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.
Although some analysts had suggested dosing was a risk factor, Gilead management had consistently expressed confidence in approval. Wall Street projected $2 billion in peak annual sales. For this reason, the drug became something of a litmus test for chief executive officer Daniel O’Day, who arrived early last year from Roche and quickly overhauled the leadership and began pursuing deals, mostly in oncology.
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Let’s don’t forget remdesivir fiasco in pricing, insufficient efficacy data, lack of interest or commitment for further large scale clinicsl studies, totally insane decision to license out to a Indian and Bsnf hkekafesh companies without collecting royalties, lack of transparency nor detail for manufacturing deal with Pfizer, lack of response to the State AG’s patent March in appeal to the GGS, and the list goes on. Martin and Milligan must be taking anti-depressants and or anxioolytics for the past genes months. Time for class action lawsuit by stockholders for apparent and dismal lack of due diligence in fiduciary duty obligation!