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 an end-of-day summary of the day's Biotech Stock Price Movers and Pipeline Database updates.

Showing 150 drugs
Ticker
Price
Drug
Stage
Catalyst
Ticker Price Drug Stage Catalyst
VERU
$2.27
+0.04  +2.02%
Zuclomiphene citrate
Hot flashes
Phase 2
Fall 2019
Phase 2 data due fall of 2019.
BIIB
$300.26
+0.87  +0.29%
Aducanumab (Aβ mAb) - EMERGE
Alzheimer’s disease
Phase 3
Phase 3 trial discontinued due to futility - unlikely to meet primary endpoint upon completion - March 21, 2019. However, noted October 22, 2019 that it intends to submit a BLA filing early 2020 based on data that showed the primary endpoint was met. Data released December 5, 2019 noted rate of decline in CDR-SB of 23% on high dose (p=0.0101 ); 14% on low dose (p=0.1171).
EPZM
$18.22
+2.92  +19.09%
Tazemetostat
Follicular lymphoma
Phase 2
ASH 2019
NDA filing due December 2019. Updated Phase 2 data due at ASH 2019.
PRNB
$37.39
+0.99  +2.72%
PRN1008
Immune thrombocytopenic purpura (ITP)
Phase 2
ASH 2019
Phase 2 data due at ASH December 2019.
MGTA
$13.29
+0.31  +2.39%
MGTA-145
Healthy volunteers
Phase 1
Phase 1 initial data due at ASH December 7, 2019, 5:30pm.
BMY
$59.95
+0.47  +0.79%
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
$1.99
-0.15  -7.01%
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
$3.85
+0.02  +0.52%
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
$0.48
+0.1  +26.60%
Momelotinib - (Simplify 1)
Myelofibrosis
Phase 3
Presentation at ASH December 7, 2019 at 5:30pm EST.
ATNM
$0.26
+0.02  +6.31%
Iomab-B
Acute myeloid leukemia (AML)
Phase 3
Phase 3 data due at ASH December 7, 2019 at 5:30pm ET.
BLUE
$79.42
-1.23  -1.53%
LentiGlobin - HGB-206
Sickle disease
Phase 1/2
Phase 1/2 presentation of data due at ASH December 7, 2019, 5:30pm.
MOR
$32.87
+0.46  +1.42%
MOR208 + idelalisib (COSMOS)
Chronic Lymphocytic Leukemia
Phase 2
Phase 2 data to be presented at ASH December 7, 2019 at 9am EST.
UMRX
$0.69
+0.02  +2.37%
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
$0.69
+0.02  +2.37%
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
$1.32
+0.07  +5.60%
Duvelisib
Peripheral T-Cell Lymphoma (PTCL)
Phase 2
Phase 2 presentation at ASH December 7, 2019; 5:30-7:30PM ET.
AUTL
$14.74
-0.04  -0.27%
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
$1.33
-0.01  -0.75%
Onvansertib (PCM-075)
Acute Myeloid Leukemia (AML)
Phase 1/2
Phase 1/2 presentation at ASH December 7, 2019 at 2:15pm EST.
AUTL
$14.74
-0.04  -0.27%
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
$2.56
-0.01  -0.39%
APTO-253
Acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
Phase 1b
ASH December 2019
Phase 1b data to be presented during ASH December 2019.
GWPH
$101.05
-2.47  -2.39%
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
$0.60
+0.07  +12.37%
CYC065 + venetoclax
Chronic lymphocytic leukemia (CLL)
Phase 1
Phase 1 initial data due at ASH December 7, 2019 at 5:30 PM ET.
ONCT
$5.40
+0.12  +2.27%
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
$11.66
+0.07  +0.56%
SB-525
Hemophilia A
Phase 1/2
Phase 1/2 presentation at ASH December 7, 2019, 5:30pm ET.
XLRN
$49.88
+1.2  +2.47%
Luspatercept
Myelofibrosis
Phase 2
Phase 2 data due at ASH December 9, 7:00 a.m. EST.
BMY
$59.95
+0.47  +0.79%
Luspatercept
Myelofibrosis
Phase 2
Phase 2 data due at ASH December 9, 7:00 a.m. EST.
