FDA Calendar

Upcoming PDUFA dates, Phase 2 and 3 trial data releases and links to PRs all sorted monthly and quarterly.

TickerPriceTypeCatalyst Date (due by)Catalyst Notes - click for details
CLDX4.11Phase 2b05/23/2012Phase 2b interim, topline data of CDX-011 for Metastatic breast due to be released May 23, 2012
DND1.30PDUFA05/29/2012PDUFA date Mat 29, 2012 for CIP-ISOTRETINOIN, a formulation of the acne medication isotretinoin,
CHTP1.99FDA Meeting05/31/2012FDA meeting scheduled 2Q 2012 following Northera Complete Response Letter
ARIA15.98PDUFA06/05/2012PDUFA June 5 2012 of ridaforolimus for metastatic soft-tissue or bone sarcomas
XNPT5.83PDUFA06/09/2012PDUFA 6/9/12 for sNDA of Horizant for post-herpetic neuralgia (PHN)
ONXX41.82Advisory Committee06/20/2012Oncologic Drugs Advisory Committee (ODAC) to meet June 20 to review Captisol-enabled Carfilzomib, for the treatment for multiple myeloma, partnered with LGND.
LGND11.71Advisory Committee06/20/2012Oncologic Drugs Advisory Committee (ODAC) to meet June 20 to review Captisol-enabled Carfilzomib, for the treatment for multiple myeloma, partnered with ONXX.
RGEN4.48PDUFA06/21/2012PDUFA June 21 2012 of RG1068 - SecreFlo for Pancreatic imaging under priority review - COMPANY EXPECTS CRL
ARNA5.52PDUFA06/27/2012PDUFA date June 27 2012 for lorcaserin in patients with obesity
ALKS16.42Phase 206/30/2012Phase 2b data of Opioid-induced constipation mid-2012
ALNY9.91Phase 206/30/2012Phase 2b data for RSV (respiratory syncytial virus) infected adult lung transplant patients due mid 2012)
ALTH1.79Phase 1/206/30/2012Phase 1/2 FOLOTYN data 2nd line Non-Hodgkin Lymphoma combination Pralatrexate + Gemcitabine 1H 2012
ANTH1.95Phase 2b06/30/2012Phase 2b topline data of A-623 Blisibimod for lupus due 2Q 2012
APPA0.49NDA filing06/30/2012NDA filing of APF530 due mid 2012 for patients with chemotherapy-induced nausea and vomiting
APPY0.56Phase 306/30/2012Pivotal trial initiation of AppyScore for diagnosis of appendicitis expected mid 2012
ARIA15.98Phase 206/30/2012Phase 2 trial of AP26113 for ALK-positive and EGFR-positive lung cancer to be initiated mid 2012
ARRY3.49Phase 206/30/2012Further Phase 2 data of Selumetinib (AZD6244) plus docetaxel for NSCLC due 2Q 2012
ASTM2.01Phase 206/30/2012Initiate Phase 2b ixmyelocel-T for DCM in 1H 2012
CHTP1.99Phase 206/30/2012Phase 2 topline data for Rheumatoid Arthritis due 2Q
CLDX4.11Phase 2b06/10/2012Phase 2b data of CDX-011 Metastatic breast due at ASCO early June 2012
CRIS4.47Phase 1/206/30/2012Phase 1/2 initiation of Debio 0932 for lung cancer 2Q 2012
CYTK0.90Phase 2b06/30/2012Decision regarding progression to the second cohort of the ATOMIC-AHF trial in 2Q 2012 following a review of data from the first cohort
DRRX0.7606/30/2012Pfizer to conduct two bioavailability studies in 2Q 2012 and then meet with the FDA during 3Q to discuss next steps for REMOXY
ECYT4.52Phase 206/30/2012Phase 2 initiation of EC145 for NSCLC 2Q 2012
EXEL4.61Phase 306/30/2012Phase 3 2Q 2012 initiation of Castration-Resistant Prostate Cancer - 2nd Phase 3 COMET-1, focused on overall survival
EXEL4.61NDA Filing06/30/2012Rolling NDA of XL184 cabozantinib for Medullary thyroid cancer to be completed 1H 2012
FOLD4.67Phase 206/30/2012Interim Phase 2 data of Migalastat co-administered with enzyme replacement therapy (ERT) for Fabry disease (Study 013) due 3Q 2012 with final results due at Fall 2012 scientific conference
FOLD4.67Phase 206/30/2012Phase 2 preliminary data of AT2220 co-administered with the ERT alglucosidase alfa in patients with Pompe Disease due 2Q 2012
