Biotech Stock Catalyst and FDA Calendar for your biotech stock investing. Use our tools on your road to profit in the stock market. Biotech stocks with key binary events/catalysts - FDA Approval/PDUFA dates, Advisory Committee and Phase 2 & 3 trial data releases dates are noted. Phase 1 catalysts for small-cap companies only are listed. Refer to the FDA Calendar Glossary for a list of terms used in the FDA Decision Calendar and the Biotech Historical Catalyst Calendar for completed biotech stock catalysts.
NOTE: LARGE CAP CATALYSTS - generally only Phase 3 catalysts noted in company presentations and/or earnings releases are shown. Only NASDAQ and NYSE stocks are covered. Stocks listed on PINK/OTC exchanges are not covered.
The dates shown are provided by companies. A regulatory event, for example a PDUFA date or Advisory Committee Meeting, will be issued with an exact date by the FDA. However, most clinical release dates (i.e. Phase 1/2/3) are provided in a range format by companies (e.g, mid-2019 or 4Q 2019). Exact dates for clinical data releases are only rarely issued.
Click on the date for the source of the catalyst. Financial data are delayed 15-25 minutes.
Subscribe HERE to ensure you receive your weekly FREE copy of the BioPharmCatalyst Biotech Stock Watch list and/or our daily option of Biotech Stock Price Movers and Pipeline Database updates.
The public FDA Calendar is limited to 150 events in chronological order. The full calendar of approximately 800 events is available to PREMIUM MEMBERS.
Ticker | Price | Drug | Stage | Catalyst |
---|---|---|---|---|
BHC |
$23.75
+0.24 +1.02%
|
DUOBRII (halobetasol propionate and tazarotene)
Psoriasis
|
PDUFA | |
TCON |
$1.03
-0.02 -1.90%
|
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.
|
ORTX |
$15.78
+0.17 +1.08%
|
OTL-101
Adenosine deaminase severe combined immunodeficiency (ADA-SCID)
|
Phase 1/2 | |
BCRX |
$9.00
+0.3 +3.45%
|
BCX7353 - ZENITH-1
Angioedema attacks in patients with hereditary angioedema (HAE)
|
Phase 2 | |
ATNM |
$0.62
+-0.13%
|
Iomab-B
Hematopoietic Stem Cells Transplantation
|
Phase 3 | |
AIMT |
$23.72
+0.79 +3.45%
|
AR101
Peanut Allergy
|
Phase 3 | |
ORTX |
$15.78
+0.17 +1.08%
|
OTL-102
X-linked chronic granulomatous disease (X-CGD)
|
Phase 1/2 | |
BHC |
$23.75
+0.24 +1.02%
|
Loteprednol Gel 0.38%
Ocular Inflammation
|
PDUFA | |
KPTI |
$5.07
-3.9 -43.48%
|
Selinexor
Quadruple Refractory Multiple Myeloma
|
PDUFA priority review |
Advisory Committee 02/26/2019; PDUFA 04/06/2019
PDUFA date under priority review April 6, 2019. Advisory Committee Meeting February 26, 2019 - 12:30pm. Briefing notes released February 22, 2019.
