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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The public FDA Calendar is limited to 150 events in chronological order. The full calendar of approximately 800 events is available to PREMIUM MEMBERS.


Showing 150 drugs
Ticker
Price
Drug
Stage
Catalyst
Ticker Price Drug Stage Catalyst
AUPH
$6.82
-0.07  -1.02%
Voclosporin Ophthalmic Solution (VOS)
Dry eye syndrome
Phase 2
Phase 2 data released January 22, 2019. Primary endpoint not met, secondary met.
SNY
$41.62
+0.13  +0.31%
Fluzone Quadrivalent (Influenza Vaccine)
Influenza A - children 6-35 months of age.
PDUFA
PDUFA for sBLA January 28, 2019.
AQST
$7.68
+0.12  +1.59%
APL-130277
Parkinson’s Disease with motor fluctuations
PDUFA
PDUFA date January 29, 2019 through partner Sunovion (private company).
ALKS
$32.44
-0.61  -1.85%
ALKS 5461
Major depressive disorder
PDUFA
PDUFA date of January 31, 2019. Advisory Committee Meeting November 1, 2018 voted 2-21 against recommending approval.
SNNA
$2.78
-0.05  -1.77%
SNA-001
Reduction of light-pigmented hair
Phase 3
Late January/early February 2019.
Phase 3 data due late January/early February 2019.
EOLS
$16.19
-0.05  -0.31%
DWP-450
Glabellar lines
PDUFA
CRL announced May 16, 2018. New PDUFA date February 2, 2018.
AVRO
$14.24
+0.74  +5.48%
AVR-RD-01
Fabry disease
Phase 1/2
Phase 1 study update and two-year data for first patient at WORLDSymposium February 6, 2019 9a.m. ET.
SGMO
$11.06
-0.01  -0.09%
SB-318
MPS Type 1
Phase 1/2
Phase 1/2 preliminary safety and biochemical measurements due at WORLDSymposium, February 7, 2019 11:15am.
CBIO
$7.75
-0.25  -3.12%
Marzeptacog alfa
Hemophilia
Phase 2/3
Phase 2 data at EAHAD 6-8 February 2019.
SGMO
$11.06
-0.01  -0.09%
SB-913 - CHAMPIONS
MPS Type 2
Phase 1/2
Biochemical and safety data due at the 2019 WORLDSymposium - February 7, 2019. 11am ET (MINOR CATALYST). More significant ERT withdrawal data due later in 2019.
MTFB
$10.01
+0.05  +0.47%
Iclaprim - REVIVE-2
Acute bacterial skin and skin structure infections (ABSSSI)
PDUFA priority review
PDUFA date February 13, 2019.
VERU
$1.35
  +0.00%
Zuclomiphene citrate
Hot flashes
Phase 2
Phase 2 poster at ASCO Genitourinary, February 14, 2019 11:30 AM.
BHC
$23.29
+0.37  +1.61%
DUOBRII (halobetasol propionate and tazarotene)
Psoriasis
PDUFA
CRL issued June 18, 2018. New PDUFA date February 15, 2019.
MRK
$75.44
-0.39  -0.51%
KEYTRUDA - EORTC1325/KEYNOTE-054
Melanoma
PDUFA
PDUFA date February 16, 2019.
TCON
$0.95
-0.09  -8.90%
TRC105 + Opdivo
Non-small cell lung cancer (NSCLC)
Phase 1/2
IASLC February 20-23, 2019
Phase 1 data to be presented at IASLC 2019 February 20-23, 2019.
INCY
$75.20
-2.13  -2.75%
Ruxolitinib
Graft versus host disease
PDUFA priority review
PDUFA date under priority review February 24, 2019.
NVS
$88.15
-0.17  -0.19%
Ruxolitinib
Graft versus host disease
PDUFA priority review
PDUFA date under priority review February 24, 2019.
BHC
$23.29
+0.37  +1.61%
Loteprednol Gel 0.38%
Ocular Inflammation
PDUFA
PDUFA date February 25, 2019.
NVO
$47.40
-0.79  -1.64%
N8-GP
Hemophilia A
PDUFA
BLA filing announced February 27, 2018. Estimated PDUFA February 26, 2019.
