FDA Calendar

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

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

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

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

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The public FDA Calendar is limited to 150 events in chronological order. The full calendar of approximately 700 events is available to PREMIUM MEMBERS.


Showing 150 drugs
Ticker
Price
Drug
Stage
Catalyst
Ticker Price Drug Stage Catalyst
BGNE
$133.85
+2.43  +1.85%
Tislelizumab
Urothelial carcinoma - Bladder cancer
Phase 1/2
Phase 1/2 data from ongoing trial to be presented at ESMO-IO December 14, 2018.
APLS
$18.69
-0.02  -0.11%
APL-2
Geographic atrophy (GA) associated with age-related macular degeneration (AMD)
Phase 3
1H December 2018
Phase 3 enrollment has temporarily halted due to non-infectious inflammation in patients. Update due 1H December 2018.
ACHN
$3.11
+0.04  +1.30%
ACH-4471
C3 glomerulopathy (C3G)
Phase 2
Phase 2 interim data due December 17, 2018.
ACHN
$3.11
+0.04  +1.30%
ACH-4471
Paroxysmal nocturnal hemoglobinuria (PNH)
Phase 2
Phase 2 interim data due December 17, 2018.
ACHN
$3.11
+0.04  +1.30%
ACH-5228
Healthy volunteers
Phase 1
Phase 1 interim data due December 17, 2018.
ACHN
$3.11
+0.04  +1.30%
ACH-5548
Healthy volunteers
Phase 1
Phase 1 interim data due December 17, 2018.
ACHN
$3.11
+0.04  +1.30%
ACH-4471
C3 glomerulopathy (C3G)
Phase 2
Phase 2 updated data due December 17, 2018.
ADMA
$4.53
-0.3  -6.21%
BIVIGAM
Primary humoral immunodeficiency
PDUFA
PDUFA date delayed two months to December 18, 2018.
JAZZ
$140.56
-1.54  -1.08%
JZP-110
Excessive sleepiness associated with narcolepsy
PDUFA
PDUFA date December 20, 2018.
SUPN
$35.76
+0.16  +0.45%
Oxtellar XR
Epilepsy
PDUFA
December 2018
sNDA to expand label to include monotherapy treatment. PDUFA date by the end of December 2018. NO EXACT DATE GIVEN.
RHHBY
$31.09
-0.81  -2.54%
Baloxavir marboxil
Influenza
PDUFA priority review
PDUFA date under priority review December 24, 2018.
MRK
$76.48
-1.98  -2.52%
Keytruda KN-17
Merkel Cell Carcinoma
PDUFA priority review
PDUFA date under priority review for sBLA December 28, 2018.
BMY
$52.12
-1.52  -2.83%
Sprycel (dasatinib)
Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
PDUFA
PDUFA date for sBLA December 29, 2018.
MRNS
$3.62
-0.09  -2.43%
Ganaxolone
Refractory status epilepticus (RSE)
Phase 2
4Q 2018
Phase 2 data due 4Q 2018.
KMDA
$4.68
-0.04  -0.90%
Alpha-1 antitrypsin (AAT)
Prevention of lung transplant rejection
Phase 1/2
2H 2018
Phase 2 initiated April 2016. Interim analysis 2H 2018. Top-line data due 2H 2019.
CBIO
$9.62
-0.25  -2.53%
CB 2679d/ ISU304
Hemophilia B
Phase 1/2
December 2018
Cohort 6 patients (2) safety concerns - presence of neutralizing antibodies - noted June 18, 2018. Additional data due December 2018.
VTGN
$1.62
-0.01  -0.61%
AV-101
Monotherapy Treatment Major Depressive Disorder
Phase 2
2H 2018
Phase 2 trial to be completed 2H 2018.
GILD
$65.57
-1.78  -2.64%
Tirabrutinib (GS-4059)
Chronic lymphocytic leukemia (CLL)
Phase 2
4Q 2018
Phase 2 24-week endpoint due 4Q 2018.