|
SRPT |
$139.98
+3.44 +2.52%
|
MYO-101
Duchenne muscular dystrophy - LGMD2E
|
Phase 1/2 | |
HTBX |
$1.37
+0.02 +1.41%
|
HS-110 and nivolumab (Opdivo)
Non-small cell lung cancer (NSCLC)
|
Phase 2 | |
PRNB |
$31.46
+1.86 +6.28%
|
PRN1008
Pemphigus
|
Phase 2 | |
VRCA |
$10.82
-0.27 -2.43%
|
VP-102
Molluscum contagiosum
|
Phase 3 | |
CNCE |
$14.56
+0.24 +1.68%
|
CTP-543
Alopecia areata
|
Phase 2a | |
MNLO |
$8.19
+0.9 +12.35%
|
Serlopitant
Pruritus associated with psoriasis
|
Phase 2 | |
ATNX |
$13.12
+0.38 +2.98%
|
KX-01 (KX2-391) Ointment
Actinic keratosis
|
Phase 3 | |
JNJ |
$136.60
+1.18 +0.87%
|
Esketamine
Treatment resistant depression
|
PDUFA priority review | |
REGN |
$422.52
+3.9 +0.93%
|
Dupixent (dupilumab)
Atopic dermatitis 12-17 year-olds
|
PDUFA priority review | |
SNY |
$41.18
-0.15 -0.36%
|
Dupixent (dupilumab)
Atopic dermatitis 12-17 year-olds
|
PDUFA priority review | |
CELG |
$89.14
+0.49 +0.55%
|
TECENTRIQ (atezolizumab) plus Abraxane
Triple-negative breast cancer
|
PDUFA | |
RHHBY |
$34.73
+0.17 +0.51%
|
TECENTRIQ (atezolizumab) plus Abraxane
Triple-negative breast cancer
|
PDUFA | |
AERI |
$40.04
+1.34 +3.46%
|
Roclatan
Glaucoma
|
PDUFA | |
NVS |
$90.78
+0.27 +0.30%
|
BAF312
Secondary progressive multiple sclerosis
|
PDUFA priority review |
March 2019
PDUFA date under priority review set for March 2019. Exact date not noted.
|
RHHBY |
$34.73
+0.17 +0.51%
|
Tecentriq+cb+etoposide - IMpower133
Squamous non-small cell lung cancer (NSCLC)
|
PDUFA priority review | |
AMRN |
$19.87
+2.44 +14.00%
|
Vascepa REDUCE-IT outcomes trial
High Triglycerides With Mixed Dyslipidemia
|
Phase 3 | |
SAGE |
$153.97
+7.79 +5.33%
|
Brexanolone - SAGE-547 (202C)
Postpartum Depression - moderate
|
PDUFA priority review | |
JAZZ |
$126.01
+0.8 +0.64%
|
JZP-110
Excessive sleepiness associated with narcolepsy
|
PDUFA | |
LXRX |
$5.51
+0.17 +3.18%
|
Sotagliflozin
Type 1 Diabetes
|
PDUFA | |
SNY |
$41.18
-0.15 -0.36%
|
Sotagliflozin
Type 1 Diabetes
|
PDUFA | |
REPH |
$8.36
-0.04 -0.48%
|
Intravenous (IV) meloxicam
Acute pain following bunionectomy surgery
|
PDUFA | |
EIGR |
$13.18
-0.54 -3.94%
|
Avexitide (Exendin 9-39)
Post-Bariatric Hypoglycemia (PBH)
|
Phase 2 | |
HALO |
$16.81
+0.2 +1.20%
|
Trastuzumab (Herceptin) using ENHANZE
Breast cancer
|
PDUFA |
1Q 2019
PDUFA date 1Q 2019.
|
ALNY |
$78.18
+1.97 +2.58%
|
Givosiran
Acute hepatic porphyrias
|
Phase 3 |
March 2019
Phase 3 positive interim analysis reported September 27, 2018. Data due March 2019. Rolling NDA has been initiated.
|
UROV |
$11.23
+0.13 +1.17%
|
Vibegron
Overactive bladder (OAB)
|
Phase 3 |
March 2019
Phase 3 data due March 2019.
|
CMTA |
$14.94
+0.06 +0.40%
|
Palovarotene
Healthy volunteers
|
Phase 1 |
1Q 2019
Phase 1 initiation announced October 2, 2018 with data due 1Q 2019.
|
BYSI |
$18.06
-0.17 -0.96%
|
Plinabulin (Trial 103)
Non small cell lung cancer - refractory
|
Phase 3 |
Early 2019
Phase 3 interim data due early 2019.
|
NVUS |
$4.45
-0.3 -6.32%
|
OP0201
Acute Otitis Media - adults
|
Phase 1 |
1Q 2019
Phase 1 data due 1Q 2019.
|
AKTX |
$1.80
-0.05 -2.70%
|
Coversin
Atopic keratoconjunctivitis
|
Phase 1/2 |
1Q 2019
Phase 1/2 data due 1Q 2019.
|
AKTX |
$1.80
-0.05 -2.70%
|
Coversin
Bullous Pemphigoid
|
Phase 2 | |
RYTM |
$27.52
+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.
