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RETA:
I think this type of situation is always a possibility.
The drug's impact on eGFR was not in doubt, and was published in the NEJM paper. The issue is how you finesse a drug that increases mortality in the long term versus this short term trial outcome.
This is a prime example of a "catalyst" field of view versus a long term fundamental view.
I think AF is playing the long game here and positioning himself for a future SRPT outcome.
ARNA:
Weird data.
I'm a bit confused by the stats they used so can't comment on that and how it dealt with the baseline discrepancies.
But perhaps above all, I'm shocked that the arm with the prostacyclin analogue had better safety results. Especially when tolerability was a major issue at every step with this drug (and this class as a whole).
PRTO:
Their final P 3 tho is only with Radiocephalic fistulas and I believe at the highest ( 30ug ) dose .
INCY:
The individual ORRs across these tumors range from 33% to 39%, so there isn't a huge variance across the cohorts.
INCY / MRK / BMY:
INCY—Feuerstein should credit ‘poorgradstudent’ (@Ogut_Ozgur) for noticing the selective withholding of data from the trial in question.
Selectively withholding data is generally a bad sign (#msg-33973103, bottom).
CYAD / C-Cure:
Looking better with each news release. I thought C-Cure was dead. Will be interesting to see if they can find a partner. If they do, and the terms are favorable, CYAD share price (today) looks like a bargain.
SNDX:
The 23% RR in PD-(L)1 naive is pretty much the response rate for pembro / nivo monotherapy, isn't it?
Seems fluffy.
Re: FGEN/AKBA
That said, to be testing 2 different dosing regimens in phase 3 is odd and potentially problematic - e.g. how can you aggregate safety data across trials that way?
GLPG/INCY:
I actually like what Gilead is doing beyond RA if no major safety issues this could be a really big class of drugs (assuming FDA is actually going to approve another JAK).
Someone on twitter posted this about an investor call with the company.
Management noted that the issues ultimately leading to the CRL arose following the major amendment, but it was unrelated to the questions that originally prompted the additional data submission.
GLPG:
GLPG has a higher royalty (tiered starting at 20%) and significant milestones (was 1.35B at time of signing but that covers a multitude of indications).
JAK's safety profile. It was interesting in their 4 week studies filgotinib seemed to have a positive effect on Lipids but not in the 12/24 week studies.
For what its worth my impression from the press release was Lilly was going to try to do some sort of appeal by the wording of their opinion.
GLPG:
I'll be interested to see how filgotinib fares. I think it has a bit of an advantage on the hemoglobin issue.
Otherwise, I don't think there is any clarity on its AE profile being safer. Lipids, creatinine etc... appear to overlap with baricitinib.
But in any case, it definitely has taken a huge leap towards catching up and possibly overtaking baricitinib.
You are right; they are not the same. But are you here to make money or to make a point. You sound like you'd rather be right than be rich. LOL
FDA:
Agree. Apart from exceptions like SRPT (that had nothing to do with data), I think the FDA does an excellent job. Because of that, I'm genuinely curious what their concern is. Nothing obvious jumps out to me, but then again I don't have all the data the FDA do.
LLY/INCY:
LLY/INCY have a lot of work ahead to get Baricitinib approved
INCY
I am aware of the ruxolitinib data to date, so thank you.
I was more curious what ACRS intends to achieve (dew gave a view there), and how realistic that is.
Perhaps mcbio will give his thoughts.
ACRS:
I would appreciate a clarification on this one. As I said, my patents knowledge stinks.
- They're receiving patents on the use of someone else's compounds in a specific indication?
- If they have a novel compound with its own IP, why do they need use patents of baricitinib / juxolitinib? Is it in an attempt to block the latter two from being used in that indication?
- Incyte is moving ahead with a topical formulation in this indication. Is that due to these patent applications?
Kinases:
I appreciate this post.
I’ve argued for a while that the kinase inhibitors were generally pretty unpredictable drugs – because they were too unspecific
OT: Demand
The New Orders Index registered 65.1 percent, an increase of 4.7 percentage points from the January reading of 60.4 percent.
The Production Index registered 62.9 percent, 1.5 percentage points higher than the January reading of 61.4 percent.
Trump , if nothing else , has been successful in minimizing the growth of regulation ( remember the decree ..for every new regulation 2 old ones need to be removed )
All signs are they will now focus on some degree of tax reform including repatriation of funds held over seas.....all of which is good for Biotech.
