NBIX Neurocrine Biosciences Inc.

115
+3.92  (+4%)
Previous Close 111.08
Open 111.47
52 Week Low 72.14
52 Week High 136.265
Market Cap $10,744,352,595
Shares 93,429,153
Float 92,232,256
Enterprise Value $9,726,523,263
Volume 1,289,787
Av. Daily Volume 1,038,738
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Upcoming Catalysts

Drug Stage Catalyst Date
TAK-831 / NBI-1065844
Negative symptoms of schizophrenia
Phase 2
Phase 2
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Valbenazine
Huntington's disease
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
NBI-921352
SCN8A developmental and epileptic encephalopathy (SCN8A-DEE)
Phase 2
Phase 2
Phase 2 trial to commence 3Q 2021.
Crinecerfont
Congenital Adrenal Hyperplasia (CAH) - children
Phase 2
Phase 2
Phase 3 trial planned for 2021.
TAK-653 / NBI-1065845
Treatment-resistant depression
Phase 2
Phase 2
Phase 2 trial planned for 2021.
TAK-041 / NBI-1065846
Anhedonia in depression
Phase 2
Phase 2
Phase 2 trial planned for 2021.
Crinecerfont (CAHtalyst)
Congenital Adrenal Hyperplasia (CAH) - adults
Phase 3
Phase 3
Phase 3 trial enrolling.
VY-AADC02 (RESTORE-1)
Parkinson's Disease
Phase 2
Phase 2
Phase 2 trial placed on clinical hold - December 22, 2020.
ACT-709478 (NBI-827104)
Pediatric epilepsy
Phase 2
Phase 2
Phase 2 trial has commenced.
Elagolix
Uterine Fibroids
Approved
Approved
FDA approval announced May 29, 2020.
Opicapone
Parkinson's disease
Approved
Approved
FDA Approval announced April 27, 2020.
INGREZZA - T-Force GOLD
Tourette syndrome - juvenile
Phase 2b
Phase 2b
Phase 2 top-line data released December 12, 2018 did not meet primary endpoint.
Elagolix
Endometriosis
Approved
Approved
FDA approval announced July 24, 2018.
INGREZZA
Tardive dyskinesia
Approved
Approved
Approved April 11, 2017.
INGREZZA
Tourette syndrome - adults
Phase 2
Phase 2
Phase 2 data released January 18, 2017 did not meet primary endpoint.
INGREZZA
Tardive dyskinesia
Approved
Approved
Approval for sNDA 80 mg capsules announced October 5, 2017.

Latest News

  1. SAN DIEGO, Jan. 20, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) announced today that it will report fourth quarter and year-end 2020 financial results after the Nasdaq market closes on Thursday, Feb. 4, 2021. Neurocrine will then host a conference call and webcast to discuss its financial results and provide a company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

    Participants can access the live conference call by dialing 800-895-3361 (US) or 785-424-1062 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine's website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-conference-call-and-webcast-of-fourth-quarter-and-year-end-2020-financial-results-301211835.html

    SOURCE Neurocrine Biosciences, Inc.

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  2. SAN DIEGO, Jan. 8, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today provided an update on its business performance, including preliminary net product and inventory adjusted sales results of INGREZZA® (valbenazine) for 2020, and key commercial and clinical development milestones for 2021. Kevin Gorman, Chief Executive Officer of Neurocrine Biosciences, will discuss these updates as part of a webcast presentation at the 39th Annual J.P. Morgan Healthcare Conference to be held virtually on Monday, January 11 at 2:00 p.m. Eastern Time, followed by a Question and Answer session at approximately 2:20 p.m. Eastern Time.

    Preliminary Fourth Quarter and Full-Year 2020 INGREZZA® (valbenazine) Net Product Sales and Inventory Adjusted Net Product Sales (Unaudited)

    Based on preliminary unaudited financial information, the Company expects INGREZZA net product sales for the three months and full-year ended December 31, 2020 to be approximately $240 million and $993 million respectively. Preliminary analysis of INGREZZA net product sales suggests:

    - INGREZZA inventory adjusted net product sales for the fourth quarter were approximately $258 million reflecting an $18 million channel inventory decrease in Q4

    - New prescriptions and refills increased in the fourth quarter of 2020 vs. the third quarter of 2020

    - Full-year 2020 total INGREZZA prescriptions grew 32% to approximately 175,700 versus 2019 total prescriptions of approximately 132,700 