|
ASND |
$71.99
+3.02 +4.38%
|
TransCon hGH
Growth hormone deficiency in children
|
Phase 3 |
1Q 2019
Phase 3 data due 1Q 2019.
|
FWP |
$1.38
+0.04 +3.36%
|
TransCon hGH
Growth hormone deficiency in children
|
Phase 3 |
1Q 2019
Phase 3 data due 1Q 2019.
|
ADXS |
$0.36
-0.02 -6.07%
|
ADXS-PSA and Keytruda - KEYNOTE-046
Castrate-resistant prostate cancer
|
Phase 1/2 |
1Q 2019
Updated data due 1Q 2019.
|
AST |
$0.93
+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.
|
BTX |
$1.24
-0.04 -3.12%
|
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 |
$4.04
+0.05 +1.25%
|
PTI-428 + Symdeko
Cystic fibrosis
|
Phase 2 |
1Q 2019
Phase 2 data due 1Q 2019.
|
GLPG |
$98.18
+0.33 +0.34%
|
Filgotinib - FINCH 3
Rheumatoid arthritis (RA)
|
Phase 3 |
1Q 2019
Phase 3 data due 1Q 2019.
|
GILD |
$65.74
+0.19 +0.29%
|
Filgotinib - FINCH 3
Rheumatoid arthritis (RA)
|
Phase 3 |
1Q 2019
Phase 3 data due 1Q 2019.
|
GLPG |
$98.18
+0.33 +0.34%
|
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.
|
AXSM |
$9.01
+0.53 +6.25%
|
AXS-05 STRIDE-1
Treatment resistant depression
|
Phase 3 |
1Q 2019
Phase 3 final data due 1Q 2019.
|
ALDX |
$7.81
-0.15 -1.88%
|
Reproxalap (ADX-102)
Allergic conjunctivitis
|
Phase 3 |
Early 2019
Phase 3 data due early 2019.
|
PFE |
$42.96
+0.82 +1.95%
|
PF-05280014
Herceptin biosimilar
|
PDUFA |
1Q 2019
BsUFA date 1Q 2019.
|
DVAX |
$10.47
-0.12 -1.13%
|
DV281
Non-small Cell Lung Cancer (NSCLC)
|
Phase 1 |
1Q 2019
Phase 1 safety and biomarker data due 1Q 2019 estimate.
|
ACIU |
$4.35
-0.28 -6.05%
|
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 |
$118.30
+1.28 +1.09%
|
Esuberaprost - BEAT
Pulmonary arterial hypertension (PAH)
|
Phase 3 |
March 2019
Phase 3 unblinding of data March 2019
|
MGTX |
$12.76
+0.32 +2.57%
|
AAV-RPE65
RPE65-Deficiency
|
Phase 1/2 |
1Q 2019
Phase 1/2 data 1Q 2019.
|
NVAX |
$1.92
+0.02 +1.05%
|
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 |
$2.39
-0.01 -0.42%
|
TTP399
Type 1 Diabetes
|
Phase 1/2 |
Early 2019
Phase 2 data due early 2019.
|
CANF |
$1.14
+0.00%
|
Namodenoson (CF102)
Cancer - advanced liver cancer second line
|
Phase 2 |
1Q 2019
Phase 2 data due 1Q 2019.
|
HZNP |
$21.20
-0.04 -0.19%
|
Teprotumumab
Thyroid Eye Disease (TED)
|
Phase 3 |
1Q 2019
Phase 3 data due 1Q 2019.
|
INSY |
$6.16
+0.51 +9.03%
|
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 |
$51.56
+0.95 +1.88%
|
SPK-7001 (SPK-CHM)
Choroideremia
|
Phase 1/2 |
1Q 2019
Phase 1/2 update YE 2018.
|
CELG |
$89.14
+0.49 +0.55%
|
Oral Azacitidine - CC-486-AML-001
Post induction AML Maintenance
|
Phase 3 |
1Q 2019
Phase 3 data estimated 1Q 2019.
|
GTHX |
$20.33
+0.34 +1.70%
|
G1T38 plus Faslodex
ER+ breast cancer
|
Phase 1b |
1Q 2019
Phase 1b preliminary released at ASCO 2018 - 17% PR. Additional data due 1Q 2019.
