Insider schreef op 29 oktober 2020 22:31:
www.evaluate.com/vantage/articles/new...Gilead is to discuss with the FDA by the end of the year what might be done with Jyseleca in RA. If this suggests that it is a no-go, Mr Persay said two options were on the table: abandoning Jyseleca in RA but moving forward in Crohn’s disease and ulcerative colitis, or giving up any attempt to get the drug to the US market in any indication.
The company is awaiting data from the Manta and Manta-Ray studies looking at the testicular safety of filgotinib in inflammatory bowel disease and various arthritic conditions respectively. It will decide once these are out at the start of next year.
As for another programme that originated with Galapagos, Gilead said it would decide whether to opt in to the "Toledo" assets once they are “de-risked to the appropriate level”. Gilead has the option to buy ex-Europe rights to these candidates, now confirmed to target SIK1, 2 and 3 kinases, for $150m per programme plus royalties.
“If you saw, hypothetically, a huge response in one indication that was really unexpected and blew it out of the water, we might opt in more early,” Mr Parsey said. Clinical successes on that scale are exactly what Gilead needs; time for investors to cross their fingers.