HALO7.90Phase 306/30/2012Complete Phase 2 study with Viropharma for SC Cinryze - 1H 2012
HGSI13.99Phase 306/30/2012Initial Phase 3 data of Albiglutide for Type 2 diabetes due mid 2012
INSM2.87Phase 206/30/2012Phase 2 initiation of ARIKACE in patients with non-tuberculous mycobacteria (NTM) lung disease mid 2012
ISTA9.07NDA filing06/30/2012NDA filing of PROLENSA for Postoperative inflammation and reduction of ocular pain post-cataract extraction due 1H 2012
ISTA9.07Phase 206/30/2012Phase 2 data of BEPOSONE for Seasonal allergic rhinitis due 1H 2012
LGND11.71Phase 306/30/2012Initiate pivotal trial of Captisol-Enabled Melphalan for multiple myeloma duirng 2012
LGND12.16NDA filing06/30/2012NDA filing of Aprela for Menopausal symptoms due "soon" as of May 2 2012. End of 2Q estimate only
LXRX1.51Phase 206/30/2012Phase 2b data of LX4211 for diabetes due mid 2012
LXRX1.51Phase 206/30/2012Phase 2 data of LX2931 in rheumatoid arthritis patients due 2Q 2012
MAPP11.54FDA Meeting06/30/2012FDA meeting scheduled 2Q 2012 following LEVADEX Complete Response Letter
MDCO20.88Phase 2b06/30/2012Phase 2b initiation of MDCO-2010 for Reduction of blood loss during surgery 2Q 2012
MDCO20.88Phase 306/30/2012Phase 3 enrolment completion of Oritavancin for ABSSSI 2Q 2012
MDVN83.15Phase 306/30/2012Phase 3 Dimebon CONCERT Huntington disease trial data due 1H
MDVN83.15Phase 306/30/2012NDA filing of enzalutamide in post-chemotherapy prostate cancer patients due to be filed 2Q 2012
MNOV3.15Phase 206/30/2012Phase 2 preliminary data of MN-221-CL-007 for acute exacerbations of asthma and chronic obstructive pulmonary disease exacerbations due 2Q 2012
NBIX6.55Phase 306/30/2012Initiate Phase 3 Elagolix for endometriosis 2Q 2012
NBIX6.55Phase 206/30/2012Initiate Phase 2b trial of NBI-98854 in tardive dyskinesia patients mid 2012
NLNK11.21Phase 206/30/2012Phase 2b/3 initiation of NSCLC 1H 2012
NLNK11.21Phase 206/30/2012Phase 2 data of HyperAcute Melanoma due 1H 2012
OREX3.4406/30/2012Expect to initiate cardiovascular outcomes trial late 2Q 2012 for Contrave for obesity
PATH3.03NDA filing06/30/2012Resubmit NDA for migraine patch 1H 2012
PCYC28.60Phase 206/30/2012Phase 2 PCI-32765 for Diffuse Large B-cell Lymphoma (DLBCL), complete enrolment 1H (1106)
PCYC28.60Phase 206/30/2012Phase 2 PCI-27483 for pancreatic cancer interim data due 1H 2012
PCYC28.60Phase 206/30/2012Phase 2 complete enrolment of PCI-32765 for relapsed or refractory MCL 1H 2012
PCYC28.60Phase 206/30/2012Phase 2 data (initial) due mid 2012 of PCI-32765 in combination with ofatumumab (PCYC-1109) for CLL/SLL
PCYC28.60Phase 206/30/2012Phase 2 data (initial) due mid 2012 of PCI-32765 (PCYC-1102) CLL/SLL
PGNX7.52NDA filing06/30/2012NDA filing of Oral Methylnaltrexone for Chronic, Non-Cancer Pain Subjects with Opioid-Induced Constipation due mid 2012
PPHM0.44Phase 206/30/2012Phase 2 Data Bavituximab for Refractory NSCLC to be unblinded 1H 2012
PPHM0.44Phase 206/30/2012Phase 2 interim Data Bavituximab for pancreatic cancer due sometime during 2012
RIGL7.55Phase 206/30/2012Phase 2 initiation of R333 for Discoid Lupus Erythematosus during summer of 2012
SCMP8.00sNDA filing06/30/2012sNDA filing for Opioid-induced bowel dysfunction expected mid-2012
SNTA3.80Phase 2b06/30/2012Phase 2b interim data of Ganetespib for NSCLC due 2Q 2012
THRX20.33NDA filing06/30/2012NDA filing of Relovair for chronic obstructive pulmonary disease (copd) due mid 2012
THRX20.33Phase 2b06/30/2012Phase 2b data of TD−1211 for Opioid-induced constipation (OIC) due mid-2012
