They've had a host of releases but this move, just noted on CNBC feels like something else. Could it be that they and INCY are together in Italy talking more than Bari? Oh the possibilities!!!
Sounded as good as it possibly could be. If it was only Incyte running the show, that would definitely be enough to start the filing. But it's easy to see how Lilly wants everything in place. Remember the slow initial roll-out of Jakafi? That is NOT how you introduce a super blockbuster. And make no mistake: this has the potential to be the world's biggest selling drug [pause for breath]. With good management, they can start selling in US, Canada and Germany pretty much simultaneously. And the way the safety profile looks right now, they can have 80% of the anti-TNF patient population switched over within a year. Even one of the adverse events looks favorable: the TB patient who got into the study didn't worsen dramatically with treatment.
The difference in safety results between the RA and diabetic nephropathy trials, while modest and expected (since the drug is excreted in urine, damaged kidneys means more exposure at the same dose), is going to need investigation.
Very faint impression: as in MF, a little more JAK-1 inhibition might be a little better. The pharmacology of Bari is SO good that tweaking the molecule doesn't look promising; combination therapy adding a JAK-1 specific agent may be an eventual follow-on.
Will someone please expand the acronym 'MACE' for me; I can see that it refers to circulatory events, but it isn't in my usual acronym dictionaries.
For the buy-out fans: I think this moves the lowest successful tender price up to around $190, with an auction plausibly going twice that high. NOT a genie I'd choose to free.
think we might have turned the tide. Anyone that listened to presentation this morning would be a buyer thats for sure.... I think eventually LLY buys us out....
MRDTINO; I am puzzled every time I check CALL option lists ...this GEM has great fundamental and clear important announcements coming this year on high bullish probability plus possible M&A ....ALL these catalysts, why people are not betting with CALLs? I am not CALL player but like to see heavy participation,buyers ...that gives me more confidence in selling NAKED PUTs...Dec,Jan has hugh pay offs at near current price for strike......Looks too good even PPS stay flat, rewards are pretty good . You can't make more than option fees in case of buyout offer but when hold together with longs, it's great money making strategy ...when stock is loaded with pending bullish fundamentals (clinical goals this year)
Joint disease. Psoriasis. I'll leave the "label" talk to Jacosa and Sooz. 52 week study release seems to be the key for safety, etc...but agree Maddi...all indications our GEM seems to have got something good here with Lilly. Still perplexed as to why the Lilly's, Novartis' and Pfizers of the world aren't clammering to take this GEM and add it to their collection, unless they're each sending smoke signals over to them!! Upgrades with price movement North would be nice!!
just listenned to call as well. LLY guys were very upbeat and positive. Mentioned we will get data on the last 2 P3 early in the 4th quarter with submission late this year or early 2016. After listening to call my gut is we get several upgrades in next couple of days. Also mention of diabetic nephroposy..... very positive on that front as well. just my 2 cents worth.
mrdtino; I am smelling same....not too bad of morning...early morning down swing is getting milder ..hope it's not due to strong background.. selling pressure drying up...today's closing in my mind is green.
I'm trying to talk FDA, which can get COLD. And sometimes drug selling gets even colder. Remember Vioxx? When its risks got defined, it took down pretty much the whole class of COX-2 inhibitors. Pretty much only Celebrex survived, mostly because Pfizer moved early and vigorously to establish that it had the best safety profile of the group (For those who weren't around: even Vioxx was probably safer, net of everything, than out-of-class comparable drugs, but the risks were sort of novel). Xeljanz is already problematic (partly for real reasons, but probably mostly for accidental ones) and "guilt by association" is pretty much the biggest risk to Bari's super-blockbuster potential.
On the bright side, it now looks a lot more likely that Bari gets a commercial name tomorrow.
qui; if i did not own so many shares &option in GEM ,i will be buyer here...what a good chance with many positive factors pushing upward....risk/reward is exceptionally good... also ACAD looks sure winner...only question is NDA
safety data is an acceptable and telerable level.... keep in mind that current treatments of biologics(non hodgkins lymphoma risk) methotrexate(liver and lung toxcity), steroids(liver and weight issue to name 2 of many)..... I view the abstracts as a "home run" and think the filing/acceptance will be much sooner. at the very least, approval for patients that failed previous treatments.
p.s. as a person with ra... the comment about lives not being endangered while true is not reflective. left untreated you have the joint damage, disability, depression and guaranteed premature death. not to mention, many patients suffer from drug and alcohol abuse.
i bought massively this morning!
Still low volume trading in INCY. LLY turned to green for the day looking for INCY shakers to get out of the way and we will be green.
Sentiment: Strong Buy