Zuranolone

iStock, RomoloTavani These deals radically reshaped the biopharma world, either by one vaccine rival absorbing another, a Big Pharma doubling down after another failed acquisition or, in the case of Pfizer and Novo, two heavyweights duking it out over a hot obesity biotech. 2025 proved to be a high-drama year for dealmaking as pharmas fought over companies, swallowed their rivals and found inspiration in other companies’ transactions. The biggest deal of the year—Johnson & Johnson’s $14.6 billion buy of Intra-Cellular all the way back in January—didn’t even make the list of what BioSpace editors consider the most influential M&A deals of the year. While the year won’t go down as the biggest in value by any means, some of these deals will have an indelible impact on the industry for years to come. Pharmas dealt in obesity, cancer, cell therapy, mental health and a slate of others, growing and expanding their businesses. These deals, such as Pfizer’s fight to get an up-and-coming obesity biotech, AbbVie doubling down on psychedelics for mental health conditions and the fall of gene therapy’s darling shook and reshaped the biopharma sector in 2025, setting up excitement for the year ahead. Read on for 2025’s seven most impactful biopharma M&A deals. 1. The Pfizer/Novo/Metsera Saga, Obviously There could only be one story in the top spot, and it was the epic bidding war between Pfizer and Novo Nordisk over obesity startup Metsera. To make a long story short: Pfizer tried and repeatedly failed to develop a competitive obesity pipeline in-house. After several flunks earlier in 2025, the company looked to its business development team. Pfizer made a $4.9 billion offer for Metsera in September, to gain access to a long-acting GLP-1 and a long-acting amylin analogue. The deal seemed to be on the way to closing, until Novo offered an unsolicited $8.5 billion bid for the company a month later. Facing a different set of problems as the obesity space’s early leader, Novo was looking to rebuild its pipeline as rival Eli Lilly seemingly scored one win after another. A series of counteroffers, legal threats and FTC scrutiny followed, with Pfizer finally winning out for a price of about $9.2 billion for Metsera. With the dust now settled, Pfizer is back in the obesity business. The size of the obesity market, according to a Reports and Data analysis, is set to hit $27 billion yearly by as soon as 2028 and $150 billion by the early 2030s. The fight over Metsera seemed to indicate that Big Pharmas are still willing to go big in the obesity market. On the other hand, analysts wondered: Was it worth it? Obesity Is Metsera Worth the Fuss? Pfizer and Novo Nordisk seem to want Metsera bad. Analysts are wondering, though: Is the obesity biotech really worth this much effort? November 5, 2025 · 4 min read · Annalee Armstrong 2. BMS Spends $1.5B for Orbital as Others Retreat From Cell Therapy Over the course of 2025, there was a massive pullback from cell therapy, with Takeda and Novo Nordisk abandoning billions in long-term investments. But Bristol Myers Squibb doubled down. The Big Pharma plunked down $1.5 billion to get Orbital Therapeutics, snagging OTX-201, a circular RNA therapy that induces a patient’s own cells to make anti-CD19 CAR type constructs. The therapy is being tested to treat B cell–driven autoimmune disorders. The Orbital deal deepens BMS’ roots in cell therapy, adding to its approved anti-BCMA therpay Abecma , for relapsed or refractory multiple myeloma, and the CD19-directed Breyanzi for blood cancers. But the buy also told the industry that there is still potential in cell therapy if you know where to look. 3. Novo Deepens MASH Stature With $5.2B Akero Buy Metabolic dysfunction–associated steatohepatitis—MASH—is suddenly one of the buzziest sectors in the pharma industry again. Novo Nordisk paid $5.2 billion to get Akero Therapeutics in October, adding efruxifermin, which reduced liver fibrosis by 24% in a Phase IIb study that read out earlier this year . It was such a good result that it pushed Roche to go hunting for an anti-MASH molecule, spurring that company’s purchase of 89bio for $3.5 billion in September. The Akero buy only deepened Novo Nordisk’s presence in the MASH space, as its multi-blockbuster GLP-1 Wegovy received approval for the liver condition in August . The Roche and Novo deals marked a turning point for the MASH space, which Big Pharma had largely abandoned years ago after numerous failures. The small biopharma Madrigal Pharmaceuticals finally broke through with the 2024 approval of Rezdiffra in MASH, reigniting interest in the space. Psychedelics Psychedelics Space Enters New Era as AbbVie Dives In With AbbVie’s $1.2 billion acquisition of Gilgamesh Pharmaceuticals’ lead depression drug, the psychedelic therapeutics space has soundly rebounded from Lykos’ rejection last year. There are now seven programs in Phase III trials across the sector, with multiple companies vying for that first approval. September 22, 2025 · 6 min