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rob_cos 55 posts  |  Last Activity: 1 hour 32 minutes ago Member since: Dec 31, 1997
  • Reply to

    What i care most about for CELG

    by dividendseeker Aug 28, 2014 11:58 AM
    rob_cos rob_cos 1 hour 32 minutes ago Flag

    ISI thinks it could be a $5 billion a yr blockbuster...Ph 2 data coming - could be curative

    October 21, 2014 – Oral Presentation at the United European Gastroenterology Week (UEGW) meeting on in Vienna of Data from the 166-patient Phase II induction trial of GED-0301 in Crohn’s Disease (Celgene clearly excited about this data & says people will understand why they bought this when they see it…ISI says this could be a $5 billion drug).

    See investorvillage CELG board for link

  • rob_cos rob_cos Aug 30, 2014 3:13 PM Flag

    we would expect that concession to be quite modest and to occur in early to mid 2015.

    Among Celgene's patents for Revlimid, the '800 patent offers the strongest and the longest protection. Of the 18 patents at issue in this case, the latest-to expire is the '800 patent which claims the hemihydrated crystalline form (polymorph) of Revlimid (lenalidomide). This patent expires in the US in April 2027, and we have regarded it as the most significant protection beyond the actual composition of matter patents that expire in 2019. The claims of this patent, presuming it is upheld, are likely to prevent Natco from proceeding with a "nearly the same" version of Revlimid, which is almost equivalent to the protection afforded by true composition of matter patents in our view. For example, if Natco proceeds with a version of lenalidomide that is not a hemihydrate, then it is unlikely to be considered truly bioequivalent to Revlimid. If they proceed with a hemihydrated form, however, they are likely to infringe the claims in the '800 patent, particularly after the relatively broad interpretation allowed by the Judge in this trial in the recent Markman hearing.
    Natco's original strategy focused on circumventing the '800 patent and invalidating the other less important patents, particularly method of use and distribution patents. Natco's legal strategy has focused on invalidating all the extant patents asserted by Celgene, with the notable exception of the '800 polymorph patent. In both the Markman hearing and the additional pre-trial motions, it is clear that the '800 patent is also of real importance to Natco. From the outset, Natco attempted to propose a narrow interpretation of the term "hemihydrate" to circumvent Celgene's claim without breaking the patent; presumably, the patent could help Natco deter other potential generic entrants until 2027. The Natco strategy appears to be driven more by commercial considerations than by legal considerations, and it may have backfired with the broad interpretation of the "hemihydrate" claims in the Markman ruling. This may explain why Natco appear to be back-tracking in terms of their strategy with respect to the '800 patent.
    The Markman ruling in May was a significant setback to Natco's non-infringement arguments against the '800 patent. As we have discussed before, the Judge sided with Celgene's proposed interpretation of the term "hemihydrate", which is considerably broader than Natco's proposed interpretation. We believe the Judge's ruling may have dealt a significant blow to Natco's arguments for non-infringement. With the claim language being as broad as it is, it may have become more difficult for Natco to engineer a version of the drug with similar properties to Revlimid that does not infringe the '800 patent. In addition, Natco may have been caught flat-footed without other arguments against the patent either.
    Recent court maneuvers by Natco suggest that Celgene has a strong case in defending the '800 patent. Natco recently petitioned to the Court for permission to now advance invalidity arguments against the '800 patent, suggesting that the company has decided to change strategy in light of the Markman ruling. However, Natco faces an uphill battle to add new invalidity arguments at this point, almost four years into the case. According to our legal advisors, there is at least a 50-50 chance that the Court will deny Natco's petition outright. Even if Natco is allowed to present its invalidity arguments (based on indefiniteness and lack of written description), the arguments they are making do not strike us as particularly convincing.
    We expect Celgene to settle the case on favorable terms by Q1 next year. While Celgene appears to have a strong case, going to trial may not be the best option due to additional legal costs, distraction for management, and overhang on the stock due to the small but catastrophic risk of a negative outcome. Based on current timelines, a trial would not start until Q2 or Q3 next year. In our recent conversations with Celgene, the message is clear: "We are open to settlement if it's in our shareholders' interest." Right now, Celgene appears to be applying maximum pressure through legal maneuvers to drive Natco to the settlement table with Celgene holding a strong negotiating position. We think the most likely timing for a settlement is in Q1 2015, after the completion of expert discovery and before the start of the trial. It would not surprise us if initial discussions with Natco have already taken place.
    The Cubicin patent settlement provides a template for settlement in the Revlimid case. During our recent investor dinner with Celgene, the Cubicin patent settlement was mentioned as an example for a settlement that favors the branded manufacturer. As part of the settlement, Cubist granted Teva a license to launch a generic Cubicin 15 months before the latest patent expiry; Teva agreed to purchase its generic drug exclusively from Cubist during the license period, and pay COGS plus margin, as well as a share of its profits, thus largely hedging the innovator against the loss of revenue from the earlier entrant. In the case of Revlimid, the market currently prices in the equivalent of 2023/2024 generic entry; therefore, a settlement that bars generic entry until 2025/2026 (or 1-2 yrs before the '800 patent expiry) would be a win for Celgene, particularly if it involved terms similar to the Cubicin arrangement.
    We continue to recommend Celgene's stock strongly at these levels. We believe that the Revlimid patent is likely to be upheld through 2025, the company has sustainable revenue and earnings growth through 2017 based on new markets and indications for Revlimid, and the early stage pipeline remains underappreciated by investors. The company does have a "gap" in late stage development candidates, but we expect more visibility about their recent acquisitions and collaborations in the second half of the year that may bolster their portfolio. Our revenue forecast for Celgene remains 1-2% above consensus and our EPS estimates are 6-9% higher based on lower share count and improving margins. We believe the emerging early to mid stage pipeline offers significant and under-appreciated optionality for investors looking beyond the next 3-6 months.

