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. Phase 1 catalysts for small-cap companies only are listed.

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. Stocks listed on PINK/OTC exchanges are not 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-2019 or 4Q 2019). 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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Showing 150 drugs
Ticker
Price
Drug
Stage
Catalyst
Ticker Price Drug Stage Catalyst
ADMP
$0.87
-0.06  -6.70%
Higher Dose Naloxone Injection
Opioid overdose
PDUFA
10/31/2019 - overdue
PDUFA date October 31, 2019. Company noted as of November 4, 2019 no communication has been received from the FDA.
XON
$5.64
+0.03  +0.53%
INXN-4001
Heart failure
Phase 1
Phase 1 dosing has been completed - noted November 7, 2019. Initial data to be presented at AHA November 17, 2019.
KRTX
$17.68
+0.29  +1.67%
KarXT
Acute psychosis in patients with schizophrenia
Phase 2
Phase 2 top-line data to be released pre-market November 18, 2019.
ALNY
$92.05
+1.59  +1.76%
Inclisiran - ORION-9
Hypercholesterolemia
Phase 3
Phase 3 data met all endpoints - September 25, 2019. Detailed data due at American Heart Association Scientific Session November 18, 2019 9:24 am EST.
MDCO
$51.98
+1.09  +2.14%
Inclisiran - ORION-9
Hypercholesterolemia
Phase 3
Phase 3 data met all endpoints - September 25, 2019. Detailed data due at American Heart Association Scientific Session November 18, 2019 9:24 am EST.
PIRS
$3.87
+0.03  +0.78%
PRS-343 and atezolizumab (Tecentriq)
HER2-positive solid tumors
Phase 1
Phase 1 dose escalation data to be presented November 19, 2019.
IDYA
$7.81
-0.29  -3.58%
IDE196
Solid tumors
Phase 1/2
Phase 1 data to be presented at SMR on November 20, 2019. Phase 2 interim data expected in 2Q/3Q 2020.
VBIV
$0.59
+0.03  +5.14%
VBI-1901
Recurrent glioblastoma multiforme (rGBM)
Phase 1/2
Phase 1/2 data to be presented at SNO meeting November 22, 2019.
DMPI
$0.77
-0.01  -1.77%
VAL-083
MGMT-unmethylated newly diagnosed Glioblastoma Multiforme (GBM)
Phase 2
Phase 2 enrolment to be completed 4Q 2020. Update due at the Society of Neuro-Oncology meeting November 22, 2019.
DMPI
$0.77
-0.01  -1.77%
VAL-083
MGMT-unmethylated Recurrent Glioblastoma Multiforme (GBM)
Phase 2
Phase 2 enrolment to be completed 4Q 2020. Update due at the Society of Neuro-Oncology meeting November 22, 2019.
AGIO
$35.68
+1.47  +4.30%
Ivosidenib and Vorasidenib (AG-881)
IDHm low-grade glioma
Phase 1
Phase 1 updated data due at Society for Neuro-Oncology meeting November 22-24, 2019.
VERU
$1.89
-0.03  -1.56%
Zuclomiphene citrate
Hot flashes
Phase 2
Fall 2019
Phase 2 data due fall of 2019.
EVFM
$5.43
+0.01  +0.18%
Amphora - AMPREVENCE
Prevention of urogenital Chlamydia trachomatis infection in women
Phase 2/3
November 2019
Phase 2b data due November 2019.
BHC
$28.48
+0.73  +2.63%
EM-100
Allergic conjunctivitis
NDA Filing
November 2019
CRL issued July 12, 2019. NDA to be resubmitted in November 2019.
ETON
$5.86
-0.15  -2.50%
EM-100
Allergic conjunctivitis
NDA Filing
November 2019
CRL issued July 12, 2019. NDA to be resubmitted in November 2019.
RVNC
$15.81
+0.62  +4.08%
DAXI (RT002)
Moderate to severe glabellar (frown) lines
BLA Filing
November 2019
BLA filing due November 2019.
YMAB
$28.45
+0.35  +1.25%
Naxitamab
Relapsed/Refractory High-Risk Neuroblastoma
BLA Filing
November 2019
Rolling BLA filing to commence November 2019 and to be completed by 1Q 2020.
