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
VERU
$2.29
+0.03  +1.10%
Zuclomiphene citrate
Hot flashes
Phase 2
Fall 2019
Phase 2 data due fall of 2019.
BLUE
$76.20
-3.22  -4.05%
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
$14.80
+1.51  +11.36%
MGTA-456
Acute Lymphoblastic Leukemia
Phase 2
Phase 2 data due at ASH December 9, 2019, 4pm EST.
CYAD
$12.59
-0.09  -0.71%
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
$6.19
+0.02  +0.32%
Danicopan (ACH-4471)
Paroxysmal nocturnal hemoglobinuria (PNH)
Phase 2
Phase 2 presentation at ASH December 9, 2019 at 6pm ET.
ALXN
$113.77
-0.12  -0.11%
Danicopan (ACH-4471)
Paroxysmal nocturnal hemoglobinuria (PNH)
Phase 2
Phase 2 presentation at ASH December 9, 2019 at 6pm ET.
AGIO
$46.04
+5.1  +12.46%
AG-348 - Mitapivat (DRIVE)
Pyruvate Kinase Deficiency
Phase 2
Phase 2 data to be presented at ASH December 9, 2019 from 6pm ET.
ORTX
$11.93
-0.04  -0.38%
OTL-203
MPS I
Phase 1/2
Phase 1 data to be presented at ASH December 9, 2019 7am ET.
GMAB
$23.39
-0.41  -1.72%
GEN3013 (DuoBody-CD3xCD20)
B-cell Lymphoma
Phase 1/2
Phase 1/2 initial data to be presented at ASH December 9, 2019.
KDMN
$4.68
+0.18  +4.00%
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.
APRE
$28.43
+2.38  +9.14%
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
$5.01
-0.09  -1.76%
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
$76.20
-3.22  -4.05%
bb21217
Multiple Myeloma
Phase 1
Phase 1 data due at ASH December 9, 2019, 6:45 p.m. ET.
BMY
$60.57
+0.62  +1.03%
bb21217
Multiple Myeloma
Phase 1
Phase 1 data due at ASH December 9, 2019, 6:45 p.m. ET.
AGIO
$46.04
+5.1  +12.46%
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
$0.31
-0.04  -12.26%
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.
IMGN
$4.09
+0.23  +5.82%
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
  +0.00%
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.
XNCR
$41.05
-0.01  -0.02%
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
$76.20
-3.22  -4.05%
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
$9.86
+0.18  +1.86%
Flotetuzumab
AML/MDS
Phase 1
Phase 1 updated data to be presented at ASH December 9, 2019 at 2:45pm ET.
CNST
$49.19
+5.49  +12.56%
CPI-0610 and ruxolitinib
Myelofibrosis
Phase 2
Phase 2 additional data due at ASH December 9, 2019 at 11:15 AM.
REGN
$371.34
-0.92  -0.25%
REGN1979
Follicular Lymphoma
Phase 1
Phase 1 updated data due at ASH December 9, 2019, 4PM.
STML
$10.44
+0.12  +1.21%
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%
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
$1.53
+0.02  +1.32%
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
$28.43
+2.38  +9.14%
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.
XLRN
$49.92
+0.04  +0.08%
Luspatercept
Myelofibrosis
Phase 2
Phase 2 data due at ASH December 9, 7:00 a.m. EST.
BMY
$60.57
+0.62  +1.03%
Luspatercept
Myelofibrosis
Phase 2
Phase 2 data due at ASH December 9, 7:00 a.m. EST.
CYAD
$12.59
-0.09  -0.71%
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.
CORV
$1.37
+0.07  +5.38%
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
$9.86
+0.18  +1.86%
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
$42.59
+1.31  +3.17%
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
$234.34
+0.57  +0.24%
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
$23.39
-0.41  -1.72%
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
$45.75
-0.28  -0.61%
Sutimlimab (BIVV009) - Cardinal
Cold agglutinin disease
Phase 3
Phase 3 data to be presented at ASH December 10, 2019 at 7:45AM.
