The surprise decision by the FDA to reject a Gilead Sciences (GILD) drug for treating inflammatory diseases is clearly a setback for the biotech. The question now, though, is whether Gilead can still be considered a turnaround story that can diversify beyond its core virology business and return to growth levels seen in the past.
First, let’s recap the news: The agency issued a complete response letter for filgotinib, a JAK inhibitor drug to treat rheumatoid arthritis, but wants more data on the effect on patient sperm counts. In particular, the FDA is concerned about toxicity for a 200mg dose. Gilead is running two studies to answer those concerns, but results are not going to be available until the first half of next year.