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.

Subscribe HERE to ensure you receive your weekly FREE copy of the BioPharmCatalyst Biotech Stock Watch list and/or our daily option of Biotech Stock Price Movers and Pipeline Database updates.


The public FDA Calendar is limited to 150 events in chronological order. The full calendar of approximately 1000 events is available to PREMIUM MEMBERS.


Showing 150 drugs
Ticker
Price
Drug
Stage
Catalyst
Ticker Price Drug Stage Catalyst
NVS
$82.39
+0.38  +0.46%
Zolgensma AVXS-101
Spinal muscular atrophy (SMA) Type 1
 PDUFA priority review
May 2019
PDUFA date under priority review May 2019. Exact date not released.
PIRS
$3.67
+0.03  +0.82%
PRS-060
Asthma
 Phase 1
Phase 1 initial data due at ATS meeting May 22, 2019 1:30pm.
INCY
$78.68
+1.85  +2.41%
Ruxolitinib
Graft versus host disease
 PDUFA priority review
PDUFA date under priority review extended by three months to May 24, 2019.
NVS
$82.39
+0.38  +0.46%
Ruxolitinib
Graft versus host disease
 PDUFA priority review
PDUFA date under priority review extended by three months to May 24, 2019.
CNCE
$11.37
+0.86  +8.18%
CTP-692 (single dose)
Schizophrenia
 Phase 1
Phase 1 data to be presented at ASCP May 28-31, 2019.
AGN
$138.48
-0.3  -0.22%
Cariprazine
Bipolar I Depression
 PDUFA
May 2019
PDUFA date for sNDA filing May 2019.
BHC
$24.49
+0.26  +1.07%
EM-100
Allergic conjunctivitis
 PDUFA
May 2019 or July 2019
FDA decision due May 2019 or July 2019.
ETON
$7.90
-0.02  -0.25%
EM-100
Allergic conjunctivitis
 PDUFA
May 2019 or July 2019
FDA decision due May 2019 or July 2019.
JAZZ
$139.91
+1.58  +1.14%
CPX-351
Acute myeloid leukemia (AML)
 Phase 1/2
Phase 1/2 presentation at ASCO May 31, 2019, 3:45 p.m. CT.
ELOX
$10.57
-0.38  -3.47%
ELX-02
Multiple-ascending dose (MAD)
 Phase 1b
May 2019
Phase 1b MAD final cohort data due May 2019.
FPRX
$9.37
+0.54  +6.12%
FPA150
Solid tumors
 Phase 1
Phase 1b commencement of dosing announced February 21, 2019. Initial data due at ASCO June 1 2019, 8am.
BPMC
$78.97
+3.09  +4.07%
Avapritinib BLU-285 - NAVIGATOR
PDGFRα driven Gastrointestinal stromal tumors (GIST)
 Phase 1
NDA filing due 2Q 2019. Data at ASCO June 1, 2019, 3pm CT.
IOVA
$16.20
+0.59  +3.78%
LN-144 - lifileucel
Refractory metastatic melanoma
 Phase 2
Phase 2 completion of enrolment of final cohort due 2020. Updated Cohort 2 data due at ASCO June, 1, 2019. 8am.
IOVA
$16.20
+0.59  +3.78%
LN-145
Cervical cancer
 Phase 2
Phase 2 poster at ASCO June 1, 2019, 8am. Abstract released May 15, 2019 noted 44% ORR.
ATNX
$14.18
+0.23  +1.65%
Oratecan
Solid Tumors
 Phase 1
Phase 1 poster at ASCO June 1, 2019, 8:00 AM ET.
BLCM
$2.73
+0.02  +0.74%
BPX-601
Pancreatic cancer
 Phase 1
Phase 1 initial data due at ASCO June 1, 2019, 8am CT.
CRVS
$4.01
+0.09  +2.30%
CPI-006
Solid tumors
 Phase 1b
Phase 1/1b poster at ASCO June 1, 2019, 8am CT and presentation June 2, 2019, 9:24 am.
SRRA
$1.45
+0.04  +2.84%
SRA737
Advanced Solid Tumors or Non-Hodgkin's Lymphoma (NHL)
 Phase 1/2
Phase 1/2 preliminary data due at ASCO June 1, 2019. 8am CT.