MRUS
$12.46
+0.42  +3.49%
MCLA-117
Acute Myeloid Leukemia
Phase 1
4Q 2018
Phase 1 early activity data is expected 4Q 2018.
DVAX
$10.62
+0.13  +1.24%
DV281
Non-small Cell Lung Cancer (NSCLC)
Phase 1
4Q 2018
Phase 1 safety and biomarker data due 4Q 2018.
ACIU
$11.19
-0.51  -4.36%
ACI-24 (anti-Abeta vaccine)
Alzheimer's disease-like characteristics in individuals with Down syndrome
Phase 1/2
Late-2018
Phase 1/2 interim data due late-2018.
SESN
$1.40
-0.04  -2.78%
Vicinium
Non-muscle invasive bladder cancer (NMIBC)
Phase 3
December 2018
Phase 3 12-month data due mid-2019. 6-month data due December 2018.
SNY
$44.05
-0.84  -1.87%
Fluzone Quadrivalent (Influenza Vaccine)
Influenza
Phase 3
4Q 2018
Phase 3 data due 4Q 2018.
HTBX
$1.29
+0.01  +0.78%
HS-110 and nivolumab (Opdivo)
Non-small cell lung cancer (NSCLC)
Phase 2
4Q 2018
Phase 2 interim data due 4Q 2018.
ONCE
$40.09
+0.81  +2.06%
SPK-7001 (SPK-CHM)
Choroideremia
Phase 1/2
YE 2018
Phase 1/2 update YE 2018.
ENTX
$3.96
-0.44  -10.00%
EB612
Hypoparathyroidism
Phase 2
4Q 2018
Phase 2 PK/PD data due 4Q 2018.
LXRX
$7.26
+0.17  +2.40%
LX9211
Neuropathic pain
Phase 1a
4Q 2018
Phase 1a data due 4Q 2018.
CELG
$68.20
-1.54  -2.21%
Oral Azacitidine - CC-486-AML-001
Post induction AML Maintenance
Phase 3
4Q 2018
Phase 3 data due 4Q 2018.
LXRX
$7.26
+0.17  +2.40%
LX2761
Type 2 diabetes
Phase 1b
4Q 2018
Phase 1b data due 4Q 2018.
CELG
$68.20
-1.54  -2.21%
ABRAXANE - PANC-003 apact
Adjuvant Therapy in Surgically Resected Pancreatic Cancer
Phase 3
4Q 2018
Phase 3 data due 4Q 2018.
CFRX
$2.08
+0.03  +1.46%
CF-301
Serious infections caused byStaph aureus including MRSA
Phase 2
4Q 2018
Phase 2 data due 4Q 2018.
CELG
$68.20
-1.54  -2.21%
REVLIMID - ROBUST
First-line ABC Diffuse large B-cell lymphoma (DLBCL)
Phase 3
4Q 2018
Phase 3 data due 4Q 2018.
EVFM
$3.54
-0.31  -8.06%
Amphora - AMPOWER
contraceptive vaginal gel
Phase 3
Late-2018
Phase 3 data due late-2018.
MRK
$76.48
-1.98  -2.52%
Keytruda KN-204
Classical Hodgkin Lymphoma
Phase 3
4Q 2018
Phase 3 data due 4Q 2018.
MRK
$76.48
-1.98  -2.52%
Keytruda KN-119
Triple negative breast cancer (TNBC)
Phase 3
4Q 2018
Phase 3 data due 4Q 2018.
MRK
$76.48
-1.98  -2.52%
Keytruda KN-522
Triple negative breast cancer (TNBC)
Phase 3
4Q 2018
Phase 3 data due 4Q 2018.
DCPH
$26.21
+0.78  +3.07%
DCC-3014
Solid tumors or hematological malignancies
Phase 1
YE 2018
Phase 1 update due YE 2018.
RARE
$46.01
-1.3  -2.75%
DTX401
GSD1
Phase 1/2
YE 2018
Phase 1/2 low dose cohort data due YE 2018.
