Sage is going to have to wait a while
Sage Therapeutics’ ambitions of winning a 2020 approval for a novel depression drug were cast aside, as a meeting with the FDA resulted in plans for more clinical trials.
As STAT’s Matthew Herper and Adam Feuerstein report, Sage is now planning to run three more studies — one in postpartum depression and two in major depressive disorder — to prove its oral treatment can improve symptoms. That means it won’t be able to make its case to the FDA until some time next year.
The news will come as a disappointment to investors betting Sage could convince regulators to consider the postpartum depression data it already has. It also might mean changes at Sage. The company said it is “currently re-assessing its resource allocation and prioritization strategy” in light of the FDA’s guidance, which could portend restructuring.
Read more.
As STAT’s Matthew Herper and Adam Feuerstein report, Sage is now planning to run three more studies — one in postpartum depression and two in major depressive disorder — to prove its oral treatment can improve symptoms. That means it won’t be able to make its case to the FDA until some time next year.
The news will come as a disappointment to investors betting Sage could convince regulators to consider the postpartum depression data it already has. It also might mean changes at Sage. The company said it is “currently re-assessing its resource allocation and prioritization strategy” in light of the FDA’s guidance, which could portend restructuring.
Read more.
.png)
No hay comentarios:
Publicar un comentario