read · Heather McKenzie 4. AbbVie Goes Back to the Mental Health Well With Gilgamesh Buy AbbVie paid $1.2 billion to get just one asset from neurotech biotech Gilgamesh Pharmaceuticals in August . That gave them an entree at a table that Big Pharma has nibble at for a while: psychedelics. AbbVie gained bretisilocin, a fast-acting analogue of dimethyltryptamine (DMT) for major depressive disorder (MDD). The rest of Gilgamesh’s pipeline spun out into a separate company, Gilgamesh Pharma Inc., which carries on an existing AbbVie partnership. The Gilgamesh buy suggested that AbbVie was undeterred after a $9 billion quagmire in the form of Cerevel . AbbVie paid the princely sum to get the company and its schizophrenia asset emraclidine in 2023, which went on to flunk Phase II trials one year later . The Gilgamesh deal helped galvanize interest in psychedelics. AbbVie’s investment came at a time when most neuropsych-focused pharmas “have kept a distance,” from psychedelics according to Aaron Bartlone, CEO of the Canadian mental health biotech Cybin. The only other Big Pharmas in the psychedelics space right now are Johnson & Johnson, with its ketamine derivative Spravato, and Japanese giant Otsuka. The latter paid $59 million in 2023 to absorb Mindset, a Canadian psychedelics biotech. 5. Bluebird—Ahem, Genetix—Goes Private Bluebird was the standard bearer of gene therapy, until it wasn’t. Private equity outfits The Carlyle Group and SK Capital bought the biotech, which at one time had been worth north of $10 billion, for a scant $50 million in February . It was a precipitous fall for bluebird, which had more than $1 billion in cash the first quarter of 2021. That number fell to just $118.7 million by the third quarter of 2023 . Gene therapy is facing a “ cold winter ,” as promising science has not translated to good business, with sky-high costs and infrastructure issues hobbling the sector. Still, Carlyle and SK have options for turning bluebird’s assets into profits—including just selling the three approved gene therapies off, as PitchBook Senior Biotech Analyst Kazi Helal suggested to BioSpace in July. Those assets are Lyfgenia for sickle cell disease, Skysona for cerebral adrenoleukodystrophy and Zynteglo for beta thalassemia. Bluebird’s sale was the biggest indicator of a growing trend: the entry of private equity into the biotechnology space. In the last few years, PE firms like BlackStone have launched life sciences–focused funds, put billions of dollars into backing new ventures and even funded individual professors’ research. Bluebird renamed itself to Genetix in September , shedding a unique biopharma name adopted in 2010 and returning to its original moniker. Deals Bluebird Go-Private Deal Signals the ‘PE-ization of Pharma’ Why did two private equity firms with more than $460 billion under management want a little old gene therapy biotech called bluebird bio? We wanted to know. July 2, 2025 · 7 min read · Annalee Armstrong 6. Once Hot Sage Fades Away in Supernus Buy In late November 2024, Sage’s lead asset dalzanemdor flunked a Phase II trial for Huntington’s disease, the third such fail for the drug. It was just the capstone of a series of setbacks for Sage over the last few years; another asset, SAGE-324, flunked a Phase II study for essential tremor and was discontinued, and its Biogen-partnered postpartum depression drug Zurzuvae failed to get FDA approval in major depressive disorder. Maryland-based Supernus stepped in and scooped up Sage for $795 million in June . It was a “good end” for the company, according to analysts, and represented a much larger buyout than one put forward by long-time partner Biogen in January. Biogen offered $469 million to fold in its partner in Zurzuvae in January 2025 . Sage declined the offer with extreme prejudice, going so far as to sue Biogen. Along with Zurzuvae, Supernus absorbed Sage’s other approved drugs: the ADHD medication Qelbree; Onapgo, a wearable device for treating motor fluctuations associated with Parkinson’s disease; and Gocovri, for treating dyskinesia in Parkinson’s. Stifel analysts, writing at the time of the Supernus buy, said that it “feels like an unremarkable outcome for a company that was once one of the hottest stories” in treating central nervous system disorders. 7. BioNTech Ends CureVac Rivalry With a Pot of Money In 2022, BioNTech said in a lawsuit that it faced “threats of a groundless patent infringement suit” from a company that was “unable to bring to market any product to help in the fight against COVID-19.” Three years later, BioNTech bought that company, CureVac, for $1.25 billion, ending a winding legal drama that was still ongoing at the time of the deal. That purchase gave BioNTech a new mRNA-based therapy for the tough brain cancer glioblastoma. Despite both companies gaining fame for working on vaccines, the deal was motivated mostly by interest in cancer. Getting access to CureVac’s pipeline of cancer immunotherapies “marks the next milestone in the execution of [BioNTech’s] oncology strategy,” the company said in announcing the deal. Despite regulatory headwinds prevailing against mRNA-based therapies and vaccines in the U.S.