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Amgen, Inc. (AMGN) Message Board

Rob_Cos 375 posts  |  Last Activity: Jul 1, 2014 12:07 PM Member since: Dec 31, 1997
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  • Go to Investor Village CELG board for a better color version of this Celgene Truck....

    LOOK OUT SHORTS!!!!! THE CELGENE TRUCK IS NOW BURSTING AT THE SEAMS WITH NEAR TERM CATALYSTS, BARRELING THROUGH ALL TIME HIGHS!!!

    |^^^^^^^^^^^^^^^|||___________
    |Positive Markman/ 90%+ margin!! |
    |20+ early bio partners/ Dr Fouse! ! |
    |Split/2015 dividend/ Cash Flow $$ |
    |Otezla/Pomalyst/Abrax/GED0301....|
    |Pending EU Front line approval___
    |NHL data/Best Bio Pipeline_||||____\,___
    |_..__..___..__..__..======|===|$88+ ]]]]]]]] HONK!!HONK!!HONK!!
    (@)''''(@''''''''''''''''''''''''''''''''''''(@)***(@)******(@)+ Shorts' Charred Carcasses:-)

    Someone asked to bring back the Celgene Truck...this one's for long term holders....this truck is 10 yrs old but adding cargo everyday.

    Sentiment: Strong Buy

  • Reply to

    Short shares...oh my

    by crecy_war_knight Jun 23, 2014 11:18 AM
    rob_cos rob_cos Jun 23, 2014 1:33 PM Flag

    Accelerant for the coming move much higher....this could get interesting. Kindling for the fire. I love high short interest. So does Baker Bros.

  • LADENBURG THALMANN

    TG THERAPEUTICS, INC.

    Positive TG-1101 Plus Ibrutinib Combination Phase II Data Presented at EHA 2014

    TGTX (NASDAQ)

    Company & Market Data

    Closing Price (as of June 13, 2014): $9.61

    Rating: BUY

    Price Target: $18.00

    Prior Price Target: $12.00

    52 Week Range: $2.97 - $10.15

    Shares Outstanding (MM): 38

    Market Capitalization (MM): $362

    Cash (MM): $54.5

    Fiscal Year End: Dec

    *Cash (MM): As of March 31, 2014

    Chart data: Bloomberg

    Highlights

    Positive initial TG-1101 plus ibrutinib combination Phase II trial data presented

    at the European Hematology Association (EHA) Conference. The TG-1101 plus

    ibrutinib combo study is a Phase II single arm study in relapsed or refractory MCL

    and CLL (as per the ibrutinib label). Patients enrolled in the trial had a median of 2

    prior therapies (range of 1 to 6) with 43% 3 prior therapies and 96% with prior anti-

    CD20 therapy. The study currently has 28 patients (21 CLL and 7 MCL) evaluable

    for safety and 10 (7 CLL and 3 MCL) evaluable for efficacy. The initial results for the

    first efficacy assessment show an overall response rate (ORR) of 90% with one CR

    and 8 PRs. Six of seven (86%) CLL patients showed a PR on the first assessment

    with the seventh patient showing 40% nodal response. We believe this patient could

    convert to a PR in the future. The data show the addition of TG-1101 controls the

    ibrutinib-related lymphocytosis (reduces the severity and the duration thereby creating

    earlier clinical responses), with a 79% reduction in ALC. Additionally, it is important to

    realize the efficacy data is early as the study is ongoing and this is only the first efficacy

    assessment. We are impressed with the initial data as they show the combo treatment

    is well tolerated and highly active resulting in a more rapid and more pronounced

    response rate (ORR) in this patient population. We believe the preliminary response

    rate results are compelling (initial ORR of 90% versus ibrutinib alone which showed an

    ORR of 71% in this patient population).

    TG presented a positive update for the ongoing TGR-1202 Phase I/II dose

    escalation study. The ongoing Phase I/II study TGR-1202 single agent dose

    escalation study is in patients with relapsed or refractory hematologic malignancies.