BMY
$60.57
+0.62  +1.03%
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
SGEN
$117.20
-0.29  -0.25%
(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
$23.14
+0.24  +1.05%
Lerociclib (G1T38) plus Faslodex
ER+ breast cancer
Phase 1b
Phase 1b additional data due at SABCS December 11, 2019.
AGN
$186.41
+0.04  +0.02%
UBROGEPANT
Migraine
PDUFA
December 2019
NDA acceptance announced March 11, 2019. PDUFA December 2019. No exact date provided.
GRTS
$9.39
+0.3  +3.30%
GRANITE-001 (GO-004)
Solid tumors
Phase 1/2
Phase 1 preliminary immunogenicity and safety data due at ESMO-IO December 12, 2019. Efficacy data due mid-2020.
NLNK
$1.58
+0.06  +3.95%
Indoximod in combination with chemotherapy and radiation
Diffuse intrinsic pontine glioma (DIPG)
Phase 1
ESMO-IO 2019
Phase 1 updated data due at ESMO Immuno-Oncology Congress 2019, 11-14 December 2019
GRTS
$9.39
+0.3  +3.30%
SLATE-001
Solid tumors
Phase 1
Phase 1 preliminary immunogenicity and safety data due at ESMO-IO December 12, 2019. Efficacy data due mid-2020.
ONCS
$2.40
+0.16  +7.14%
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
$5.56
+0.16  +2.96%
Cirmtuzumab and paclitaxel
Breast cancer
Phase 1
Phase 1 data due at SABCS December 12, 2019 from 5pm.
BLRX
$2.40
+0.09  +3.90%
BL-8040 in combination with KEYTRUDA
Pancreatic cancer
Phase 2a
Phase 2a data to be presented at ESMO December 13, 2019.
BLRX
$2.40
+0.09  +3.90%
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
$19.68
+0.15  +0.77%
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
$17.45
-0.3  -1.69%
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
$4.54
+0.12  +2.72%
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
$6.39
+0.1  +1.51%
AV001
Hospital product
PDUFA
PDUFA date extended by three months to December 15, 2019.
EPZM
$18.63
+0.41  +2.25%
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
$38.20
-0.09  -0.22%
XTANDI (ARCHES)
Metastatic hormone sensitive prostate cancer
PDUFA priority review
4Q 2019
PDUFA date under priority review 4Q 2019.
BHC
$29.08
-0.03  -0.10%
IDP-123
Psoriasis
PDUFA
PDUFA date December 22, 2019.
ITCI
$10.64
+0.44  +4.31%
Lumateperone
Schizophrenia
PDUFA
PDUFA date extended by three months to December 27, 2019. No advisory committee meeting expected.
AMRN
$22.30
-0.15  -0.67%
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
$56.81
+0.07  +0.12%
PYY 1562
Obesity
Phase 1
4Q 2019
Phase 1 data due 4Q 2019.
BIIB
$303.64
+3.38  +1.13%
BIIB092 - Anti Tau
Progressive supranuclear palsy (PSP)
Phase 2
4Q 2019
Phase 2 data due 4Q 2019.
AXSM
$46.36
+0.93  +2.04%
AXS-05 -GEMINI
Major Depressive Disorder
Phase 3
4Q 2019
Phase 3 data due 4Q 2019.
SAGE
$63.72
-0.74  -1.15%
SAGE-718
Huntington's disease
Phase 1
4Q 2019
Phase 1 data due 4Q 2019.
VTGN
$0.44
  +0.69%
AV-101
Healthy volunteers
Phase 1b
4Q 2019
Phase 1b data due 4Q 2019.
SPPI
$9.87
+0.03  +0.29%
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
  +0.00%
TWIN
Acne
Phase 3
4Q 2019
Phase 3 data due 4Q 2019.
RGNX
$45.24
+0.5  +1.13%
RGX-121
MPS II
Phase 1/2
YE 2019
Phase 1/2 update due at the end of 2019.
GILD
$67.15
+0.07  +0.10%
Cilofexor (GS-9674) and firsocostat (GS-0976) - ATLAS
Nonalcoholic steatohepatitis (NASH)
Phase 2
4Q 2019
Phase 2b 48-week data due 4Q 2019.