  • Go to CELG investorvillage board for full report that wont fit on yahoo...

    BERNSTEIN * Celgene: Natco's Case Getting Weaker; We See Settlement in Q1'15 Barring Revlimid Generic Entry Until 2025/26. Expect concession to be quite modest. Pressure will mount on Natco...Got unrestricted version of July 22nd report - a MUST READ

    - Perhaps one of the most important analyst reports ever written on CELG

    BERNSTEIN * Celgene: Natco's Case Getting Weaker; We See Settlement in Q1'15 Barring Revlimid Generic Entry Until 2025/26.

    Highlights

    Despite the strength of Celgene's stock recently, the major issue facing the company near term remains the ongoing Natco challenge to the Revlimid patents. In 2010, Natco and its partners filed an Abbreviated NDA for a generic version of Revlimid, claiming the many issued patents protecting the drug are invalid, unenforceable and/or would not be infringed by the generic. We have taken a relatively sanguine view of the outlook for this challenge, and believe that a settlement barring generic entry until 2025/2026 (or 1-2 yrs before last patent expiry) remains the highest probability outcome. We have had counsel retained on this issue since we first initiated coverage of Celgene, and their advice has informed our views and valuation. In this note we summarize the landscape as we see it today, and provide a foundation on which future disclosures, and research, will build. Although there continues to be sparring between the parties during the final stages of pre-trial discovery and expert testimony, it appears to us that Celgene started with the upper hand, has had the better of the exchanges, and remains in a dominant position. A settlement with some concessions seems likely to minimize the small but catastrophic risk of a negative trial outcome, but

  • RBC - Otezla total scripts up 7% wk/wk (+174% QTD) - Q2 undercaptured rate because of free titration starter packs -We see greater appreciation for Otezla over next couple quarters...

    Event:
    Reporting eighth week of Q3:14 IMS scripts (week ending 8/22/14).