ORTX
$11.97
+0.49  +4.27%
OTL-103
Wiskott-Aldrich Syndrome (WAS)
Phase 1/2
Phase 1/2 presentation at ASH December 8, 6pm ET.
TGTX
$7.12
-0.56  -7.29%
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
$23.80
-0.32  -1.33%
HexaBody-DR5/DR5
Solid tumors
Phase 1/2
Phase 1/2 initial data to be presented at ASH December 8, 2019.
MOR
$32.87
+0.46  +1.42%
Tafasitamab - First-MIND
Diffuse Large B-cell Lymphoma
Phase 1
Phase 1 data to be presented at ASH December 8, 2019 at 9am.
QURE
$66.05
+1.47  +2.28%
AMT-061
Hemophilia B
Phase 2b
Phase 2b data to be presented at ASH December 8, 2019 at 6pm ET.
AUTL
$14.74
-0.04  -0.27%
AUTO2
Relapsed or refractory multiple myeloma
Phase 1/2
Phase 1 data due at ASH December 8, 2019 at 6PM ET.
BMY
$59.95
+0.47  +0.79%
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
$0.26
+0.02  +6.31%
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
$29.21
+0.86  +3.03%
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
$22.36
+2.65  +13.47%
RP-L102
Fanconi Anemia (FA)
Phase 1
Phase 1 data to be presented at ASH December 8, 2019 at 6pm EST.
FBIO
$1.99
-0.15  -7.01%
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
$3.85
+0.02  +0.52%
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
$2.82
+0.32  +12.80%
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
$0.32
-0.03  -8.57%
Vecabrutinib (SNS-062)
Advanced B-Cell Malignancies
Phase 1/2
Phase 1/2 data to be presented at ASH December 8, 2019, 6pm ET. ASH poster mistakenly uploaded showed 7/15 stable disease, zero partial responses.
ALPN
$3.07
+0.1  +3.37%
ALPN-101
Healthy volunteers
Phase 1
Phase 1 presentation at ASH December 8, 2019: 11:00 AM ET.
KURA
$15.61
+0.4  +2.63%
Tipifarnib
Relapsed or refractory peripheral T-cell lymphoma
Phase 2
Phase 2 data due at ASH December 8, 2019 at 1:15pm ET.
BGNE
$186.92
-2.28  -1.21%
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
$2.56
-0.01  -0.39%
CG-806
Chronic lymphocytic leukemia (CLL/SLL) or non-Hodgkin lymphomas (NHL)
Phase 1
ASH December 2019
Phase 1 data to be presented during ASH December 2019.
AUTL
$14.74
-0.04  -0.27%
AUTO3 - (AMELIA)
Acute Lymphoblastic Leukemia
Phase 1/2
Phase 1 data due at ASH December 8, 2019 at 6PM ET.
BPMC
$78.48
+3.92  +5.26%
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
$119.64
-0.13  -0.11%
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
$2.83
-0.02  -0.70%
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
$79.42
-1.23  -1.53%
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
$13.29
+0.31  +2.39%
MGTA-456
Acute Lymphoblastic Leukemia
Phase 2
Phase 2 data due at ASH December 9, 2019, 4pm EST.
CYAD
$12.68
+0.61  +5.05%
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
$6.17
+0.02  +0.33%
Danicopan (ACH-4471)
Paroxysmal nocturnal hemoglobinuria (PNH)
Phase 2
Phase 2 presentation at ASH December 9, 2019 at 6pm ET.
ALXN
$113.89
+6.47  +6.02%
Danicopan (ACH-4471)
Paroxysmal nocturnal hemoglobinuria (PNH)
Phase 2
Phase 2 presentation at ASH December 9, 2019 at 6pm ET.
AGIO
$40.94
+0.86  +2.15%
AG-348 - Mitapivat (DRIVE)
Pyruvate Kinase Deficiency
Phase 2
Phase 2 data to be presented at ASH December 9, 2019 from 6pm ET.
SGMO
$11.66
+0.07  +0.56%
ST-400
beta-thalassemia
Phase 1/2
Phase 1/2 presentation at ASH December 9, 2019, 6pm ET.