TZYM3.00Phase 306/30/2012Phase 3 topline data of Ulimorelin ULISES 008 trial due by end of June 2012
VTUS10.50Phase 306/30/2012First of two Phase 3 trials of VEN 309 (iferanserin) for Symptomatic hemorrhoids. Data due late June early July 2012. June 30 midpoint estimate only
XOMA2.37Phase 306/30/2012Phase 3 initiation of Behcet's uveitis 2Q 2012
YMI1.97Phase 1/206/30/2012Phase 1/2 Prelim data of CYT997 in glioma expected 1H 2012
YMI1.97Phase 309/30/2012Phase 3 initiation of CYT387 for Myelofibrosis planned 3Q 2012
VVUS22.92PDUFA07/17/2012PDUFA 7/17/12 of Qnexa for obesity. 3 month extension due to REMS submission
HZNP3.80PDUFA07/26/2012PDUFA 7/26/12 of LODOTRA for rheumatoid arthritis
AMRN10.07PDUFA07/26/2012PDUFA 7/26/12 of AMR101 for very high triglyceride levels
ONXX41.82PDUFA07/27/2012PDUFA date of July 27, 2012 for Onyx Pharmaceuticals,for Captisol-enabled Carfilzomib, for the treatment for multiple myeloma, partnered with LGND
LGND11.71PDUFA07/27/2012PDUFA date of July 27, 2012 for Onyx Pharmaceuticals,for Captisol-enabled Carfilzomib, for the treatment for multiple myeloma, partnered with LGND
PGNX7.52PDUFA07/27/2012PDUFA 7/27/12 for subcutaneous RELISTOR for chronic pain - extended by 3 months
SLXP49.03PDUFA07/27/2012PDUFA 7/27/12 for subcutaneous RELISTOR for chronic pain - extended by 3 months
ZIOP4.44Phase 307/31/2012Phase 3 initiation of palifosfamide for small cell lung SCLC by early 3Q 2012
TLON0.75PDUFA08/12/2012PDUFA 8/12/12 for Marqibo for 2nd line adult Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) - extended 3mths from original PDUFA date
GILD49.94PDUFA08/27/2012PDUFA August 27 2012 for Quad, a complete single-tablet HIV regimen containing elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate.
ARRY3.58Phase 208/31/2012Phase 2 topline data of ARRY 797 for pain due summer 2012
DCTH2.60NDA filing08/31/2012NDA filing for CHEMOSAT system due August 2012
DRRX0.76NDA meeting08/31/2012Pre-NDA meeting for POSIDUR summer 2012
RIGL8.07Phase 208/31/2012Phase 2 initiation of R343 for asthma during late summer of 2012
SLXP49.40PDUFA09/05/2012PDUFA Sept 5 2012 crofelemer for diarrhea in patients with HIV/AIDS on anti-retroviral therapy (ART). PDUFA extended by 3 months
IRWD11.27PDUFA09/09/2012PDUFA date extended by 3 mths, likely early Sept 2012 for irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC) - exact date TBC
NAVB2.94PDUFA09/10/2012PDUFA 9/10/12 for Lymphoseek - Lymphatic-tissue tracing agent. 3-month extension from original date
ARIA15.98NDA filing09/30/2012NDA filing of Oral ponatinib for chronic myeloid leukemia, acute lymphoblastic leukemia due 3Q 2012
ARIA15.98Phase 309/30/2012Phase 3 initiation of ponatinib in newly diagnosed chronic myeloid leukemia, acute lymphoblastic leukemia 3Q 2012
AVEO11.28NDA filing09/30/2012NDA for tivozanib in patients with advanced renal cell carcinoma due to be filed 3Q 2012
BCRX3.30Phase 309/30/2012Phase 3 Peramivir - Interim analysis due following end of Southern Hemishphere flu season
BCRX3.30Phase 209/30/2012Complete enrolment of BCX4208 for Moderate renal impairment 3Q 2012
BDSI2.20Pivotal09/30/2012Data from pivotal pharmacokinetic study of BEMA Buprenorphine/Naloxone (BNX) for the treatment of opioid dependence due late 3Q 2012
BDSI2.20Pivotal09/30/2012Initiate two Phase 3 trials of BEMA Buprenorphine for chronic pain during 3Q 2012
BIOD0.65Phase 209/30/2012Phase 2 BIOD-123 trial in patients with Type 1 Diabetes due to be initiated 3Q 2012
FOLD4.67Phase 309/30/2012Phase 3 data (Study 011) of migalastat HCl for Fabry disease due 3Q 2012.
