FDA Calendar

Biotech Stock Catalyst and FDA Calendar for your biotech stock investing. Use our tools on your road to profit in the stock market. Biotech stocks with key binary events/catalysts - FDA Approval/PDUFA dates, Advisory Committee and Phase 2 & 3 trial data releases dates are noted. Refer to the FDA Calendar Glossary for a list of terms used in the FDA Decision Calendar and the Biotech Historical Catalyst Calendar for completed biotech stock catalysts.

NOTE: LARGE CAP CATALYSTS - generally only Phase 3 catalysts noted in company presentations and/or earnings releases are shown. Only NASDAQ and NYSE stocks are covered. 

The dates shown are provided by companies. A regulatory event, for example a PDUFA date or Advisory Committee Meeting, will be issued with an exact date by the FDA. However, most clinical release dates (i.e. Phase 1/2/3) are provided in a range format by companies (e.g, mid-2018 or 4Q 2018). Exact dates for clinical data releases are only rarely issued.

Click on the date for the source of the catalyst. Financial data are delayed 15-25 minutes.

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The public FDA Calendar is limited to 150 events in chronological order. The full calendar of approximately 800 events is available to PREMIUM MEMBERS.


Showing 150 drugs
Ticker
Price
Drug
Stage
Catalyst
Ticker Price Drug Stage Catalyst
MNK
$30.86
-0.57  -1.81%
MNK-812
Pain
PDUFA
Advisory Committee Meeting November 14, 2018 voted 10-7 recommending approval. PDUFA date November 16, 2018
VBIV
$1.79
-0.03  -1.65%
VBI-1901
Recurrent glioblastoma multiforme (rGBM)
Phase 1/2
Phase 1/2a initial data due to be presented November 16, 2018, 7:30pm CDT with 6-month PFS and OS data due 1H 2019.
RDHL
$7.90
-0.19  -2.35%
YELIVA
Refractory or relapsed multiple myeloma - cancer
Phase 1/2
Phase 1/2 poster presentation at EORTC-NCI-AACR November 16, 2018.
CLDX
$0.33
-0.01  -2.08%
Varlilumab and nivolumab
Solid tumors - cancer
Phase 2
Phase 1/2 data to be presented November 17, 2018 at the Society for Neuro-oncology (SNO) Meeting.
PULM
$0.42
+0.03  +8.41%
Pulmazole (PUR1900)
Allergic bronchopulmonary aspergillosis in patients with asthma.
Phase 1
Phase 2a trial to be initiated 4Q 2018. Phase 1/1b data to be presented November 17, 2018.
TCON
$1.30
+0.01  +0.78%
TRC102 and Temodar
Glioblastoma - cancer
Phase 2
Phase 2 data at Society for Neuro-Oncology annual meeting in November 18, 2018.
LOXO
$156.52
+4.99  +3.29%
Larotrectinib (LOXO-101)
Solid tumors that harbor a TRK fusion.
PDUFA priority review
PDUFA date under priority review November 26, 2018.
CPRX
$3.09
+0.21  +7.29%
Firdapse
Lambert-Easton Myasthenic Syndrome (LEMS)
PDUFA priority review
Refusal to file letter reported on February 17, 2016. NDA resubmitted with new PDUFA date under priority review of November 28, 2018.
ONCS
$0.81
+0.01  +1.24%
OMS-100
Melanoma
Phase 2
11/30/2018 4:50 PM CEST
Phase 2 data to be presented November 30, 2018; 4:50 PM CEST.
HSGX
$0.45
+0.01  +1.39%
NeoCart
Cartilage defects in the knee
Phase 3
Phase 3 data released September 5, 2018. Primary endpoint not met. Update regarding possibility of filing BLA expected by end of November, 2018.
CBIO
$10.96
+0.2  +1.86%
Marzeptacog alfa
Hemophilia
Phase 2/3
Phase 2 data due at ASH December 1, 2018 6:15pm PT.
KPTI
$11.16
+0.16  +1.45%
Selinexor - SADAL
Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)
Phase 2b
Phase 2b top-line data due at ASH December 1, 2018; 6:15pm.
BPTH
$0.45
+0.03  +7.91%
Prexigebersen - BP1001
Acute myeloid leukemia (AML)
Phase 2
Phase 2 presentation at ASH December 1, 2018, 6:15 PM.
