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.
Hmmm, sounds like a job for Matt Foley, Motivational Speaker.
How Harvey really felt at the end of the GS presentation.
True, if CELG acquires a majority of the outstanding CELGZ shares, they can force the remaining shareholders to redeem at the average price paid to acquire the 51%. However, in practicality, given the low float/lack of liquidity, it would likely be difficult for them to acquire the shares "on the cheap."
LOL, ever the optimist.
The FDA will send a CRL to MRK/ARIAD who will then issue a PR. Since the news is already factored in, for all practical purposes, it's a non-event.
Well, to be fair, you also made the argument that the stock was overvalued when it was trading at $11.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=68938352
I'm not aware of any bad news...the data released yesterday found no safety issues associated with CPP115.
Obviously I spoke too soon. The stock is getting pummeled today. It appears the company was unable to raise the full round which raises the uncertainty around whether they'll be able to progress the pipeline far enough to attract a partner.
Jan, sorry for the delay in getting back to you...somehow I missed your post. The news today was the first step in what ultimately will end in a partnership for CPP-115. While today's news is constructive, unfortunately, the recently announced offering is going to keep a lid on the stock. When you combine the dilution with a lack of near term catalysts, I don't expect to see much movement up/down until we get closer to the CPP109 results. Of course at a 21mm market cap, the downside is rather limited and I'm more than happy to add to my position at these levels.
Insider sales are apparently the new "hot button" on this board, however, trying to predict future price movement based on insider transaction data is, for the most part, pointless. A number of studies, including "The Relation between Aggregate Insider Transactions and Stock Market Returns", has found that "investors cannot use aggregate insider transactions to profitably predict future market returns."
So, what are insider transactions highly correlated with? Not surprisingly, it's the overall return on the market. That's right, the selling is driven by macro events more than anything else. Beyond that, many of these transactions are being motivated by diversification or liquidity needs. So, there is no great conspiracy theory. I'm not saying it never happens but the data simply doesn't support the theory.
My understanding is that they completely spun argent out about a year ago. I don't think the terms were disclosed but I believe Ariad holds an equity stake and is eligible to receive milestones in both Bellicum and ReGenX.
bw, we are range bound until the CPP-115 phase 1 results. Not unsurprisingly, both the cowen and roth presentations had little impact on the stock. The lack of float and small cap means CPRX is primarily a retail investor play at this point - some of whom will grow impatient. I believe that will change as additional data becomes available.
Thanks. Considering Roche and Pfizer are actively pursuing endometrial combo trials, I wonder if it has more to do with the lack of a PI3K inhibitor in MRK's pipeline.
I'm surprised MRK hasn't announced a rida/PI3K trial-it's shown a lot of promise in endometrial but so far they don't seem to be pursuing it.
About 10 years ago, I recall the FDA going against an advisory committee recommendation for the flu drug Relenza. The drug ended up being approved despite an advisory committee voting 13-4 against. I'm not holding my breath.
Today's vote surprised me - given the SPA was met, I thought it was going to be closer than 13-1. Mtors with similar AE's have been approved. In the end the committee decided the potential benefits didn't outweigh the safety concerns. I still have a lot of confidence in mTor inhibitors as a class but it's pretty clear that the increased signaling through AKT that occurs with mTOR inhibition limits the drugs effectiveness as a stand-alone drug.
Irregardless, I don't expect the decision to have much impact on the stock price beyond a short-term gut shot reaction. There was very little run up going into today's meeting and, due to the agreement restructuring last year, very little of the Ariads' market cap is now tied to rida. The immediate impact is primarily associated with the $40mm in milestone payments - which represented about $0.25 per share (and accounts for most of the after hour drop). I'm also assuming that ARIAD will also incur somewhat higher sales/marketing expenses as Merck would have compensated Ariad for up to 20 percent of its US sales efforts under the co-promotion agreement.
http://www.abstractsonline.com/plan/AdvancedSearch.aspx
Search for "ariad" in the Title/Abstract Body
You are comparing apples and oranges. The GSK trial enrolled pts with "High or intermediate grade of soft tissue sarcoma; Low grade tumours allowed provided there is disease progression." The rida trial enrolled pts who were disease stable.
pre-market reaction to the report issued this morning was initially negative. Although, the SPA for PFS was met, at the 2nd interim the DMC stated, “Although the primary endpoint, PFS, technically met the boundary for the secondary interim analysis for efficacy, the overall survival estimates are premature, limited by a 40-week median follow-up time. Therefore, it is not yet clear that overall survival is supportive. The PFS advantage of 7 weeks is not of sufficient clinically meaningful benefit, especially considering the toxicity, and is insufficient to suggest early termination for efficacy without at least a positive trend on overall survival.”
