Wednesday, the FDA approved TG Therapeutics Inc’s (NASDAQ: TGTX) 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.
Price Action: TGTX shares are up 18.30% at $10.01 on the last check Thursday.
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