AQST
$6.00
-0.14  -2.28%
Exservan (riluzole) Oral Film
Amyotrophic Lateral Sclerosis
PDUFA
PDUFA date November 30, 2019.
AQST
$6.00
-0.14  -2.28%
Libervant - AQST-203
Epileptic seizures
NDA Filing
November 2019
Rolling NDA filing to be completed November 2019.
FLXN
$16.09
+0.11  +0.69%
Zilretta - FX006 repeat
Osteoarthritis of the knee
PDUFA
November/December 2019 est
PDUFA date for sNDA filing delayed. Decision due in the coming weeks - noted November 11, 2019.
IMMU
$17.54
+0.24  +1.39%
SACTUZUMAB GOVITECAN (IMMU-132)
Cancer - metastatic triple-negative breast cancer
NDA Filing
Late-November / early December 2019
NDA to be refiled late-November / early December, 2019.
CELG
$110.02
  +0.00%
TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and Abraxane) - IMpower130
Squamous non-small cell lung cancer (NSCLC)
PDUFA
PDUFA date for sBLA extended by three months to December 2, 2019.
RHHBY
$37.53
+0.19  +0.51%
TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and Abraxane) - IMpower130
Squamous non-small cell lung cancer (NSCLC)
PDUFA
PDUFA date for sBLA extended by three months to December 2, 2019.
ACAD
$46.10
+0.63  +1.39%
Pimavanserin - Harmony
Alzheimer’s disease psychosis
Phase 3
Phase 3 trial stopped early after meeting primary endpoint - September 9, 2019. Data to be presented at CTAD meeting December 4, 2019.
SAVA
$1.24
  +0.00%
PTI-125
Alzheimer’s disease
Phase 2
Phase 2a data to be presented at CTAD December 5, 2019 at 8:15 a.m. PT. Phase 2b data due 4Q 2020.
ALEC
$15.98
+0.47  +3.03%
AL002
Alzheimer’s disease
Phase 1
Phase 1 data to be presented at CTAD December 6, 2019.
EPZM
$15.36
+0.1  +0.66%
Tazemetostat
Follicular lymphoma
Phase 2
ASH 2019
NDA filing due December 2019. Updated Phase 2 data due at ASH 2019.
PRNB
$30.05
-0.57  -1.86%
PRN1008
Immune thrombocytopenic purpura (ITP)
Phase 2
ASH 2019
Phase 2 data due at ASH December 2019.
MGTA
$9.42
-0.01  -0.11%
MGTA-145
Healthy volunteers
Phase 1
Phase 1 initial data due at ASH December 7, 2019, 5:30pm.
CELG
$110.02
  +0.00%
liso-cel (JCAR017) - TRANSCEND NHL-001
r/r B cell non-Hodgkin lymphoma - cancer
Phase 1
Phase 1 data due at ASH December 7, 8:45 a.m ET.
FBIO
$1.78
+0.13  +7.88%
MB-107
X-linked Severe Combined Immunodeficiency (XSCID)
Phase 1/2
Phase 1/2 presentation at ASH December 7, 2019, 5:30-7:30 p.m. ET.
MBIO
$2.83
+0.23  +8.85%
MB-107
X-linked Severe Combined Immunodeficiency (XSCID)
Phase 1/2
Phase 1/2 presentation at ASH December 7, 2019, 5:30-7:30 p.m. ET.
SRRA
$0.24
-0.01  -4.08%
Momelotinib - (Simplify 1)
Myelofibrosis
Phase 3
Presentation at ASH December 7, 2019 at 5:30pm EST.
ATNM
$0.25
  +-0.76%
Iomab-B
Acute myeloid leukemia (AML)
Phase 3
Phase 3 data due at ASH December 7, 2019 at 5:30pm ET.
BLUE
$74.99
+1.23  +1.67%
LentiGlobin - HGB-206
Sickle disease
Phase 1/2
Phase 1/2 presentation of data due at ASH December 7, 2019, 5:30pm.
MOR
$26.11
+0.04  +0.15%
MOR208 + idelalisib (COSMOS)
Chronic Lymphocytic Leukemia
Phase 2
Phase 2 data to be presented at ASH December 7, 2019 at 9am EST.
UMRX
$0.80
-0.21  -21.29%
ACTR707 + rituximab (ATTCK-20-03)
CD20+ Non-Hodgkin Lymphoma (NHL)
Phase 1
Phase 1 presentation at ASH December 7, 2019, 5:30 p.m. ET.
