- TG Therapeutics Inc's (NASDAQ:TGTX) shares are plunging after new data showed that ublituximab /Ukoniq showed an elevated risk of death in the phase 3 Unity combo trial for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL)
- HC Wainwright has slashed the price target from $68 to $19, with the Buy rating unchanged.
- Analyst Edward White writes that with TG stepping back from its oncology franchise and performing a full portfolio review, all focus is now on approval and launch in relapsing forms of multiple sclerosis for ublituximab.
- The analysts noted previously announced ublituximab data that exhibited an Annualized Relapse Rate (ARR) of 0.076 compared to 0.188 for Aubagio in the ULTIMATE I study, representing a relative reduction of approximately 60%.
- In ULTIMATE II, ublituximab resulted in an ARR of 0.091 compared to 0.178 for Aubagio, representing a relative reduction of approximately 50%.
- The FDA accepted the BLA for ublituximab for multiple sclerosis (MS), with a PDUFA date of September 28.
- White believes that a faster infusion time could enable ublituximab to quickly gain share and acknowledge that the company might use price to facilitate patient access.
- He estimates sales of $5.6 million in 2022 for ublituximab in MS, growing to $559 million in 2028.
- Price Action: TGTX shares are down 23.7% at $6.76 during the market session on the last check Monday.