    Forty patients are evaluable for safety and 35 patients are evaluable for efficacy. The

    clinical activity data from the study show clear, robust nodal responses of greater than

    50% in 8 out of 9 (89%) CLL patients treated at 800mg or higher (at ASCO TG reported

    7 out of 9 or 78%). The one remaining patient achieved 40% nodal reductions on the

    first assessment scan and remains on study awaiting the next scan. We are impressed

    with the clinical activity data observed in relapsed/refractory CLL patients as it clearly

    indicates TGR-1202 is a highly active agent upon achieving clinically relevant doses.

    The data also show TGR-1202 has been well tolerated with no evidence of liver toxicity

    and no colitis events. Importantly, with 38% of the evaluable patients treated at 800mg

    on study for over 6 months (with some for 1 year) TGR-1202 has an AE profile which

    supports combination therapy. No patient has discontinued due to a drug-related AE

    and the MTD has not been reached.

    We reiterate our BUY rating and increase our price target to $18 from $12.

    Our price target increase is based on the positive initial TG-1101 plus ibrutinib data

    combined with the maturation of the mono-therapy studies which continue to show solid

    safety and efficacy profiles for both TGR-1202 and TG-1101 to date. We look forward

    to additional data presentation at upcoming medical conferences with a focus on initial

    top-line data from the ongoing TGR-1202 plus TG-1101 combination study and the

    definition of a regulatory path with the initiation of a pivotal program in 2014.

    TGTX (NASDAQ)

    Company & Market Data

    Closing Price (as of June 13, 2014): $9.61

    Rating: BUY

    Price Target: $18.00

    Prior Price Target: $12.00

  • Reply to

    TGTX Reality Check

    by ubelite617 Jun 13, 2014 10:24 AM
    rob_cos rob_cos Jun 13, 2014 6:51 PM Flag

    Man you don't understand biotech very much it appears....the key to TGTX's drug is that its SAFE and EFFECTIVE and safe enough that it can be used in combination with Imb. This market cap is small and this company will be gobbled up by PCYC or JNJ by yr end imo

  • TGTX: Sweet Imbruvica Combo Data; Target Raised to $20; Reiterate Focus Pick



    TGTX announced data to be presented at EHA from its Phase II study ofTG-1101 & ibrutinib combination in r/r CLL or MCL. The first ten evaluable patients demonstrated an ORR of 90% and no patients progressed to date.

    While the patient numbers are small we are quite impressed with the data. We are raising our price target to $20 from $15 and reiterate our Focus Pick.

    Event

    TGTX announced two important and impressive sets of data from their "match made in heaven" combo study of TG-1101 & Pharmcyclics' (PCYC-Buy- $94.84) Imbruvica in r/r CLL and MCL and from their single-agent study of TGR-1202 in CLL. Ten evaluable patients in the combination study achieved an ORR of 90%. In CLL patients, 86% (6/7) achieved a PR at only the first assessment. In MCL patients, 100% (3/3) achieved a response, one CR and two PRs. Additionally, CLL patients exhibited an ~80% reduction of ALC at 4 months, indicating that TG-1101 is able to significantly reduce imbruvicarelated lymphocytosis. The combination data also presents safety data for 28 evaluable patients, showing that the combination treatment is well tolerated.

    Impact

    We are quite impressed with the data, despite the small patient numbers, and believe TGTX is shining at EHA. As we stated in our prior note, we believe the underlying hurdle for the combination regiment would need to be in the 90% range and we are highly encouraged that the bar has already been reached at this early stage of the study with 10 evaluable patients. Importantly, the data show that TG-1101 significantly reduces the Imbruvica-related lymphocytosis by an impressive rate of ~80%. Spikes in ALC counts were an issue raised previously when treating with Imbruvica and it is encouraging to see that TG-1101 is mitigating the effect quicker using the combination treatment, emphasizing further the advantage of this approach. We believe this combo regimen could yield a true "mopping up" strategy in reducing residual disease in patients. We would project that much higher response rates would also have a positive impact on extending survival.