|
OPK |
$2.81
+0.07 +2.55%
|
OPK88003
Obesity and diabetes
|
Phase 2b |
1Q 2019
Phase 2b top-line data due 1Q 2019.
|
SRPT |
$139.98
+3.44 +2.52%
|
SRP-5051 - PPMO
Duchenne muscular dystrophy
|
Phase 1/2 |
1Q 2019
Phase 1 trial safety and dosing insight due 1Q 2019.
|
CELG |
$89.14
+0.49 +0.55%
|
Ozanimod - RADIANCE
Relapsing Multiple Sclerosis
|
NDA Filing |
1Q 2019
Refusal-to-file letter issued February 27, 2018. NDA to be refiled 1Q 2019.
|
GLPG |
$98.18
+0.33 +0.34%
|
Filgotinib - FINCH 1
Rheumatoid arthritis (RA)
|
Phase 3 |
1Q 2019
Phase 3 data due 1Q 2019.
|
GILD |
$65.74
+0.19 +0.29%
|
Filgotinib - FINCH 1
Rheumatoid arthritis (RA)
|
Phase 3 |
1Q 2019
Phase 3 data due 1Q 2019.
|
CLDX |
$5.92
-0.07 -1.17%
|
CDX-3379
Recurrent/metastatic head and neck squamous cell cancer
|
Phase 2 |
1Q 2019
Phase 2 data due 1Q 2019.
|
CLBS |
$4.20
-0.02 -0.47%
|
CLBS03 (The Sanford Project T-Rex Study)
Type 1 diabetes
|
Phase 2 |
Early 2019
Phase 2 top-line data due early 2019.
|
DCPH |
$27.61
+1.15 +4.35%
|
DCC-3014
Solid tumors or hematological malignancies
|
Phase 1 |
1Q 2019
Phase 1 update due 1Q 2019 est.
|
CLSN |
$2.20
-0.01 -0.23%
|
GEN-1 OVATION 2
Ovarian cancer
|
Phase 1/2 |
1Q 2019
Phase 1/2 data due 1Q 2019.
|
TCON |
$1.03
-0.02 -1.90%
|
TRC105 (TAPPAS)
Angiosarcoma cancer
|
Phase 3 |
1Q 2019
Phase 3 dosage of first patient announced February 16, 2017. Interim analysis due 1Q 2019.
|
CORT |
$11.40
+0.31 +2.80%
|
Relacorilant
Solid tumors - cancer
|
Phase 1/2 |
1Q 2019
Phase 2 pancreatic data due 1Q 2019.
|
MACK |
$6.16
+0.17 +2.84%
|
MM-310
Solid tumors
|
Phase 1 |
1Q 2019
Phase 1 safety data due 1Q 2019.
|
IMRN |
$8.09
-0.01 -0.18%
|
IMRN
Nonalcoholic fatty liver disease (NAFLD) - pediatric
|
Phase 2 |
1Q 2019
Phase 2 data due 1Q 2019.
|
AGLE |
$8.25
+0.19 +2.36%
|
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 |
$3.00
+0.03 +1.01%
|
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 |
$71.23
+2.07 +2.99%
|
Enfortumab vedotin - EV201
Urothelial cancer
|
Phase 2 |
1Q 2019
Phase 2 pivotal data due 1Q 2019.
|
MNK |
$21.49
+0.97 +4.73%
|
CPP-1X/sulindac
Familial Adenomatous Polyposis (FAP)
|
Phase 3 |
Early 2019
Phase 3 data due early 2019.
|
NVO |
$49.78
+0.12 +0.24%
|
Semaglutide - oral - PIONEER
Type 2 diabetes
|
NDA Filing |
1Q 2019
Regulatory filing due 1Q 2019.
|
AZN |
$40.94
+0.51 +1.26%
|
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 |
$46.50
+0.82 +1.80%
|
RGX-501
Homozygous familial hypercholesterolemia (HoFH)
|
Phase 1/2 |
Early-2019
Phase 1/2 update early 2019.