UMRX
$0.80
-0.21  -21.29%
ACTR087 + rituximab (ATTCK-20-2)
Non-Hodgkin Lymphoma (NHL)
Phase 1
Phase 1 trial placed on clinical hold - July 2, 2019. Data to be presented at ASH December 7, 2019: 2:45 PM.
VSTM
$0.90
-0.04  -4.45%
Duvelisib
Peripheral T-Cell Lymphoma (PTCL)
Phase 2
Phase 2 presentation at ASH December 7, 2019; 5:30-7:30PM ET.
AUTL
$11.79
+0.62  +5.55%
AUTO3 - (ALEXANDER)
Relapsed or refractory diffuse large B-celllymphoma (DLBCL)
Phase 1/2
Phase 1 interim data due at ASH December 7, 2019 at 3:15 PM. Phase 2 decision on initiation in DLBCL is expected for mid-2020
TROV
$1.52
-0.03  -1.94%
Onvansertib (PCM-075)
Acute Myeloid Leukemia (AML)
Phase 1/2
Phase 1/2 presentation at ASH December 7, 2019 at 2:15pm EST.
AUTL
$11.79
+0.62  +5.55%
AUTO1
Acute lymphoblastic leukemia (ALL)
Phase 1/2
Phase 2 trial to be initiated 2H 2019. Updated Phase 1 data due at ASH December 7, 2019 at 2:45 PM ET.
APTO
$2.38
-0.08  -3.25%
APTO-253
Acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
Phase 1b
ASH December 2019
Phase 1b data due at ASH December 2019.
CRIS
$1.44
-0.02  -1.37%
Fimepinostat (CUDC-907) and venetoclax
Diffuse-large B-cell lymphoma (DLBCL)
Phase 1b
ASH December 2019
Phase 1 safety data due at ASH December 2019.
GWPH
$108.41
+2.4  +2.26%
Epidiolex
Tuberous Sclerosis Complex
Phase 3
Phase 3 data to be presented at American Epilepsy Society meeting December 6-10, 2019. sNDA filing due early 2020.
CYCC
$0.39
+0.02  +4.64%
CYC065 + venetoclax
Chronic lymphocytic leukemia (CLL)
Phase 1
Phase 1 initial data due at ASH December 7, 2019 at 5:30 PM ET.
ONCT
$6.06
+0.03  +0.50%
Cirmtuzumab and ibrutinib
Chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL)
Phase 1/2
Phase 2 data due at ASH December 7, 2019, 5:30 PM ET.
SGMO
$9.41
-0.04  -0.48%
SB-525
Hemophilia A
Phase 1/2
Phase 1/2 presentation at ASH December 7, 2019, 5:30pm ET.
AZN
$47.44
+0.07  +0.15%
Calquence
1st line - Chronic lymphocytic leukaemia
Phase 3
Phase 3 data June 6, 2019 met primary endpoint. Presentation of data December 7, 2019 at 7:30am ET.
XLRN
$40.97
-2.02  -4.71%
Luspatercept
Myelofibrosis
Phase 2
Phase 2 data due at ASH December 9, 7:00 a.m. EST.
CELG
$110.02
  +0.00%
Luspatercept
Myelofibrosis
Phase 2
Phase 2 data due at ASH December 9, 7:00 a.m. EST.
ORTX
$10.40
-0.32  -2.99%
OTL-103
Wiskott-Aldrich Syndrome (WAS)
Phase 1/2
Phase 1/2 presentation at ASH December 8, 6pm ET.
TGTX
$8.00
+0.03  +0.31%
Umbralisib + Ublituximab + Venetoclax
Chronic Lymphocytic Leukemia
Phase 1/2
Phase 1/2 data to be presented at ASH December 8, 2019; 7:30 AM ET.
GMAB
$22.34
+0.28  +1.27%
HexaBody-DR5/DR5
Solid tumors
Phase 1/2
Phase 1/2 initial data to be presented at ASH December 8, 2019.
MOR
$26.11
+0.04  +0.15%
Tafasitamab - First-MIND
Diffuse Large B-cell Lymphoma
Phase 1
Phase 1 data to be presented at ASH December 8, 2019 at 9am.