FURX15.76Phase 309/30/2012Phase 3 initiation of MuDelta for diarrhea-predominant irritable bowel syndrome 3Q 2012
GTXI3.41Phase 309/30/2012 Intends to initiate Phase 2 trial on lower dose of GTx-758 Capesaris in patients with prostate cancer, during 3Q 2012
NBY1.37Phase 209/30/2012Topline Phase 2 data NVC422 for urinary infection due later in 2012 - 3Q estimate only
NBY1.03Phase 209/30/2012Ph2b initiation of NVC422 for Impetigo skin infection later in 2012 - 3Q estimate only
NGSX0.33FDA meeting09/30/2012End of Phase 2 meeting for NGX-1998 for Neuropathic pain planned for 3Q 2012 with possible Phase 3 initiation late 2012
NPSP7.13PDUFA09/30/2012PDUFA date of September 30, 2012 for Gattex for the treatment of adult short bowel syndrome or SBS.
NVAX1.16Phase 209/30/2012Phase 2 topline data for seasonal flu vaccine due 3Q 2012
PTN0.60Phase 209/30/2012Phase 2b data of bremelanotide for female sexual dysfunction (FSD) due 3Q 2012
RNN0.40Phase 209/30/2012Phase 2 data of Archexin for pancreatic cancer due 3Q 2012
RPRX7.40Phase 309/30/2012Hopes to initiate a Phase 2/3 trial of Proellex for endometriosis in 3Q 2012
RVX1.36Phase 2b09/30/2012Phase 2b data of RVX-208 (SUSTAIN trial) due 3Q 2012
SNSS2.46Phase 309/30/2012Phase 3 interim analysis of vosaroxin in combination with cytarabine in first relapsed or refractory AML, in 3Q-2012
SNTS5.64Phase 309/30/2012Phase 3 Rhucin for Hereditary Angioedema (HAE) attacks to be completed 3Q 2012
ZLCS1.01Phase 209/30/2012Phase 2b topline data of of Synavive in Rheumatoid Arthritis 3Q 2012
SNTS5.64PDUFA10/16/2012PDUFA on or about Oct 16, 2012 for UCERIS™ (budesonide) Tablets 9 mg for the induction of remission of mild to moderate active ulcerative colitis
IPXL20.97PDUFA10/21/2012PDUFA date October 21, 2012 of IPX066 for the treatment of idiopathic Parkinson’s disease (PD)
UTHR41.64PDUFA10/27/2012PDUFA October 27, 2012 for treprostinil diethanolamine sustained release tablets for the treatment of pulmonary arterial hypertension
CRTX5.27PDUFA10/29/2012PDUFA date of October 29, 2012 for CRTX 080, in patients with hyponatremia.
ACAD1.42Phase 312/31/2012Phase 3 completion of Pimavanserin in patients with Parkinson's Disease later in 2012
ACRX3.50Phase 312/31/2012Phase 3 topline data of ARX-01 for post-operative pain following open abdominal surgery due 2H 2012 (two Phase 3 trials). Third Phase 3 trial data due late 2012/early 2013
AEGR14.14Phase 312/31/2012Phase 3 initiation of Lomitapide for familial chylomicronemia sometime 2012
AEZS0.46NDA filing12/31/2012NDA filing for diagnostic test for Adult Growth Hormone Deficiency (AGHD) likely sometime 2012
AEZS0.46Phase 312/31/2012Phase 3 initiation of AEZS-108 for endometrial cancer during 2012
ALNY9.91Phase 212/31/2012Phase 2 initiation of ALN-TTR02 for Transthyretin-mediated amyloidosis (ATTR) during 2H 2012
ALTH1.79Phase 212/31/2012Phase 2 Bladder Cancer Data expected sometime in 2012
ALTH1.79Phase 212/31/2012Phase 2 Breast Cancer Data expected sometime in 2012
AMRN10.0712/31/2012Initiation of REDUCE-IT cardiovascular outcomes trial by end of 2012
ANAC5.59Phase 212/31/2012Phase 2 safety / PK and efficacy study of AN2728 in atopic dermatitis in adolescents are due in 2H 2012.