CORT
$16.11
-1.08  -6.28%
Relacorilant
Solid tumors - cancer
Phase 1/2
YE 2018
Phase 2 pancreatic data due by end of 2018.
AGLE
$7.50
-0.19  -2.47%
Pegzilarginase (AEB1102) + KEYTRUDA
Small cell lung cancer (SCLC)
Phase 1/2
4Q 2018
Phase 1/2 top-line safety and clinical data due 4Q 2018.
FGEN
$39.55
+0.18  +0.46%
Roxadustat - ANDES
Anaemia in Chronic Kidney Disease
Phase 3
4Q 2018
Phase 3 completion of enrollment announced June 7, 2018 with data due 4Q 2018. Pooled MACE safety data 1H 2019.
AZN
$39.15
-0.09  -0.23%
Roxadustat - ANDES
Anaemia in Chronic Kidney Disease
Phase 3
4Q 2018
Phase 3 completion of enrollment announced June 7, 2018 with data due 4Q 2018. Pooled MACE safety data 1H 2019.
PTLA
$18.85
-0.26  -1.36%
Andexxa
Factor Xa inhibitor reversal agent
PDUFA
Approval announced May 3, 2018. PDUFA date December 31, 2018 for Prior Approval Supplement (PAS).
AZN
$39.15
-0.09  -0.23%
Anifrolumab
Lupus
Phase 3
2H 2018
Phase 3 TULIP 1 data released August 31, 2018. Primary endpoint not met. TULIP 2 data are due later in 2018.
NVO
$46.50
-0.27  -0.58%
Concizumab - explorer
Hemophilia A
Phase 2
4Q 2018
Phase 2 Explorer 4 data due 4Q 2018.
AMGN
$192.07
-5.46  -2.76%
AMG 301
Migraine
Phase 2
YE 2018
Phase 2 data due by end of 2018.
MRKR
$6.82
+0.04  +0.59%
TPIV200 + durvalumab
Platinum-sensitive ovarian cancer
Phase 2
2H 2018
Phase 2 interim data due 2H 2018.
PRQR
$18.00
+0.03  +0.17%
QR-313
Epidermolysis bullosa
Phase 1/2
Late 2018
Phase 1/2 trial initiation announced June 28, 2018. Interim data late 2018 with full data due 2019.
ARPO
$2.04
+0.05  +2.51%
AKB-4924 (GB004)
Ulcerative Colitis
Phase 1
4Q 2018
Phase 1 multiple ascending dose data due 4Q 2018.
SCYX
$0.49
-0.03  -5.77%
SCY-078 - oral (FURI)
Invasive candidiasis
Phase 3
4Q 2018
Phase 3 open label trial commenced 3Q 2017. Preliminary data review 4Q 2018.
FLXN
$13.35
-0.32  -2.34%
Zilretta - SHIP
Osteoarthritis of the Shoulder and Hip
Phase 2
4Q 2018
Phase 2 top-line data due 4Q 2018.
COCP
$3.12
-0.31  -9.04%
CC-31244
Hepatitis C
Phase 2a
December 2018
Phase 2a initial data due December 2018.
SPHS
$2.07
-0.08  -3.72%
Topsalysin (PRX302)
Localized low to intermediate risk prostate cancer
Phase 2
4Q 2018
Phase 2b complete data due by end of 2018.
ASLN
$4.35
-0.42  -8.80%
Varlitinib
Gastric cancer
Phase 2/3
4Q 2018
Phase 2 data due 4Q 2018.
ASLN
$4.35
-0.42  -8.80%
Varlitinib
Gastric cancer
Phase 1/2
Late-2018
Phase 1/2 interim data due 4Q 2018.
PIRS
$2.92
-0.14  -4.58%
PRS-060
Healthy subjects
Phase 1
4Q 2018 est (upcoming meeting)
Phase 1 initial data due at upcoming meeting.
TCON
$1.03
-0.08  -7.21%
TRC105 + Opdivo
Non-small cell lung cancer (NSCLC)
Phase 1/2
December 2018
Phase 1 data due December 2018.
