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.
i've noticed that motley fool has tried to be provocative in their titling, not just for MACK but for many other companies, and i think they do this to increase clicks and readers. They are useless, less so than Seeking Alpha (which depending on the SA author is saying something) and should be on everyone's ignore list.
It was an interesting call. The stock was all over the place today - but i think that had to the announced in licensing of the Ligand IRAK4 program, but that is so early stage (lead development, they are close to but don't yet have a clinical candidate identified) that it's not likely to yield any data for at least a year and a half.
are you the same dbag who chides me on my investment in TGTX? C'mon on over there and change your focus from here. I have even more shares in TGTX.
Just to clarify, the reason that Tarceva was returned to OSI was not because Pfizer did not want to develop the drug, it was because Pfizer was in the process of merging with Warner Lambert which had a competing EGFR inhibitor in development. Due to potential FTC concerns, Pfizer parted with the drug that was easiest and quickest to dispose of under the circumstances, and that was Tarceva due to the pre-existing relationship with OSI. Recall that OSI's stock tripled the day it was announced that they were getting full rights to Tarceva from Pfizer. I think the situation here is quite different - in this case, Sanofi has several expensive development programs (I have noted PCSK9) and likely simply decided to drop MM-121 due to resource constraints even though it likely still sees promise in MM-121. There are other examples that are even better than the Tarceva example - focusing on PFE, they outlicensed neratinib (now being developed by Puma). PFE, i am sure, knows that neratinib holds promise and will likely become a drug but likely outlicensed it due to resource constraints. All of big pharma takes this approach - limited R & D resources force it.