OT: Market
When you look at the gains in some small-cap names (including several biotech stocks) since the US election, it seems that investors are expecting more than a token reduction in the US corporate-tax rate.
AKOA / PLSE:
Have not looked at either. I have a very small number that I track... 99% of bio investors are able to follow many more stocks than I am.
RETA:
Absolutely bearish on this. Their drug actually worsened outcomes in CKD (published in NEJM), and now they're trying to find a niche where increasing GFR will be sufficient.
The company claims they've identified the baseline characteristics of patients that were likely to be harmed by the drug. In effect, it was a subgroup that ostensibly drove the adverse events. Now they're omitting that subgroup in future trials.
It does raise one interesting question: are retrospectively defined subgroups more reliable for AEs than they are for efficacy going forward?
GNMX:
I expect that trial to be a "success" because that's how the narrative of biotechs works.
Hematological Malignancies:
This may be a quiz, but I'm trying to remember the last agent approved for blood cancers that did not show an objective response in its phase I.
Anyone have an example?
Irrespective of US corporate-tax rates and other changes, medical-device companies should come out ahead under the Trump administration since the 2.3% ObamaCare excise tax on medical devices (which is not tax-deductible) is likely to be permanently killed.
RE: Arginase / IDO / TDO
I don't really know. Hard to compare without clinical data.
At some point MRK could favour their own internal IDO and IDO-related drugs. I would think that *if* it gets to that, then the IDO class would have proven to be valuable.
On CALA's website, they note they've licensed things from Mars Corporation. I'm assuming this isn't Mars of Mars bars?
CD47/SIRP:
Are you suggesting there are concerns now about the viability of targeting SIRP-CD47 in general?
Reproducibility / SIRP-CD47:
The cancer reproducibility project is trying to reproduce select papers. The pivotal one from Weissman appears to have ran into some trouble.
AA / Patents:
I wonder if INCY has patents specific to use of JAKs for alopecia and related disorders or if ACRS could stand to benefit on this front (even if actually behind in the clinic).
Re: JAK / Alopecia
Early results seem promising. Doesn't appear to me that INCY and PFE are directly involved in these studies so perhaps ACRS is one of the few (only?) companies that is directly involved in pursuing JAKs for alopecia for now.
INCY / IO etc...
So you get that multiplicative effect of increasing the value of existing IO drug(s) that may have high efficacy like a PD-1 even with an add on drug that increases efficacy only a little bit, since that combo can now be differentiated from the crowd (even modestly so)
INCY:
When the initial data were released in 2016, we talked about how the market was overreacting on the downside.
At that time, I think people were looking at every incremental IO target as being on the order of magnitude of PD-1. Since then, there has been IDO-like "lackluster" data from a couple of the newer ones. I think people are recalibrating their expectations, with execution and time to market (rather than blowout phase 1/2 data) becoming key.
MYOK:
I'm still in wait and see mode. I remain unconvinced the company can effectively enrich their trials. I thought they were going to be very specific with their cardiomyopathy cohort (specific protein, specific mutation) but they seem to have moved away from that.
I like their approach of reducing the force of contraction better than CYTK's aim to increase. However, I'm not ready to place any money to back their efforts.
By the way . I found many of your posts / opinions in 2016 to be proven correct .
Big loss for dialysis patients.
PRTO:
I joked on twitter that it worked better than I expected. I was seriously expecting those two curves to be indistinguishable.
I don't suggest anyone go dumpster diving with this one. There isn't much hope left imo.
ALXN:
Am I being too cynical to assume that their departure for "personal reasons" helps protect their severance packages from being endangered by the outcome of the sales fraud investigations?
amyloidosis:
Organs but not the brain right?
In AD the “sink hypothesis” assumes equilibrium between peripheral and brain a-beta, so perhaps the "sink" is not as relevant in cns amyloidosis.
Sink hypothesis:
But in any case, I think the “sink hypothesis” has been discredited by the latest Solanezumab data.
PFE Trading Halt:
In addition to the corporate angle, I'm fine with a trading halt for something like palbo. It was a first in class drug with clear benefits, and the NDA submission was an early signal for the breast cancer caregivers.
The n+1th pd-1/pd-l1 drug isn't in comparable imo.
PRTO:
I think we're talking past each other at this point.
Good luck with your investment. I'll be curious to see how things turn out.