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ACADIA Pharmaceuticals Inc. Message Board

rob_cos 35 posts  |  Last Activity: Aug 31, 2015 5:32 PM Member since: Dec 31, 1997
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  • Raymond James initiates CELG with Strong Buy $160 target - Good commercial momentum. Strong catalyst flow ahead.


    Our Call:

    o Good commercial momentum. We think there could be potential upside to expectations, with Revlimid’s expansion into newly-diagnosed multiple myeloma (NDMM).

    o Strong catalyst flow ahead. Potential Revlimid approval/launch in Europe in NDMM setting, ASH meeting, etc.

    Biotechnology

    Valuation

    oOur $160 target derives from a 25X multiple to our 2017E EPS of $7.60, discounted back by 15% per year, which is a premium to large-cap biotechs (~25x 2015E EPS).

    oGiven Celgene’s current Revlimid NDMM and Otezla launches, 2017 reflects a more steady-state revenue growth level

    Bulls say…

    o Unencumbered cancer story with strong growth prospects

    o Story diversifying beyond flagship blockbuster Revlimid, with Abraxane, Pomalyst and newly launched Otezla

    Bears say…

    o Increasingly competitive oncology therapeutic landscape, particularly with emergence of immunotherapy agents

    o Overvalued – particularly with potential Revlimid IP risk

    Our Call:

    o Good commercial momentum. We think there could be potential upside to expectations, with Revlimid’s expansion into newly-diagnosed multiple myeloma (NDMM).

    o Strong catalyst flow ahead. Potential Revlimid approval/launch in Europe in NDMM setting, ASH meeting, etc.

    Company Description

    o New Jersey-based biotech with extensive hematology portfolio, complemented by expanding inflammation/immunology targeted franchise

  • Ask yourself this.....Kirk/Cooper excited about brain cancer trial...started about May abstracts due about now...after 4 months if you have not seen something stunning why rush results to present at SNO in November...

    and if results in this OPEN LABEL trial are great....I doubt they can be kept under wraps until November....could we get a topside P/R earlier??

    From 10Q - IL-12 Breast cancer data at AACR meeting Sept 16-19 & Brain Cancer data at SNO Nov 19-22 (plus cooper says CD-19 & other data at ASH December)...

    We have completed the Phase 2 monotherapy studies in melanoma and breast cancer using Ad-RTS-IL-12 + veledimex. We will present two poster presentations entitled “Demonstration of systemic antitumor immunity via intratumoral regulated expression of IL-12 in advanced breast cancer and melanoma patients” and “Demonstration of systemic antitumor immunity via intratumoral regulated expression of IL-12 as a gene therapy approach to treatment of cancer” at the upcoming CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference, Translating Science into Survival, September 16-19, 2015 in NY, NY.

    On April 27, 2015, we announced the initiation of a Phase 1b/2 study of Ad-RTS-hIL-12 + veledimex following standard chemotherapy for the treatment of patients with locally advanced or metastatic breast cancer. The study will be conducted at the Memorial Sloan Kettering Cancer Center in New York. We have also initiated a multi-center Phase 1 trial to evaluate Ad-RTS-IL-12 + veledimex as a single agent in the treatment of patients with brain cancer in the first half of 2015. We will report early data from this Phase 1 study as our abstract entitled “Intratumoral regulated expression of IL-12 as a gene therapy approach to treatment of glioma,” has been accepted for presentation at the upcoming Society for Neuro-Oncology (SNO) 20th Annual Scientific Meeting, November 19-22, 2015 in San Antonio, TX.

    Sentiment: Strong Buy

  • Med Tech -Two Phase I/II Data Readouts & Partnership (?) By The End of 2015; Loeb Initiates ZIOP Position

    A wild rumor that a patient had died in a KITE CAR-T trial circulated Wall Street last week and all the CAR-T stocks, including ZIOP, sold off in sympathy. KITE held a conference call to clear up the mess this week and said that the patient died from natural causes, not the CAR-T therapy. Regardless, the patient death boldly illustrates, in our view, why ZIOP’s second-generation gene therapy is the future of CAR-T. ZIOP’s RheoSwitch provides a significant additional safety factor with a turnoff switch which is simply activated by taking a pill. In our view, in a more rational market environment, ZIOP’s stock should have went up on KITE’s problem as they have the simple and elegant solution to manage CAR-T patient safety via RheoSwitch.