|
NVO |
$49.78
+0.12 +0.24%
|
Concizumab - explorer
Hemophilia A
|
Phase 2 |
1Q 2019
Phase 3 data estimated 1Q 2019.
|
AMGN |
$187.50
+2 +1.08%
|
AMG 301
Migraine
|
Phase 2 |
1Q 2019
Phase 2 data estimated 1Q 2019
|
MESO |
$4.44
+0.25 +5.97%
|
MSC-100-IV
acute graft versus host disease (aGVHD) in children
|
BLA Filing |
1Q 2019
BLA filing due 1Q 2019.
|
MYOK |
$43.41
+0.23 +0.53%
|
Mavacamten (MYK-461) - PIONEER-OLE
Non-obstructive Hypertrophic cardiomyopathy (HCM)
|
Phase 2 |
1Q 2019
Phase 2 additional interim data due 1Q 2019.
|
PRQR |
$12.55
-0.06 -0.48%
|
QR-313
Epidermolysis bullosa
|
Phase 1/2 |
Early 2019
Phase 1/2 interim data due early 2019.
|
ARPO |
$2.85
-0.17 -5.63%
|
AKB-4924 (GB004)
Ulcerative Colitis
|
Phase 1 |
1Q 2019
Phase 1 multiple ascending dose data due 1Q 2019.
|
ARPO |
$2.85
-0.17 -5.63%
|
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 |
$6.16
+0.51 +9.03%
|
Cannabidiol
Refractory childhood absence epilepsy
|
Phase 2 |
Late-1Q 2019
Phase 2 data due late 1Q 2019.
|
IONS |
$58.76
+1.35 +2.35%
|
IONIS-SOD1Rx
Amyotrophic lateral sclerosis (ALS)
|
Phase 1/2 |
Early 2019
Phase 1/2 data possibly due early 2019.
|
FCSC |
$1.93
-0.02 -1.03%
|
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 |
$26.27
+0.53 +2.06%
|
AT342 - VALENS
Crigler-Najjar
|
Phase 1/2 |
1Q 2019
Phase 1/2 updated data due 1Q 2019.
|
FGEN |
$57.02
+1.13 +2.02%
|
FG-3019
Duchenne muscular dystrophy
|
Phase 2 |
1Q 2019
Phase 2 initial data due late 1Q 2019.
|
AXSM |
$9.01
+0.53 +6.25%
|
AXS-05
Smoking cessation
|
Phase 2 |
1Q 2019
Phase 2 top-line data due 1Q 2019.
|
PTN |
$0.84
+0.03 +4.07%
|
PL-8177
Inflammatory bowel diseases
|
Phase 1 |
1Q 2019
Phase 1 data due 1Q 2019.
|
SUPN |
$36.75
+0.12 +0.33%
|
SPN-812
ADHD
|
Phase 3 | |
CYTX |
$0.25
-0.02 -7.41%
|
SCLERADEC II
Scleroderma
|
Phase 2 |
1Q 2019
Phase 2 data estimated 1Q 2019
|
PTI |
$4.04
+0.05 +1.25%
|
PTI-801 + Symdeko: Corrector
Cystic fibrosis
|
Phase 1 |
1Q 2019
Phase 1 data due 1Q 2019.
|
CNCE |
$14.56
+0.24 +1.68%
|
CTP-692 (single dose)
Schizophrenia
|
Phase 1 |
1Q 2019
Phase 1 initiation announced December 17, 2018 with data due 1Q 2019.
|
PTI |
$4.04
+0.05 +1.25%
|
PTI-801 and PTI-808
Cystic fibrosis
|
Phase 1 |
1Q 2019
Phase 1 data from fourth cohort are due 1Q 2019.
|
SNDX |
$6.31
+0.08 +1.28%
|
Entinostat plus Tecentriq - ENCORE 603
Ovarian cancer
|
Phase 1/2 |
1Q 2019
Phase 2 top-line data due 1Q 2019.
|
PTI |
$4.04
+0.05 +1.25%
|
PTI-428 + PTI-801 + PTI-808
Cystic fibrosis
|
Phase 1 |
1Q 2019
Phase 1 full data due 1Q 2019.