BLCM
$4.29
-0.2  -4.45%
BPX-501
Adjunct T-cell therapy administered after allogeneic HSCT - (hematopoietic stem cell transplantation) - cancer
Phase 1/2
Clinical hold announced January 30, 2018. Announced April 11, 2018 that hold has been lifted. Additional interim data due at ASH December 1, 2018, 6:15pm with final data due 2019.
MOR
$28.60
+0.76  +2.73%
MOR202
Multiple Myeloma (MM)
Phase 1/2
Phase 2 final data due at ASH December 1, 2018, 12pm. However, further development will not be pursued.
UMRX
$8.06
+0.06  +0.75%
ACTR087 + SEA-BCMA
Multiple Myeloma
Phase 1
Phase 1 initial data due at ASH December 1, 2018 6:15pm.
MOR
$28.60
+0.76  +2.73%
Lenalidomide + MOR208 - L-MIND
Relapsed or refractory diffuse large B cell lymphoma
Phase 2
Phase 2 data due at ASH December 1, 2018, 4pm PST with final data due mid-2019.
AMGN
$194.18
+1.73  +0.90%
AMG 330
Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
Phase 1
Phase 1 data at ASH December 1, 2018 7:30 a.m.
BGNE
$127.02
+0.02  +0.02%
Zanubrutinib (BGB-3111)
Relapsed or refractory mantle cell lymphoma (MCL)
Phase 2
Phase 2 data to be presented at ASH December 1, 2018, 12:45pm PT.
XLRN
$52.23
+1.57  +3.10%
Luspatercept - BELIEVE
b -thalassemia
Phase 3
Phase 3 data released July 9, 2018. Primary and key secondary endpoints met. Data to be presented at ASH December 1, 2018, 3pm.
CELG
$69.65
-0.33  -0.47%
Luspatercept - BELIEVE
b -thalassemia
Phase 3
Phase 3 data released July 9, 2018. Primary and key secondary endpoints met. Data to be presented at ASH December 1, 2018, 3pm.
ONTX
$4.38
+0.13  +3.06%
Oral Rigosertib and azacitidine
First-line HR-MDS (high risk myelodysplastic syndromes)
Phase 2
Phase 3 trial planned for 2H 2018. Phase 2 data to be presented at ASH December 1, 2018: 4:00 PM.
IMGN
$5.98
+0.15  +2.57%
IMGN779
Relapsed/refractory acute myeloid leukemia (AML)
Phase 1
Phase 1 additional data due at ASH December 1, 2018, 7:45am PST.
AFMD
$4.26
+0.13  +3.15%
AFM13 with Keytruda
Hodgkin Lymphoma - Cancer
Phase 1b
Phase 1b updated data due at ASH December 1, 2018 6:15 PM.
XENE
$8.47
+0.19  +2.29%
XEN1101
Epilepsy
Phase 1
Phase 1 data to be presented at AES November 30 - December 4, 2018.
XENE
$8.47
+0.19  +2.29%
XEN901
Healthy Volunteers
Phase 1
Phase 1 final data due at AES November 30 - December 4, 2018.
ALRN
$2.17
-0.08  -3.56%
ALRN-6924
Peripheral T-cell lymphoma (PTCL)
Phase 2a
Phase 2a interim data due at ASH December 1, 2018: 6:15 PM.
FATE
$12.70
+0.11  +0.87%
ProTmune - PROTECT
Acute graft-versus-host disease (GvHD) undergoing hematopoietic cell transplantation (HCT)
Phase 1/2
Phase 2 efficacy part of trial has been initiated - noted September 18, 2017. Updated Phase 1 data due at ASH December 1, 2018, 6:15 PM.
STML
$11.39
+0.02  +0.18%
SL-401
High Risk Myeloproliferative Neoplasms
Phase 2
Phase 1/2 data to be presented at ASH December 1, 2018 6:15 PM.
TRIL
$2.90
+0.07  +2.47%
TTI-621-02
Solid tumors
Phase 1
Phase 1 update at ASH December 1, 2018, 6:15 PM.
SYRS
$8.16
+0.26  +3.29%
SY-1425
Relapsed or refractory Acute myeloid leukemia (AML) and relapsed high-risk Myelodysplastic Syndrome (MDS) - cancer
Phase 2
Phase 2 initial data from combination arms due at ASH December 2, 2018, 6pm PT.
MGTA
$7.77
+0.6  +8.37%
MGTA-456
Inherited Metabolic Disorders (IMD)
Phase 2
Phase 2 initial data to be presented at ASH December 2, 2018 6pm PT.
