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Biogen Idec Inc. Message Board

dinepat203 359 posts  |  Last Activity: Sep 12, 2014 3:48 PM Member since: Sep 29, 2011
  • dinepat203 dinepat203 Aug 22, 2014 1:18 PM Flag

    20 Aug 2014 Bristol-Myers Squibb Co:To establish a clinical trial collaboration with Celgene.To evaluate safety, tolerability and preliminary efficacy of a combination regimen of Bristol-Myers Squibb's investigational PD-1 immune checkpoint inhibitor, OPDIVO, and Celgene's nab (technology-based chemotherapy ABRAXANE), in a Phase I study.Multiple tumor types will be explored in the study including HER-2 negative metastatic breast cancer, pancreatic cancer and non-small cell lung cancer

  • dinepat203 dinepat203 Aug 22, 2014 12:56 PM Flag

    $31.70 TGT by AUG end can you believe?

  • dinepat203 dinepat203 Aug 22, 2014 12:50 PM Flag

    The Celldex-Bristol-Myers = AstraZeneca -Incyte.

  • dinepat203 dinepat203 Aug 22, 2014 12:48 PM Flag

    May be started with $15.88 the day before yesterday?

  • dinepat203 dinepat203 Aug 22, 2014 12:44 PM Flag

    How much short you hold ? ....nerves ? LOL

  • dinepat203 dinepat203 Aug 22, 2014 12:33 PM Flag

    “There’s a lot of flexibility, and it gets us to the point where we can negotiate in real time, with data, as opposed to anticipating what that data would be and possibly doing a deal that’s not as [good] as we would like.”.

    Celldex believes the future of immunotherapy lies in combination regimens that further unlock the power of the immune system to deliver the greatest benefit to the largest population of patients possible,” said Marucci, in a statement. “Based on our clinical data and preclinical models for both programs, we think the combination of varlilumab and nivolumab could play an important role in maximizing the body’s immune response to cancer.”

  • dinepat203 dinepat203 Aug 22, 2014 12:19 PM Flag

    2014 Milestones
    Rindopepimut
    •Continue execution on the ACT IV Phase 3 registration study in frontline GBM
    •Report data from ReACT Phase 2 study in recurrent GBM in late 2014
    Glembatumumab vedotin (CDX-011)
    •Continue accrual of METRIC accelerated approval study in triple negative breast cancer
    •Initiate Phase 2 study in metastatic melanoma and finalize preparations for Phase 2 study in squamous cell lung cancer
    Varlilumab (CDX-1127)
    •Initiate Phase 1/2 study of varli and Opdivo
    •Initiate Phase 1/2 study of varli and Yervoy plus CDX-1401 in NY-ESO+ positive patients
    •Continue to finalize plans for multiple combination studies (both alone and in collaboration) with a broad array of agents
    CDX-1401
    •Support Phase 2 study of CDX-1401/CDX-301 in melanoma (NCI sponsored)
    CDX-301
    •Initiate pilot study of CDX-301 alone and with Mozobil in HSCT
    •Support Phase 1/2 study of CDX-301/Hiltonol/radiation in B-cell lymphoma (investigator sponsored)

  • dinepat203 dinepat203 Aug 22, 2014 12:14 PM Flag

    Puma Biotech PBYI has no offer from any big pharma what so ever. Whereas CLDX Bristol-Myers would have been entitled to future milestone payments and royalties on Celldex’s program, because of an old deal Celldex had in place with Medarex—the company Bristol-Myers bought in 2009, and the one Celldex was spun out of a few years earlier. But those potential milestone payouts have been waived—and the royalty rates reduced—as part of the transaction.

    CLDX is a BMS potential target for acquisition after Medarex and collaboration is just the beginning of bright future CLDX holds in the hands of BMS.

  • dinepat203 dinepat203 Aug 22, 2014 11:52 AM Flag

    Updated, 10:15 am ET] Big pharmaceutical companies everywhere are playing the mix and match game to come up with the best possible combination of immunotherapy drugs to treat cancer. Hampton, NJ-based Celldex Therapeutics has become the latest beneficiary of that strategy through a deal today with Bristol-Myers Squibb.