    Action

    We reiterate our Buy rating and Focus Pick and are raising our price target to $20 from $15. We believe that TG is positioning itself strongly with their lead candidate drugs with the potential to be integrated in the evolving standard of care for B-cell malignancies.

    In assessing these early data, it is important to highlight the patient demographics below, especially the level of prior treatments. This includes 96% of patients having seen prior anti- D20 therapy. The trial’s inclusion criteria allows for enrollment of patients with prior BTK and/or PI3K inhibitor treatment. We look forward to seeing whether any patients with these priors are enrolled into the study.

    Patient Demographics

    Source: TGTX poster presentation – European Hematology Association – June 13, 2014

    The overall response rates from the study are delineated in the chart and table below and recall these data are only from assessment following the first efficacy “look”. While the patient numbers are small, we are certainly impressed with the early efficacy data in these relapsed/refractory patients.

    Overall Response Rates at First Efficacy Assessment

    Source: TGTX poster presentation – European Hematology Association – June 13, 2014

    TG THERAPEUTICS, INC. Company Note - June 13, 2014

    The figure below is the waterfall chart of patient nodal responses. The highlight here includes the CR seen in the MCL patient and the significant reductions in nodal size for CLL patients with poor cytogenetics (17p and 11q).

    Waterfall Chart of Patient Nodal Responses

    Source: TGTX poster presentation – European Hematology Association – June 13, 2014

    Lymphocytosis was seen early on in monotherapy ibrutinib studies, based primarily on the “recompartmentalizing” of tumor cells from the lymph node to the periphery before potential clearance. The data below indicate that TG-1101 can “mop” up the lymphocytosis (Absolute Lymphocyte Count – ALC) quicker than seen in ibrutinib monotherapy studies.

    Percent Change in ALC from Baseline

    Source: TGTX poster presentation – European Hematology Association – June 13, 2014

    From a safety standpoint, the combination was shown to be well tolerated with no overlapping toxicities. All rash, elevated creatinine and Grade 3/4 diarrhea events were deemed related to ibrutinib per investigator assessment and all infusion related reactions (IRR) were related to TG-1101. With regard to dose reductions and/or treatment discontinuation; 1) ibrutinib was dose reduced in 2 patients (1 diarrhea, 1 rash), 2) one patient stopped ibrutinib to to diarrhea and 3) no patients had their TG-1101 dose reduced (infusion interruptions only due to IRRs). Two drug related serious adverse events (SAEs) occurred in the same patients; 1) one Grade 3 diarrhea (deemed ibrutinib related) and 2) one Grade 4 thrombocytopenia (deemed ibrutinib related).

    Safety – Related Adverse Events Occurring in 2 patients (n=28)

    Source: TGTX poster presentation – European Hematology Association – June 13, 2014

    Study conclusions:

    · Preliminary data suggest TG-1101, in combination with ibrutinib is both a well-tolerated and highly active regimen for patients with relapsed or refractory MCL and CLL

    · The addition of TG-1101 appears to mitigate ibrutinib related lymphocytosis producing earlier clinical responses than historically seen with ibrutinib monotherapy

    · Preliminary signs of increased depth of response seen with the combination of TG-1101 and ibrutinib, with one MCL patient achieving a complete response at first efficacy assessment.

    VALUATION

    We reiterate our Buy rating and Focus Pick and are raising our price target to $20 from $15. The primary drivers to our valuation change include; 1) changing our projected chance of success for TG-1101 from 20% to 25% and 2) changing our projected chance of success for TGR-1202 from 10% to 15%.

    Our valuation of TG Therapeutics is based on our probability-weighted clinical net present value (NPV) valuation model. We believe this method is appropriate in capturing the value of the clinical stage pipeline. Factors that could impact the shares of TG reaching our price target are negative data readouts from the ongoing and planned clinical studies, any perceived delays with the regulatory progress for TG-1101 and TGR-1202, as well as TG's ability to continue to fund its operations.