Is median OS of 20.8 months in the ridaforolimus arm vs 19.6 months in the placebo arm (HR 0.93, p = 0.46) enough given possible safety concerns. My bet is that it'll be close but will ultimately be approved....hence the bumpy ride this morning.
This has been a test. If this had been an actual emergency, you would have been instructed where to tune in your area for news and official information.
My suggestion...turn off Fox News.
A 13G is the SEC form used to report passive ownership of over 5% of a publicly traded company. Given CPRX's low-float and small market cap, I view Fidelity's investment as a net positive.
Fidelity 13G filing - 1,836,840 shares or 7.436% of the total outstanding Common Stock at December 31, 2011
Ok, re-listened to the video and Berger does say that 113 should enter clinical trials lately. So, basically IR is issuing dated information...great job, Maria.
I've had it on my watch list for awhile myself. I never pulled the trigger because I haven't had the time to do the dd on why attempts by other companies to use hypoxia as a targeting agent failed. Also, as a general rule I try to avoid pancreatic phase 2's.
I am interested in the upcoming P3 sarcoma results expected by the end of the year and may take a position closer to that time.
At least I did include the name in my charity portfolio, lol.
I'm not sure when the video was made but it was posted by the company today. As far as "No More Partnering" goes, this wouldn't be the first time that Berger has said one thing and done another. Either the video is accurate, Berger is being misleading, or they've been approached with a deal in the last few weeks that's changed their mind.
Ariad has posted a new investor overview video. The one thing of interest is Bergers discussion of the company's ponatinib partnering plans (begins at around the 2 minute mark). In a nutshell, the company plans to partner regionally outside the US in order to "take advantage of the strength of partners in those markets as well as the added financial resources that that can bring to help us develop our overall pipeline of products."
So, in theory, pts who show low frequency mutations on gleevec could be switched to ponatinib after only three months? I don't think that's built into any ones model yet, lol.
A pdf of the Feb 2, 2012 Epilepsy Pipeline Update Conference presentation is available for download.
http://ir.catalystpharma.com/events.cfm
BW,
With the next catalyst several months off (the CPP-115 phase 1 results), the price action is pretty much par for the course. The lack of news combined with low float and lack of liquidity likely means we are range bound for the next few months. Of course, that same low float can also work in ones favor as new buyers discover the stock.
Upcoming Milestones (per post 15757)
-Finalization and communication of front-line design for Phase III CML trial with ponatinib (1Q12)
-Complete enrollment of Phase Ib/IIa trial of AP-26113 (1H12)
-Update on preliminary results from PACE Trial (1H12)
-Filing of ponatinib for accelerated approval with FDA (Mid-2012)
-FDA ODAC hearing for the approval of ridaforolimus for the maintenance treatment of soft tissue sarcoma (1H12)
-Approval of ridaforolimus by the FDA (PDUFA: June 5, 2012)
-Approval of ridaforolimus by the EMEA (2H12)
-FDA acceptance of ponatinib application for Accelerated Approval (3Q12)
-FDA Approval and launch of ponatinib for patients with positive-T315I mutational status or whose disease have failed other approved TKIs (1Q13)
-Initiation of registration-directed trial with AP-26113 (2013)
Doesn't dark chocolate have anti-cancer benefits? Could this somehow be related to Ariad's next blockbuster drug??? LOL.
I wouldn't be so fast to equate that list of character "flaws" with failure. A case can be made that in business many of those traits are actually quite desirable - take, for example, Carnegie, Morgan, Rockefeller or Ford. John D. Rockefeller didn't became the world’s first billionaire by being a nice guy. And Carnegie was even worse, as demonstrated by the ruthlessness he displayed squashing the 1892 Homestead Strike. His views on natural selection were downright radical and would make him the poster boy for that list, lol. Of course the same traits that made them so successful professionally, wreaked havoc on their personal lives.
By no means am I putting Berger in this class...not by a long shot...just pointing out that the traits in of themselves don't portend ultimate failure.
On January 31, 2007 Wolverine entered into a consulting agreement with Texada Consulting Inc. The contract is for a period of three years and one month ending on February 28, 2010 (the "minimum term"). Under the terms of the agreement Wolverine will pay Texada $10,000 per month plus expenses for consulting services. If a major commercially viable mineral resource deposit is discovered, Wolverine will issue a bonus of 5% of the total common shares outstanding at the date bonus is paid. If Wolverine does terminate the consulting agreement prior to the minimum term without cause, it will have to pay liquidated damages to Texada Consulting Inc.
Since "a major commercially viable mineral resource deposit" is yet to be discovered, I would have thought the 5% "bonus" would have expired in 2010. But it seems that this sweetheart deal was extended indefinitely...how convenient. You can read the language change in the company's most recent filing:
"On January 31, 2007, the Company entered into a consulting agreement with a company whereby it has agreed to pay $10,000 per month. The Company is obligated to issue a bonus of 5% of the Company’s issued and outstanding common shares as of the date of the payment of the bonus upon and only in the event of the discovery of a major commercially viable mineral resource deposit.
