FDA Calendar

2015 Biotech Calendar and beyond.

IMPORTANT: The BioPharmCatalyst FDA Calendar is NOT an official calendar. It has absolutely NO affiliation with the FDA. The calendar is created using company SEC filings and press releases.

IMPORTANT: Note that the catalyst date is the LATEST expected date for the catalyst to occur by.

For example ,if the catalyst date is 12/31/15, this means it is expected to occur BY 12/31/15. It does not necessarily mean that the catalyst will occur ON this date. In most cases it will occur well BEFORE the date.

Please READ the CATALYST NOTES in the RIGHT HAND COLUMN for FULL details.

 

FDA Approval Calendar dates  (PDUFA dates), Phase 2 & 3 trial data releases and links to press releases and SEC filings.

Please refer to the “FDA Calendar Glossary” for a list of terms used in the FDA Decision Calendar.

Catalyst dates are based on press releases and company filings or other official sources (e.g. FDA).

AMEX and NASDAQ companies are listed. Generally no OTC/PINK companies are listed unless the upcoming catalyst is a PDUFA or Advisory Committee event.

LARGE cap companies are generally NOT featured in the database, with the exception of companies with PDUFA dates. Over time, clinical catalysts from large cap companies might be added. There is no strict criteria as to which companies might or might not be featured.

