Dalzanemdor

iStock, wassam siddique After the FDA rejection of Zurzuvae in one type of depression and the triple failure of neuro asset dalzanemdor, Sage was searching for a path forward at the end of December 2024. Biogen CEO Chris Viehbacher spied a possible deal, but the smaller company wasn’t interested. After the FDA rejected one out of two indications for the depression drug Zurzuvae in the summer of 2023, Sage Therapeutics embarked on a whirlwind tour of the biotech fundraising universe to find a partner or other transaction to keep afloat. According to regulatory documents posted Wednesday, that meant meeting with 43 different parties throughout 2024 and into 2025. We now know that the result of that tour was the up to $795 million acquisition by Supernus Pharma , inked last month. The focus of the deal was Zurzuvae, which received an FDA nod for post-partum depression in August 2023, but missed out on the larger indication of major depressive disorder which would have opened up a much wider market. Sage had long been partnered with Biogen on the drug. The regulatory documents show how the Sage-Biogen relationship broke down after Zurzuvae’s mixed approval. Thanks But No Thanks After the FDA rejection, and the triple failure of leading pipeline candidate dalzanemdor, Sage was left searching for a path forward at the end of December 2024. The board was pursuing a royalty financing with an unnamed party, which would have provided as much as $200 million in capital. During a regularly scheduled meeting to discuss Zurzuvae commercialization efforts that month, Biogen CEO Chris Viehbacher raised the possibility of an acquisition with Sage CEO Barry Greene. At a board meeting later that month, Sage’s executives determined that a royalty transaction was prudent. But to do so, they would need Biogen’s cooperation. Days later, Viehbacher returned with a more concrete offer to acquire Sage at the current stock price plus a 30% premium. Greene declined the offer. In early January, the royalty transaction was advancing. Viehbacher reached out again, this time warning Greene that Biogen was about to put in an unsolicited offer to buy his company. Greene indicated that he believed public disclosure of this intention would violate the companies’ standstill provision from Biogen’s original stock purchase agreement. Viehbacher stood his ground. The offer was coming. On January 10, Biogen publicly offered to buy Sage for $7.22 per share, which was a 30% premium to the stock price that day of $5.55. The deal valued Sage at about $470 million. Sage acknowledged the offer in a press release. Sage formally filed a lawsuit against Biogen on January 16, arguing that the public disclosure was a violation of their standstill agreement . The board nevertheless agreed to consider Biogen’s offer. Greene and his deputies headed into the J.P. Morgan Healthcare Conference a few days later to meet with investors. Many encouraged them to accept the Biogen offer but push for more. Others suggested that Sage should seek to reacquire the rights to Zurzuvae, which had long been a hope of the Sage team. On January 27, Sage announced a plan to explore strategic alternatives , including consideration of a sale or other transaction. The board also at that time formally rejected Biogen’s offer. Meetings with potential buyers followed, including Supernus, who had long been in touch with Sage about a potential partnership or acquisition. During this period, shareholders put pressure on Sage’s management to do something to stop the cash burn and enter into some sort of deal—and quickly. They suggested that Sage drop its R&D pipeline, among other options. A court in late January sided with Sage in the standstill litigation, preventing Biogen from issuing any further public offers. They later settled the litigation. Greene and Viehbacher met again in February for their regularly scheduled meeting, during which Viehbacher indicated that Biogen would not put forward another bid. In the months that followed, Sage’s board and executives met with multiple parties and considered myriad partnering solutions. They considered chopping up the company and spinning out the pipeline; handing Zurzuvae rights to Biogen; selling the entire company and more. Supernus was one of the leading companies in the discussions and ultimately won out on June 13 with an offer of $8.50 per share in cash, or $561 million, at closing. A contingent value right put up another $3.50 per share, or $234 million, payable upon certain sales and commercial milestones. The deal was valued at up to $12 per share in cash or $795 million. Analysts that day called the Supernus acquisition a “good end” for Sage, but an “unremarkable outcome” for an entity that was once one of the most exciting companies working on central nervous system disorders. While management had been maneuvering in private for more than two years, staff at Sage had a more abrupt end; last week, all 338 remaining workers were sent out the door .

