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Andrew Nava LLC is a healthcare focused consulting and investment firm. Prior to launching Andrew Nava LLC, I was a venture analyst, buy-side analyst, and most recently, the Director of Research at Actin Biomed, a New York-based healthcare investment firm where I was responsible for the medical,... More
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Andrew Nava, LLC
  • New Biotech Milestones and Database Updates for July 26, 2010
    Below is a sample morning note to clients, including new catalysts/milestones added to our database, as well as companies and products that have new data.

    Dear Sample Client,

    Here are the latest updates at AndrewNava.com...

    NEW MILESTONES

    ALXN: Increased 2010 Soliris sales guidance to $515-530M (up from
    $505-520M).
    AMLN: Phase 2 data expected 1H11 for Exenatide monthly suspension.
    APPY: Plans to initiate a pivotal clinical trial of the AppyScore cassette-based test in 2011.
    BIIB: Rituxan PDUFA January 29, 2011 for follicular NHL sBLA, expected sBLA filing 2H10 for ANCA-associated vasculitis.
    CPIX: Acetadote PDUFA 9/10/10.
    EXAS: External validation data expected by Oct 29 (see andrewnava.com for full client note).
    GENZ: Decreased E2010 revenue to $4.4-4.5B, mipomersen data expected this quarter.
    INHX: On track to report top-line data in 4Q10 for FV-100 herpes zoster trial.
    NPSP: Gattex on track for STEPS trial data in 1Q11.
    OSIR: Approx Prochymal Canadian approval by Jan 10, 2011 for GvHD (180 day timeline as of July 21, 2010).
    THRX: Data expected 4Q10 from TD-1211 opioid-induced constipation study; Telavancin EMA decision expected 1H11.
    UGNE & EMIS: Data expected 4Q10 from Study 2301 (knee OA), NVS to file NDA in 2011 for osteoporosis indication.

    EARNINGS: Several new updates (see website)

    DATABASE UPDATES: BIIB (all sales), BG-12, Avonex, Rituxan, XOMA, BMTI, CBLB502, NVLT, MNTA (Lovenox), BTIM, palifosfamide, FRX, Abraxane, Namenda, ADLS, ETRM (financials), THRX (financials), GENZ (product sales and financials), FRX (product sales and financials), NVC-422 (data), AppyScore (data), AMLN (product sales and financials), HGSI (financials)

    RESEARCH
    : BPAX, AVII, EXAS, CORT, ALXA, SNGX, PLX

    For full milestones, clinical trial data, and drug sales, please visit http://andrewnava.com

    Andrew Nava LLC provides equity research services for both institutional and retail healthcare investors. We focus on fundamental research of small- to mid-cap healthcare companies with the potential for significant market cap appreciation in the next 6-12 months. Our investment theses are based on event-driven catalysts and value-driven growth.

    Our research is powered by our database. Information is derived exclusively from public sources and is useful for tracking clinical trial data and upcoming company milestones. As of June 2010, the database covers over 290 publicly-traded biotechnology and pharmaceutical companies, more than 1000 profiles of approved and development-stage drugs, devices and diagnostics, and 17 different catalyst types.

    For more information, please visit andrewnava.com

    Disclosure: No positions
    Jul 26 10:14 AM | Link | Comment!
  • Tracking Six New Companies: NPC.TO, CPTS, PHMD, GNMK, NEOP, QTXB
    AndrewNava.com has added profiles for six new companies: Allon Therapeutics (NPC.TO), Conceptus (NASDAQ:CPTS), PhotoMedex (NASDAQ:PHMD), GenMark Diagnostics (NASDAQ:GNMK), Neoprobe (NEOP) and QuantRX Biomedical (OTCQB:QTXB).

    Our database is now tracking clinical and financial data from 299 publicly-traded healthcare companies.  The database is updated daily and contains hundreds of clinical trial results, upcoming company milestones, sales data, key company financial information, deals and news summaries, and profies on over 1000 approved and development-stage drugs, devices and diagnostics.

    Here's some key data on the new companies we added:

    Allon Therapeutics (NPC.TO)

    Primarily focusing on developing intranasal and intravenous formulations of Davunetide (tau inhibitor) for Progressive Supranuclear Palsy, Alzheimer’s disease, frontotemporal dementia, schizophrenia-related cognitive impairment.  No near term catalysts. $33 million market cap. 

    Conceptus (CPTS)

    Women's health company marketing the Essure device/procedure for permanent contraception. 1Q10 Essure sales: domestic sales $25.4 million (up 20% from 1Q09), international sales $8.0 million (up 33% from 1Q09) Cash: $99.3 million as of March 31, 2010.  CPTS recently lowered its 2Q10 and 2010 sales guidance which tanked the stock 20%+.  Earnings expected in August.