HTBX
$1.33
-0.03  -2.21%
HS-110 and nivolumab (Opdivo)/Keytruda
Non-small cell lung cancer (NSCLC)
Phase 2
Phase 2 interim data to be presented at 2019 ASCO-SITC February 28, 2019 1pm PST. First-line maintenance treatment with Keytruda announced January 14, 2019.
SCYX
$0.73
-0.03  -4.47%
SCY-078 - oral (FURI)
Invasive candidiasis
Phase 3
February 2019
Phase 3 open label top-line data due February 2019.
JNJ
$128.80
  +0.00%
Esketamine
Treatment resistant depression
PDUFA
NDA filing announced September 4, 2018. PDUFA estimate March 3, 2019 assuming priority review.
REGN
$401.21
-3.54  -0.87%
Dupixent (dupilumab)
Atopic dermatitis 12-17 year-olds
PDUFA priority review
PDUFA date under priority review March 11, 2019.
SNY
$41.62
+0.13  +0.31%
Dupixent (dupilumab)
Atopic dermatitis 12-17 year-olds
PDUFA priority review
PDUFA date under priority review March 11, 2019.
CELG
$86.50
+0.5  +0.58%
TECENTRIQ (atezolizumab) plus Abraxane
Triple-negative breast cancer
PDUFA
PDUFA date March 12, 2019.
RHHBY
$32.48
+0.28  +0.85%
TECENTRIQ (atezolizumab) plus Abraxane
Triple-negative breast cancer
PDUFA
PDUFA date March 12, 2019.
ABBV
$88.45
-0.21  -0.24%
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
$43.64
-0.35  -0.80%
Roclatan
Glaucoma
PDUFA
PDUFA date March 14, 2019.
NVS
$88.15
-0.17  -0.19%
BAF312
Secondary progressive multiple sclerosis
PDUFA priority review
March 2019
PDUFA date under priority review set for March 2019. Exact date not noted.
RHHBY
$32.48
+0.28  +0.85%
Tecentriq+cb+etoposide - IMpower133
Squamous non-small cell lung cancer (NSCLC)
PDUFA priority review
PDUFA date under priority review March 18, 2019.
AMRN
$17.71
+0.19  +1.08%
Vascepa REDUCE-IT outcomes trial
High Triglycerides With Mixed Dyslipidemia
Phase 3
sNDA filing due late 1Q 2019. New data due March 18, 2019 at ACC.
SAGE
$130.74
-6.55  -4.77%
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.
JAZZ
$128.01
-0.65  -0.51%
JZP-110
Excessive sleepiness associated with narcolepsy
PDUFA
PDUFA date extended by three months to March 20, 2019.
LXRX
$5.01
-0.74  -12.87%
Sotagliflozin
Type 1 Diabetes
PDUFA
PDUFA date March 22, 2019. Advisory Committee Meeting January 17, 2019 voted 8-8 that benefits outweigh risks.
SNY
$41.62
+0.13  +0.31%
Sotagliflozin
Type 1 Diabetes
PDUFA
PDUFA date March 22, 2019. Advisory Committee Meeting January 17, 2019 voted 8-8 that benefits outweigh risks.
REPH
$7.82
+0.14  +1.82%
Intravenous (IV) meloxicam
Acute pain following bunionectomy surgery
PDUFA
CRL announced May 24, 2018. New PDUFA date March 24, 2019.
HALO
$15.73
-0.18  -1.13%
Trastuzumab (Herceptin) using ENHANZE
Breast cancer
PDUFA
1Q 2019
PDUFA date 1Q 2019.
AXON
$0.96
  +0.00%
AXO-AAV-GM2
GM2 gangliosidosis
Phase 1
1Q 2019
Initial data due 1Q 2019.
GILD
$68.25
-0.3  -0.44%
Selonsertib (GS-4997) - STELLAR 4
Nonalcoholic steatohepatitis (NASH)
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
AXON
$0.96
  +0.00%
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
$8.49
-0.56  -6.19%
Vibegron
Overactive bladder (OAB)
Phase 3
March 2019
Phase 3 data due March 2019.
