Sage Shares Soar After FDA Gives Green Light for This

Shares of Sage Therapeutics were exploding in Tuesday trading after the Food and Drug Administration gave the ‘ok’ to expediting development of the company’s drug, SAGE-217, to treat major depressive disorder and postpartum depression.

Shares were up as much as 15% after the company announced the news. It was in February that the drug had received breakthrough therapy designation.

The company said its ongoing trial in women that have postpartum depression will now be designate a pivotal trial. If the data from the trial is positive it will support a regulatory filing.

Plans for a phase III trial in major depressive disorder is expected to commence in the second half of the year.

Commissioner Scott Gottlieb has pushed the administration to review and approve drugs faster.

Sage CEO Dr. Jeff Jonas remarked, “Sage is excited to receive feedback from the FDA that provides a possible groundbreaking path forward for the development of SAGE-217 for the treatment of depression.”
Disclaimer: We have no position in SAGE Therapeutics Inc. (NASDAQ: SAGE) and have not been compensated for this article.