    PhotoMedex (PHMD)

    Dermatology company marketing light and laser devices for aesthetics and other skin diseases.  Main brands include Lumiere, Omnilux Light Therapy, VTRAC Excimer Lamp System and XTRAC Lasers.  No near term catalysts. $15.88 million market cap.

    GenMark Diagnostics (GNMK)

    Recent IPO. Develops and markets molecular diagnostics. Maker of the XT-8 System, a compact and easy-to-use workstation with self-contained, disposable test cartridges. FDA-approved diagnostic tests for use with the XT-8 System include Cystic Fibrosis Genotyping Test, Warfarin Sensitivity Test and Thrombophilia Risk Test.  GNMK is developing a Plavix Sensitivity and K-ras Mutation test and plans to complete a clinical trial for its Respiratory Viral Panel in 2010 with an FDA submission in 2011. $53 million market cap.

    Neoprobe (NEOP)

    Main development program is Lymposeek ([99mTc] DTPA-mannosyl-dextran), a radioactive tracing agent for use in breast cancer and melanoma.  NEOP plans on submitting an NDA by the end of this summer, but not before requesting a formal pre-NDA meeting with the FDA to review the complete Lymphoseek regulatory package. NEOP will hold a conference call Monday, July 19th at 4:00 PM ET to provide a business update, discuss its product pipeline and provide an update on matters from the 2010 Annual Meeting of the Company’s stockholders scheduled for July 16th.  $163 million market cap.

    QuantRX Biomedical (OTCQB:QTXB)

    Recently submitted a 510K for its Q-Reader Thyroid Testing System. $7.5 million market cap. 

    Andrew Nava LLC provides equity research services for both institutional and retail healthcare investors. We focus on fundamental research of small- to mid-cap healthcare companies with the potential for significant market cap appreciation in the next 6-12 months. Our investment theses are based on event-driven catalysts and value-driven growth.

     



    Disclosure: No positions
    Tags: CPTS, PHMD, GNMK, NAVB
    Jul 13 5:53 PM | Link | Comment!
  • Exact Sciences - Validation Data Expected in the Coming Months
    Investors can expect significant news in the coming months/weeks from Exact Sciences (NASDAQ:EXAS). The company has disclosed that results from its preclinical validation study, along with full biomarker panel data, will be released in 2H10.  We're expecting greater clarity from management in the coming days/weeks.

    Below is an excerpt from our latest report on EXAS to research clients:

    EXAS is developing a next generation, non-invasive colon cancer screening assay as an alternative to colonoscopy, FOBT (fecal occult blood test) and FIT tests (fecal immunochemical test).  EXAS’s stool-based sDNA test is targeting a cancer sensitivity of 85% and a pre-cancer sensitivity of 50%.  EXAS’s previous assay, PreGen-Plus, had sensitivities of 52% and 18% and suffered from limited clinician uptake. In 2007, EXAS received an FDA warning letter that stated a PMA would be required to continue commercialization. 
     
    In April 2009, EXAS brought in new management (Kevin Conroy as CEO and Maneesh Arora as CFO) from Third Wave Technologies after its $580M acquisition by Hologic.  While at Third Wave, Conroy and Arora developed and received approval for Cervista, an HPV assay utilizing the Invader chemistry detection process, a highly specific chemiluminescent amplification technology. 
     
    In June 2009, EXAS licensed exclusive rights to intellectual property developed by David Ahlquist at Mayo Clinic. The licensed patents cover sample processing, analytical testing and data analysis specifically for non-invasive, stool-based DNA screening for colorectal cancer.
     
    In October 2009, EXAS licensed worldwide rights to Hologic's Invader plus and real-time Invader detection chemistries for colorectal screening applications.
     
    EXAS now plans to use the Invader technology along with a better DNA extraction process (magnetic bead capture vs. DNA precipitation) which yields ~10X more DNA than the legacy method.  The new method will also offer a shorter sensitivity time of 3 hours vs. 48 hours.


    To read the full report and learn more about EXAS's validation study, please visit andrewnava.com or email us at anava@andrewnava.com

    Andrew Nava LLC provides institutional and retail healthcare investors with buy-side equity research tools that focus on value-driven investing, profitable trading ideas and clinical, commercial, and regulatory catalysts. Our research is supported by our database of clinical trial data and upcoming company milestones and by consulting with KOL's, industry professionals, analysts, and company management.



    Disclosure: No positions
    Tags: EXAS
    Jul 12 2:36 PM | Link | Comment!
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