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Alkermes: Progress in Treating Depression
11/02/2016 10:00 am EST
This recommended biotech stock has delivered the goods with outstanding positive topline data in a treatment for depressions, explains leading biotech analyst John McCamant, editor of The Medical technology Stock Letter.
Alkermes (ALKS) reported these positive results for what is known as FORWARD-5, the third Phase III trial to read out from the FORWARD pivotal program for ALKS 5461.
This is a once-daily, oral compound for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies.
The trial met its prespecified primary endpoint showing treatment with ALKS-5461 significantly reduced symptoms of depression in patients with MDD compared to placebo.
ALKS 5461 was generally well-tolerated. The most common adverse events observed for ALKS 5461 were nausea, dizziness and fatigue.
Based on these results, along with the substantial data collected to date on the efficacy and safety of ALKS 5461 for the treatment of MDD, the company plans to request a meeting with the FDA’s Division of Psychiatric Products to discuss the filing strategy for this Fast Track designated medicine.
In the study, ALKS 5461 2Mg/2Mg met the pre-specified primary endpoint of significantly reducing depression scores compared to placebo, as measured by 6-item Montgomery–Åsberg Depression Rating Scale (MADRS-6).
It also demonstrated statistically significant reductions in 10-item MADRS scores compared to placebo. This is huge news for ALKS as Wall Street had left ‘5461 for dead after the first two failed trials.
The safety data from the previous two trials combined with one positive Phase III trial may be enough for ALKS to file an NDA with the FDA.
Clarity will be provided after the FDA meeting, however, the company was clear on the conference call that they believe they can file for approval based on this positive trial.
In our view, the fact that Fast Track has already been granted, the outstanding safety profile and the lack of quality treatments for MDD will add up to an FDA NDA acceptance, setting up a path to approval for ‘5461. ALKS is a buy under $55 for a target price of $75.
By John McCamant, Editor of The Medical technology Stock Letter
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