CGEN
$3.34
-0.11  -3.19%
COM701
Solid tumors
 Phase 1
Phase 1 presentation at ASCO June 1, 2019, 8am. Enrolment in monotherapy dose escalation arm to be completed 3Q 2019.
CTMX
$11.26
+0.33  +3.02%
CX-072 - PROCLAIM-CX-072
Solid tumors
 Phase 1/2
Phase 1/2 updated data at ASCO June 1, 2019.
GTHX
$23.24
+0.69  +3.06%
Trilaciclib
Second/third-line small-cell lung cancer
 Phase 2
Phase 2 additional data due at ASCO June 1, 2019, 3:03pm.
CLDX
$3.24
+0.13  +4.18%
CDX-3379
Recurrent/metastatic head and neck squamous cell cancer
 Phase 2
Phase 2 data due at ASCO June 1, 2019, 1:15pm CT.
MRSN
$4.97
+0.19  +3.97%
XMT-1536
Ovarian Cancer, Non Small Cell Lung Cancer
 Phase 1
Phase 1 data due at ASCO June 1, 2019, 8am CT.
IMGN
$1.95
+0.01  +0.52%
Mirvetuximab soravtansine - FORWARD II
Ovarian cancer and relapsed endometrial cancer
 Phase 1/2
Phase 1b/2 presentation at ASCO June 1, 2019, 4:30pm.
MRNA
$22.70
+0.1  +0.44%
mRNA-4650
Autologous Cancer
 Phase 1/2
Phase 1 data to be presented at ASCO June 1, 2019, 8am.
RCUS
$9.69
+0.05  +0.52%
AB928 + AB122
Solid tumors
 Phase 1
Phase 1 initial data due at ASCO June 1, 2019, 8am.
MEIP
$3.20
-0.1  -3.03%
ME-344
HER2-negative Breast Cancer
 Phase 1
Phase 1 final data due at ASCO June 1, 2019, 8am.
BGNE
$130.63
+6.8  +5.49%
Tislelizumab
Nasopharyngeal cancer
 Phase 3
Phase 3 initial China data due at ASCO June 1, 2019, 8am CT.
GNCA
$0.59
-0.07  -10.47%
GEN-009 vaccine
Various cancers
 Phase 1/2
Phase 1/2 initial immunogenicity data due at ASCO June 1, 2019, 8am CT.
REPL
$14.95
+0.41  +2.82%
RP1 and nivolumab
Solid tumors
 Phase 1/2
Presentation at ASCO June 1, 2019. Phase 1 data to be presented 2H 2019 with Phase 2 part of trial to be initiated 1H 2019.
SRRA
$1.45
+0.04  +2.84%
SRA737 + Low-Dose Gemcitabine
Solid Tumors
 Phase 1/2
Phase 1/2 preliminary data due at ASCO June 1, 2019. 8am.
MRNA
$22.70
+0.1  +0.44%
mRNA-4157 - KEYNOTE-603
Personalized cancer vaccine
 Phase 1
Phase 1 updated data due at ASCO June 1, 2019, 1:15 PM
VCNX
$7.01
+0.3  +4.47%
VX15 and avelumab
Non-small cell lung cancer (NSCLC)
 Phase 1/2
Phase 1/2 trial initial data due at ASCO June 1, 8am CT. Trial to be completed 2H 2019.
DVAX
$6.55
+0.52  +8.62%
SD-101 + Pembrolizumab
Melanoma and head and neck squamous cell carcinoma (HNSCC)
 Phase 1/2
Phase 1/2 data to be presented at ASCO 2019. HNSCC presentation due June 01, 1:15 PM; Melanoma presentation June 03, 1:15 PM CT.
INCY
$78.68
+1.85  +2.41%
DPX-Survivac and epacadostat (DeCidE1)
Ovarian cancer
 Phase 1/2
Phase 2 monotherapy data due at ASCO June 1, 2019, 1:15pm CT. Top-line data due 2H 2019.
IMV
$3.90
  +0.00%
DPX-Survivac and epacadostat (DeCidE1)
Ovarian cancer
 Phase 1/2
Phase 2 monotherapy data due at ASCO June 1, 2019, 1:15pm CT. Top-line data due 2H 2019.