PTN
$0.72
-0.01  -1.52%
PL-8177
Inflammatory bowel diseases
Phase 1
4Q 2018
Phase 1 data due 4Q 2018.
SNNA
$3.48
-0.63  -15.33%
SNA-125
Atopic dermatitis
Phase 1/2
4Q 2018
Phase 1/2 commencement of dosing announced March 12, 2018 with top-line data due 4Q 2018.
AQST
$7.39
-0.59  -7.39%
AQST-117
Amyotrophic Lateral Sclerosis
Phase 3
December 2018
Top-line data due December 2018.
CYTX
$0.32
+0.01  +2.19%
SCLERADEC II
Scleroderma
Phase 2
4Q 2018
Phase 2 data due 4Q 2018.
PTI
$4.81
-0.07  -1.43%
PTI-428 + PTI-801 + PTI-808
Cystic fibrosis
Phase 1
4Q 2018
Preliminary data from first cohort due 4Q 2018 with complete data due 1Q 2019.
TCON
$1.03
-0.08  -7.21%
TRC105 and Inlyta
Renal Cell Carcinoma (RCC) - cancer
Phase 2
December 2018
Phase 2 top-line data due December 2018.
BTAI
$3.84
-0.34  -8.13%
BXCL501
Schizophrenia and senile dementia of the Alzheimer’s type (SDAT)
Phase 1b
4Q 2018
Phase 1 data due 4Q 2018.
SVRA
$7.44
+0.11  +1.50%
Molgradex
Nontuberculous mycobacteria (NTM)
Phase 2a
4Q 2018
Phase 2a interim data due 4Q 2018 top-line data due 2Q 2019.
ITCI
$13.55
-0.76  -5.31%
ITI-007-201
Agitation in patients with dementia
Phase 3
4Q 2018
Phase 3 interim analysis due 4Q 2018.
PFE
$43.80
-0.77  -1.73%
XTANDI (ARCHES)
Metastatic hormone sensitive prostate cancer
Phase 3
Late-2018
Phase 3 ongoing. Primary completion date estimated late-2018.
OVID
$3.00
-0.01  -0.33%
OV935
Developmental and Epileptic Encephalopathies (dEE)
Phase 1/2
4Q 2018
Phase 1/2 top-line data 4Q 2018.
CARA
$14.05
-0.03  -0.21%
KORSUVA (CR845/difelikefalin) injection - KALM-1
Chronic kidney disease (CKD) on hemodialysis (HD) with Moderate-to Severe Pruritus
Phase 3
Late-2018/early-2019
Phase 3 interim assessment late-2018 or early 2019.
PBYI
$22.58
-0.63  -2.71%
Neratinib
Third-line HER2-positive metastatic breast cancer
Phase 3
4Q 2018 or 1H 2019
Phase 3 data due 4Q 2018 or 1H 2019.
IONS
$52.93
-0.54  -1.01%
IONIS-SOD1Rx
Amyotrophic lateral sclerosis (ALS)
Phase 1/2
2H 2018/early 2019
Phase 1/2 data possibly due 2H 2018.
HSGX
$0.55
+0.03  +5.97%
NeoCart
Cartilage defects in the knee
Phase 3
Late-2018/Early 2019
Phase 3 data released September 5, 2018. Primary endpoint not met. Update regarding possibility of filing BLA expected by end 2018 or early 2019.
ACOR
$16.18
+0.2  +1.25%
INBRIJA (CVT-301)
OFF episodes of Parkinson’s disease (PD)
PDUFA
Refuse-To-File letter August 30, 2017. New PDUFA date October 5, 2018 extended to January 5, 2018.
SPHRY
$10.40
+0.01  +0.10%
VivaGel
Bacterial vaginosis (BV)
PDUFA priority review
NDA acceptance under priority review announced July 8, 2018. No PDUFA date provided. Estimate PDUFA date of January 7, 2019 using 6-month timeline.