TickerPriceMktCapTypeCatalyst Date (due by)Catalyst Notes - click for details
ARRY7.371.1bPhase 203/31/2015Phase 2 preliminary results of ARRY 797 for LMNA-Related DCM due by early 2015
AUXL36.471.9bPhase 2b 03/31/2015Phase 2b data if XIAFLEX for Frozen Shoulder syndrome due 1Q 2015
BSTC39.15261.4mPhase 2b03/31/2015Phase 2b data if XIAFLEX for Frozen Shoulder syndrome due 1Q 2015
DSCO1.19101.0mPhase 2a03/31/2015Phase 2a data of Aerosurf for Respiratory Distress Syndrome due 1Q 2015
DYAX16.752.3bPhase 203/31/2015Phase 2 topline data of Anti-LINGO - RENEW trial for Acute optic neuritis due early 2015
INSV0.1924.7mNDA filing03/31/2015NDA filing of BromSite (ISV-303) for pain after cataract surgery due 1Q 2015
ISIS63.677.7bPhase 203/31/2015Phase 2 data of ISIS-GCCRRx for Type 2 diabetes due early 2015
MACK11.881.3bPhase 303/31/2015NDA fling of MM-398 data for second line pancreatic cancer due late 1Q or early 2Q 2015
OPK14.176.6bNDA filing03/31/2015NDA filing of CTAP101 Capsules (Rayaldee) for Secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) and vitamin D insufficiency, due 1Q 2015
PFNX15.94341.1mPhase 1/203/31/2015Phase 1/2 of PF582 - Biosimilar candidate to Lucentis for retinal diseases - interim data due 1Q 2015. Phase 3 to be initiated mid 2015
RTGN3.3016.3mPhase 1/203/31/2015Phase 1/2 trial of RUT58-60 for the prevention of infection post abdominal surgery to be completed 1Q 2015
SCMP15.56689.6mPhase 303/31/2015Phase 3 interim data of Rescula (unoprostone isopropyl) for Retinitis pigmentosa due 1Q 2015
SRNE11.56411.3mBioequivalence03/31/2015Top-line pharmacokinetic results from TRIBECA (TRIal establishing bioequivalence BE between Cynviloq and Albumin-bound paclitaxel) due in March 2015
AMGN159.85124.7bPhase 303/31/2015Phase 3 data of ABP 501 (adalimumab) for Moderate-to-severe rheumatoid arthritis due 1Q 2015
MDCO28.021.9bAdvisory Committee04/15/2015Cardiovascular and Renal Drugs Advisory Committee will meet on April 15, 2015 to discuss the NDA of cangrelor injection for the proposed indication of reduction of thrombotic cardiovascular events including stent thrombosis (events related to blood clots in a stent, a device inserted to keep the artery open) in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI). PCI refers to the opening of narrowed blood vessels supplying the heart muscle by a balloon inserted through an artery puncture with or without a stent.
ATHX2.88229.5mPhase 204/19/2015Phase 2 initial data of Multistem for Ischemic stroke due mid April 2015
AMGN159.85124.7bAdvisory Committee04/29/2015Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) and the Oncologic Drugs Advisory Committee (ODAC) will review the Biologics License Application (BLA) for talimogene laherparepvec for the treatment of patients with injectable regionally or distantly metastatic melanoma on April 29, 2015.
CLDN18.94505.0mPhase 2b04/30/2015Phase 2b data due April 2015 for MYDICAR in patients with ischemic or dilated cardiomyopathy - CUPID 2 Trial
THRX15.721.9bPDUFA04/30/2015sNDA PDUFA April 30 2014 - BREO ELLIPTA for Asthma
MDCO28.021.9bPDUFA04/30/2015PDUFA date of Raplixa for Hemostasis extended to April 30 2015
EBS28.761.1bPDUFA 05/09/2015sBLA PDUFA date estimated May 9 2015 - BioThrax for Anthrax Vaccine Adsorbed
VRTX117.9729.4bAdvisory Committee05/12/2015Pulmonary-Allergy Drugs Advisory Committee will meet on May 12, 2015 to discuss the the combination of lumacaftor and ivacaftor in people with CF ages 12 and older who have two copies of the F508del mutation - priority review
KYTH50.151.3bPDUFA05/13/2015PDUFA May 13 2015 of ATX-101 for Reduction of Localized Subcutaneous Fat in the Submental Area
PTX10.69403.8mPDUFA Priority Review05/14/2015sNDA filed Nov 14 2014. Granted priority review. Estimated PDUFA May 14 2015 - TREXIMET for Adolescent migraine patients
AERI31.34751.9mPhase 305/15/2015Phase 3 data of Rhopressa for Glaucoma due mid-2Q 2015 (Rocket 1) - Note that May 15 is only an estimate only based on company guidance of a "mid-2Q" data release
AMGN159.85124.7bPDUFA Priority Review05/19/2015PDUFA date under priority review May 19, 2015 - Blinatumomab for Acute Lymphoblastic Leukemia
SLXP172.8110.9bPDUFA05/27/2015PDUFA extented to May 27, 2015 for XIFAXAN 550mg sNDA for Treatment of Irritable Bowel Syndrome with Diarrhea
AMGN159.85124.7bPDUFA Priority Review05/27/2015Original PDUFA date of Corlanor (ivabradine) for Chronic heart failure Feb 27, 2015. 3 month extension due to request for more clinical data. New PDUFA under priority review is May 27, 2015
ARGS8.91187.1mPhase 305/31/2015Interim analysis of Phase 3 ADAPT trial of AGS-003 for mRCC due late May 2015
XLRN38.061.2bPhase 206/01/2015Phase 2 data of Dalantercept for Renal Cell Carcinoma due at ASCO 2015
AAVL40.52994.0mPhase 2a06/30/2015Phase 2a data of AVA-101 for Wet-AMD due mid 2015
ADMA9.8098.1mBLA filing06/30/2015BLA filing of RI-002 for Primary Immune Deficiency Diseases due 1H 2015
AEZS0.5448.8mPhase 306/30/2015Phase 3 interim analysis of AEZS-108 for Endometrial cancer due 1H 2015
ALDR28.861.1bPhase 2b06/30/2015Phase 2b topline data of Clazakizumab for Rheumatoid arthritis (RA) due 1H 2015
ALNY104.429.1bPhase 2 06/30/2015Phase 2 open label data of Patisiran for Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR due mid 2015
AMPE7.53386.2mPhase 306/30/2015Data of Ampion for Osteoarthritis of the Knee - STRIDE study - due 2Q 2015
AMPE7.53386.2mPhase 2b06/30/2015Phase 2b data of OptimEyes Study for the treatment of Diabetic Macular Edema due 2015, possibly during 1H
AQXP8.2291.1mPhase 206/30/2015Phase 2 data of AQX-1125 (LEADERSHIP) for bladder pain syndrome/interstitial cystitis (BPS/IC) due mid 2015
AQXP8.2291.1mPhase 206/30/2015Phase 2 data of AQX-1125 (FLAGSHIP) for Chronic obstructive pulmonary disease (COPD) due mid 2015
ARDX13.09245.7mPhase 2a06/30/2015Phase 2a data of Tenapanor for Late-stage chronic kidney disease (CKD), due 2Q 2015
ARRY7.371.1bPhase 306/30/2015Phase 3 estimated primary completion date of Selumetinib for metastatic uveal melanoma is mid-2015
ASPX100.273.2bPhase 2/306/30/2015Phase 2b topline data of SD-809 for Tardive Dyskinesia (TD) due mid 2015
ASPX100.273.2bNDA filing06/30/2015NDA filing of SD-809 for Huntington's disease (HD) due by mid 2015
AVNR16.963.3bNDA filing06/30/2015NDA resubmission of AVP-825 for Acute migraine likely 1H 2015
BLUE120.774.0bPhase 1/206/30/2015Phase 1/2 initial data of LentiGlobin (HGB-205) for sickle disease due most likely 1H 2015
BMRN124.6220.5bPhase 1/206/30/2015Phase 2 data on first three cohorts in Phase 1/2 with BMN 111 for the treatment of achondroplasia due late 2Q 2015
CANF2.2323.9mPhase 206/30/2015Phase 2 data of CF101 for Glaucoma due 2Q or 3Q 2015
CARA10.05234.0mPhase 206/30/2015Phase 2 topline data of CR845 for Uremic Pruritus due 2Q 2015
CLDX27.872.7bPhase 306/30/2015Phase 3 first interim analysis of CDX-110 rindopepimut - ACT IV for glioblastoma multiforme (GBM) front line due mid 2015
CLVS58.312.5bNDA filing06/30/2015NDA filing of Rociletinib for 2nd line T790M+ NSCLC due mid 2015
CNAT7.12118.2mPhase 2b06/30/2015Phase 2b initial open-label biomarker data of Emricasan for Liver fibrosis post-orthotopic liver transplant due to Hepatitis C virus infection (HCV-POLT), expected 2Q 2015.
CPXX2.8682.3mPhase 306/30/2015Phase 3 initial induction response rate analysis of CPX-351 for Secondary AML due 2Q 2015. Overall survival data due 1Q 2016.
CYTR3.37180.5mPhase 306/30/2015Phase 3 PFS data of aldoxorubicin with doxorubicin for refractory soft tissue sarcomas due mid 2016
DCTH0.9611.8mPhase 206/30/2015Phase 2 data for Hepatocellular carcinoma (HCC) due towards the end of 2Q 2015
DYAX16.752.3bBLA filing06/30/2015BLA filing of CYRAMZA (ramucirumab) for colorectal cancer due 1H 2015
EGRX41.89617.0mNDA filing06/30/2015NDA filing of RTU bivalirudin liquid due 2Q 2015
ESPR92.602.1bPhase 206/30/2015Phase 2 data of ETC-1002-014 for Hypercholesterolemia and hypertension due mid 2015
EXEL2.57528.9mPhase 306/30/2015Phase 3 data of cabozantinib for metastatic renal cell cancer (RCC) due 2Q 2015
FATE4.89103.0mPhase 206/30/2015Phase 2 primary endpoint data of ProHema for Adult hematologic malignancies due 2H 2015
GALE1.39216.9mPhase 206/30/2015Phase 2a data of GALE 301 Folate Binding Protein (FBP) vaccine for endometrial and ovarian cancer due mid 2015
GALE1.39216.9mPhase 206/30/2015Phase 2 topline data of GALE-401 in patients with elevated platelet counts in myeloproliferative neoplasms (MPNs) including essential thrombocythemia (ET), due mid-2015.
GLMD9.42108.0mPhase 206/30/2015Phase 2a data of Aramchol for Cholesterol Gallstones due 1H 2015
GNCA11.86282.0mPhase 206/30/2015Phase 2 interim data of GEN-003 for Herpes simplex virus type 2 (HSV-2) due late 2Q 2015
GTXI0.6897.1mPhase 206/30/2015Phase 2 data of GTx-758 Capesaris for Prostate cancer due 2Q 2015
HTBX6.3653.4mPhase 206/30/2015Phase 2 first interim data of HS-110 for NSCLC non-small cell lung cancer due 2Q 2015
HRTX14.55426.1mNDA filing06/30/2015NDA refiling of APF530 (Sustol) for Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV) due mid 2015
ICPT282.026.7bNDA filing06/30/2015Completion of NDA filing of Obeticholic acid (OCA) for Primary biliary cirrhosis (PBC) planned in 2Q 2015
IMMU3.83363.3mPhase 306/30/2015Phase 3 data of epratuzumab in the treatment of patients with moderate to severe lupus due 1H 2015
KMDA4.42163.8mPhase 2/306/30/2015Phase 3 data of KamRAB for Prophylaxis of rabies disease due 1by mid 2015
LPTN2.4747.7mPhase 206/30/2015Phase 2 data of iSONEP for Wet-AMD due 2Q 2015
MRNS8.99135.3mPhase 206/30/2015Phase 2 trial of Ganaxolone for Fragile X Syndrome to be completed during 2015
NKTR11.001.5bPhase 306/30/2015Phase 3 data of Inhaled Amikacin Solution (BAY41-6551T) for Gram-Negative Pneumonia (INHALE 1) due 1H 2015
NKTR11.001.5bPhase 306/30/2015Bayer Phase 3 program called RESPIRE of Cipro DPI (Cipro Dry Powder Inhaler) for Non-cystic fibrosis bronchiectasis. Data due mid-2015
NLNK54.711.6bPhase 306/30/2015Second analysis of HyperAcute Pancreas - IMPRESS trial - due 1Q or 2Q 2015
OCUL41.99914.5mNDA filing06/30/2015NDa filing of OTX-DP for Ocular inflammation and pain following cataract surgery due 2Q 2015
OTIC35.36859.7mPhase 2b06/30/2015Phase 2b data of OTO-104 for Ménière's disease due 2Q 2015
PBYI236.117.7bPhase 206/30/2015Phase 2 trial of PB272 as a Neoadjuvant treatment for patients with HER2-positive breast cancer (NSABP FB-7) due to be completed 1H 2015
PCYC255.953.5bPhase 306/30/2015Phase 3 interim data of IMBRUVICA in combination with bendamustine and rituximab - HELIOS (CLL3001) for Refractory Chronic Lymphocytic Leukemia/Small Cell Lymphocytic Lymphoma (CLL/SLL) due 1H 2015
PTLA37.96914.5mPhase 306/30/2015Phase 3 second part data of Andexanet alfa, Factor Xa inhibitor reversal agent due mid-2015
QURE24.3219.5bPhase 1/206/30/2015Phase 1/2 interim data of AAV5 Gene therapy for hemophilia B due mid 2015
RDUS41.161.6b06/30/2015Data from AcitveExtend extension study of Abaloparatide-SC for Osteoporosis due 2Q 2015
SGYP4.62433.8mPhase 306/30/2015Phase 3 topline data from first trial of Plecanatide for Chronic idiopathic constipation (CIC) due 2Q 2015
SRPT13.28573.0mNDA Filing06/30/2015NDA filing of Eteplirsen for Duchenne muscular dystrophy to be filed mid-2015
SSH4.2475.8mPivotal 06/30/2015Pivotal data due of C-Pulse Heart Assist System - OPTIONS HF study in Moderate to severe heart failure, mid 2015
STEM1.0271.4mPhase 1/206/30/2015Additional Phase 1/2 final data of HuCNS-SC cells for spinal cord injury due mid-2015.
STEM1.0271.4mPhase 1/206/30/2015Additional Phase 1/2 final data of HuCNS-SC cells for Age-Related Macular Degeneration due mid-2015.
TKMR17.46823.3mPhase 1/206/30/2015Phase 1/2 final data of TKM-PLK1 for Gastrointestinal Neuroendocrine Tumors (GI-NET) due mid-2015
TRGT2.97101.4mPhase 1/206/30/2015Phase 1/2 topline data of TC-6499 for Diabetic Gastroparesis due 1H 2015
TRVN6.52260.6mPhase 2b06/30/2015Phase 2b (second trial) topline data of TRV130 for Moderate to severe acute pain due mid 2015
TTNP0.7178.1mPhase 306/30/2015Phase 3 data of Probuphine for Opioid dependence, in response to CRL, due 2Q 2015. NDA due late 2015.
TTPH36.641.4bPhase 306/30/2015Phase 3 Eravacycline (TP-434) for cUTI - complicated urinary tract infections. Data due mid 2015
VICL0.9481.3mPhase 1/206/30/2015Phase 1/2 data of Vaxfectin-formulated therapeutic vaccine for Herpes due mid 2015
VSTM10.17377.2mPhase 206/30/2015Phase 2 interim data of COMMAND trial of VS-6063 in patients with mesothelioma prior to surgery due 2Q 2015
VTAE11.71242.2mPhase 206/30/2015Phase 2 data of VTP-34072 forType 2 Diabetes due 2Q 2015
AMGN159.85124.7bPhase 306/30/2015Phase 3 data from its head-to-head study of AMG 416 vs Sensipar for Secondary hyperparathyroidism due 1H 2015
TCON14.04173.2mPhase 206/30/2015Phase 2 data of TRC105 for Renal Cell Carcinoma due early to mid 2016
ASND17.35414.5mPhase 206/30/2015Phase 2 topline data of TransCon for Growth hormone deficiency in children due mid 2015
TTHI6.83239.7mPhase 206/30/2015Phase 2 data of ELND005 for Alzheimer's Disease due mid 2015
ADHD5.63126.6mPhase 2b06/30/2015Phase 2b data of MDX (Metadoxine Extended Release (MG01CI)) for Fragile X Syndrome due 2Q 2015