ANX0.54Phase 312/31/2012Phase 3 initiation for Sickle cell disease by end of 2012
ARQL5.78Phase 312/31/2012Phase 3 MARQUEE trial in patients with non-squamous non-small cell lung cancer (NSCLC) - complete patient enrollment in 2012 with interim data also due later in 2012
ARRY3.58Phase 212/31/2012Phase 2 Selumetinib (AZD6244) + plus dacarbazine for melanoma due in 2012
ASTX1.59Phase 212/31/2012Phase 2 data of SGI-110 for AML/MDS due late 2012
BCRX3.3012/31/2012Partnership required for Phase 3 initiation of BCX4208 for gout due by end of 2012
CLDX4.11Phase 212/31/2012Phase 2 initiation of CDX-1135 in dense deposit disease (DDD) during 2H 2012
CLSN1.76Phase 312/31/2012Phase 3 ThermoDox for liver cancer 380 PFS Events Projected to Occur in Late 2012
CLVS18.49Phase 312/31/2012Phase 3 topline data of CO-101 for pancreatic cancer due 4Q 2012
CTIC0.86NDA filing12/31/2012NDA withdrawn for Pixantrone for NHL. Plans to resubmit during 2012
CTIC1.29Phase 312/31/2012Initiate Phase 3 Tosedostat for MDS 2H 2012
CTIC1.29Phase 212/31/2012Phase 2 Data Pixantrone for breast cancer due 2012
CYTK1.04Phase 212/31/2012Phase 2a CK-2017357 for myasthenia gravis due 2H 2012
DEPO5.12NDA filing12/31/2012NDA filing of Serada for hot flashes due to be filed 2H 2012
DRRX0.76NDA filing12/31/2012NDA filing of POSIDUR late 2012 dependent on outcome of Pre-NDA meeting
DYAX1.61Phase 212/31/2012Phase 2 data of Ecallantide for ACE Inhibitor-Induced Angioedema due 2H
FOLD4.67Phase 312/31/2012Phase 3 enrolment of Migalastat HCl monotherapy for Fabry Disease due to be completed by end of 2012.
GERN1.37Phase 212/31/2012Phase 2 initiation of GRN1005 for GBM 2012
GERN1.37Phase 212/31/2012Phase 2 Topline data of Imetelstat for breast cancer due by end of 4Q 2012
GERN1.37Phase 212/31/2012Phase 2 Topline data of Imetelstat for multiple myeloma due by end of 4Q 2012
GERN1.37Phase 212/31/2012Phase 2 Topline data of Imetelstat for breast cancer due by end of 4Q 2012
GERN1.37Phase 212/31/2012Phase 2 Topline data of Imetelstat for essential thrombocythemia due by end of 4Q 2012
GENT9.63NDA filing12/31/2012Company "hopeful" of filing new NDA for Defibrotide during 2012. Withdrew original NDA during 2011
HGSI13.99Phase 312/31/2012Phase 3 initiation of Benlysta for Vasculitis sometime during 2012
HGSI13.99Phase 312/31/2012Phase 3 initiation of Benlysta for Active lupus nephritis sometime during 2012
HGSI13.99Phase 212/31/2012Phase 2 enrolment of Mapatumumab with sorafenib for cardiovascular disease sometime during 2012
IDIX8.08Phase 2b12/31/2012Phase 2b data of IDX184 for HCV due 2H 2012
IMGN13.51Phase 212/31/2012Phase 2 Data of IMGN901 lorvotuzumab mertansine for small-cell lung cancer SCLC due 2H 2012
IMMU3.40Phase 312/31/2012Phase 3 initiation of 90Y-clivatuzumab tetraxetan in patients with advanced pancreatic cancer possibly late 2012
INCY21.75Phase 212/31/2012Phase 2 initiation of INCB24360 in patients with ovarian cancer late 2012
INCY21.75Phase 212/31/2012Phase 2 data of LY3009104 in patients with rheumatoid arthritis due late 2012
INFI12.45Phase 212/31/2012Phase 2 enrolment of Retaspimycin Hydrochloride with docetaxel for NSCLC to be completed 2H 2012
INFI12.45Phase 212/31/2012Phase 1b/2 Retaspimycin Hydrochloride with docetaxel topline data of dose-escalation portion of the Phase 1b/2 trial for NSCLC due 2H 2012
INFI12.45Phase 212/31/2012Phase 2 topline data of IPI-926 Saridegib for Pancreatic Cancer due 2H 2012
INFI12.45Phase 212/31/2012Phase 2 topline data of Saridegib for Myelofibrosis due 2H 2012
INFI12.45Phase 212/31/2012Phase 2 enrolment of IPI-926 Saridegib for Chondrosarcoma complete 2H 2012
ISTA9.07Phase 312/31/2012Phase 3 initiation of T-PRED for Uveitis and allergic conjunctivitis during 2H 2012
ITMN10.08Phase 312/31/2012Phase 3 enrolment due to be completed by end of 2012 for Pirfenidone for Idiopathic pulmonary fibrosis
LGND14.15NDA filing12/31/2012GSK expects to release safety data for its PROMCATA trial in the treatment of thrombocytopenia in patients with Hepatitis C during 1H 2012 and file a sNDA during 2012
LGND12.11Phase 312/31/2012Merck will initiate Phase 3 trials for cancer drug dinaciclib - no timeline
MNKD1.6012/31/2012Expect to complete both trials requested by FDA following CRL for AFREZZA by or near the end of 2012. Expect to submit the results to the FDA as an amendment to NDA during 1H 2013.