SPHRY
$10.40
+0.01  +0.10%
VivaGel
Bacterial vaginosis (BV)
PDUFA priority review
NDA acceptance under priority review announced July 8, 2018. No PDUFA date provided. Estimate PDUFA date of January 7, 2019 using 6-month timeline.
AXSM
$3.01
-0.06  -1.95%
AXS-05 ASCEND
Major Depressive Disorder
Phase 2
Early January 2019
Phase 2 data due early January 2019.
MRK
$76.48
-1.98  -2.52%
Keytruda - KEYNOTE-042
Non-small cell lung cancer (NSCLC)
Phase 3
PDUFA date under priority review January 11, 2019.
EXEL
$21.03
-0.26  -1.22%
Cabozantinib (CELESTIAL)
Advanced hepatocellular cancer (HCC)
Phase 3
PDUFA date January 14, 2019.
AMGN
$192.07
-5.46  -2.76%
EVENITY (Romosozumab)
Osteoporosis
PDUFA
CRL issued July 16, 2017. BLA filing resubmission announced July 13, 2018. Advisory committee meeting January 16, 2019.
RNN
$1.02
-0.01  -0.97%
RX-3117 in combination with Abraxane
First-line pancreatic cancer
Phase 2a
ASCO-GI
Phase 2 updated data due at ASCO-GI January 17-19, 2019.
LXRX
$7.26
+0.17  +2.40%
Sotagliflozin
Type 1 Diabetes
PDUFA
Advisory Committee 01/17/2019; PDUFA 03/22/2019
PDUFA date March 22, 2019. Advisory Committee Meeting January 17, 2019.
SNY
$44.05
-0.84  -1.87%
Sotagliflozin
Type 1 Diabetes
PDUFA
Advisory Committee 01/17/2019; PDUFA 03/22/2019
PDUFA date March 22, 2019. Advisory Committee Meeting January 17, 2019.
TCON
$1.03
-0.08  -7.21%
TRC105 and Nexavar
Hepatocellular carcinoma (HCC) - cancer
Phase 2
GI ASCO January 17-19, 2019
Phase 2 dosing initiated May 2016 with poster presented January 19, 2018 at ASCO GI showing 2/8 partial responses. Full data to be presented at GI ASCO January 17-19, 2019.
ASLN
$4.35
-0.42  -8.80%
Varlitinib + gemcitabine and cisplatin
Biliary tract cancer
Phase 1/2
Phase 1/2 new data to be presented at at ASCO Gastrointestinal Cancers Symposium January 18, 2019 11:30 AM.
TYME
$3.86
-0.32  -7.66%
SM-88
Pancreatic cancer
Phase 2
Phase 2 interim data to be presented January 18, 2019 at 11:30 AM at Gastrointestinal Cancers Symposium.
FPRX
$9.64
-0.17  -1.73%
FPA144 + chemo (FIGHT)
Gastric and gastro-esophageal junction cancer
Phase 1
ASCO GI January 2018
Phase 3 portion of Phase 1/3 trial has been initiated - noted September 10, 2018. Phase 1 data to be presented at ASCO GI January 18-20, 2018.
ZLAB
$23.39
-1.33  -5.38%
FPA144 + chemo (FIGHT)
Gastric and gastro-esophageal junction cancer
Phase 1
ASCO GI January 2018
Phase 3 portion of Phase 1/3 trial has been initiated - noted September 10, 2018. Phase 1 data to be presented at ASCO GI January 18-20, 2018.
IMMU
$18.73
-0.37  -1.94%
SACTUZUMAB GOVITECAN (IMMU-132)
Cancer - metastatic triple-negative breast cancer
PDUFA priority review
PDUFA date under priority review January 18, 2019.
SNY
$44.05
-0.84  -1.87%
Fluzone Quadrivalent (Influenza Vaccine)
Influenza A - children 6-35 months of age.
PDUFA
PDUFA for sBLA January 28, 2019.