    ZIOP and their partner Intrexon have both released their Q2 results. Two important pieces of information related to their recent partnership with Merck Serono were revealed. The collaboration’s first two CAR-T targets of interest were recently selected, and Intrexon and ZIOP have started R&D efforts on these programs. The specific targets were not disclosed for competitive reasons, but we were informed that they were unique and do not target CD-19 which is what KITE, JUNO et.al. are all targeting with their first generation CAR-T technologies. The Q2 release also showed that on July 31 ZIOP received $57.5 million from Intrexon related to the upfront payment from Merck Serono deal.

    Two Phase I/II Data Readouts & Partnership (?) By The End of 2015; Loeb Initiates ZIOP Position

    In April 2015, ZIOP started a Phase 1b/2 study of Ad-RTS-hIL-12 and veledimex following standard chemotherapy in patients with locally advanced or metastatic breast cancer. In May 2015, the Company started a multi-center Phase 1 study of Ad-RTS-hIL-12 and veledimex in patients with recurrent or progressive glioblastoma multiforme, a form of brain cancer. A

    Sentiment: Strong Buy

  • So if rumor of KITE death because of cytokine storm....well that just makes the ZIOP-XON Rheo Switch even more valuable doesn't it.
    Street will catch up - bought the dip

  • From 10Q - IL-12 Breast cancer data at AACR meeting Sept 16-19 & Brain Cancer data at SNO Nov 19-22 (plus cooper says CD-19 & other data at ASH December)...

    We have completed the Phase 2 monotherapy studies in melanoma and breast cancer using Ad-RTS-IL-12 + veledimex. We will present two poster presentations entitled “Demonstration of systemic antitumor immunity via intratumoral regulated expression of IL-12 in advanced breast cancer and melanoma patients” and “Demonstration of systemic antitumor immunity via intratumoral regulated expression of IL-12 as a gene therapy approach to treatment of cancer” at the upcoming CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference, Translating Science into Survival, September 16-19, 2015 in NY, NY.

    On April 27, 2015, we announced the initiation of a Phase 1b/2 study of Ad-RTS-hIL-12 + veledimex following standard chemotherapy for the treatment of patients with locally advanced or metastatic breast cancer. The study will be conducted at the Memorial Sloan Kettering Cancer Center in New York. We have also initiated a multi-center Phase 1 trial to evaluate Ad-RTS-IL-12 + veledimex as a single agent in the treatment of patients with brain cancer in the first half of 2015. We will report early data from this Phase 1 study as our abstract entitled “Intratumoral regulated expression of IL-12 as a gene therapy approach to treatment of glioma,” has been accepted for presentation at the upcoming Society for Neuro-Oncology (SNO) 20th Annual Scientific Meeting, November 19-22, 2015 in San Antonio, TX.

    Sentiment: Strong Buy

  • Unless someone outbids them ZIOP will be a wholly owned sub of Merck Germany with deal commencing this yr imo...

    I talked with a large holder after the call and we both agree - it likely Merck Germany (tough to close deals in Germany in August)... the 2 targets cost them up to a billion....Kirk confirmed he is talking with Merck about other targets - lets say they do 6 more - that's up to $4 billion allowing others the rights to everything after that, TCR, IL-12 brain cancer, NK Cells, etc......So why not pay $5 or $6 billion for it all and pay yourselfthe first $billion.....There may be competing bids but its just too economical for Merck. You may want to stall if you are Kirk until the Brain cancer data comes at SNO in November and the blood cancer data comes at ASH in December, but as wrong as you were about ZIOP having a call despite what there executives said - you are just as wrong about thinking ZIOP is not on the market despite multiple public comments by a CEO/Chairman with a legal background that it is. The same people that did not believe Kirk when he said "Significant Transactions Underway" before the MDA, Merck and NCI deals are the ones who don't believe Kirk for his publicly stated reasons for dividending the ZIOP shares and for his ZIOP acquisition statement. WHy they don't believe the man is beyond me. Stay alert.....Merck wants to be a big player in this space....remember reasons 33, 35 and 43

