Alkermes (ALKS) Stock: Halted On FDA AD Comm Review!


Alkermes Plc ALKS Stock NewsAlkermes Plc (NASDAQ: ALKS) is halted in the pre-market this morning, and for good reason. The company is in a meeting with the FDA advisory Committee, hoping to receive a vote for approval of a treatment for Major Depressive Disorder (MDD). Of course, when the halt is over, this thing will likely either fly or sink. Today, we’ll talk about:

  • What’s happenting with ALKS;
  • what the advisory committee meeting means for the company and its investors; and
  • what we’ll be watching for ahead.

ALKS Halted On FDA Advisory Committee Review

As mentioned above, Alkermes is halted in the pre-market this morning as investors awit the result of an FDA Advisory Committee Review. In a press release issued early this morning, the company said that the NASDAQ has temporarily halted trading of the company’s shares due to the meeting.

At the moment, ALKS is in the midst of a joint meeting of the Psychpharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. These committees are meeting with the company and the FDA today to review the New Drug Application for ALKS 5461. This is a once-daily, oral investigational medicine designed for the treatment of Major Depressive Disorder (MDD) in patients with inadequate response to standard antidepressant therapies.

ALKS started the meeting today with the FDA and its advisory committees at 8 a.m. ET. If you would like to learn more about the meeting, click here to view briefing materials and webcast information.

Why This Meeting Is So Important

The truth is that today is a very big day for Alkermes. At the end of the day, while Advisory Committees don’t have the final say when it comes to the approval or rejection of a treatment, their opinion is incredibly important. In fact, I’ve been following drug approvals for years now and it is very seldom that the result of a New Drug Application is any different than the result of the Advisory Committee review. So, if the review goes well, there’s a good chance that ALKS 5461 will be approved. Adversely, if the meeting doesn’t go well, there’s a good chance of a Complete Response Letter being issued.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on ALKS. In particular, we’re interested in following the news to see what the outcome of the Advisory Committee review ends up being. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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