2025年6月16日，Supernus Pharmaceuticals和Sage Therapeutics宣布达成最终协议，Supernus将以每股8.50 美元的现金支付（总计约 5.61 亿美元）收购Sage的所有已发行股份。此外，Sage股东还将获得一份不可交易的或有价值权 (CVR)，该权利在达到某些特定的销售和商业里程碑时，每股可额外支付高达 3.50 美元（总计约 2.34 亿美元）。因此本次交易的潜在总对价最高可达每股 12.00 美元，总额约 7.95 亿美元。相较与“合作伙伴”Biogen给出以不足5亿美元“抄底”价格，Supernus这次绝对算得上诚意满满。该交易预计将于2025年第三季度完成。所有现金对价将通过现有资产负债表现金提供资金。此次收购为Supernus带来了重磅产品：URZUVAE® (zuranolone) 胶囊 CIV。这是美国FDA批准的首个也是唯一一个用于治疗产后抑郁症 (PPD) 成人的口服药物。临床数据显示：产后抑郁症患者在使用Zuranolone的第3天就显示出抑郁症状的改善，并持续至45天，显著满足了患者对“快速起效”药物的迫切需求。2024年全年和2025年第一季度，ZURZUVAE的净销售合作收入分别为3610万美元和1380万美元，Supernus对其未来的增长前景充满信心。值得注意的是，FDA批准该药物治疗PPD的同时，却拒绝了针对重度抑郁症（MDD）治疗的上市申请。此次收购协议中包含一项关键里程碑条款：在2026年6月30日之前，ZURZUVAE在日本治疗重度抑郁症（MDD）的监管批准后，在日本向第三方客户出售。未来该药物是否能在MDD人群中取得显著临床证据，进而拓展更大市场，药时代会持续关注。Sage在研临床管线 来源：Sage官网除了ZURZUVAE外，此次收购还将增强Supernus在中枢神经系统（CNS）领域的研发平台与专业能力，并且与Supernus现有基础设施高度契合，预计将带来每年高达2亿美元的成本协同效益。公司预计该交易将在2026年显著增厚其收益。Biogen欲“抄底”Sage，价格没谈拢反被告回顾今年初，Sage的收购传闻主角原本是其合作伙伴Biogen，药时代曾对此进行报导。推荐阅读：4.42亿美元！Biogen“抄底”Sage早在2020年，Biogen便以约6.5亿美元投资Sage，获得其10%股权。此外Biogen还取得了Zuranolone在全球（除日本、韩国及中国台湾地区）的独家合作开发权。双方在美国市场按1:1比例共担成本并共享利润，而Biogen独立负责美国以外市场的开发与商业化。Biogen对Sage的收购之心或许能理解为股东对于公司代理权的争夺战。2025年1月，Biogen以不足5亿美元的价格向sage提出收购要约。当时sage发布声明表示，“董事会将在咨询独立财务和法律顾问后，仔细审查和评估该提案，以确定符合公司及所有股东最佳利益的行动方案。”董事会很快谈妥，一周后将向特拉华州法院对Biogen提起诉讼，要求法院颁布禁令，阻止交易达成。如今看来就是五个字“价格没谈拢”，Sage认为Biogen的报价太低了。虽然Biogen的报价相比前收盘价溢价30%。但实际上，经历2024年底的重大重组后，Sage的财务状况比较稳健。截至2024年三季度末，公司账上总现金达5.69亿美元，提出7000万美元左右的负债后，净现金也达到4.99亿美元。这意味着，如果完成收购，渤健不仅能获得Zurzuvae全部权益，还能得到约5亿美元的净现金。这样算，Biogen的收购意图在财务方面确实太聪明，反误了收购大计。Sage临床接连失败，暴跌近75%Sage能引来多家公司的关注，也怨其时运不济，临床接连失败，但自身又有商业化的强劲产品，此时被收购还有选择谈判的机会。2024年，Sage多次宣布主要资产Dalzanemdor（SAGE-718）临床失败，严重打击了投资者信心。4月，Sage宣布Dalzanemdor在用于治疗帕金森病相关认知障碍的II期试验中，未达主要终点；10月，Sage再公布Dalzanemdor在用于治疗阿尔茨海默病的II期试验中未达主要终点；11月，Sage第三次宣布Dalzanemdor临床失败，在用于治疗亨廷顿病（HD）的II期试验中，未达主要终点；2024年的三次失败后，Sage最终宣布终止该药物开发。屋漏连夜偏逢雨。2024年7月24日，Sage/Biogen宣布双方合作开发的SAGE-324治疗ET（特发性震颤）的临床2期试验KINETIC2研究失败。基于已有的临床结果，Sage/Biogen放弃了SAGE-324在ET适应症方面的探索。目前Sage只有两款商业化产品，一款是Brexanolone，另一款就是Zurzuvae。两者均是治疗产后抑郁症（PPD）的产品，而后者是前者的迭代产品。由于brexanolone给药方式不便、治疗费用高昂、且存在过度镇静和意识丧失的风险，如今已成为“时代的眼泪”，Sage已于2024年12月31日终止了Brexanolone的在美销售。结语面对接连的临床失败与产品销售的终止，Sage在2024年遭遇重创，股价全年累计下跌近75%。2025年初Sage被Biogen看中，又花落Supernus，在这场收购博弈中坚持了五个月，Sage成功将收购价提升了近3亿美元。至此Sage波折起伏发的研发路画下终点。而对于Supernus来说，这或许是一次改变格局的战略布局。未来ZURZUVAE能否在更大的精神疾病市场中打开局面，将成为这场交易成败的关键。在收并购交易中，最具争议的问题之一就是估值。实际上，没有任何方法能够提供一个正确的价值。只有在资产实现时，价值才能被准确衡量。在“现金为王”的当下，选择高价出售以实现股东价值的最大化，才是“上上策”。参考资料：1.https://www.biospace.com/business/sages-story-comes-to-good-end-with-up-to-795m-acquisition-by-supurnushttps://cn.innoventbio.com/2.https://www.sagerx.com/programs-research/pipeline3.其他公开资料图片来源：豆包AI单国洪卸任武田中国总裁，加入百济神州2025-06-17重磅！创新药大利好！临床试验60日默示许可缩短为30日！2025-06-16GCG“燃脂”独特机制直击肥胖核心：脂肪过剩2025-06-15版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢!药时代官方网站:www.drugtimes.cn联系方式:电话:13651980212微信:27674131邮箱:contact@drugtimes.cn点击这里，查看更多精彩！