IRWD
$12.42
-0.3  -2.36%
MD-7246
Irritable Bowel Syndrome
Phase 2
1Q 2019
Phase 2 trial to be initiated 1Q 2019.
CMTA
$13.73
+0.39  +2.92%
Palovarotene
Healthy volunteers
Phase 1
1Q 2019
Phase 1 initiation announced October 2, 2018 with data due 1Q 2019.
BYSI
$18.20
+0.6  +3.41%
Plinabulin (Trial 103)
Non small cell lung cancer - refractory
Phase 3
Early 2019
Phase 3 interim data due early 2019.
AKTX
$1.91
+0.01  +0.53%
Coversin
Atopic keratoconjunctivitis
Phase 1/2
1Q 2019
Phase 1/2 data due 1Q 2019.
AKTX
$1.91
+0.01  +0.53%
Coversin
Bullous Pemphigoid
Phase 2
Phase 2 data due 1Q 2019.
RYTM
$28.78
-1.19  -3.97%
Setmelanotide
POMC Heterozygous Deficiency Obesity, Alstrom Syndrome, POMC Epigenetic Disorders
Phase 2
1Q 2019
Phase 2 updated data due 1Q 2019.
SRPT
$118.72
-1.56  -1.30%
MYO-101
Duchenne muscular dystrophy - LGMD2E
Phase 1/2
1Q 2019
Phase 1/2 biomarker data due 1Q 2019.
ASND
$73.02
-0.63  -0.86%
TransCon hGH
Growth hormone deficiency in children
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
FWP
$1.04
-0.06  -5.45%
TransCon hGH
Growth hormone deficiency in children
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
ADXS
$0.31
-0.04  -10.09%
ADXS-PSA and Keytruda - KEYNOTE-046
Castrate-resistant prostate cancer
Phase 1/2
1Q 2019
Updated data due 1Q 2019.
AST
$0.71
  +-0.03%
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
$0.92
-0.02  -2.37%
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
$2.91
  +0.00%
PTI-428 + Symdeko
Cystic fibrosis
Phase 2
1Q 2019
Phase 2 data due 1Q 2019.
GLPG
$102.02
-1.66  -1.60%
Filgotinib - FINCH 3
Rheumatoid arthritis (RA)
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
GILD
$68.25
-0.3  -0.44%
Filgotinib - FINCH 3
Rheumatoid arthritis (RA)
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
GLPG
$102.02
-1.66  -1.60%
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.
MGNX
$11.40
-0.13  -1.13%
Margetuximab SOPHIA study
Metastatic breast cancer
Phase 3
1Q 2019
Phase 3 PFS data due 1Q 2019.
AXSM
$8.32
-0.2  -2.35%
AXS-05 STRIDE-1
Treatment resistant depression
Phase 3
1Q 2019
Phase 3 final data due 1Q 2019.
ALDX
$8.51
+0.03  +0.35%
Reproxalap (ADX-102)
Allergic conjunctivitis
Phase 3
Early 2019
Phase 3 data due early 2019.
VRTX
$189.89
-3.99  -2.06%
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.
PFE
$42.16
-0.11  -0.26%
PF-05280014
Herceptin biosimilar
PDUFA
1Q 2019
BsUFA date 1Q 2019.
DVAX
$11.22
-0.42  -3.61%
DV281
Non-small Cell Lung Cancer (NSCLC)
Phase 1
1Q 2019
Phase 1 safety and biomarker data due 1Q 2019 estimate.
ACIU
$10.25
-0.58  -5.36%
ACI-24 (anti-Abeta vaccine)
Alzheimer's disease-like characteristics in individuals with Down syndrome
Phase 1/2
1Q 2019
Phase 1/2 interim data due 1Q 2019 est.
UTHR
$114.62
+0.72  +0.63%
Esuberaprost - BEAT
Pulmonary arterial hypertension (PAH)
Phase 3
March 2019
Phase 3 unblinding of data March 2019
AGTC
$2.97
-0.01  -0.34%
AAV Gene Therapy
CNGB3 Achromatopsia
Phase 1/2
1Q 2019
Phase 1/2 dose escalation part of trial to be completed 1Q 2019.
