Neurocrine Biosciences, Inc.

SAN DIEGO, April 3, 2024 /PRNewswire/ -- 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. NBI-1070770 is a novel, selective, and orally active, negative allosteric modulator (NAM) of the NR2B subunit-containing N-methyl-D-aspartate (NMDA NR2B) receptor. "Based upon our Phase 1 first-in-human study, we are excited to bring this novel oral compound, which acts through a clinically validated mechanism of action, into clinical development as a potential treatment for major depressive disorder," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "The selectivity of NBI-1070770 for the NMDA NR2B receptor has the potential to benefit patients who have moderate to severe depression." The NBI-1070770 Phase 2 multi-center, randomized, double-blind, placebo-controlled study will enroll approximately 72 adults and is being conducted at centers throughout the United States. The study will evaluate the safety and efficacy of NBI-1070770 in subjects with major depressive disorder compared to placebo on improving symptoms of depression as measured by the Montgomery-Åsberg Depression Rating Scale. For more information about the Phase 2 study (NBI-1070770-MDD2029), visit Clinicaltrials.gov. Neurocrine Biosciences acquired the rights to develop and commercialize NBI-1070770 from Takeda Pharmaceutical Company, Ltd. About Neurocrine Biosciences Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (formerly Twitter), and Facebook. (*in collaboration with AbbVie) NEUROCRINE BIOSCIENCES, NEUROCRINE, and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. The Neurocrine logo is a trademark of Neurocrine Biosciences, Inc. Forward-Looking Statement 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 the potential benefits of NBI-1070770. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, 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; our future financial and operating performance; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and 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 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; risks associated with U.S. federal or state legislative or regulatory and/or policy efforts which may result in, among other things, an adverse impact on our revenues or potential revenue; risks associated with potential generic entrants for our products; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's annual report on Form 10-K for the year ended December 31, 2023. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. SOURCE Neurocrine Biosciences, Inc.

SAN DIEGO, March 28, 2024 /PRNewswire/ -- 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. NBI-1065890 is an investigational, oral, selective inhibitor of the vesicular monoamine transporter-2 (VMAT2) for the potential treatment of certain neurological and neuropsychiatric conditions. "Neurocrine has deep scientific expertise and experience in VMAT2 inhibition, exemplified by the successful discovery and development of valbenazine for the treatment of tardive dyskinesia and chorea in Huntington's disease," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "We're excited to bring this next-generation, internally discovered, highly potent, oral, selective VMAT2 inhibitor into the clinic with the hope of providing differentiated benefit in treating certain neurological and neuropsychiatric conditions." VMAT2 small molecule inhibitors have been clinically validated as effective treatments for hyperkinetic movement disorders, playing an important role in presynaptic dopamine storage and release. Neurocrine successfully developed and received U.S. Food and Drug Administration approval in 2017 for valbenazine, a selective VMAT2 inhibitor, for use as the first drug ever developed for the treatment of tardive dyskinesia. In 2023, the company received FDA approval for valbenazine as a treatment for chorea associated with Huntington's disease. About Neurocrine Biosciences Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (formerly Twitter), and Facebook. (*in collaboration with AbbVie) NEUROCRINE BIOSCIENCES, NEUROCRINE, and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. The Neurocrine logo is a trademark of Neurocrine Biosciences, Inc. Forward-Looking Statement 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 the potential benefits of NBI-1065890. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, 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; our future financial and operating performance; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and 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 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; risks associated with U.S. federal or state legislative or regulatory and/or policy efforts which may result in, among other things, an adverse impact on our revenues or potential revenue; risks associated with potential generic entrants for our products; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's annual report on Form 10-K for the year ended December 31, 2023. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than required by law. Company Codes: NASDAQ-NMS:NBIX

LEXINGTON, Mass., March 26, 2024 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to advancing neurogenetic medicines, has entered into an employment agreement with Toby Ferguson, M.D., Ph.D. that, among other things, 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. The inducement awards were approved by the Compensation Committee of Voyager’s Board of Directors in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4). The option award became effective on March 25, 2024, and the restricted stock unit award is scheduled to become effective on April 1, 2024. The stock option award to Dr. Ferguson provides for the purchase of an aggregate of 210,000 shares of Voyager’s common stock, and the restricted stock unit award to Dr. Ferguson will represent 105,000 shares of Voyager’s common stock. The stock option has a ten-year term and an exercise price of $9.26 per share, which is equal to the closing price of Voyager's common stock on March 25, 2024, the effective date of grant. The stock option vests over four years, with 25% of the shares underlying the stock option vesting on the first anniversary of the effective date of grant and 75% of the shares underlying the stock option vesting in 36 equal monthly installments following the first anniversary of the effective date of grant. The restricted stock unit award vests annually in equal installments over three years, beginning on the first anniversary of the effective date of grant. Vesting of Dr. Ferguson’s equity awards is subject to Dr. Ferguson’s continued employment with Voyager. Each equity award is also subject to the terms and conditions of an award agreement. About Voyager TherapeuticsVoyager Therapeutics, Inc. (Nasdaq: VYGR) is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of – and ultimately cure – neurological diseases. Our pipeline includes programs for Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and multiple other diseases of the central nervous system. Many of our programs are derived from our TRACER™ AAV capsid discovery platform, which we have used to generate novel capsids and identify associated receptors to potentially enable high brain penetration with genetic medicines following intravenous dosing. Some of our programs are wholly owned, and some are advancing with partners including Alexion, AstraZeneca Rare Disease; Novartis Pharma AG; Neurocrine Biosciences, Inc.; and Sangamo Therapeutics, Inc. For more information, visit www.voyagertherapeutics.com. Voyager Therapeutics® is a registered trademark, and TRACER™ is a trademark, of Voyager Therapeutics, Inc. ContactsTrista Morrison, NACD.DC, tmorrison@vygr.com Investors: Adam Bero, Ph.D., abero@kendallir.com Media: Brooke Shenkin, brooke@scientpr.com