  • Added 10k TGTX at 7.78....Roth just raised target to $20 from $15..Big combo data tomorrow...just wrote Aug 10 calls on new shares for $1.50....15k older shrs uncovered....Roth coms.
    ..
    Big TGR1202/ibrutiib combo data Saturday - if that's great I think TGTX gets taken out this yr - perhaps by PCYC or JNJ

    Roth 'Encouraged' by TG Therapeutics' (TGTX) TG-1101 Phase 2 Prelim Results; Boosts PT to $20
    Roth Capital boosts its price target on TG Therapeutics (Nasdaq:TGTX) from $15 to $20 and affirms its Focus Pick rating followingpreliminary clinical results from its ongoing Phase 2 study of TG-1101 (ublituximab).

    Analyst Joseph Pantginis commented, We are quite impressed with the data, despite the small patient numbers, and believe TGTX is shining at EHA. As we stated in our prior note, we believe the underlying hurdle for the combination regiment would need to be in the 90% range and we are highly encouraged that the bar has already been reached at this early stage of the study with 10 evaluable patients. Importantly, the data show that TG-1101 significantly reduces the Imbruvica-related lymphocytosis by an impressive rate of ~80%. Spikes in ALC counts were an issue raised previously when treating with Imbruvica and it is encouraging to see that TG-1101 is mitigating the effect quicker using the combination treatment, emphasizing further the advantage of this approach. We believe this combo regimen could yield a true "mopping up" strategy in reducing residual disease in patients. We would project that much higher response rates would also have a positive impact on extending survival.

    For an analyst ratings summary and ratings history on TG Therapeutics click here. For more ratings news on TG Therapeutics click here.

    TG Therapeutics closed at $8.82 yesterday.

  • Jeffries - Positive Pimavanserin Feedback FromMovement Disorder Society Congress - Reiterate Buy and $38 target

  • rob_cos rob_cos Jun 13, 2014 9:56 AM Flag

    Jefferies

    ACADIA Pharm. (ACAD)

    Positive Pimavanserin Feedback FromMovement Disorder Society Congress

    EQUITY RESEARCH AMERICAS

    BUY

    Price target $38.00

    Price $23.03

  • We recently spoke to 14 neurologists at the Movement Disorder Society Congress in Stockholm. Non-motor symptoms in Parkinson’s disease (PD) were highlighted during the conference. Feedback on pimavanserin efficacy and safety was positive, and we were also encouraged by feedback on the potential to expand treatment of PDP with a drug like pimavanserin.

    Specialists Suggest Pimavanserin Profile Could Expand PDP Treatment. We spoke with 14 specialists on how they treat PD-related psychosis (PDP). All use either Seroquel or clozapine to treat psychosis to varying degrees. However, there were two camps on how early to begin antipsychotic therapy. One camp advocated a more conservative approach to wait until psychosis becomes bothersome. The other camp advocated prescribing antipsychotics early under the assumption that psychosis inevitably worsens. From four different specialists: “often transient psychosis is a prelude to chronic psychosis and those patients get drug,” “not going to wait until it becomes a chronic issue,” “I don’t see psychosis as transient. If it happens as part of the disease state, then it’s chronic,” “the thing about non-troublesome psychosis is that it affects the way you’re treated Parkinson’s disease so I would rather give antipsychotics early.” Physician feedback leads us to believe that the benign safety and proven efficacy profile of pimavanserin may help with conversion to earlier use in the former camp and perhaps more aggressive use overall. For instance, one of the self-described conservative treaters stated that “pimavanserin’s safety does make it more appealing,” and a self-described aggressive treater stated that he would “give pimavanserin even faster because it’s well tolerated.”