SAGE50.231.3bPhase 2a06/30/2015Phase 2a data of SAGE-547 for Postpartum Depression due mid 2015
SAGE50.231.3bPhase 2a06/30/2015Phase 2a data of SAGE-547 for Essential tremor due mid 2015
ZSPH42.081.1bNDA Filing06/30/2015NDA filing of ZS-9 for Hyperkalemia due 2Q 2015
GBIM7.3441.5mPhase 206/30/2015Phase 2 48-week results of GS-4774 for Chronic hepatitis B infection are expected to be available 1H 2015.
OGXI2.1548.8mPhase 206/30/2015Phase 3 second analysis of Custirsen (ENSPIRIT trial) for NSCLC due mid-2015
SNY49.44133.6bPDUFA Priority Review07/24/2015PDUFA priority review date July 24 2015 for Praluent in patients with Hypercholesterolemia
REGN451.4847.2bPDUFA Priority Review07/24/2015PDUFA priority review date July 24 2015 for Praluent in patients with Hypercholesterolemia
ALKS60.979.3bPDUFA Priority Review07/24/2015Three-Month INVEGA SUSTENNA (paliperidone palmitate) for Schizophrenia. Priority Review. Estimated PDUFA July 24 2015.
JNJ100.60282.4bPDUFA Priority Review07/24/2015Three-Month INVEGA SUSTENNA (paliperidone palmitate) for Schizophrenia. Priority Review. Estimated PDUFA July 24 2015.
AMGN159.85124.7bPDUFA Priority review07/26/2015PDUFA date under priority review of July 26, 2015 for Kyprolis for Relapsed multiple myeloma
AMGN159.85124.7bPDUFA07/28/2015PDUFA July 28 2015 - Talimogene laherparepvec for Melanoma
EXEL2.57528.9mPDUFA Priority Review08/11/2015PDUFA August 11, 2015 under priority review of Vemurafenib for BRAF V600 Mutation-Positive Advanced Melanoma
ESALY71.5521.9bPDUFA08/19/2015sNDA filed Aug 19 2014. Estimated PDUFA Aug 19 2015 - Fycompa for Primary generalized tonic-clonic seizures (PGTC)
ALKS60.979.3bPDUFA08/22/2015PDUFA date August 22 2015 for Aripiprazole lauroxil for patients with Schizophrenia
AMGN159.85124.7bPDUFA08/27/2015PDUFA August 27, 2015 - Evolocumab for LDL Cholesterol-Lowering Medication
GEVA97.533.7bPDUFA Priority Review09/08/2015PDUFA Sep 8 2015 for Late onset lysosomal acid lipase deficiency (LAL Deficiency) - under priority review
OPK14.176.6bPDUFA09/08/2015NDA filed early Sept 2014. Estimated PDUFA Sept 8 2015 - Rolapitant for Prevention of chemotherapy induced nausea and vomiting, or CINV
TSRO57.402.3bPDUFA09/08/2015NDA filed early Sept 2014. Estimated PDUFA Sept 8 2015 - Rolapitant for Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients
AERI31.34751.9mPhase 309/30/2015Phase 3 data of Rhopressa for Glaucoma due 3Q 2015 (Rocket 2)
VTL25.01610.9mPhase 309/30/2015Phase 3 preliminary data of VTI-208 for Alcohol-induced liver decompensation(AILD) due 3Q 2015
AKBA11.11222.4mPhase 2a09/30/2015Phase 2a data of AKB-6548 for Anemia related to chronic kidney disease (CKD) who are undergoing dialysis due 3Q 2015
CNAT7.12118.2mPhase 209/30/2015Phase 2 data of Emricasan for Portal Hypertension due 3Q 2015
CPRX4.33342.1mNDA filing09/30/2015Rolling NDA of Firdapse for Lambert-Easton Myasthenic Syndrome (LEMS) to be completed 3Q 2015
PLX1.78649.0mPhase 1/209/30/2015Phase 1/2 interim data of PRX-102 for Fabry disease due 3Q 2015. Full data due 4Q 2015
SGYP4.62433.8mPhase 309/30/2015Phase 3 topline data from second trial of Plecanatide for Chronic idiopathic constipation (CIC) due 3Q 2015
XNPT7.12455.6mPhase 209/30/2015Phase 2 topline data of XP23829 for Moderate-to-severe plaque psoriasis due 3Q 2015
XENE16.86243.8mPhase 2b09/30/2015Phase 2b data of TV-45070 for Osteoarthritis due 3Q 2015
ANAC57.852.5bPhase 309/30/2015Phase 3 data of AN2728 for Mild-to-moderate atopic dermatitis due 3Q 2015
RLYP36.071.5bPDUFA10/21/2015PDUFA October 21 2015 for Patiromer for Oral Suspension (Patiromer FOS) in patients with Hyperkalemia
BDSI10.50549.9mPDUFA10/23/2015Announced Dec 23 2014 that they have submitted their NDA filing. Estimated PDUFA date October 23 2015 for BEMA Buprenorphine for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate
ENDP89.7015.8bPDUFA10/23/2015Announced Dec 23 2014 that they have submitted their NDA filing. Estimated PDUFA date October 23 2015 for BEMA Buprenorphine for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate
SPPI6.07408.6mPDUFA10/23/2015PDUFA October 23 2015 for Captisol-Enabled Melphalan as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma
LGND77.111.5bPDUFA10/23/2015PDUFA October 23 2015 for Captisol-Enabled Melphalan as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma
BMY64.50109.6bPDUFA10/28/2015PDUFA date for supplemental Biologics License Application (sBLA) for Yervoy for the adjuvant treatment of patients with stage 3 melanoma is October 28, 2015.
MCUR9.28158.3mPhase 310/31/2015Phase 3 data of CureXcell for Diabetic Foot Ulcers due October 2015
GILD98.13149.3bPDUFA11/06/2015NDA filed approx Nov 6 2014. Estimated PDUFA Nov 6 2015 - Elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide for HIV
JNJ100.60282.4bPDUFA 11/24/2015NDA filed approx Nov 24 2014. Estimated PDUFA Nov 24 2015 - YONDELIS for Advanced soft tissue sarcoma (STS)
BAX68.5037.4bPDUFA12/01/2015BLA filed about Dec 1 2014. Estimated PDUFA Dec 1 2015 - BAX 855 for Hemophilia A
BAYRY150.26128.3bPDUFA12/17/2015BLA filed about Dec 17 2014. Estimated PDUFA Dec 17 2015 - BAY 81-8973 for Hemophilia A
BAX68.5037.4bPDUFA12/22/2015BLA filed about Dec 22 2014. Estimated PDFUA Dec 22 2015 - BAX111 for Von Willebrand Disease
ALIOF116.8513.3bPDUFA12/22/2015PDUFA Dec 22 2015 of Selexipag - Uptravi for Pulmonary arterial hypertension (PAH).
CERU9.01193.6mPhase 212/31/2015Phase 2 data of CRLX101 for ovarian cancer due 2015
ACAD32.593.3bNDA filing12/31/2015NDA filing of Pimavanserin for Parkinson’s disease psychosis (PDP) due 2H 2015
BIND5.49110.9mPhase 212/31/2015Phase 2 final overall survival data of BIND-014 for NSCLC broad patient population due 2015
ACHN9.861.2bPhase 212/31/2015Phase 2 SVR4 results of ACH-3102 and sovaprevir with sofosbuvir for Hepatitis C viral infection (HCV) are expected 2H 2015
ACHN9.861.2bPhase 212/31/2015Phase 2 SVR4 results of ACH-3422 in combination with ACH-3102 for HCV Hepatitis C are expected 2H 2015
ADMS17.49308.2mPhase 312/31/2015Phase 3 data from first trial of ADS-5102 for Levodopa-Induced Dyskinesia expected around the end of 2015.
ALDR28.861.1bPhase 2b12/31/2015Phase 2b data of ALD403 for Migraine due 2H 2015
ALDX10.3869.7mPhase 212/31/2015Phase 2 preliminary data of NS2 for Sjögren-Larsson Syndrome (SLS) due by end of 2015
ALDX10.3869.7mPhase 212/31/2015Phase 2 preliminary data of NS2 for Acute anterior uveitis due 2H 2015
ALNY104.429.1bPhase 212/31/2015Present data in late 2015 from ongoing Phase 2 OLE study of Revusiran in patients with TTR cardiac amyloidosis.
APRI1.8796.8mPhase 2a12/31/2015Phase 2a trial of RayVa for Secondary Raynaud's Phenomenon is expected to be completed in 2015.
ATRA41.571.0bPhase 212/31/2015Phase 2 unblinding of data of PINTA 745 for Protein-energy wasting due by end of 2015
BCRX9.03619.8mPhase 2b12/31/2015Phase 2b data of BCX4161 - OPuS-2 trial - for Hereditary angioedema due by the end of 2015
BIND5.49110.9mPhase 212/31/2015Phase 2 preliminary data of BIND-014 for Advanced KRAS Mutant or Squamous NSCLC due 4Q 2015
BLRX2.11115.5mPhase 212/31/2015Phase 2a top-line data of BL-8040 Acute myeloid leukemia (AML) due 2H 2015
BMRN124.6220.5bPhase 1/212/31/2015Phase 1/2 data of BMN 190 for Batten Disease due 2H 2015
BMRN124.6220.5bPhase 212/31/2015Phase 2/3 data of BMN-701 for Pompe Disease due 4Q 2015
CAPR8.70146.8mPhase 212/31/2015Phase 2 topline data of Cenderitide for Ambulatory heart failure due 2H 2015
CNAT7.12118.2mPhase 212/31/2015Phase 2 topline data of first part of trial of Emricasan for Liver Cirrhosis due 4Q 2015
CORT5.60569.9mPhase 1/212/31/2015Phase 1/2 data of Korlym for triple-negative breast cancer due 2015
CTIC1.81337.1mPhase 212/31/2015Phase 2 data of Tosedostat for older patients with AML or high-risk myelodysplastic syndrome (MDS), possibly due 2015
DPRX13.64120.9mPhase 312/31/2015Phase 3 data of Locilex for Mild infections of diabetic foot ulcers, due 2H 2015
ENTA30.62585.8mPhase 2b12/31/2015Phase 2b data of ABT-493 for HCV due 2015.
FLXN22.52499.3mPhase 2b12/31/2015Phase 2b data of FX006 for Osteoarthritis of the knee due 4Q 2015.
GEVA97.533.7bPhase 1/212/31/2015Phase 1/2 preliminary data of SBC-103 for Mucopolysaccharidosis IIIB due 2H 2015
GNCA11.86282.0mPhase 212/31/2015Phase 2 interim data of GEN-004, a universal vaccine candidate against pneumococcus, due 4Q 2015
GWPH91.131.7bPhase 212/31/2015Phase 2 data of GWP42003 for Schizophrenia due 2H 2015
GWPH91.131.7bPhase 312/31/2015Top line Phase 3 data of Epidiolex for Dravet Syndrome expected by the end of 2015
GWPH91.131.7bPhase 312/31/2015Data from at least one of the two Phase 3 trials of Epidiolex for Lennox-Gastaut syndrome (LGS) due by the end of 2015
GWPH91.131.7bPhase 312/31/2015First of three Phase 3 trials of Sativex for Cancer pain failed. Data from two additional Phase 3 cancer pain trials expected 2H 2015
IMGN8.95733.6mPhase 312/31/2015Phase 3 data of Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) for 2nd-line metastatic HER2+ gastric cancer due 2015
INFI13.98700.5mPhase 212/31/2015Phase 2 topline data of Duvelisib (IPI-145) for Indolent non-Hodgkin lymphoma due 2H 2015
INNL8.28156.0mPhase 312/31/2015Phase 3 data of Cogenzia for Diabetic foot ulcer infections due 1H 2016
IRWD16.002.3bPhase 212/31/2015Phase 2 data of Linaclotide for Opioid-induced constipation (OIC) due 2H 2015.
HTBX6.3653.4mPhase 212/31/2015Phase 2 second interim data of HS-110 for NSCLC non-small cell lung cancer due 4Q 2015
LPCN6.9088.3mNDA filing12/31/2015NDA filing of LPCN 1021 for men with low testosterone (Low T) due 2H 2015
LGND77.111.5bPhase 312/31/2015Data from second Phase 3 trial of Captisol-enabled Delafloxacin IV for ABSSSI due 2H 2015
MDWD7.24153.0mPhase 212/31/2015Phase 2 data of EscharEx for Chronic and other hard-to-heal wounds due 2H 2015 (Israel)
NBIX39.713.5bPhase 312/31/2015Phase 3 data of VMAT2 NBI-98854 - Kinect 3 trial for Tardive dyskinesia due 2H 2015
NBIX39.713.5bPhase 312/31/2015Phase 3 data from second trial of Elagolix for Endometriosis due towards the end of 2015
NBIX39.713.5bPhase 2b12/31/2015Phase 2b data of Elagolix for Uterine Fibroids due 2H 2015.
OCUL41.99914.5mPhase 2b12/31/2015Phase 2b data of OTX-DP for Glaucoma and ocular hypertension due 4Q 2015
OGXI2.1548.8mPhase 312/31/2015Phase 3 data of Custirsen in combination with Jevtana (cabazitaxel) - AFFINITY trial for second-line castrate-resistant prostate due late 2015 or early 2016
PCYC255.9519.5bPhase 312/31/2015Phase 3 Ibrutinib RESONATE -2 data in newly diagnosed elderly CLL/SLL patients, 2H 2015
PTCT60.852.2bPhase 312/31/2015Phase 3 top-line data of Ataluren for Duchenne muscular dystrophy caused by nonsense mutations (nmDMD) due 4Q 2015
PTLA37.962.0bPhase 312/31/2015BLA filing of Andexanet alfa, Factor Xa inhibitor reversal agent due by end of 2015
PLX1.78649.0mPhase 1/212/31/2015Phase 1/2 interim data of PRX-102 for Fabry disease due 3Q 2015. Full data due 4Q 2015
RARE62.092.2bPhase 212/31/2015Phase 2 data of Triheptanoin for Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD) due 2H 2015
RARE62.092.2bPhase 212/31/2015Phase 2 data of Triheptanoin for Glucose Transporter Type-1 Deficiency Syndrome (Glut1 DS) due 2H 2015
RDUS41.161.6bNDA filing12/31/2015NDA filing of Abaloparatide-SC for Osteoporosis due 2H 2015
RPTP10.87833.5mPhase 2b12/31/2015Phase 2b data of RP103 for Non-alcoholic fatty liver disease (NAFLD) in children due 2H 2015
RPTP10.87833.5mPhase 212/31/2015Phase 2b data of RP103 for Mitochondrial disorders including Leigh syndrome due 2015
RVNC20.73470.1mPhase 212/31/2015Phase 2 data of RT002 for Moderate to severe glabellar (frown) lines due late 2015
SGMO15.681.1bPhase 212/31/2015Phase 2 data of CERE-110 for Alzheimer's Disease due 2015
SGMO15.681.1bPhase 212/31/2015Phase 2 data of SB-728-1401 for HIV/AIDS due by the end of 2015
SNTA1.94254.3mPhase 312/31/2015Phase 3 interim analysis of Ganetespib GALAXY-2 to be conducted in 2H 2015
SPHS0.589.3mPhase 312/31/2015Full data of Phase 3 trial of PRX302 for Benign prostatic hyperplasia due 2H 2015
TSRO57.402.3bPhase 312/31/2015Phase 3 initial data of Niraparib - NOVA for ovarian cancer due 2015.
TTPH33.191.4bNDA filing12/31/2015NDA filing of Eravacycline (TP-434) for cIAI (complicated intra-abdominal infections) due by end of 2015
VSTM10.17377.2mPhase 212/31/2015Phase 2 data of VS-6063 for KRAS-mutated NSCLC due 2H 2015
XOMA3.64433.4mPhase 312/31/2015Data from Phase 3 EYEGUARD-A and C trials due 2015
ZFGN39.611.1bPhase 312/31/2015Initial data from first of two Phase 3 trials of Beloranib for Prader-Willi Syndrome (PWS) due 4Q 2015
AMGN159.85124.7bBLA filing12/31/2015BLA filing of Brodalumab for Moderate-to-severe plaque psoriasis to be filed in 2015
AMGN159.85124.7bPhase 312/31/2015Phase 3 data of ABP 215 (bevacizumab) for advanced non-small cell lung cancer due 2H 2015
BLCM23.17597.5mPhase 1/212/31/2015Phase 1/2 topline data of BPX-501 for Adjunct T-cell therapy administered after allogeneic HSCT - (hematopoietic stem cell transplantation) due 2H 2015
NEOT8.21111.6mPhase 312/31/2015Phase 3 topline data of LIPO-202 for Reduction of central abdominal bulging due to subcutaneous fat in non-obese patients due by end of 2015
TCON14.04173.2mPhase 212/31/2015Phase 2 data of TRC105 for Soft tissue sarcoma due late 2015
