Benzinga -
- 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.
| Jan 2022 | HC Wainwright & Co. | Maintains | Buy | |
| Jan 2022 | HC Wainwright & Co. | Maintains | Buy | |
| Dec 2021 | Evercore ISI Group | Maintains | Outperform |
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