This week we are featuring Sage Therapeutics. The company has upcoming PDUFA data for their GABA program in MDD and PDD. The program is currently partnered with Biogen and together they have shared a number of P2 and P3 studies all of which confirm therapeutic benefit. In MDD the data is a bit underwhelming, but should still be supportive of approval, particularly in light of recent FDA decision making. On the PDD side it is a no brainer and near certain to be approved. Since this outcome is pretty much a foregone conclusion we do not see much potential for significant reaction from the larger $BIIB. However, $SAGE is likely to see some movement on price action.
Every Monday we are out with public biotech research, profiling biotech companies with near term catalysts. This will focus primarily on the major market moving biotech events such as data readouts from the major scientific conferences as well as potential regulatory approvals.
We will not offer specific trading advice (and we do not hold any publicly traded biotech equity), but rather flag emerging events that will likely materially drive stock prices (sometimes +/-100% in either direction).
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HOW TO PLAY BIOTECH APPROVAL/DATA READOUTS ANNOUNCEMENTS
While biotech equities will move on news of announcement, often if there is high conviction in a positive read, a large run up ahead of the news will occur and the actual event turns into a sell the news event. Sometimes, investors wait for the actual event to make a long/short decision. And obviously if the news is disappointing (more often than not) the stock will tank.
This is not financial advice so you will have to make your own call on how to best play these events.
ALERT: Sage Therapeutics ($SAGE) GABA MDD/PDD PDUFA
DATE: August 5th, 2023
IMPLIED VOLATILITY: +30%
BACKGROUND:
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