Opop schreef op 29 oktober 2018 21:53:
The other material issue that has unfortunately moved down from the "good" category to meh (my opinion) is the major pipeline drug filgotinib. This always had a bit of a long slog to be very material to GILD's financial results, given my rough estimate that the drug's inventor, Galapagos (GLPG), is in line for about a 30% cut of the action. But the drug was showing excellent Phase 3 results in RA and strong Phase 2 results in two other important autoimmune diseases, and I've been carrying filgotinib as having a smallish but material positive value for GILD. However, what was assumed to be a minor irritant to the filgotinib story was a known problem in animal studies regarding male fertility. This necessitated a safety study. The study GILD chose is called MANTA. During the conference call, GILD disclosed in its prepared remarks that:
... enrollment in MANTA will likely be the rate limiting factor to filing an NDA in the United States. While we have been making every effort to expedite enrollment, the full impact of the efforts and their impact on the overall timeline are uncertain at this time.
In response to a question on the matter from Geoffrey Porges, GILD's head of R&D, Dr. McHutchison, did not make anyone feel better when he provided color on this issue:
We have spent an inordinate amount of effort trying to enhance the enrollment in the MANTA study. It's too early to gauge the effectiveness of those modifications to inclusion criteria, et cetera. I think we'll provide an update in the future when we can have more clarity about the timeline. I will say we are having discussions internally and with regulators about different options...
This is not good. Filgotinib has been a major part of the otherwise yucky GILD pipeline - basically the major part except for hopes for the Kite-related pipeline.
So I would average the otherwise good/great filgotinib story with this rather ugly news and now get to neutral. If a drug launches much later than several members of the competition, it has to be that much better to do very well. At about a $90 B market cap, GILD needs big hits to move the needle enough to care about a pipeline possibility, and now it is under a cloud.seekingalpha.com/article/4215555-gile...