|
LPTX |
$1.64
+0.07 +4.46%
|
DKN-01 and Paclitaxel
Endometrial Cancer
|
Phase 2 |
March 2019
Phase 2 data due March 2019.
|
LLY |
$124.00
+1.28 +1.04%
|
Abemaciclib (Verzenio)
HER2+ breast cancer
|
Phase 2 |
Early 2019
Phase 2 data due early 2019.
|
BFRA |
$12.75
+0.00%
|
Ameluz
Actinic keratosis
|
Phase 3 |
1Q 2019
Phase 3 data due 1Q 2019.
|
REGN |
$422.52
+3.9 +0.93%
|
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 |
$41.18
-0.15 -0.36%
|
Dupixent (dupilumab)
Nasal polyps
|
BLA Filing |
1Q 2019
Phase 3 data released October 16, 2018 - primary and secondary endpoints met. sBLA filing 1Q 2019.
|
SRRK |
$18.57
+1.61 +9.49%
|
SRK-015
Spinal muscular atrophy (SMA
|
Phase 1 |
1Q 2019
Phase 1 interim data 1Q 2019.
|
JNJ |
$136.60
+1.18 +0.87%
|
Guselkumab vs Cosentyx - ECLIPSE
Psoriasis
|
Phase 3 |
Early 2019
Phase 3 data due early 2019.
|
MOR |
$24.53
-1.92 -7.26%
|
Guselkumab vs Cosentyx - ECLIPSE
Psoriasis
|
Phase 3 |
Early 2019
Phase 3 data due early 2019.
|
IMV |
$5.25
+0.2 +4.06%
|
DPX-Survivac and pembrolizumab
Diffuse Large Cell Lymphoma
|
Phase 2 |
1Q 2019
Phase 2 top-line data due 1Q 2019.
|
IMV |
$5.25
+0.2 +4.06%
|
DPX-Survivac and pembrolizumab
Ovarian cancer
|
Phase 2 |
1Q 2019
Phase 2 data due 1Q 2019.
|
NBIX |
$78.91
+1.6 +2.07%
|
NBI-74788
Congenital Adrenal Hyperplasia (CAH) - adults
|
Phase 2a |
1Q 2019
Phase 2a data due 1Q 2019.
|
ALLK |
$37.68
+2.52 +7.17%
|
AK002
Severe Allergic Conjunctivitis
|
Phase 1 |
Late 1Q/Early 2Q 2019
Phase 1 data due late 1Q/Early 2Q 2019.
|
EVOK |
$3.11
+0.08 +2.64%
|
Gimoti - EVK-001
Female diabetic gastroparesis
|
PDUFA | |
ADMA |
$4.35
+0.37 +9.30%
|
RI-002
Primary Immune Deficiency Diseases
|
PDUFA | |
ICPT |
$93.35
+1.52 +1.66%
|
Ocaliva (Obeticholic acid (OCA)) - REGENERATE
Adult nonalcoholic steatohepatitis (NASH) patients.
|
Phase 3 |
EASL April 10-14, 2019.
Phase 3 data met one of two co-primary endpoints - February 19, 2019. Full data due at EASL April 10-14, 2019.
|
MRK |
$80.77
+0.94 +1.18%
|
Keytruda - KEYNOTE-042
Non-small cell lung cancer (NSCLC)
|
Phase 3 | |
DERM |
$8.01
+0.94 +13.30%
|
Lebrikizumab
Atopic Dermatitis
|
Phase 2b |
Early April 2019
Phase 2b data due by early April 2019.