    SEE investorvillage ZIOP board for link to all the 101 reasons

    33. This past March, Kirk delivered Transaction #2 when Intrexon signed a very lucrative agreement with Europe's Merck Serono to develop CAR-T therapies for MS with its technology partner, Ziopharm...It is a testament to the value of the two companies' underlying technology that MS agreed to pay an upfront fee of $115 million to XON and ZIOP + another $826 million in milestone(s) payments + tiered royalties...and all this for developing therapies for two initial cancer targets! Furthermore, MS has the right of first refusal on any additional therapies that XON / ZIOP may develop for other cancer targets. Of course should MS decide to buy manufacturing and distribution rights for therapies other than the initial two targets, they will have to dole out additional cash to XON and ZIOP. That's the Cash ATM we alluded to above! http://tinyurl.com/plu2s75
    35. Any CAR-T targets identified with the help of MDA will of course first be offered to Merck Serono for development. Should MS agree to pursue any of the offered targets, additional monies will have to be paid to XON and ZIOP
    36.
    43. In a recent article in Nature, Joern-Peter Halle, Merck Serono's Head of Strategy Realization, Operational Excellence and President's Office, was asked about his company's recent agreement with Intrexon / ZIOP and this is what he said: "In the CAR-T area the ability to regulate the response after you've infused the T cells back into the patients is an important element and may overcome some of the challenges we see with the current generation of CAR-T now in the clinic." It's clear from this quote that Halle considers XON / ZIOP technology as 2nd Generation! Halle further said: "The other big area for improvement is the complexity of the procedure itself, says Halle, and Merck Serono will work with Intrexon on allogeneic, 'universal' T cells and other approaches 'that are reliable and effective on one hand, and commercially viable on the other. We're committed to innovating in the space for the long run."

  • Full Cowen rpt...CELG - a large cap top pick- Preparing To Dominate Heme/Onc For A Long Time...Ozanimod Highly Attractive Product Profile...P&L Offers Good Leverage..
    Cowen and Company

    Biotechnology

    Celgene

    Equity Research Quick Take: Company Update

    August 11, 2015

    Price Target: $150.00

    OUTPERFORM (1)

    Preparing To Dominate Heme/Onc For A Long Time To Come

    The Cowen Insight

    Last week we hosted a meeting with Celgene’s President & COO Mark Alles, CFO Peter Kellogg, and IR Director Lisa Hayes. With Revlimid leading the way, management was particularly bullish on its ~10-year growth outlook, and is increasing focused on building a leading heme/onc franchise that will sustain growth beyond Revlimid's eventual patent expiration. CELG remains a top large cap biotech pick. Revlimid’s Future Looks Bright...

    Management remains confident that Revlimid is positioned to be the backbone of Multiple Myeloma (MM) therapy with multiple datasets now showing that continuous Rev/dex treatment is superior to multiple other myeloma regimens. In addition, several trials now built upon the Rev/dex backbone with triple combinations (Rev/ dex + a novel therapy) setting a new standard for efficacy. Management noted three growth drivers in particular that provides confidence on the longer-term commercial outlook for Revlimid (1) Duration gains: management notes that essentially all new drugs are being evaluated on top of continuous Rev/dex regimen, and as these new therapies improves PFS, the duration of Revlimid treatment will also benefit. In addition, multiple trials have also shown that continuous Rev/dex treatment is superior to fixed duration Rev/dex treatment, thereby prompting additional physicians to alter their prescribing patterns. Recall that the average duration of Revlimid dosing is 19-20 months in the U.S. versus a company goal of ~24 months. In Europe, duration is only 9-10 months and we don’t see any reason why duration couldn't eventually approximate U.S. levels; (2) Market share gains: management mentioned that new scrips are setting records despite the typical adverse summer seasonality, and attributed this growth to the recent newly diagnosed multiple myeloma (NDMM) claim in the U.S. In Europe, though Revlimid is still very early in its NDMM launch and the majority of country-by-country reimbursement is still on the come, early trends are very favorable and significant market share gains are expected. Current market share in Europe is

