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Mike Havrilla (@mikehavrilla) on Twitter

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My Twitter account includes frequent updates throughout the day in real-time for notifications and web links to new investing articles, research reports, FDA / clinical trial updates, and bio-medical industry news.

Mike Havrilla on Twitter

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FDA Calendar Overview and Tutorial

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The BioMedReports.com FDA Calendar database includes over 350 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results.

The FDA Calendar landing page includes a button - Press here to load the latest updates and data - that must be clicked in order to fill the calendar database with the latest information. From left to right, the columns include (1) Company Name, (2) Ticker, (3) Type (e.g. clinical trial, FDA decision, FDA resubmission, FDA new filing, etc.), (4) FDA Date (this is the estimated or published catalyst date for expected study results, FDA decisions, FDA filings, etc.), (5) Details (this is the most extensive entry which contains a text summary of the entry), (6) Last Update (the time / date stamp for the most recent update for each entry).

Some tips for using the FDA Calendar include the ability to sort the database by each column (other than details), which can be very useful, e.g. sorting by ‘Last Update' column yields all of the most recently updated entries. By default the FDA Calendar database is sorted by date in descending order (with catalyst dates that are furthest in the future listed first). Alphabetical sorts by company name or ticker are useful for finding specific companies in the FDA Calendar while sorting by Type groups pending FDA decisions, clinical trial results, FDA new filings, etc.


Small-Cap Stocks Battling Brain Cancer

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Each year nearly 20,000 people in the U.S. are diagnosed with primary brain cancers (with a similar number in Europe), according to NCI/NIH statistics, with Schering-Plough's (NYSE:SGP) Temodar (temozolomide or TMZ is classified as a DNA-methylating chemotherapy drug) given to nearly every patient with a diagnosis of GBM (the most common and aggressive form of brain cancer). Newly diagnosed individuals with GBM typically undergo surgery (if possible) to remove the tumor, followed by radiation and chemotherapy with a median survival outcome of about 10-12 months.

 


New Indexes to Track Healthcare Trends and More

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Below are links and descriptions for stock indexes I have created, revised, and tracked over the past few years which are now featured at the website Investars YOU. This site includes automated index tracking and allows investors to link their brokerage accounts to create custom stock portfolios based on their individual preferences from the stock indexes at the site.

However, unregistered users have the ability to generate stock ideas from any of the free indexes (including all of mine listed below) by following these steps: 1) Click 'Add to You' at top third of page at left column; 2) Choose the front/center option (in white inside a divided circle) to add all of the index stocks to your portfolio; 3) Click 'expand section' at lower/right column of page that appears with the stocks generated from the index that was originally chosen, which are sorted alphabetically.

Cosmetic and Restorative Medicine Index

The Cosmetic and Restorative Medicine Index is actively managed and tracks the performance of companies that derive over 50% of revenue from any of the following activities: (1) prescription skin care therapeutics; (2) medical devices, products, services, OR equipment for procedures which are intended to enhance appearance; (3) medical devices, products, services, OR equipment for use as joint replacements, tissue repair agents, tissue reconstruction agents, surgical adhesives, and cardiovascular procedures; and (4) regenerative medicine products, services, and/or an active clinical pipeline which seeks to restore or repair the functionality of lost or damaged organ, tissue, cellular, and genetic material.

Cancer Diagnostic & Therapeutic (Dx/Tx) Micro-Cap Index

The actively managed Cancer Diagnostic & Therapeutic (Dx/Tx) Micro-Cap Index constituents reflect a cross-section of emerging cancer companies with market caps below $250 million at the time of index inclusion, encompassing the following categories: (1) diagnostics (molecular diagnostics and device-based diagnostics), (2) lab services (personalized medicine applications to guide and track the effectiveness of cancer treatments), (3) drug discovery (screening and modifying compounds to achieve anti-cancer effects during the early stages of preclinical and Phase 1 clinical studies), (4) immunotherapy (a.k.a. cancer vaccines which are designed to stimulate the immune system to eradicate cancer), and (5) commercial or late-stage (Phase 2-3) clinical development therapeutics, devices, or diagnostics intended for use by cancer patients.

Emerging Diagnostics Index

The Emerging Diagnostics Index is actively managed and tracks the performance of companies with market caps below $250 million at the time of inclusion. The index includes diabetes monitoring device makers, laboratory services, clinical diagnostics, diagnostic imaging, diagnostic equipment makers, and molecular diagnostics.

Global Airline Index

The Global Airline Index is actively managed and tracks the performance of companies with market caps over $200 million upon inclusion that derive over 50% of revenue from passenger airline services.