So basically the Presidents brother, through Texada Consulting, is getting 10k a month PLUS 5% of the shares outstanding shares. Gee, the more shares the company issues the more stock he gets...how wonderful for him.
Newbies will often interpret a longer than expected trial as "proof" that the drug is working. The certainty with which they express their conviction, or "newbitude", can lead to some interesting exchanges. Alas, some bio investors are destined to always remain "newbies" ;)
Catalyst Pharmaceutical Partners, Inc. Announces FDA Designation of CPP-115 as a Fast Track Development Program
CORAL GABLES, Fla., Dec. 20, 2011 (GLOBE NEWSWIRE) -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX - News) today announced that its investigational drug, CPP-115, a novel GABA aminotransferase inhibitor, has been designated as a Fast Track development program by the FDA for the treatment of cocaine dependency.
"We are delighted that CPP-115 has been granted Fast Track status by the FDA for the treatment of cocaine dependency, as they have previously done for CPP-109," said Patrick J. McEnany, Catalyst's President and Chief Executive Officer. "Via the development and commercialization of CPP-109, we hope to offer providers and their patients safe and effective therapies for cocaine dependency and other addictions. Our interactions with the FDA as part of the Fast Track program have helped to expedite CPP-109 into its current Phase II(b) trial for cocaine dependency. CPP-115 will allow us to extend and enhance our cocaine dependency franchise and we look forward to expanding our relationship and interactions with the FDA to address this significant unmet medical need."
CPP-115 is a novel GABA aminotransferase inhibitor and vigabatrin analogue that is more potent than vigabatrin and has reduced side effects from those associated with vigabatrin in preclinical studies. Catalyst is planning to develop CPP-115 for several indications, including drug addiction, epilepsy and other selected CNS diseases, and recently initiated a Phase I(a) safety study in 48 healthy subjects. CPP-115 has also been granted orphan-drug designation by the FDA for the treatment of infantile spasms.
About FDA's Fast Track Drug Development Program
Under the Federal Food, Drug, and Cosmetic Act, the FDA is directed to facilitate the development and expedite review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designation emphasizes communication between Catalyst and the FDA, and provides Catalyst with benefits that may help to expedite the approval process. For instance, Catalyst may receive input from the FDA regarding the design of its clinical studies, which may expedite the development and review of its FDA submissions and may provide greater overall certainty in the regulatory process, although there is no assurance that this will happen.
About Catalyst Pharmaceutical Partners
Catalyst Pharmaceutical Partners, Inc. is a development-stage biopharmaceutical company focused on the development and commercialization of prescription drugs targeting diseases of the central nervous system with a focus on the treatment of addiction and epilepsy. Catalyst has two products in development, CPP-109 and CPP-115, and is currently evaluating its lead product and first-in-class GABA aminotransferase inhibitor candidate, CPP-109, for the treatment of cocaine addiction. CPP-109 has been granted "Fast Track" status by the U.S. Food & Drug Administration (FDA) for the treatment of cocaine addiction. Catalyst also expects to evaluate CPP-109 for the treatment of other addictions. Catalyst believes that it controls all current intellectual property for drugs that have a mechanism of action related to the inhibition of GABA aminotransferase. For more information about Catalyst, go to www.catalystpharma.com.
A PhRMA survey conducted in 2005 found that, on average, it takes 15 years to bring a new oncology drug to market - 6.5 years to move from discovery to clinical trials and an additional 8.5 years to conduct the necessary trials and receive approval. But of course, this was before the FDA announced their "Program to Streamline Cancer Drug Development" in 2009.
(as an aside, Ariad is on track to bring ponatinib to market in about half that time but then again it took'em 20 years to get ridaforolimus to NDA, so, on average....lol.
It's possible. It depends on 1) how quickly the phase 1 trial enrolls, 2) what the safety profile is, 3) whether the fda accepts a phase 2 registration trial and 4) if they do accept a pivotal P2, what the trial design is (eg sufficient crizotinib failures to power the trial). 2014 is much more likely, imo, which gives us all (well, some of us anyway) something to look forward to, lol.
One thing to keep in mind with AP113 is that while crizotinib has shown very high initial response rates (50%+), patients quickly develop resistance, primarily from the T790M mutation. As a result, "although many patients derive substantial clinical benefit, the development of drug resistance has curbed the impact of crizotinib in this disease." http://www.pnas.org/content/108/18/7535.full
Given this situation, once it passes the safety hurdle, AP113, imo, has an excellent opportunity to move immediately to a pivotal phase 2 registration trial.