HEPA
$5.09
-0.1  -1.99%
CRV431
Hepatitis B
Phase 1
4Q 2019
MAD trial commencement of dosing announced August 14, 2019 with data due 4Q 2019.
BMY
$60.57
+0.62  +1.03%
liso-cel (JCAR017) - TRANSCEND NHL-001
r/r B cell non-Hodgkin lymphoma - cancer
BLA Filing
4Q 2019
Phase 1 trial met primary and secondary endpoints. ORR 73%; CR 53%. BLA filing due 4Q 2019.
BMRN
$79.98
+0.06  +0.08%
Vosoritide
Achondroplasia - young children
Phase 2
YE 2019
Phase 3 top-line data due end of 2019.
GSK
$45.55
+0.04  +0.09%
TSR-042 - GARNET
Endometrial cancer
Phase 1
2H 2019
Phase 1 pivotal data and BLA filing due 2H 2019.
VRTX
$225.16
+1.91  +0.86%
VX-147
Healthy volunteers
Phase 1
4Q 2019
Phase 1 trial to be completed in 4Q 2019.
ACER
$3.79
+0.12  +3.27%
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.
KPTI
$16.99
+0.7  +4.29%
Selinexor - SADAL
Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)
NDA Filing
4Q 2019
NDA filing due 4Q 2019.
MTEM
$12.20
-0.04  -0.33%
MT-5111
HER2-positive solid tumors
Phase 1
4Q 2019
Phase 1 update due 4Q 2019.
ACST
$1.85
-0.01  -0.80%
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
$6.51
+0.04  +0.54%
GOCOVRI (amantadine)
Multiple sclerosis (MS)
Phase 3
December 2019
Phase 3 data due second half of December 2019.
HALO
$19.23
+0.07  +0.37%
Efgartigimod (ARGX-113) and Enhanze
Phase 1
YE 2019
Phase 1 data due YE 2019.
ARGX
$151.15
+3.73  +2.53%
Efgartigimod (ARGX-113) and Enhanze
Phase 1
YE 2019
Phase 1 data due YE 2019.
SRNE
$3.62
+0.1  +2.84%
Resiniferatoxin
Osteoarthritis Knee
Phase 1b
YE 2019
Phase 1b trial to conclude by end of 2019 with Phase 3 trial to commence 1Q 2020.
CHRS
$18.10
-0.05  -0.29%
Lucentis Biosimilar
Biosimilar
BLA Filing
4Q 2019
BLA filing due 4Q 2019.
REGN
$371.34
-0.92  -0.25%
SAR440340
Chronic Obstructive Pulmonary Disease (COPD)
Phase 2
4Q 2019
Phase 2 data due 4Q 2019.
SNY
$45.75
-0.28  -0.61%
SAR440340
Chronic Obstructive Pulmonary Disease (COPD)
Phase 2
4Q 2019
Phase 2 data due 4Q 2019.
CYCN
$1.93
+0.04  +2.11%
IW-6463
Healthy volunteers
Phase 1
4Q 2019
Phase 1 data due 4Q 2019.
LLY
$119.18
-0.46  -0.38%
Empagliflozin
Heart failure with preserved ejection fraction (HFpEF)
Phase 3
4Q 2019
Phase 3 data due 4Q 2019.
PFNX
$10.60
-0.02  -0.19%
PCV-15 (V114)
Pneumococcal disease
Phase 3
YE 2019
Phase 3 data possibly due by end of 2019.
LLY
$119.18
-0.46  -0.38%
Empagliflozin
Heart failure with reduced ejection fraction (HFrEF)
Phase 3
4Q 2019
Phase 3 data due 4Q 2019.
SNY
$45.75
-0.28  -0.61%
Sutimlimab (BIVV009)
Immune Thrombocytopenic Purpura
Phase 1
4Q 2019
Phase 1 data due 4Q 2019.
XERS
$8.77
+0.02  +0.23%
Self administered glucagon
Exercise-Induced Hypoglycemia
Phase 2
4Q 2019
Phase 2b data due 4Q 2019.
XERS
$8.77
+0.02  +0.23%
Self administered glucagon
Post-Bariatric Hypoglycemia
Phase 2
4Q 2019
Phase 2b data due 4Q 2019.