KDMN
$3.92
  +0.00%
KD025-208
Chronic graft-versus-host disease (cGVHD)
Phase 2
ASH December 2019
Phase 2 data due to be presented at ASH December 2019.
QURE
$52.87
+0.31  +0.59%
AMT-061
Hemophilia B
Phase 2b
Phase 2b data to be presented at ASH December 8, 2019 at 6pm ET.
AUTL
$11.79
+0.62  +5.55%
AUTO2
Relapsed or refractory multiple myeloma
Phase 1/2
Phase 1 data due at ASH December 8, 2019 at 6PM ET.
CELG
$110.02
  +0.00%
Liso-cel (JCAR017) - TRANSCEND CLL-004
Chronic Lymphocytic Leukemia (CLL)
Phase 1
Phase 1 updated data due at ASH December 8, 2019 at 5:30 p.m.
ATNM
$0.25
  +-0.76%
Actimab-A in combination with CLAG-M
Relapsed or refractory acute myeloid leukemia (AML)
Phase 1
Phase 1 data due at ASH December 8, 2019 at 6pm EST.
PTLA
$27.21
+0.34  +1.27%
Cerdulatinib (PRT2070)
Refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia - cancer
Phase 2
Phase 2a interim data to be presented at ASH December 8, 2019, at 12:45 p.m. EST.
RCKT
$14.55
-0.14  -0.92%
RP-L102
Fanconi Anemia (FA)
Phase 1
Phase 1 data to be presented at ASH December 8, 2019 at 6pm EST. Phase 2 data due 2020.
FBIO
$1.78
+0.13  +7.88%
MB-106
B-cell Non-Hodgkin Lymphoma & Chronic Lymphocytic Leukemia (CLL)
Phase 1
Phase 1 data to be presented at ASH December 8, 2019, 6:00 PM.
MBIO
$2.83
+0.23  +8.85%
MB-106
B-cell Non-Hodgkin Lymphoma & Chronic Lymphocytic Leukemia (CLL)
Phase 1
Phase 1 data to be presented at ASH December 8, 2019, 6:00 PM.
PDSB
$2.12
-0.31  -12.70%
PDS0101
Head and neck cancer / human papillomavirus-16 (HPV16) infection
Phase 1
Phase 2 trial planned for 1Q 2020 with interim data due 2Q 2021. Phase 1 trial data to be presented at ASH December 8, 2019 6pm ET.
SNSS
$0.37
-0.02  -4.86%
Vecabrutinib (SNS-062)
Advanced B-Cell Malignancies
Phase 1/2
Phase 1/2 next update due at ASH December 8, 2019, 6pm ET.
ALPN
$2.60
-0.12  -4.41%
ALPN-101
Healthy volunteers
Phase 1
Phase 1 presentation at ASH December 8, 2019: 11:00 AM ET.
KURA
$14.71
-0.17  -1.14%
Tipifarnib
Relapsed or refractory peripheral T-cell lymphoma
Phase 2
Phase 2 data due at ASH December 8, 2019 at 1:15pm ET.
BGNE
$198.25
+1.85  +0.94%
Zanubrutinib (BGB-3111) - SEQUOIA
First-line chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Phase 3
Phase 3 presentation at ASH Sunday, December 8, 2019 at 4:30pm ET.
APTO
$2.38
-0.08  -3.25%
CG-806
Chronic lymphocytic leukemia (CLL/SLL) or non-Hodgkin lymphomas (NHL)
Phase 1
Phase 1 data to be presented at ASH December 8, 2019, 6pm ET.
AUTL
$11.79
+0.62  +5.55%
AUTO3 - (AMELIA)
Acute Lymphoblastic Leukemia
Phase 1/2
Phase 1 data due at ASH December 8, 2019 at 6PM ET.
BPMC
$75.35
+3.26  +4.52%
Avapritinib BLU-285 - PIONEER
Indolent and smoldering systemic mastocytosis (SM)
Phase 2
Phase 2 initial data due at ASH December 8, 2019 at 6pm ET.
LLY
$113.19
+1.8  +1.62%
LOXO-305
Refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), non-Hodgkin’s lymphomas (NHL)
Phase 1/2
Phase 1/2 presentation at ASH December 8, 2019, 4:30pm.
