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Celldex Therapeutics, Inc. Message Board

  • adamryderca adamryderca Feb 6, 2014 6:02 PM Flag

    CLDX Pipeline & FDA Status as of 6 FEB 2014 and Peak Sales

    I hope this post will serve as clarification or refutation of the lies spread by shorts. I will let the Gurus and experts answer the peak sales for the each of the Drugs in Phase 2 or Phase 3
    Rindopepimut for Front-Line Glioblastoma -- Phase 3 -- ACT IV
    CDX-011 Breast Cancer -- Phase 2 -- Emerge
    Rindopepimut for Recurrent Glioblastoma -- Phase 2 -- ReACT
    CDX-1135 -- Phase 2 --

    Peak Sales for each of the above ?????

    Rindo and CDX-011 already have Fast Track designation
    CDX-011 is in an accelerated approval trial.
    CDX-1127 may get breakthrough designation.

    Best Biotech Ideas for 2014
    Celldex - In February, the company should provide an update on enrollment numbers in the pivotal phase III ACT IV trial for rindopepimut in front-line [tumor specific oncogene] EGFRvIII+ glioblastoma (GBM) and report first clinical data for CDX-1135 in dense deposit disease (DDD). We continue to see a good probability of positive interim results in ACT IV in late 2014, based on consistent and convincing phase II results. In addition, we expect positive full data from the phase II ReAct trial for rindopepimut+Avastin in Avastin-naive/refractory EGFRvIII+ GBM in second-half 2014, based on very encouraging early results from this trial. More importantly, we expect second-half 2014 results on the about 75-patient ReAct expansion cohort in Avastin-refractory EGFRvIII+ GBM to confirm the initial results. We remain very enthusiastic about CDX-1127's potential to move to the main stage among developmental cancer immuno therapies, and we expect updated phase I expansion cohort data in hematologic malignancies and solid tumors (likely at ASCO '14) will heighten focus on the drug

    Dr. Adam Ryder

    Sentiment: Strong Buy

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    • Cantor Fitzgerald Shows Best Global Equity Research Ideas for 2014 The company is expected to update their CDX-1135 drug status next month (Feb 2014), which could be a huge catalyst. The Cantor Fitzgerald price target is set at $39.

      Oppenheimer analyst Boris Peake price target is set at $40 as he wrote "Our valuation revision is based on the addition of CDX-1127 to our model. We did not make any changes to our valuation of rindo ($5/share), CDX-011 ($18/share), CDX-1135 ($2/share), and added CDX-1127 ($15/share). We believe that CDX-1127 holds the largest commercial potential compared to CDLX's other assets"

      According to analysts, CDX-011 could earn $600 million and Rindopepimut could exceed $1 billion in worldwide revenue. With a $2.1 billion market cap, Celldex trades at 1.3 times peak sales on its two lead drugs. Currently, the drug industry trades at 3.4 times sales, which implies upside of nearly 300 percent from Celldex’s current price, based solely on the fundamentals of its two key programs.

      While CDX-011 and Rindopepimut have been great value drivers for Celldex investors, the company also has a robust pipeline that could spark the next wave of gains. One such program is CDX-1135, a complement modulator that’s being studied to treat an orphan condition called dense deposit disease. Currently, the company is testing CDX-1135 in a pilot study, but positive results will move it quickly into a late-stage trial.

      Sentiment: Strong Buy

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