Sage Therapeutics’ brexanolone achieves primary endpoint in Phase 3 trial
Sage Therapeutics (SAGE) announced positive top-line results from two Phase 3 clinical trials with its proprietary i.v. formulation of brexanolone;
- Study 202B in severe postpartum depression and
- Study 202C in moderate PPD.
Brexanolone achieved the primary endpoint in both trials, a mean reduction from baseline in the Hamilton Rating Scale for Depression total score compared to placebo at 60 hours.
Patients treated with brexanolone demonstrated mean reductions from baseline in HAM-D total scores of 14 to 20 points at 60 hours maintained to 30 days in both trials.
Brexanolone was generally well tolerated and showed a similar safety profile as seen in earlier studies.
Sage believes these data will be sufficient to support submissions of regulatory applications seeking approval of brexanolone for PPD.
Sage plans to file a New Drug Application with the FDA in 2018.
Shares of Marinus Pharmaceuticals (MRNS) are also higher. The move comes after Sage Therapeutics announced that its Phase 3 clinical trial with its proprietary i.v. formulation of #brexanolone in severe postpartum depression achieved its primary endpoint.
#Marinus is preparing to initiate clinical trials with Captisol-enabled ganaxolone IV in patients with postpartum depression.
H.C. Wainwright analyst Joseph #Pantginis notes Ligand Pharmaceuticals (LGND) partner Sage Therapeutics announced positive top-line data of brexanolone for patients with moderate and severe postpartum depression. Recall that brexanolone is one of the “Big Six assets” at Ligand which is expected to receive a 3% royalty on sales, Pantginis tells investors in a research note. The analyst raised his price target for Ligand shares to $159 from $157 and keeps a Buy rating on the shares.
BMO Capital analyst Gary Nachman calls today’s Phase 3 data in post-partum depression a “very significant milestone” for Sage Therapeutics. The analyst sees a “high probability of approval” in the U.S. and Europe based on these data.
Further, he thinks they could potentially bode well for the anticipated SAGE-217 results in both major depressive disorder and for in postpartum depression. #Nachman reiterates an Outperform rating on Sage with an $80 price target.
In Thursday’s trading SAGE is up 44% to $90.65 per share.
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