Uterine Fibroids

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.

While big pharmas regularly undergo turnover, this quarter’s layoff list has a particularly large pharma presence. The biotech industry has been holding its breath, hoping that 2024 would bring some reprieve from 2023’s brutal bear market. But market recovery is a slow process, and the number of layoffs reported this quarter reflects that sentiment, with 57 layoff rounds reported for the first three months—the exact number reported during the same period last year.    Both these totals are nearly double 2022’s first quarter total of 30 layoff rounds reported.  https://public.flourish.studio/visualisation/17346360/ While it's hard to fully understand the human impact of the layoffs, at least 2,398 people lost their jobs from the 25 companies reporting numbers of employees affected this quarter, according to data from the Fierce Biotech Layoff Tracker. The remaining companies either reported layoffs as a percentage of the total workforce or didn’t share how many staff members would be laid off. Of the 31 times that companies did provide a percentage of staff eliminated, 34% was the mean reduction size.   Breaking up the reported layoffs by month, January saw the highest number of workforce reductions, totaling 24 different rounds compared to 16 in February and 17 in March.    https://public.flourish.studio/visualisation/17331518/ Many of the biotechs laying off staff cited the current market environment, with Sumitomo Pharma dubbing the conditions a “severe business environment.” Other cuts follow clinical trial flops, such as Synlogic’s 90% workforce cull and planned closure after a pivotal phase 3 study of its lead phenylketonuria drug was found to be unlikely to succeed on the primary endpoint.   A few other biotechs had to close shop entirely. In late February, Swiss company ObsEva said all employees would be laid off as operations were wound down. Things had been grim for the biotech since July 2022, when its stock plummeted after the FDA said its highly touted uterine fibroid candidate linzagolix wasn’t fit for an on-time approval. Meanwhile, China-based LianBio set out plans for a prolonged dissolution expected closer to 2027, with half of the biotech’s staff to lose their jobs by the end of March.  https://public.flourish.studio/visualisation/17330903/ While Big Pharmas regularly undergo turnover, this quarter’s layoff list has a particularly large presence from these larger companies. Names like Bayer, Bristol Myers Squibb, GSK, Takeda, Moderna, Johnson & Johnson, Roche and Pfizer all appear on 2024’s tracker—often more than once. Companies like Pfizer, Moderna and J&J have been forced to pivot after previously investing heavily in COVID-19, for which demand has greatly declined over the past year. Pfizer’s global cost-cutting campaign has left hundreds of unemployed people in its wake, while J&J shuttered a nearly 200,000-square-foot R&D outpost in California less than 18 months after it opened. https://public.flourish.studio/visualisation/17331305/ Other Big Pharmas have stoked the fires of the M&A market, snapping up biotechs and their pipelines, but often discarding the majority of the company’s team.       This phenomenon can be seen as recently as March 26, when Bristol Myers Squibb announced that 252 Mirati workers would be heading out two months after closing a multibillion-dollar acquisition of the oncology biotech. Just days before, on March 22, GSK confirmed that an undisclosed number of Bellus Health employees would lose their jobs after the pharma paid $2 billion to buy the Canadian company last summer. https://public.flourish.studio/visualisation/17331425/ This extends beyond just Big Pharma acquisitions, too. Last week, clinical-stage Avalo Therapeutics agreed to pay $22 million to acquire AlmataBio and the biotech's anti-IL-1β monoclonal antibody AVTX-009. None of Almata's workers will be retained under the new owner.   Meanwhile, biotechs like Aurinia Pharmaceuticals have searched for a buyer, but, after failing to secure one, reach the same conclusion—layoffs are required to survive.   The data presented here is likely a gross underestimate of the actual layoffs occurring across the industry. We’ve received several layoff tips that haven’t yet been corroborated while numerous reductions in force at private companies are able to fly under the radar. As always, if you know of a layoff occurring at a biotech, please reach out to the Fierce Biotech editorial team and let us know.

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