American biopharmaceutical company headquartered in San Diego, California, developing treatments for neurological and endocrine-related diseases; its valbenazine (Ingrezza) is FDA-approved for tardive dyskinesia.
相关临床试验
86
4 进行中
药物批准
4
批准总数
监管机构
1
监管机构数
成立时间
1992
进行中（未招募）
3
3.5%
已完成
55
64.0%
Enrolling By Invitation
1
1.2%
招募中
14
16.3%
终止
10
11.6%
Unknown
1
1.2%
撤回
2
2.3%
- Novartis's pelacarsen and Novo Nordisk's ziltivekimab both failed to separate from placebo in late-stage cardiovascular outcome trials despite strong genetic support for their targets. - Cardiologist Ethan Weiss said the field can no longer claim that genetics is undefeated in predicting which drugs will work in outcome studies. - Novartis shares fell 14% in a single session and Amgen dropped 9.8% as investors repriced roughly 35,000 patients still enrolled in Lp(a) outcome trials. - Weiss attributed the Lp(a) failure largely to background therapy, arguing the risk signal diminishes in patients already on statins and other powerful medicines.
- Neurocrine Biosciences has received FDA IND acceptance for a Phase 2 study of NBI-1117567 in Alzheimer's cognition, triggering a $10 million milestone payment to partner Nxera Pharma. - NBI-1117567 is an investigational oral muscarinic M1 receptor preferring (M1/M4) selective agonist discovered using Nxera's proprietary NxWave drug discovery platform. - The compound is the third in the companies' muscarinic agonist portfolio to reach Phase 2, following direclidine (NBI-1117568) in Phase 3 and NBI-1117570 in Phase 2. - Under the November 2021 collaboration, Nxera is eligible for up to $2.6 billion in R&D funding plus development, regulatory and commercial milestones, with royalties.
- A group of Prader-Willi syndrome physicians and experts notified clinicians of patient deaths and severe side effects potentially associated with Vykat XR, a newly approved Neurocrine Biosciences drug. - Seven people prescribed Vykat XR have died since its FDA approval in March 2025, according to the FDA's Adverse Event Monitoring System. - More than 100 reports of serious adverse events, mostly hospitalizations for swelling, respiratory, and heart complications, have been reported to the FDA. - Vykat XR was approved to curb the intense hunger sensation in children and adults with Prader-Willi syndrome, a rare disease causing an insatiable desire to eat.
- Neurocrine Biosciences has dosed the first participants in a Phase I first-in-human study of NBIP-1968, an investigational GLP-1/GIP/glucagon receptor triple agonist for obesity. - The study will evaluate safety and tolerability of single ascending doses in adults across a range of body mass index categories, including overweight and obese. - NBIP-1968 is designed for once-weekly subcutaneous administration and is intended for use in a fixed-dose combination with NBIP-2118, a CRF2 agonist aimed at preserving lean mass during weight loss. - The triple agonist approach seeks to build on the success of dual incretin therapies like tirzepatide by adding glucagon receptor activation to potentially enhance energy expenditure and weight loss.
- Draig Therapeutics raised $65 million in an oversubscribed Series B round led by Deep Track Capital to accelerate its neuropsychiatric pipeline. - The funding will support two Phase 2 trials of DT-101, an oral AMPA receptor positive allosteric modulator, as both monotherapy and adjunctive treatment for major depressive disorder. - DT-101 aims to deliver rapid antidepressant effects with potential cognitive benefits by amplifying glutamate signaling rather than directly activating AMPA receptors. - Initial clinical readouts from both Phase 2 studies are expected in 2027, with earlier-stage GABA-A modulator programs DT-201 and DT-301 planned to enter the clinic in 2026.
- The global tardive dyskinesia market across the 7MM was valued at USD 4.4 billion in 2025, with the United States accounting for approximately 98% of the total market share. - Currently approved VMAT2 inhibitors valbenazine (INGREZZA) and deutetrabenazine (AUSTEDO XR) remain the standard of care, though they address symptoms without reversing underlying neurobiological dysfunction. - Emerging therapies including NBI-1065890, SOM3355, LY03015, and ACP-271 are advancing through clinical development, with Neurocrine's NBI-1065890 in Phase II as the most advanced pipeline asset. - Underdiagnosis persists as a major challenge, as involuntary movements are frequently misattributed to psychiatric disorders, medication effects, or normal aging, delaying treatment initiation.
- Vir Biotechnology appointed Timothy Coughlin, former CFO of Neurocrine Biosciences, to its Board of Directors and as Chair of the Audit Committee, effective June 9, 2026. - Coughlin brings extensive experience guiding companies from clinical-stage to fully integrated commercial enterprises, including navigating regulatory setbacks. - The appointment comes as Vir advances its potential best-in-class treatment for chronic hepatitis delta and its pipeline of masked T-cell engagers for solid tumors. - Coughlin currently serves on the boards of aTyr Pharma, ADC Therapeutics, and Travere Therapeutics, and previously served on boards including Fate Therapeutics and Peloton Therapeutics.
- Exelixis surged 5.0% to $50.99 on Wednesday amid a broad biotechnology rally, with no company-specific catalysts driving the move. - PTC Therapeutics jumped 5.1% to $89.80 on Tuesday, riding the same sector-wide momentum alongside peers posting gains of 4.0% to 6.9%. - Coordinated buying across multiple biotech names suggests institutional investors are rotating into the sector, reflecting improved risk appetite toward growth-oriented healthcare. - Trading volumes remained moderate, with Exelixis at 1.1M shares and PTC Therapeutics at 823,046 shares, indicating measured rather than explosive positioning.
- Neurocrine Biosciences has launched a Phase 1 first-in-human clinical study evaluating NBIP-2118, a potential first-in-class corticotropin-releasing factor type 2 receptor agonist for obesity treatment. - The investigational drug targets a novel non-incretin mechanism designed to promote weight loss while preserving lean muscle mass, addressing a key limitation of existing obesity therapies. - NBIP-2118 demonstrated high selectivity and potency in preclinical models, with weight loss primarily driven by fat reduction while maintaining or increasing skeletal muscle mass. - Initial safety and tolerability data from the single ascending dose study in healthy-weight and overweight/obese participants is expected in 2027.
- New two-year data from the CAHtalyst trials demonstrate that CRENESSITY (crinecerfont) provides sustained reductions in glucocorticoid doses and durable androgen control in both pediatric and adult patients with classic congenital adrenal hyperplasia. - In pediatric patients, 60% of those who were overweight or obese at baseline experienced clinically meaningful improvements in body mass index, while 61% of those with insulin resistance at baseline were no longer insulin resistant after two years of treatment. - Adult patients maintained substantial glucocorticoid dose reductions with 69% reaching physiologic-range dosing at two years, and 75% of participants originally taking dexamethasone successfully transitioned to dexamethasone-free regimens. - The treatment was well tolerated across both populations with no new safety signals observed and study retention rates exceeding 80% in pediatric patients and 91% in adults at one year.