—like the federal government canceling hundreds of millions of dollars in research dollars aimed at projects using the technology—BioNTech’s bid to swallow up its rival is a signal that, even as the company diversifies into other modalities like bispecifics , mRNA-based therapies as a platform are here to stay. .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to BioPharm Executive! 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Postpartum depression (PPD) affects up to one in five Canadian women 1 ; it is the most common complication 2 related to childbearing and a leading cause of maternal death in Canada 3 Left untreated, PPD can have short- and long-term consequences on maternal health, child development and family well-being 4,5,6 ZURZUVAE is a 14-day, oral single course of treatment that offers relief from depressive symptoms as early as Day 3, a significant step forward from the current standards of PPD care TORONTO--(BUSINESS WIRE)--Biogen Canada Inc. today announced that Health Canada has issued a Notice of Compliance (NOC) for ZURZUVAE™ (zuranolone) for the treatment of moderate or severe postpartum depression (PPD) in adults following childbirth. ZURZUVAE is a once-daily, 14-day oral single course treatment for women with PPD. This first-of-its-kind treatment offers relief from depressive symptoms, with benefits seen in clinical studies as early as day 3, significant reduction of symptoms by the end of treatment at Day 15, and sustained effect through day 45 compared to placebo. ZURZUVAE offers a novel therapeutic approach due to its onset as early as Day 3 and a targeted mode of action that addresses mood dysregulation thought to be related to the significant hormone fluctuations after childbirth7,8. Unlike traditional antidepressants, which target serotonin pathways, ZURZUVAE modulates the activity of gamma-aminobutyric acid A (GABAA) receptors in the brain, whose signaling is involved in the regulation of mood7,8. By enhancing the activity of GABA, ZURZUVAE may help restore function in the dysregulated parts of the brain causing depressive symptoms.8,9 “A treatment developed specifically for postpartum depression marks an important step forward for maternal mental health,” said Dr. Crystal Clark, MD, MSc, Canada Research Chair in Reproductive Mental Health and Associate Head of Research, Department of Psychiatry, Women’s College Hospital. “Postpartum depression is often driven by profound hormonal shifts that occur during and after childbirth, and expanding treatment options with a therapy designed to address the impact of these biological changes on mental health addresses a longstanding gap in medical care. For postpartum individuals — who are caring for a newborn while managing major hormonal, physiological, and life transitions — ZURZUVAE offers a quick-acting, 14-day treatment, and new hope for reducing the debilitating burden of depression and improving family outcomes." PPD is a common, serious maternal mental health issue that starts during or after pregnancy.9 Symptoms may include depressed mood, anxiety, functional impairment of daily activities, feelings of guilt and worthlessness, doubts about motherhood, and thoughts of self- or infant harm.4 It can have debilitating short- and long-term impacts on both the mother and child. Left untreated, PPD can affect a mother and baby’s ability to bond, impacting the baby’s sleep, feeding, and long-term development, and is linked to a higher risk of anxiety and depression later in life.4 PPD also has a ripple effect on families and society with links to lower marital satisfaction, higher separation rates9, 10, as well as higher levels of stress, anxiety and depression in partners.4 “There are notable gaps across the country with respect to the diagnosis, treatment and care of post-partum depression, which can have a devastating impact on mothers and families,” said Claire Zlobin, Founder, Life With a Baby. “We must make maternal mental health a national priority and elevate the standards of care. Ignoring these issues costs Canada over an estimated $6 billion in healthcare, social services and lost productivity costs each year.11 We welcome the news of a new treatment option specifically developed for post-partum depression as an important step in supporting mothers and babies.” The approval of ZURZUVAE is based on the NEST clinical development program, which included the ROBIN and SKYLARK studies. Both studies met their primary endpoint, a significant mean reduction from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score, a common measure of depression severity, at Day 15 as compared to placebo. The SKYLARK study additionally showed statistically significant reduction in depressive symptoms seen as early as Day 3 and sustained through Day 45 compared to placebo. ZURZUVAE was generally well-tolerated with a consistent