ONCE77.501.8bPhase 312/31/2015Phase 3 data of SPK-RPE65 for Inherited retinal dystrophies due 2H 2015
PBYI236.117.7bPhase 212/31/2015Phase 2 data of PB272 for HER2-negative breast cancer patients who have a HER2 mutation due 2H 2015
PBYI236.117.7bPhase 212/31/2015Phase 2 data of PB272 for HER2+ MBC that has metastasized to the brain potentially due 2H 2015
TTHI6.83239.7mPhase 212/31/2015Phase 2 data of TT401 (LY2944876) for Type 2 diabetes due 4Q 2015
KERX12.731.4bPhase 312/31/2015Phase 3 trial of Auryxia for Iron deficiency anemia in non-dialysis dependent CKD patients due to be completed by end of 2015
TLOG4.38103.5mPhase 1/212/31/2015Phase 1/2 data of Birinapant for 3rd line ovarian cancer due 2015
TLOG4.38103.5mPhase 212/31/2015Phase 2 SHAPE data for Cutaneous T-Cell Lymphoma due 2015
TLOG4.38103.5mPhase 1/212/31/2015Phase 1/2 data of Birinapant for acute myelogenous leukemia or AML due 2015
ISIS63.677.7bPhase 1/212/31/2015Phase 1/2 trial data of ISIS-DMPK Rx for Myotonic Dystrophy Type 1 (DM1) due 2015
ISIS63.677.7bPhase 212/31/2015Phase 2 data of ISIS-GCCRRx for Type 2 diabetes due 2015
ISIS63.677.7bPhase 212/31/2015Phase 2 data of ISIS-APO(a)Rx for High lipoprotein(a), or Lp(a) due 2015
TNXP6.32100.9mPhase 212/31/2015Phase 2 data of TNX-201 for Episodic tension-type headache due 4Q 2015.
EGLT12.93226.8mNDA filing12/31/2015NDA filing of Egalet-001 Abuse-Deterrent Morphine planned by end of 2015
CTIC1.81337.1mNDA filing12/31/2015Data from second Phase 3 trial of Pacritinib for Myelofibrosis and NDA filing due by late 2015
MRNS8.99135.3mPhase 212/31/2015Phase 2 data of Ganaxolone for Female children with Epilepsy due 2H 2015
SPPI64.50408.6mPDUFA12/31/2015NDA filing of Apaziquone for bladder cancer due 2015
TKMR64.50823.3mPhase 212/31/2015Phase 2 data of TKM-Ebola-Guinea for Ebola due 2H 2015
EBIO64.50167.5mPhase 312/31/2015Phase 3 topline data of EBI-005 for Moderate to severe dry eye disease due 2Q 2015
FOLD10.881.0bNDA filing12/31/2015NDA filing of Migalastat HCl monotherapy for Fabry Disease due 2H 2015
SYN2.19166.5mPhase 212/31/2015Phase 2 data of SYN-004 for Constipation-Predominant Irritable Bowel Syndrome (C-IBS) due 2H 2015
SYN2.19166.5mPhase 212/31/2015Phase 2b data of SYN-004 for C. difficile Infection due 2H 2015
ACRX3.86160.4mPhase 312/31/2015Phase 3 data of ARX-04 for Moderate-to-severe acute pain due 4Q 2015
RARE62.092.2bPhase 212/31/2015Phase 2 40-week data of KRN23 for X-linked Hypophosphatemia (XLH) due late 2015 or early 2016
CARA10.05234.0mPhase 212/31/2015Phase 2 trial of Oral CR845 for Acute pain - potential data release by end of 2015
AQXP8.2291.1mPhase 203/31/2016Phase 2 data of AQX-1125 (KINSHIP) for Atopic dermatitis (AD) due by 1Q 2016
INNL8.28156.0mPhase 303/31/2016Phase 3 data of XaraColl for Post-operative pain due 1Q 2016
MRNS8.99135.3mPhase 303/31/2016Phase 3 top-line data of Ganaxolone for Epilepsy due 1Q 2016
AGRX9.27207.4mPhase 303/31/2016Phase 3 data of Twirla Contraceptive patch due 1Q 2016
BMRN124.6220.5bPhase 303/31/2016Phase 3 data of PEG-PAL for Phenylketonuria (PKU) due 1Q 2016
CMRX37.691.6bPhase 303/31/2016Phase 3 data of SUPPRESS trial of CMX001 for prevention of Cytomegalovirus (CMV) infection following an allogeneic hematopoietic stem cell transplant (HSCT), due early 2016
CPXX2.4782.3mPhase 303/31/2016Phase 3 initial induction response rate analysis of CPX-351 for Secondary AML due 2Q 2015. Overall survival data due 1Q 2016.
EARS5.35154.0mPhase 303/31/2016Phase 3 topline data of AM-101 for Acute inner ear tinnitus due early 2016
THLD4.06290.8mPhase 303/31/2016Phase 3 TH-302 overall survival analysis for soft tissue sarcoma (406 trial) due 2H 2015 or 1Q 2016.
MSTX0.4979.3mPhase 303/31/2016Phase 3 top-line data of ANX-188 for Sickle cell disease (EPIC trial) due 1Q 2016
PBYI236.117.7bNDA filing03/31/2016NDA filing of PB272 for the extended adjuvant HER2-positive early stage breast cancer due 1Q 2016
PTLA37.962.0bPhase 303/31/2016Phase 3 data of Betrixaban (The APEX Study) for the prevention of Venous thromboembolism (VTE) due early 2016
RIGL3.57294.9mPhase 303/31/2016Phase 3 data from first of two trials of Fostamatinib for Immune Thrombocytopenic Purpura (ITP) due 1Q 2016
RIGL3.57294.9mPhase 203/31/2016Phase 2 data of R348 for Chronic dry eye disease - as a result of patients with acute or chronic graft vs. host disease (GvHD) due 1Q 2016
RIGL3.57294.9mPhase 203/31/2016Phase 2 data of Fostamatinib for IgA nephropathy due early 2016
SCMP15.56689.6mPhase 303/31/2016Phase 3 completion of Lubiprostone for Pediatric functional constipation due early 2016
VCEL3.7088.7mPhase 2b03/31/2016Phase 2b Topline data of ixmyelocel-T in patients with ischemic dilated cardiomyopathy due towards the end of 1Q 2016
THLD4.06290.8mPhase 303/31/2016Phase 3 topline data of TH-302 MAESTRO trial for pancreatic cancer due possibly late 2015 or early 2016
CERU9.01193.6mPhase 206/30/2016Phase 2 data of CRLX101, in combination with Avastin for Relapsed Renal Cell Carcinoma due 2Q 2016
BOTA2.3079.3mPhase 2b06/30/2016Phase 2b top-line data of Vapendavir for Human rhinovirus (HRV) due mid 2016
GLMD9.42108.0mPhase 2b06/30/2016Phase 2b Interim analysis of Aramchol for Non-Alcoholic Steatohepatitis (NASH) due 1H 2016. Final Data due 2H 2016
IMMU3.83363.3mPhase 306/30/2016Phase 3 data of Clivatuzumab tetraxetan for pancreatic cancer due mid 2016
INSM20.801.1bPhase 306/30/2016Phase 3 data from one of two trials of ARIKAYCE for Non-tuberculous Mycobacterial Lung Disease data due mid 2016. Data from second trial due 2017.
ARRY7.371.1bPhase 306/30/2016Phase 3 estimated primary completion date for the ASTRA study, Selumetinib (AZD6244) combined with radioactive iodine for differentiated thyroid cancer, is June 2016
IRWD16.002.3bPhase 2a06/30/2016Phase 2a data of IW-9179 for Gastroparesis due 1H 2016
PTN1.0243.2mPhase 306/30/2016Phase 3 top-line data of Bremelanotide for female sexual dysfunction (FSD) due mid-2016
RCPT164.895.0bPhase 206/30/2016Phase 2 topline data of RPC4046 for Eosiniphilic Esophagitis due 1H 2016
RGDO1.2240.3mPhase 2b06/30/2016Phase 2b top-line data of Cenicriviroc (CVC) - CENTAUR trial, for Non-alcoholic steatohepatitis (NASH) are due in 2Q 2016
SNTA1.94254.3mPhase 306/30/2016Phase 3 final analysis of Ganetespib GALAXY-2 to be conducted in 1H 2016
TRVN6.52260.6mPhase 2b06/30/2016Phase 2b data of TRV027 (BLAST-AHF) trial for Acute heart failure due 1H 2016
VSAR18.37553.8mPhase 306/30/2016Phase 3 interim 6 month height velocity analysis of VRS-317 for Growth hormone deficiency in pediatric patients are due by mid-2016 and top line data on the 12 month height velocity primary endpoint is expected in early 2017.
XENE16.86243.8mPhase 2b06/30/2016Phase 2b trial completion of TV-45070 for Postherpetic neuralgia due mid 2016
AMGN159.85124.7bPhase 306/30/2016Phase 3 data of Romosozumab for Postmenopausal osteoporosis due 1H 2016
TCON14.04173.2mPhase 206/30/2016Phase 1b data of TRC105 for Hepatocellular carcinoma due early 2015. Phase 2 data due early to mid 2016
TCON14.04173.2mPhase 206/30/2016Phase 2 data of TRC105 for Glioblastoma due early to mid 2016
TCON14.04173.2mPhase 206/30/2016Phase 2 data of TRC105 for Breast Cancer due mid to late 2016
MCUR9.28158.3mPhase 306/30/2016Phase 3 data of CureXcell for Venous Leg Ulcers due 1H 2016
OGXI2.1548.8mPhase 206/30/2016Phase 2 data of OGX-427 and carboplatin and pemetrexed - (SpruceTrial) for NSCLC due mid 2016
ARRY7.371.1bPhase 307/31/2016The Phase 3 estimated primary completion date for the SELECT-1 study, of Selumetinib (AZD6244) in Combination With Docetaxel for NSCLC second line non small lung cancer, is July 2016
ANTH3.78129.4mPhase 309/30/2016Phase 3 final data of Blisibimod for Lupus due 3Q 2016.
RARE62.092.2bPhase 312/31/2016Phase 3 data of rhGUS for Mucopolysaccharidosis 7 (MPS 7) due 2016.
ANTH4.47129.4mPhase 312/31/2016Phase 3 data of Blisibimod for IgA nephropathy due 2H 2016
HTBX6.3653.4mPhase 212/31/2016Phase 2 data of HS-410 for bladder cancer due 2H 2016
ALKS60.979.3bPhase 312/31/2016Phase 3 data of ALKS 5461 for Major depressive disorder due 2016.
ASPX100.273.2bPhase 312/31/2016Phase 3 topline data of SD-809 for Tardive Dyskinesia (TD) due 2016 - second pivotal trial
CYTR3.37180.5mPhase 2b12/31/2016Phase 2b data of Aldoxorubicin for relapsed/refractory small cell lung cancer due by end of 2016
DSCI8.47225.7mPhase 312/31/2016Phase 3 DSC127 for Diabetic foot ulcers to be completed 2H 2016
DYAX16.752.3bPhase 212/31/2016Phase 2 topline data of Anti-LINGO - SYNERGY trial for relapsing forms of multiple sclerosis due 2016
GLMD9.42108.0mPhase 2b12/31/2016Phase 2b Interim analysis of Aramchol for Non-Alcoholic Steatohepatitis (NASH) due 1H 2016. Final data due 2H 2016
FLXN22.52499.3mPhase 312/31/2016Phase 2b data of FX006 for Osteoarthritis of the knee due 2H 2015. Phase 3 data due 2016. NDA filing due 2016 assuming positive data
GWPH91.131.7bPhase 2b12/31/2016Phase 2b estimated completion date of GWP42004 for Type 2 diabetes 2016
INCY91.6616.2bPhase 312/31/2016Phase 3 data from JANUS 1 and JANUS 2 trials of Ruxolitinib for pancreatic cancer due 2016
INSY58.132.0bPhase 312/31/2016Phase 3 data of Buprenorphine in patients with acute pain undergoing a bunionectomy procedure due 2016.
INSY58.132.0bPhase 312/31/2016Phase 3 data of Subsys in patients with Acute post-operative pain due 2016.
IRWD16.002.3bPhase 312/31/2016Phase 3 data of Linaclotide for Chronic idiopathic constipation (CIC) due 2016
KPTI33.501.1bPhase 2b12/31/2016Phase 2b trial completion of Selinexor for Diffuse Large B-Cell Lymphoma (DLBCL) to be completed around the end of 2016
MDCO28.021.9bPhase 312/31/2016Phase 3 data of CARBAVANCE for Serious Bacterial Infections Due to Gram-Negative Bacteria due 2016
NKTR11.001.5bPhase 312/31/2016Phase 3 initial topline data of Fovista for Wet-AMD due 2016
OPHT46.531.6bPhase 312/31/2016Phase 3 initial topline data of Fovista for Wet-AMD due 2016
OPXA0.5515.0mPhase 2b12/31/2016Phase 2b top-line data of Tovaxin (Tcelna) for Secondary Progressive MS (SPMS) due 2H 2016.
PTCT60.852.2bPhase 312/31/2016Phase 3 data of Ataluren for Nonsense mutation cystic fibrosis due 2H 2016
VTL25.01610.9mPhase 212/31/2016Phase 2 data of ELAD (VTI-212) for Fulminant hepatic failure, or FHF, or surgery-induced acute liver failure, or SILF due 2016
INCY91.6616.2bPhase 212/31/2016Phase 2 data of Ruxolitinib for Breast Cancer due 2016
INCY91.6616.2bPhase 312/31/2016Phase 3 data of Ruxolitinib - JANUS 1 and JANUS 2 trials for Pancreatic cancer due 2016
INCY91.6616.2bPhase 212/31/2016Phase 2 data of Ruxolitinib for Non-small cell lung cancer due 2016
TNXP6.32100.9mPhase 312/31/2016Phase 3 data of TNX-102 SL for Fibromyalgia due 2H 2016
PSDV3.95116.8mPhase 312/31/2016Phase 3 data of Medidur for Posterior uveitis due 2H 2016
VTL25.01610.9mPhase 303/31/2017Phase 3 data of ELAD (VTI-210) for Severe acute alcoholic hepatitis due early 2017
PRTO11.63188.5mPhase 303/31/2017Phase 3 data of PRT-201 for Chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF) due 1Q 2017
VSAR18.37553.8mPhase 303/31/2017Phase 3 interim 6 month height velocity analysis of VRS-317 for Growth hormone deficiency in pediatric patients are due by mid-2016 and top line data on the 12 month height velocity primary endpoint is expected in early 2017.
MNOV3.5288.9mPhase 2b06/30/2017Phase 2b data of MN-166 for Progressive multiple sclerosis (progressive MS) due 1H 2017
ALKS60.979.3bPhase 206/30/2017Topline data from second Phase 2 trial of ALKS 3831 for Schizophrenia due mid 2017
OPK14.176.6bPhase 306/30/2017Phase 3 data of Fermagate Tablets for hyperphosphatemia in CKD patients on chronic hemodialysis due 1H 2017
EXEL2.57528.9mPhase 312/31/2017Phase 3 data of cabozantinib (CELESTIAL trial) for patients with advanced hepatocellular cancer (HCC) due 2017
INSM20.801.1bPhase 312/31/2017Phase 3 data from one of two trials of ARIKAYCE for Non-tuberculous Mycobacterial Lung Disease data due mid 2016. Data from second trial due 2017.
RCPT164.895.0bPhase 312/31/2017Expects to complete Phase 3 program of RPC1063 for Relapsing Multiple Sclerosis (RMS) in 2017
DERM15.35378.0mPhase 312/31/2017Phase 3 data of Cimzia for Moderate-to-severe plaque psoriasis due 2017
HSGX9.99120.9mPhase 312/31/2017Phase 3 data of NeoCart for Cartilage defects in the knee due 2H 2017
FGEN31.381.9bPhase 312/31/2017Phase 3 data of Roxadustat FG-4592 for Anemia in chronic kidney disease due 2017
AMRN2.34421.2m12/31/2018REDUCE-IT outcomes trial interim efficacy look by the independent Data Monitoring Committee (DMC) due 2016 and, if not stopped early, for completion in 2017 and presentation/publication of results in 2018
GALE1.39216.9mPhase 312/31/2018Phase 3 final endpoint of NeuVax (E75) for low-to-intermediate HER2+ breast cancer is expected to be reached in 2018
GTHP0.1615.1mPMACompany noted Feb 3, 2015 that they have been in communication with the agency and is hoping to receive the agency’s decision within the next several weeks regarding their PMA of LuViva, a device to detect cervical disease.
XOMA3.64433.4mPhase 3Phase 3 Gevokizumab EYEGUARD-B data for Behcet's uveitis due six weeks following final exacerbation. Data might be available in 1H 2015 - but no guarantee regarding this!