    "I am very proud of our team's resilience and adaptability to bring INGREZZA to patients living with tardive dyskinesia this past year and we remain encouraged by the continued strength in persistence and refill rates, which is a testament to the many benefits of INGREZZA. We also continue to focus on healthcare provider educational initiatives, patient outreach programs and investing in telemedicine capabilities to improve diagnosis and treatment rates for the estimated 80% of patients with tardive dyskinesia who have not yet been diagnosed," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "Adding to our movement disorder portfolio, we launched our second commercial treatment, ONGENTYS, and continue to make great progress in our development programs with plans to initiate seven mid-to-late stage clinical studies in 2021 focused on neurological, endocrine and psychiatric disorders."

    2021 Expected Milestones and Key Activities

    Program

    Indication

    2021 Milestones / Key Activities

    Valbenazine

    Chorea in Huntington Disease

    Phase III Top-Line Data Expected in Q4 2021

    Neurological Indication

    Initiate Phase III

    Psychiatric Indication

    Initiate Phase II

    Crinecerfont

    Congenital Adrenal Hyperplasia (Adult)

    Continue Phase III Enrollment

    Congenital Adrenal Hyperplasia (Pediatric)

    Initiate Phase III

    NBI-1065844

    Negative Symptoms of Schizophrenia

    Phase II Top-Line Data Expected in

    1st Half of 2021

    NBI-1065845

    Treatment Resistant Depression

    Initiate Phase II

    NBI-1065846

    Anhedonia in Depression

    Initiate Phase II

    NBI-827104

    Rare Pediatric Epilepsy:

    Epileptic Encephalopathy with Continuous Spike and Wave During Sleep

    Continue Phase II Enrollment

    Neurological Indication

    Initiate Phase II

    NBI-921352

    Focal Onset Seizure in Adults

    Initiate Phase II

    Rare Pediatric Epilepsy: SCN8A-DEE

    Ongoing Dialogue with FDA

    NBIb-1817

    Gene Therapy for Parkinson's Disease

    Determine Regulatory Path with FDA

    About Tardive Dyskinesia (TD)

    Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is caused by prolonged use of treatments that block dopamine receptors in the brain, such as antipsychotics commonly prescribed to treat mental illnesses such as schizophrenia, bipolar disorder and depression, and certain anti-nausea medications. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be severe and are often persistent and irreversible. TD is estimated to affect at least 500,000 people in the U.S.

    About INGREZZA® (valbenazine) Capsules

    INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first FDA-approved product indicated for the treatment of adults with tardive dyskinesia, a condition associated with uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts.

    INGREZZA is thought to work by reducing the amount of dopamine released in a region of the brain that controls movement and motor function, helping to regulate nerve signaling in adults with tardive dyskinesia. VMAT2 is a protein in the brain that packages neurotransmitters, such as dopamine, for transport and release in presynaptic neurons. INGREZZA, developed in Neurocrine Biosciences's laboratories, is novel in that it selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic, or muscarinic receptors. Additionally, INGREZZA can be taken for the treatment of tardive dyskinesia as one capsule, once-daily, together with psychiatric medications such as antipsychotics or antidepressants.

    Important Information

    Approved Use

    INGREZZA® (valbenazine) capsules is a prescription medicine used to treat adults with movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).

    It is not known if INGREZZA is safe and effective in children.

    Important Safety Information

    Do not take INGREZZA if you are allergic to valbenazine, or any of the ingredients in INGREZZA.

    INGREZZA may cause serious side effects, including:

    • Sleepiness (somnolence). Do not drive, operate heavy machinery, or do other dangerous activities until you know how INGREZZA affects you.
    • Heart rhythm problems (QT prolongation). INGREZZA may cause a heart problem known as QT prolongation.
    • Symptoms of QT prolongation may include: fast, slow, or irregular heartbeat, shortness of breath, dizziness or fainting.
    • Parkinson-like symptoms. Symptoms include: shaking, body stiffness, trouble moving or walking, or keeping your balance.

    Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint.

    Before taking INGREZZA, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

    The most common side effect of INGREZZA is sleepiness (somnolence). Other side effects include changes in balance (balance problems, dizziness) or an increased risk of falls, headache, feelings of restlessness, dry mouth, constipation, and blurred vision.

