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
BHC
$23.75
+0.24  +1.02%
DUOBRII (halobetasol propionate and tazarotene)
Psoriasis
PDUFA
CRL issued June 18, 2018. Noted February 15, 2019 that the FDA has been unable to meet the PDUFA data of February 15, 2019 and expects a decision soon.
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
Phase 1/2 data to be presented February 22, 2019 9:30a.m. CT.
BCRX
$9.00
+0.3  +3.45%
BCX7353 - ZENITH-1
Angioedema attacks in patients with hereditary angioedema (HAE)
Phase 2
Phase 2 data to be presented February 23, 9:45 a.m. PT at AAAAI meeting.
ATNM
$0.62
  +-0.13%
Iomab-B
Hematopoietic Stem Cells Transplantation
Phase 3
Phase 3 data to be presented at TCT meeting February 24, 2019, 12:30pm CT.
AIMT
$23.72
+0.79  +3.45%
AR101
Peanut Allergy
Phase 3
BLA filing announced December 21, 2018. Phase 3 data to be presented February 24, 9:45 a.m at AAAAI Annual Meeting.
ORTX
$15.78
+0.17  +1.08%
OTL-102
X-linked chronic granulomatous disease (X-CGD)
Phase 1/2
Phase 1/2 data to be presented February 24, 2019 12 noon CT.
BHC
$23.75
+0.24  +1.02%
Loteprednol Gel 0.38%
Ocular Inflammation
PDUFA
PDUFA date February 25, 2019.
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
Phase 1/2 data due February 27, 2019. CC 8am EST.
HTBX
$1.37
+0.02  +1.41%
HS-110 and nivolumab (Opdivo)
Non-small cell lung cancer (NSCLC)
Phase 2
Phase 2 interim data to be presented at 2019 ASCO-SITC February 28, 2019 1pm PST.
PRNB
$31.46
+1.86  +6.28%
PRN1008
Pemphigus
Phase 2
Phase 2 trial met primary endpoint. Final data to be presented at AAD meeting March 2, 2019 at 2:10pm ET. Phase 3 trial initiation announced November 30, 2018.
VRCA
$10.82
-0.27  -2.43%
VP-102
Molluscum contagiosum
Phase 3
Phase 3 trials met primary endpoints - January 9, 2019. Data to be presented at AAD meeting March 2, 2019 3:30pm.
CNCE
$14.56
+0.24  +1.68%
CTP-543
Alopecia areata
Phase 2a
Phase 2 8mg data released November 12, 2018 - primary endpoint met. Oral presentation of data at AAD meeting March 2, 2019, 1pm. 12mg data due 3Q 2019.
MNLO
$8.19
+0.9  +12.35%
Serlopitant
Pruritus associated with psoriasis
Phase 2
Phase 2 data released December 10, 2018 - primary endpoint met. Presentation of data March 2, 2019 1pm at American Academy of Dermatology Annual Meeting. Phase 3 planned for 2019.
ATNX
$13.12
+0.38  +2.98%
KX-01 (KX2-391) Ointment
Actinic keratosis
Phase 3
Phase 3 data released July 26, 2018. Primary endpoint met. Presentation at American Academy of Dermatology Annual Meeting March 2, 2019.
JNJ
$136.60
+1.18  +0.87%
Esketamine
Treatment resistant depression
PDUFA priority review
PDUFA estimate March 3, 2019 assuming priority review. FDA Advisory Committee Meeting February 12, 2019 voted 14-2 that benefits outweigh risks.
REGN
$422.52
+3.9  +0.93%
Dupixent (dupilumab)
Atopic dermatitis 12-17 year-olds
PDUFA priority review
PDUFA date under priority review March 11, 2019.
SNY
$41.18
-0.15  -0.36%
Dupixent (dupilumab)
Atopic dermatitis 12-17 year-olds
PDUFA priority review
PDUFA date under priority review March 11, 2019.
CELG
$89.14
+0.49  +0.55%
TECENTRIQ (atezolizumab) plus Abraxane
Triple-negative breast cancer
PDUFA
PDUFA date March 12, 2019.
RHHBY
$34.73
+0.17  +0.51%
TECENTRIQ (atezolizumab) plus Abraxane
Triple-negative breast cancer
PDUFA
PDUFA date March 12, 2019.
AERI
$40.04
+1.34  +3.46%
Roclatan
Glaucoma
PDUFA
PDUFA date March 14, 2019.
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
PDUFA date under priority review March 18, 2019.
AMRN
$19.87
+2.44  +14.00%
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
$153.97
+7.79  +5.33%
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
$126.01
+0.8  +0.64%
JZP-110
Excessive sleepiness associated with narcolepsy
PDUFA
PDUFA date extended by three months to March 20, 2019.
LXRX
$5.51
+0.17  +3.18%
Sotagliflozin
Type 1 Diabetes
PDUFA
PDUFA date March 22, 2019. Advisory Committee Meeting January 17, 2019 voted 8-8 that benefits outweigh risks.
SNY
$41.18
-0.15  -0.36%
Sotagliflozin
Type 1 Diabetes
PDUFA
PDUFA date March 22, 2019. Advisory Committee Meeting January 17, 2019 voted 8-8 that benefits outweigh risks.