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.

169 Responses to “FDA Calendar”

  1. Ken says:

    TTNP is slated for Probuphine NDA September 2012, with Pre-NDA meeting with FDA complete. Is there a specific reason this isn’t included on your list?http://www.titanpharm.com/products.htm#gpm1_1

    • admin says:

      Hi Ken,

      Thanks for your message. I only follow companies that are listed on AMEX or NASDAQ. I haven’t followed TTNP as it is OTC listed. However, if an OTC stock has an upcoming major event, such as an NDA filing or PDUFA date, and a reader brings it to my attention then I do make exceptions.

      I’ll add the September event later tonight :)

  2. Ken says:

    Thanks. Your site is very helpful keep up the good work!

  3. Firas says:

    Where is the upcoming NDA filling from Spectrum pharmaceutical, belinostat for PTCL.
    It use to be on you list.
    Now i only see a phase 3 result, without any FDA filling to follow, why?

    • admin says:

      Hi Firas,

      Thanks for your enquiry.

      I’m not sure why the entry was deleted but I have re-entered the NDA Filing which is due to filed this year (according to its latest 10-Q) pending positive data from its Phase 3 trial.

  4. AP says:

    Please can you remove old date (Jun Date) and update it.

    Regrads,
    AP

    • admin says:

      AP,

      That’s always been a problem with the Calendar. I had a quick look at the entries. Company guidance has a few like APPA re-filing its NDA during mid-2012. I’ve got to put a date in, so for those events I’ve always put June 30 as an estimate as that is “mid-year”, when it could actually be July or even August. Maybe I’ll just change the date to read July 31. What do you (and others) think?

      The other events refer to clinical trial initiations. The problem with these is that some are so minor that some companies don’t release PRs about the initiations until they release their financial reports for that quarter, and we won’t hear from most companies till about early August. So I either wait till then for a company update, or I just delete them off the calendar. Thoughts??

  5. nimer hasan says:

    can you tell me what are the status of anth and dcth on the fda calendar

    • admin says:

      The status of ANTH and DCTH are correct as of their last PRs, although they may provide an update when they provide their 10Qs over the next few weeks.Use the “keyword” function to find ANTH and DCTH. eg. Type “DCTH” in the KEYWORD tool on the FDA Calendar. The KEYWORD function is located immediately above the FDA Calendar menu (Price, ticker, Type, catalyst date, notes)

  6. nimer hasan says:

    thanks for your prompt reply , and would like to know what does it mean for dcth to FILL NDA?AND WONDER IF IT HAS PASSED ANY PHASES ?
    THANKS IN ADVANCE
    NIMER

    • admin says:

      In late December 2010 DCTH filed their NDA for their chemosaturation system used in the treatment of patients with metastatic melanoma in the liver. Once a company files their NDA, the FDA assigns a PDUFA date to decide whether to approve the product or not. However, in early 2011 the FDA REFUSED to file DCTH’s NDA. This is rare and occurs in less than 5% of cases. They’ll get another chance soon.

