INCY PDUFA

The FDA postponed this decision by 3 months so that they could review data that was submitted late by INCY.  Subjectively, INCY had the option of pulling the plug on the PDUFA decision if they thought they needed to collect new data.  In this case, they determined that if they submitted data late, it would be worth the delay that would result.

Runup traders might find a lot to like about this one.  Having additional time for the FDA to review the data gives the optimists plenty to work with in the weeks ahead of the decision.  Using the 1 hour and 4 hour technical indicators (MACD and Williams %R especially), runup period traders (buy the rumor, sell the news type traders) will be able to key in on the point when optimists take hold of the narrative, and the price action reflects that.  This group of traders is likely to exit that trade BEFORE the actual PDUFA date, as even good news from the FDA doesn’t necessarily lead to a stock price increase.  Traders are keenly aware that approval in one stage leads to expenditures in the next, and the money to spend needs to come from somewhere.  Stock offerings are often the method companies use to raise the money needed, which can lead to traders selling it off right as the good news hits.  Having insight on the companies cash burn rate and cash position at the last Earnings Announcement would be key information worth looking up for these traders.

Event traders would want to know information about previously released Data, both safety and efficacy.  They would also monitor the price action leading up to the event.  If the price has been rocketing, some of these traders may opt to stay away from an Event trade.

Link to PDUFA PR: https://www.biospace.com/article/releases/incyte-announces-u-s-fda-has-extended-the-supplemental-new-drug-application-review-period-for-ruxolitinib-cream-opzelura-for-the-treatment-of-vitiligo/