Global Carbon Trading Index

The Global Carbon Trading Index is actively managed and tracks the performance of companies which generate carbon credits through their business operations, are involved with the trading of carbon credits, and/or reduce carbon emissions through their business activities. Examples of these activities include the following: waste-to-energy, landfill or methane gas collection, financial exchanges for carbon credits, carbon credit investment firms, and renewable energy projects that result in the generation of carbon credits (e.g. hydro-power, farming, industrial).

Global Generic Drug Index

The Global Generic Drug Index is actively managed and tracks the performance of companies which meet any of the following three requirements: (1) Derive either $500 million (USD) OR more than 50% of trailing 12-month revenues from the manufacture and sale of any type of generic (off-patent) prescription or over-the-counter (OTC) drug product intended for use by humans, including contract manufacturing services for drug products and biological agents; (2) Have one or more compound(s) in active clinical development OR have a pending ANDA with the FDA for a generic drug candidate; (3) As an alternative to the revenue requirement, companies may also qualify by receiving FDA approval for an abbreviated new drug application (ANDA) within the past 12 months.

Global Health Information Technology (Health IT) Index

The Global Health Information Technology (Health IT) Index is actively managed and tracks the performance of companies with market caps below $10 billion that derive over either $50 million or 50% of their trailing 12-month revenue from products and services for the following activities: (1) electronic transmission, storage, and processing of prescriptions; (2) secure e-mail transmission for healthcare facilities; (3) electronic transmission, storage, and processing of medical imaging and diagnostic information; (4) electronic storage and systems for administrative functions of healthcare facilities and medical records; (5) electronic transmission, storage, and systems for healthcare market data and clinical trial data; (6) electronic systems, devices, and services for remote, real-time monitoring of patient health parameters; (7) medical transcription services, products, and systems for conversion into electronic medical records.

Global Metal Mining Index

The Global Metal Mining Index is actively managed and tracks the top-rated companies with market caps over $1 billion upon inception that derive over 50% of revenue from the exploration, mining, extraction, processing, and sale of all types of precious metals, minerals, and industrial metals. The top rated companies are chosen based on their trailing 12-month stock price performance, market cap weighting, and net income weighting.

Global Railroad Index

The Global Railroad Index is actively managed and tracks the performance of companies that derive either more than 50% OR $100 million of trailing 12-month revenue from any of the following activities: (1) passenger or freight rail transport services; (2) railcar and locomotive leasing; (3) railcar and locomotive fleet management; (4) rail infrastructure, railcar, locomotive, and railcar/locomotive component parts manufacturing; (5) railcar, locomotive, and component parts repair or refurbishment.

Global Stem Cell Index

The Global Stem Cell Index is actively managed and tracks the performance of regenerative medicine companies (with stock prices of at least 15 cents at the time of inclusion) which derive over 50% of revenue or have compound(s) in active pre-clinical or clinical development which are designed to restore, replace, repair, or enhance the functionality or appearance of tissue and organ systems, including all types of embryonic and adult stem cell therapeutics. In addition, all types of products and services for stem cell banking are included in this index.

Global Telecom Services Dividend Index

The Global Telecom Services Dividend Index is actively managed and tracks the performance of companies with market caps over $1 billion at the time of inclusion that meet the following requirements: (1) All such companies must derive at least 50% of their trailing 12-month revenue from any types of voice and data telecom services such as fixed line communications, wireless communications, and internet access provider services and (2) All such companies must have a trailing 12-month dividend yield of at least 1.5%.

Global Tobacco Index

The Global Tobacco Index is actively managed and tracks the performance of companies which derive over 50% of their revenue from the distribution or manufacturing of any type of tobacco product (e.g. cigarettes, cigars, chewing tobacco) or any related tobacco supplies (e.g. wrapping papers, tobacco leafs, filters).

Global Trucking & Logistics Index

The Global Trucking & Logistics Index is actively managed and tracks the performance of companies with market caps over $100 million at the time of inclusion that derive at least 50% of trailing 12-month revenue from any of the following activities: logistics and management support services for all types of transportation companies; all types of land-based, roadway freight forwarding freight transportation services; mail package delivery, transportation, and logistics services; and logistics management support services for roadway transportation companies.

Health Benefit Providers Index

The Health Benefit Providers Index is actively managed and tracks the performance of retail pharmacies, pharmacy benefit managers, managed care companies, health insurers, hospital pharmacy operators, workers compensation insurers, and specialty health benefit providers.