    General Neurologists And Psychiatrists Could Be Strong Adopters OfPimavanserin. Several Parkinson’s specialists to whom we spoke indicated that psychiatrists do not really play a role in the treatment of their PDP patients, although psychiatrists may become involved with treatment of other non-motor symptoms such as depression or anxiety. In fact, one specialist indicated that, because they do not understand the underlying disease, psychiatrists will not treat these patients properly. That said, Parkinson’s specialists also noted that general neurologists are less experienced in treating psychosis and may be quicker to add on antipsychotics rather than lower doses of other medications. General neurologists may also reach out to psychiatrists for help with more difficult patients and that psychiatrists will likely be fast to prescribe anti-psychotics and likely gravitate toward pimavanserin given its safety profile. One specialist noted that the patients referred by general neurologists are generally on too many medications. ACAD has stated that, in addition to neurologists, it will also have small sales forces targeting high prescribing psychiatrists and nursing homes.

    Pimavanserin Highlighted In Oral Session. In a presentation on recent clinical trial developments, the presenter noted that -020 study and called the results encouraging. He also pointed out that the SAPS-PD scale used in the trial is not well studied and would need to be compared with a validated scale (we note that pimavanserin also showed positive data on the validated SAPS scale). His overall view was positive, and he called it the first solid, positive study since clozapine. As a reminder, there have been several studies of Seroquel in PDP that were actually negative, including all three placebo-controlled studies conducted historically, even though Seroquel remains the first-line drug of choice for PDP

  • Reply to

    THE CC WAS O.K BUT NO Q & A

    by portsmouthohio Jun 2, 2014 10:57 AM
    rob_cos rob_cos Jun 2, 2014 2:07 PM Flag

    Listen to the end of the BAC/ML replay from May for my 3 questions to Uli on on the possibility of 6 month stability testing being accepted for filing with 12 months submitted before final approval and EU discussions - that is worth the replay - go to end and listen to Q&A from that replay

  • Said it at 61 and I will say it again now at 66 - I love the way IOC has traded the past 2 wks and I think something of substance that is positive is coming.

  • Dorsey Wright positive note out today on ACAD - Ascending Triple Top Breakout on 1.0 P&F chart - 21 buy signal - Next Major resistance comes in form of old highs of 32 providing an attractive risk reward here.

    Price precedes news....in other words things always leak and perhaps the ramp from 17s to 21 and a technical breakout means someone knows something,

  • Dorsey Wright positive note out today on ACAD - Ascending Triple Top Breakout on 1.0 P&F chart - 21 buy signal - .

    "Stock stabilized above bullish support line and gave near term buy signal at 21 to confirm that trend support has held. The next major resistance comes in form of the old highs of 32 providing an attractive risk reward here"

    .25, .50 and 1.0 P&F's all broke out last couple of days - Ascending Triple Top Breakout

  • The last few days were not normal imo for IOC and I suspect are just not market related. On an option expiration friday IOC actually went up on low volume and they did not try to pin it under a strike as is the norm. Then on Tues the volume tripled and we were up 2.50....feels like some news is coming.

  • rob_cos rob_cos May 17, 2014 8:54 PM Flag

    IV is much better as you can pot unlmited length posts and bashing is not tolerated - bold and other text enhancements like yellow highlighting are also better

  • rob_cos rob_cos May 16, 2014 4:44 PM Flag

    yahoo cuts it off - go to investor village ACAD message board for FULL MUST READ ACAD JPMORGAN INITIATION REPORT u know you have to add . and the three letters beginning with co and ending in m to link - if I even post that it deletes post

  • Positive Phase 3 Data + Unmet Medical Need = Compelling Investment Opportunity...Initiating at OW

    We are initiating coverage of ACADIA Pharmaceuticals with an Overweight rating based on the potential of pimavanserin in Parkinson’s Disease Psychosis (PDP) and, to a lesser extent, in Alzheimer’s Disease Psychosis (ADP). Psychotic symptoms develop in 20-50% of PD and AD pts, though there are currently no approved therapies to treat them. While antipsychotics are used off-label, they are associated with significant side effects. In contrast, pimavanserin has been shown to be effective in the treatment of PDP with a remarkably clean safety/tolerability profile. In PDP alone, we (conservatively) estimate pimavanserin has peak sales potential of ~$1B in just the US, and ADP represents ~3-4x that opportunity. Thus, with a high probability of success (highly positive Phase 3 data in hand), we believe ACAD’s paucity of 2014 catalysts plus the recent biotech sell-off have combined to create a highly compelling long-term investment opportunity. Our December 2014 price target of $33 reflects 80% probability of success in PDP and 30% in ADP.

