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21 results on '"Neurocrine Biosciences Inc. -- Planning"'

1. Neurocrine Biosciences Announces U.S. FDA Accepts New Drug Applications and Grants Priority Review for Crinecerfont for Pediatric and Adult Patients with CAH

Subjects
United States. Food and Drug Administration -- Planning, Neurocrine Biosciences Inc. -- Planning, Pediatrics, Grants-in-aid, Drugs -- Prescribing -- Planning, Biotechnology industry -- Planning, Company business planning, Business, News, opinion and commentary
Abstract

PDUFA Target Action Dates in Late December 2024 Highly Selective CRF[sub.1] Antagonist is the Potential First New Treatment for CAH in 70 Years SAN DIEGO, July 1, 2024 /PRNewswire/ -- [...]

Published
2024

2. Sosei Heptares' Partner Neurocrine Biosciences Confirms its Plans to Evaluate Two New Muscarinic Agonist Candidates in Phase 1 Clinical Studies

Subjects
Neurocrine Biosciences Inc. -- Planning, Medical research, Medicine, Experimental, Clinical trials, Neurosciences, Company business planning, Banking, finance and accounting industries, Business
Abstract

Both NBI-1117569 (an M4-preferring agonist) and NBI-1117567 (an M1-preferring agonist) are investigational, oral, muscarinic agonists discovered by Sosei Heptares that may have the potential to treat neurological and neuropsychiatric conditions [...]

Published
2023

3. Sosei Heptares' partner Neurocrine Biosciences to evaluate 2 new muscarinic agonist candidates in Phase 1 clinical studies

Subjects
Neurocrine Biosciences Inc. -- Planning, Medical research, Medicine, Experimental, Biotechnology industry -- Planning, Clinical trials, Company business planning, General interest, News, opinion and commentary
Abstract

TOKYO: Sosei Group Corporation, notes its partner Neurocrine Biosciences Inc. (Neurocrine), a leading neuroscience-focused biopharmaceutical company, has confirmed its plans to evaluate two new muscarinic agonist candidates in Phase 1 [...]

Published
2023

4. Neurocrine sees initiation of registrational crinecerfont study in 2H20

Subjects
Neurocrine Biosciences Inc. -- Planning, Biotechnology industries -- Planning, Glucocorticoids, Adrenocortical hormones, Aldosterone, Medical research, Enzymes, Company business planning, Business, News, opinion and commentary
Abstract

Neurocrine Biosciences plans to initiate a single, global registrational study of crinecerfont in adult patients with classic CAH in the second half of 2020. Classic CAH is a genetic disorder, [...]

Published
2020

5. Voyager Therapeutics continues to advance earlier-stage research efforts

Subjects
Neurocrine Biosciences Inc. -- Planning, Biotechnology industries -- Planning -- Research, Antibodies, Biotechnology, Production management, Ataxia, Novels, Company business planning, Business, News, opinion and commentary
Abstract

Voyager continues to advance its earlier-stage research efforts, including wholly-owned and partnered programs with AbbVie and Neurocrine Biosciences. These initiatives include Friedreich's ataxia, SOD1 ALS, vectorized antibodies, novel AAV capsids, [...]

Published
2020

6. US FDA approves Neurocrine Biosciences,CO once-daily Ongentys as an add-on treatment for patients with Parkinson,COs disease experiencing 'off' episodes

Subjects
Neurocrine Biosciences Inc. -- Planning, United States. Food and Drug Administration -- Planning, Drug therapy, Planning, Diseases, Development and progression, Company business planning, Business planning, Entacapone -- Planning, Biotechnology industries -- Planning, Drug approval, Time
Abstract

Neurocrine Biosciences, Inc. announced that the US Food and Drug Administration (FDA) has approved once-daily oral Ongentys (opicapone) 25 mg and 50 mg capsules as an add-on treatment to levodopa/carbidopa [...]

