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Andrew Nava
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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
  • Daily Updates from AndrewNava.com - May 5, 2010 0 comments
    May 5, 2010 2:04 PM | about stocks: AGEN, ALSE, AVNR, BMRN, CELG, CHTP, CYTK, GSK, IMGN, MDCO, NBIX, PTIE, REGN, RPRX
    Below is a sample of our daily updates available only to monthly subscribers of AndrewNava.com.  Our database contains more than 1000 catalysts spread across 17 different catalyst types.  We also archive clinical trial data, drug sales, deals and have more than 1000 profiles of approved and development stage drugs, devices and diagnostics.

    NEW MILESTONES

    AGEN
    : Oncophage glioma data is being presented May 20th at theInternational Conference on Brain Cancer Therapy.

    ALSE
    : Needs to raise cash asap, runway ends this month.

    AVNR: Potential acceptance of response to Zenvia approvable letter (2Q10)and new PDUFA date late Oct 2010 (if classified as Class 2 resubmission).

    BMRN:
    Data from BMN-195 DMD study now expected 2Q10.

    CELG
    : 50+ abstracts expected at ASCO w/ 10+ oral presentations (CALGB andIFM Post-ASCT MM, REVLIMID in Elderly CLL, REVLIMID in DLBCL, REVLIMID andRituxan in Follicular Lymphoma, Pomalidomide in Relapsed/Refractory MM).

    CHTP
    : Droxidopa Study 306 top-line results still expected in 3Q10.

    CYTK
    : Initial ALS data from CK-2017357 sometime in 2H10.

    HGSI
    : Benlysta MAA and BLA submissions still on track for 2Q10.

    IMGN: For the near term, expecting data at ASCO from IMGN388, BIIB015, andTrastuzumab-DM1 Phase 1b/2 combo w/ pertuzumab, Roche still on track tosubmit NDA 1H10 w/ possible approval YE10 (3rd-line MBC setting).

    MDCO: Angiomax's 404 patent interim expiration is May 23 2010, Argatrobanready-to-use formulation has a PDUFA date in 2010 but the exact dateremains undisclosed by MDCO and Eagle Pharmaceuticals (licensor).

    NBIX
    : Elagolix top-line data from 901 Study/Tulip PETAL study expected endof May 2010, 561679 depression data expected after June.

    PTIE
    : Remoxy refiling now expected by YE2010.

    REGN: Rilonacept gout data from SURGE and PRE-SURGE 1 expected in 2Q10.

    RPRX
    : Possible lift of full Proellex clinical hold, company plans to submita modified trial protocol after FDA mentioned it would be open to changingfrom full to partial clinical hold if the study evaluated a lower dose anddose-escalated.

    DATABASE UPDATES


    Several new earnings dates, VPHM (Q1 sales), MDCO (Angiomax Q1 sales),HGSI, IMGN, CERS (Intercept Blood System Q1 sales), CHTP, QCOR (Acthar Q1sales), BMRN (BMN 110 data), BMRN (all Q1 sales), SNSS, APPY, GERN, ABIO,MNKD (mfg facility update and CRL progress), ZIOP ($100M shelf), MBRK, NGSX(Cowen deal), CYCC, POZN (Vimovo approval), XOMA, AVNR (Wedbush initiationand approvable letter response submission), RGEN, ANX (cash position), CLDX(ASCO abstracts), ENDP (all Q1 sales), ACOR (Zanaflex, Ampyra Q1 sales),ISTA (all Q1 sales), UTHR (all Q1 sales), CELG (all Q1 sales)

    RESEARCH


    Coming Soon: Undisclosed

    For full milestones, clinical trial data and drug sales, please visit www.andrewnava.com

    Disclosure: No positions
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