  • PBYI -$237(Mkt Cap $7.5Billion) whereas CLDX$14.5 (Mkt Cap $1.25B)
    The careful vetting of all experimental cancer drugs by "the market" -- investors and Big Pharma -- is a key, underlying tenet of the Feuerstein-Ratain Rule. The most promising cancer drugs are identified relatively early, which leads to higher market valuations for the companies developing these drugs and Big Pharma partnerships or acquisitions. Or both. Conversely, experimental cancer drugs vetted early but found to be lacking tend to be orphaned i.e. the companies developing them are unable to sign a Big Pharma partner and their market valuations are relatively low.

  • Reply to

    Rindo data

    by acogan08003 Aug 22, 2014 7:25 AM
    dinepat203 dinepat203 Aug 22, 2014 11:28 AM Flag

    “There is no hesitation in using this. It is a vaccine so administration is not an issue, and if the phase III data is similar to what is described here, the improvement in OS is clinically significant.” – Physician (UK)

  • dinepat203 dinepat203 Aug 22, 2014 11:24 AM Flag

    Having all these in place CLDX can plan Go-To-Market even before PBYI as PBYI is planning for NDA by end of 2015 whereas Rindopepimut (front-line)- Oncologists across six markets were enthusiastic about prescribing rindopepimut in their newly diagnosed GBM population based on the improvement in OS.

    Most respondents discussed readily using this product in all eligible newly diagnosed patients.
    The newly diagnosed population presents the most “hope” in terms of positive outcomes and success in treatment.

  • dinepat203 dinepat203 Aug 22, 2014 11:16 AM Flag

    Expanded development before the YE - (Year End)

    •Clinical trial collaboration with Bristol Mayer Squibb (Opdivo) – study to start YE 2014 (Celldex led; shared development costs)
    •Clinical trial collaboration with Oncothyreon (ONT-10) – (Oncothyreon led and funded)
    •Phase 1/2 study of varli and Yervoy® (plus CDX-1401 in NY-ESO+ patients) – protocol finalized; study to start by YE
    •Multiple other studies in queue
    Investigator sponsored Phase 1/2 study of intratumoral injection of CDX-301 and Hiltonol in combo with low-dose radiotherapy for patients with low-grade B-cell lymphoma - ongoing
    •Pilot study of CDX-301 in hematopoietic stem cell transplant in combination with Mozobil expected to initiate in Q3 2014

  • dinepat203 dinepat203 Aug 22, 2014 11:12 AM Flag

    Rindopepimut Profile Tested Well with Physicians Across Europe and is Expected to Fill Unmet Need in GBM

  • Commercial opportunity defined for US, EU and ROW
    –Positive feedback on product profile from MD, pharmacist and payer stakeholders
    •Disease education platform (GBM, EGFRvIII)
    –US and EU - ongoing
    •Go-to-market business model and hiring plan
    –US - complete
    –EU - in progress
    •Distribution model, provider services and patient access plans
    –US and EU - in progress
    •Payer and Health Technology Assessment (HTA) launch plan
    –US and EU - in progress
    Rindopepimut Profile Tested Well with Physicians Across Europe and is Expected to Fill Unmet Need in GBM
    10
    Physicians expressed strong enthusiasm for rindo and look forward to using it in 90% of EGFRvIII patients irrespective of resection type
    GBM seen as having high unmet need; requires centralized treatment settings
    Stakeholders across all countries studied in the EU acknowledged the poor prognosis of GBM and the need for therapies to help improve patient survival
    Currently, across all countries studied, the vast majority of GBM patients are treated in centralized locations that have the physician teams required to manage surgery, prescriptions, imaging and follow-up of these patients
    Source: Putnam Associates Rindopepimut EU Opportunity Assessment , May 2014
    MOA
    Efficacy
    Safety
    Physicians were excited by rindo’s MOA and consider it to be the next step for GBM therapies
    “There has been a lot of excitement around immuno-therapies within oncology lately and I think Product X is part of that wave of novel therapies.” – UK KOL
    Biomarker specific agents were seen as having a stronger MOA than non-targeted treatments
    PFS & OS are the key metrics physicians are interested in while assessing therapies for GBM treatment
    “With the aggressive nature of this disease, we are always on the lookout for statistically significant incremental benefit in PFS or OS.”– Italian MD
    Physicians were impressed with the survival benefit that rindo could provide over current standard of care
    “The mOS data is phenomenal… survival benefit of 6 mont