TNXP
$1.08
+0.02  +1.88%
TNX-601
PK trial
Phase 1
4Q 2019
Phase 1 initiation of dosing announced September 4, 2019 with data due by the end of 2019.
BMRN
$79.98
+0.06  +0.08%
Valoctocogene roxaparvovec (BMN 270)
Hemophilia A
BLA Filing
4Q 2019
BLA filing due 4Q 2019.
MRK
$88.21
-0.64  -0.72%
Keytruda KN-177
Colorectal cancer (CRC)
Phase 3
2019
Phase 3 data due 2019.
MRK
$88.21
-0.64  -0.72%
Keytruda KN-361
Bladder cancer
Phase 3
2019
Phase 3 data due 2019.
MRK
$88.21
-0.64  -0.72%
Keytruda KN-604
Small cell lung cancer (SCLC)
Phase 3
2019
Phase 3 data due 2019.
IMMP
$1.70
+0.04  +2.41%
Eftilagimod alpha - INSIGHT-004
Solid tumors
Phase 1
4Q 2019
Phase 1 initial data due 4Q 2019.
GILD
$67.15
+0.07  +0.10%
GS-9131
HIV
Phase 2
4Q 2019
Phase 2 data due 4Q 2019.
BCRX
$2.70
+0.03  +1.12%
BCX7353 - APeX-2
Reduce or eliminate attacks in HAE patients
NDA Filing
4Q 2019
NDA filing due 4Q 2019.
ALNY
$123.65
-0.11  -0.09%
Lumasiran (ALN-GO1) ILLUMINATE-A
Primary Hyperoxaluria Type 1 (PH1)
Phase 3
Late-2019
Phase 3 data due late-2019.
LLY
$119.18
-0.46  -0.38%
LOXO-292
RET-fusion non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other tumors
NDA Filing
YE 2019
NDA filing due YE 2019.
BGNE
$189.68
+2.76  +1.48%
Zanubrutinib (BGB-3111) - ASPEN
Waldenström’s macroglobulinemia
Phase 3
4Q 2019
Phase 3 top-line data due 4Q 2019.
NERV
$6.38
+0.13  +2.06%
MIN-117
Major Depressive Disorder
Phase 2a
4Q 2019
Phase 2b data due 4Q 2019.
WVE
$32.90
+0.56  +1.73%
WVE-120102
Huntington’s disease
Phase 1/2
YE 2019
Phase 1b/2a top line data due by YE 2019.
BMRN
$79.98
+0.06  +0.08%
Vosoritide
Achondroplasia
Phase 3
YE 2019
Phase 3 top-line data due end of 2019.
FIXX
$18.44
+0.27  +1.49%
HMI-102
Phenylketonuria (PKU)
Phase 1/2
4Q 2019
Phase 1/2 data due 4Q 2019.
MOR
$33.79
+0.92  +2.80%
Lenalidomide + MOR208 - L-MIND
Relapsed or refractory diffuse large B cell lymphoma
BLA Filing
4Q 2019
Rolling BLA filing has been initiated. To be completed by end of 2019.
AGEN
$3.94
+0.03  +0.77%
Zalifrelimab - AGEN1884 (anti-CTLA-4)
Solid cancers
Phase 1
YE 2019
Phase 1 interim analysis due by end of 2019.
MEIP
$1.99
+0.03  +1.52%
Pracinostat in combination with Vidaza
High-risk Myelodysplastic Syndrome (MDS)
Phase 2
YE 2019
Phase 2 updated data due by the end of 2019.
SLS
$4.31
+0.24  +5.86%
Nelipepimut-S (NPS)
Ductal Carcinoma in Situ (DCIS)
Phase 2
YE 2019
Phase 2 initial data due by the end of 2019.
SNY
$45.75
-0.28  -0.61%
Sutimlimab (BIVV009) - Cadenza
Cold agglutinin disease
Phase 3
4Q 2019
Phase 3 data due 4Q 2019.
INCY
$95.26
+0.78  +0.83%
INC280 - capmatinib
Non-small cell lung cancer
NDA Filing
2019
NDA filing due 2019.