UMRX
$8.06
+0.06  +0.75%
ACTR707 + rituximab (ATTCK-20-03)
CD20+ Non-Hodgkin Lymphoma (NHL)
Phase 1
Phase 1 initial data to be presented at ASH December 2, 2018 6pm.
APLS
$15.09
+0.63  +4.36%
APL-2 PADDOCK
Paroxysmal Nocturnal Hemoglobinuria
Phase 1
Phase 1 updated data due at ASH December 2, 2018 6:00 PM.
INCY
$66.51
+1.48  +2.28%
INCB50465 and ruxolitinib
Myelofibrosis
Phase 2
Phase 2 data due at ASH December 2, 2018, 9:30am.
BLUE
$125.34
+2.56  +2.08%
bb21217
Multiple Myeloma
Phase 1
Phase 1 initial data at ASH December 2, 2018, 4:45 PT.
CELG
$69.65
-0.33  -0.47%
bb21217
Multiple Myeloma
Phase 1
Phase 1 initial data at ASH December 2, 2018, 4:45 PT.
AUTL
$34.99
-0.72  -2.02%
AUTO3
Relapsed or refractory diffuse large B-celllymphoma (DLBCL)
Phase 1/2
Phase 1/2 trial initiated 3Q 2017. Phase 1 data to be presented at ASH December 2, 2018.
BPMC
$55.25
+2.99  +5.72%
Avapritnib BLU-285 - EXPLORER
Advanced Systemic mastocytosis (SM)
Phase 1
Phase 1 updated data due at EHA June 15, 2018. ORR 83%. Further update due at ASH December 2, 2018: 9:30 AM.
CELG
$69.65
-0.33  -0.47%
REVLIMID - AUGMENT
Relapsed or Refractory Follicular Lymphoma
Phase 3
Phase 3 data released July 23, 2018. Primary endpoint met. Regulatory filing due 1Q 2019. Data to be presented at ASH December. 2, 2018, 4:30 p.m
XLRN
$52.23
+1.57  +3.10%
Luspatercept - MEDALIST
Myelodysplastic syndromes (MDS) cancer
Phase 3
Phase 3 trial met primary endpoint - June 28, 2018. Data to be presented at ASH December 2, 2018: 2:00 PM.
CELG
$69.65
-0.33  -0.47%
Luspatercept - MEDALIST
Myelodysplastic syndromes (MDS) cancer
Phase 3
Phase 3 trial met primary endpoint - June 28, 2018. Data to be presented at ASH December 2, 2018: 2:00 PM.
NLNK
$1.88
-0.21  -10.05%
Indoximod plus standard-of-care chemotherapy
Acute myeloid leukemia (AML)
Phase 1b
Phase 1b data to be presented at ASH December 2, 2018, 9:30am.
IMGN
$5.98
+0.15  +2.57%
IMGN632
Acute Myeloid Leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN)
Phase 1
Phase 1 additional data due at ASH December 2, 2018, 6pm PT.
CELG
$69.65
-0.33  -0.47%
Liso-cel (JCAR017) - TRANSCEND CLL-004
Chronic Lymphocytic Leukemia (CLL)
Phase 1
Phase 1 trial initiated 1Q 2018. Data due at ASH December. 2, 2018 8:45 a.m.
AFMD
$4.26
+0.13  +3.15%
AFM13
CD30-positive lymphoma
Phase 1/2
Phase 1b/2a updated data due at ASH December 2, 2018 6:00 PM.
MEIP
$3.03
-0.04  -1.30%
ME-401
Relapsed/refractory Follicular Lymphoma/Chronic Lymphocytic Leukemia (CLL)
Phase 1b
Phase 1b updated data at ASH December 2, 2018, 6:00 p.m PT.
APLS
$15.09
+0.63  +4.36%
APL-2 PHAROAH
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Phase 1b
Phase 1b update due at ASH December 2, 2018: 6:00 PM.
MGEN
$3.48
+0.13  +3.88%
Cobomarsen MRG-106
Chronic Lymphocytic Leukemia (CLL); Diffuse Large B-Cell Lymphoma (DLBCL); Cutaneous T-cell Lymphoma (CTCL)
Phase 1
Phase 1 data to be presented at ASH December 2, 2018 6pm.
SNSS
$1.23
-0.02  -1.60%
SNS-062
Advanced B-Cell Malignancies
Phase 1/2
Phase 1/2 safety/PK update at ASH December 2, 2018, 6:00 PM.