ADRO
$3.22
-0.02  -0.62%
ADU-S100 and Spartalizumab
Solid tumors or lymphomas
 Phase 1b
Phase 1b presentation at ASCO June 2, 2019, 8:00 AM CT.
CELG
$96.25
+1.42  +1.50%
CC-220
Relapsed and/or refractory multiple myeloma (RRMM)
 Phase 1/2
Phase 1/2 data to be presented at ASCO June 2, 2019, 11:45am.
CANF
$3.48
+0.22  +6.75%
Namodenoson (CF102)
Cancer - advanced liver cancer second line
 Phase 2
Phase 2 data did not meet primary endpoint - March 27, 2019. Presentation at ASCO June 02, 2019 8:00 am CDT and at ILCA September 22, 2019.
AMGN
$169.69
+1.3  +0.77%
AMG 420
Relapsed. Refractory (R/R) Multiple Myeloma (MM)
 Phase 1
Phase 1 data due at ASCO June 2, 2019, 11:57am.
ZIOP
$4.36
+0.07  +1.63%
Ad-RTS-hIL-12
recurrent glioblastoma (rGBM)
 Phase 1
Phase 1 data due at ASCO June 2, 2019, 8am.
VBIV
$2.05
+0.03  +1.49%
VBI-1901
Recurrent glioblastoma multiforme (rGBM)
 Phase 1/2
Phase 1/2a expanded Part A data to be presented at ASCO June 2, 2019, 8:00 AM ET.
PBYI
$16.17
+0.54  +3.45%
Neratinib monotherapy with high dose loperamide prophylaxis - CONTROL
Extended adjuvant treatment of early stage HER2-positive breast cancer
 Phase 2
Phase 2 additional data due at ASCO June 2, 2019, 8am CT.
AZN
$37.88
+0.34  +0.91%
Lynparza (POLO)
Pancreatic cancer
 Phase 3
Phase 3 data released February 26, 2019 - PFS primary endpoint met. Data to be presented at ASCO June 2, 2019, 3:15pm CEST.
MRK
$79.50
+0.62  +0.79%
Lynparza (POLO)
Pancreatic cancer
 Phase 3
Phase 3 data released February 26, 2019 - PFS primary endpoint met. Data to be presented at ASCO June 2, 2019, 3:15pm CEST.
ZIOP
$4.36
+0.07  +1.63%
Ad-RTS-hIL-12 plus veledimex in combination with OPDIVO (nivolumab)
Refractory glioblastoma multiforme (GBM)
 Phase 1
Phase 1 initial data due at ASCO June 2, 2019, 8am.
BPMC
$78.97
+3.09  +4.07%
BLU-667 - ARROW
RET-altered solid tumors
 Phase 1
Phase 1 updated data at ASCO June 3, 2019, 8am CT.
ATNM
$0.30
-0.01  -2.56%
Iomab-B
Hematopoietic Stem Cells Transplantation
 Phase 3
Phase 3 presentation at ASCO June 3, 2019, 8am CT.
AMGN
$169.69
+1.3  +0.77%
AMG 510
Solid tumors
 Phase 1
Phase 1 data due at ASCO June 3, 2019, 9am CT.
AGIO
$51.36
+2.75  +5.66%
Ivosidenib
IDH1 mutant newly diagnosed AML ineligible for standard therapies
 Phase 1
Phase 1 updated data due at ASCO June 3, 2019, 8am.
AGIO
$51.36
+2.75  +5.66%
Ivosidenib and azacitidine ( Vidaza)
Newly diagnosed AML with an IDH1 mutation
 Phase 1
Phase 1 updated data due at ASCO June 3, 2019, 1:15-4:15 p.m. CT.
INCY
$78.68
+1.85  +2.41%
INC280
Non-small cell lung cancer
 Phase 2
Phase 2 released October 19, 2018. ORR 72% in treatment-naive patients, 39% in previously treated patients. Presentation at ASCO June 3, 2019, 9:12am CT.
NVS
$82.39
+0.38  +0.46%
INC280
Non-small cell lung cancer
 Phase 2
Phase 2 released October 19, 2018. ORR 72% in treatment-naive patients, 39% in previously treated patients. Presentation at ASCO June 3, 2019, 9:12am CT.