Published
2020

7. Neurocrine announces FDA approval for ONGENTYS

Subjects
Neurocrine Biosciences Inc. -- Planning, Drug approval, Time, Business planning, Diseases, Company business planning, Business, News, opinion and commentary
Abstract

Neurocrine Biosciences announced that the FDA has approved once-daily oral ONGENTYS 25 mg and 50 mg capsules as an add-on treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing 'off' [...]

Published
2020

8. United States : Neurocrine Biosciences Leases New Headquarters in San Diegos Carmel Valley

Subjects
Neurocrine Biosciences Inc. -- Planning, Biotechnology industry -- Planning, Leases -- Planning, Periodical publishing -- Planning, Company business planning, Business, international
Abstract

Cooley advised Neurocrine Biosciences, a neuroscience-focused biopharmaceutical company, on its agreement to lease a new 535,000-square-foot space at the Aperture Del Mar campus in San Diegos Carmel Valley, which will [...]

Published
2022

9. Neurocrine Biosciences Leases New Headquarters in San Diego's Carmel Valley

Subjects
Neurocrine Biosciences Inc. -- Planning, Biotechnology industry -- Planning, Leases -- Planning, Periodical publishing -- Planning, Company business planning, General interest, News, opinion and commentary
Abstract

Palo Alto, California: Cooley LLP has issued the following press release: Cooley advised Neurocrine Biosciences, a neuroscience-focused biopharmaceutical company, on its agreement to lease a new 535,000-square-foot space at the [...]

Published
2022

10. Co. to Launch Parkinson's Drug in U.S.: Cultivating Relationships Pays Off for Neurocrine Biosciences

Author

Adamek, Steve

Subjects
United States. Food and Drug Administration -- Planning, AbbVie Inc. -- Planning, Neurocrine Biosciences Inc. -- Planning, Dopa -- Planning, Biotechnology industry -- Planning, Pharmaceutical industry -- Planning, Company business planning, Business, Business, regional, Ongentys, Ongentys (Medication)
Abstract

Neurocrine Biosciences, a San Diego-based biopharmaceutical company, recently announced that the U.S. Food and Drug Administration has approved Ongentys as an add-on treatment for patients with Parkinson's disease experiencing 'off [...]

Published
2020

11. Voyager Therapeutics Provides Update on NBIb-1817 (VY-AADC) Gene Therapy Program

Subjects
United States. Food and Drug Administration -- Planning, Neurocrine Biosciences Inc. -- Planning, Biotechnology industry -- Planning, Gene therapy, Company business planning, Business, international, Law
Abstract

(GlobeNewswire) - Voyager Therapeutics, Inc. (Nasdaq: VYGR) today announced that Neurocrine Biosciences, Inc. (Nasdaq: NBIX) provided notice of termination of the Parkinsons disease portion of the collaboration agreement, effective August [...]

Published
2021

12. Voyager Therapeutics Provides Update on NBIb-1817 (VY-AADC) Gene Therapy Program

Subjects
United States. Food and Drug Administration -- Planning, Neurocrine Biosciences Inc. -- Planning, Biotechnology industry -- Planning, Gene therapy, Company business planning, Banking, finance and accounting industries, Business
Abstract

CAMBRIDGE, Mass., Feb 02, 2021 (GLOBE NEWSWIRE via COMTEX) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR) today announced that Neurocrine Biosciences, Inc. (Nasdaq: NBIX) provided notice of termination of the Parkinson's [...]

Published
2021

13. Voyager Therapeutics Provides Update on NBIb-1817 (VY-AADC) Gene Therapy Program

Subjects
United States. Food and Drug Administration -- Planning, Neurocrine Biosciences Inc. -- Planning, Biotechnology industry -- Planning, Gene therapy, Company business planning, Business, international, Law
Abstract

(GlobeNewswire) - 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 [...]

Published
2020

14. Neurocrine Biosciences exercises option to license Idorsia's novel treatment for rare pediatric epilepsy

Subjects
United States. Food and Drug Administration -- Planning, Neurocrine Biosciences Inc. -- Planning, Pediatric epilepsy, Calcium channels, Biotechnology industries -- Planning, Pediatrics, Media executives, Epilepsy, Company business planning, Business, international, Law
Abstract

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) and Idorsia Ltd (SIX: IDIA) today announced that following Investigational New Drug (IND) application acceptance by the US Food and Drug Administration (FDA), Neurocrine Biosciences [...]