ONCE
$39.17
+0.17  +0.44%
SPK-8011
Hemophilia A
Phase 1/2
Phase 1/2 data updated data due at ASH December 2, 2018: 4:30 PM.
ARGX
$93.23
+1.4  +1.52%
ARGX-110
Acute myeloid leukemia (AML)
Phase 1
Phase 1/2 data at ASH December 2, 2018, 6:00 PM.
KURA
$12.37
+0.43  +3.60%
Tipifarnib
Relapsed or refractory peripheral T-cell lymphoma
Phase 2
Preliminary data at ASH December 2, 2018 6pm.
GLYC
$11.95
+0.31  +2.66%
Uproleselan (GMI-1271)
Acute myeloid leukemia (AML) newly diagnosed and refractory - cancer
Phase 1/2
Phase 1/2 data to be presented at ASH December 2, 2018 9:30 AM PST.
GILD
$69.20
-0.58  -0.83%
Yescarta (axicabtagene ciloleucel)
Refractory Non-Hodgkin's Lymphoma (NHL) - cancer
Phase 2
Approved October 18, 2017. 2-year data due at ASH December 2, 2018 6pm.
BLUE
$125.34
+2.56  +2.08%
LentiGlobin - HGB-212 Northstar-3
TDT and the β0/β0genotype
Phase 3
Phase 3 first patient treated - noted November 16, 2017. Data due at ASH December 3, 2018: 6:15 PM.
CYAD
$27.00
+0.34  +1.28%
CYAD-01 - THINK
Various cancers - solid and hematologic cancers
Phase 1/2
Phase 1 updated data due at ASH December 3, 2018, 4:45 p.m PT.
CLLS
$22.00
-0.51  -2.27%
UCART19 (PALL)
Acute lymphoblastic leukemia (ALL)
Phase 1
Phase 1 update at ASH December 3, 2018, 4:30pm.
ALLO
$27.98
+1.05  +3.90%
UCART19 (PALL)
Acute lymphoblastic leukemia (ALL)
Phase 1
Phase 1 update at ASH December 3, 2018, 4:30pm.
BGNE
$127.02
+0.02  +0.02%
Tislelizumab - BGB-A317
Relapsed or refractory classical Hodgkin lymphoma (cHL)
Phase 2
Phase 2 pivotal preliminary data released July 23, 2018. ORR 73%, CR 50%. Presentation at ASH December 3, 2018 11:15am PT.
ATNM
$0.46
-0.02  -3.75%
Iomab-B
Hematopoietic Stem Cells Transplantation
Phase 3
Phase 3 initiated June 2016. Enrollment to be completed in 2019. Initial data due at ASH December 3, 2018.
GBT
$36.31
-0.34  -0.93%
GBT440 - HOPE
Sickle cell disease in adults
Phase 3
Phase 3 Part A data released June 27, 2018. Primary endpoint met. Further data due at ASH December 3 7am PT.
BLUE
$125.34
+2.56  +2.08%
LentiGlobin - HGB-206
Sickle disease
Phase 1/2
Data due at ASH December 3, 2018, 7:30 PT.
MOR
$28.60
+0.76  +2.73%
MOR208 + idelalisib (COSMOS)
Chronic Lymphocytic Leukemia
Phase 2
Phase 2 data due at ASH December 3, 2018, 6pm PST.
SRRA
$1.71
+0.05  +3.01%
Momelotinib
Myelofibrosis
Phase 2
Phase 2 presentation at ASH December 3, 2018, 6:00 PM
AGIO
$69.64
+2.37  +3.52%
Ivosidenib
Acute Myeloid Leukemia (AML)
Phase 1
Phase 1 data to be presented at ASH December 3, 2018 at 7:30 a.m. PST.
AMGN
$194.18
+1.73  +0.90%
AMG 420
Relapsed. Refractory (R/R) Multiple Myeloma (MM)
Phase 1
Phase 1 data at ASH December 3, 2018 6:30 p.m. PT
KDMN
$2.62
+0.05  +1.95%
KD025 - ROCKstar (KD025-213)
Chronic graft-versus-host disease (cGVHD)
Phase 2
Phase 2 pivotal trial initiation announced October 25, 2018. Updated data from earlier trial due at ASH December 3, 2018, 7:00am.
TROV
$0.76
-0.01  -1.31%
Onvansertib (PCM-075)
Acute Myeloid Leukemia (AML)
Phase 1/2
Phase 1/2 update at ASH December 3, 2018; 6:00 PM.
