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Sage Therapeutics宣布战略重组,优先考虑ZURZUVAE®的商业化,并专注于其开发组合

Sage Therapeutics Announces Strategic Reorganization to Prioritize ZURZUVAE ® Commercialization and Focus its Development Portfolio

businesswire 等信源发布 2024-10-17 17:00

可切换为仅中文


CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sage Therapeutics, Inc. (Nasdaq: SAGE), today announced a strategic reorganization of its business operations to support the ongoing launch of ZURZUVAE in postpartum depression and focus pipeline development efforts ahead of a clinical study readout for dalzanemdor in Huntington’s Disease expected later this year.

马萨诸塞州剑桥市。-(商业新闻短讯)--Sage Therapeutics,Inc.(纳斯达克代码:Sage)今天宣布对其业务运营进行战略性重组,以支持正在进行的产后抑郁症ZURZUVAE的推出,并在预计今年晚些时候进行的亨廷顿舞蹈病dalzanemdor临床研究读数之前关注管道开发工作。

The reorganization is intended to enable Sage to strengthen its balance sheet, extend cash runway, and position the company for long-term growth potential..

此次重组旨在使Sage能够加强其资产负债表,延长现金流,并为公司的长期增长潜力定位。。

The reorganization is planned to be substantially completed by the end of the 4th quarter of 2024 and expected to:

重组计划在2024年第四季度末基本完成,预计将:

Impact over 165 employees (approximately 33% of the company’s total workforce and approximately 55% of the company’s R&D workforce), including changes to the leadership team

影响超过165名员工(约占公司总劳动力的33%,约占公司研发劳动力的55%),包括领导团队的变化

Implement early-stage pipeline prioritization

实施早期管道优先级排序

“We are being deliberate and purposeful in our efforts to reorganize the company with the goal of having the flexibility to execute immediate priorities and build for long term growth and value creation. This is difficult but necessary and we believe it will right-size Sage for future growth potential.

“我们正在审慎而有目的地重组公司,目标是能够灵活地执行眼前的优先事项,并为长期增长和价值创造奠定基础。这很困难但也是必要的,我们相信这将正确衡量Sage未来的增长潜力。

This move allows for continued focused investment in the ongoing launch of ZURZUVAE for women with postpartum depression and development of our prioritized portfolio,” said Barry Greene, Chief Executive Officer at Sage Therapeutics. “I want to extend my deepest gratitude to our departing employees for their significant contributions to our work and their dedication to making a difference for patients.”.

Sage Therapeutics首席执行官巴里·格林(BarryGreene)表示:“这一举措允许继续集中投资,为产后抑郁症女性推出ZURZUVAE,并开发我们的优先投资组合。”。“我要向即将离职的员工表示最深切的感谢,感谢他们为我们的工作做出了重大贡献,并致力于为患者带来改变。”。

The changes to Sage’s leadership team include:

Sage领导团队的变化包括:

Anne Marie Cook, Senior Vice President, General Counsel; Kimi Iguchi, Chief Financial Officer; Matt Lasmanis, Chief Technology and Innovation Officer; Heinrich Schlieker, Ph.D., Senior Vice President of Technical Operations; and Amy Schacterle, Ph.D., Senior Vice President of R&D Strategy and Business Management will depart Sage..

;首席财务官Kimi Iguchi;首席技术和创新官Matt Lasmanis;Heinrich Schlieker博士,技术运营高级副总裁;研发战略和商业管理高级副总裁艾米·沙克特尔博士将离开Sage。。

Chris Benecchi will take on an expanded role as Chief Operating Officer and will oversee Finance, Information Technology, and Technical Operations in addition to continuing to oversee Business Development, Medical Affairs and Commercial.

Greg Shiferman will be promoted to Senior Vice President, General Counsel.

格雷格·希弗曼(GregShiferman)将晋升为高级副总裁兼总法律顾问。

Vanessa Procter will take on an expanded role as Senior Vice President of Corporate Affairs and will oversee Investor Relations in addition to Corporate Communications, Government Affairs and Patient Advocacy.