ORTX
$11.97
+0.49  +4.27%
OTL-203
MPS I
Phase 1/2
Phase 1 data to be presented at ASH December 9, 2019 7am ET.
GMAB
$23.80
-0.32  -1.33%
GEN3013 (DuoBody-CD3xCD20)
B-cell Lymphoma
Phase 1/2
Phase 1/2 initial data to be presented at ASH December 9, 2019.
KDMN
$4.50
+0.41  +10.02%
KD025-208
Chronic graft-versus-host disease (cGVHD)
Phase 2
Phase 2 data due to be presented at ASH December 9, 2019, 4:30p.m. ET.
OBSV
$4.57
+0.26  +6.03%
Linzagolix OBE2109 - PRIMROSE 2
Uterine fibroids
Phase 3
Phase 3 data to be announced Monday December 9, 2019. CC 8am EST.
APRE
$26.05
+1.89  +7.82%
APR-246 and azacitidine
TP53 mutated myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML)
Phase 2
Phase 2 data to be presented at ASH December 9, 2019.
GMDA
$5.10
+0.01  +0.20%
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
$79.42
-1.23  -1.53%
bb21217
Multiple Myeloma
Phase 1
Phase 1 data due at ASH December 9, 2019, 6:45 p.m. ET.
BMY
$59.95
+0.47  +0.79%
bb21217
Multiple Myeloma
Phase 1
Phase 1 data due at ASH December 9, 2019, 6:45 p.m. ET.
AGIO
$40.94
+0.86  +2.15%
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
+0.06  +19.82%
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
$14.44
+0.3  +2.12%
5F9 + Azacitidine
Acute myeloid leukemia (AML)
Phase 1
Phase 1b presentation at ASH December 9, 2019, 8:00 a.m EST.
IMGN
$3.87
-0.03  -0.64%
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.
CALA
$4.68
+0.26  +5.88%
Telaglenastat (CB-839) and azacitidine
Myelodysplastic Syndrome
Phase 2
Phase 2 data to be presented at ASH December 9 at 7:30 a.m. EST.
TGTX
$7.12
-0.56  -7.29%
TG-1701
Non Hodgkin Lymphoma / Chronic Lymphocytic Leukemia
Phase 1
Phase 1 data to be presented at ASH December 9, 2019; 6:00 PM ET.
CRIS
$1.57
-0.27  -14.67%
CA-4948
Relapsed or Refractory Non-Hodgkin Lymphoma
Phase 1
Phase 1 update due later at ASH December 9, 2019, 6:00 p.m. Dose escalation to continue.
ARQL
$9.66
+0.15  +1.63%
ARQ 531
B-cell malignancies
Phase 1
Phase 1 presentation at ASH December 9, 2019 at 6pm EST.
XNCR
$41.06
+0.45  +1.11%
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
$79.42
-1.23  -1.53%
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
$9.68
+0.42  +4.59%
Flotetuzumab
AML/MDS
Phase 1
Phase 1 updated data to be presented at ASH December 9, 2019 at 2:45pm ET.
CNST
$43.70
+1.05  +2.46%
CPI-0610 and ruxolitinib
Myelofibrosis
Phase 2
Phase 2 additional data due at ASH December 9, 2019 at 11:15 AM.
REGN
$372.26
+3.92  +1.06%
REGN1979
Follicular Lymphoma
Phase 1
Phase 1 updated data due at ASH December 9, 2019, 4PM.
STML
$10.31
+0.51  +5.15%
SL-401 (Elzonris)
Myelofibrosis (MF)
Phase 2
Phase 1/2 presentation at ASH December 9, 2019 8:15 AM ET.
CTIC
$0.93
-0.03  -2.90%
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
$1.51
-0.01  -0.66%
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.
APRE
$26.05
+1.89  +7.82%
APR-246 and azacitidine
Myelodysplastic syndromes (MDS)
Phase 2
Phase 2 data to be presented at ASH December 9, 2019 at 11:15 am ET.
CYAD
$12.68
+0.61  +5.05%
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
$19.66
+1.15  +6.21%
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
$1.30
-0.86  -39.81%
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
$9.68
+0.42  +4.59%
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
$41.28
+0.12  +0.29%
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.
