Tgtx
This from Roth today regarding Zydelig's approval: Analyst Joseph Pantginis commented, We believe that Zydelig's approval is positive for TGTX in that it lays the regulatory groundwork for TGR-1202, and we see significant advantages for TGR-1202 over Zydelig, including safety and dosing. First, Zydelig was issued a black box warning regarding the risk of fatal and serious toxicities including hepatic toxicity, severe diarrhea, colitis, pneumonitis, and intestinal perforation. We believe this broad boxed warning will lead docs to be cautious with this drug. In studies to date, '1202 has been shown to have a significantly improved safety profile, especially that it does not significantly raise liver enzymes to date. In terms of dosing, '1202 is dosed once per day versus Zydelig and others, which are dosed twice per day. In addition, doctors have been quite vocal that they would like to see the approval of as many PI3K inhibitors as possible to give them options for patients. This approval comes on the heels of TGTX's presentation of data from the combination study of TG-1101 and TGR-1202 at PPLC, in which 100% of CLL/SLL patients saw significant nodal reductions and two out of five DLBCL patients achieved a PR. The combination was well tolerated with no DLTs to date as well as no ALT/AST liver enzyme elevations. We look forward to additional data readouts from the company's single agents and 1101 with 1202 combination studies at ASH in December this year."