    CELG: Otezla TRx 927, +7% wk/wk (+174% QTD), and NRx 544, +4% wk/wk in 21st week of launch
    Q2 sales were $5M, which undercaptured because of free titration starter packs that led to commercial drug after reimbursement approval.
    We see greater appreciation for Otezla over the next couple quarters, because scripts are tracking much higher than Xeljanz's launch, implying Q3 cons estimates of $29M are achievable. PFE's Xeljanz reported TRx/NRx of 569/335 in its 21st week of launch (ending 04/05/13), and $22M during its second full quarter of launch.

  • Deustche Banks - We just added GILD, CELG and BIIB and AMGN as BUYs to DB's SOLAR (short term conviction ideas).

    We just added GILD, CELG and BIIB and AMGN as BUYs to DB's SOLAR (short term conviction ideas).

    In short, our call is that there will be upside earnings revisions from new product launches and each company has pipeline catalysts that read out near term and are not in models.

    Rationale for each below...

    ********************************************************************************


    CELG

    There is a new SOLAR idea on the Deutsche Bank Research Website.

    Stock: Buy Celgene (CELG.OQ)

    Analyst: Robyn Karnauskas

    Comment:

    Basis for the short-term investment idea:

    The company has data read-out from a new pipeline product that uses antisense technology to treat Crohne's disease; the product is GED-031. Data will be released in Vienna at the Gastroenterology meeting. This is NOT in numbers. In addition, we see upside revisions to earnings expectations for Celgene on the back of the Otezla launch.

    Catalysts:

    1) GED-031 read-out in Vienna October 18-22; 2) ASH - additional data; 3) JPM - January - company could give updated guidance; 4) quarterly call color on Otezla sales.

    Risks to the short-term investment idea:

    1) Disappointing earnings; 2) disappointing clinical trial results; 3) concern about patent cliff.

    Long-Term Fundamental Rating: Buy

  • This is it - the best
    Robert Hugin -Celgene Chairman, Chief Executive Office

    Capturing the full value of our franchises is the highest order of corporate priority. We’re making exceptional progress in building for the future. During the quarter, we strengthened our hematology product portfolio with important new clinical data in MDS, AML, and mantle cell lymphoma. The future of our hematology franchise was further enhanced through meaningful progress on strategic collaborations, including ACE-011 and ACE-536 in beta thalassemia, and exciting data in targeted relapse refractory AML with AG-221. We’re aggressively moving these programs forward with our partners, Acceleron and Agios

    Mark Alles - Celgene President

    We are excited about the data from the ongoing Phase I study of AG-221, a small molecule oral inhibitor of the mutant form of IDH-2 discovered by our partner, Agios Pharmaceuticals, that was presented at EHA. These results summarized the activity and safety of AG-221 in 35 patients homogenously defined with the IDH-2 mutation positive relapsed and refractory AML. Treatment with AG-221 demonstrated a very high objective response rate with a very manageable safety profile. Given these early but promising Phase I data, we exercised our option to an exclusive worldwide license to AG-221 in June. This is now a high priority program and we are rapidly advancing plans to conduct global registration trials

  • Deutsche Bank BIO- CELG- *IMS suggests 3Q Otezla sales at ~$13M +180% from Q2


    Celgene Alert - IMS suggests 3Q Otezla sales at ~$13M
    08 August 2014 (1 page/ 122 kb)



    Celgene {Ticker: CELG.OQ, Closing Price: 85.22 USD, Target Price: 115.00 USD, Recommendation: Buy}

