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Alkermes (ALKS) Receives FDA CRL in Relation to ALKS 3831 logo 11/18/2020

Alkermes Plc. ALKS announced that it has received a Complete Response Letter (CRL) from the FDA regarding its new drug application (NDA) for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and bipolar I disorder.

ALKS 3831 (olanzapine/samidorphan) is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate being evaluated for the treatment of adults with schizophrenia and bipolar I disorder. Schizophrenia is a chronic, severe and disabling brain disorder. Bipolar disorder is a brain disorder that causes unusual shifts in a person's mood, energy and ability to function. 

Alkermes’ shares have lost 10.3% so far this year against the industry’s growth of 0.8%.

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Per Alkermes, the agency required the resolution of certain conditions related to the tablet coating process at its facility in Wilmington, OH, before the drug could be approved. The company noted that the CRL did not identify or raise any concerns about the clinical or non-clinical data in the NDA and the FDA has not asked Alkermes to complete any new clinical trials to support the approval of the application. These observations were based on some development batches of ALKS 3831 and the company feels that it has enough data available to address these issues.

The company is preparing data for submission and plans to work closely with the FDA to resolve the items in a timely manner and complete labeling discussions for the application.

We remind investors that in October 2020, Alkermes received positive votes for ALKS 3831 from the joint meeting of the Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, appointed by the FDA. During the joint meeting, the group voted that the samidorphan meaningfully mitigates olanzapine-associated weight gain with a 16-1 vote. The committee also ruled the safety profile of ALKS 3831, which has been adequately characterized with a 13-3 vote. The committees jointly voted that labeling is sufficient to mitigate the risks related to the opioid antagonist action of samidorphan in an 11-6 vote.

Zacks Rank & Stocks to Consider

Apellis currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the healthcare sector include ASLAN Pharmaceuticals Ltd. ASLN, Abeona Therapeutics Inc. ABEO and Alimera Sciences Inc. ALIM, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

ASLAN’s loss per share estimates have narrowed from 42 cents to 40 cents for 2020 and from 60 cents to 57 cents for 2021 over the past 60 days. Shares of the company have decreased 19.7% year to date.

Abeona’sloss per share estimates have narrowed from 96 cents to 88 cents for 2020 and from 69 cents to 64 cents for 2021 over the past 60 days. Shares of the company have increased 60.8% year to date.

Alimera’s loss per share estimates have narrowed from $1.31 to 96 cents for 2020 over the past 60 days. Shares of the company have decreased 29.9% year to date.

Alkermes plc Price

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