    These are not all of the possible side effects of INGREZZA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Please see INGREZZA full Product Information.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn. (*in collaboration with AbbVie)

    Forward-Looking Statements

    In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: our preliminary unaudited financial information; the benefits to be derived from our products and product candidates; the value our products and/or our product candidates may bring to patients; the continued success of INGREZZA; our financial and operating performance, our collaborative partnerships; expectations regarding the impact of COVID-19 on our business, including patient and healthcare provider access to INGREZZA, our ability to continue our ongoing clinical trials and other development activities, and to otherwise advance our business objectives; and the timing of completion of our clinical, regulatory, and other development activities and those of our collaboration partners. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: risks and uncertainties associated with items that may be identified during the financial statement closing process that cause adjustments to the estimates included in this press release; our future financial and operating performance; risks associated with the commercialization of INGREZZA and ONGENTYS; the impact of the COVID-19 pandemic on our business and the business operations of our customers; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting global, national, and local economic and financial disruptions; risk and uncertainties related to any COVID-19 quarantines, shelter-in-place, social distancing and other government orders that are currently in place or that may be put in place in the future, including the impact of such orders on our business operations and the business operations of the third parties on which we rely; risks related to the development of our product candidates; risks associated with our dependence on third parties for development and manufacturing activities related to INGREZZA and our product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks associated with our dependence on AbbVie for the commercialization of ORILISSA and ORIAHNN, as well as the continued development of elagolix; risks associated with our dependence on BIAL for manufacturing activities for ONGENTYS, and our ability to manage BIAL; risks that clinical development activities may not be completed on time or at all, or may be delayed for regulatory, manufacturing, COVID-19 or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in our periodic reports filed with the SEC, including without limitation our quarterly report on Form 10-Q for the quarter ended September 30, 2020. Neurocrine disclaims any obligation to update the statements contained in this press release after the date hereof.

    This press release refers to preliminary unaudited net sales in certain non-GAAP financial measures. These non-GAAP financial measures should not be considered replacements for, and should be read together with, the comparable GAAP financial measures, which are included in this press release.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/neurocrine-biosciences-provides-preliminary-fourth-quarter-and-full-year-2020-net-product-sales-results-and-2021-program-milestones-301203297.html

    SOURCE Neurocrine Biosciences, Inc.

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  3. SAN DIEGO, Jan. 4, 2021 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) will present at the 39th Annual J.P. Morgan Healthcare Conference at 2:00 p.m. Eastern Time on Monday Jan. 11, 2021. Kevin Gorman, Chief Executive Officer, will present at the conference.

    The live presentation will be webcast and may be accessed on the Company's website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

    ###

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    SOURCE Neurocrine Biosciences, Inc.

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  4. CAMBRIDGE, Mass., Dec. 22, 2020 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ:VYGR) today announced that the U.S. Food and Drug Administration (FDA) has notified Neurocrine Biosciences (NASDAQ:NBIX) that it has placed a clinical hold on the RESTORE-1 clinical trial of NBIb-1817 (VY-AADC). As previously announced, trial sites participating in RESTORE-1 had not been screening, enrolling or dosing patients as a result of the COVID-19 pandemic and more recently, as a result of the independent Data Safety Monitoring Board (DSMB)'s request to pause dosing pending its review of additional data. The DSMB has requested additional patient level data from the trial and now plans to review these data in early 2021. The clinical hold follows the…

    CAMBRIDGE, Mass., Dec. 22, 2020 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ:VYGR) today announced that the U.S. Food and Drug Administration (FDA) has notified Neurocrine Biosciences (NASDAQ:NBIX) that it has placed a clinical hold on the RESTORE-1 clinical trial of NBIb-1817 (VY-AADC). As previously announced, trial sites participating in RESTORE-1 had not been screening, enrolling or dosing patients as a result of the COVID-19 pandemic and more recently, as a result of the independent Data Safety Monitoring Board (DSMB)'s request to pause dosing pending its review of additional data. The DSMB has requested additional patient level data from the trial and now plans to review these data in early 2021. The clinical hold follows the submission by Neurocrine Biosciences of an IND Safety Report related to the observation of MRI abnormalities in some RESTORE-1 study participants. The clinical implications of this observation are currently unknown and are being evaluated.