    Weekly IMS scripts indicate Otezla sales of ~$13M for 3Q using the calculated capture rate (113%). This represents ~180% growth from 2Q’14 number ($4.6M). Total Scripts were flat w/w (739 vs. 736) while the new scripts were down 4% w/w (475 vs. 497). Scripts for July are ~3700 which is slightly below the number of scripts written in the entire 2Q (~3968). Celgene mentioned on their 2Q14 call that July monthly sales would meet or beat the entire 2Q (~$5M). Please ask for our Otezla calculator.
    ◾We use script based calculations and note that IMS indicated 2Q sales at ~$5.2M vs. $4.6M actual. This gives a capture rate of 113% for 2Q.
    ◾Using this capture rate and Gross to net of 30%, we arrive at $13M sales for 2Q. We model ~4% weekly script growth every week for the rest of the Q. At 100% capture rate we see 3Q’14 sales at $15M.
    ◾We model higher gross to net in this market as such discounts are normal in these channels. Our survey indicated a 25-30% discount for Anti-TNFs vs. their WAC price.
    ◾Caveats: Capture rate and gross to net are key variables in these calculations. Our capture rates are based on early trends. We also note that IMS does not capture inventory which in the launch phase could provide upside.

  • Reply to

    UPGRADES & PRICE TARGETS $38, $33, $46

    by portsmouthohio Aug 7, 2014 5:27 AM
    rob_cos rob_cos Aug 7, 2014 5:43 PM Flag

    Investor Village is infinitely better than yahoo finance message board -

    1) you can post unlimited length posts - yahoo cuts off at random - one post on IV has to be broken up into some times 5 posts on yahoo and then yahoo sometimes randomly deletes the replies
    2) ON IV you can post charts, pictures, graphs, drawings...
    3) IV you can post colors, fonts, bold, italics, yellow highlighting, bullets - so analysts reports are shown similar to reports themselves
    4) IV does not tolerate trolls, bashers, name callers, imposter IDs close to other real IDs, multiple ID's...Admin deletes quickly and bans these type of posters
    5) intelligence level on CELG., SGMO, ACAD and other boards is high - many CELG investors use that board as home page - first place they visit every day

  • Reply to

    CELG News and information

    by hedgecutter10 Aug 7, 2014 12:30 PM
    rob_cos rob_cos Aug 7, 2014 2:24 PM Flag

    Rob has been recommending the stock for 15 yrs since 39 cents - 8 3/8s divided by 24 for 1 total splits...its no scam its hard work, lots of due diligence, attending CELG presentations at healthcare conferences, attending annual shareholders meetings, getting to know CELG execs and board members and reading every analyst report....Go to investorvillage CELG board and you will see my posts for yrs - and see that I am approaching 100,000 visitor recommendations on my CELG posts - this is by far the most recommeations of any IV poster....The stock has risen over 200 times (20,000%) since I first recommended and it just tripled in the last couple of yrs....its going to double from here. Do your own due diligence - by far Investorvillage CELG board is the place to get the most CELG information - a recent yahoo poster who went there posted that recently.....BTY I posted CELG post #8 on this yahoo finance board in 1998 and also posted post 100,000 back when they were numbered....we moved to IV because of better posting ability (bigger posts allowed, links allowed, colors and text highlighting/bolding/fonts, pictures/slides/charts postable, etc) Go there everyday if you are a CELG investor - really.

  • CELG CEO/Chairman & CELG Pres on AGIO...exciting data in targeted rr AML with AG-221. We’re aggressively moving these programs forward/ Ecited about AG-221.This is now a high priority program &we are rapidly advancing plans to conduct global re


    Robert Hugin - Chairman, Chief Executive Office

    Capturing the full value of our franchises is the highest order of corporate priority. We’re making exceptional progress in building for the future. During the quarter, we strengthened our hematology product portfolio with important new clinical data in MDS, AML, and mantle cell lymphoma. The future of our hematology franchise was further enhanced through meaningful progress on strategic collaborations, including ACE-011 and ACE-536 in beta thalassemia, and exciting data in targeted relapse refractory AML with AG-221. We’re aggressively moving these programs forward with our partners, Acceleron and Agios

    Mark Alles - Global Head, Hematology and Oncology (now promoted to President as of Aug 1)

    We are excited about the data from the ongoing Phase I study of AG-221, a small molecule oral inhibitor of the mutant form of IDH-2 discovered by our partner, Agios Pharmaceuticals, that was presented at EHA. These results summarized the activity and safety of AG-221 in 35 patients homogenously defined with the IDH-2 mutation positive relapsed and refractory AML. Treatment with AG-221 demonstrated a very high objective response rate with a very manageable safety profile. Given these early but promising Phase I data, we exercised our option to an exclusive worldwide license to AG-221 in June. This is now a high priority program and we are rapidly advancing plans to conduct global registration trials