INCY
$66.51
+1.48  +2.28%
INCB54828 (FIGHT-203)
MPN (Myeloproliferative Neoplasms)
Phase 2
Phase 2 interim data due at ASH December 3, 2018, 10:30am.
APLS
$15.09
+0.63  +4.36%
APL-2 subcutaneous
Auto-immune Hemolytic Anemia (AIHA)
Phase 2
Phase 2 monotherapy data due at ASH December 3, 2018: 6:00 PM.
BLUE
$125.34
+2.56  +2.08%
LentiGlobin - HGB-207 Northstar-2
non-β0/β0 transfusion-dependent thalassemia (TDT)
Phase 3
Data due at ASH December 3, 2018, 7:15 – 7:30 p.m. PST.
MGNX
$17.51
+0.03  +0.17%
Flotetuzumab
AML/MDS
Phase 1
Phase 1 interim data released at ASH December 3, 2018: 2:45 PM.
PTLA
$20.00
-0.2  -0.99%
Cerdulatinib (PRT2070)
Refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia - cancer
Phase 2
Phase 2 updated data due at ASH December 3, 2018 at 7:15 p.m. PST.
AGIO
$69.64
+2.37  +3.52%
Ivosidenib or enasidenib
Frontline AML with IDH1 or IDH2 mutation
Phase 1
Phase 1 updated data at ASH December 3, 2018 at 7:15 a.m. PST. Phase 3 trial to be initiated 4Q 2018.
CELG
$69.65
-0.33  -0.47%
JCARH125 - EVOLVE
Multiple myeloma
Phase 1
Phase 1 trial initiated 1Q 2018. Data due at ASH December. 3, 2018 5:00 p.m PT.
ALRN
$2.17
-0.08  -3.56%
ALRN-6924
Acute myeloid leukemia (AML); Myelodysplastic syndrome (MDS)
Phase 1b
Phase 1/1b interim data due at ASH December 3, 2018: 6:00 PM.
ALXN
$118.62
-1.06  -0.89%
ALXN1210
Paroxysmal nocturnal hemoglobinuria (PNH)
PDUFA priority review
PDUFA 02/18/2019; ASH 12/3/2018
PDUFA date under priority review February 18, 2019. Presentation at ASH December 3, 2018, 11:00am PT.
INCY
$66.51
+1.48  +2.28%
Ruxolitinib
Graft versus host disease
PDUFA priority review
ASH 12/03/2018; PDUFA 1Q 2019
PDUFA date under priority review estimated 1Q 2019. Presentation at ASH December 3, 2018, 7:00am.
NVS
$87.75
+0.51  +0.58%
Ruxolitinib
Graft versus host disease
PDUFA priority review
ASH 12/03/2018; PDUFA 1Q 2019
PDUFA date under priority review estimated 1Q 2019. Presentation at ASH December 3, 2018, 7:00am.
ARGX
$93.23
+1.4  +1.52%
ARGX-113
Immune thrombocytopenia (ITP)
Phase 2
Phase 3 trial to be initiated 2H 2019. Phase 2 full data due at ASH December 3, 2018.
GBT
$36.31
-0.34  -0.93%
GBT440 HOPE-KIDS 1
Sickle cell disease - children age 6-17.
Phase 2a
Phase 2 data to be presented at ASH December 3, 2018 8am PT.
ATRA
$37.28
+1.43  +3.99%
ATA 129
Epstein-Barr virus (EBV-PTLD)
Phase 2
Phase 2 presentation at ASH December 3, 2018 6:00 pm.
GILD
$69.20
-0.58  -0.83%
Axicabtagene ciloleucel - KTE-C19 (ZUMA-3)
Adult patients with r/r ALL - cancer
Phase 1/2
Phase 2 pivotal trial initiated 4Q 2018. Phase 1 updated data at ASH December 3, 2018 5pm.
RHHBY
$31.40
+0.39  +1.26%
TECENTRIQ (atezolizumab) - IMpower150
Non-squamous non-small cell lung cancer (NSCLC)
Phase 3
PDUFA date extended by three months to December 05, 2018.
GTHX
$41.35
-0.46  -1.10%
Trilaciclib
Triple-negative breast cancer
Phase 2
Phase 2 preliminary data due at San Antonio Breast Cancer Symposium on December 5, 2018. 5pm.
IMGN
$5.98
+0.15  +2.57%
Kadcyla (KATHERINE).