NVAX
$2.06
+0.04  +1.98%
RSV vaccine - prepare trial
Respiratory Syncytial Virus (RSV) in healthy pregnant women - protect infants via maternal immunization
Phase 3
1Q 2019
Phase 3 top-line data due 1Q 2019.
VTVT
$2.74
+0.02  +0.74%
TTP399
Type 1 Diabetes
Phase 1/2
Early 2019
Phase 2 data due early 2019.
CANF
$1.16
+0.01  +0.87%
Namodenoson (CF102)
Cancer - advanced liver cancer second line
Phase 2
1Q 2019
Phase 2 data due 1Q 2019.
HZNP
$21.88
-0.04  -0.18%
Teprotumumab
Thyroid Eye Disease (TED)
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
INSY
$4.02
-0.09  -2.19%
Naloxone nasal spray
Opioid overdose
Phase 3
March 2019
NDA filing due 1Q 2019 following data from nonclinical juvenile toxicity trial due March 2019.
ONCE
$42.42
-0.89  -2.06%
SPK-7001 (SPK-CHM)
Choroideremia
Phase 1/2
1Q 2019
Phase 1/2 update YE 2018.
CELG
$86.50
+0.5  +0.58%
Oral Azacitidine - CC-486-AML-001
Post induction AML Maintenance
Phase 3
1Q 2019
Phase 3 data estimated 1Q 2019.
GTHX
$20.02
+0.44  +2.25%
G1T38 plus Faslodex
ER+ breast cancer
Phase 1b
1Q 2019
Phase 1b preliminary released at ASCO 2018 - 17% PR. Additional data due 1Q 2019.
AUTL
$26.37
-2.28  -7.96%
AUTO1
Acute lymphoblastic leukemia (ALL)
Phase 1
1Q 2019
Phase 1 data due 1Q 2019.
OPK
$3.63
-0.05  -1.36%
OPK88003
Obesity and diabetes
Phase 2b
1Q 2019
Phase 2b top-line data due 1Q 2019.
SRPT
$118.72
-1.56  -1.30%
SRP-5051 - PPMO
Duchenne muscular dystrophy
Phase 1/2
1Q 2019
Phase 1 trial safety and dosing insight due 1Q 2019.
CELG
$86.50
+0.5  +0.58%
Ozanimod - RADIANCE
Relapsing Multiple Sclerosis
NDA Filing
1Q 2019
Refusal-to-file letter issued February 27, 2018. NDA to be refiled 1Q 2019.
GLPG
$102.02
-1.66  -1.60%
Filgotinib - FINCH 1
Rheumatoid arthritis (RA)
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
GILD
$68.25
-0.3  -0.44%
Filgotinib - FINCH 1
Rheumatoid arthritis (RA)
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
CLDX
$0.32
  +-0.09%
CDX-3379
Recurrent/metastatic head and neck squamous cell cancer
Phase 2
1Q 2019
Phase 2 data due 1Q 2019.
CLBS
$4.60
-0.11  -2.34%
CLBS03 (The Sanford Project T-Rex Study)
Type 1 diabetes
Phase 2
Early 2019
Phase 2 top-line data due early 2019.
MRK
$75.44
-0.39  -0.51%
Keytruda KN-204
Classical Hodgkin Lymphoma
Phase 3
1Q 2019
Phase 3 data estimated 1Q 2019.
VRTX
$189.89
-3.99  -2.06%
VX-445 in combination with tezacaftor and ivacaftor
Cystic fibrosis (CF) who have two copies of the F508del mutation
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
MRK
$75.44
-0.39  -0.51%
Keytruda KN-119
Triple negative breast cancer (TNBC)
Phase 3
1Q 2019
Phase 3 data estimated 1Q 2019.
MRK
$75.44
-0.39  -0.51%
Keytruda KN-522
Triple negative breast cancer (TNBC)
Phase 3
1Q 2019
Phase 3 data estimated 1Q 2019.
DCPH
$25.74
-0.63  -2.39%
DCC-3014
Solid tumors or hematological malignancies
Phase 1
1Q 2019
Phase 1 update due 1Q 2019 est.