  • RJ Kirk on XON Q2 call...
    "We are close to wrapping up with our early ECC's" ....hmm that NEW comment would fit with a sale of ZIOP to large pharma keeping huge economics...RJ often is obvious....says what he means. - See Reason #2 of "101 Reasons to own ZIOP"...(see investorvillage for link to 101 reasons)

  • RJ Kirk "2 "novel"Targets have been chosen...and we are discussing others with Merck...These are not the same targets others have chosen.Others don't have a "drug" ...the motif is extremely compelling....

    a new paradIGM.... they are "novel" targets (not just another CD-19 CAR T ) and we have expectations of generally superior performance."

  • Could AGN with its $125 billion market cap bid for CELG ($100 billion) in an accretive deal? If you knew you were gonna lose the ACT/Natco RLI patent case...why not sell generic business & go after CELG.....

    Stock + cash deal....doesn't mean CELG would take it as they know they are winning also but could be interesting and NO Celgene is not to big.

    Interesting they sell the generic business....would you do that if you think you are going to win Revlimid.....he likely knows CELG comes on top with a small settlement...if so and say Revlimid gets to 2026 - MAYBE you make a play...on Mad Money yesterday CEO Saunders said they need to find a big deal to get back the EPS and they are committed to making it and have to fill the void left by the huge generic business...He said he could do it with buybacks but would prefer to buy a large company with growth......not saying it is going to happen - just an interesting setup.....hoping for SOME M&A in sector to stop the slide.....maybe some small to mid cap names like BMRN, HALO, ACAD, ZIOP, INCY or maybe ICPT by GILD.....while we wait to decide what huge company AGN goes after....interesting AGN CEO knows CELG growth is stellar per ISI note I previously posted....
    ________

    ISI talk with AGN CEO on M&A.....- Difficult to do transformational with companies with higher growth rate than our 10% … only one with higher rev growth rate than us is CELG. Allergan CEO, Brent Saunders, made some comments on transformation M&A. Given the overwhelming investor interest in this topic, I thought I will send my raw notes from his response to my question just now:

    Umer: Brent how do you think about transformational M&A with companies that have lower revenue CAGR than your 10%, and/or companies with large biosimilar headwinds?

    - Difficult to do transformational with companies with higher growth rate than our 10% … only one with higher rev growth rate than us is CELG - so that would really limit the universe
    (SEE investor village CELG)

  • Great news $CELG's Otezla on $CVS/ $ESRX 2016 formulary for inflammatory diseases just released despite exclusion of other orals/injectables

  • rob_cos rob_cos Aug 5, 2015 3:25 PM Flag

    Suppression? Stock has more than quadrupled since October (5x's really) and is 40 cents away from all time highs...there is no ignorance shares are borrowed from longs on margin. Period.

  • Great day up another 1.5% today in a Big Down market day with BTK, XBI & IBB all down. Another Higher high/low day. 5 Higher highs in a row. One big market up day & we rocket through $14 imo. Shorts would be wise to cover before XON conf call Monday.

    Great day - if market rallied and sector soared we likely would have printed new high today - but we hung in and closed up nicely 1.5%+ - short using fire power at $14....might take a time or two to get through there blocks but soon.Great day.

    Sentiment: Strong Buy

  • Yet another ZIOP higher high/low...ZIOP recommended by Stan Weinstein (The Micheal Jordan of technical analysts) - He is followed by every major hedge and mutual fund - with the XON call Monday shorts would be wise to cover. ..Also one of two cheap biotech buyout candidates in article at bottom of this post

    Recommended by Stan Weinstein (The Micheal Jordan of technical analysts) -He is followed by every major hedge and mutual fund
    Buy 14.40