  7. nimer hasan says:

    so , i understand if dcth gets the approval to fill their nda ,then they will go to phase one up to phase three later on?
    thanks

    • admin says:

      The FDA will inform the company whether their NDA filing has been accepted or not, usually 60 days after the filing. If they accept the filing then a PDUFA date (approval date) will be set, which will likely be 10-months following the filing. As an EXAMPLE, if DCTH files NDA 8/31 -> FDA informs company if NDA has been accepted or not by 10/31 -> If NDA filing has been accepted then a PDUFA date of approx 6/30/2013 will be set.

      No further trials will be required PRIOR to the PDUFA date.

      If you have any other questions please feel free to contact me using the “contact” form at the top of the website.

  8. Alpha Global Investments: Options | Alpha Global Investment says:

    […] a strangle, as it is cheaper to execute. Investors who wish to execute this strategy will find that this FDA calendar is a very helpful tool. This calendar, from BioPharmCatalyst, lists all the upcoming catalysts for […]

  9. Chad says:

    “IMGN 12/31/1969″ ?

  10. @biochaser says:

    This calendar has saved me a lot of time on research. As they say, time = money. So, I’m making another donation. Keep up the good work.

  11. Chad says:

    VTUS 3/31/12 NDA Filing. I think you mean 3/31/13?

  12. AA says:

    First, thank you for your outstanding calendar.

    Neuralstem (CUR, trades on AMEX) has a few catalysts (see third paragraph from the end of this article):

    http://seekingalpha.com/article/859871-why-neuralstem-could-provide-a-10x-return

    Could you please list them?

    Thanks again for this amazing project.

    • admin says:

      AA,

      Sorry about they dealy.

      Thanks for the feedback. I prefer to list catalysts with links to official PRs/10Qs etc rather than articles. Do you have a PR or filing handy so that I can add it with the catalyst.

      Thanks,

      BPC

  13. Steve says:

    HEB has a FDA advisory panel on December 20th for Ampligen in treating CFS.

    It is listed on page 45 of this transcript from the FDA.

    http://www.fda.gov/downloads/Drugs/NewsEvents/UCM320310.pdf

  14. Pharr says:

    Great website! Thanks for your work!

  15. Chad says:

    PPHM – 6/30/12, Shouldn’t this be 13?

  16. Steve says:

    CRMD

    “CorMedix anticipates a final review and determination regarding its CE Mark application by the end of 4Q 2012. ”

    http://finance.yahoo.com/news/cormedix-successfully-completes-passes-iso-130000848.html

  17. sandy says:

    CPRX: Result of Ph II study date is delayed and in Nov 2012

    • admin says:

      Thanks. Am planning a big catch up this weekend. Have started updating my database offline but will update all changes on the website hopefully by the end of this weekend.

  18. Steve says:

    CRMD

    CorMedix anticipates a final review and determination regarding its CE Mark application by the end of 4Q 2012.

    http://finance.yahoo.com/news/cormedix-successfully-completes-passes-iso-130000848.html

  19. rx007 says:

    PDUFA date for desvenlafaxine base ER Tablets of Alembic pharmaceuticals is in december 2012. If you can find out

    • admin says:

      I know little about Alembic. From what I’ve read they filed a aNDA, which is different from a NDA, with no PDUFA date assigned. Have you got any other information, and ideally a link to a press release and then I can investigate further?

      • rx007 says:

        They have also filed, NDA under 505(b)2. Please make some efforts to find PDUFA date

        • admin says:

          I’ve spent quite a bit of time on this but have come up empty. How do you know they have filed an NDA? And how do you know it was filed under 505(b)2? If you could give me the link of your source that would help very much and I could investigate further.

  20. steve says:

    CRMD

    They are now expecting decision on CE Mark in Q1 of 2013, according to their latest 10-Q

    http://biz.yahoo.com/e/121113/crmd10-q.html

    Thanks again for the great calendar.

  21. figurine says:

    thanks for the job! great site ;)

  22. Mike says:

    Thank you for your service. Is there any way you could make your site data exportable to x-cel? This would be fantastic if you could. Thanks again.

    • admin says:

      Mike,

      I had an excel version a few years ago that could be downloaded but found readers were uploading it to their own websites so decided to cease doing that to the general public.

      Adam

  23. steve says:

    BLRX

    Updated guidance on BL-1020 Phase II/III Schizophrenia interim data to week of March 18, 2013

    http://www.biolinerx.com/default.asp?pageid=16&itemid=166

  24. Jake says:

    To the genius who set up this site and keeps it updated……THANK YOU!

    I have been trading about 95% Bio Tech. stocks for about 5 years now, and this site BY FAR makes me the most money based on the information posted.

    You can check me out at http://www.thelion.com …. Profile name JWT where the trades can not be fudged.

    If you are new here….STAY HERE. This site by far gives you the information you need to make real money….and lots of it.

    THANK YOU SO MUCH AGAIN FOR YOUR EFFORTS !!!!!

  25. Joe says:

    This site is so well put together, great work

    • admin says:

      Great to hear the positive feedback. Appreciate it! Currently working on adding more large cap companies to the calendar (e.g GILD/GSK) so it should be more of a complete calendar soon (ish).

  26. steve says:

    CRMD another delay

    As a result, we anticipate final approval for the CE Mark certification for Neutrolin during the second quarter in 2013.

    http://biz.yahoo.com/e/130306/crmd8-k.html

  27. Michael Webb says:

    NVAX – Topline data for RSV in women of childbearing age is 4/30/2013. Topline data for RSV in the elderly is 6/30/2013.

    P.S. I love this calendar. Thank you!

    • admin says:

      Thanks Michael.

      Regarding NVAX, I presume you are asking me to make the 4/30 event clearer for readers, as I already have the event noted. I will add “in women of childbearing age” to the event. As for the 6/30 data release this does not appear in the calendar as it is a Phase 1 data release. To maintain consistency in the calendar I only list upcoming data releases in either Phase 2 or 3 development.

      Regards,

      Adam

  28. Michael Webb says:

    Got it! Thank you Adam and I did not know that. You’re great dude!

  29. NYS-Esquire says:

    I am new to your site, and love it. The information is formatted in a way that makes it a quick read. However, being new to the site and new to the industry i think it might be helpful to provide new users such as myself with a brief definition of the “type” section. I understand many of your visitors many be more experienced but as a novice, I would love to learn more as a legend or definitions section would prove useful. Thanks. P.S. wonderful work.

  30. John t says:

    Great site, great resource for the bio investor, keep up the good work. Have you added something with respect to Ampligen experts speaking at the FDA workshop (Drug Development for Chronic
    Fatigue Syndrome [CFS] and Myalgic Encephalomyelitis [ME]) next week on April 25-26. This is would be related to Hemispherx new effort to make a precursor to submiiting a formal appeal to their CRL of ampligen. http://www.hemispherx.net/PDF/BioWorld March 14, 2013.pdf

    Thanks so much for your great work!

    • admin says:

      John,

      Thank you for the feedback. Regarding HEB, I only list PDUFA dates, Adcom meetings and clinical data release dates in the calendar. I prefer to keep to these guidelines for consistency purposes so unfortunately I will not be able to list the meeting you referred to.

      Regards,
      Adam

  31. Dr. KP says:

    Great site. One correction… there is no PDUFA for DEPO’s Serada anymore. They changed the name of the drug and got a rejection and have dropped it from their pipeline list.

    • admin says:

      Thanks Dr.KP,

      I know they got a resounding negative vote at the Adcom meeting in March and said that they will no longer be devoting any resources to it, and yes I see that they have removed it from their pipeline. But the PDUFA date still stands, as far as I am aware, even though they will get a CRL. Technically the FDA still need to make a decision even if DEPO have removed it from their pipe. I’m just reading their latest 10-Q and I can’t see any mention of them officially pulling the NDA. Do you know otherwise?

      Regards,

      Adam

  32. Tia Menon says:

    Why is it the FDA calendar no longer lists the tickers?

  33. Tia Menon says:

    Hi Adam,

    Thank you. Though I am late by 3 years to visit your site, I am happy that I did at least now.

    Great site.

    Thank you.

  34. John t says:

    Hi Sir, again, as always nice to see you are keeping a good work here for an informed audience. I noticed AEZS has another milestone coming up! here it goes: Phase 2 Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia. Estimated Study Completion Date: August 2013. Clinicaltrials ID NCT01614990.

    Thank you Sir.

    John.

  35. Adam C says:

    Great Site. I don’t see CRDC upcoming catalysts (Cardica, Inc) of a Premarket Notification 510(k) submission to the FDA in the 3rd quarter of CY13. Here is a reference to that: http://phx.corporate-ir.net/phoenix.zhtml?c=195013&p=irol-newsArticle&ID=1820268&highlight=

    Again, great site.

    Thank you,

    Adam C

    • admin says:

      Thanks Adam,

      Sorry for the delay. I’ve been locked out of my website for the last few days.

      Regarding your enquiry, I only cover PDUFA and catalyst events involving drugs, rather than medical devices due to the difficulty in providing accurate estimates and if I choose to add one (e.g. CRDC) then there will be an expectation to have them all added, which realistically is not possible.

      All the best with your trading!

      Regards,

      Adam

  36. Juno says:

    Hi Adam,
    Here are a few catalyst for MSTX. I think you always do a good job informing the biotech investor community, and I would like to do my piece to help out.
    1) Sickle Cell Disease – phase 3 NCT01737814 – estimated completion December 2015 ( i think this one is worthy of mention because it is the only company in the world with phase 3 clinical trials for SCD)
    2) Acute Limb Ischemia – initiate POC study in Q1 14
    3) Acute Decompensated Heart Failure – Data from POC study expected in Q1 14.

    This information is based of their recent presentation on September 10 at Rodman and Renshaw Global Investment Conference http://wsw.com/webcast/rrshq23/MSTX/

    Hope this helps!

    • admin says:

      Juno,

      Thank you for your enquiry.

      Please note the FDA Calendar contains dates of data releases and not trial initiations and/or completion of trials. Such events are included in the Company Pipeline Database. For 1) and 2) these events were already entered into the Company Pipeline database http://www.biopharmcatalyst.com/clinical-database/.

      Regarding the catalyst mentioned in 3), I only list data releases for Phase 2 and 3 trials. I do not list pre-clinical catalysts. To maintain consistency, I won’t be including the catalyst as according to the link you sent me the trial is a non-clinical POC trial in dogs.

