SAGE Therapeutics Inc (NASDAQ: SAGE) is halted in today’s trading session, and after the halt, we’re likely to see either big gains or big declines. That’s because the halt comes as the FDA and its Advisory Committees meet to discuss a New Drug Application from the company. Should the discussions go well, the stock could fly. Should the discussions turn out negative, the stock could tank. Today, we’ll talk about:
- The Advisory Committee meeting;
- why this is so important for SAGE; and
- what we’ll be watching for with regard to the stock ahead.
SAGE Halted For FDA Advisory Committee Meeting
As mentioned above, Sage Therapeutics is halted early on in today’s trading session as the company meets with the FDA. Today, the FDA will be meeting with the company as well as the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Comittee.
During the meeting, the parties will discuss the recent New Drug Application submitted by SAGE. The application is currently under review for ZULRESSO, which is an injection for the treatment of postpartum depression.
Why This Is So Important
At the end of the day, Advisory Committees are hand selected by members of the FDA. These committees provide their opinions on whether or not a drug should be approved for marketing in the United States. While their opinions are not binding, it is very uncommon for the FDA to send a decision down the line with regard to approval that goes against the advise of these committees. So, if all goes well with the meeting, SAGE will likely rocket as investors see a strong chance of approval ahead. However, if the meeting doesn’t go well, the stock will likely tank as investors show concern for the outcome of the New Drug Application.
What To Watch For
One of the first lessons that we learn when we start to work in the market is that the news leads to moves. In the case of Sage Therapeutics, the news will move the stock as soon as the halt is lifted. The meeting is expected to run from 8:00 AM this morning until 5:00 PM tonight. Keep an eye on the documents that are released after the meeting for hints as to where the stock is headed next.
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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 SAGE. In particular, we’re interested in following the Advisory Committee meeting and the outcome of the meeting as it will likely prove to be a catalystic event. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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