FTSV
$12.54
+0.25  +2.03%
5F9
Acute myeloid leukemia (AML)
 Phase 1
Phase 1b data to be presented at ASCO June 3, 2019 4:30pm CT.
FTSV
$12.54
+0.25  +2.03%
5F9 + Azacitidine
Acute myeloid leukemia (AML)
 Phase 1
Phase 1b data to be presented at ASCO June 3, 2019 4:30pm CT.
INCY
$78.68
+1.85  +2.41%
INCB54828 (FIGHT-202)
Cholangiocarcinoma
 Phase 2
Phase 2 poster to be presented at ASCO June 3, 2019, 8am CT. NDA filing to be submitted 2H 2019.
CORT
$10.60
  +0.00%
Relacorilant plus Abraxane
Solid tumors - cancer
 Phase 1/2
Phase 1/2 to be presented at ASCO June 3, 2019, 8am CT.
SGEN
$67.12
+2.74  +4.26%
Enfortumab vedotin - EV201
Urothelial cancer
 Phase 3
Phase 2 pivotal data March 28, 2019 noted 44% ORR. Full data due at ASCO June 3, 2019, 9:24am.
MEIP
$3.20
-0.1  -3.03%
ME-401
Relapsed/refractory Follicular Lymphoma/Chronic Lymphocytic Leukemia (CLL)
 Phase 1b
Phase 1b presentation at ASCO June 3, 2019, 8am CT.
CNST
$9.77
+0.75  +8.31%
CPI-0610 and ruxolitinib
Myelofibrosis
 Phase 2
Phase 2 interim data due at ASCO on June 3, 2019, 8am CT and at EHA on June 15, 2019, 12:15 PM CEST.
STML
$15.10
+0.8  +5.59%
SL-401 (Elzonris)
Chronic myelomonocytic leukemia (CMML) - cancer
 Phase 2
Presentation at ASCO June 3, 2019, 8am CT.
NKTR
$33.42
+1.27  +3.95%
NKTR-214 and nivolumab
Sarcomas
 Phase 2
Phase 2 data to be presented at ASCO June 3, 2019, 11:30 a.m CT.
AGIO
$51.36
+2.75  +5.66%
Ivosidenib and Vorasidenib (AG-881)
IDHm low-grade glioma
 Phase 1
Phase 1 data due at ASCO June 3, 2019, 2:15pm.
STML
$15.10
+0.8  +5.59%
SL-401 (Elzonris)
Myelofibrosis (MF)
 Phase 2
Phase 1/2 presentation at ASCO Monday, June 3, 2019, 8am.
EPZM
$12.58
+1.15  +10.06%
Tazemetostat
Epithelioid Sarcoma
 Phase 2
NDA filing planned for 2Q 2019. Updated Phase 2 data due at ASCO June 3, 2019; 9:00 a.m. CDT
MRK
$79.50
+0.62  +0.79%
ZERBAXA(ceftolozane and tazobactam)
Hospital-acquired bacterial pneumonia (HABP)
 PDUFA priority review
PDUFA date under priority review June 3, 2019.
RHHBY
$33.05
-0.06  -0.18%
Tecentriq plus nab-paclitaxe - IMpassion 130
Triple-negative breast cancer
 Phase 3
Phase 3 OS update at ASCO June 4, 2019, 10:45am CT.
MGNX
$18.74
+0.5  +2.74%
Margetuximab SOPHIA study
Metastatic breast cancer
 Phase 3
Phase 3 data released February 6, 2019 met primary endpoint. Detailed data due at ASCO June 4, 2019, 9:45am. BLA filing due 2H 2019.
ABBV
$80.88
+1.06  +1.33%
Venclexta plus Gazyva
Chronic lymphocytic leukemia (CLL)
 Phase 3
Phase 3 data to be presented at ASCO June 4, 2019, 10:09am CT.
RHHBY
$33.05
-0.06  -0.18%
Venclexta plus Gazyva
Chronic lymphocytic leukemia (CLL)
 Phase 3
Phase 3 data to be presented at ASCO June 4, 2019, 10:09am CT.
CELG
$96.25
+1.42  +1.50%
Liso-cel (JCAR017) - TRANSCEND CLL-004
Chronic Lymphocytic Leukemia (CLL)
 Phase 1
Phase 1 updated data due at ASCO June 4, 2019, 9:57am.
