- Wednesday, the FDA approved TG Therapeutics Inc's Briumvi (ublituximab-xiiy) for relapsing forms of multiple sclerosis (RMS).
- Briumvi is the first and only anti-CD20 monoclonal antibody approved for RMS that can be administered in a one-hour infusion following the starting dose.
- TG expects to launch Briumvi in the U.S. in 1Q23 commercially.
- HC Wainwright reiterates a Buy rating for the stock with a price target of $24, up from $19.
- The analyst writes that a faster infusion time could enable Briumvi to gain share quickly, and there could be a large opportunity in this indication for a small disruptive sales force.
- In the U.S., it is estimated that the top 550 accounts account for >70% of patient volume. A potential European approval could occur in late 2023.
- Management has previously noted that about 20% of the global MS sales market for CD20 inhibitors could come from Europe, with the German market being the most important.
- Management has not yet decided whether it will partner with Briumvi in Europe or go alone.
- HC Wainwright estimates sales of $46.1 million in 2023 for Briumvi in MS, growing to $558.8 million in 2028.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.