HER2-positive breast cancer - residual invasive disease
Phase 3
Phase 3 data released October 15, 2018 met primary endpoint. Full data to be presented at the San Antonio Breast Cancer Symposium December 5, 2018, 11.00 am CST.
RHHBY
$31.40
+0.39  +1.26%
Kadcyla (KATHERINE).
HER2-positive breast cancer - residual invasive disease
Phase 3
Phase 3 data released October 15, 2018 met primary endpoint. Full data to be presented at the San Antonio Breast Cancer Symposium December 5, 2018, 11.00 am CST.
DNLI
$19.23
+0.45  +2.40%
DNL747
Alzheimer’s disease
Phase 1
Phase 1 data to be presented December 10, 2018.
BLCM
$4.29
-0.2  -4.45%
BPX-601
Pancreatic cancer
Phase 1
ESMO Immuno December 2018
Phase 1 initial data due at ESMO Immuno-Oncology December 13-16, 2018.
APLS
$15.09
+0.63  +4.36%
APL-2
Geographic atrophy (GA) associated with age-related macular degeneration (AMD)
Phase 3
1H December 2018
Phase 3 enrollment has temporarily halted due to non-infectious inflammation in patients. Update due 1H December 2018.
IDRA
$7.48
+0.01  +0.13%
Tilsotolimod + ipilimumab - ILLUMINATE 204
Cancer - melanoma
Phase 2
1H December 2018
Phase 2 data update 1H December 2018.
ACHN
$2.88
+0.16  +5.88%
ACH-4471
C3 glomerulopathy (C3G)
Phase 2
Phase 2 interim data due December 17, 2018.
ACHN
$2.88
+0.16  +5.88%
ACH-4471
Paroxysmal nocturnal hemoglobinuria (PNH)
Phase 2
Phase 2 interim data due December 17, 2018.
ACHN
$2.88
+0.16  +5.88%
ACH-5228
Healthy volunteers
Phase 1
Phase 1 interim data due December 17, 2018.
ACHN
$2.88
+0.16  +5.88%
ACH-5548
Healthy volunteers
Phase 1
Phase 1 interim data due December 17, 2018.
ADMA
$5.15
+0.12  +2.39%
BIVIGAM
Primary humoral immunodeficiency
PDUFA
PDUFA date delayed two months to December 18, 2018.
SAGE
$114.21
+2.33  +2.08%
Brexanolone - SAGE-547 (202C)
Postpartum Depression - moderate
PDUFA priority review
PDUFA date December 19, 2018 under priority review. Advisory Committee meeting November 2, 2018 voted 17-1 recommending approval.
JAZZ
$142.80
-0.86  -0.60%
JZP-110
Excessive sleepiness associated with narcolepsy
PDUFA
PDUFA date December 20, 2018.
SUPN
$43.93
+0.82  +1.90%
Oxtellar XR
Epilepsy
PDUFA
December 2018
sNDA to expand label to include monotherapy treatment. PDUFA date by the end of December 2018. NO EXACT DATE GIVEN.
RHHBY
$31.40
+0.39  +1.26%
Baloxavir marboxil
Influenza
PDUFA priority review
PDUFA date under priority review December 24, 2018.
ABBV
$91.53
+1.39  +1.54%
Venclexta
First line unfit AML
PDUFA priority review
PDUFA date December 25, 2018.
RHHBY
$31.40
+0.39  +1.26%
Venclexta
First line unfit AML
PDUFA priority review
PDUFA date December 25, 2018.
PFE
$43.51
+0.3  +0.69%
Glasdegib
Acute myeloid leukemia (AML)
PDUFA priority review
PDUFA data under priority review December 2018. No exact date given. Estimate December 27, 2018.
OCUL
$5.32
-0.02  -0.37%
DEXTENZA
Ocular inflammation and pain following cataract surgery
PDUFA
CRL July 25 2016 - due to manufacturing deficiencies and July 2017. NDA resubmitted with new PDUFA date December 28, 2018.
MRK
$76.06
+1.22  +1.63%
Keytruda KN-17
Merkel Cell Carcinoma
PDUFA priority review
PDUFA date under priority review for sBLA December 28, 2018.
BMY
$54.07
+0.8  +1.50%
Sprycel (dasatinib)
Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
PDUFA
PDUFA date for sBLA December 29, 2018.
CASI
$4.10
+0.58  +16.48%
ENMD-2076
Cancer - fibrolamellar carcinoma (FLC)
Phase 2
2018
Phase 2 initiated October 2015. Data due 2018.
