FDA orders Incyte to hold up yet again in the hunt for blockbuster franchise
Incyte $INCY will have to wait somewhat longer to find out the fate of its pitch to market ruxolitinib cream for the treatment of vitiligo.
The big biotech announced early Monday that the FDA had had asked for more input on the sNDA, forcing regulators to push back their PDUFA deadline from April to July — a standard 3-month delay.
SVB’s Andrew Berens is taking the news in stride. He observes:
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.