PBYI
$16.17
+0.54  +3.45%
Neratinib - NALA
Third-line HER2-positive metastatic breast cancer
 Phase 3
Phase 3 data released December 17, 2018. PFS endpoint met but OS co-primary missed. Data to be presented at ASCO June 4, 2019, 10:09am CT. NDA filing summer 2019.
ATRA
$24.37
+0.9  +3.83%
Autologous T Cells
Malignant pleural disease
 Phase 1
Phase 1 presentation at ASCO June 4, 2019, 8:36 a.m.
TGTX
$7.00
+0.25  +3.70%
TG-1101 and TGR-1202 - UNITY-NHL study
Non-Hodgkin Lymphoma (NHL)
Phase 2/3
Phase 2/3 MZL cohort met ORR primary endpoint. Data to be presented June 4, 2019, 11:45AM CT.
ANAB
$70.66
+2.11  +3.08%
ANB020 - etokimab
Severe adult eosinophilic asthma
 Phase 2a
Phase 2a data to be presented at EAACI Congress June 5, 2019.
SBPH
$6.65
-0.3  -4.32%
Inarigivir 400mg
Healthy volunteers
 Phase 1
Full data due at the Science of HBV Cure meeting in Singapore June 7-8, 2019
OPK
$2.10
+0.11  +5.53%
OPK88003
Obesity and diabetes
 Phase 2b
ADA June 2019
Phase 2b top-line data March 21, 2019 met primary endpoint. Data to be presented at ADA meeting June 7-11, 2019. Will evaluate Phase 3 options.
XERS
$12.45
+0.05  +0.40%
Glucagon Rescue Pen
Severe hypoglycemia
 PDUFA
PDUFA date June 10, 2019.
MRK
$79.50
+0.62  +0.79%
Keytruda KN-048
Head and neck squamous cell carcinoma (HNSCC)
 Phase 3
PDUFA date under priority review June 10, 2019.
IMV
$3.90
  +0.00%
DPX-Survivac and pembrolizumab
Diffuse Large Cell Lymphoma
 Phase 2
Phase 2 top-line data due June 12, 2019 at ICML.
NKTR
$33.42
+1.27  +3.95%
NKTR-358
Systemic lupus erythematosus (SLE)
 Phase 1b
Phase 1b data due at EULAR June 13, 2019, 11:15 CEST.
KURA
$16.38
+0.63  +4.00%
Tipifarnib
Relapsed or refractory peripheral T-cell lymphoma
 Phase 2
Phase 2 additional data due at EHA June 13-16, 2019.
BLUE
$125.26
+3.78  +3.11%
LentiGlobin - HGB-212 Northstar-3
TDT and the β0/β0genotype
 Phase 3
Phase 3 data to be presented at EHA June 14, 2019, 11:30a.m. CEST
BGNE
$130.63
+6.8  +5.49%
Zanubrutinib (BGB-3111)
Waldenström’s macroglobulinemia
 Phase 1/2
Phase 1 updated data due at EHA June 14, 2019, 5:30pm.
BGNE
$130.63
+6.8  +5.49%
Tislelizumab - BGB-A317
Relapsed or refractory classical Hodgkin lymphoma (cHL)
 Phase 2
Phase 2 data presentation at EHA June 14, 2019, 5:30pm.
GBT
$58.31
+1.56  +2.75%
GBT440
Sickle cell disease
 Phase 3
Phase 3 data to be presented at EHA June 14, 2019, 4:15p.m CEST. NDA to be filed under accelerated approval.
BLUE
$125.26
+3.78  +3.11%
LentiGlobin - HGB-204
β-Thalassemia
 Phase 1/2
Updated data due at EHA June 14, 2019, 11:45 am. CEST
INCY
$78.68
+1.85  +2.41%
Ruxolitinib
Atopic dermatitis
 Phase 2
6/14/2019 (Phase 3 2020)
Phase 3 data due 2020. Phase 2 data to be presented at WCD meeting June 14, 2019 at 3:20pm CET.
BPMC
$78.97
+3.09  +4.07%
Avapritinib BLU-285 - EXPLORER
Advanced Systemic mastocytosis (SM)
 Phase 1
Phase 1 updated data due at EHA June 13-16, 2019.