PRNB
$25.41
+0.36  +1.44%
PRN1008
Pemphigus vulgaris (PV)
Phase 2
YE 2018
Phase 2 final data due by the end of 2018. Phase 3 trial to be initiated by the end of 2018.
ATHX
$2.01
+0.12  +6.35%
Multistem
Acute Respiratory Distress Syndrome
Phase 1/2
2018
Phase 1/2 trial to be completed in 2018.
DVAX
$12.27
+0.24  +2.00%
SD-101
Low-grade, B cell lymphoma
Phase 1/2
2H 2018
Phase 1/2 updated data due 2H 2018 with Phase 3 trial to be initiated YE 2018.
BYSI
$21.30
-0.2  -0.93%
Plinabulin (Trial 105)
Chemotherapy-induced neutropenia (CIN)
Phase 2/3
4Q 2018
Phase 3 interim data due 4Q 2018.
VNDA
$23.88
+0.05  +0.21%
Tradipitant
Gastroparesis
Phase 2
YE 2018
Phase 2 data due by end of 2018.
GILD
$69.20
-0.58  -0.83%
GS-9674
Primary biliary cholangitis
Phase 2
4Q 2018
Phase 2 data due 4Q 2018.
CYCC
$1.10
+0.05  +4.76%
CYC065
Advanced cancers
Phase 1
2018
Phase 1 trial presented at AACR April 15, 2018. Updated data due 2018.
MRNS
$4.46
-0.09  -1.98%
Ganaxolone
Refractory status epilepticus (RSE)
Phase 2
4Q 2018
Phase 2 data due 4Q 2018.
MRNS
$4.46
-0.09  -1.98%
Ganaxolone
Postpartum depression
Phase 2
4Q 2018
Phase 2 data due 4Q 2018.
KMDA
$5.32
+0.02  +0.38%
Alpha-1 antitrypsin (AAT)
Prevention of lung transplant rejection
Phase 1/2
2H 2018
Phase 2 initiated April 2016. Interim analysis 2H 2018. Top-line data due 2H 2019.
AGLE
$8.31
+0.24  +2.97%
AEB1102 + KEYTRUDA
Small cell lung cancer (SCLC)
Phase 1/2
4Q 2018.
Phase 1/2 top-line safety and clinical data due 4Q 2018.
CBIO
$10.96
+0.2  +1.86%
CB 2679d/ ISU304
Hemophilia B
Phase 1/2
December 2018
Cohort 6 patients (2) safety concerns - presence of neutralizing antibodies - noted June 18, 2018. Additional data due December 2018.
FPRX
$11.88
+0.31  +2.68%
Cabiralizumab (FPA008) and Opdivo (nivolumab)
Solid tumors
Phase 1b
2H 2018
Phase 1b update due 2H 2018.
AGLE
$8.31
+0.24  +2.97%
AEB1102
Solid tumors
Phase 1
4Q 2018
Monotherapy data due 4Q 2018.
TOCA
$12.39
+0.05  +0.41%
Toca 511 (Toca 6)
Solid tumors
Phase 1b
2018
Phase 1b updates due 2018 and 2019.
ONCS
$0.81
+0.01  +1.24%
ImmunoPulse IL12
Triple Negative Breast Cancer (TNBC)
Phase 1
2H 2018
Phase 1 top-line data due 2H 2018.
RHHBY
$31.40
+0.39  +1.26%
Actemra
Systemic sclerosis
Phase 3
2H 2018
Phase 3 data due 2H 2018.
CLLS
$22.00
-0.51  -2.27%
UCART19 - CALM
Refractory B-cell Acute Lymphoblastic Leukaemia
Phase 1
Late 2018
Phase 1 interim data update likely late 2018.
ALLO
$27.98
+1.05  +3.90%
UCART19 - CALM
Refractory B-cell Acute Lymphoblastic Leukaemia
Phase 1
Late 2018
Phase 1 interim data update likely late 2018.
MNLO
$6.97
+0.15  +2.20%
Serlopitant
Pruritus associated with psoriasis
Phase 2
December 2018
Phase 2 data due December 2018.
BGNE
$127.02
+0.02  +0.02%
Pamiparib (BGB-290)
Ovarian Cancers or Triple-Negative Breast Cancer
Phase 1
2018
Phase 1 preliminary data released April 16, 2018. Updated data due 2018.
