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Sage Therapeutics' (SAGE) depression (MDD) drug fails in clinical trial missing endpoint, stock price gets its clock cleaned

December 6, 2019 10:30am

Dropping -$89.03 on Thursday and is up +$4.23 or +7.91% on Friday

One day removed after shares of SAGE falling -59.7%, the stock is "bouncing" higher in trading after hitting 52-week lows on Thursday.

SAGE’s P3 study on SAGE-217 for the treatment of major depressive disorder (MDD) failed to meet the primary endpoint. The MOUNTAIN study evaluated the efficacy, safety and pharmacokinetics of SAGE-217 in adult patients diagnosed with MDD.

The P3 study did not meet its primary endpoint due to a statistically significant reduction from baseline compared to placebo in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15. SAGE-217 30 mg, given once-daily as an oral treatment, was associated with a mean reduction of 12.6 in HAM-D total score compared to 11.2 for placebo.

However, patients in the SAGE-217 30 mg group achieved statistically significant reductions in the HAM-D total score at Days 3, 8 and 12. The SAGE-217 development program includes five other pivotal studies, two of which have reported positive data, one in MDD and another in postpartum depression (PPD), and three are ongoing.

Comparable VistaGen (VTGN) also announced disappointing results from a mid-stage study, ELEVATE, on pipeline candidate, AV-101. While, earlier this year, Alkermes (ALKS) received a Complete Response Letter from the FDA regarding its new drug application for ALKS 5461 for the adjunctive treatment of MDD.

Reiterating, "Cell and gene therapy i.e. biotech is not for amateurs – that highs are extraordinary and the lows are even deeper – it's known that acquisitions sets the sector on fire while clinical failures douse the flames of share pricing!"

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