NBIX6.55Phase 212/31/2012Phase 2 trial of elagolix in the treatment of uterine fibroids is expected to be completed in late 2012
NBIX6.55Phase 2b12/31/2012Data from Phase 2b trial of Phase2b trial of NBI-98854 in tardive dyskinesia patients due by end of 2012
NLNK11.21Phase 312/31/2012Interim Phase 3 pancreatic cancer data due late 2012
NPSP7.13NDA filing (BLA)12/31/2012File BLA NPSP558 for Hypoparathyroidism towards end of 2012
OMER9.52Phase 312/31/2012Phase 3 OMS103HP for arthroscopy data due 2H 2012
OMER9.52Phase 312/31/2012Phase 3 second trial data of OMS302 for intra-ocular lens replacement surgery 2H 2012
OPXA0.47Phase 2b12/31/2012Phase 2b initiation of Tovaxin for Secondary Progressive MS (SPMS) possibly by end of 2012 subject to funding
OGXI12.73Phase 312/31/2012Initiate second Phase 3 trial of Custirsen for castrate-resistant prostate cancer 2H 2012
OGXI12.73Phase 312/31/2012Complete enrolment in first Phase 3 trial of Custirsen for castrate-resistant prostate cancer 2H 2012
OGXI12.73Phase 312/31/2012Phase 3 initiation trial of Custirsen for NSCLC 2H 2012
OGXI12.73Phase 212/31/2012Iniatiate Phase 2 OGX-427 in castrate-resistant prostate cancer later in 2012
OXGN0.88Phase 312/31/2012Possible initiation of Phase 3 ZYBRESTAT clinical program in anaplastic thyroid cancer (ATC) in 4Q 2012
PBTH4.95Phase 312/31/2012Phase 3 initiation of hGH-CTP in adults with growth hormone deficiency during 2012
PPHM0.44Phase 212/31/2012Phase 2 final overall survival data Bavituximab for first line NSCLC due 2H 2012
QLTI6.70Phase 212/31/2012Phase 2 data of Punctal Plug Drug Delivery System (PPDS) for the treatment of Glaucoma 2H 2012
RIGL7.55Phase 212/31/2012Phase 3 interim data of Fostamatinib for rheumatoid arthritis due 2H 2012
RPRX7.40Phase 212/31/2012Phase 2 data of Proellex in a vaginal administration study for uterine fibroids in 4Q 2012, followed by End of Phase 2 meeting with FDA and possible Phase 3 initiation late 2012 or early 2013
SCMP8.00Phase 212/31/2012Phase 2 initiation of Unoprostone isopropyl - (rescula) for Dry age-related macular degeneration (dry AMD) by late 2012
SGEN20.06Phase 312/31/2012Phase 3 initiation of ADCETRIS for front-line advanced stage Hodgkin lymphoma late 2012 / late 2013
SGEN20.06Phase 312/31/2012Phase 3 initiation of ADCETRIS for front-line mature T-cell lymphomas, including sALCL late 2012 / early 2013
SGYP4.32Phase 2/312/31/2012Topline Phase 2/3 data of Plecanatide for Chronic idiopathic constipation (CIC) due 4Q 2012
SGYP4.32Phase 212/31/2012Phase 2 initiation of Plecanatide for IBS-C sometime during 2012
SNTA3.80Phase 2b / Phase 312/31/2012Phase 2b Final PFS data and preliminary OS data of Ganetespib in NSCLC due 2H 2012 and initiation of the Phase 3 portion expected during 2H 2012.