  • TARGET: US$46.00

    C O N C L U S I O N

    Acadia reported 2Q financials yesterday. No major updates on the U.S. pimavanserin (pima') program, but for Europe the company now plans to file the MAA for pima' in Parkinson's disease psychosis (PDP) on the single 020 study. Although we had previously published this as a possibility, and we expect ACADIA will be successful in obtaining E.U. as well as U.S. approval with this plan, we believe that the new strategy will represent time line contraction and risk reduction for some investors.

    • We continue to maintain a modest level of sales in the U.S. in 2015, but move our EU sales to 2016 anticipating a mid-to-2H15 MAA filing. With an eye to eventual label expansion, we view pima' as a pipeline in a product candidate and reiterate our Overweight rating. We are rolling our discount period to YE15 resulting in a new $46 price target (from $42).

    • The company ended 2Q with $354M in cash and we model no further financing for ACAD. Pre-commercial activities from the pima' commercial team are progressing and Acadia maintained guidance to an NDA filing "near" YE. Acadia reiterated its plans to field a specialist sales force in the U.S. targeting primarily neurologists. The company characterized its interactions with the FDA as positive and data from the stability testing batches are consistent with data from the clinical trials. Supportive clinical studies like drug-drug interaction are also on track according to management commentary.

    • Fully informed E.U. filing strategy. The European filing plans were made following discussions with member states and consultants that Acadia said were previously working at the highest levels in the EMA. Acadia considers the clinical package for submission very good and believes filing is the "optimal" path to approval vs. seeking additional scientific advice.

    • Alzheimer's psychosis study, and others (soon), making progress. In support of our pipeline-in-a-product thesis for pima', Acadia is studying pima' in a Phase II study in Alzheimer's disease psychosis (ADP). Recall this study is being run at a single (large) site in the U.K. Final data collection is late 2015 according to clinicaltrials.gov, although we suspect that these timelines may not account for actual progress in the study and that data may come closer to mid '15. In addition, protocol plans are being formed for studies in improving sleep, likely to be conducted in Parkinson's patients, which may start later this year or in early 2015. Acadia is also working on the design (duration, patient population, etc.) of a study in schizophrenia that is likely to start in 2015.

  • JPMorgan full report - Progress on the European Front - Reiterate Overweight and $33 target - bio selloff creates highly compelling long-term investment opportunity

    J.P. Morgan

    ACADIA Pharmaceuticals Overweight
    ACAD, ACAD US

    2Q Snapshot...Progress on the European Front

    Price Target: $33.00

    Biotechnology

    We are reiterating our OW rating on ACAD following the 2Q report. The biggest

    update to come out of the call was a timeline/path forward in the EU for pimavanserin

    for PDP: the co plans to file an MAA in the EU 6-9 mos post filing in the US. Pre-

    NDA meetings have been completed, and the company remains on track for US filing

    around year-end (with the rate limiting step being 12 mos stability testing started in

    Oct 2013). Progress with the ADP trial continues as planned. The co is also planning

    an additional study to further characterize pima’s potential sleep benefit in addition to

    a trial in schizophrenia. Bottom line, everything is progressing as expected, and we

    continue to think that ACAD’s lack of 2014 catalysts plus the recent biotech sell-off

    have combined to create a highly compelling long-term investment opportunity.

     Key incremental takeaway: ACAD noted it is moving forward with an MAA

    filing in Europe without requesting formal Scientific Advice/without having spoken

    with the EMA on the adequacy of a single pivotal trial for filing. This decision was

    made based partly on guidance from external consultants (who ACAD noted are

    former EMA employees) and also the company’s confidence in the existing data

    package.

