Biotech Values

[DewDiligence]

Clinical / Regulatory / Litigation Calendar

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Edits: ABBV/ENTA, GILD.


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).

ENTA/ABBV—ABT-493/ABT-530 2-DAA regimen: ENTA decision whether opt in for US profit sharing expected any day (http://investorshub.advfn.com/boards/read_msg.aspx?message_id=106500227 ). (Ph2b trial of this regimen already started.)

ENTA/NVS—EDP-239/Alisporivir: 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; approved by EU’s CHMP 9/26/14, awaiting rubber-stamping by EU Commission.

GILD—TAF (replacement for Viread in HIV combinations): top-line data from treatment-naïve ph3 reported 9/24/14; NDA/MAA submissions 4Q14.

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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