      Thanks again.

      Adam

  37. Jonathan Thomas says:

    Awesome Site!

    I had a question about LGND’s PDUFA date for Bazedoxifene. I thought LGND lost all royalty agreements on Bazedoxifene when LGND signed over the rights to manufacture Lasofoxifene to Ethicor on July 24th of this year? And didn’t Pfizer obtain all rights to Bazedoxifene when it acquired Wyeth back in ’09? I think I might have this wrong but if LGND still has some sort of small royalty on Bazedoxifene, is that significant enough for a catalyst play?

    investor.ligand.com – Ligand Signs – License Agreement – Ethicor – Lasofoxifene

    Also, this might be another dumb question, but do you think that the FDA will use their 90-day extension on PFE for Bazedoxifene?

    Thanks for setting up this site, it made me a lot of money on VRX back in May :)

    JT

  38. Apoca says:

    Hey thanks for a great job. Really appreciate it

    Per

  39. Jason says:

    This is a great site, but how often is it updated?

    • admin says:

      Hi Jason,

      The FDA Calendar and Company Pipeline Database are both generally updated daily, or at least Mon-Thur nights. There may be a period during Xmas and other times of the year when I am overseas, which prevents me from updating the site, but it’s generally updated daily. Following reporting season I go through all events in the FDA Calendar to ensure they are up to date as I miss some of the PRs during what is a very busy time of the year. This is what I am currently doing, and the audit should be complete by next week. The news updates on the homepage take time to write up. I try and get a post out Mon-Thur nights but that’s not always possible.

      Regards,

      Adam

      Regards,

  40. Financial News, Blogs, Twits, Analysis for Momo Trade | Momentum Stocks says:

    […] 6) http://www.biopharmcatalyst.com/fda-calendar/ 7) 8) […]

  41. steve says:

    If pinksheets are allowed ACUS has upcoming catalyst in the first Q of 2014

    The validation process for the MAA has been successfully completed, and the substantive review process is now underway by the Committee for Medicinal Products for Human Use (CHMP). The CHMP opinion is expected in Q1 2014

    http://www.acusphere.com/

  42. Pharma stock potential - Page 17 says:

    […] is and FDA calendar you guys might helpful: FDA Calendar | BioPharmCatalyst The stock market is never obvious. It is designed to fool most of the people, most of the […]

  43. Alfredo says:

    Great job. One of the best sources for biotech.

    FYI,

    TRLPF (OTC) has a pdufa date of Feb 28 2014 and is not in the calendar

    Trimel Pharmaceuticals Corporation (OTCMKTS:TRLPF) announced that the New Drug Application (“NDA”) for its bioadhesive intranasal gel testosterone product (“CompleoTRT™”) has been formally accepted for review by the United States Food and Drug Administration (the “FDA”). The NDA is supported by efficacy and safety results from 306 patients who participated in the pivotal Phase III study.

    Additionally, the FDA has confirmed that under the United States Prescription Drug User Fee Act, the NDA will be subject to a standard review and the target action date for the NDA is February 28, 2014.

  44. JERMAINE says:

    I NEED SOME HELP WITH TRADING STOCKS….SO FORTH AS WHAT INFO THAT COMES OUT IS GOOD OR BAD AND SO FORTH

    • admin says:

      Jermaine,

      That’s not an easy question to answer.

      In simple terms, when a trial meets an endpoint or shows efficacy with statistical improvement then this is regarded as good news. Likewise, if the trial did not meet its endpoint then this is negative. However, at times, if the good news has been priced in then you may actually see a decline in the price per share. It all depends whether the actual data exceed expectations, or not.

      To fully understand whether the data are good or not, you need to have a good understanding of science and that’s not easy to explain in an email or post.

      If you don’t understand whether the data released are positive or negative, I would highly recommend against investing/trading biotech stocks as you will most likely lose most of your money, especially when the current speculative bubble bursts.

  45. steve says:

    ACST

    Clinical Trials

    Acasti continues to make significant progress in its research and clinical development program. Recently, Acasti announced that the FDA had given it clearance to initiate a PK trial in the U.S. This is a significant milestone and a key first step towards securing regulatory approval to distribute and market CaPre® as a prescription drug in the U.S. Quintiles, the world’s largest provider of biopharmaceutical development and commercial outsourcing services, has been engaged to conduct the trial. The PK study is expected to start in the second quarter of calendar 2014 and results would be announced in the following quarter.

    http://www.acastipharma.com/en/investor-relations/press-releases/170-acasti-announces-third-quarter-results

    Thanks again for the great site

  46. steve says:

    ACST

    Patient recruitment for the Phase II TRIFECTA study, a randomized, double-blind, placebo-controlled trial is on-going and special focus is being given to recruiting patients in the moderate to severe hypertriglyceridemia population (triglyceride levels over 500 mg/dL). The Corporation continues to aim for trial completion by the first half of calendar 2014

    http://www.acastipharma.com/en/investor-relations/press-releases/170-acasti-announces-third-quarter-results

    This was the main trial I wanted to link to for ACST the PK study hasn’t started yet

  47. steve says:

    Sorry about all the duplicate posts. Thanks again

  48. Alex says:

    Hi there,
    I didn’t see ADMP (newly listed to nasdaq from otc). ADAMIS PHARMACEUTICALS has NDA filing for their Epinephrine syringe.
    From report released by CRT capital group few days ago here:

    • In Q1 2014, Adamis plans on filing its epinephrine pre-filled syringe to the FDA via the 505(b)(2) pathway. The Company expects to hear back on an approval decision by late 2014/early 2015. Adamis is partnered with Catalent, who is the contract manufacturer.

    • By mid-2014, Adamis plans to conduct a small, 80-patient study with its Taper Dry owder Inhaler (DPI) for treatment of COPD/asthma. We believe the main purpose of this trial will be to demonstrate the comparable efficacy profile of its recently acquired inhaler vs. GSK’s Advair (the “gold standard” product in the market). We believe this trial could be completed by Q4’14. Adamis will be supplied the product by 3M. ”

    if you can update this that would be great.

    Thank you

    Alex

    • admin says:

      Thanks ALex,

      I’ve added the NDA filing to the FDA Calendar and APC 1000/3000 to the Company Pipeline database as per information from their SEC filings.

  49. Grant Payne says:

    Hi there,
    I noticed that there is only one upcoming event due end of 2014 for CYTR coming up.
    But I know that, or at least believe, there were other events due in Sept 2014 for a PIII data read out.
    Also, they are supposed to be presenting at ASCO this June, unless they canceled that. But that’d be new to me.

    Can you say whether or not you’ve updated events coming up for CYTR lately, and if so removed some?

    Thanks so much for the great site!!!

    • admin says:

      Hi Grant,

      Currently CYTR do not have any candidates in Phase 3 development. A Phase 3 trial of aldoxorubicin is scheduled to commence this quarter. I keep a record of previous entries and I can say that since late December I haven’t removed any CYTR events. Prior to that, I can’t say for certain as I don’t have those records prior to late Dec 2013. They have a corporate presentation on Monday so they might give an update then.

      As for ASCO, I generally have a seperate ASCO Calendar and will try and place events there. FYI, last year’s is here http://www.biopharmcatalyst.com/asco2013/

      I track about 250 companies so there will always be some catalysts I miss out so am happy to add them if official sources are provided.

      Hope that helps.

  50. John says:

    Wasn’t there an FDA decision for CHTP in mid January? I notice the calendar shows an event on 02/12/14. Just curious, great info here.

    • admin says:

      Hi John,

      The mid-January event was a FDA Advisory Committee meeting where a panel of experts were asked to give their opinion on NORTHERA. The committee returned an overwhelming positive opinion. The FDA now have to make a final decision whether to approve NORTHERA or not. They will take into account the Advisory Committee positive opinion. While they usually make a decision in line with the opinion given by the advisory committee, the FDA do not necessarily need to do so.

      By the way, the FDA decision date (PDUFA) is February 14 (not Feb 12).

  51. Ouwen says:

    It is a good website to give updated information on FDA and phase trials. However, for historical information I can only see FDA approval history while no phase trials’ results, where can I find it? Thanks

  52. Michael says:

    Hi Admin, Love the site and use it frequently!Would you by chance know how long the FDA has to respond/review IGXT response for CRL of migraine film? IGXT submitted it March 3 and I have tried to find this information with no luck. The best I could determine its either 60 days or 6 months, but any help on this would be greatly appreciated!
    Michael

    • admin says:

      Hi Michael,

      For a resubmission, the FDA should announce a new PDUFA date 2-4 weeks following the resubmission, so you should hear back by the end of the month. The new PDUFA date would be 2-6 months following the resubmission, depending on the type of review.

      Regards,
      Adam

  53. Paul says:

    Hi Admin.

    I wonder if you have any data, or even a gut feel, for how often the FDA makes a decision BEFORE the PDUFA date that they’ve announced. Is an early decision rare? I’m thinking specifically of MNKD, who had a very positive Advisory Committee meeting on 4/1/14, prior to a scheduled PDUFA date of 4/15. The FDA just moved this back 90 days to 7/15. Speculation is that they weren’t expecting a positive Adcom and are now scrambling, although the official announcement is time to analyze more data. I’m just wondering if under circumstances like this, you’ve seen the FDA not use all their extension time, or whether the tendency is to take it all. Thanks!

    Paul

    • admin says:

      Hi Paul,

      Apologies about the delay in getting back to you. Yes, I’m sure the FDA weren’t expecting the Adcom result

      Yes, there are times when the FDA do not use all of their extension time, for example UTHR in late 2013, but there are also times when they use all of it. I would say that it is more common for the FDA to use the entire three months (eg VVUS in 2012.).

      I can’t think of a time when the FDA were so negative with their briefing notes but the Adcom issued a positive vote, COUPLED with the fact that the Adcom date was so close to the PDUFA date, so it’s difficult to compare the current situation with those cases listed above.

      Regards,

      Adam

  54. DrSeattle says:

    Hi, This is wonderful website!
    Question:
    When do FDA aspect to decide on APPY approval?

  55. SurfingKook says:

    Where is rxii?

  56. G.M. says:

    Hi Admin,
    I have a new catalyst to add to your calendar. These two companies are working in partnership (Intelgenx (IGXT) and RedHill Biopharma (RDHL)) and are expected to produce results of a comparative bioavailability clinical study of their anti-migraine VersaFilm by June 2014. I hope that you can help maintain the good work you are doing, and as always happy to donate to your hard work!!!
    http://www.intelgenx.com/investors/pressreleases/2014/2014-04-28.html

    G.M.

  57. taswell thompson says:

    Hey, Im looking for any new info for POZN ?

    • admin says:

      Thank you for your enquiry. Unfortunately, I’m not aware of any new information regarding their manufacturing issues following their recent CRL.

      Regards,

      Adam

  58. Andrew Downs says:

    Any chance in getting any data on ISR?

