next phase of growth, expands its commercial portfolio and progresses its neuroscience pipeline. The moves include hiring Bret Paulson as SVP, Market Access, and promoting David Bradfute to SVP and Global Head of Intellectual Property, and Aaron Vosburgh to SVP, Finance and Accounting.

Paulson will lead global market access strategy and payer relationships. Bradfute will direct global IP strategy and serve as Managing Director of Neurocrine Switzerland GmbH in Basel. Vosburgh will oversee enterprise financial strategy, including capital allocation, long-range planning and portfolio investment alignment.

Neurocrine Biosciences (Nasdaq: NBIX) appointed Samir Siddhanti as Chief Business Officer and member of its executive Management Committee, effective July 21, 2026. He will lead enterprise growth strategy, including business development, corporate strategy, alliance management and program management to maximize value from Neurocrine's pipeline.

Siddhanti joined Neurocrine in 2017 and most recently served as Vice President, Business Development. He led multiple strategic transactions, notably Neurocrine's $2.9 billion acquisition of Soleno Therapeutics, and serves as Program Team Leader for direclidine in schizophrenia and bipolar disorder.

Neurocrine Biosciences (Nasdaq: NBIX) will release its second quarter 2026 financial results on July 30, 2026, followed by a conference call and webcast at 1:30 p.m. PT (4:30 p.m. ET). The webcast and replay will be available in the Investors section of neurocrine.com.

Neurocrine Biosciences (Nasdaq: NBIX) has initiated a Phase 2 open-label, single-arm study of crinecerfont (CRENESSITY) in 20 children aged 3 months to under 4 years with classic congenital adrenal hyperplasia (CAH).

The 24-week study will primarily assess safety and tolerability, with secondary endpoints evaluating pharmacokinetics and hormone biomarker effects. Results are expected to support a supplemental U.S. New Drug Application to expand crinecerfont’s indication to patients under 4 years. Neurocrine also reached target enrollment for a separate Phase 2 CAH study in the EU in children from birth to under 2 years.

Soleno Therapeutics, a Neurocrine Biosciences (Nasdaq: NBIX) company, reported new Phase 3 VYKAT XR (diazoxide choline) data in Prader-Willi syndrome at ENDO 2026. After a 16-week randomized withdrawal, restarting VYKAT XR led to HQ-CT hyperphagia score improvements by Week 13, sustained through two years.

Continuous VYKAT XR treatment maintained benefits, with smaller but durable HQ-CT gains. Over three years, VYKAT XR showed statistically significant hyperphagia reductions versus PATH for PWS natural history controls and sustained improvements across all six PWSP behavioral domains, while BMI remained relatively stable.

Neurocrine Biosciences (Nasdaq: NBIX) reported the first retrospective case series of CRENESSITY (crinecerfont) in 15 pediatric and adult patients with classic congenital adrenal hyperplasia due to 11β‑hydroxylase deficiency, presented at ENDO 2026.

Androstenedione and adrenal precursors fell markedly, with median decreases of 92% in DOC, 95% in 11‑deoxycortisol, and 65% in androstenedione among patients with elevated baseline levels. Fourteen of 15 patients reduced glucocorticoid doses, and 2 of 5 on antihypertensives lowered or stopped these drugs. Hormone normalization was seen as early as one month, and blood pressure improved in adults. The case series is described as preliminary, early evidence supporting CRENESSITY’s efficacy and safety in this rare subtype, where the drug is already approved as an adjunct to glucocorticoids for classic CAH regardless of enzyme deficiency.