     Key upcoming events. The most notable event in 2014 will be submission of the

    NDA for pimavanserin in PDP which is expected near year-end. In the EU, an

    MAA filing is anticipated 6-9 mos following NDA submission. In the meantime, we

    expect incremental updates on commercial preparations in the US throughout the

    year. ACADIA also plans to announce more details on the life-cycle management

    opportunities for pimavanserin, specifically planned studies in schizophrenia, later

    this year. A key event in 2015 should be pimavanserin data in ADP (likely 2H).

     2Q results. 2Q EPS was ($0.22) vs. JPMe/cons of ($0.18)/($0.11). 2Q OpEx was

    $22M vs. JPMe of $19M (R&D was $14M vs. JPMe of $12M). That said, ACAD is

    not an earnings story.

     Estimate revisions; establishing a Dec 15 target of $33. We have updated our

    model for 2Q results, and have made minor tweaks to the expense expectations

    going forward. We’re also establishing a Dec 15 PT of $33 (unchanged vs. our

    previous YE14 target).

     Balance sheet update. ACAD ended 2Q14 with ~$354M in cash, which the

    company believes will be sufficient through at least 2017.

  • Rob Cos' detailed list of incredible near term Celgene upcoming milestones/ catalysts - A MUST READ!!!

    Also with Dr Fouse fully in charge of hem/onc now - I suspect Celgene accelerates some of these dates - I expect 3 to 4 Phase 3's including partner programs to start before yr end. There is no biotech with this many near term catalysts....Round out your CELG position in August....many catalysts are coming

    Celgene Upcoming Milestones
    Event Timing - Milestone

    Aug 10-13 – Update on Celgene partner Epizyme (EPZM) EPZ-6438 for the treatment of EZH2-positive tumor types,also layout their exciting therapeutic target landscape for B-cell related malignancies - at the ASH Meeting on Lymphoma Biology in Colorado Springs

    Sept – Many healthcare conferences – RBC sees these as catalysts with CELG management as positive as it has been being able to give incremental updates

    H2:14 Obtain broad EU reimbursement for Imnovid (pomalidomide) – Reimbursement is country by country – by H2 we should have all major countries with pricing approval

    September 23, 2014 -Otezla approval (PDUFA) date for psoriasis

    Sept – Oct - Publication of Data from the 166-patient Phase II trial of GED-0301 in Crohn’s Disease (Celgene has said publication of data may even come before the oral presentation)

    October 21, 2014 – Oral Presentation of Data from the 166-patient Phase II induction trial of GED-0301 in Crohn’s Disease (Celgene clearly excited about this data & says people will understand why they bought this when they see it…ISI says this could be a $5 billion drug).

    November 14 – 19, 2014 – Important Otezla Palace-1 2 year data at ACR’s 2014 Annual Meeting in Boston, Massachusetts. Celgene is excited about this data on Q2 call – efficacy improves with time vs biologics where it declines

    H2:14 Phase II sotatercept (ACE-011) data in MDS H2:14 – Accelron (XLRN) drug

    H2:14 Phase II data on ACE-536 in MDS and b

    Sentiment: Strong Buy

  • We think stock goes higher for five reasons; nearterm oral Crohn's data could impress

    Our view: Price target to $100 now - our ongoing positive thesis is: 1)

    upcoming Crohn's data will increase Street confidence in $1B opportunity,

    2) eventual settlement with ACT in 2015, 3) second inning of pipeline

    thesis, 4) company keeps buying back more stock, 5) will bullish new 2020

    long-term guidance start becoming a topic of conversation?

    Key points:

    We think the stock will generally grind higher because Phase II Crohn's

    data in October will probably look much better than Humira, plus it's in

    oral form - we review data and competitors inside. We've repeatedly said

    that we think settlement with ACT is likely in 2015, which opens up P/E

    expansion. We expect front-line EU myeloma approval to finally occur in

    spring 2015 as pipeline visibility also increases, an area that hasn't gotten

    much attention yet.