IMV
$2.49
+0.08  +3.32%
DPX-Survivac and pembrolizumab
Diffuse Large Cell Lymphoma
Phase 2
Phase 2 presentation at ASH December 8, 2019 at 6pm. Top-line data due 1H 2020.
BLUE
$74.99
+1.23  +1.67%
LentiGlobin - HGB-212 Northstar-3
TDT and the β0/β0genotype
Phase 3
Phase 3 presentation of data at ASH December 9, 2019, 5:30 p.m ET.
MGTA
$9.42
-0.01  -0.11%
MGTA-456
Acute Lymphoblastic Leukemia
Phase 2
Phase 2 data due at ASH December 9, 2019, 4pm EST.
CYAD
$8.68
-0.07  -0.80%
CYAD-01 - THINK
Various cancers - solid and hematologic cancers
Phase 1/2
Phase 1 data due at ASH December 9, 2019, 6 p.m ET.
ACHN
$6.25
-0.09  -1.42%
Danicopan (ACH-4471)
Paroxysmal nocturnal hemoglobinuria (PNH)
Phase 2
Phase 2 presentation at ASH December 9, 2019 at 6pm ET.
ALXN
$108.37
+2.48  +2.34%
Danicopan (ACH-4471)
Paroxysmal nocturnal hemoglobinuria (PNH)
Phase 2
Phase 2 presentation at ASH December 9, 2019 at 6pm ET.
AGIO
$35.68
+1.47  +4.30%
AG-348 - Mitapivat (DRIVE)
Pyruvate Kinase Deficiency
Phase 2
Phase 2 data to be presented at ASH December 9, 2019 from 6pm ET.
SGMO
$9.41
-0.04  -0.48%
ST-400
beta-thalassemia
Phase 1/2
Phase 1/2 presentation at ASH December 9, 2019, 6pm ET.
ORTX
$10.40
-0.32  -2.99%
OTL-203
MPS I
Phase 1/2
Phase 1 data to be presented at ASH December 9, 2019 7am ET.
GMAB
$22.34
+0.28  +1.27%
GEN3013 (DuoBody-CD3xCD20)
B-cell Lymphoma
Phase 1/2
Phase 1/2 initial data to be presented at ASH December 9, 2019.
GMDA
$4.80
-0.1  -2.04%
NAM-NK (GDA-201)
Non-Hodgkin lymphoma; Multiple myeloma
Phase 1
Phase 1 additional data due at ASH December 9, 2019, 3:15 p.m. ET.
BLUE
$74.99
+1.23  +1.67%
bb21217
Multiple Myeloma
Phase 1
Phase 1 data due at ASH December 9, 2019, 6:45 p.m. ET.
CELG
$110.02
  +0.00%
bb21217
Multiple Myeloma
Phase 1
Phase 1 data due at ASH December 9, 2019, 6:45 p.m. ET.
AGIO
$35.68
+1.47  +4.30%
Ivosidenib and azacitidine ( Vidaza)
Newly diagnosed AML with an IDH1 mutation
Phase 1
Phase 1 updated data at ASH December 9, 2019 at 10:30 a.m. ET.
ONTX
$0.35
+0.05  +16.70%
Oral Rigosertib and azacitidine
First-line HR-MDS (high risk myelodysplastic syndromes)
Phase 3
Phase 3 Special Protocol Assessment (SPA) submission announced January 2, 2019. Phase 2 presentation at ASH December 9, 2019, 7am ET.
FTSV
$10.69
+0.28  +2.69%
5F9 + Azacitidine
Acute myeloid leukemia (AML)
Phase 1
Phase 1b presentation at ASH December 9, 2019, 8:00 a.m EST.
IMGN
$3.31
+0.04  +1.22%
IMGN632
Acute Myeloid Leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN)
Phase 1
Phase 1 updated data due at ASH December 9, 2019, 3:00pm EST.
CRIS
$1.44
-0.02  -1.37%
CA-4948
Relapsed or Refractory Non-Hodgkin Lymphoma
Phase 1
Phase 1 update due later at ASH December 9, 2019, 6:00 p.m.
ARQL
$7.88
+0.06  +0.70%
ARQ 531
B-cell malignancies
Phase 1
Phase 1 presentation at ASH December 9, 2019 at 6pm EST.
