Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
At this point, even if they did another Phase 3, it would likely be throwing MORE money down the drain considering MetMab is likely to succeed in the patient set that tivantinib would be most suiited for. Ergo, tivantinib in NSCLC is a goner.
Didnt they basically say on the conference call that they were all done in NSCLC
Agree with this assessment. It's really what continues to worry me the most: the macro. I have plenty of time to get more ARQL if I really want it - its gonna be a long time before people get excited about this company after this blowup. Hell, you even had one sellside guy quoting that with this failure, the entire program is up in the air...which isnt true.
I have been wanting to step back into ARIA in a good way, and always looking for my spot. I just think that, heaven forbid, there is some really spooky event that kills the market, they're going to crush the leaders, at least for a scare-all trade.
Yeah, but what's another Phase 2 trial worth? 20% pop, or 50 cents or something?
They're so far off from approval of a drug right now, and, after this debacle, it's questionable if they can even properly design a trial (although, they spent tens of millions on this NSCLC trial and hopefully learned from their sloppiness). This likely trades between $1.50 (tax loss dumpage), and the higher gap ($5.00) over the next 18 months (if we're lucky). $5.00 wouldn't be bad, it's just not going to be anything of a home-run (like it would have been had they succeeded with MARQUEE ie., $15-20 stock) over the next 18 months - like I said, mainly Deadsville.
Agreed on tivantinib being an active drug. Question relating to the stock is: do you average in here, or wait until this thing gets whacked some more due to EOY selling for tax purposes (this is gonna be a big harvest for this name). With +$100 million in cash, and a marketcap around $150M, if you have time to wait (and a lot of time), this market-cap level (and lower) is very compelling. But, it's Deadsville money for a long time.
Just can't have any more sloppy/lazy trial designs. It's a shame; they probably could have really had a good result here had they done a better design with a more specific patient population.
IMO, management probably leaked a conference call schedule to someone, who told someone else, who told a trader, who told, etc etc.
If you're a shareholder from $4-7-10, and you get wind of imminent binary data within 12-18 hours, I think you're probably crazy not to take some profits off the table and derisk, instead of, in the event of bad news, doing a round-trip back to $7.00.
SRPT Wednesday 8:00 am conference call
CAMBRIDGE, MA, Oct 02 (Marketwire) --
Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a developer of innovative
RNA-based therapeutics, announced today it will hold a conference call at
8:00 a.m. EDT (5:00 a.m. PDT) on Wednesday, October 3, 2012 to discuss
48-week results from its Phase IIb study evaluating eteplirsen for the
treatment of Duchenne muscular dystrophy (DMD).
The conference call may be accessed by dialing 866.356.3093 for domestic
callers and 617.597.5381 for international callers. The passcode for the
call is 93880948. Please specify to the operator that you would like to
join the "Sarepta Therapeutics 48-Week Results Call." The conference call
will be webcast live under the events section of Sarepta's website at
www.sareptatherapeutics.com and will be archived there following the call
for 90 days. Please connect to Sarepta's website several minutes prior to
the start of the broadcast to ensure adequate time for any software
download that may be necessary.
About Sarepta Therapeutics
There are people on this board a lot smarter that you or I who were long ARQL. So was Ohad Hammer
And, as usual, you slice and dice words.
Perhaps I should have said in the original message post: Daiichi isn't known for preclinical through late stage development of oncology drugs - they're more of a CV company. Hence, their description on their own website as "We currently market therapies in hypertension, dyslipidemia, diabetes, acute coronary syndrome and metastatic melanoma." (the last of which they got through acquisition - not because they developed it internally in any early stage of the development.
If I knew I was being graded on language wording here, I probably would have been more careful.
He knows he fucked up badly and was apologetic about it
True; which they bought- after it was already well into development. Daiichi more a CV company - not oncology specialist.
Daiichi isn't an oncology company, not even in the slightest. To me, their trial design was either laziness, or greediness.
Really helps to have a company with real oncology experience as a partner.
P.S. Pucci's ruminations on Phase II and III trial designs in cancer are interesting to listen to.
prospective study of charts and how they predict phase III outcomes
Just so I'm clear, are these the same charts that were telling investors PPHM was an up and comer?
Somehow the results were known to some traders for awhile
Tivantinib: who here thinks this drug isn't an active drug in NSCLC versus this just being a case of incredibly stupid trial design? The way they designed this trial has been argued here many times
I say the latter, by a mile.
Well?
Chart had been telling the "story" on this for past few weeks; so did the very bearish options print.
Daichhi Sankyo is the kiss of death for any oncology partnership.
Surprise surprise.
stock action been saying this has been coming for weeks.