AMGN
$233.77
+0.36  +0.15%
KYPROLIS (CANDOR)
Multiple Myeloma
Phase 3
Phase 3 data met primary endpoint - September 13, 2019. LBA at ASH December 10, 2019, 7:30 AM.
GMAB
$23.80
-0.32  -1.33%
KYPROLIS (CANDOR)
Multiple Myeloma
Phase 3
Phase 3 data met primary endpoint - September 13, 2019. LBA at ASH December 10, 2019, 7:30 AM.
SNY
$46.03
-0.05  -0.11%
Sutimlimab (BIVV009) - Cardinal
Cold agglutinin disease
Phase 3
Phase 3 data to be presented at ASH December 10, 2019 at 7:45AM.
BMY
$59.95
+0.47  +0.79%
Oral Azacitidine - CC-486-AML-001
AML Maintenance
Phase 3
Phase 3 trial met primary endpoint - September 12, 2019. LBA at ASH December 10, 2019, 7:30 AM
GRTS
$9.09
+0.67  +7.96%
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.
SGEN
$117.50
+0.34  +0.29%
(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
$22.90
+2.36  +11.49%
Lerociclib (G1T38) plus Faslodex
ER+ breast cancer
Phase 1b
Phase 1b additional data due at SABCS December 11, 2019.
GRTS
$9.09
+0.67  +7.96%
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
$186.37
+0.29  +0.16%
UBROGEPANT
Migraine
PDUFA
December 2019
NDA acceptance announced March 11, 2019. PDUFA December 2019. No exact date provided.
ONCS
$2.24
+0.03  +1.36%
TAVO + KEYTRUDA KEYNOTE-890
Triple negative breast cancer (TNBC)
Phase 2
Phase 2 interim data to be presented at SABCS December 12, 2019 from 5:00 p.m CT.
ONCT
$5.40
+0.12  +2.27%
Cirmtuzumab and paclitaxel
Breast cancer
Phase 1
Phase 1 data due at SABCS December 12, 2019 from 5pm.
BLRX
$2.31
+0.27  +13.24%
BL-8040 in combination with KEYTRUDA
Pancreatic cancer
Phase 2a
Phase 2a data to be presented at ESMO December 13, 2019.
BLRX
$2.31
+0.27  +13.24%
BL-8040 in combination with KEYTRUDA - COMBAT trial
Pancreatic cancer
Phase 2
Phase 2 data released December 5, 2019 noted 4/15 partial responses. Updated data due at ESMO-IO, December 13, 2019 with PFS data due mid-2020.
FLXN
$19.53
+0.54  +2.84%
Zilretta - FX006 repeat
Osteoarthritis of the knee
PDUFA
December 2019 est
PDUFA date for sNDA filing delayed. Decision due in the coming weeks - noted November 11, 2019.
ATNX
$17.75
+1.31  +7.97%
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.
LIFE
$4.42
-0.02  -0.53%
ATYR1923
Pulmonary sarcoidosis
Phase 1/2
December 9-13, 2019
Phase 1/2 interim data due second week of December 2019 with final data due mid-2020.
AVDL
$6.30
+0.54  +9.38%
AV001
Hospital product
PDUFA
PDUFA date extended by three months to December 15, 2019.
EPZM
$18.22
+2.92  +19.09%
Tazemetostat
Epithelioid Sarcoma
PDUFA priority review
Advisory Committee 12/18/2019; PDUFA 01/23/2020
PDUFA date priority review January 23, 2020. FDA Advisory Committee meeting December 18, 2019 from 1pm ET.
PFE
$38.29
+0.26  +0.68%
XTANDI (ARCHES)
Metastatic hormone sensitive prostate cancer
PDUFA priority review
4Q 2019
PDUFA date under priority review 4Q 2019.
BHC
$29.11
+0.16  +0.55%
IDP-123
Psoriasis
PDUFA
PDUFA date December 22, 2019.
ITCI
$10.20
+0.39  +3.98%
Lumateperone
Schizophrenia
PDUFA
PDUFA date extended by three months to December 27, 2019. No advisory committee meeting expected.