ARQL
$7.17
+0.42  +6.22%
ARQ 531
B-cell malignancies
 Phase 1a
Phase 1 presentation at EHA June 13-16, 2019.
REGN
$309.95
+7.38  +2.44%
REGN1979
Non-Hodgkin Lymphoma (NHL)
 Phase 1
EHA June 2019
Phase 2 trial to commence 1H 2019. Updated Phase 1 data due at EHA June 13-16, 2019.
SNSS
$1.13
-0.01  -0.88%
SNS-062
Advanced B-Cell Malignancies
 Phase 1/2
EHA June 2019
Phase 1/2 update due at EHA meeting June 13-16, 2019.
STRO
$10.49
+0.36  +3.55%
STRO-001
Non-Hodgkin lymphoma (NHL)
 Phase 1
Phase 1 initial safety data due at EHA June 15, 2019, 5:30pm CEST.
CYAD
$20.04
+1.09  +5.75%
CYAD-01 - THINK
Various cancers - solid and hematologic cancers
 Phase 1/2
Phase 1 update due at EHA June 15, 2019, 5:30pm.
INCY
$78.68
+1.85  +2.41%
Ruxolitinib
Vitiligo
 Phase 2
Phase 2 data to be presented at WCD meeting June 15, 2019 at 9:25am CET.
FTSV
$12.54
+0.25  +2.03%
5F9 + rituximab
Non-Hodgkin Lymphoma (NHL) - cancer
 Phase 1/2
Phase 2 data to be presented at EHA June 15, 2019, 4:15pm.
GERN
$1.60
+0.06  +3.90%
Imetelstat - IMerge Study
Myelodysplastic syndromes
 Phase 2/3
Phase 3 trial to commence mid-2019. Phase 2 updated data at EHA June 15, 2019. 11:30a.m. CET
CYAD
$20.04
+1.09  +5.75%
CYAD-01 and chemotherapy (DEPLETHINK)
AML or myelodysplastic syndrome (MDS)
 Phase 1
Phase 1 update due at EHA June 15, 2019, 5:30pm.
BLUE
$125.26
+3.78  +3.11%
LentiGlobin - HGB-206
Sickle disease
 Phase 1/2
Phase 1/2 updated data due at EHA June 16, 2019, 8:15a.m. CEST
BLUE
$125.26
+3.78  +3.11%
LentiGlobin - HGB-207 Northstar-2
non-β0/β0 transfusion-dependent thalassemia (TDT)
 Phase 3
Phase 3 updated data due at EHA June 16, 2019, 8a.m. CEST
PIRS
$3.67
+0.03  +0.82%
PRS-080
Anemia of chronic disease
 Phase 2a
Phase 2a data to be presented at EHA June 16, 2019.
MRK
$79.50
+0.62  +0.79%
Keytruda - KN-158
Small cell lung cancer (SCLC)
 PDUFA priority review
PDUFA date under priority review June 17, 2019.
TBPH
$19.65
-0.19  -0.96%
Ampreloxetine (TD-9855)
nOH
 Phase 2
Phase 3 initiation of dosing announced January 28, 2019. Phase 2 five-month data to be presented 16 – 19 June, 2019 at IAPRD meeting.
EPZM
$12.58
+1.15  +10.06%
Tazemetostat
Follicular lymphoma
 Phase 2
NDA filing due 4Q 2019. Phase 2 updated data due at ICML June 21, 2019; 2:45p.m. CEST
AMAG
$10.22
+0.15  +1.49%
Vyleesi (Bremelanotide)
Female sexual dysfunction (FSD)
 PDUFA
PDUFA date extended to June 23, 2019.
PTN
$1.55
  +0.00%
Vyleesi (Bremelanotide)
Female sexual dysfunction (FSD)
 PDUFA
PDUFA date extended to June 23, 2019.
ACER
$19.71
+0.32  +1.65%
EDSIVO
Vascular Ehlers-Danlos Syndrome
 PDUFA priority review
PDUFA date under priority review June 25, 2019.