SNTS5.64Phase 312/31/2012Phase 3 trial of Rifamycin for Travelers’ diarrhea to be completed 2H 2012
SPPI11.08Phase 312/31/2012Phase 3 data of Belinostat for Peripheral T-Cell Lymphoma due 4Q 2012
SPPI11.08Phase 212/31/2012Phase 2 top-line Belinostat results of progression free survival and response rate for Carcinoma of Unknown Primary (CUP) due 2H 2012
THLD6.11Phase 1/212/31/2012Phase 1/2 topline data of TH-302 for multiple myeloma (408 trial) due by end of 2012
THLD6.11Phase 1/212/31/2012Phase 1/2 topline data of TH-302 for renal cell carcinoma, gastrointestinal stromal tumors or pancreatic neuroendocrine tumors (410 trial) due by end of 2012
THLD6.11Phase 2b12/31/2012Phase 2b overall survival data of TH-302 for pancreatic cancer due 2H 2012
TRGT4.12Phase 212/31/2012Phase 2 data of TC-TC-5214 for Attention deficit/hyperactivity disorder (ADHD) due 2H 2012
TZYM3.00Phase 2b12/31/2012Phase 2b data of TZP-102 for Diabetic gastroparesis due by end of 2012
VICL2.84Phase 312/31/2012Phase 3 initiation of Collategene for Peripheral arterial disease sometime 2012
VICL2.84Phase 312/31/2012Phase 3 topline data Allovectin-7 for melanoma late 2012
VICL3.39Phase 312/31/2012Phase 3 initiation of TransVaxT CMV vaccine for HCT patients during 2H 2012
VICL3.39Phase 212/31/2012Phase 2 initiation of TransVaxT CMV vaccine for solid organ transplant (SOT) patients during 2H 2012 or shortly after
VNDA4.02NDA filing06/30/2013NDA filing of Tasimelteon for insomnia due to be filed mid 2013. Phase 3 data due end of 2013
VTUS10.50Phase 312/31/2012Phase 3 US trial of VEN 307 (diltiazem cream) for Anal fissures due to be initiated 2H 2012
XNPT5.83Phase 312/31/2012Phase 3 topline data of Arbaclofen placarbil for multiple sclerosis (MS) due late 2012
XOMA2.37Phase 212/31/2012Phase 2 proof of concept data of XOMA 052 Gevokizumab for Moderate to Severe Acne Vulgaris due 2012
XOMA2.37Phase 212/31/2012Phase 2 initiation of Gevokizumab for Cardiovascular disease during 2012
YMI1.97Phase 1/212/31/2012Final CYT387data of Phase 1/2 Core trial due by end 2012. Interim data from Phase 1/2 Extension trial due by end of 2012. Interim data from the BID (twice-daily dosing) Phase 2 trial also due by end of 2012.
ZIOP4.44Phase 312/31/2012Phase 3 data of palifosfamide for metastatic soft tissue sarcoma due 2H 2012
ZIOP4.44Phase 212/31/2012Phase 2 initiation of Interleukin-12 (IL-12) in 2H 2012
ZLCS0.77Phase 212/31/2012Phase 2 initiation of Z160 in patients with Neuropathic pain 2H 2012
AEGR12.50PDUFA01/05/2013PDUFA date on or about January 5, 2012 for lomitapide in patients with Homozygous familial hypercholesterolemia (HoFH)
CPRX1.07Phase 201/31/2013Phase 2b Top-line data trial evaluating CPP-109 for the treatment of cocaine addiction due early 1Q 2013 - Jan 31 2013 estimate only for calendar purposes
ANAC5.57Phase 301/31/2013Phase 3 topline data of first trial of Tavaborole for Onychomycosis due January 2013
AIS2.72NDA filing03/31/2013NDA filing of VIBEX for Rheumatoid arthritis (RA) due 1Q 2013
ANAC5.31Phase 303/31/2013Phase 3 topline data of second trial of Tavaborole for Onychomycosis due 1Q 2013
ARRY3.43Phase 203/31/2013Phase 2 topline data of ARRY 502 for asthma due 1Q 2013
ARRY3.43Phase 203/31/2013Phase 2 data of MEK162 (ARRY-162) for melanoma due by 1Q 2013
ARRY3.43Phase 203/31/2013Phase 2 ARRY-520 plus dexamethasone data for Refractory Multiple Myeloma MM due by early 2013
ARRY3.43Phase 1b03/31/2013Phase 1b combination data for ARRY-520 plus Velcade (bortezomib) in patients with triple-refractory MM
ASTX1.59Phase 203/31/2013Phase 2 SGI-110 data due by early 2013
ASTX1.59Phase 203/31/2013Phase 2 Amuvatinib data due by early 2013
ATHX1.36Phase 203/31/2012Phase 2 topline data of Multistem for Ulcerative colitis due early 2013
OMER9.52NDA filing03/31/2013NDA filing of OMS302 for intra-ocular lens replacement surgery to be filed first part of 2013
OXGN0.88Phase 203/31/2013Phase 2 progression-free survival data for ovarian cancer due early 2013
POZN7.73NDA filing03/31/2013File NDA 1Q 2013 of PA32540 for secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers
RVX1.50Phase 2b03/31/2013Phase 2b data of RVX-208 (ASSURE trial) due Q1 2013
THLD6.15Phase 303/31/2013Phase 3 interim data of TH-302 for soft tissue sarcoma due start of 2013
TSPT6.99Phase 203/31/2013Phase 2 TO-2061 in adult patients with obsessive compulsive disorder (OCD) data due 1Q 2013
TSRX4.99Phase 303/31/2013Phase 3 data of second trial of torezolid phosphate for ABSSSI due early 2013
ALKS16.42Phase 306/30/2013Pivotal ALKS 9070 in patients with schizophrenia data due mid 2013
ALKS16.42Phase 206/30/2013Phase 2 data ALKS 5461 for Depression due 1H 2013
ANAC5.59Phase 206/30/2013Phase 2 data of AN2728 in atopic dermatitis -safety / PK and efficacy study in children and the Phase 2 dose-ranging bilateral trial are due in 1H 2013.