|
GSK |
$40.55
+0.01 +0.02%
|
Dolutegravir + lamivudine
HIV
|
PDUFA priority review | |
ABBV |
$80.02
+1.27 +1.61%
|
Risankizumab
Psoriasis
|
PDUFA | |
REGN |
$422.52
+3.9 +0.93%
|
Praluent (alirocumab) ODYSSEY OUTCOMES
Cardiovascular events
|
PDUFA | |
SNY |
$41.18
-0.15 -0.36%
|
Praluent (alirocumab) ODYSSEY OUTCOMES
Cardiovascular events
|
PDUFA | |
HRTX |
$27.14
-0.93 -3.31%
|
HTX-011
Post operative pain
|
PDUFA priority review | |
NBRV |
$2.07
+0.04 +1.97%
|
Contepo
Complicated urinary tract infections (cUTI)
|
PDUFA priority review | |
SNY |
$41.18
-0.15 -0.36%
|
Dengvaxia
Dengue
|
PDUFA priority review | |
BOLD |
$26.27
+0.53 +2.06%
|
AT132 - ASPIRO
X-Linked Myotubular Myopathy
|
Phase 1/2 | |
REGN |
$422.52
+3.9 +0.93%
|
EYLEA - PANAROMA
Nonproliferative Diabetic Retinopathy
|
PDUFA | |
NVS |
$90.78
+0.27 +0.30%
|
AVXS-101
Spinal muscular atrophy (SMA) Type 1
|
PDUFA priority review |
May 2019
PDUFA date under priority review May 2019. Exact date not released.
|
INCY |
$84.85
+1.52 +1.82%
|
Ruxolitinib
Graft versus host disease
|
PDUFA priority review | |
NVS |
$90.78
+0.27 +0.30%
|
Ruxolitinib
Graft versus host disease
|
PDUFA priority review | |
NKTR |
$40.05
-0.21 -0.52%
|
NKTR-181
Lower back pain
|
PDUFA | |
BMRN |
$87.87
-0.94 -1.06%
|
Valoctocogene roxaparvovec (BMN 270)
Hemophilia A
|
Phase 2 |
May 2019
Phase 1/2 update May 22, 2018 noted 97% decrease in bleeding rate. Further data due May 2019 with BLA filing due 2H 2019.
|
AGN |
$136.70
+0.1 +0.07%
|
Cariprazine
Bipolar I Depression
|
PDUFA |
May 2019
PDUFA date for sNDA filing May 2019.
|
MRK |
$80.77
+0.94 +1.18%
|
ZERBAXA(ceftolozane and tazobactam)
Hospital-acquired bacterial pneumonia (HABP)
|
PDUFA priority review | |
XERS |
$9.85
+0.21 +2.18%
|
Glucagon Rescue Pen
Severe hypoglycemia
|
PDUFA | |
MRK |
$80.77
+0.94 +1.18%
|
Keytruda KN-048
Head and neck squamous cell carcinoma (HNSCC)
|
Phase 3 | |
PFE |
$42.96
+0.82 +1.95%
|
BAVENCIO (avelumab) and INLYTA (axitinib)
Renal cell carcinoma (RCC)
|
PDUFA priority review | |
MRK |
$80.77
+0.94 +1.18%
|
Keytruda - KN-158
Small cell lung cancer (SCLC)
|
PDUFA priority review | |
MRK |
$80.77
+0.94 +1.18%
|
KEYTRUDA and Inlyta - KEYNOTE-426
Renal cell carcinoma
|
PDUFA priority review | |
PFE |
$42.96
+0.82 +1.95%
|
KEYTRUDA and Inlyta - KEYNOTE-426
Renal cell carcinoma
|
PDUFA priority review | |
AGIO |
$58.86
+2.73 +4.86%
|
Ivosidenib
Frontline AML with IDH1 mutation
|
PDUFA priority review | |
AMAG |
$15.51
+0.2 +1.31%
|
Vyleesi (Bremelanotide)
Female sexual dysfunction (FSD)
|
PDUFA | |
PTN |
$0.84
+0.03 +4.07%
|
Vyleesi (Bremelanotide)
Female sexual dysfunction (FSD)
|
PDUFA | |
ACER |
$23.61
-0.26 -1.09%
|
EDSIVO
Vascular Ehlers-Danlos Syndrome
|
PDUFA priority review | |
ALXN |
$129.73
+2.18 +1.71%
|
Eculizumab
Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD)
|
PDUFA priority review | |
ATRA |
$38.58
+0.41 +1.07%
|
ATA 129 (tab-cel) - ALLELE
Epstein-Barr virus (EBV-PTLD) after solid organ transplant (SOT)
|
Phase 3 |
1H 2019
Phase 3 trial initiation announced January 3, 2017. Data due 1H 2019.
|