MDWD
$4.82
-0.06  -1.23%
NexoBrid
Severe burns
Phase 3
January 2019
Phase 3 data due January 2019.
ALKS
$32.82
-0.95  -2.81%
ALKS 5461
Major depressive disorder
PDUFA
PDUFA date of January 31, 2019. Advisory Committee Meeting November 1, 2018 voted 2-21 against recommending approval.
BLPH
$1.08
-0.06  -5.26%
INOpulse delivery device
Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD)
Phase 2b
January 2019
Phase 2b top-line Cohort 1 data due January 2019 with Cohort 2 and 3 data due later in 2019.
SAGE
$101.99
+1.37  +1.36%
SAGE-217
Postpartum depression (PPD)
Phase 2
January 2019
Phase 3 data due January 2019.
AQST
$7.39
-0.59  -7.39%
APL-130277
Parkinson’s Disease with motor fluctuations
PDUFA
January 2019
PDUFA date January 2019.
AUPH
$6.01
-0.07  -1.15%
Voclosporin Ophthalmic Solution (VOS)
Dry eye syndrome
Phase 2
January 2019
Phase 2 data due January 2019.
GNMX
$1.21
+0.04  +3.42%
AEVI-001 (NFC-1)
ADHD - 9-Gene subset
Phase 2
January 2019
Phase 2 data due January 2019.
URGN
$44.51
-0.82  -1.81%
MitoGel - UGN-101
Urothelial Carcinoma
Phase 3
January 2019
Phase 3 data due January 2019.
VRNA
$10.99
  +0.00%
RPL554
COPD
Phase 2a
January 2019
Phase 2a add-on trial data due January 2019.
SNNA
$3.48
-0.63  -15.33%
SNA-001
Reduction of light-pigmented hair
Phase 3
Late January/early February 2019.
Phase 3 data due late January/early February 2019.
SNNA
$3.48
-0.63  -15.33%
SNA-001
Acne
Phase 3
Late January/early February 2019.
Phase 3 data released July 30, 2018 did not meet primary endpoint. Data from separate trial due late January/early February 2019.
EOLS
$12.66
+0.35  +2.84%
DWP-450
Glabellar lines
PDUFA
CRL announced May 16, 2018. New PDUFA date February 2, 2018.
SGMO
$11.48
-0.09  -0.78%
SB-913 - CHAMPIONS
MPS Type 2
Phase 1/2
02/04/2019-02/08/2019
Phase 1/2 initial mixed data released September 5, 2018. Further data due at the 2019 WORLDSymposium - February 4-8.
MTFB
$6.08
-0.22  -3.53%
Iclaprim - REVIVE-2
Acute bacterial skin and skin structure infections (ABSSSI)
PDUFA priority review
PDUFA date February 13, 2019.
ALLK
$60.70
+0.76  +1.27%
AK002
Chronic Urticaria
Phase 2
Mid-1Q 2019
Phase 2 data due mid-1Q 2019.
BHC
$22.87
-0.78  -3.30%
DUOBRII (halobetasol propionate and tazarotene)
Psoriasis
PDUFA
CRL issued June 18, 2018. New PDUFA date February 15, 2019.
MRK
$76.48
-1.98  -2.52%
KEYTRUDA - EORTC1325/KEYNOTE-054
Melanoma
PDUFA
PDUFA date February 16, 2019.
ALXN
$109.43
-3  -2.67%
ALXN1210
Paroxysmal nocturnal hemoglobinuria (PNH)
PDUFA priority review
PDUFA date under priority review February 18, 2019.
STML
$10.36
+0.39  +3.91%
SL-401
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) cancer
PDUFA priority review
PDUFA date under priority review February 21, 2019.
INCY
$66.25
-1.04  -1.55%
Ruxolitinib
Graft versus host disease
PDUFA priority review
PDUFA date under priority review February 24, 2019.
NVS
$87.39
-1.01  -1.14%
Ruxolitinib
Graft versus host disease
PDUFA priority review
PDUFA date under priority review February 24, 2019.