NVS
$92.25
+0.18  +0.20%
INC280 - capmatinib
Non-small cell lung cancer
NDA Filing
2019
NDA filing due 2019.
LCTX
$0.76
-0.02  -2.69%
VAC2
Non-small cell lung cancer (NSCLC)
Phase 1/2
YE 2019
Phase 1 immunogenicity data due around end of 2019.
GILD
$67.15
+0.07  +0.10%
GS-9688
HBV
Phase 2
4Q 2019
Phase 2 data due 4Q 2019.
CTXR
$0.49
+0.02  +3.59%
Mino-Lok
Catheter related blood stream infection
Phase 3
4Q 2019
Phase 3 interim analysis 4Q 2019.
FOLD
$9.99
-0.12  -1.19%
CLN6 Gene Therapy
Batten disease
Phase 1/2
YE 2019
Phase 1/2 additional data due by the end of 2019.
EXEL
$17.41
+0.05  +0.29%
IMspire150 - cobimetinib, atezolizumab and vemurafenib - TRILOGY
BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma
Phase 3
2H 2019
Phase 3 data due 2H 2019.
RHHBY
$38.39
-0.18  -0.47%
IMspire150 - cobimetinib, atezolizumab and vemurafenib - TRILOGY
BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma
Phase 3
2H 2019
Phase 3 data due 2H 2019.
SUPN
$22.99
+0.16  +0.70%
SPN-810 (P302)
Attention Deficit Hyperactivity Disorder (ADHD)
Phase 3
4Q 2019
Phase 3 data due by the end of 2019.
CHMA
$5.33
+0.06  +1.14%
Mycapssa - OPTIMAL
Acromegaly
NDA Filing
4Q 2019
NDA filing due 4Q 2019.
FTSV
$19.83
+5.39  +37.33%
5F9 + cetuximab
Colorectal cancer
Phase 1/2
4Q 2019
Phase 1b/2 data due 4Q 2019.
MRTX
$103.75
+1.13  +1.10%
Sitravatinib and tislelizumab
Solid tumors
Phase 1/2
4Q 2019
Phase 1b initial data due 4Q 2019.
BGNE
$189.68
+2.76  +1.48%
Sitravatinib and tislelizumab
Solid tumors
Phase 1/2
4Q 2019
Phase 1b initial data due 4Q 2019.
ELOX
$5.28
+0.14  +2.83%
ELX-02
Cystinosis
Phase 2
4Q 2019
Phase 2 data due 4Q 2019.
GTHX
$23.14
+0.24  +1.05%
Trilaciclib
Second/third-line small-cell lung cancer
NDA Filing
4Q 2019
Rolling NDA filing to commence 4Q 2019. To be completed 2Q 2020.
GLPG
$216.77
+3.27  +1.53%
Filgotinib
Rheumatoid arthritis (RA)
NDA Filing
4Q 2019
NDA filing due 4Q 2019.
GILD
$67.15
+0.07  +0.10%
Filgotinib
Rheumatoid arthritis (RA)
NDA Filing
4Q 2019
NDA filing due 4Q 2019.
CLSN
$1.49
+0.04  +2.76%
GEN-1 OVATION 2
Ovarian cancer
Phase 1/2
4Q 2019
Phase 1/2 data due 4Q 2019.
PBYI
$8.12
+0.24  +3.05%
Neratinib SUMMIT
HER2 non-amplified breast cancer that has a HER2 mutation
Phase 2
4Q 2019
Phase 2 additional data due 4Q 2019.
PBYI
$8.12
+0.24  +3.05%
Neratinib monotherapy with high dose loperamide prophylaxis - CONTROL
Extended adjuvant treatment of early stage HER2-positive breast cancer
Phase 2
4Q 2019
Phase 2 additional data due 4Q 2019.
EYPT
$1.50
+0.01  +0.33%
Yutiq
Non-infectious uveitis
sNDA Filing
2019
sNDA filing due 2019 for 6-month formulation.
BHC
$29.08
-0.03  -0.10%
EM-100
Allergic conjunctivitis
NDA Filing
December 2019
CRL issued July 12, 2019. NDA to be resubmitted in December 2019.