AMRN
$22.45
+0.64  +2.93%
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
$56.74
-0.33  -0.58%
PYY 1562
Obesity
Phase 1
4Q 2019
Phase 1 data due 4Q 2019.
BIIB
$300.26
+0.87  +0.29%
BIIB092 - Anti Tau
Progressive supranuclear palsy (PSP)
Phase 2
4Q 2019
Phase 2 data due 4Q 2019.
AXSM
$45.43
+2.19  +5.06%
AXS-05 -GEMINI
Major Depressive Disorder
Phase 3
4Q 2019
Phase 3 data due 4Q 2019.
SAGE
$64.46
+4.28  +7.11%
SAGE-718
Huntington's disease
Phase 1
4Q 2019
Phase 1 data due 4Q 2019.
VTGN
$0.44
  +1.12%
AV-101
Healthy volunteers
Phase 1b
2H 2019
Phase 1b data due 2H 2019.
IONS
$64.61
+0.08  +0.12%
IONIS-FXIRx
End-stage renal disease
Phase 2b
2019
Phase 2b data likely due 2019.
SPPI
$9.84
+0.34  +3.58%
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
$8.36
-0.61  -6.80%
TWIN
Acne
Phase 3
4Q 2019
Phase 3 data due 4Q 2019.
RGNX
$44.74
+1.21  +2.78%
RGX-121
MPS II
Phase 1/2
YE 2019
Phase 1/2 update due at the end of 2019.
GILD
$67.08
+1.15  +1.74%
Cilofexor (GS-9674) and firsocostat (GS-0976) - ATLAS
Nonalcoholic steatohepatitis (NASH)
Phase 2
4Q 2019
Phase 2b 48-week data due 4Q 2019.
ARQL
$9.66
+0.15  +1.63%
Miransertib - ARQ 092
Solid tumors
Phase 1b
2H 2019
Phase 1b data due 2H 2019.
HEPA
$5.19
-0.2  -3.71%
CRV431
Hepatitis B
Phase 1
4Q 2019
MAD trial commencement of dosing announced August 14, 2019 with data due 4Q 2019.
TRIL
$0.30
-0.01  -2.82%
TTI-622
Refractory lymphoma or multiple myeloma
Phase 1b
Late-2019
Phase 1a/b preliminary data due late-2019.
BMRN
$79.92
-0.16  -0.20%
Vosoritide
Achondroplasia - young children
Phase 2
YE 2019
Phase 3 top-line data due end of 2019.
BGNE
$186.92
-2.28  -1.21%
Tislelizumab
Hepatocellular carcinoma (HCC) - second-line
Phase 2
2019
Phase 2 data due 2019 or early 2020.
KMDA
$7.37
-0.03  -0.41%
Alpha-1 antitrypsin (AAT)
Prevention of lung transplant rejection
Phase 1/2
YE 2019
Phase 2 top-line data due YE 2019.
GSK
$45.51
+0.3  +0.66%
TSR-042 - GARNET
Endometrial cancer
Phase 1
2H 2019
Phase 1 pivotal data and BLA filing due 2H 2019.
VRTX
$223.25
+0.18  +0.08%
VX-147
Healthy volunteers
Phase 1
4Q 2019
Phase 1 trial to be completed in 4Q 2019.
ACER
$3.67
+0.09  +2.51%
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
$18.26
+0.08  +0.44%
DNL747
Amyotrophic Lateral Sclerosis
Phase 1b
4Q 2019
Phase 1b commencement of dosing announced January 8, 2019. Data due 4Q 2019.
RHHBY
$38.57
+0.14  +0.36%
Idasanutlin (RG7388) - MIRROS
Acute myeloid leukemia (AML)
Phase 3
4Q 2019
Phase 3 data due 4Q 2019.
KPTI
$16.29
-1.16  -6.65%
Selinexor - SADAL
Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)
NDA Filing
4Q 2019
NDA filing due 4Q 2019.
AKTX
$1.98
  +0.00%
Coversin
Atopic keratoconjunctivitis
Phase 1/2
4Q 2019
Phase 1/2 Part B data due 4Q 2019.
