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MEDX Analysis & Videos »
MEDX: Bull or Bear?
Access Pharma (OTC:ACCP): MuGard Poised for Blockbuster Sales
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<> On 7/23/09, Access Pharma (OTC:ACCP) (ACCP.OB) announced that its European partner, SpePharm, is collecting data from a post-approval marketing study of MuGard in head and neck cancer patients undergoing radiation treatment in the UK showing prevention of oral mucositis (OM). In a multi-center study expected to enroll a total of 280 patients, patients are provided with seven weeks of MuGard therapy, and begin using MuGard one week prior to radiation treatment and then throughout the subsequent six weeks of planned therapy. The first 140 patients being treated in this assessment study hav<><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><>...
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FDA Calendar Updates: EURX, AMGN, FOLD, ONTY, MEDX
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<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of <font> BioMedReports.com </font> , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-st...
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FDA, Clinical Trial Updates: Pro-Pharma Looks Promising
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<> The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete r...
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Updated FDA, Clinical Trial Calendars: CTIC, DNDN, MRX, JNJ, MEDX
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The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 115 entries through 4/14/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description. <> <>http://biomedreports.c...
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Bullish on MEDX ...
MEDX
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Medarex, Inc., a biopharmaceutical company, discovers, develops, and commercializes human antibody-based therapeutic products to treat cancer, inflammation, autoimmune disorders, as well as other life-threatening and debilitating diseases. The companyÂ’s product pipeline includes ipilimumab, a Phase III clinical trial product in development with Bristol-Myers Squibb for the treatment of melanoma and other cancers; and multiple Phase II clinical trial products, including MDX-1100 for ulcerative colitis and rheumatoid arthritis, MDX-066 and MDX-1388 with MBL for treating C. difficile infectio...
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A Coiled Spring: Near-Term Catalysts & Oversold Stocks
MEDX
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<> AMAG Pharma (AMAG) more than doubled on word that the FDA accepted its complete response for a NDA of iron-deficiency anemia drug ferumoxytol in patients with chronic kidney disease and will issue a final ruling before year-end. The news is a major relief for AMAG as no new clinical trials were required and the quick decision deadline before year-end is encouraging for the approval prospects of ferumoxytol.
A trio of companies expect FDA decisions for abuse-resistant pain drugs before year-end, including Pain The...
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Full Calendar of FDA Decisions
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<> 
The accompanying table [click to enlarge] includes an updated calendar of 73 expected FDA decision dates. Click here for my previous articles and FDA calendars , including several companies with expected decisions before year-end expected to have major stock price impacts, but keep in mind the backlog of delayed decisions that is building means that none of the dates are certain to produce final decisions. <> Genzyme (GENZ) could hear back from the FDA as early as Monday for approval of Myozyme at the 2,000L...
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Updated 3-Month FDA Calendar
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<> 
The accompanying table includes an updated calendar of FDA decisions expected to occur within the next three months. Most recently, the FDA continued its tough stance toward new antibiotic approvals and issued a complete response letter for ceftobiprole to Johnson & Johnson (JNJ) and its Swiss partner, Basilea Pharma ( Switzerland: BSLN ) – sending the latter down sharply to new lows on Wednesday with a sharp rebound of 30% by the end of the week, but still down by about 43% in the last year.
The FDA cited concerns ...
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Updated 3-Month FDA Calendar
MEDX
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<> 
The accompanying table includes an updated calendar of FDA decisions expected to occur within the next three months. Most recently, the FDA continued its tough stance toward new antibiotic approvals and issued a complete response letter for ceftobiprole to Johnson & Johnson (JNJ) and its Swiss partner, Basilea Pharma ( Switzerland: BSLN ) – sending the latter down sharply to new lows on Wednesday with a sharp rebound of 30% by the end of the week, but still down by about 43% in the last year.
The FDA cited conce...
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Short-term sell, Long-term hold
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I'm changing my Buy rating to a Sell based on the most recent results MEDX presented at today's Bear Stearns conference. The initial Phase III data for Ipililumab as a MONOTHERAPY are not spectacular. Only 19% of patients treated with Ipililumab reported durable responses and 13% of patients demonstrated response kinetics. I don't know if these numbers will impress the FDA; but since this is a second-line treatment, maybe these trials will be sufficient. Either way, I don't like the odds. <> The data are not spectacular, and immunology suggests that the true potential of Ipiluma...
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Bullish on MEDX ...
MEDX
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MEDX is a biotech company that develops antibody-based therapeutics using proprietary technology to create fully human antibodies. <> <> This is a pure speculation play for whoever owns these shares. Medarex owns the rights for producing fully human antibodies in genetically modified mice. The antibody market is a multi-billion dollar market and for me, the proof is in the pipeline. They have 6 phase 3, and almost 30 phase 1-2 drugs. The value of this technology is evident by the number of high-profile collaborations ongoing in their trials. Their business model is also novel in<><>...
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About Medarex Inc.
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