PFE
$41.67
+0.08  +0.19%
PF-06939926
Duchenne muscular dystrophy (DMD)
 Phase 1b
Phase 1b data due at PPMD Annual Conference, June 26-30, 2019
ASND
$126.36
+2.2  +1.77%
TransCon hGH
Growth hormone deficiency in children
 Phase 3
Phase 3 data released March 4, 2019. Primary endpoint met. Phase 3 fliGHt trial detailed data due June 26, 2019.
REGN
$309.95
+7.38  +2.44%
Dupixent (dupilumab)
Nasal polyps
 PDUFA priority review
PDUFA date under priority review June 26, 2019.
SNY
$41.18
-0.25  -0.60%
Dupixent (dupilumab)
Nasal polyps
 PDUFA priority review
PDUFA date under priority review June 26, 2019.
CELG
$96.25
+1.42  +1.50%
REVLIMID - AUGMENT
Relapsed or Refractory Follicular Lymphoma
 PDUFA priority review
PDUFA date under priority review June 27, 2019.
ALXN
$128.80
+1.57  +1.23%
Eculizumab
Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD)
 PDUFA priority review
PDUFA date under priority review June 28, 2019.
ATRA
$24.37
+0.9  +3.83%
ATA 129 (tab-cel) - ALLELE
Epstein-Barr virus (EBV-PTLD) after solid organ transplant (SOT)
 Phase 3
1H 2019
Phase 3 data due 1H 2019.
ARQL
$7.17
+0.42  +6.22%
ARQ 092
Overgrowth Diseases
 Phase 1/2
1H 2019
Phase 1b data due 1H 2019.
SAGE
$171.03
+7.62  +4.66%
SAGE-718
Huntington's disease
 Phase 1
1H 2019
Phase 1 biomarker data due 1H 2019 with Huntington’s Disease Phase 1 cohort data due 2H 2019.
NVS
$82.39
+0.38  +0.46%
AIN457 (Cosentyx)
Psoriatic arthritis
 Phase 3
2Q 2019
Phase 3 trial to be completed 2Q 2019.
CNCE
$11.37
+0.86  +8.18%
CTP-692 (multiple ascending dose)
Schizophrenia
 Phase 1
2Q 2019
Phase 1 top-line data due 2Q 2019.
NVO
$47.53
+0.27  +0.57%
Anti-IL 21 GLP-1 T1D (NNc)
Type 1 diabetes
 Phase 2
2Q 2019
Phase 2 data due 2Q 2019.
VRCA
$8.90
+0.11  +1.25%
VP-102
Common warts
 Phase 2
2Q 2019
Phase 2 data due 2Q 2019.
AFMD
$3.32
-0.02  -0.60%
AFM11
Non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL)
 Phase 1
2Q 2019
Phase 1 trial placed on clinical hold - October 8, 2018. Expects to hear back from FDA during 2Q 2019.
RMTI
$4.86
-0.04  -0.82%
IV Triferic
Anemia
 NDA Filing
2Q 2019
NDA filing due 2Q 2019.
AXSM
$23.60
+0.9  +3.96%
AXS-12
Narcolepsy
 Phase 2
2Q 2019
Phase 2 trial initiation announced January 30, 2019 with top-line data due 2Q 2019.
RETA
$91.63
+2.14  +2.39%
RTA 1701
Healthy Volunteers
 Phase 1
1H 2019
Phase 1 initiation announced June 20, 2018. Initial data due 1H 2019.
ITCI
$12.75
+0.46  +3.74%
ITI-007 - Monotherapy (Study 401)
Bipolar depression
 Phase 3
2Q 2019
Phase 3 top-line data due 2Q 2019.
KPTI
$5.23
+0.09  +1.75%
Eltanexor
Solid tumors
 Phase 2
1H 2019
Phase 2 data due 1H 2019.
KPTI
$5.23
+0.09  +1.75%
KPT-9274
Non-Hodgkin Lymphoma
 Phase 1/2
2Q 2019
Phase 1/2 updated tolerability data due 2Q 2019.
PHAS
$10.64
+0.02  +0.19%
PB2452
Reversal agent for ticagrelor
 Phase 2a
2Q 2019
Phase 2a initial data due 2Q 2019.
KZR
$19.57
-0.09  -0.46%
KZR-616
Lupus
 Phase 1/2
2Q 2019
Initial Phase 1b top-line data due 2Q 2019.
REGN
$309.95
+7.38  +2.44%
SAR440340
Asthma
Phase 2
2Q 2019
Phase 2 data due 2Q 2019.