CLSN
$2.06
-0.26  -11.21%
GEN-1 OVATION 2
Ovarian cancer
Phase 1/2
1Q 2019
Phase 1/2 data due 1Q 2019.
TCON
$0.95
-0.09  -8.90%
TRC105 (TAPPAS)
Angiosarcoma cancer
Phase 3
1Q 2019
Phase 3 dosage of first patient announced February 16, 2017. Interim analysis due 1Q 2019.
CORT
$14.97
+0.29  +1.98%
Relacorilant
Solid tumors - cancer
Phase 1/2
1Q 2019
Phase 2 pancreatic data due 1Q 2019.
MACK
$5.12
  +0.00%
MM-310
Solid tumors
Phase 1
1Q 2019
Phase 1 safety data due 1Q 2019.
BCRX
$8.81
-0.12  -1.34%
BCX7353 - ZENITH-1
Angioedema attacks in patients with hereditary angioedema (HAE)
Phase 2
1Q 2019
Phase 2 trial to be completed 1Q 2019.
IMRN
$7.38
+0.31  +4.38%
IMRN
Nonalcoholic fatty liver disease (NAFLD) - pediatric
Phase 2
1Q 2019
Phase 2 data due 1Q 2019.
AGLE
$8.49
-0.25  -2.86%
Pegzilarginase (AEB1102) + KEYTRUDA
Small cell lung cancer (SCLC)
Phase 1/2
1Q 2019
Phase 1/2 top-line safety and clinical data due 1Q 2019.
PRTO
$2.63
+0.03  +1.15%
Vonapanitase (PRT-201) PATENCY-2
Chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF)
Phase 3
March 2019
Phase 3 data due March 2019.
SGEN
$70.53
-0.22  -0.31%
Enfortumab vedotin - EV201
Urothelial cancer
Phase 2
1Q 2019
Phase 2 pivotal data due 1Q 2019.
MNK
$20.18
+0.19  +0.95%
CPP-1X/sulindac
Familial Adenomatous Polyposis (FAP)
Phase 3
Early 2019
Phase 3 data due early 2019.
AGTC
$2.97
-0.01  -0.34%
AAV-based gene therapy
X-linked Retinitis Pigmentosa (XLRP)
Phase 1/2
1Q 2019
Phase 1/2 dose escalation part of trial to be completed 1Q 2019.
AZN
$36.69
+0.42  +1.16%
Anifrolumab
Lupus
Phase 3
1Q 2019
Phase 3 TULIP 1 data released August 31, 2018. Primary endpoint not met. TULIP 2 data are due estimate 1Q 2019.
RGNX
$42.98
-0.83  -1.89%
RGX-501
Homozygous familial hypercholesterolemia (HoFH)
Phase 1/2
Early-2019
Phase 1/2 update early 2019.
NVO
$47.40
-0.79  -1.64%
Concizumab - explorer
Hemophilia A
Phase 2
1Q 2019
Phase 3 data estimated 1Q 2019.
AMGN
$201.56
-0.42  -0.21%
AMG 301
Migraine
Phase 2
1Q 2019
Phase 2 data estimated 1Q 2019
MESO
$4.78
+0.09  +1.92%
MSC-100-IV
acute graft versus host disease (aGVHD) in children
BLA Filing
1Q 2019
BLA filing due 1Q 2019.
KZIA
$2.84
-0.16  -5.31%
GDC-0084
Glioblastoma multiforme
Phase 2
Early 2019
Phase 2 trial initial efficacy data due early 2019.
MYOK
$42.75
-1.64  -3.69%
Mavacamten (MYK-461) - PIONEER-OLE
Non-obstructive Hypertrophic cardiomyopathy (HCM)
Phase 2
1Q 2019
Phase 2 additional interim data due 1Q 2019.
ALXN
$117.00
+2.71  +2.37%
ALXN1210
atypical Hemolytic Uremic Syndrome (aHUS)
Phase 3
Early 2019
Phase 3 data due early 2019.
PRQR
$15.17
-0.42  -2.69%
QR-313
Epidermolysis bullosa
Phase 1/2
Early 2019
Phase 1/2 interim data due early 2019.
