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Sage Therapeutics fires 40% of staff after FDA rejected MDD bid

2023-09-01

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临床3期上市批准引进/卖出高管变更临床结果

Adam Zamecnik

@a_zamecnik

Sage Therapeutics announced plans to layoff 40% of workforce as it plans to launch its postpartum depression drug later this year. Image Credit: Shutterstock / Nicoleta Ionescu.

Sage Therapeutics will reduce its workforce by 40% following the US Food and Drug Administration’s (FDA) rejection of its drug Zurzuvae (zuranolone) in adults with major depressive disorder (MDD).

Sage Therapeuticsany will pause some undisclosed early-stage programs and focus insteadpostpartum depression its compounds SAGE-718 and SAGE-324, per the 31 August announcement. Sage’s leadership will also change with the departure of the current chief scientific officer (CSO) Al Robichaud and the chief development officer (CDO) Jim Doherty.

Sage Therapeutics comes at a time when the company plans the commercFood and Drug AdministrationreatFDA postpartum depression wZurzuvaeexzuranolonelate 2023. On 4 Amajor depressive disorder (MDD)e’s use in women with postpartum depression while simultaneously issuing a complete response letter (CRL) for the treatment’s use in MDD. The CRL stated that the drug’s application did not provide substantial evidence of effectiveness in MDD and that further studies are needed.

The drug’s approval in postpartum depression was based on the NEST program, which included the Phase III ROBIN (NCT02978326SAGE-718YLARKSAGE-32442503) studies. Both trials met their primary endpoints. Zurzuvae is a neuroactive steroid GABA-A receptor positive allosteric modulator. The GABA system is the major signalling pathway in the brain and central nervous system and contributes to regulating brain function, based on the company’s website.

According to consensus forecasts from GlobalData’s Pharma Intelligence Centre, ZurZurzuvaen earn an estipostpartum depression in global sales in 2029. GlobalData is the parentFDAmpany of PZurzuvaetical Technology.postpartum depression MDD MDD

Soon after the approvalpostpartum depressionthat it was evaluating resource allocation options, which included pipeline prioritisation and workforce reorganisation to stretch out its cash runway, per aZurzuvaecement from the time.GABA-A receptor positive allosteric modulator GABA-A receptor

Sage has a global collaboration agreement with Biogen for the development of Zurzuvae, and SAGE-324, which is being explored in indications such as essential tremors, epileptiform disordPharmaceutical Technologyase.

As part of the agreement, Biogen and Sage split responsibilities and costs for the development and commercialisation of the treatments in the US, while Biogen is responsible for the those functions abroad, except for Zurzuvae’s development in Japan, South Korea, and Taiwan.

Sage has an existing collaboration agreement wiBiogenonogi that gave the JapaZurzuvaepany tSAGE-324 for all clinical development, regulatory filings,essential tremorsatepileptiform disordersse thrParkinson’s disease2018.

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