XNCR
$35.98
+0.02  +0.06%
XmAb13676
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Phase 1
Phase 1 initial data due at ASH December 9, 2019, 6:00 p.m EST.
BLUE
$74.99
+1.23  +1.67%
LentiGlobin - HGB-207 Northstar-2
non-β0/β0 transfusion-dependent thalassemia (TDT)
Phase 3
Phase 3 presentation of data at ASH December 9, 2019, 6pm.
MGNX
$8.64
+0.26  +3.10%
Flotetuzumab
AML/MDS
Phase 1
Phase 1 updated data to be presented at ASH December 9, 2019 at 2:45pm ET.
CNST
$38.48
+0.56  +1.48%
CPI-0610 and ruxolitinib
Myelofibrosis
Phase 2
Phase 2 additional data due at ASH December 9, 2019 at 11:15 AM.
STML
$9.91
+0.43  +4.54%
SL-401 (Elzonris)
Myelofibrosis (MF)
Phase 2
Phase 1/2 presentation at ASH December 9, 2019 8:15 AM ET.
CTIC
$0.72
-0.02  -2.17%
Pacritinib - PACIFICA
Myelofibrosis
Phase 3
Phase 3 trial initiation announced October 1, 2019 with data due mid-2021. Presentation at ASH December 9, 2019 at 6pm.
GERN
$1.31
-0.06  -4.38%
Imetelstat - IMerge Study
Myelodysplastic syndromes
Phase 2/3
Phase 3 commencement of dosing announced October 10, 2019 with data due mid-2022. Presentation at ASH December 9, 2019 at 6pm ET.
CYAD
$8.68
-0.07  -0.80%
CYAD-01 and chemotherapy (DEPLETHINK)
AML or myelodysplastic syndrome (MDS)
Phase 1
Phase 1 data due at ASH December 9, 2019, 6 p.m ET.
DTIL
$12.11
+0.31  +2.63%
PBCAR0191
Relapsed or refractory B-cell precursor acute lymphoblastic leukemia and R/R non-hodgkin lymphoma
Phase 1/2
Phase 1/2 interim data due at ASH December 9, 2019 at 6:00 p.m. ET.
CORV
$2.27
+0.08  +3.65%
Brinavess
Atrial fibrillation (AF)
PDUFA
Advisory Committee 12/10/2019; PDUFA 12/24/2019
PDUFA date December 24, 2019. FDA Advisory Committee meeting December 10, 2019.
MGNX
$8.64
+0.26  +3.10%
Margetuximab SOPHIA study
Metastatic breast cancer
Phase 3
SABCS 2019
Second interim overall survival analysis noted OS 21.6 months vs 19.8 months; HR 0.885; p=0.326. Presentation at SABCS December 10-14, 2019. BLA filing due 4Q 2019.
ZLAB
$38.93
  +0.00%
Margetuximab SOPHIA study
Metastatic breast cancer
Phase 3
SABCS 2019
Second interim overall survival analysis noted OS 21.6 months vs 19.8 months; HR 0.885; p=0.326. Presentation at SABCS December 10-14, 2019. BLA filing due 4Q 2019.
GRTS
$7.34
+0.2  +2.80%
GRANITE-001 (GO-004)
Solid tumors
Phase 1/2
Phase 1 initial safety data due at ESMO-IO December 11-14, 2019. Efficacy data due mid-2020.
BLRX
$2.67
+0.09  +3.36%
BL-8040 in combination with KEYTRUDA - COMBAT trial
Pancreatic cancer
Phase 2
Phase 2 response data due 4Q 2019 with PFS data due mid-2020. Presentation at ESMO-IO, December 11-14, 2019.
SGEN
$114.75
+1.46  +1.29%
(Tucatinib ONT-380) + Herceptin and Xeloda - HER2CLIMB trial
HER2+ Metastatic Breast Cancer (MBC)
Phase 2
Phase 2 trial met primary and key secondary endpoints - October 21, 2019. Data to be presented at SABCS December 11, 2019. NDA filing due 1Q 2020.
GTHX
$22.95
+0.72  +3.24%
Lerociclib (G1T38) plus Faslodex
ER+ breast cancer
Phase 1b
Phase 1b additional data due at SABCS December 11, 2019.