Highly Defensive Index

The Highly Defensive Index is actively managed and tracks the performance of 35 companies based in the Americas, Canada, and Europe which are market cap leaders from the following industry groups: (A) Mass Merchant Discount Retailer (1); (B) Consumer Staples (11); (C) Telecom Services (3); (D) At-Home Services (2): Cable TV/Internet Provider (1), Internet Portal/Search Provider (1); (E) Electric Utilities – Domestic (U.S. based) (2); (F) Fast Food Restaurants (1); (G) Commodities (2): Gold Mining (1) Agri-Biotech (Seeds & Fertilizers) (1); (H) Healthcare (11); (I) Aerospace (Non-Commercial) & Defense (1); (J) Energy (1).

Nation Cap Leaders Index

The Nation Cap Leaders Index is actively managed and tracks the performance of companies that are market cap leaders from each nation (at least $5 billion), including developed, emerging, and frontier markets.

NordiCaps Region Index

The NordiCaps Region Index is actively managed and tracks the top-rated companies with market caps over $1 billion upon inception that are based in the Nordic Region countries of Sweden, Denmark, Finland, Iceland, and Norway. The top rated companies are chosen based on their trailing 12-month stock price performance, market cap weighting, and revenue weighting.

Preventative Medicine Index

The Preventative Medicine Index is actively managed and tracks the performance of companies with market caps over $100 million at the time of inclusion that derive over either 50% or $100 million in trailing 12-month revenue from any of the following activities: (1) human vaccines which are already on the market or in active clinical development; (2) diagnostics and lab services; (3) diabetes care; and (4) vitamins, health supplements, functional foods, and weight loss products or services.

Regulatory Catalyst Index

The actively managed Regulatory Catalyst Index tracks the performance of healthcare companies with pending new drug, biological agent, or medical device/diagnostic product decisions at the FDA.

Pet Care & Animal Farma Index

The Pet Care & Animal Farma Index is actively managed and tracks the performance of companies with market caps below $5 billion at the time of inclusion that are active in the following business segments: animal breeding, animal `pharming`, veterinary stem cells, veterinary services, pet retailers, animal feeds nutrition, and veterinary medicine diagnostics. Favorable growth trends for the pet and animal care industry include (1) pet spending in the U.S. is estimated at $43.4B in 2008, up from $32.4B in 2003; (2) about 63% of U.S. households have a pet, which equals over 71M homes; and (3) the worldwide market for animal healthcare, excluding bulk feed and nutrition products, is expected to reach just under $20B in 2008, experiencing growth of 26% from $15.6B in 2003.

Emerging Bio-Pharma Index

The Emerging Bio-Pharma Index is actively managed and tracks the performance of top-rated companies with market caps between $100 million to $2.5 billion at the time of inclusion. The rating system reflects the following factors: (1) the number of innovative clinical pipeline and marketed products, (2) the market cap weighting, (3) the historical stock price return, and (4) the revenue weighting.

Global Hospital Index

The Global Hospital Index is actively managed and tracks the performance of companies which derive over 50% of revenue from the following activities: hospitals, inpatient rehabilitation facilities, dialysis facilities, hospice providers, inpatient behavioral healthcare facilities, and ambulatory surgery centers. The revenue requirement for this index excludes the following activities: home healthcare, outpatient medical services, and senior living centers.


The stock research section of BioMedReports has been updated to include my 8-page report for Mentor Capital (MNTR.pk), which is current as of the 8/28/09 publication date. Highlights from the report that make Mentor's stock a compelling investment for individuals interested in the small/micro-cap biomed space are outlined below. Click here for my initial overview article on the Company and click here to view the Mentor Capital Cancer Immunotherapy Index of 10 stocks.

1.) Blockbuster, billion dollar sales potential for QI's experimental cancer immunotherapy

2.) Quantum Immunologics (QI) expects to have all 27 women started in the three-month procedure by end of December 2009, which puts them at reportable stage by March 2010 for possible reporting of Phase I/II clinical data by May 2010


The stock research section of BioMedReports.com has been updated with my 12-page PDF stock profile report for Lixte Biotech (LIXT.ob) (OTC:LIXT) to reflect corporate and preclinical research developments along with current 2Q09 financial statistics. Other resources include Lixte's Pro-Active News Room site for a compilation of links, videos, presentations, and social media sites for the Company, including its Facebook and Twitter pages.

 

Lixte was originally founded as a diagnostics company in 2005 evaluating biomarkers (indicators of disease at the molecular level), but has shifted its focus to cancer drug discovery research that is primarily focused on the development of compounds for malignancies with few effective treatment options - such as certain types of brain cancer (glioblastoma multiforme or GBM, neuroblastoma, and medulloblastoma) and pancreatic cancer. Areas of secondary focus for the Company include the early-stage, preclinical drug discovery of improved anti-fungal treatments for patients with compromised immunity (e.g. HIV/AIDS and bone marrow transplant patients) and the treatment of neurodegenerative conditions such as Alzheimer's disease, Parkinson's disease, and Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's Disease).