ARPO
$3.51
-0.05  -1.40%
AKB-4924 (GB004)
Ulcerative Colitis
Phase 1
1Q 2019
Phase 1 multiple ascending dose data due 1Q 2019.
ARPO
$3.51
-0.05  -1.40%
AKB-9778 - TIME 2B
Non-Proliferative Diabetic Retinopathy
Phase 2
March 2019
Phase 2 completion of dosing announced January 17, 2019 with data due March 2019.
INSY
$4.02
-0.09  -2.19%
Cannabidiol
Refractory childhood absence epilepsy
Phase 2
Late-1Q 2019
Phase 2 data due late 1Q 2019.
IONS
$57.21
-0.23  -0.40%
IONIS-SOD1Rx
Amyotrophic lateral sclerosis (ALS)
Phase 1/2
Early 2019
Phase 1/2 data possibly due early 2019.
FCSC
$1.89
-0.06  -3.08%
FCX-007
Recessive dystrophic epidermolysis bullosa
Phase 1/2
1Q 2019
Phase 2 interim data due 1Q 2019 with Phase 3 trial to commence 1H 2019.
BOLD
$23.19
-0.77  -3.21%
AT342 - VALENS
Crigler-Najjar
Phase 1/2
1Q 2019
Phase 1/2 updated data due 1Q 2019.
FGEN
$51.91
+0.48  +0.93%
FG-3019
Duchenne muscular dystrophy
Phase 2
1Q 2019
Phase 2 initial data due late 1Q 2019.
AXSM
$8.32
-0.2  -2.35%
AXS-05
Smoking cessation
Phase 2
1Q 2019
Phase 2 top-line data due 1Q 2019.
ZSAN
$2.19
  +0.00%
M207-ADAM
Migraine
Phase 3
1Q 2019
12-mth safety data 1Q 2019.
PTN
$0.70
-0.01  -1.41%
PL-8177
Inflammatory bowel diseases
Phase 1
1Q 2019
Phase 1 data due 1Q 2019.
SUPN
$37.00
-0.62  -1.65%
SPN-812
ADHD
Phase 3
Phase 3 data from two of its trials in children released December 6, 2018 met primary endpoints but with concerns regarding effect size vs competition. Data from first adolescent trial due by the end of December 2018 while data from the second trial are due 1Q 2019.
SLDB
$22.93
-2.66  -10.39%
SGT-001
Duchenne Muscular Dystrophy
Phase 1/2
1Q 2019
Phase 1/2 initial data due 1Q 2019. Interim analysis 2H 2019.
CYTX
$0.34
  +-0.56%
SCLERADEC II
Scleroderma
Phase 2
1Q 2019
Phase 2 data estimated 1Q 2019
PTI
$2.91
  +0.00%
PTI-801 + Symdeko: Corrector
Cystic fibrosis
Phase 1
1Q 2019
Phase 1 data due 1Q 2019.
CNCE
$14.04
-0.24  -1.68%
CTP-692
Schizophrenia
Phase 1
1Q 2019
Phase 1 initiation announced December 17, 2018 with data due 1Q 2019.
PTI
$2.91
  +0.00%
PTI-801 and PTI-808
Cystic fibrosis
Phase 1
1Q 2019
Phase 1 data from fourth cohort are due 1Q 2019.
SNDX
$5.18
-0.1  -1.89%
Entinostat plus Tecentriq - ENCORE 603
Ovarian cancer
Phase 1/2
1Q 2019
Phase 2 top-line data due 1Q 2019.
PTI
$2.91
  +0.00%
PTI-428 + PTI-801 + PTI-808
Cystic fibrosis
Phase 1
1Q 2018
Phase 1 full data due 1Q 2019.
SNY
$41.62
+0.13  +0.31%
Isatuximab
Refractory Multiple Myeloma
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
LPTX
$2.69
-0.04  -1.47%
DKN-01 and Paclitaxel
Endometrial Cancer
Phase 2
March 2019
Phase 2 data due March 2019.
LLY
$118.79
+1.7  +1.45%
Abemaciclib (Verzenio)
HER2+ breast cancer
Phase 2
Early 2019
Phase 2 data due early 2019.