  • Jeffries-more positive about CELG-arguments make us more confident in a likely broader interpretation around claims....We Believe CELG Has The Upper Hand. Buy $197 target...

    Celgene Corp. (CELG): No Material Changes Following Markman Hearing On Revlimid Patents
    Rating BUY

    Price Target $197.00 Price $148.85


    Key Takeaway

    We attended the Markman hearing in Newark, which was the definition/claims construction hearing in advance of the Revlimid patent trial between Natco and CELG. Although the Judge was largely silent during the proceedings and was not overly expressive, we are incrementally more positive about CELG as the arguments make us more confident in a likely broader interpretation around claims. A ruling is expected “shortly,” which we believe means in the next 2 months.

    Not Much New During Markman Hearing. After agreeing to five interpretations of terms including chemical name, unit dosage form and three definitions surrounding administration late on Wednesday evening, lawyers from both sides stuck closely to topics and arguments outlined in their briefing documents focusing on whether Revlimid patents were limited to isomers/racemic mixtures, what constituted a hemihydrate, and the specificity of CELG’s Form A. We review the details and some incremental nuances of the arguments raised on page 3 of our note.

    We Believe CELG Has The Upper Hand. We had previously thought that CELG’s definition of Form A was too broad and that Natco may have the advantage in that argument. That said, CELG’s defense of its definition during the Markman hearing was more persuasive than we had expected, drawing on the full history of the back and forth with the patent examiner, which we believe Natco was unable to counter effectively. The judge noted that she would issue a decision “shortly,” which we think could be within the next two months. A win for CELG on the three definitions could be important to improving near-term investor sentiment. Of note, CE

  • Piper Jaffray-"CELG presented STRONG CASE...Form A / B was in CELG favor...Clearly CELG has more compelling arguments in 800 polymorph patent. Reiterate Overweight CELG"

    PIPER (full rot on InvestorVillage C

    CONCLUSION

    We attended CELG's Revlimid Markman Hearing today. CELG and Actavis (ACT,

    followed by David Amsellam) agreed on Weds. night (5/14/14) to 5 of CELG's proposed

    claim constructions so the focus of the hearing today was on Revlimid composition

    patents ('230 and '554; expire in July 2016), as well as polymorph patents ('800, '357', '219,

    and '589). '800 is expected to expire in April 2027, while '357, '219 and '598 are expected

    to expire between 2024-2025. It may take months for a decision, but our impression

    (shared by others in attendance) is that CELG's council presented a strong case against

    ACT for disputed claims regarding isomer/mixture as well as polymorph "form A" and

    "form B." We think that this part of the patent evaluation was in CELG's favor and may

    ultimately help in settlement negotiations. Overweight on CELG, $170 PT.

    • So what now? This was the first of a series of steps which will decide the duration of

    exclusivity for Revlimid. The judge will finalize claim definition in a couple of months

    and then the lengthy court case will proceed. Presumably there will be a settlement

    before or after the Markman decision. Interestingly, NVS recently announced a

    settlement for Gleevec with Sun Pharma; the polymorph patents expire in 2019, the

    compound expires in July 2015 and the settlement date was Feb. 1, 2016-- skewing

    against the polymorph patent which may be an interesting harbinger that would

    predict a patent settlement in 2025 for Revlimid. Our own view is that polymorph

    patents in general are weaker than many investors think, but we believe the current

    CELG valuation isn't dependent on those polymorph patents holding and there

    is plenty of time for a settlement sometime between the method patents and the

    polymorphs

AMGN
118.95-0.62(-0.52%)Jul 10 4:00 PMEDT

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