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Biogen and Sage Therapeutics are discontinuing further development of their drug Zurzuvae as a potential treatment for major depressive disorder, a move that follows last year’s FDA rejection of the therapy in that indication. The regulator had asked the companies to provide more evidence of efficacy from additional clinical testing. In its report of third quarter 2024 financial results posted Wednesday, Biogen said the discontinuation decision is based on the “significant new investment and time we expect would be needed to conduct additional studies.” Going forward, the two Cambridge, Massachusetts-based companies plan to focus their efforts on commercializing this drug in postpartum depression, for which it was approved last year. But postpartum depression is a much smaller market than major depressive disorder, which means Zurzuvae is unlikely to achieve the lofty sales once expected for the pill. With the renewed focus on Zurzuvae for postpartum depression, Sage will discontinue Zulresso, a product that in 2019 became the first FDA-approved postpartum depression drug. Zulresso is administered as a 60-hour infusion, a challenging dosing regimen that has limited market uptake of this Sage drug. By contrast, Zurzuvae is a pill taken once daily for 14 days. For the nine months ended Sept. 30, Sage reported Zulresso accounted for $3.1 million in revenue, down 63% compared to the same period in 2023. Sage said Zulresso will be commercially available until Dec. 31. Sponsored Post The Future of Hospitals and Pharma Companies Will Depend on Strength of Healthcare Analytics Insights PurpleLab® stands out from others in this sector by providing its data analytics services to several different groups of users across healthcare and pharma companies. By Stephanie Baum The collaboration between Biogen and Sage dates to 2020. Biogen committed $1.5 billion up front to begin the R&D alliance focused on depression and movement disorders. Results have been disappointing. Besides Zurzuvae’s rejection in major depressive disorder, collaboration on the movement disorders program SAGE-324 is ending. In July, the companies reported this oral drug failed a Phase 2 test in essential tremor. Biogen gave Sage a termination notice for SAGE-324 last month. When the termination becomes effective in February, Sage will become fully responsible for the program. In its quarterly report, Sage said it plans to evaluate other potential indications for this drug. In a note sent to investors, Leerink Partners analyst Marc Goodman said the discontinuation of further development of Zurzuvae in major depressive disorder was expected. While Leerink projects the drug could achieve $200 million to $300 million in peak sales in postpartum depression, physicians have told the firm they’re skeptical of a paradigm shift in treatment and the black box warning on the product’s label could further limit use. Sage does have other programs in the pipeline, but the company will have fewer workers to support them. In its quarterly report, the company said it will commence a business restructuring to strengthen its balance sheet and focus on the ongoing launch of Zurzuvae for postpartum depression. Sage said it will shed about 33% of its workforce. With the restructuring, the company said it expects to have enough capital to support operations into 2026.

It’s official: Sage and Biogen will not attempt to get their postpartum depression pill Zurzuvae approved in the broader population of people with major depressive disorder. Sage, which has recently gone through waves of layoffs and scientific setbacks, cited the cost of running and recruiting additional trials for MDD as the reason, and said it would focus solely on postpartum depression. In addition, the company will stop selling its infused PPD drug Zulresso at the end of this year. Zurzuvae had been in development for both PPD and MDD, with Sage promoting the drug’s mechanism of action as different from traditional antidepressants and a way to provide patients with additional options. But after clinical trial data in MDD were mixed, the FDA in August 2023 approved the drug only in PPD and rejected it in major depression, giving the company a historic approval but cutting off a potentially significant revenue stream. In the months following the MDD rejection, Sage has faced numerous setbacks. It has engaged in multiple rounds of layoffs, including a 40% cutback just weeks after the FDA decision. The company cut another 33% of its workforce earlier this month, including leadership positions, and 55% of its R&D staff. One of its other programs, dalzanemdor, also failed in Parkinson’s and Alzheimer’s this year, spurring a pipeline reorganization a few weeks ago. Sage is now focusing on that program’s Huntington’s readout that’s expected before the end of the year, an area where the company changed its pivotal trial’s primary endpoint over the summer. Sage announced the move Tuesday afternoon as part of its third-quarter earnings. Its stock price $SAGE fell about 4% in postmarket trading. As part of the ongoing reorganization, Sage said it has enough runway to operate into 2026.