ETON
$6.03
+0.06  +1.00%
EM-100
Allergic conjunctivitis
NDA Filing
December 2019
CRL issued July 12, 2019. NDA to be resubmitted in December 2019.
VNDA
$17.65
+0.18  +1.06%
HETLIOZ (tasimelteon)
Smith-Magenis Syndrome
sNDA Filing
4Q 2019
sNDA filing due 4Q 2019.
CLVS
$10.76
+1.15  +11.92%
Rubraca
BRCA-mutant advanced prostate cancer
sNDA Filing
4Q 2019
sNDA filing due 4Q 2019.
FGEN
$47.61
+0.22  +0.46%
Roxadustat
Anaemia in Chronic Kidney Disease
NDA Filing
4Q 2019
NDA filing due 4Q 2019.
AZN
$47.78
+0.1  +0.22%
Roxadustat
Anaemia in Chronic Kidney Disease
NDA Filing
4Q 2019
NDA filing due 4Q 2019.
NVS
$92.25
+0.18  +0.20%
PDR001
BRAFV600 mutant metastatic melanoma
Phase 3
4Q 2019
Phase 3 data due 4Q 2019.
PRTA
$13.12
+0.28  +2.14%
PRX004
ATTR amyloidosis
Phase 1
4Q 2019
Phase 1 preliminary data due 4Q 2019.
ONCY
$1.17
+0.03  +2.63%
Pelareorep and Tecentriq - AWARE-1
Breast cancer
Phase 1b
YE 2019
Phase 1b interim data due end of 2019 with final data due 1H 2020.
INCY
$95.26
+0.78  +0.83%
Itacitinib - GRAVITAS-301
Treatment-naïve acute GVHD
Phase 3
4Q 2019
Phase 3 data due 4Q 2019.
NBRV
$1.83
+0.04  +2.07%
Contepo
Complicated urinary tract infections (cUTI)
NDA Filing
4Q 2019
NDA resubmission due 4Q 2019.
MTEM
$12.20
-0.04  -0.33%
MT-3724 and chemotherapy
Relapsed/refractory diffuse large B-cell lymphoma (DLBCL)
Phase 2
4Q 2019
Phase 2 update due 4Q 2019.
PTCT
$49.24
+0.04  +0.08%
GT-AADC
AADC deficiency
BLA Filing
4Q 2019
BLA filing due 4Q 2019.
RGNX
$45.24
+0.5  +1.13%
RGX-501
Homozygous familial hypercholesterolemia (HoFH)
Phase 1/2
YE 2019
Phase 1/2 update due at the end of 2019.
BHVN
$55.28
+0.43  +0.78%
Vazegepant
Acute treatment of migraine
Phase 2/3
4Q 2019
Phase 2/3 top-line data due 4Q 2019.
BLPH
$0.43
+0.02  +3.71%
INOpulse delivery device
Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD)
Phase 2b
YE 2019
Phase 2b Cohort 2 data due by end of 2019 with pivotal cohort 3 (Phase 3) initiation due 1Q 2020.
REGN
$371.34
-0.92  -0.25%
Dupixent (dupilumab)
Atopic dermatitis 6-11 year-olds
sNDA Filing
4Q 2019
sBLA filing due 4Q 2019.
SNY
$45.75
-0.28  -0.61%
Dupixent (dupilumab)
Atopic dermatitis 6-11 year-olds
sNDA Filing
4Q 2019
sBLA filing due 4Q 2019.
CLVS
$10.76
+1.15  +11.92%
Rucaparib - TRITON2
Castrate-resistant prostate cancer (mCRPC)
sNDA Filing
4Q 2019
sNDA due 4Q 2019.
MESO
$6.70
+0.03  +0.48%
MSC-100-IV
acute graft versus host disease (aGVHD) in children
BLA Filing
4Q 2019
Rolling BLA has been filed. To be completed 4Q 2019.
ALNY
$123.65
-0.11  -0.09%
ALN-AAT02
alpha-1 anti-trypsin deficiency-associated liver disease
Phase 1/2
Late-2019
Phase 1/2 data due late-2019.

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