BHC
$22.87
-0.78  -3.30%
Loteprednol Gel 0.38%
Ocular Inflammation
PDUFA
PDUFA date February 25, 2019.
AZN
$39.15
-0.09  -0.23%
Lynparza - SOLO 1
First-line ovarian cancer following platinum-based chemotherapy
PDUFA priority review
PDUFA date under priority review 1Q 2019.
MRK
$76.48
-1.98  -2.52%
Lynparza - SOLO 1
First-line ovarian cancer following platinum-based chemotherapy
PDUFA priority review
PDUFA date under priority review 1Q 2019.
REGN
$381.17
+2.66  +0.70%
Dupixent (dupilumab)
Atopic dermatitis 12-17 year-olds
PDUFA priority review
PDUFA date under priority review March 11, 2019.
SNY
$44.05
-0.84  -1.87%
Dupixent (dupilumab)
Atopic dermatitis 12-17 year-olds
PDUFA priority review
PDUFA date under priority review March 11, 2019.
ABBV
$85.61
-2.1  -2.39%
Imbruvica and Gazyva - iLLUMINATE
Chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL)
Phase 3
1Q 2019
sNDA accepted for priority review - noted October 16, 2018. PDUFA date not given. Estimate 1Q 2019.
AERI
$38.22
-0.79  -2.03%
Roclatan
Glaucoma
PDUFA
PDUFA date March 14, 2019.
NVS
$87.39
-1.01  -1.14%
BAF312
Secondary progressive multiple sclerosis
PDUFA priority review
March 2019
PDUFA date under priority review set for March 2019. Exact date not noted.
RHHBY
$31.09
-0.81  -2.54%
Tecentriq+cb+etoposide - IMpower133
Squamous non-small cell lung cancer (NSCLC)
Phase 3
PDUFA date under priority review March 18, 2019.
SAGE
$101.99
+1.37  +1.36%
Brexanolone - SAGE-547 (202C)
Postpartum Depression - moderate
PDUFA priority review
PDUFA date extended three months to March 19, 2018. Advisory Committee meeting November 2, 2018 voted 17-1 recommending approval.
AMAG
$16.80
-0.19  -1.12%
Vyleesi (Bremelanotide)
Female sexual dysfunction (FSD)
PDUFA
PDUFA date March 23, 2019 but noted November 13, 2018 that a 3-6 month delay is likely due to FDA request for further data.
PTN
$0.72
-0.01  -1.52%
Vyleesi (Bremelanotide)
Female sexual dysfunction (FSD)
PDUFA
PDUFA date March 23, 2019 but noted November 13, 2018 that a 3-6 month delay is likely due to FDA request for further data.
REPH
$7.64
+0.07  +0.92%
Intravenous (IV) meloxicam
Acute pain following bunionectomy surgery
PDUFA
CRL announced May 24, 2018. New PDUFA date March 24, 2019.
ATHX
$1.92
-0.07  -3.52%
Multistem
Acute Respiratory Distress Syndrome
Phase 1/2
1Q 2019
Phase 1/2 data due 1Q 2019.
GILD
$65.57
-1.78  -2.64%
Selonsertib (GS-4997) - STELLAR 4
Nonalcoholic steatohepatitis (NASH)
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
AXON
$1.01
-0.12  -10.62%
AXO-Lenti-PD - SUNRISE-PD
Parkinson's disease
Phase 1/2
March 2019
Phase 1/2 data from first two patients due March 2019.
UROV
$6.00
  +0.00%
Vibegron
Overactive bladder (OAB)
Phase 3
March 2019
Phase 3 data due March 2019.
CMTA
$11.40
-0.43  -3.63%
Palovarotene
Healthy volunteers
Phase 1
1Q 2019
Phase 1 initiation announced October 2, 2018 with data due 1Q 2019.
VRCA
$10.04
-0.18  -1.76%
VP-102
Molluscum contagiosum
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
BYSI
$20.40
+0.2  +0.99%
Plinabulin (Trial 103)
Non small cell lung cancer - refractory
Phase 3
Early 2019
Phase 3 interim data due early 2019.