    • admin says:

      Andrew,

      I just came across ISR yesterday.It looks like that they don’t go through Phase 1-3 testing (from what I’ve just briefly read over the last few minutes) so if this is the case it won’t be covered here. If I’ve read this incorrectly then please let me know and I’ll look into it further.

  59. Andrew Downs says:

    Thanks for the feedback!
    I have one more of interest if you have any data on ONCS

  60. Andrew Downs says:

    IDRA is another of interest for many

  61. Andrew Downs says:

    *DJ BioLine RX Says Upcoming Efficacy Study Expected to Commence in Early 2015 >BLRX

  62. ZIGGY says:

    I try to find info about FDA approval for LPCN1021

    • admin says:

      Ziggy,

      Lipocine Inc and LPCN1021 have been added to the database. Phase 3 data are due this quarter. Assuming positive data a NDA filing will be submitted in 2H 2015, which would result in a FDA Approval (PDUFA) date in 2H 2016.

  63. ZIGGY says:

    Thank you very much.
    I am watching it very close, see what happen than

  64. ZIGGY says:

    What about nbs? Do you have any data when they will get fda approved?

  65. ZIGGY says:

    would you please explain what is “NDA Filling” and “PDUFA” – I’m kind of new in this bio topic.
    Thanks

    • admin says:

      Apologies about the delay in getting back to you.

      An NDA filing is when a company submits an application for a new drug to be approved. About a couple months after the FDA receives the NDA filing they will set a PDUFA date. The PDUFA is the date when the FDA will issue a decision whether to approve the drug, or not.

  66. Vincent Ippolito says:

    Hi there, I was just inquiring if there is a way I can access the FDA Calendar with the Catalyst Due Date fro previous years rather than only the PDUFA?

    Thank you.

  67. ric says:

    ADAM
    thanks for putting all the hard work you do to keep us updated on new developments in the bio tech industry. I am curious to know how people use this site and interpret whats on your site to make a decision if a stock is a good one to invest or not. Are there other criteria that people look at to make the decision to invest in or not and what would those criteria be if any. Is it multiple news clips, volume, technical analysis of the stock
    what prompts people to jump in or not
    this would be helpful for all beginners

  68. Tony says:

    Admin, remember to add GTHP in the list of upcoming PMA Approvals (January 24, 2015). According to GTHP “We also are anxiously awaiting word from the FDA on our PMA Amendment, which, based on FDA guidelines, could be received by January 24, 2015 or sooner.” (source: http://www.guidedinc.com)

  69. FarmaZutical says:

    Hi, Thanks a lot for your comprehensive list. Good job.

    I want to bring your attention to one of the most promising biotechs I have ever come across. It’s on the OTC and therefore not on your watchlist. But they are looking to uplist in the very near future and I think you would be glad that you invested a few hours on dd at this stage even though they are not on a major excange yet.

    Cellceutix, CTIX, recently published topline results for their breakthrough antibiotic, Brilacidin, and one single dose was found to be equivalent to 7 days of Daptomycin for ABSSSI. Brilacidin is based on a new platform for antibiotics called Defensin Mimetics and the big scoop is that there is close to zero % risk of developing resistance. Hence, this could be the sollution to the superbug problem the World is facing.

    FDA issued a QIDP designation to Brilacidin last week and the company is discussing Phase 3 protocols with FDA probably as I write this to you.

    But Brilacidin is not the only compound in the pipeline. Kevetrin is an anti cancer drug currently in Phase 1 at the Dana Farber Institute under Harvard Uni. Kevetrin activates P53 known as the guardian angel of the genome. The trial is almost fisnished with patients now advancing into cohort 10. Another big catalyst this month.

    So Cellceutic might not fit your Nasdaq requirements but it will soon. And the pipeline is one of the most interesting I have ever seen, so I would certainly find it worthy of a place on your list.

    All best and happy hollidays,
    Farma

  70. Andrew Downs says:

    Anyone have any thoughts or dates for AEMD?
    http://finance.yahoo.com/news/zacks-upgrades-aemd-buy-130000386.html

  71. Chris Hamilton says:

    One I don’t see here is CLDX. Its study completion date is estimated for June 2015 according to clinicaltrials https://clinicaltrials.gov/ct2/show/NCT01498328?term=rindopepimut&rank=1.

    • admin says:

      Chris,

      Thank you for your enquiry. I understand the guidance given by clinicaltrials.gov but in order for the trial to be added to the FDA Calendar the company needs to issue a SEC filing or PR stating that they intend to release data in June. I haven’t seen such a PR but if I have missed it then feel free to send it through.

      Regards,

      Adam

  72. Andrew Downs says:

    Any info on BIOD?
    They are supposed to provide topline results from phase2a trial of BIOD-531 in Type 2 Diabeties in early January 2015

  73. Andrew Downs says:

    Keep an eye on IPCI
    Lots of new drugs in the pipeline!

  74. Evan says:

    EDAP PMA filing in April. Please add

    Thanks

    • admin says:

      Evan,

      In order for a catalyst to be added to the calendar a company PR with the expected CATALYST DATE is required. If you have such information it would be appreciated if you could send it through and I will add it to the calendar.

      Adam

  75. Allisondbl says:

    Wonderful site! Keep up the good work!

  76. Rob says:

    SRNE, Tribeca Cynviloq Study Results due in March 2015 as per article.

    http://finance.yahoo.com/news/sorrento-provides-status-cynviloq-registrational-140000313.html

  77. samuel says:

    Thank you for the updates. Is there anyway I can subscribe to the events in google calendar.

    • admin says:

      Thank you for your enquiry.

      Currently it’s not possible to subscribe to the FDA events in the google calendar. It might be possible in the future to link the PDUFA Calendar to Google but a decision hasn’t been made on that.

      Regards,

      Adam

  78. RC says:

    JAZZ/CNCE: JZP-386 data expected in Q2 2015. http://finance.yahoo.com/news/jazz-pharmaceuticals-concert-pharmaceuticals-jzp-133000623.html

    You’re welcome! Thank you! You rock! :D

  79. john says:

    PPHM have a shot?

  80. GB says:

    Noted that the calender states it Generally does not include large cap companies, when/why do you make exceptions to include large cap companies?

    • admin says:

      GB,

      There’s no single answer to that question but I’ll give it a go. I will update the description in the calendar.

      Yes, originally large cap companies were not included due to the sheer workload required to cover all of them and the fact that there is a limit to the number of companies that can fit into the database. However, coincidentally, just last week a decision was made to include PDUFA dates from as many companies as possible (to the best of my ability), including large cap companies so that is one reason why you will see some included.

      Some large cap companies (e.g. PCYC) were originally small cap when they were entered into the database and still remain so that’s one other reason.

      Also, coincidentally today, I added a few catalysts for AMGN, following their earnings report. I will be aiming to include more but as mentioned there is a limit in terms of the workload required and the number of entries that will fit into the database. If you’re wondering why I chose to add AMGN and not PFE/BMY who also reported yesterday, that’s simply because the catalysts were noted in the AMGN release, saving me time, but there was not a lot of detail regarding upcoming catalysts from the other two.

      Coverage of large cap companies is a work in progress. It’s not possible to include all of them but readers have requested that at least some coverage is given. There is no strict criteria as to which companies will make it into the database or not.

      Regards,

      Adam

  81. ziggy says:

    Not see in your list BNHLF, they have phase 3 completed.
    Thanks.

    • admin says:

      Ziggy,

      Thank you for your enquiry.

      I see that the stock concerned is listed on OTC. As noted on the FDA Calendar page, “Generally no OTC/PINK companies are listed unless the upcoming catalyst is a PDUFA or Advisory Committee event.” Once they have been assigned a PDUFA date following their BLA filing it’ll appear in the database.

      Regards,
      Admin

  82. Andrew Downs says:

    $BIOD Received feedback and guidance from FDA on pivotal trial design and toxicology requirements in support of NDA filing for BIOD-531; plans underway to initiate pre-clinical development studies required to initiate pivotal trials and Phase 2b multi-dose study in patients with type 2 diabetes in first half 2015

  83. Andrew Downs says:

    $CPXX catalysts are in their Quarterly and 8k, they have Phase 3 data due in Q2

  84. Vinod says:

    Admin: you are doing a great job. Keep it up. Thanks

  85. Evan says:

    EDAP has a PMA due by April 29th/15 for Ablatherm.

    It’s in the 6K on Nov.6th/14

    Can you add it to the FDA calendar please?

    Thanks

    • admin says:

      Evan,

      I read their PR

      “In order to continue the process, the Company must submit a major amendment, to include the additional information requested by the FDA, by April 29, 2015. This major amendment, which will have the same PMA number as the Company’s initial filing, may extend the FDA review period up to 180 days after submission.”

      This means that they need to submit some information by April 29. No PMA decision will occur on this day.

      Regards,

      Adam

  86. Jim says:

    Admin, Ocata Therapeutics (OCAT) was up-listed to NASDAQ on 26 Feb 2015. Please add OCAT to your tracking list. Thank you, Jim

  87. julia says:

    AAVL expects topline Ph 2a results in Wet AMD from AVA-101 in mid-2015..

  88. andre says:

    EBIO
    in Q2 of 2015
    will report top-line data for their pivotal Phase 3 clinical study for EBI-005 in pts with moderate to severe dry eye disease

    • andre says:

      from the press release:
      http://ir.elevenbio.com/releasedetail.cfm?ReleaseID=899847

      “”We completed patient enrollment in our pivotal Phase 3 clinical study for EBI-005 in patients with moderate to severe dry eye disease and expect to report top-line results from that study in the second quarter of 2015.”

      • admin says:

        Thanks Andre.

        I will wait until FGEN release their 4Q report so I have an up to date link to add to the database. I presume this will be within the next week or so.

        All other changes have been made. Regarding MRNS, I have used information from their PR a couple days ago which included guidance of Phase 3 ganaxolone data due in 1Q 2016.

  89. andre says:

    Hi
    ZFGN
    just reported data in the Phase 2 trial of beloranib, in patients with hypothalamic injury associated obesity (HIAO). You have it in the calendar for 12/31/2015

    Thank you for the great service!
    Andre

  90. andre says:

    FGEN
    FG-3019: Interim Ph 2 data in neoadjuvant pancreatic cancer (combo w/ gemcitabine and Abraxane)
    FG-3019: Phase 2 data from HBV-associated liver fibrosis

    Thanks
    –andre–

  91. andre says:

    MRNS
    you have Ph 3 for ganaxolone for 6/30/2015.
    However it is indicated for H2 of 2015

    Ph 2 data in PCDH19 female pediatric epilepsy in H1 of 2015

    thanks– andre–

  92. Fezz says:

    Halozyme (HALO) CEO said on 3/2 that she has a meeting “in weeks” and at the end of Q1- with the FDA to discuss a Phase 3 registration study on pegpH20- any word from the FDA?

    Thanks a lot!

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