瓦妮莎·普罗克特(VanessaProcter)将担任公司事务高级副总裁,除负责公司沟通、政府事务和患者宣传外,还将负责监督投资者关系。

Sage expects a non-recurring charge of approximately $26 million to $28 million associated with the reorganization, primarily incurred in the fourth quarter of 2024. The company anticipates that the implementation of the restructuring will extend its cash runway and expects to provide updated cash runway guidance in the near future..

Sage预计,与重组相关的非经常性费用约为2600万至2800万美元,主要发生在2024年第四季度。该公司预计重组的实施将延长其现金跑道,并预计在不久的将来提供最新的现金跑道指导。。

SELECT IMPORTANT SAFETY INFORMATION FOR ZURZUVAE:

为ZURZUVAE选择重要的安全信息:

ZURZUVAE (zuranolone) CIV, is a neuroactive steroid gamma-aminobutyric acid A (GABAA) receptor positive modulator indicated for the treatment of postpartum depression in adults.

ZURZUVAE(zuranolone)CIV是一种神经活性类固醇γ-氨基丁酸a(GABAA)受体阳性调节剂,用于治疗成人产后抑郁症。

This does not include all the information needed to use ZURZUVAE safely and effectively. See full prescribing information for ZURZUVAE.

这并不包括安全有效地使用ZURZUVAE所需的所有信息。请参阅ZURZUVAE的完整处方信息。

ZURZUVAE may cause serious side effects. The most common side effects of ZURZUVAE include sleepiness or drowsiness, dizziness, common cold, diarrhea, feeling tired, weak, or having no energy, and urinary tract infection. ZURZUVAE may decrease your awareness and alertness, which can affect your ability to drive safely or safely do other dangerous activities.

ZURZUVAE可能会引起严重的副作用。ZURZUVAE最常见的副作用包括嗜睡或嗜睡,头晕,感冒,腹泻,感到疲倦,虚弱或没有活力,以及尿路感染。ZURZUVAE可能会降低您的意识和警觉性,从而影响您安全驾驶或安全进行其他危险活动的能力。

Do not drive, operate machinery, or do other dangerous activities until at least 12 hours after taking each dose during your 14-day treatment course of ZURZUVAE. You may not be able to tell on your own if you can drive safely or tell how much ZURZUVAE is affecting you. ZURZUVAE may cause sleepiness, drowsiness, slow thinking, dizziness, confusion, and trouble walking.

在为期14天的ZURZUVAE治疗过程中,服用每剂药物至少12小时后,才能驾驶、操作机器或进行其他危险活动。你可能无法自己判断自己是否能安全驾驶,也无法判断祖尔祖瓦(ZURZUVAE)对你的影响有多大。ZURZUVAE可能会导致困倦、嗜睡、思维迟缓、头晕、困惑和行走困难。

Because of these symptoms, you may be at a higher risk for falls during treatment with ZURZUVAE. Taking alcohol, other medicines that cause CNS depressant effects, or opioids while taking ZURZUVAE can make these symptoms worse and may also cause trouble breathing. Tell your healthcare provider if you develop any of these symptoms, or if they get worse during treatment with ZURZUVAE.

由于这些症状,在使用ZURZUVAE治疗期间,您可能会有更高的跌倒风险。服用ZURZUVAE时服用酒精、其他引起中枢神经系统抑制作用的药物或阿片类药物会使这些症状恶化,也可能导致呼吸困难。告诉你的医疗保健提供者,如果你出现任何这些症状,或者在使用ZURZUVAE治疗期间症状恶化。

Your healthcare provider may decrease your dose or stop ZURZUVAE treatment if you develop these symptoms. ZURZUVAE is a federal controlled substance (C-IV) because it contains zuranolone, which can be abused or lead to dependence. Tell your healthcare provider right away if you become pregnant or plan to become pregnant during treatment with ZURZUVAE.

