Partnering MM 121 - now where have i heard that before? Believe it when i see it. Base your investment in MACK on MM 398 and the rest of the pipeline, but not on the speculative prospect of partnering MM 121.
i actually owned Aveo right when it went public. I bought it at 8, it went as high as about 21, and then i sold it at 14. It's been down hill ever since, primarily because of poorly designed clinical trials. Their drug - tivozanib - is really quite active and selective for the VEGF isoforms, as active as PFE's Inlyta (at least), but Aveo screwed up the trials. The CEO should have taken a huge hit on this - but to my knowledge has not. I see that the stock went up 30% today based on a conference call outlining a benefit in colon cancer in patients having a particular biomarker - if this is true (or proves true in a subsequent trial based on the biomarker), then you are correct that it is undervalued.
i thought that Alan Auerback founded and was CEO of Cougar (and now Puma)
Are you talking about Auerbach (currently at Puma)? Majority shareholder of which firm?
Wait now - the phase III includes imbruvica so the overall safety profile that combo at least will be roughly same as imbruvica. The key there is an improvement in efficacy. Then with the 1101 + 1202 studies - look for at least some improvement but better safety. And finally, with the triple therapy - look for tolerable safety (won't be perfect - we are using three agents) but efficacy in some rituxan refractory patients and even some imbruvica refractory patients (that would be big if continues to appear in larger patient pool)
ARIAD's CEO owns about 3.5 million shares of ARIAD's stock, which at today's price is worth about 25 million. A few years ago, when the stock was 4 times higher, it was worth about 100 million. Just because the CEO owns a lot of the company's stock doesn't mean he/she will undertake a development or commercial strategy that will lead to further stock gains. Clearly, ARIAD's CEO didn't do the right thing. In the case of TGTX, Weiss thinks he has two clinical assets that will transform TGTX into the next Pharmacyclics - my point is that this might be an overly ambitious strategy and could be undermined as other clinical trials involving ibrutinib in combo with other agents read out.
I've been tied into big pharma for 26 years - it better be clear on its face or big pharma will move onto another deal. Look - I own a lot of TGTX and am a big supporter, I just raise these issues to spur debate and see if anyone has a helpful view. I don't want to see TGTX go the way of AVEO which also had a very active drug but screwed up the clinical development. See also ARIAD for an example, but in that case the drug had a pretty bad tox profile so not as compelling as an example. I'm just saying that even with a good clinical asset, you have to think very carefully about the development pathway
Yep - and if these studies show results comparable to TG-1303, then what? You can point to a better safety profile for TG-1303, but there is the risk that physicians will view the other combinations as "safe enough". Hope we show differentiated benefit beyond simply being "somewhat safer"
Clarification - ibrutinib is indicated for CLL in patients who have received at least one prior therapy or first line in CLL patients with 17p deletion. But again - ibrutinib is essentially becoming std of care in this setting so the above comments stand.
1st line CLL is interesting because TGTX would only do it if they thought they could be better than ibrutinib in terms of overall safety and efficacy. At a minimum, you would want to be as good in efficacy and a bit better in safety. But the home run would be better - even just a bit better - in both efficacy and safety.
Might be that the stock has put in a bottom in the 12-13 range, rather than the 10-12 range, so I might have projected too far to the downside. I was happy to see the data related to 1101 + 1202 where 1202 was dosed at 800 and 1200 micronized and demonstrated higher patient exposure than idelasib. That is the type of potential efficacy differentiation that can be very helpful (can't just be a low tox story, in my view). I am watching Pharmacyclics to see what they reveal in terms of ongoing studies for ibrutinib. They have a number of combo studies ongoing - and my hope there is that none of them overly raise the bar for TGTX. In other words, if they release data showing high efficacy for ibrutinib in combo with another agent (besides TGTX's candidates), then that could impact how TGTX's prospects are perceived. I haven't seen anything negative on that front yet, however.
i actually thought it was pretty good and look forward in particular to further data on TG-1303 where 1202 is dosed at 800 micronized and 1200 micronized. The data there might be very compelling. Also, i am wondering if they will be increasing the dose of 1202 in the triple therapy (ibrutinib, 1202, 1101) because it is currently 400 micronized and might be much more effective at 800 micronized (without appreciable increase in AEs except maybe an increase in neutropenia).
i probably over state it with regard to 121. Yes, i agree that a proper biomarker designed phase III for 121 would very likely be successful and promising. But MACK can't seem to strike a deal with 121, and i wonder whether their expectations are too high. The patent life is running on this asset - but that is ok at least with respect to the US, EU and JP where data exclusivity will provide an adequate amount of time. MACK needs to get a deal of some type and not necessarily view this as a "lipitor-esque" opportunity for the other party because competition in area is growing, particularly in breast cancer.
Sorry - TGTX has further to fall, like I said - 10-12 range. I doesn't help that the overall biotech market is cratering, Gazyva is doing great (Roche just stopped a trial for indolent NHL due to high benefit seen for Gazyva - and other trials ongoing), and TGTX's Weiss seems distracted by pursuing an IRAK4 program where he has no leverage relative to competitors in the area.
Really? i'm staying long but the stock is now well below 13 and 12 isn't that far away. I'm not a fan of iluvcorruption but I think he's right that it'll go below 12 sooner than you think. I wouldn't add until the stock hits 11s
i think it's more than the ATM - as i said, nice clinical assets but likely decline to 10-12 range until possible share appreciation near or post ASCO