On Friday, SAGE Therapeutics Inc (NASDAQ: SAGE) ended up receiving some overwhelmingly positive news. The company said that an FDA advisory committee had voted in favor of approval of a New Drug Application. Of course, should the application be approved, it will represent another opportunity for the company to grow revenue. So, the news excited investors and the stock is running as a result. Today, we’ll talk about:
- The advisory committee review;
- what we’re seeing from SAGE stock as a result; and
- what we’ll be watching for ahead.
SAGE Announces Advisory Committee Review Results
As mentioned above, Sage Therapeutics is climbing in the pre-market hours this morning after breaking news on Friday that will likely lead to an FDA approval. Late in the session, the company said that the United States Food and Drug Administration Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee have jointly voted in favor of approval of a New Drug Application.
The committees voted 17 yes and 1 no, stating that the data support a favorable benefit-risk profile of ZULRESSO injection. The treatment was developed and submitted to the FDA as an option for postpartum depression when administered by qualified staff in a facility that has been certified under a Risk Evaluation and Mitigation Strategies program. In the release, SAGE said that the vote in favor of approval was the result of positive safety and efficacy data that was generated through three placebo-controlled clinical studies.
In a statement, Jeff Jonas, M.D., CEO At SAGE, had the following to offer:
We are pleased the FDA Advisory Committee agreed that the benefit/risk profile of ZULRESSO supports this novel approach to treating PPD, reflecting the need for an innovative treatment option that may rapidly alleviate suffering for women with PPD and their families… This is another step forward in Sage’s effort to maximize patient benefit by bringing game-changing new treatments to the market.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that it’s important to keep a close eye on the news. After all, the news moves the market. In the case of Sage Therapeutics, the news proved to be overwhelmingly positive. After all, a positive vote from the FDA’s advisory committee(s) generally leads to approval by the FDA. Sure, the Advisory Committee isn’t the end-all-be-all, but it is very rare for the FDA to make a decision that goes against advisory committee recommendations. So, it only makes sense that investors are excited as they see the potential for an NDA approval down the line. As is just about always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:45), SAGE is trading at $146.00 per share after a gain of $8.45 per share or 6.14% thus far today.
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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 story surrounding ZULRESSO and the company’s attempt to bring it to patients in need. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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