Sage Therapeutics Inc.'s stock jumped more than 42% on positive results from a late-stage study of postpartum depression drug SAGE-217, which outperformed placebo in reducing the symptoms of the mood disorder that can affect some women after childbirth.
The Cambridge, Mass.-based company's stock was up 42.6% to $139.13 after market close Jan. 7.
Sage Therapeutics enrolled 151 adult female patients with postpartum depression in the phase 3 trial called the Robin Study.
The participants were treated with SAGE-217, an oral treatment, and placebo on a daily basis for two weeks, with a follow-up study that continued until four weeks.
After four weeks, 53% of patients in the SAGE-217 group had no signs of the disease compared to 30% in patients receiving placebo. Sage Therapeutics said in a Jan. 7 press release that the therapy was well-tolerated in the trial with drowsiness, headache and dizziness reported as the most common adverse reactions.
The U.S. FDA granted the treatment a fast-track designation in May 2017.
The trial results come as the company awaits an approval decision from the U.S. Food and Drug Administration for its other postpartum depression therapy, which has been pushed back to March. A U.S. FDA panel in November 2018 recommended Sage Therapeutic's brexanolone injection, also known as Zulresso, for approval despite safety concerns raised over loss of consciousness experienced during a trial, as well as the therapy's required 60-hour infusion. The FDA's Psychopharmacologic Drugs and the Drug Safety and Risk Management advisory committees nevertheless determined that the benefits outweighed the risks, and voted 17-1 in favor of approving the brexanolone injection for use.