Sage Therapeutics Inc. is reducing its workforce by 40% and pausing its earlier-stage programs, just a few weeks after receiving mixed news of both a U.S. FDA approval and a complete response letter for its depression drug Zurzuvae (zuranolone). The move offers the Cambridge, Mass.-based company an annualized net savings of approximately $240 million, 60% of which is related to R&D, and will extend its runway into 2026.
Despite the U.S. FDA’s approval of Sage Therapeutics Inc.’s priority NDA for postpartum depression, the accompanying complete response letter (CRL) for major depressive disorder has undercut the company’s plans. Withholding the approval for MDD slices away a huge amount of the potential market for Sage and its collaborator, Biogen Inc.
With the launch of intravenous Leqembi (lecanemab-irmb) for Alzheimer’s disease (AD) underway, Priya Singhal, Biogen Inc.’s head of development and interim head of research, said the firm, along with partner Eisai Co. Ltd., aims to “address the long-term duration question” with a subcutaneous version, recently touted at the Alzheimer's Association International Conference.
Avenue Therapeutics Inc.’s takeover of Baergic Bio Inc. pursuant to the previously disclosed share contribution agreement with its parent company, Fortress Biotech Inc., highlighted the potential of targeting GABAA, an approach under investigation in various quarters.
Biogen Inc. has announced contrasting results from phase III trials of therapies for a rare eye disease and depression, following last week’s controversial FDA approval of Alzheimer’s drug Aduhelm. The Cambridge, Mass.-based firm said a phase III gene therapy study in the rare retinal disease choroideremia missed its primary and secondary endpoints, although the news was better from a potential therapy for major depressive disorder.
Sage Therapeutics Inc. on March 17 disclosed another batch of positive phase III data with zuranolone, its oral, once-daily, two-week therapy for the treatment of major depressive disorder (MDD) and postpartum depression. News regarding the GABAA receptor-positive allosteric modulator came the same day that Praxis Precision Medicines Inc. reported fourth-quarter and full-year financial results, updating investors on PRAX-114, its drug in the same class for MDD.
Sage Therapeutics Inc.’s chief business officer, Michael Cloonan, said the firm is “not going to give details around the geographies and the number of sites” that will continue to use Zulresso (brexanolone) for postpartum depression (PPD) after the restructuring of the Cambridge, Mass.-based firm.