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Alkermes Rallies as FDA Accepts NDA for Depression Drug

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Shares of Alkermes plc ALKS jumped about 4.5% when the FDA accepted for review the new drug application (NDA) for ALKS 5461 for the treatment of major depressive disorder (“MDD”). The FDA had initially issued a Refusal to File letter on Mar 30 for the candidate stating that the NDA did not have enough evidence for the oral medication to work.

The FDA suggested that additional studies might be required to demonstrate the drug’s overall effectiveness for the proposed indication. Following FDA’s decision, the stock had plunged about 21%.

Over a year, shares of the company have decreased 21.8% compared with the industry’s decline of 8.5%.

ALKS 5461, a once-daily oral medication has been developed for the adjunctive treatment of MDD in patients who have not responded well to standard antidepressant therapies. The NDA for the candidate was filed in January 2018. 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.

The FDA's acceptance of the ALKS 5461 NDA and rescission of the Refusal to File letter followed productive interactions with the Agency in which Alkermes clarified certain aspects of the NDA submission. No additional data or analyses were submitted by Alkermes to FDA. The FDA has set an action date of Jan 31, 2019.

Per Alkermes, the NDA submission was supported by encouraging efficacy and safety data package from more than 30 studies conducted on over 1,500 patients. 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.

Alkermes plc Price

Alkermes plc Price | Alkermes plc Quote


Zacks Rank and Stocks to Consider

Alkermes carries a Zacks Rank #3 (Hold).

A few better-ranked stocks from the same space worth considering are Ligand Pharmaceuticals LGND, Protagonist Therapeutics PTGX and Catabasis Pharmaceuticals CATB. While Ligand and Protagonist sport a Zacks Rank #1 (Strong Buy), Catabasis carries a Zacks Rank #2 (Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.

Ligand’s earnings per share estimates have moved up $3.78 to $4.40 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 58.9% over a year.

Protagonist’s loss estimates narrowed from $1.30 to 66 cents for 2018 and from $1.99 to $1.26 for 2019, over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 24.95%.

Catabasis’ loss estimates narrowed from $1.09 to 92 cents for 2018 and from $1.76 to $1.48 for 2019, in the last 60 days. The company came up with a positive earnings surprise in all the preceding four quarters, with an average beat of 14.56%. The stock has rallied 21.8% so far this year.

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Alkermes plc (ALKS) : Free Stock Analysis Report
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