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Alkermes Depression Candidate Positive in Phase III Study
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Alkermes plc (ALKS - Free Report) announced positive top-line data from the third phase III efficacy study, FORWARD-5 (Focused On Results With A Rethinking of Depression) on its pipeline candidate, ALKS 5461. The company is evaluating ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD) in patients who have an inadequate response to standard antidepressant therapies. We expect investors to react positively to the news.
The randomized, double-blind, multi-center, placebo-controlled, sequential parallel- comparison design study was conducted to evaluate the safety, tolerability and efficacy of two dose levels of ALKS 5461 (2mg/2mg and 1mg/1mg). Data from the study showed that ALKS 5461 2mg/2mg met the pre-specified primary endpoint of significantly reducing the symptoms of depression in patients with MDD in comparison to placebo. Though the 1mg/1mg dose of ALKS 5461 led to improvement in depressive symptoms in the study, it did not vary significantly from placebo.
On the safety front, ALKS 5461 was found to be well tolerated and the most commonly reported adverse events were consistent with those observed in the previously reported studies on the candidate.
Alkermes intends to present detailed data from the FORWARD-5 study at a forthcoming medical meeting.
On the basis of these data as well as considerable amount of 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 on the regulatory path ahead for the candidate.
We note that the FORWARD-5 is one of the phase III efficacy study that was conducted under the FORWARD program on ALKS 5461. Results from FORWARD-3 and FORWARD-4 were announced earlier in Jan 2016.
We are encouraged by the latest study results. As per Alkermes’ press release, MDD affects an estimated 17 million people in the U.S. in any given year, the majority of whom may not adequately respond to initial antidepressant therapy. ALKS 5461 enjoys Fast Track status in the U.S.
We expect investor focus to remain on pipeline updates from the company.
Alkermes carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the healthcare sector include Infinity Pharmaceuticals, Inc. , BioMarin Pharmaceutical Inc. (BMRN - Free Report) and Exelixis, Inc. (EXEL - Free Report) . While Infinity and Exelixis sport a Zacks Rank #1 (Strong-Buy), BioMarin carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Infinity’s loss estimates narrowed from $3.84 to $3.79 for 2016 and remained stable for 2017 over the last 60 days. The company has posted a positive surprise in all the four trailing quarters with an average beat of 67.62%.
BioMarin’s loss estimates narrowed from 28 cents to 25 cents for 2016 and from $1.16 to $1.11 for 2017 over the last 60 days.
Exelixis’ loss estimates narrowed from 71 cents to 63 cents for 2016 and from 19 cents to earnings of 3 cents for 2017 over the last 60 days. The company has posted a positive surprise twice in the four trailing quarters with an average beat of 9.1%. Its share price has skyrocketed over 100% year to date.
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Alkermes Depression Candidate Positive in Phase III Study
Alkermes plc (ALKS - Free Report) announced positive top-line data from the third phase III efficacy study, FORWARD-5 (Focused On Results With A Rethinking of Depression) on its pipeline candidate, ALKS 5461. The company is evaluating ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD) in patients who have an inadequate response to standard antidepressant therapies. We expect investors to react positively to the news.
The randomized, double-blind, multi-center, placebo-controlled, sequential parallel- comparison design study was conducted to evaluate the safety, tolerability and efficacy of two dose levels of ALKS 5461 (2mg/2mg and 1mg/1mg). Data from the study showed that ALKS 5461 2mg/2mg met the pre-specified primary endpoint of significantly reducing the symptoms of depression in patients with MDD in comparison to placebo. Though the 1mg/1mg dose of ALKS 5461 led to improvement in depressive symptoms in the study, it did not vary significantly from placebo.
On the safety front, ALKS 5461 was found to be well tolerated and the most commonly reported adverse events were consistent with those observed in the previously reported studies on the candidate.
Alkermes intends to present detailed data from the FORWARD-5 study at a forthcoming medical meeting.
On the basis of these data as well as considerable amount of 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 on the regulatory path ahead for the candidate.
We note that the FORWARD-5 is one of the phase III efficacy study that was conducted under the FORWARD program on ALKS 5461. Results from FORWARD-3 and FORWARD-4 were announced earlier in Jan 2016.
We are encouraged by the latest study results. As per Alkermes’ press release, MDD affects an estimated 17 million people in the U.S. in any given year, the majority of whom may not adequately respond to initial antidepressant therapy. ALKS 5461 enjoys Fast Track status in the U.S.
We expect investor focus to remain on pipeline updates from the company.
ALKERMES INC Price
ALKERMES INC Price | ALKERMES INC Quote
Zacks Rank & Stocks to Consider
Alkermes carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the healthcare sector include Infinity Pharmaceuticals, Inc. , BioMarin Pharmaceutical Inc. (BMRN - Free Report) and Exelixis, Inc. (EXEL - Free Report) . While Infinity and Exelixis sport a Zacks Rank #1 (Strong-Buy), BioMarin carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Infinity’s loss estimates narrowed from $3.84 to $3.79 for 2016 and remained stable for 2017 over the last 60 days. The company has posted a positive surprise in all the four trailing quarters with an average beat of 67.62%.
BioMarin’s loss estimates narrowed from 28 cents to 25 cents for 2016 and from $1.16 to $1.11 for 2017 over the last 60 days.
Exelixis’ loss estimates narrowed from 71 cents to 63 cents for 2016 and from 19 cents to earnings of 3 cents for 2017 over the last 60 days. The company has posted a positive surprise twice in the four trailing quarters with an average beat of 9.1%. Its share price has skyrocketed over 100% year to date.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>