  • One company, Celldex (NASDAQ:CLDX), has seen great appreciation in its stock price due to its lead drug candidate, rindopepimut (CDX-110), a targeted immunotherapeutic which is now in Phase III. The market cap of Celldex in this presently challenging biotech market (due to Fed comments twice this year) is now at $1.2 billion and was 3 times higher earlier this year. So, if Ziopharm can demonstrate very early success in this open label trial to that level or greater, then I am sure that it would at least add $100 million or more to its market cap in Phase I to Phase II. And there is such a great need for a treatment of Glioblastoma and treatment will likely end up being the best of what is to be seen in a combo treatment either after success of singular trials with great success, or a required combo treatment trial as determined by the FDA or data to come.

  • Reply to

    New headline on

    by bostonblackie02066 Aug 19, 2014 2:48 PM
    dinepat203 dinepat203 Aug 19, 2014 3:31 PM Flag

    Sources: National Cancer Institute; National Cancer Institute Physician Data Query (PDQ); American Cancer Society Cancer Facts & Figures 2014; Cedars Sinai Brain Tumors and Brain Cancer web page; GLOBOCAN 2012; CRI grantee progress reports and other CRI grantee documents Last Updated June 2014 -
    Urgent Need
    It is estimated that 1 in 161 individuals born today will develop brain or nervous system cancer at some point in their lives. In the U.S., 23,380 men and women are diagnosed with cancer of the brain and nervous system every year, and 14,320 deaths are caused by the disease. Although significant advances have been made in understanding the biology of brain cancers—as well as in tumor diagnosis, treatments, and quality of life of patients with the disease—the mortality rate for brain cancer has remained steady for more than 30 years. The cause of brain tumors is not yet understood. Glioblastoma (GBM) is the most dangerous and aggressive form of brain cancer. GBM patients typically have short-term life expectancies; few will live to see three years after diagnosis. For newly diagnosed GBM patients treated with current standard of care, median progression free survival is just 6.9 months, and median overall survival is 14.6 months. Only a quarter of newly diagnosed GBM patients survive for 24 months, and under 10% of patients survive more than 5 years. -
    Rindopepimut (CDX-110), a therapeutic vaccine targeting a mutant peptide called EGFRvIII, that is expressed in approximately one-third of GBM tumors. Rindopepimut is currently being tested in the following trials that are enrolling patients with EGFRvIII positive tumors: a phase III trial in patients with newly diagnosed glioblastoma (NCT01480479) and a phase II trial in patients with relapsed glioblastoma (NCT01498328). For information on the 3 phase II trials of rindopepimut that formed the basis for the current randomized phase III trial, see Celldex’s recent news release summarizing the results.

  • Reply to

    New headline on

    by bostonblackie02066 Aug 19, 2014 2:48 PM
    dinepat203 dinepat203 Aug 19, 2014 3:15 PM Flag

    "The ACT IV study will include 700 patients with EGFRvIII positive glioblastoma from more than 200 clinical trial sites across 22 countries—the most comprehensive study conducted by a biotech company to date in this orphan disease. We are extremely proud of our team and very grateful to the patients, families and physicians who are participating in this study.

    In the second quarter, we also accomplished a number of additional, significant milestones—advancing our accelerated approval study of glembatumumab vedotin in triple negative breast cancer, publishing positive data from the CDX-1401 program, presenting positive data from our Phase 1 varlilumab program at ASCO and announcing a clinical trial collaboration with BMS for the varlilumab program. This momentum is expected to continue in the second half of 2014 as we initiate multiple new studies across our pipeline and present data from our Phase 2 ReACT study in recurrent glioblastoma at year-end

  • dinepat203 dinepat203 Aug 19, 2014 12:53 PM Flag

    Not to worry with Micky mouse games of retail traders - 92% institutional HOLD GOOD ENOUGH to get the leap jump on fine day.

  • dinepat203 dinepat203 Aug 18, 2014 3:49 PM Flag

    Jul 23, 2014 - Alan Auerbach, CEO, president, and chairman of Puma Biotechnology (NYSE: PBYI ) , you just personally made over $700 million after your biotech suddenly soared 295% (more if ... Puma's current market cap is $7 billion.

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