Sage, Bio­gen head to FDA with $3.1B de­pres­sion drug; Sana puts down $50M to tap Beam's CRISPR tech

Weeks af­ter an­nounc­ing they would drop a pair of stud­ies deemed un­nec­es­sary to file the de­pres­sion drug zu­ra­nolone for ap­proval, Sage and Bio­gen are go­ing for it.

Fol­low­ing a pre-NDA meet­ing with the FDA, the part­ners say they plan to sub­mit an NDA in the sec­ond half of 2022 for ma­jor de­pres­sive dis­or­der, with a sec­ond for post­par­tum de­pres­sion to fol­low in 2023.

“We have iden­ti­fied what we be­lieve is the most ef­fi­cient path for­ward for an FDA fil­ing and po­ten­tial ap­proval,” Sage CEO Bar­ry Greene said in a state­ment.

Endpoints News

To read Endpoints News become a free subscriber

Unlock this article instantly, along with access to limited free monthly articles and our suite of newsletters