Bert12345 schreef op 19 februari 2021 12:44:
We anticipate a year filled with announcements on regulatory developments with Jyseleca as well as progress in our deep pipeline
of novel target-based candidates.
In early 2021, Jyseleca received a recommendation by NICE in the UK for use in moderate to severe active RA patients. This is a
landmark decision, as Jyseleca is the first JAK inhibitor and first advanced therapy recommended by NICE in the moderate
disease population. Going forward, we anticipate reimbursement decisions in most key European markets for Jyseleca in RA this
year, as we complete the transition to a full European commercial operation by year end. We anticipate a Committee for
Medicinal Products for Human Use (CHMP) opinion and a European Commission (EC) approval decision for Jyseleca in UC, as
well as Gilead’s submission for approval of Jyseleca in UC in Japan. We expect to update the markets on the MANTA/RAy
semen parameter studies, which determines the path forward for inflammatory bowel disease (IBD) indications with Jyseleca in
the U.S. We expect that our collaboration partner Gilead will complete recruitment for the global DIVERSITY Phase 3 trial in
Crohn’s disease this year.
Within our broader inflammation portfolio, we expect to report topline results from several trials this year, including a Phase 1b
trial with TYK2 inhibitor ‘3667 in psoriasis, a Phase 1b trial with JAK1 inhibitor ‘555 via intra-articular injection in OA, and
three proof-of-concept studies with lead Toledo candidate SIK2/3 inhibitor ‘3970 in psoriasis, UC and RA.
Within our fibrosis portfolio, we expect to progress early clinical compounds with novel mechanisms of action, casting a wide net
with the aim to develop novel treatments to help patients suffering from this debilitating disease.
Following the very recent discontinuation of the ziritaxestat trials, we aim to review our plans for 2021, after which we expect to
give cash burn guidance for 2021.