safety profile across both studies. The most frequently reported side effects ≥ 10% in ZURZUVAE (50mg) and > 2% than placebo were somnolence, dizziness, and sedation. “This approval addresses a critical unmet need for Canadian mothers, marking an important step in elevating how we treat what can be a devastating maternal health issue,” said Eric Tse, General Manager, Biogen Canada Inc. "To any mother experiencing postpartum depression, prompt symptom relief and return to more normal functioning is critical. For the first time, mothers will have access to effective treatment, specifically indicated for PPD. This innovation builds on Biogen’s proven history of pioneering first-in-class treatments for unmet medical needs, and we are working collaboratively with decision-makers across Canada to enable timely access to ZURZUVAE.” ZURZUVAE is available in the U.S. with coverage through most major insurers12. The U.S. Food and Drug Administration (FDA) approved ZURZUVAE in August 2023 and the Drug Enforcement Agency (DEA) scheduled it as a Class IV controlled substance in October 2023. ZURZUVAE received regulatory approvals in the U.K. by the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Commission in August and September 2025, respectively. About ZURZUVAE ™ (zuranolone) ZURZUVAE™ is a neuroactive steroid (NAS) that acts as a positive allosteric modulator of GABA-A receptors, enhancing inhibitory signalling in the brain. The GABA system is the major inhibitory signaling pathway of the central nervous system and contributes to regulating brain function. ZURZUVAE was discovered by Sage Therapeutics, Inc., and in 2020 Biogen and Sage Therapeutics entered into a collaboration to jointly develop and commercialize ZURZUVAE in the U.S. As part of the agreement, Biogen received exclusive rights to develop and commercialize ZURZUVAE outside of the U.S., excluding Japan, Taiwan and South Korea. In July 2025, Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) completed its acquisition of Sage Therapeutics and is now the collaboration partner with whom Biogen is working in the U.S. About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment, to deliver long-term growth. Biogen has been proudly serving Canadian patients for more than 25 years. For information about Biogen Canada, please visit www.biogen.ca. References: Vigod SN, Frey BN, Clark CT, Grigoriadis S, Barker LC, et al. Canadian Network for Mood and Anxiety Treatments 2024 clinical practice guideline for the management of perinatal mood, anxiety, and related disorders. Canadian Journal of Psychiatry. 2025. Available at: https://journals.sagepub.com/doi/full/10.1177/07067437241303031 . Centre for Addiction and Mental Health. Postpartum Depression: Clinical Overview. 2025. Available at: https://www.camh.ca/-/media/files/ppd_clinical_overview-pdf.pdf . Campbell, J., Cuthbert, C., Deave, T. et al. J. Women’s Health 30, 236–244 (2021) Moore Simas TA, Huang M-Y, Patton C, Reinhart M, Chawla AJ, Clemson C, Eldar-Lissai A. The humanistic burden of postpartum depression: a systematic literature review. Current Medical Research and Opinion. 2019;35(3):383-393. Available at: https://doi.org/10.1080/03007995.2018.1552039 . Rogers A, Holbrook K, et al. Association between maternal perinatal depression and anxiety and child and adolescent development: a meta-analysis. JAMA Pediatrics. 2020;174(11):1082-1092. Available at: https://jamanetwork.com/journals/jamapediatrics/fullarticle/2770120 . Goodman JH. Paternal postpartum depression, its relationship to maternal postpartum depression, and implications for family health. Journal of Advanced Nursing. 2004;45(1):26-35. Available at: https://onlinelibrary.wiley.com/doi/abs/10.1046/j.1365-2648.2003.02857.x. Maguire J. Neuroactive steroids and GABAergic involvement in the neuroendocrine dysfunction associated with major depressive disorder and postpartum depression. Frontiers in Cellular Neuroscience. 2019. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC6418819/ . Letourneau NL, Dennis CL, Benzies K, Duffett-Leger L, Stewart M, Tryphonopoulos PD, Este D, Watson W. Postpartum depression is a family affair: addressing the impact on mothers, fathers, and children. Issues in Mental Health Nursing. 2012;33(7):445-457. Available at: https://pubmed.ncbi.nlm.nih.gov/22757597/ . Kerstis B, et al. Association between parental depressive symptoms and impaired bonding with the infant. Archives of Women’s Mental Health. 2016;19(1):87-94. Available at: https://pubmed.ncbi.nlm.nih.gov/25854998/ . Canadian Perinatal Mental Health Collaborative. Time for action: Why Canada needs a national perinatal mental health strategy now more than ever. Ottawa, Canada: Canadian Perinatal Mental Health Collaborative; 2021. 48 p. Policy Center for Maternal Mental Health. One year later: How insurers are covering Zurzuvae, the first postpartum depression pill. 2024. Available at: https://policycentermmh.org/one-year-later-how-insurers-are-covering-zurzuvae-the-first-postpartum-depression-pill/ .