    RESTORE-1 is a Phase 2 clinical trial of NBIb-1817 (VY-AADC), an intracerebral AAV-based investigational gene therapy, in development for the treatment of Parkinson's disease. The RESTORE-1 DSMB has been informed of the clinical hold, as have the study investigators and central and local ethics committees. Neurocrine Biosciences and Voyager will work closely with the FDA and the DSMB to determine the next steps for the RESTORE-1 clinical trial.

    About Parkinson's Disease and NBIb-1817 (VY-AADC)

    Parkinson's disease is a chronic, progressive, and debilitating neurodegenerative disease that affects approximately one million people in the U.S. and ten million people worldwide. It is characterized by a loss of dopamine and neuronal degeneration with a concomitant loss of the aromatic L-amino acid decarboxylase (AADC) enzyme required to synthesize dopamine in the brain, leading to associated impairment in motor, neuropsychiatric, and autonomic functions. Dopamine is a chemical "messenger" that is produced in the brain and is involved in the control of movement. It is made when AADC converts the chemical levodopa to dopamine. As Parkinson's disease progresses, there is less AADC enzyme in parts of the brain where levodopa is converted to dopamine.

    NBIb-1817 (VY-AADC) is an investigational recombinant adeno-associated viral (AAV) serotype 2 vector encoding the gene for human AADC that is designed to help produce the AADC enzyme in brain cells where it can convert levodopa to dopamine. NBIb-1817 (VY-AADC) is administered into the brain using intraoperative monitoring with magnetic resonance imaging (MRI)-facilitated targeted delivery.

    About Voyager Therapeutics

    Voyager Therapeutics is a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of AAV gene therapy through innovation and investment in vector engineering and optimization, manufacturing, and dosing and delivery techniques. Voyager's wholly-owned and partnered pipeline focuses on severe neurological diseases for which effective new therapies are needed, including Parkinson's disease, Huntington's disease, Friedreich's ataxia, and other severe neurological diseases. For more information on Voyager Therapeutics, please visit the company's website at www.voyagertherapeutics.com or follow @VoyagerTx on Twitter and LinkedIn.

    Voyager Therapeutics® is a registered trademark of Voyager Therapeutics, Inc.

    Voyager Therapeutics Forward-Looking Statements

    This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "may," "might," "will," "would," "should," "expect," "plan," "anticipate," "believe," "estimate," "undoubtedly," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identify forward-looking statements. For example, all statements Voyager makes regarding the ability of Neurocrine and Voyager to gather additional information to further characterize the safety profile of NBIb-1817 (VY-AADC) and to work with the FDA to determine the next steps for the RESTORE-1 clinical trial.

    All forward-looking statements are based on estimates and assumptions by Voyager's management that, although Voyager believes such forward-looking statements to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Voyager expected. Such risks and uncertainties include, among others, the ability of Neurocrine and Voyager to complete their evaluation and to meet the information requests of, and to resolve questions raised by, the FDA required to bring an end to the clinical hold on the RESTORE-1 clinical trial. These statements are also subject to a number of material risks and uncertainties that are described in Voyager's Annual Report on Form 10-K filed with the Securities and Exchange Commission, as updated by its subsequent filings with the Securities and Exchange Commission. All information in the press release is as of the date of this press release, and any forward-looking statement speaks only as of the date on which it was made. Voyager undertakes no obligation to publicly update or revise this information or any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

    Contact Information

    Voyager Therapeutics

    Investors:        

    Media:        

    Sheryl Seapy

    W2Opure

    949-903-4750

     



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  5. SAN DIEGO, Nov. 19, 2020 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced that Neurocrine Biosciences management will present at the following investor conferences:

    • Matt Abernethy, Chief Financial Officer, and Eiry Roberts, Chief Medical Officer, will present at the Piper Sandler 32nd Annual Virtual Healthcare Conference at 10:00 a.m. Eastern Time on Monday, November 23, 2020.



    • Kevin Gorman, Chief Executive Officer, and Matt Abernethy, Chief Financial Officer, will present at the Evercore ISI 3rd Annual HealthCONx Conference at 1:50 p.m. Eastern Time on Tuesday, December 1, 2020.

    The live presentations will be webcast and may be accessed on the Company's website under Investors at www.neurocrine.com. A replay of the presentations will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

    About Neurocrine Biosciences

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, Neurocrine Biosciences has specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn(*in collaboration with AbbVie)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/neurocrine-biosciences-to-present-at-upcoming-healthcare-conferences-301177243.html

    SOURCE Neurocrine Biosciences, Inc.

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