    1. We reviewed data on current Crohn's drugs and new CELG GED-0301 literature and prior studies (see summary thoughts inside). We

    predict Phase II data at UEG conf (Oct 21) will show much better results

    vs. current drugs (TNFs), which have modest 22-48% "remission" and

    35-55% "response". Key is current drugs show responses halve every

    3-6 mos, lacking durability. Mgmt is bullish and we think much higher

    responses, dose response, and biomarker activity support overall

    totality of promising first oral drug. Bull case is rational target, high

    efficacy over 4 weeks, good safety; bear case is single-country/site,

    open-label study, CDAI endpoint needs placebo control.

    2. Based on commentary by CELG and separate RBC notes on ACT

    meetings, we expect rational market behavior, and we think

    Markman results could lead to settlement in 2015 making it much

    more "ownable" for generalists with overhang removed.

    3. We see 23+ partnered pipeline assets and are most positive on Phase I/II MOR202 anti-CD38 antibody for myeloma with data starting in

    2015, and others such as XLRN, AGIO, EPZM, CNCE, etc gaining more

    investor appreciation in 2015.

    4. CELG continues buying back stock: purchased $475M in Q2 and

    $2.1B YTD with $3.9B left, which seems likely to continue over time,

    particularly on pullbacks and because of obvious accretion to EPS.

    5. Commentary on Q2 call seems to imply mgmt looking at drivers

    post-2017 to talk about soon: "...clarity over the next couple of

    quarters will give you and us the ability to really articulate more clearly

    what is the incredible opportunity for us that we see, say, in 2020...".

    Recent AMGN ASPIRE (and Phase III pending ABBV Elo) all clearly show

    duration of Rev/dex way longer than anyone imagined...this grows

    duration by ~25-50% and is the "key" to why Revlimid guidance looks

    reasonable over long run

  • The expert advisors say file on Phase 3 trial - compelling data package and EU wants alt to deadly anti-psychotics. EU approval is not in this stock. Adding AH before analyst reports come out

  • Sounds like they are going directly to EMEA MAA filing in Europe next yr on one trial after discussing with multiple country experts, EMEA personnel and advisory group....This to me is pretty big - seems like they don't need a second phase 3. If that is right this is good news imo not priced in this stock?

    Said they don't need a scientific review as those are for earlier stage drugs per the experts. Committee advice

  • Did ACAD just say....that they are filing in Europe next yr (meaning on only 1 trial)?? That would be huge imo - did I mishear?

  • Amgen (AMGN, Buy) announced positive data from its Phase 3 ASPIRE study in relapsed multiple myeloma, in which Kyprolis with Revlimid and low-dose dexamethasone (KRd) led to a much longer progression free survival (PFS) than Rd alone. Given the shifting landscape of first-line MM treatment, we see the real value of ASPIRE being a proxy for the efficacy of a Kd-Pomalyst regimen for relapsed MM and the potential for KRd to extend duration in the first-line.​

    Kyprolis-Containing Regimen Shows PFS Benefit. Amgen announced results from a Phase 3 trial that showed Kyprolis in combination with Revlimid and low-dose dexamethasone (KRd) led to a longer progression free survival (PFS) than Revlimid and low-dose dexamethasone (Rd) alone (26.3 months v. 17.6 months; hazard ratio: 0.690, 95% confidence interval [CI]: 0.570, 0.834, p

  • Took former CEO Frost over to Intrexon preparing for sale imo. Was in 14s then trial halted - trial has been restarted promptly and now they just got an unexpectedly bullish FDA panel vote for upside. Stock trading in 9s is insanely cheap - no reason why this stock should not be back to 12-13 after trial restarted - especially after the positive Panel vote. Kirk sells in 20s by yr end - earning lots of capital for intrexon.

  • rob_cos rob_cos Aug 5, 2014 10:46 AM Flag

    See investor village celg board for Bernstein comments - they think initial settlement discussions have started - could happen at any time imo and I think before most think - conservative est is Q4/Q1 imo

IOC
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