MTEM
$12.24
+0.4  +3.38%
MT-5111
HER2-positive solid tumors
Phase 1
4Q 2019
Phase 1 update due 4Q 2019.
ACST
$1.86
-0.04  -2.11%
CaPre (TRILOGY 1 and 2)
Hypertriglyceridemia
Phase 3
December 2019
Phase 3 top-line data due in December 2019 (1) and late-January 2020 (2).
ADMS
$6.47
-0.04  -0.69%
GOCOVRI (amantadine)
Multiple sclerosis (MS)
Phase 3
4Q 2019
Phase 3 data due 4Q 2019.
HALO
$19.16
+0.1  +0.52%
Efgartigimod (ARGX-113) and Enhanze
Phase 1
YE 2019
Phase 1 data due YE 2019.
ARGX
$147.42
-2.2  -1.47%
Efgartigimod (ARGX-113) and Enhanze
Phase 1
YE 2019
Phase 1 data due YE 2019.
NLNK
$1.52
-0.05  -3.18%
Indoximod in combination with chemotherapy and radiation
Diffuse intrinsic pontine glioma (DIPG)
Phase 1
YE 2019
Phase 1 updated data due later in 2019.
KPTI
$16.29
-1.16  -6.65%
KPT-9274
Non-Hodgkin Lymphoma
Phase 1/2
2019
Phase 1/2 updated tolerability data due 2019.
SRNE
$3.52
+0.26  +7.98%
Resiniferatoxin
Osteoarthritis Knee
Phase 1b
2H 2019
Phase 1b trial to conclude in 2019 with Phase 3 trial to commence 1H 2020.
IONS
$64.61
+0.08  +0.12%
Durvalumab Plus Danvatirsen
Refractory head and neck cancer
Phase 1/2
2019
Phase 1b/2 data likely due 2019.
AZN
$47.68
+0.06  +0.13%
Durvalumab Plus Danvatirsen
Refractory head and neck cancer
Phase 1/2
2019
Phase 1b/2 data likely due 2019.
CHRS
$18.15
+0.58  +3.30%
Lucentis Biosimilar
Biosimilar
BLA Filing
4Q 2019
BLA filing due 4Q 2019.
REGN
$372.26
+3.92  +1.06%
SAR440340
Chronic Obstructive Pulmonary Disease (COPD)
Phase 2
4Q 2019
Phase 2 data due 4Q 2019.
SNY
$46.03
-0.05  -0.11%
SAR440340
Chronic Obstructive Pulmonary Disease (COPD)
Phase 2
4Q 2019
Phase 2 data due 4Q 2019.
CYCN
$1.89
-0.04  -2.07%
IW-6463
Healthy volunteers
Phase 1
4Q 2019
Phase 1 data due 4Q 2019.
VTGN
$0.44
  +1.12%
AV-101
Monotherapy Treatment Major Depressive Disorder
Phase 2
4Q 2019
Phase 2 data due 4Q 2019.
LLY
$119.64
-0.13  -0.11%
Empagliflozin
Heart failure with preserved ejection fraction (HFpEF)
Phase 3
4Q 2019
Phase 3 data due 4Q 2019.
PFNX
$10.62
  +0.00%
PCV-15 (V114)
Pneumococcal disease
Phase 3
YE 2019
Phase 3 data possibly due by end of 2019.
LLY
$119.64
-0.13  -0.11%
Empagliflozin
Heart failure with reduced ejection fraction (HFrEF)
Phase 3
4Q 2019
Phase 3 data due 4Q 2019.
SNY
$46.03
-0.05  -0.11%
Sutimlimab (BIVV009)
Immune Thrombocytopenic Purpura
Phase 1
4Q 2019
Phase 1 data due 4Q 2019.
XERS
$8.75
+0.07  +0.81%
Self administered glucagon
Exercise-Induced Hypoglycemia
Phase 2
4Q 2019
Phase 2b data due 4Q 2019.
XERS
$8.75
+0.07  +0.81%
Self administered glucagon
Post-Bariatric Hypoglycemia
Phase 2
4Q 2019
Phase 2b data due 4Q 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.