Published
2020

15. Neurocrine Biosciences up 4% premarket; in-licenses epilepsy candidate from Idorsia

Subjects
Neurocrine Biosciences Inc. -- Planning, Epilepsy, Royalties (Intellectual property), Youth, Pediatrics, Pediatric epilepsy, Company business planning, General interest, News, opinion and commentary
Abstract

Neurocrine Biosciences (NASDAQ:NBIX) has exercised its option to in-license global rights Idorsia's (OTCPK:IDRSF) ACT-709478, an orally available brain-penetrating T-type calcium blocker for the potential treatment of a rare type of [...]

Published
2020

16. Neurocrine Biosciences Exercises Option to License Idorsia's Novel Treatment for Rare Pediatric Epilepsy

Subjects
United States. Food and Drug Administration -- Planning, Neurocrine Biosciences Inc. -- Planning, Pediatric epilepsy, Calcium channels, Biotechnology industries -- Planning, Pediatrics, Media executives, Epilepsy, Company business planning, General interest, News, opinion and commentary
Abstract

SAN DIEGO: Neurocrine Biosciences, Inc. has issued the following press release: Neurocrine Biosciences, Inc. (Nasdaq: NBIX) and Idorsia Ltd (SIX: IDIA) today announced, following Investigational New Drug (IND) application acceptance [...]

Published
2020

17. Neurocrine Biosciences Provides COVID-19 Business Update

Subjects
United States. Food and Drug Administration -- Planning, Neurocrine Biosciences Inc. -- Planning, Biotechnology industry -- Planning, Health care industry -- Planning, Health care industry, Company business planning, Business, News, opinion and commentary, Ingrezza (Medication)
Abstract

SAN DIEGO, April 3, 2020 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today provided an update regarding the company's business operations during the COVID-19 pandemic as part of its commitment [...]

Published
2020

18. Neurocrine Biosciences Will File New Drug Application for Opicapone for Parkinson's Disease Based on Existing Pivotal Clinical Trial Data

Subjects
United States. Food and Drug Administration -- Planning, Neurocrine Biosciences Inc. -- Planning, Biotechnology industry -- Planning, Clinical trials, Antiparkinsonian agents, Company business planning, Business, News, opinion and commentary
Abstract

Neurocrine Plans to File the NDA During the First Half of 2019 SAN DIEGO, Feb. 14, 2018 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX), a biotechnology company focused on neurological [...]

Published
2018

19. Neurocrine Biosciences, Inc. (Lehman Brothers)

Author

Wood, Michael

Subjects
Neurocrine Biosciences Inc. -- Planning, Biotechnology industry -- Planning, Banking, finance and accounting industries, Business, Insurance
Abstract

COMPANY DESCRIPTION: Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. INVESTMENT CONCLUSION: The current strength in biotech stocks is characterized by investor [...]

Published
2002

20. Biotechnology campus planned in San Diego

Subjects
Neurocrine Biosciences Inc. -- Finance, Neurocrine Biosciences Inc. -- Planning, Biotechnology industry -- Finance, Biotechnology industry -- Planning, Company financing, Company business planning, Business, Business, general
Abstract

A San Diego deal shows the strength of the biotech industry. Neurocrine Biosciences paid $17 million for 9.4 acres to build a campus at San Diego Corporate Center and is [...]

Published
2003

21. Neurocrine gets positive data in indiplon studies

Subjects
Neurocrine Biosciences Inc. -- Product development, Neurocrine Biosciences Inc. -- Planning, Insomnia -- Drug therapy, Biotechnology industry -- Product development, Biotechnology industry -- Planning, Company business planning, Biotechnology industry, Indiplon (Medication) -- Testing
Abstract

Neurocrine Biosciences Inc. released Favorable data from two long-term Phase III studies proving that its insomnia candidate, indiplon, remains effective For at least three months and is associated with quality-of-life [...]

Published
2004

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