ANAC5.31NDA Filing06/30/2013NDA filing of Tavaborole for Onychomycosis due 1H 2013
ANAC5.59Phase 306/30/2013Phase 3 initiation of AN2728 in atopic dermatitis mid 2013
BDSI4.01NDA Filing06/30/2013NDA filing of BEMA Buprenorphine/Naloxone (BNX) for the treatment of opioid dependence in 1H 2013
GERN1.37Phase 206/30/2013Phase 2 GRN1005 data of brain metastases arising from breast cancer due mid 2013
GERN1.37Phase 206/30/2013Phase 2 GRN1005 data of brain metastases arising from NSCLC due mid 2013
GTXI3.41Phase 306/30/2013Phase 3 data of Enobosarm (OstarineTM, GTx-024) for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer due 1H 2013
IDRA2.08Phase 206/30/2013Phase 2 trial IMO-3100 for Psoriasis expected to be completed during 1H 2013
IPXL20.97Phase 2b06/30/2013Phase 2b data of IPX159 for restless legs due mid 2013
MDCO20.88NDA filing06/30/2013Possible NDA filing of Oritavancin for ABSSSI 1H 2013
MNKD1.60NDA filing06/30/2013Expect to complete both trials requested by FDA following CRL for AFREZZA by or near the end of 2012. Expect to submit the results to the FDA as an amendment to NDA during 1H 2013.
NBY0.99Phase 2b06/30/2013Phase 2b data for Viral conjunctivitis due 1H 2013
VNDA4.02NDA filing06/30/2013NDA filing of Tasimelteon for insomnia due to be filed mid 2013. Phase 3 data due end of 2013
VNDA4.02Phase 2b/306/30/2013Phase 2b/3 data of Tasimelteon for depression due 1H 2013
BIOD0.65NDA filing12/31/2013NDA filing of Liquid glucagon formulation for use as a rescue treatment for patients experiencing severe hypoglycemia projected for 4Q 2013 or 1Q 2014
CTIC1.29Phase 312/31/2013Phase 3 interim analysis of OPAXIO for ovarian cancer due 2013
INCY21.75Phase 312/31/2013Phase 3 data of INCB18424 ruxolitinib in patients with Polycythemia Vera due 2H 2013
INCY21.75Phase 212/31/2013Phase 3 data of INCB18424 ruxolitinib in combination with capecitabine in patients with refractory metastatic pancreatic cancer due 2H 2013
INCY21.75Phase 2b12/31/2013Phase 2b data of LY3009104 in patients with Psoriasis due 2013
INSM2.87ARIKACE12/31/2013Phase 3 European topline data of Arikace in Cystic Fibrosis (CF) patients with Pseudomonas aeruginosa (Pa) lung infections due 2H 2013.
PBMD4.84Phase 3 12/31/2013Phase 3 trial of CVac as a maintenance treatment for ovarian cancer due to complete enrolment Q3 or Q4 2013
ONTY3.43Phase 312/31/2013Phase 3 data of Stimuvax for NSCLC due 2013
BNHLF0.39Phase 312/31/2013Phase 3 data of Urocidin for bladder cancer due end of 2013
RPRX7.40NDA Filing03/31/2014Possible NDA filing of Androxal for the treatment of secondary hypogonadism early 2014
ECYT4.52Phase 203/31/2014Phase 2 PFS data of EC145 for NSCLC due early 2014
ECYT4.52Phase 206/30/2014Phase 3 PFS data of EC145 for ovarian cancer due 1H 2014
ITMN15.28Phase 306/30/2014Phase 3 pirfenidone study, ASCEND for IPF, data due 1H 2014.
OREX3.44NDA filing06/30/2014Possible NDA filing mid-2014 for Contrave for obesity, pending data from cardiovascular outcomes trial
HGSI13.99Phase 312/31/2014Phase 3 data of Subcutaneous BENLYSTA for lupus due 2H 2014

About the author

Currently residing in New Zealand and employed in the education industry, Mr. A. Burden holds a M.Com in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.
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