Wall Street Trader schreef op 18 september 2021 10:46:
The UK UC approval is expected a couple of months after broader Europe.
We await the MANTA trial results (now H1 2022)
to find out from Gilead about any US potential for the drug in UC and Crohn’s.
Crohn’s still actively recruiting whilst in the US UC data are waiting to be filed.
Also of note, they gave the timing for MANTA data (H1 2022), which we believe is a small push back (we were expecting trial completion Dec 2021 and data 1Q 2022).
In terms of the US approval for Jyseleca in UC and the trial and potential approvals in Crohn’s (data H1 2023), the company reiterated the ball remains in Gilead’s court. We would note that Gilead have not been sounding too positive on UC submission.
Galapagos announced earlier that Jyseleca should obviously reach breakeven. Galapagos thinks that they can get pretty close to breakeven with a fully loaded cost view as you go to the 2024 time frame.