Biotech Values

[DewDiligence]

Clinical / Regulatory / Litigation Calendar

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Edits: NAVB (Lymphoseek approved—entry deleted); MNTA (miscellaneous updates); XOMA (data readouts for EYEGUARD studies).


ABT – ‘Absorb’ bioresorbable stent: US launch possible in 2013, pending clinical results. (Launched in 30 countries including EU 9/25/12.)

AGN – Phase-2 DARPin data in AMD: 2H13.
AGN – Latisse for androgenetic alopecia: phase-2 data in men and women at unspecified medical conference in 2013. AGN – PMA for Juvederm Voluma: PDUFA date 1H13.

AMGN – Xgeva sBLA submission for bone health in non-metastatic cancer: 2013 pending results of phase-3 trial in breast cancer.

AMRN – Vascepa (f/k/a AMR101) approved by FDA 7/26/12; decision on NCE status pending.

BAX: Gammagard in AD: top-line results of 1st ph3 2Q13; full dataset Jul 2013.

BIIB – BG-12 for MS: PFUFA date 3/28/13 (extended 3m); MAA pending—no further info available.

BMY – Eliquis: see PFE.

BMY – Yervoy phase-3 in 2nd-line CRPC: data mid 2013.

GILD –‘Quad Prime’ based on TAF (f/k/a GS-7340): Data from two phase-2 studies early 2013—one tests Quad Prime vs Atripla and one tests Quad Prime vs Prezista + Cobicstat + Truvada. (Ph2 testing Quad Prime vs Stribild reported 10/31/12.)
GILD – “Standalone” Evitegravir NDA: PDUFA (standard review) on or about 4/27/13.
GILD – “Standalone” Cobicstat NDA: PDUFA date on or about 4/28/12. MAA submitted 5/23/12; no further info.

IDIX – IDX719 (NS5A inhibitor, now IDIX’s lead drug): 3-day PoC phase-1b monotherapy data reported 6/20/12.

ITMN – Pirfenidone: No specific timeline for response to FDA’s CRL of 5/4/10 requesting a new trial.

JNJ – Xarelto sNDA in PCI sub-indication of ACS: PDUFA date Mar 2013 (sNDA resubmitted 9/7/12).

LGND - Promacta for HCV: EU MAA submitted 5/30/12. (Approved by FDA 11/19/12.)

MNTA – See http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84700153

PFE – Eliquis in VTE prevention: US plans unclear, but ph3 data in *secondary* VTE prevention were stellar (http://investorshub.advfn.com/boards/read_msg.aspx?message_id=82279247 ); approved in EU 3/18/11.

SNY – Aubagio for RRMS: MAA accepted for review 2/23/12; (approved by FDA 9/12/12). Lemtrada for RRMS: RTF issued 8/27/12; resubmission pending.

TEVA – Thrice-weekly formulation of Copaxone: timing of NDA unclear according to 6/14/12 PR announcing positive top-line results from GALA study.

VRTX – Phase-2b testing multiple (non-response-guided) protocols for Incivek + VX-222 + ribavirin in treatment-naïve genotype-1 to start 3Q12. (Data on no-IFN arms of ZENITH study reported 2/23/12.)

XOMA – Data readouts from EYEGUARD-A/B/C phase-3 studies in uveitis: A (active NIU) end 2013; B (Behçet’s) mid 2014; C (maintenance NIU) 1Q14.

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