GRTS
$7.34
+0.2  +2.80%
SLATE-001
Solid tumors
Phase 1
Phase 1 initial safety data due at ESMO-IO December 11-14, 2019. Efficacy data due mid-2020.
AGN
$183.61
+1.14  +0.62%
UBROGEPANT
Migraine
PDUFA
December 2019
NDA acceptance announced March 11, 2019. PDUFA December 2019. No exact date provided.
BLRX
$2.67
+0.09  +3.36%
BL-8040 in combination with KEYTRUDA
Pancreatic cancer
Phase 2a
Phase 2a data to be presented at ESMO December 13, 2019.
ATNX
$11.63
+0.4  +3.56%
Oraxol
Metastatic breast cancer
Phase 3
Phase 3 top-line data met primary endpoint (ORR), secondary endpoints (PFS/OS) yet to hit. Presentation due at SABCS December 13, 2019.
AMGN
$220.86
+2.36  +1.08%
ABP 710
REMICADE biosimilar - rheumatoid arthritis
PDUFA
BsUFA date December 14, 2019.
AVDL
$4.99
+0.03  +0.60%
AV001
Hospital product
PDUFA
PDUFA date extended by three months to December 15, 2019.
PFE
$37.28
+0.73  +2.00%
XTANDI (ARCHES)
Metastatic hormone sensitive prostate cancer
PDUFA priority review
4Q 2019
PDUFA date under priority review 4Q 2019.
BHC
$28.48
+0.73  +2.63%
IDP-123
Psoriasis
PDUFA
PDUFA date December 22, 2019.
ITCI
$9.02
+0.18  +2.04%
Lumateperone
Schizophrenia
PDUFA
PDUFA date extended by three months to December 27, 2019. No advisory committee meeting expected.
AMRN
$24.02
+2.53  +11.77%
Vascepa
High Triglycerides With Mixed Dyslipidemia
PDUFA priority review
PDUFA date December 28, 2019. Advisory Committee meeting November 14, 2019 voted 16-0 in favor.
NVO
$57.28
-0.61  -1.05%
PYY 1562
Obesity
Phase 1
4Q 2019
Phase 1 data due 4Q 2019.
CCXI
$8.84
+0.09  +1.03%
Avacopan - CCX168 (ADVOCATE)
Associated vasculitis (AAV)
Phase 3
4Q 2019
Phase 3 data due 4Q 2019.
BIIB
$282.27
+7.12  +2.59%
BIIB092 - Anti Tau
Progressive supranuclear palsy (PSP)
Phase 2
4Q 2019
Phase 2 data due 4Q 2019.
AXSM
$27.68
+1.36  +5.17%
AXS-05 -GEMINI
Major Depressive Disorder
Phase 3
4Q 2019
Phase 3 data due 4Q 2019.
SAGE
$146.32
+5.53  +3.93%
SAGE-718
Huntington's disease
Phase 1
4Q 2019
Phase 1 data due 4Q 2019.
VTGN
$0.30
  +-1.33%
AV-101
Healthy volunteers
Phase 1b
2H 2019
Phase 1b data due 2H 2019.
IONS
$58.61
+0.82  +1.42%
IONIS-FXIRx
End-stage renal disease
Phase 2b
2019
Phase 2b data likely due 2019.
SPPI
$8.30
+0.27  +3.36%
Poziotinib
Non-small cell lung cancer (NSCLC) with exon 20 insertion mutation in EGFR or HER2
Phase 2
December 2019
Phase 2 top-line data from Cohort 1 due December 2019. Cohort 2 data due mid-2020.
SLGL
$8.00
+0.39  +5.12%
TWIN
Acne
Phase 3
4Q 2019
Phase 3 data due 4Q 2019.
RGNX
$37.16
+0.84  +2.31%
RGX-121
MPS II
Phase 1/2
YE 2019
Phase 1/2 update due at the end of 2019.
GILD
$65.07
+1.26  +1.97%
Cilofexor (GS-9674) and firsocostat (GS-0976) - ATLAS
Nonalcoholic steatohepatitis (NASH)
Phase 2
4Q 2019
Phase 2b 48-week data due 4Q 2019.
ARQL
$7.88
+0.06  +0.70%
Miransertib - ARQ 092
Solid tumors
Phase 1b
2H 2019
Phase 1b data due 2H 2019.