    Yet another higher high and higher low today....5th consecutive higher high.......Once we print a new high this will be off to the races....shorts would be wise to cover before the XON call Monday.
    Here's the link to "101 Reasons to Own ZIOP"....the prediction of Bill Miller commenting on ZIOP at Delivering Alpha and the wedge and P&F breakouts predicted already have happened....more reasons here:

    this weekly candlestick chart as well as the 1.0 Dorsey Wright P&F chart are things of beauty....we also broke the wedge/triangle from the "101 Reasons to Own ZIOP" posted when stock was $11 as well.....
    Hey I am mostly a fundamental guy - and ZIOP's fundamentals have never been better, the 4 recent transactions (including hiring Dr Cooper as CEO) in the first half of the yr, the selection of the CAR T targets and payment of $57.5 million to ZIOP and the prospects for data and deals this yr - well that combining with a positive technical environment and all time high short interest that has doubled since Oct. despite the stock more than quadrupling with every short $1 away from being underwater and half being $6 or more underwater.....well that is the perfect storm...so yes we like the breakout from the wedge/triangle, the Ascending triple top breakout on the 1.0 P&F and the higher highs and higher lows the past few days combined with a beautiful cup with handle....I will take that on top of tamazing fundamentals & the"101 Reasons to own ZIOP" SEE INVESTORVILLAGE ZIOP BOARD FOR LINKS TO "101 Reasons" & ZIOP buyout article

  • Reply to

    Question

    by stockup98 Aug 1, 2015 2:46 PM
    rob_cos rob_cos Aug 1, 2015 7:08 PM Flag

    From the "101 Reasons to Own ZIOP" posted when stock was $11 a few weeks ago - link is available on Investorvillage ZIOP board

    32.An ever present concern of investors in small, pre-revenue stage biotech companies is that their company will need to raise cash and thus dilute existing shareholders...Investors in ZIOP can breathe a sigh of relief because the company currently has sufficient cash to fund its operations well beyond 2017. Furthermore, they also have installed a brand new ATM in their back office that will dole out cash to fund the company's future development needs for years to come...And best of all, this cash infusion will not penalize its shareholders with dilution. In other words, ZIOP investors need not worry about future secondaries! So what exactly is this ATM? For answer, see #33 below:

    33.This past March, Kirk delivered Transaction #2 when Intrexon signed a very lucrative agreement with Europe's Merck Serono to develop CAR-T therapies for MS with its technology partner, Ziopharm...It is a testament to the value of the two companies' underlying technology that MS agreed to pay an upfront fee of $115 million to XON and ZIOP + another $826 million in milestone(s) payments + tiered royalties...and all this for developing therapies for two initial cancer targets! Furthermore, MS has the right of first refusal on any additional therapies that XON / ZIOP may develop for other cancer targets. Of course should MS decide to buy manufacturing and distribution rights for therapies other than the initial two targets, they will have to dole out additional cash to XON and ZIOP. That's the Cash ATM we alluded to above!

  • Reply to

    Question

    by stockup98 Aug 1, 2015 2:46 PM
    rob_cos rob_cos Aug 1, 2015 6:47 PM Flag

    Plenty of cash and just got more from Merck when they picked the 2 CAR T targets. No secondary next 2 yrs at least imo. Likely sale of ZIOP this yr though. I suggest you go to the investorvillage ZIOP board and get the link to "101 Reasons to Own ZIOP" - which yahoo does not let you post

  • Cup with handle breakout on monthly and intraday charts...broke wedge/triangle to upside following recent Ascending triple top breakout on 1.0 P&F.....New HIghs coming with short interest at all time highs.
    See investorvillage ZIOP board for charts and comments and 101 reasons to own ZIOP links that can't be posted here.

  • First close over $13.00 in over 4 months since mid march....it shouldn't be long now.

  • Kirk is about to destroy the ZIOP and XON shorts....I can't post the charts or the links to "101 Reasons to Own ZIOP" as they don't let you here....MAKE SURE you visit investorvillage ZIOP board for the breakout charts posted there and the MUST READ "101 Reasons to Own ZIOP" link - do it now

    Seriously this idea that shorts are all knowing and never get hurt is ridiculous....time and time again shorts lose in a big way on news and deals throughout the market.....short funds have underperformed for yrs...in biotech they have occasional wins but also huge losses - more losses than wins the past few yrs...This is particularly the case when they are lazy - shorting a myth like the BS that Kirk is a fraud (when in actuality he is the least promotional CEO/Chairman I have ever seen in 25 yrs of investing often not announcing news others would blare through a trumpet}....They have simply not done enough due diligence....this week I spoke to 2 large ZIOP/XON investors who spoke to two XON/ZIOP shorting funds....the rationale of the shorts for their short position amounted to incomprehensible blather....neither had talked to Kirk, Cooper, Krishan,...the buzz becomes short ZIOP so they do....then there are a few who just have a personal vendetta against Kirk.

