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In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA's decisions in 2024.
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Neurocrine Biosciences Reports Positive Phase 2 Data for NBI-1065845 in Adults with Major Depressive Disorder
4/23/2024
Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced positive topline data for its Phase 2 SAVITRI™ study. This randomized, double-blind, placebo-controlled dose-finding study assessed the efficacy and safety of NBI-1065845 in adult subjects with major depressive disorder (MDD).
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The FDA will close out April with five target action dates around indications that include pediatric seizures and a neurological cancer in children.
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Voyager Therapeutics to Present Broad Set of Translational Data Supporting IV-Delivered, CNS Gene Therapy Programs Advancing Toward Clinical Trials at the ASGCT 27th Annual Meeting
4/22/2024
Voyager Therapeutics, Inc. announced that it will present a broad set of data related to its TRACER™ capsid discovery platform and TRACER-driven gene therapy programs across 12 oral and poster presentations at the upcoming American Society of Gene & Cell Therapy’s 27th annual meeting taking place in Baltimore, May 7-11.
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On the heels of a late-stage victory for its antipsychotic drug Caplyta in patients with major depressive disorder, Intra-Cellular Therapies is now offering 6.8 million shares at $73 a piece.
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Gene Therapy Market Size Poised to Surge USD 52.40 Billion by 2033
4/18/2024
The global gene therapy market size was valued at USD 8.75 billion in 2023 and is poised to grow from USD 10.47 billion in 2024
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Voyager Therapeutics Announces Selection of Development Candidate for GBA1 Program in Collaboration with Neurocrine Biosciences, Triggering Milestone Payment
4/16/2024
Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to advancing neurogenetic medicines, today announced that the joint steering committee with its collaborator Neurocrine Biosciences has selected a lead development candidate in the GBA1 gene therapy program for the potential treatment of Parkinson’s disease and other GBA1-mediated diseases.
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Nxera Pharma Notes Successful Development Progress of Partnered Schizophrenia Candidate NBI-1117568
4/16/2024
Nxera Pharma Co., Ltd. has been notified by its partner Neurocrine Biosciences Inc. that NBI-1117568, an oral selective muscarinic M4 receptor agonist being advanced in Phase 2 clinical trials by Neurocrine for the treatment of schizophrenia and other neuropsychiatric disorders, has successfully completed a long-term preclinical toxicity program that meets US FDA requirements to allow for safe, chronic dosing in future clinical trials.
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Neurocrine Biosciences Announces Conference Call and Webcast of First Quarter 2024 Financial Results
4/10/2024
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that it has scheduled its first quarter 2024 financial results conference call and webcast for 5:00 a.m. Pacific Time (8:00 a.m. Eastern Time) on May 1, 2024.
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Neurocrine Biosciences Announces First-Patient Dosed in Phase 2 Clinical Study Evaluating NBI-1070770 in Adults with Major Depressive Disorder
4/3/2024
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that the first patient has been randomized for its Phase 2 clinical study to evaluate the efficacy, safety, and tolerability of investigational compound NBI-1070770 in adults with major depressive disorder.
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Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating Effects of NBI-1065890, a Second-Generation VMAT2 Inhibitor, in Healthy Adults
3/28/2024
Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced the initiation of its Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1065890 in healthy adult participants.
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Voyager Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - March 26, 2024
3/26/2024
Voyager Therapeutics, Inc. provides for the grant to Dr. Ferguson of a non-qualified stock option and restricted stock units as an inducement material to Dr. Ferguson’s entering into employment with Voyager.
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Voyager Therapeutics Announces Appointment of Toby Ferguson as Chief Medical Officer
3/13/2024
Voyager Therapeutics, Inc. today announced the appointment of Toby Ferguson, M.D., Ph.D., as Chief Medical Officer (CMO), effective March 25, 2024.
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Neurocrine Biosciences to Participate at Virtual Investor Conferences in March
3/11/2024
Neurocrine Biosciences, Inc. will participate at two upcoming virtual investor conferences in March.
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Xenon Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update
2/29/2024
Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a corporate update.
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Voyager Therapeutics Reports Fourth Quarter and Full Year 2023 Financial and Operating Results
2/28/2024
Voyager Therapeutics, Inc., a biotechnology company dedicated to advancing neurogenetic medicines, reported fourth quarter and full year 2023 financial and operating results.
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Neurocrine Biosciences to Participate at Investor Conferences in March 2024
2/27/2024
Neurocrine Biosciences, Inc. will participate at three upcoming investor conferences in March.
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Voyager Therapeutics Announces Selection of Gene Therapy Development Candidate for Friedreich’s Ataxia in Collaboration with Neurocrine Biosciences, Triggering Milestone Payment
2/26/2024
Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to advancing neurogenetic medicines, today announced that the joint steering committee with its collaborator Neurocrine Biosciences has selected a lead development candidate in the Friedreich’s ataxia (FA) program.
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Voyager Therapeutics Announces Fourth Quarter 2023 Conference Call and Webcast
2/21/2024
Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to advancing neurogenetic medicines, today announced it will report fourth quarter 2023 financial and operating results after market close on Wednesday, February 28, 2024.
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Voyager Therapeutics Reports Robust Preclinical Activity in Tau Silencing Gene Therapy Program for Alzheimer’s Disease and Advances Program into Late Research
2/20/2024
Voyager Therapeutics, Inc. announced new data from its two preclinical programs targeting pathological tau for the treatment of Alzheimer’s disease.