ALNY
$73.16
+3.79  +5.46%
ALN-CC5 (cemdisiran)
Atypical hemolytic-uremic syndrome (aHUS)
Phase 1/2
2018
Phase 2 trial initiation announced September 26, 2017 with initial data due 2018.
CNAT
$4.82
+0.16  +3.43%
Emricasan
NASH cirrhosis - ENCORE-PH trial
Phase 2
4Q 2018
Phase 2b data due 4Q 2018.
ADRO
$3.28
-0.01  -0.30%
ADU-S100 and PDR001
Solid tumors or lymphomas
Phase 1b
2H 2018
Initial data due 2H 2018.
VTGN
$1.79
-0.06  -3.24%
AV-101
Monotherapy Treatment Major Depressive Disorder
Phase 2
2H 2018
Phase 2 trial to be completed 2H 2018.
XERS
$21.03
+0.42  +2.04%
Continuous glucagon
Congenital Hyperinsulinism
Phase 2
4Q 2018
Phase 2 enrollment has been completed. Interim data 4Q 2018.
ALKS
$34.49
+0.4  +1.17%
ALKS 3831 - ENLIGHTEN-2
Schizophrenia
Phase 3
4Q 2018
Phase 3 data due 4Q 2018.
SGMO
$11.21
+0.85  +8.20%
SB-FIX
Hemophilia B
Phase 1/2
2018
Phase 1/2 data due 2018.
GILD
$69.20
-0.58  -0.83%
Tirabrutinib (GS-4059)
Chronic lymphocytic leukemia (CLL)
Phase 2
4Q 2018
Phase 2 24-week endpoint due 4Q 2018.
APTX
$23.39
+0.88  +3.91%
NYX-2925
Fibromyalgia
Phase 2
4Q 2018
Phase 2 interim analysis 4Q 2018 with top-line data due 2H 2019.
AXON
$2.00
+0.08  +4.17%
Nelotanserin
DLB patients experiencing REM Behavior Disorder (RBD)
Phase 2
2H 2018
Phase 2 data due 2H 2018.
JNJ
$145.99
+1.49  +1.03%
DARZALEX (Daratumumab) MAIA
Frontline multiple myeloma (transplant)
Phase 3
2018
Phase 3 data likely due 2018.
SNNA
$9.92
+0.05  +0.51%
SNA-001
Reduction of light-pigmented hair
Phase 3
4Q 2018
Phase 3 data due 4Q 2018.
SNNA
$9.92
+0.05  +0.51%
SNA-001
Acne
Phase 3
4Q 2018
Phase 3 data released July 30, 2018 did not meet primary endpoint. Data from separate trial due 4Q 2018.
STML
$11.39
+0.02  +0.18%
SL-801
Solid tumors
Phase 1
2H 2018
Phase 1 data to be presented 2H 2018.
MRUS
$14.06
-0.18  -1.26%
MCLA-128
Gastric cancer, ovarian, endometrial and non-small cell lung cancer
Phase 1/2
4Q 2018
Phase 1/2 data due 4Q 2018.
MRUS
$14.06
-0.18  -1.26%
MCLA-117
Acute Myeloid Leukemia
Phase 1
4Q 2018
Phase 1 early activity data is expected 4Q 2018.
ADRO
$3.28
-0.01  -0.30%
pLADD
Colorectal Cancer
Phase 1
YE 2018
Phase 1 additional additional immunological data due by end of 2018.
ADRO
$3.28
-0.01  -0.30%
pLADD
Colorectal Cancer
Phase 1
YE 2018
Phase 1 additional additional immunological data due by end of 2018.
NKTR
$38.23
+0.04  +0.10%
NKTR-214 + TECENTRIQ + KEYTRUDA (PROPEL)
Solid tumors - cancer
Phase 1/2
2H 2018
Phase 1/2 commencement of dosing announced September 12, 2017. Data due 2H 2018.
DVAX
$12.27
+0.24  +2.00%
DV281
Non-small Cell Lung Cancer (NSCLC)
Phase 1
2H 2018
Phase 1 safety and biomarker data due 2H 2018.
ACIU
$9.77
+0.12  +1.24%
ACI-24 (anti-Abeta vaccine)
Alzheimer's disease-like characteristics in individuals with Down syndrome
Phase 1/2
Late-2018
Phase 1/2 completion of recruitment of low-dose cohort noted September 12, 2017. Interim data due late-2018. Completion of recruitment for high dose cohort announced August 20, 2018.