Unfortunately, there are several months between now and ASH, and it looks like the stock will decline steadily until it settles - probably around $7.5 - $8. i have not sold - and i am surprised given what i interpreted as positive results - but it seems that others read the data a bit differently.
potentially months away - at the ASH conference in December. So if you are thinking of getting in, might be worth waiting a bit and letting it settle. I could go down a bit. i'm in and staying there.
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."
This from Fiercebiotech: But a black-box warning on the drug's label could stand in its way. Zydelig has been linked to fatal and serious toxicities of the liver, according to the FDA, and its packaging spells out risks of severe diarrhea, colitis, pneumonitis and intestinal perforation. Whether that'll seriously affect its market potential remains to be seen, but investors are taking the warning seriously: Gilead's shares stayed about flat on the announcement, but Pharmacyclics' shot up more than 10% on Wednesday morning.
Within the 1101/1202 results this week was mention of higher response rates for certain indications where 1202 was dosed at the highest dose available in the study. This sort of supports TGTX's effort to modify the 1202 dosage to achieve higher exposure levels. It's still speculative at this point, but this approach could provide a clinical benefit and differentiating benefit relative to other PI3K deltas in terms of exposure levels and clinical efficacy in addition to the already known safety benefit of 1202.
PBYI ph III data related to HER2+ EARLY stage BC patients. The data looked great, and that's a big patient population. MM398 looks good too but in a smaller patient population - 2nd line PC. MM121 still has promise - i'm waiting for the triple negative BC results. When are those due?
while i think the data was positive, i think some were expecting even more in terms of efficacy. I don't think the sell off is simply a buy the rumor/sell the news thing - i think it's a fundamental reaction to the data by some fund investors and retail investors.
Maybe if the data readouts continue to be as positive as they have been. At the end of the year, after ASH, at earliest, but i honestly hope it doesn't happen until much later because i think this company could have a $2B market cap if the data plays out as i hope.
And that price target should go up significantly as more positive data is released related to 1101 and 1202. If 1202 continues to prove to be as potent as idelalisib BUT with lower adverse events (particularly in terms of liver toxicity and potentially also other AEs such as cholitis). It is possible that 1202 may prove to be even more effective than idelalisib if the new 1202 micronized formulations do in fact lead to greater exposure in patients as TGTX's CEO hopes.
Here is what one analyst said today about Gilead's Idelalisib (and consider that these arguments could apply equally to 1202): We are raising our long-run idelalisib estimates from $773m in 2019 (vs $1.1bn consensus) to $1.5bn in 2019. We now assume $1.2bn for use in CLL /iNHL and a heavily risk-adjusted $300m (20% probability of success) for its possible use in immuno-oncology (I/O) drug combinations that target solid tumours, given the highly promising pre-clinical data showing the pivotal role that idelalisib's target PI3Kδ plays in't reg cell suppression of the anti-cancer effect of CD8+ T-cells.
Or maybe just TGTX's famous volatility - you never know. Anyway - the $10.15 AH trade was just 325 shares. I expect TGTX to be all over the map, up and down, until the next data release in mid July.