如果您出现这些症状,您的医疗保健提供者可能会减少您的剂量或停止ZURZUVAE治疗。ZURZUVAE是一种联邦管制物质(C-IV),因为它含有zuranolone,可被滥用或导致依赖。。

You should use effective birth control (contraception) during treatment with ZURZUVAE and for 1 week after the final dose. ZURZUVAE and other antidepressant medicines may increase the risk of suicidal thoughts and actions in people 24 years of age and younger. ZURZUVAE is not for use in children..

在使用ZURZUVAE治疗期间以及服用最终剂量后1周内,您应该使用有效的节育(避孕)。ZURZUVAE和其他抗抑郁药物可能会增加24岁及以下人群自杀念头和行为的风险。ZURZUVAE不适用于儿童。。

About Sage Therapeutics

关于Sage Therapeutics

Sage Therapeutics (Nasdaq: SAGE) is a biopharmaceutical company committed to our mission of pioneering solutions to deliver life-changing brain health medicines, so every person can thrive. Sage developed the only two FDA-approved treatments indicated for postpartum depression and is advancing a robust pipeline to target unmet needs in brain health.

Sage Therapeutics(纳斯达克股票代码:Sage)是一家生物制药公司,致力于提供改变生命的大脑健康药物的开创性解决方案,使每个人都能茁壮成长。Sage开发了仅有的两种FDA批准的产后抑郁症治疗方法,并正在推进一条强大的管道,以满足大脑健康方面未满足的需求。

Sage was founded in 2010 and is headquartered in Cambridge, Mass..

Sage成立于2010年,总部位于马萨诸塞州剑桥。。

Find out more at www.sagerx.com or engage with us on Facebook, LinkedIn, Instagram, and X.

请访问www.sagerx.com了解更多信息,或在Facebook、LinkedIn、Instagram和X上与我们联系。

Sage Forward-Looking Statements

Sage前瞻性声明

Various statements in this release concern Sage's future expectations, plans and prospects, including without limitation our statements regarding: the amount and timing of the expected non-recurring charge associated with the reorganization; our expectation that the reorganization will strengthen our balance sheet and extend our cash runway; the number of employees expected to be impacted by the reorganization; our belief that the reorganization will right-size the organization for future growth potential; our goal to position the company for long-term growth and value creation and the potential to achieve that goal; our plans to implement our early-stage pipeline prioritization; the expected timing of readout of the DIMENSION Study of dalzanemdor in Huntington’s Disease; the potential for ongoing success in the launch of ZURZUVAE in the treatment of women with PPD; and the mission and goals for our business.

本版本中的各种声明涉及Sage的未来预期、计划和前景,包括但不限于我们关于以下方面的声明:与重组相关的预期非经常性费用的金额和时间;我们预计重组将加强我们的资产负债表,延长我们的现金流;预计受重组影响的员工人数;我们相信,重组将正确调整组织规模,以满足未来的增长潜力;我们的目标是定位公司的长期增长和价值创造以及实现该目标的潜力;我们实施早期管道优先顺序的计划;达尔扎内姆多在亨廷顿舞蹈病中的维度研究的预期读出时间;启动ZURZUVAE治疗PPD女性的持续成功潜力;。

These statements constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: we may incur additional charges or expenses associated with the reorganization; we may not realize cost savings from the reorganization at the levels we expect, and as a result, the reorganization may not strengthen our balance sheet or enable us to extend our cash runway; the internal and external costs required for our ongoing, planned and other future activities, and the resulting impact on expense and use .

。这些前瞻性声明既不是对未来业绩的承诺,也不是对未来业绩的保证,并且受到各种风险和不确定性的影响,其中许多风险和不确定性超出了我们的控制范围,这可能导致实际结果与这些前瞻性声明中预期的结果产生重大差异,包括以下风险:我们可能会产生与重组相关的额外费用或支出;我们可能无法从重组中实现预期水平的成本节约,因此,重组可能不会加强我们的资产负债表或使我们能够延长我们的现金跑道;我们正在进行的、计划的和其他未来活动所需的内部和外部成本,以及由此产生的对费用和使用的影响。