OPNT
$14.31
+0.09  +0.63%
OPNT001
Bulimia Nervosa
Phase 2
1Q 2019
Phase 2 data due 1Q 2019.
BFRA
$13.29
  +0.00%
Ameluz
Actinic keratosis
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
REGN
$401.21
-3.54  -0.87%
Dupixent (dupilumab)
Nasal polyps
BLA Filing
1Q 2019
Phase 3 data released October 16, 2018 - primary and secondary endpoints met. sBLA filing 1Q 2019.
SNY
$41.62
+0.13  +0.31%
Dupixent (dupilumab)
Nasal polyps
BLA Filing
1Q 2019
Phase 3 data released October 16, 2018 - primary and secondary endpoints met. sBLA filing 1Q 2019.
TYME
$2.13
-0.05  -2.29%
SM-88
Prostate cancer
Phase 2
1Q 2019
Phase 2 update due 1Q 2019.
ICPT
$110.63
-0.3  -0.27%
Ocaliva (Obeticholic acid (OCA)) - REGENERATE
Adult nonalcoholic steatohepatitis (NASH) patients.
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
SRRK
$15.76
+1.05  +7.14%
SRK-015
Spinal muscular atrophy (SMA
Phase 1
1Q 2019
Phase 1 interim data 1Q 2019.
JNJ
$128.80
  +0.00%
Guselkumab vs Cosentyx - ECLIPSE
Psoriasis
Phase 3
Early 2019
Phase 3 data due early 2019.
MOR
$29.13
-0.03  -0.10%
Guselkumab vs Cosentyx - ECLIPSE
Psoriasis
Phase 3
Early 2019
Phase 3 data due early 2019.
IMV
$5.51
-0.12  -2.13%
DPX-Survivac and pembrolizumab
Diffuse Large Cell Lymphoma
Phase 2
1Q 2019
Phase 2 top-line data due 1Q 2019.
IMV
$5.51
-0.12  -2.13%
DPX-Survivac and pembrolizumab
Ovarian cancer
Phase 2
1Q 2019
Phase 2 data due 1Q 2019.
NBIX
$89.32
-1.96  -2.15%
NBI-74788
Congenital Adrenal Hyperplasia (CAH) - adults
Phase 2a
1Q 2019
Phase 2a data due 1Q 2019.
TBPH
$27.05
+0.48  +1.81%
Closed Triple
Asthma
Phase 3
Early-2019
Phase 3 completion early 2019.
GSK
$39.07
+0.1  +0.26%
Closed Triple
Asthma
Phase 3
Early-2019
Phase 3 completion early 2019.
INVA
$19.69
+0.16  +0.82%
Closed Triple
Asthma
Phase 3
Early-2019
Phase 3 completion early 2019.
ALLK
$42.84
+1.69  +4.11%
AK002
Severe Allergic Conjunctivitis
Phase 1
Late 1Q/Early 2Q 2019
Phase 1 data due late 1Q/Early 2Q 2019.
EVOK
$2.76
-0.04  -1.25%
Gimoti - EVK-001
Female diabetic gastroparesis
PDUFA
PDUFA date April 1, 2019.
ADMA
$3.22
-0.18  -5.29%
RI-002
Primary Immune Deficiency Diseases
PDUFA
CRL issued July 29 2016. New PDUFA date April 2, 2019.
KPTI
$8.94
-0.22  -2.40%
Selinexor
Quadruple Refractory Multiple Myeloma
PDUFA priority review
PDUFA date under priority review April 6, 2019.
MRK
$75.44
-0.39  -0.51%
Keytruda - KEYNOTE-042
Non-small cell lung cancer (NSCLC)
Phase 3
PDUFA date under priority review extended to April 11, 2019.
ABBV
$88.45
-0.21  -0.24%
Risankizumab
Psoriasis
PDUFA
BLA filing announced April 25, 2018. PDUFA estimate April 24, 2019.
REGN
$401.21
-3.54  -0.87%
Praluent (alirocumab) ODYSSEY OUTCOMES
Cardiovascular events
PDUFA
PDUFA date for sBLA filing April 28, 2019.