Unreal
Given the way the MARQUEE trial is stratified, sub-groups etc and the secondary endpoints....could it be possible if the overall population failed to meet the necessary endpoint, but the secondary endpoints showed positive endpoints? Can they submit that to the FDA for approval in subtypes, or would you think they would be required to do another Phase 3?
Yeah, I hate ARQL so much I'll be buying more as well :)
$300m seems very low.
I was under the impression that non-squamous (the patients that are being screen for only inclusion into the MARQUEE) are high c-Met, no?
In retrospect, it does seem incredibly silly that they would not have tested specifically for high c-Met NSCLC patients ONLY (and not simply going for an all-comers type of non-squam NSCLC) using a diagnostic.
Wrong stock.
Pig and a dog is ARQL, not EXEL.
Maybe you have your ARQL chart upside down?
LOL, I think this was a very good weekend for EXEL at ESMO.
Zelboraf+MEK moving directly from P1b to Phase 3, and the CRPC results at 40mg are looking pretty darn good.
http://twitter.com/drsteventucker/status/252344221007233024/photo/1
ARIA
ARIAD Completes Rolling Submission of New Drug Application for Ponatinib to the U.S. Food and Drug Administration
http://phx.corporate-ir.net/phoenix.zhtml?c=118422&p=irol-newsArticle&ID=1739175&highlight=
ARIAD Completes Rolling Submission of New Drug Application for Ponatinib to the U.S. Food and Drug Administration
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep. 27, 2012-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced it has completed the rolling submission of the New Drug Application (NDA) for its investigational BCR-ABL inhibitor, ponatinib, to the U.S. Food and Drug Administration (FDA). ARIAD provided the FDA with remaining chemistry, manufacturing, and controls (CMC) data. ARIAD is seeking U.S. marketing approval of ponatinib in patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). The Company has requested accelerated approval and a priority review of the ponatinib application by the FDA.
“In late July, we submitted the NDA for ponatinib ahead of schedule and, at the request of the FDA, in advance of having the final CMC data. We look forward to continuing our progress towards making ponatinib available to patients with CML and Ph+ ALL,” stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “If approved, we believe that ponatinib will become an important new medicine for CML and Ph+ ALL patients who have become resistant or intolerant to prior tyrosine kinase inhibitor therapy.”
ARIAD anticipates approval and commercial launch of ponatinib in the U.S. in the first quarter of 2013. Also, the Marketing Authorization Application (MAA) for ponatinib, submitted in August, has been validated by the European Medicines Agency (EMA), commencing their review of the application. The Committee for Medicinal Products for Human Use (CHMP) has granted ARIAD’s request for accelerated assessment of the MAA.
Have you seen an instance where insiders have ceased these type of sales only to see later there was a "material event" which was the reasoning for the cease of sales?
Further, if there is, in fact, a "material event" is this a legal obligation for them to stop selling, or is this just a personal trading decision by the selling party?
FWIW In practice I count such touting as a strike against a company because it either indicates sloppy understanding or a hyping attitude.
weren't people expecting the event to occur in August or September, and is ARQL now inferring it occurred in July?
If that is the case, I don't see how this is bullish for MARQUEE
BTW, OMG...I can't believe they let this guy speak (I am listening to the UBS call right now)
If they did meet the event 2 months ago, then a data read-out should be forthcoming very shortly, I would assume.
Unless Daichii is going to pull a Merck KGaa (ONTY) and tell investors that it was a continue at their earnings call...
The co announced last week (at UBS) that it has been couple months since the MARQUEE trial hit 375th event
ARQL. OK, my bad. It's a great looking chart that has performed exceptionally this year. 8.32 to 5.00, it looks like MARQUEE is a sure bet for success.
Any comments?
ARQL - Any comments on this dog?
Big options print last week was incredibly bearish, and with .BTK near all time highs, this pig is nearing its '08 lows, which clearly isn't positive if you believe MARQUEE is going to be successful.
The trading is indicating liquidation and zero buyer interest.
Michael Gray is a big problem for shareholders, plain and simple.
Look at the history of poor performance and the same executives. It's clear as day.
Can you tell me if Michael Gray has ever bought a single stock of Curis in the open market? I cannot. He's a freeloader and really bad for shareholders.
What large pharma do you think has the best pipeline? Bristol with their oncology program (the parts the acquired from Medarex), or Roche, or...?
on dips
OK then. The high MST must be because of poor ECOG misrepresentation and a large amount of Eastern European testing centers then, correct?
ONTY
Let me guess. These results are the result of arm-inbalances, correct?
Does anyone think the halt due to death in separate study had anything to do with the fact the START trial didnt halt for efficacy at the interim?
No one knows for sure what effect this had due to dropouts, new patients, etc., etc.
Where did this come from? ESMO?