Alkermes Progresses with its Late Stage Candidate - Analyst Blog

By
A A A

Alkermes ( ALKS ) initiated two of the three core efficacy phase III studies (FORWARD-3 and FORWARD-4) on ALKS 5461 under its FORWARD (Focused On Results With A Rethinking of Depression) program. ALKS 5461 is being developed for the adjunctive treatment of major depressive disorder (MDD).

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. Four of the 12 FORWARD studies have already begun. The third core phase III study, FORWARD-5, is also expected to be initiated soon.

The FORWARD-3 and FORWARD-4 studies will be evaluating the safety and efficacy of ALKS 5461 in patients who did not respond satisfactorily to currently available therapies, including selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors. The efficacy studies will primarily assess the change in Montgomery-Åsberg Depression Rating Scale scores from baseline in these patients.


Results from the FORWARD-3 and FORWARD-4 studies are expected in 2016. Alkermes intends to utilize the data from the FORWARD program to form the basis of its New Drug Application (NDA) submission for ALKS 5461 in the MDD indication in the U.S.

Our Take

We are encouraged by Alkermes' progress with its pipeline. The company has a series of pipeline events lined up in the quarters to come. Candidates like aripiprazole lauroxil and ALKS 3831, both for schizophrenia, hold promise. Positive news on the pipeline will boost the stock.

Alkermes, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Gilead Sciences Inc. ( GILD ), Regeneron Pharmaceuticals, Inc. ( REGN ) and Alexion Pharmaceuticals, Inc. ( ALXN ). While Gilead and Regeneron carry a Zacks Rank #1 (Strong Buy), Alexion holds a Zacks Rank #2 (Buy).


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

ALEXION PHARMA (ALXN): Free Stock Analysis Report

REGENERON PHARM (REGN): Free Stock Analysis Report

ALKERMES INC (ALKS): Free Stock Analysis Report

GILEAD SCIENCES (GILD): Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research



The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.




This article appears in: Investing , Business , Stocks

Referenced Stocks: MDD , ALXN , REGN , ALKS , GILD

Zacks.com

Zacks.com

More from Zacks.com:

Related Videos

Top Home Financing Myths
Top Home Financing Myths            

Stocks

Referenced

Most Active by Volume

64,655,493
  • $17.88 ▼ 1.38%
53,363,101
  • $18.51 ▼ 6.98%
42,789,793
  • $94.01 ▼ 1.26%
40,818,762
  • $121.30 ▼ 0.87%
38,086,152
  • $23.28 ▼ 9.17%
36,103,930
  • $14.20 ▼ 0.77%
31,870,696
  • $14.83 ▼ 1.79%
29,019,850
  • $46.70 ▼ 0.38%
As of 7/31/2015, 04:15 PM

Find a Credit Card

Select a credit card product by:
Select an offer:
Search
Data Provided by BankRate.com