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Alkermes Sinks as FDA Refuses Depression Drug Review
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Shares of Alkermes Plc. (ALKS - Free Report) declined by more than 21% when the FDA refused to review its depression candidate, ALKS 5461, stating that the new drug application (NDA) did not have enough evidence for the oral medication to work. Importantly, the FDA suggested that additional studies might be required to demonstrate the drug’s overall effectiveness for the proposed indication.
ALKS 5461, for a once-daily oral medication has been developed for the adjunctivetreatment of major depressive disorder (MDD) in patients who have not responded well to standard antidepressant therapies. The NDA for the candidate was filed in January 2018. Notably, ALKS 5461 is a fixed-dose combination of buprenorphine, a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist, and samidorphan, a mu-opioid receptor antagonist.
Per the FDA, information submitted in the NDA provided insufficient evidence of ALKS 5461’s overall effectiveness for MDD. The FDA has asked Alkermes to conduct a new set of studies before it resubmitted the NDA. Specifically, the regulatory body requested the company to conduct a bioavailability study for more bridging data between 5461 and the reference drug, buprenorphine.
Alkermes, however, is disappointed with the FDA’s decision and plans to appeal the same. In fact, the company intends to seek immediate guidance, including request a Type A meeting with the FDA, in order to find out what additional information might be needed to file a revised NDA.
Per Alkermes, the NDA submission was supported by encouraging efficacy and safety data package from more than 30 studies conducted on more than 1,500 patients with the aforementioned indication. The company is confident that ALKS 5461 has demonstrated antidepressant activity, safety and tolerability across all development programs.
Additionally, Alkermes is of the view that around 17 million people are annually diagnosed with MDD in the United States of which, a large number does not get sufficient relief from the first-line standard antidepressant therapy. Therefore, approval of this drug will provide the company with an access to a huge patient population base looking for new treatment options. The company also announced its plans to evaluate how the setback might impact Alkermes’ previously anticipated financial guidance for 2018.
Alkermes carries a Zacks Rank #3 (Hold). Shares of the company have underperformed the industry in a year’s time. The stock has declined 21.2% compared with the industry’s decrease of 8%.
Regeneron’s earnings per share estimates have moved up from $18.65 to $18.68 for 2018 in the last 30 days. The company pulled off a positive earnings surprise in three of the last four quarters, with an average beat of 9.15%.
Ligand’s earnings per share estimates have moved up $3.78 to $4.20 from $4.75 to $5.32 for 2018 and 2019, respectively, over the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 24.88%. The company’s shares have rallied 51.6% over the past year.
Enanta Pharma delivered a positive earnings surprise in three of the last four quarters, with an average beat of 373.1%. The company’s shares have surged 166.3% over a year.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
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Alkermes Sinks as FDA Refuses Depression Drug Review
Shares of Alkermes Plc. (ALKS - Free Report) declined by more than 21% when the FDA refused to review its depression candidate, ALKS 5461, stating that the new drug application (NDA) did not have enough evidence for the oral medication to work. Importantly, the FDA suggested that additional studies might be required to demonstrate the drug’s overall effectiveness for the proposed indication.
ALKS 5461, for a once-daily oral medication has been developed for the adjunctivetreatment of major depressive disorder (MDD) in patients who have not responded well to standard antidepressant therapies. The NDA for the candidate was filed in January 2018. Notably, ALKS 5461 is a fixed-dose combination of buprenorphine, a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist, and samidorphan, a mu-opioid receptor antagonist.
Per the FDA, information submitted in the NDA provided insufficient evidence of ALKS 5461’s overall effectiveness for MDD. The FDA has asked Alkermes to conduct a new set of studies before it resubmitted the NDA. Specifically, the regulatory body requested the company to conduct a bioavailability study for more bridging data between 5461 and the reference drug, buprenorphine.
Alkermes, however, is disappointed with the FDA’s decision and plans to appeal the same. In fact, the company intends to seek immediate guidance, including request a Type A meeting with the FDA, in order to find out what additional information might be needed to file a revised NDA.
Per Alkermes, the NDA submission was supported by encouraging efficacy and safety data package from more than 30 studies conducted on more than 1,500 patients with the aforementioned indication. The company is confident that ALKS 5461 has demonstrated antidepressant activity, safety and tolerability across all development programs.
Additionally, Alkermes is of the view that around 17 million people are annually diagnosed with MDD in the United States of which, a large number does not get sufficient relief from the first-line standard antidepressant therapy. Therefore, approval of this drug will provide the company with an access to a huge patient population base looking for new treatment options. The company also announced its plans to evaluate how the setback might impact Alkermes’ previously anticipated financial guidance for 2018.
Alkermes plc Price
Alkermes plc Price | Alkermes plc Quote
Zacks Rank & Key Picks
Alkermes carries a Zacks Rank #3 (Hold). Shares of the company have underperformed the industry in a year’s time. The stock has declined 21.2% compared with the industry’s decrease of 8%.
A few better-ranked stocks from the same space are Regeneron (REGN - Free Report) , Ligand Pharmaceuticals (LGND - Free Report) and Enanta Pharma (ENTA - Free Report) . All of them sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings per share estimates have moved up from $18.65 to $18.68 for 2018 in the last 30 days. The company pulled off a positive earnings surprise in three of the last four quarters, with an average beat of 9.15%.
Ligand’s earnings per share estimates have moved up $3.78 to $4.20 from $4.75 to $5.32 for 2018 and 2019, respectively, over the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 24.88%. The company’s shares have rallied 51.6% over the past year.
Enanta Pharma delivered a positive earnings surprise in three of the last four quarters, with an average beat of 373.1%. The company’s shares have surged 166.3% over a year.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>