Biotech Values

[DewDiligence]

Clinical / Regulatory / Litigation Calendar

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Edits: MRK (Keytrada approved by FDA).


ABBV—HCV program: see ENTA.

ENTA/ABBV—3-DAA HCV regimen: PDUFA date on or about 12/21/14; EMA decision on MAA expected 1H15 (MAA submitted 5/8/14). Next-gen 2-DAA regimen (ABT-493 + ABT-530): ph2 combination in HCV patients starts summer 2014; report ph1 data at unspecified venue in 2014.

ENTA/NVS—EDP-239 + Alisporvir: ph2 DDI in healthy volunteers started Jun 2014; ph2b in combination in HCV patients will start after completion of DDI study.

GILD—Sovaldi + Ledipasvir: PDUDA date 10/10/14; EMA decision expected early 2015 (MAA submitted 2/27/14 and “validated” for review 3/27/14).

GILD—TAF (replacement for Viread in HIV combinations): top-line data from treatment-naïve ph3 4Q14; NDA submission 1Q15.

GILD—Standalone elvitegravir PDUFA date 10/3/14; standalone cobicstat PDUFA date 10/4/14. (In the EU, elvitegravir is approved as Vitekta and cobicstat is approved as Tybost.)

MNTA—See http://investorshub.advfn.com/boards/read_msg.aspx?message_id=104928571

MRK—Keytrada (pembrolizumab) in melanoma: EU MAA accepted for review 6/30/14—EU approval possible in 1H15. (Approved by FDA 9/4/14.)

NVS—HCV program: see ENTA.

XOMA—EYEGUARD-B ph3 in Behçet’s uveitis: top-line data 2H14.

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