Back to top

Analyst Blog

Alkermes (ALKS - Analyst Report) announced that it has initiated a pivotal program to evaluate its major depressive disorder (MDD) candidate, ALKS 5461. The pivotal program, FORWARD (Focused On Results With A Rethinking of Depression) will evaluate ALKS 5461 in patients who did not respond satisfactorily to currently available therapies.

FORWARD comprises three core phase III efficacy studies and nine supportive studies to evaluate the long-term safety, dosing, pharmacokinetic profile and abuse potential of ALKS 5461. The company has already commenced the first FORWARD study (n = 60) to evaluate the onset of action, safety and tolerability profile of the candidate. The three core efficacy studies are expected to be initiated in mid 2014.

Alkermes plans to submit a New Drug Application (NDA) for ALKS 5461 to the U.S. Food and Drug Administration (FDA) based on efficacy and safety data from the FORWARD program.

Earlier, in Apr 2013, Alkermes had reported encouraging top-line data from a phase II study (n=142) on ALKS 5461. The study evaluated the safety and efficacy of ALKS 5461 across two doses for the treatment of MDD in patients who show inadequate response to currently available therapies. Results from the study revealed that depressive symptoms were reduced across a range of standard measures. ALKS 5461 was well tolerated during the study.

We note that the candidate enjoys a Fast Track designation in the U.S.

Our Take

We are encouraged by Alkermes’ efforts to develop its pipeline. However, we note that the MDD market currently has big players like Eli Lilly and Company (LLY - Analyst Report). We believe investors focus will remain Alkermes’ pipeline development efforts. 2014 is expected to be a data rich year for Alkermes with multiple pipeline related events lined up (aripiprazole lauroxil for schizophrenia – phase III data expected by Jun 30, 2014). Positive news on the pipeline will boost the stock.

Alkermes, a biopharmaceutical company, carries a Zacks Rank #1 (Strong Buy). Biopharma stocks Alexion Pharmaceuticals, Inc. (ALXN - Analyst Report) and Amgen Inc. (AMGN - Analyst Report) carry the same Zacks Rank as Alkermes.

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
RPC INC RES 24.91 +8.35%
LITHIA MOTO… LAD 94.59 +4.60%
DELTA AIR L… DAL 39.15 +3.90%
FLAMEL TECH… FLML 14.51 +3.50%
SOUTHWEST A… LUV 28.87 +2.92%