REPH
$8.36
-0.04  -0.48%
Intravenous (IV) meloxicam
Acute pain following bunionectomy surgery
PDUFA
CRL announced May 24, 2018. New PDUFA date March 24, 2019.
EIGR
$13.18
-0.54  -3.94%
Avexitide (Exendin 9-39)
Post-Bariatric Hypoglycemia (PBH)
Phase 2
Phase 2 data released October 16, 2018 - endpoints met. Data to be presented at ENDO March 25, 2019.
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
Phase 2 data due 1Q 2019.
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
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.
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
PDUFA date April 1, 2019.
ADMA
$4.35
+0.37  +9.30%
RI-002
Primary Immune Deficiency Diseases
PDUFA
CRL issued July 29 2016. New PDUFA date April 2, 2019.
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
PDUFA date under priority review extended to April 11, 2019.
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
NDA filing submitted October 18, 2018. PDUFA date April 17, 2019 assuming priority review.
ABBV
$80.02
+1.27  +1.61%
Risankizumab
Psoriasis
PDUFA
BLA filing announced April 25, 2018. PDUFA estimate April 24, 2019.
REGN
$422.52
+3.9  +0.93%
Praluent (alirocumab) ODYSSEY OUTCOMES
Cardiovascular events
PDUFA
PDUFA date for sBLA filing April 28, 2019.
SNY
$41.18
-0.15  -0.36%
Praluent (alirocumab) ODYSSEY OUTCOMES
Cardiovascular events
PDUFA
PDUFA date for sBLA filing April 28, 2019.
HRTX
$27.14
-0.93  -3.31%
HTX-011
Post operative pain
PDUFA priority review
PDUFA date under priority review April 30, 2019.
NBRV
$2.07
+0.04  +1.97%
Contepo
Complicated urinary tract infections (cUTI)
PDUFA priority review
PDUFA date under priority review April 30, 2019.
SNY
$41.18
-0.15  -0.36%
Dengvaxia
Dengue
PDUFA priority review
PDUFA date under priority review May 1, 2019.
BOLD
$26.27
+0.53  +2.06%
AT132 - ASPIRO
X-Linked Myotubular Myopathy
Phase 1/2
Next update at American Society of Gene and Cell Therapy (ASGCT) - April 29-May 2, 2019.
REGN
$422.52
+3.9  +0.93%
EYLEA - PANAROMA
Nonproliferative Diabetic Retinopathy
PDUFA
PDUFA date for sBLA May 13, 2019.
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
PDUFA date under priority review extended by three months to May 24, 2019.
NVS
$90.78
+0.27  +0.30%
Ruxolitinib
Graft versus host disease
PDUFA priority review
PDUFA date under priority review extended by three months to May 24, 2019.
NKTR
$40.05
-0.21  -0.52%
NKTR-181
Lower back pain
PDUFA
PDUFA date May 29, 2019. Advisory Committee Meeting likely 1Q/2Q 2019.
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
PDUFA date under priority review June 3, 2019.
XERS
$9.85
+0.21  +2.18%
Glucagon Rescue Pen
Severe hypoglycemia
PDUFA
PDUFA date June 10, 2018.
MRK
$80.77
+0.94  +1.18%
Keytruda KN-048
Head and neck squamous cell carcinoma (HNSCC)
Phase 3
PDUFA date under priority review June 10, 2019.
PFE
$42.96
+0.82  +1.95%
BAVENCIO (avelumab) and INLYTA (axitinib)
Renal cell carcinoma (RCC)
PDUFA priority review
PDUFA date under priority review June 2019. Exact date not provided.
MRK
$80.77
+0.94  +1.18%
Keytruda - KN-158
Small cell lung cancer (SCLC)
PDUFA priority review
PDUFA date under priority review June 17, 2019.
MRK
$80.77
+0.94  +1.18%
KEYTRUDA and Inlyta - KEYNOTE-426
Renal cell carcinoma
PDUFA priority review
PDUFA date under priority review June 20, 2019.
PFE
$42.96
+0.82  +1.95%
KEYTRUDA and Inlyta - KEYNOTE-426
Renal cell carcinoma
PDUFA priority review
PDUFA date under priority review June 20, 2019.
AGIO
$58.86
+2.73  +4.86%
Ivosidenib
Frontline AML with IDH1 mutation
PDUFA priority review
PDUFA date under priority review June 21, 2019.
AMAG
$15.51
+0.2  +1.31%
Vyleesi (Bremelanotide)
Female sexual dysfunction (FSD)
PDUFA
PDUFA date extended to June 23, 2019.
PTN
$0.84
+0.03  +4.07%
Vyleesi (Bremelanotide)
Female sexual dysfunction (FSD)
PDUFA
PDUFA date extended to June 23, 2019.
ACER
$23.61
-0.26  -1.09%
EDSIVO
Vascular Ehlers-Danlos Syndrome
PDUFA priority review
PDUFA date under priority review June 25, 2019.
ALXN
$129.73
+2.18  +1.71%
Eculizumab
Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD)
PDUFA priority review
PDUFA date under priority review June 28, 2019.
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.