HEPA
$2.67
-0.08  -2.91%
CRV431
Hepatitis B
Phase 1
4Q 2019
MAD trial commencement of dosing announced August 14, 2019 with data due 4Q 2019.
TRIL
$0.28
  +1.13%
TTI-622
Refractory lymphoma or multiple myeloma
Phase 1b
Late-2019
Phase 1a/b preliminary data due late-2019.
BMRN
$75.04
-0.54  -0.71%
Vosoritide
Achondroplasia - young children
Phase 2
YE 2019
Phase 3 top-line data due end of 2019.
BGNE
$198.25
+1.85  +0.94%
Tislelizumab
Hepatocellular carcinoma (HCC) - second-line
Phase 2
2019
Phase 2 data due 2019 or early 2020.
KMDA
$5.92
-0.04  -0.67%
Alpha-1 antitrypsin (AAT)
Prevention of lung transplant rejection
Phase 1/2
YE 2019
Phase 2 top-line data due YE 2019.
BVXV
$5.81
+0.04  +0.69%
M-001
Universal flu vaccine
Phase 2
YE 2019
Phase 2 data due by the end of 2019.
ALDX
$6.03
+0.01  +0.17%
ADX-102 - topical ocular reproxalap - RENEW
Dry eye syndrome
Phase 3
4Q 2019
Phase 3 (Part 1) to be completed 4Q 2019.
GSK
$44.09
+0.24  +0.55%
TSR-042 - GARNET
Endometrial cancer
Phase 1
2H 2019
Phase 1 pivotal data and BLA filing due 2H 2019.
VRTX
$209.80
+4.8  +2.34%
VX-147
Healthy volunteers
Phase 1
4Q 2019
Phase 1 trial to be completed in 4Q 2019.
ACER
$3.33
+0.2  +6.39%
ACER-001
Urea cycle disorder (UCD)
Phase 2
4Q 2019
Pivotal bioavailability and bioequivalence trial Part A data due 4Q 2019; Part B due 1Q 2020 with NDA filing 1Q 2021.
DNLI
$15.14
+0.14  +0.93%
DNL747
Amyotrophic Lateral Sclerosis
Phase 1b
4Q 2019
Phase 1b commencement of dosing announced January 8, 2019. Data due 4Q 2019.
ARDX
$6.14
-0.01  -0.16%
Tenapanor - PHREEDOM
Hyperphosphatemia in end-stage renal disease (ESRD) patients
Phase 3
4Q 2019
Phase 3 data due 4Q 2019.
RHHBY
$37.53
+0.19  +0.51%
Idasanutlin (RG7388) - MIRROS
Acute myeloid leukemia (AML)
Phase 3
4Q 2019
Phase 3 data due 4Q 2019.
KPTI
$15.60
+0.24  +1.60%
Selinexor - SADAL
Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)
NDA Filing
4Q 2019
NDA filing due 4Q 2019.
AKTX
$1.83
+0.01  +0.55%
Coversin
Atopic keratoconjunctivitis
Phase 1/2
4Q 2019
Phase 1/2 Part B data due 4Q 2019.
ACAD
$46.10
+0.63  +1.39%
Pimavanserin - Advance
Adjunctive treatment in patients with negative symptoms of schizophrenia
Phase 2
4Q 2019
Phase 2 data due 4Q 2019.
MTEM
$7.26
+0.26  +3.71%
MT-5111
HER2-positive solid tumors
Phase 1
4Q 2019
Phase 1 update due 4Q 2019.
BLUE
$74.99
+1.23  +1.67%
bb2121 - KarMMa
Relapsed/refractory multiple myeloma
Phase 2
YE 2019
Phase 2 data due by the end of 2019.
CELG
$110.02
  +0.00%
bb2121 - KarMMa
Relapsed/refractory multiple myeloma
Phase 2
YE 2019
Phase 2 data due by the end of 2019.
ACST
$2.04
+0.09  +4.62%
CaPre (TRILOGY 1 and 2)
Hypertriglyceridemia
Phase 3
December 2019
Phase 3 top-line data due in December 2019 (1) and January 2020 (2).

The public FDA Calendar is limited to 150 events in chronological order. The full calendar of approximately 800 events is available to PREMIUM MEMBERS which you can access through our 14-day FREE TRIAL.