    What I find stunning is the repeated drum beat of how the shorts control this stock - ummmmm the short interest has doubled since October...but the stock has not been controlled - no it has quadrupled (really 5x's) since the lows despite the sale of another 17 million shares they don't own bringing total to an untenable 33 million....sure can they use fire power to knock it under 13 a few times....yeah...let them...today another higher high and higher low and another intraday cup with handle....a coiled spring with the short interest about equal to the real float.....$1.50 away from everyone of the 33 million short shares being under water - and about half with like an $6 or more loss.....so whose controlling who....I say the shorts are controlling until Kirk decides they won't - just like he did in January....Stay alert....this one will be even more dramatic than the January move.

  • PR issued
    ZIOPHARM Announces Orphan Drug Designation for Ad-RTS-hIL-12 in the Treatment of Malignant Glioma
    BOSTON, July 24, 2015 (GLOBE NEWSWIRE) -- ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for Ad-RTS-hIL-12 + veledimex in the treatment of patients with malignant glioma. Ad-RTS-hIL-12 is a novel gene therapy candidate for the controlled expression of IL-12, a critical protein for stimulating an anti-cancer T cell immune response.

    The FDA's Office of Orphan Products grants orphan drug status to support development of medicines for underserved patient populations or rare disorders affecting fewer than 200,000 people in the U.S. Orphan Drug Designation provides eligibility for a seven-year period of market exclusivity in the United States after product approval, an accelerated review process, accelerated approval where appropriate, grant funding, tax benefits and an exemption from user fees.

    "Malignant glioma is an aggressive cancer with few treatment options," said Laurence J. N. Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM. "This designation supports our effort to advance Ad-RTS-IL-12, a novel immuno-oncology therapy which has demonstrated promising preclinical efficacy in brain cancer, as a potential treatment for this indication. Enrollment in our Phase 1 study is progressing well, and we look forward to early results from this clinical trial later in the year."

    Ad-RTS-hIL-12 + veledimex is currently being studied in a Phase 1 trial designed to examine a gene therapy treatment strategy for high grade gliomas, with the goal of generating an anti-tumor T cell immune response. The primary objective of the study is to determine the safety and tolerability of a single intra-tumoral Ad-RTS-hIL-12 injection plus escalating oral veledimex doses. Secondary objectives are to determine the veledimex maximum tolerated dose, the immune responses elicited by Ad-RTS-hIL-12 and veledimex, and investigator assessment of response, including the tumor objective response rate and progression-free survival, and determine overall survival, among other measures. The study is expected to enroll up to 72 subjects at up to 12 leading treatment centers.

    About ZIOPHARM Oncology, Inc.:

    ZIOPHARM Oncology is a Boston, Massachusetts-based biotechnology company employing novel gene expression, control and cell technologies to deliver safe, effective and scalable cell-based therapies for the treatment of cancer. The Company's synthetic immuno-oncology programs, in collaboration with Intrexon Corporation (NYSE:XON) and the MD Anderson Cancer Center, include chimeric antigen receptor T cell (CAR-T) and other adoptive cell based approaches that use non-viral gene transfer methods for broad scalability. The Company is advancing programs in multiple stages of development together with Intrexon Corporation's RheoSwitch Therapeutic System® technology, a switch to turn on and off, and precisely modulate, gene expression in order to improve therapeutic index. The Company's pipeline includes a number of cell-based therapeutics in both clinical and preclinical testing which are focused on hematologic and solid tumor malignancies.

    Sentiment: Strong Buy

ACAD
39.13+1.06(+2.78%)Sep 3 4:00 PMEDT