SNY
$41.18
-0.25  -0.60%
SAR440340
Asthma
Phase 2
2Q 2019
Phase 2 data due 2Q 2019.
CORV
$2.52
+0.03  +1.20%
Brinavess
Atrial fibrillation (AF)
 NDA Filing
2Q 2019
NDA filing to be resubmitted 2Q 2019.
CNCE
$11.37
+0.86  +8.18%
CTP-692 (single ascending dose)
Schizophrenia
 Phase 1
2Q 2019
Phase 1 data due 2Q 2019.
ZFGN
$2.60
+0.14  +5.69%
ZGN-1061
Diabetes
 Phase 2
2Q 2019
Update regarding clinical hold due 2Q 2019.
APTX
$3.48
+0.12  +3.57%
NYX-2925
Fibromyalgia
 Phase 2
1H 2019
Phase 2 full data due 1H 2019.
VRTX
$169.12
+3.39  +2.05%
VX-445 in combination with tezacaftor and ivacaftor
Cystic fibrosis (CF) who have one copy of the F508del mutation and one minimal function mutation
 Phase 3
2Q 2019
Phase 3 data released March 6, 2019 - primary endpoint met. Further 24-week data due 2Q 2019.
VRTX
$169.12
+3.39  +2.05%
VX-150
Acute pain following bunionectomy surgery
 Phase 2b
1H 2019
Phase 2b data due 1H 2019.
PFE
$41.67
+0.08  +0.19%
PF-06439535
Biosimilar bevacizumab
 PDUFA
2Q 2019
BsUFA date 2Q 2019.
BLCM
$2.73
+0.02  +0.74%
BPX-501 Rivo-cel
Adjunct T-cell therapy administered after allogeneic HSCT - (hematopoietic stem cell transplantation) - cancer
 Phase 1/2
2Q 2019
Phase 2 paediatric top-line data due 2Q 2019.
ACIU
$5.03
+0.14  +2.86%
ACI-24 (anti-Abeta vaccine)
Alzheimer's disease-like characteristics in individuals with Down syndrome
 Phase 1/2
1H 2019
Phase 1/2 interim high dose cohort data due 1H 2019, low dose cohort data due 2019.
NERV
$5.81
+0.08  +1.40%
MIN-202 (seltorexant)
Primary insomnia
 Phase 2b
2Q 2019
Phase 2b data due 2Q 2019.
AGN
$138.48
-0.3  -0.22%
Bimatoprost
Open-angle glaucoma or ocular hypertension
 NDA Filing
1H 2019
NDA filing due 1H 2019.
GEMP
$1.12
  +0.00%
Gemcabene
Familial Partial Lipodystrophy (FPL)
 Phase 2a
2Q 2019
Phase 2 top-line data due 2Q 2019.
VTVT
$1.61
+0.05  +3.21%
TTP399
Type 1 Diabetes
 Phase 1/2
June 2019
Phase 2 (Part 1) data due June 2019. Part 2 data due 1Q 2020.
CELG
$96.25
+1.42  +1.50%
OTEZLA
Scalp Psoriasis
 sNDA Filing
2Q 2019
sNDA filing due 2Q 2019.
INSY
$0.90
-0.05  -5.55%
Naloxone nasal spray
Opioid overdose
 NDA Filing
2Q 2019
NDA filing likely due 2Q 2019 following data from nonclinical juvenile toxicity trial.
GILD
$66.52
+0.66  +1.00%
GS-9688
HBV
 Phase 2
2Q 2019
Phase 2 data due 2Q 2019.
BGNE
$130.63
+6.8  +5.49%
Zanubrutinib (BGB-3111)
Relapsed or refractory mantle cell lymphoma (MCL)
 Phase 2
1H 2019
Phase 2 updated data due 1H 2019.
JAGX
$0.18
-0.01  -6.31%
Mytesi (crofelemer)
Cancer related diarrhea (CRD)
 Phase 2
1H 2019
Phase 2 interim data due 1H 2019.
RHHBY
$33.05
-0.06  -0.18%
Mytesi (crofelemer)
Cancer related diarrhea (CRD)
 Phase 2
1H 2019
Phase 2 interim data due 1H 2019.

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.