AKTX
$1.77
+0.07  +4.12%
Coversin
Atopic keratoconjunctivitis
Phase 1/2
1Q 2019
Phase 1/2 data due 1Q 2019.
AKTX
$1.77
+0.07  +4.12%
Coversin
Bullous Pemphigoid
Phase 2
Phase 2 data due 1Q 2019.
RYTM
$28.12
+0.02  +0.07%
Setmelanotide
POMC Heterozygous Deficiency Obesity, Alstrom Syndrome, POMC Epigenetic Disorders
Phase 2
1Q 2019
Phase 2 updated data due 1Q 2019.
SRPT
$119.52
-2.5  -2.05%
MYO-101
Duchenne muscular dystrophy - LGMD2E
Phase 1/2
1Q 2019
Phase 1/2 biomarker data due 1Q 2019.
ASND
$65.23
+1.71  +2.69%
TransCon hGH
Growth hormone deficiency in children
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
FWP
$0.88
-0.09  -9.09%
TransCon hGH
Growth hormone deficiency in children
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
ADXS
$0.24
-0.14  -36.82%
ADXS-PSA and Keytruda - KEYNOTE-046
Castrate-resistant prostate cancer
Phase 1/2
1Q 2019
Updated data due 1Q 2019.
AST
$0.82
-0.06  -6.83%
AST-OPC1 SCiSTAR
Cervical spinal cord injury
Phase 1/2
1Q 2019
Phase 1/2 12-month data from cohorts 3 and 4 released July 31, 2018 with 12-mth data from all cohorts due 1Q 2019.
BTX
$1.23
  +0.00%
AST-OPC1 SCiSTAR
Cervical spinal cord injury
Phase 1/2
1Q 2019
Phase 1/2 12-month data from cohorts 3 and 4 released July 31, 2018 with 12-mth data from all cohorts due 1Q 2019.
PTI
$4.81
-0.07  -1.43%
PTI-428 + Symdeko
Cystic fibrosis
Phase 2
1Q 2019
Phase 2 data due 1Q 2019.
GLPG
$104.12
-3.38  -3.14%
Filgotinib - FINCH 3
Rheumatoid arthritis (RA)
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
GILD
$65.57
-1.78  -2.64%
Filgotinib - FINCH 3
Rheumatoid arthritis (RA)
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
GLPG
$104.12
-3.38  -3.14%
GLPG 2451+2222+2737 - FALCON open label
Cystic fibrosis - homozygous F508del patients
Phase 1/2
1Q 2019
Phase 1b data released October 24, 2018 noted drug was well tolerated. Safety data due 1Q 2019.
ZFGN
$5.17
-0.17  -3.18%
ZGN-1061
Diabetes
Phase 2
Early 2019
Phase 2 additional data due early 2019.
MGNX
$13.69
-1.07  -7.25%
Margetuximab SOPHIA study
Metastatic breast cancer
Phase 3
1Q 2019
Phase 3 PFS data due 1Q 2019.
MGNX
$13.69
-1.07  -7.25%
Margetuximab in combination with pembrolizumab
Gastric cancer
Phase 2
1Q 2019
Phase 2 data due 1Q 2019.
APTX
$22.11
+0.51  +2.36%
NYX-2925
Neuropathic Pain Associated with Diabetic Peripheral Neuropathy
Phase 2
1Q 2019
Phase 2 data due early 1Q 2019.
AXSM
$3.01
-0.06  -1.95%
AXS-05 STRIDE-1
Treatment resistant depression
Phase 3
1Q 2019
Phase 3 final data due 1Q 2019.
ALDX
$9.46
-0.03  -0.32%
Reproxalap (ADX-102)
Allergic conjunctivitis
Phase 3
Early 2019
Phase 3 data due early 2019.
VRTX
$170.06
-3.36  -1.94%
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
1Q 2019
Phase 3 data due 1Q 2019.