Rockwell Medical (NASDAQ:RMTI) has the potential for significant stock price gains by 2012 based on the enhanced earnings power of at least $4/share at that time for its lead clinical compound Soluble Ferric Pyrophosphate (SFP) with just a 20% share of the estimated $600 million U.S. market for iron replacements in 2012. The stock appreciation potential for RMTI is similar to the exponential gains experienced by AMAG Pharma (NASDAQ:AMAG) from the earlier part of this decade, culminating in approval of its IV iron replacement drug Feraheme earlier this year.

However, Rockwell is unique because it is not merely a development-stage operation as its core dialysate business already generates significant revenue exceeding $50 million, which also serves as a built-in distribution channel for a differentiated form (compared to existing IV iron therapies) of dialysate iron replacement, SFP, upon successful clinical development and FDA approval. In addition, there is a very low clinical risk for SFP based on its excellent safety record and well established mode of action as an add-on to the Company’s core business as a dialysate iron replacement therapy that has the potential for additional applications and indications beyond the use for the treatment of anemia in patients undergoing dialysis.

The low outstanding number of shares of common stock (about 14 million) and estimated cost of $15 million to fund Phase 3 development for SFP allow RMTI to retain U.S. rights to the treatment while seeking a partnership deal for ex-U.S. markets such as Europe and Asia-Pacific. The current share price around $8 provides RMTI an opportunity to fund Phase 3 U.S. development for SFP with minimal dilution to existing shareholders and have 18-20 million fully diluted shares outstanding by the estimated market launch of SFP in 2012. Upcoming milestones for RMTI include the following.


ImmunoCellular (OTC:IMUC): A New Paradigm in Cancer Treatment

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ImmunoCellular Therapeutics (OTC: IMUC.OB) is an emerging cancer immunotherapy company that is developing therapeutic and diagnostic product candidates taking aim at the root cause of the disease, cancer stem cells (CSCs), based on two distinct technology platforms - active (cancer vaccines) and passive (monoclonal antibodies or mAbs).


This approach is in the early stages of development, but has the potential to become a disruptive, paradigm-shifting therapeutic approach to the treatment of cancer. CSCs are resistant to standard treatments such as chemotherapy and radiation, but numerous bio-markers on these cells have been identified which can be used to develop targeted mAbs and CSC immunotherapy products.


CombiMatrix (NASDAQ:CBMX): A Full Array of Pending Catalysts

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CombiMatrix (NASDAQ:CBMX) is a component in my Emerging Diagnostics and Cancer Diagnostic/Therapeutic (Dx/Tx) Micro-Cap Indexes and a spin-off company from Acacia Research (NASDAQ:ACTG) which has operated independently since August 2007 as a developer of DNA MicroArrays for lab-based personalized medicine and diagnostic applications to improve treatment outcomes. On 8/12/09, CBMX reported its 2Q09 results, which included the following highlights.


Derma Sciences (DSCI.OB): Advancing Wound Care

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The corporate presentation for wound care specialist Derma Sciences (DSCI.OB) is available in PDF format at BioMedReports.com and highlights the following: (1) new Advanced Wound Care Products are selling at a current run rate approaching $10 million in revenue, including total annualized MEDIHONEY revenues in excess of $3.5 million with a gross margin of 70%; (2) total revenues are expected to exceed $50 million in 2009 including sales from the introduction of four new advanced wound care products since 4Q08; and (3) an enterprise value for the Company that is about 0.5X trailing 12-month sales despite its recently launched wound dressing product, a strong novel pharmaceutical candidate for wound healing in Phase 2 development (at an estimated expense of $1.7M), and $3.5 million dollars in core business EBITDA to help support future growth/R&D initiatives.

As of its corporate presentation dated 8/21/09, Derma Sciences reported that it continues to move forward with a Phase 2 clinical trial of DSC127, which has the potential to be only the second approved drug on the market for accelerated wound healing. The Company stated that 33% of patients are currently enrolled in a Phase 2 diabetic foot ulcer study. DSC127 (which is an analog of a naturally occurring peptide called Angiotensin that has been shown to increase keratinocyte proliferation, increase extracellular matrix production, and increase vascularization) was licensed from the University of Southern California during 4Q07 and patient enrollment for a Phase 2 study began during 4Q08.

This study of 75 patients will look at the percentage of diabetic ulcers completely healed over a 12-week period in addition to other outcomes. Histological examination reveals that DSC127 accelerates collagen deposition six-fold and the patented amino acid peptide optimizes the wound healing capabilities of Angiotensin while removing all blood pressure effects of the compound. The Phase II results for the DSC127 Diabetic Ulcer trial are scheduled for release during early 3Q10, with an estimated date for this entry of 7/31/10.             


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