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.

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.


Showing 150 drugs
Ticker
Price
Drug
Stage
Catalyst
Ticker Price Drug Stage Catalyst
BHC
$24.19
-0.5  -2.03%
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.
SBBP
$5.00
-0.15  -2.91%
COR-003 (levoketoconazole) - SONICS
Endogenous Cushing’s syndrome
Phase 3
Phase 3 data met primary endpoint August 8, 2018. New data to be presented at ENDO March 23, 2019, 1:00 PM CT.
EIGR
$13.54
-0.36  -2.59%
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.
FCSC
$2.39
-0.11  -4.40%
FCX-007
Recessive dystrophic epidermolysis bullosa
Phase 1/2
Phase 1/2 updated data due March 27, 2019.
ADXS
$0.49
+0.01  +2.19%
ADXS-NEO
Non-small cell lung cancer (NSCLC)
Phase 1
Phase 1 safety and immunogenicity data to be presented at AACR March 31, 2019 1:00 p.m.
NVUS
$3.92
-0.33  -7.76%
OP0201
Acute Otitis Media - adults
Phase 1
1Q 2019
Phase 1 data due 1Q 2019.
AKTX
$3.87
-0.23  -5.62%
Coversin
Atopic keratoconjunctivitis
Phase 1/2
1Q 2019
Phase 1/2 data due 1Q 2019.
AKTX
$3.87
-0.23  -5.62%
Coversin
Bullous Pemphigoid
Phase 2
1Q 2019
Phase 2 data due 1Q 2019.
PTI
$1.45
-2.62  -64.50%
PTI-428 + Symdeko
Cystic fibrosis
Phase 2
1Q 2019
Phase 2 data due 1Q 2019.
GLPG
$95.21
-4.26  -4.28%
Filgotinib - FINCH 3
Rheumatoid arthritis (RA)
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
GILD
$63.38
-0.39  -0.61%
Filgotinib - FINCH 3
Rheumatoid arthritis (RA)
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
ALDX
$7.26
-0.19  -2.55%
Reproxalap (ADX-102)
Allergic conjunctivitis
Phase 3
Early 2019
Phase 3 data due early 2019.
CANF
$1.28
+0.04  +3.06%
Namodenoson (CF102)
Cancer - advanced liver cancer second line
Phase 2
1Q 2019
Phase 2 data due 1Q 2019.
INSY
$4.59
+0.18  +4.08%
Naloxone nasal spray
Opioid overdose
Phase 3
March 2019
NDA filing due 1Q 2019 following data from nonclinical juvenile toxicity trial due March 2019.
JAGX
$0.28
-0.06  -16.88%
Mytesi (crofelemer)
Cancer related diarrhea (CRD)
Phase 2
1Q 2019
Phase 2 interim data due 1Q 2019.
RHHBY
$33.79
+0.03  +0.08%
Mytesi (crofelemer)
Cancer related diarrhea (CRD)
Phase 2
1Q 2019
Phase 2 interim data due 1Q 2019.
CELG
$87.94
-0.21  -0.24%
Ozanimod - RADIANCE
Relapsing Multiple Sclerosis
NDA Filing
1Q 2019
Refusal-to-file letter issued February 27, 2018. NDA to be refiled 1Q 2019.
GLPG
$95.21
-4.26  -4.28%
Filgotinib - FINCH 1
Rheumatoid arthritis (RA)
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
GILD
$63.38
-0.39  -0.61%
Filgotinib - FINCH 1
Rheumatoid arthritis (RA)
Phase 3
1Q 2019
Phase 3 data due 1Q 2019.
PRTO
$3.50
+0.18  +5.42%
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.
NVS
$93.01
-0.41  -0.44%
BAF312
Secondary progressive multiple sclerosis
PDUFA priority review
March 2019
PDUFA date under priority review set for March 2019. Exact date not noted.
SGEN
$72.77
-1.23  -1.66%
Enfortumab vedotin - EV201
Urothelial cancer
Phase 2
1Q 2019
Phase 2 pivotal data due 1Q 2019.
ATRA
$36.80
-0.64  -1.71%
Autologous T Cells
Malignant pleural disease
Phase 1
Phase 1 presentation at AACR March 31, 2019 from 3pm.
PRQR
$14.85
-0.15  -1.03%
QR-313
Epidermolysis bullosa
Phase 1/2
1Q 2019
Phase 1/2 interim data due 1Q 2019.
INSY
$4.59
+0.18  +4.08%
Cannabidiol
Refractory childhood absence epilepsy
Phase 2
Late-1Q 2019
Phase 2 data due late 1Q 2019.
PTN
$0.96
-0.01  -0.71%
PL-8177
Inflammatory bowel diseases
Phase 1
1Q 2019
Phase 1 data due 1Q 2019.
SUPN
$34.17
-1.49  -4.18%
SPN-812
ADHD
Phase 3
1Q 2019
Phase 3 data from two of its trials released December 6, 2018 met primary endpoints but with concerns regarding effect size vs competition. Data from final trial due 1Q 2019.
PTI
$1.45
-2.62  -64.50%
PTI-801 + Symdeko: Corrector
Cystic fibrosis
Phase 1
1Q 2019
Phase 1 data due 1Q 2019.
PTI
$1.45
-2.62  -64.50%
PTI-801 and PTI-808
Cystic fibrosis
Phase 1
1Q 2019
Phase 1 data from fourth cohort are due 1Q 2019.
PTI
$1.45
-2.62  -64.50%
PTI-428 + PTI-801 + PTI-808
Cystic fibrosis
Phase 1
1Q 2019
Phase 1 full data due 1Q 2019.
IMV
$3.75
+0.15  +4.15%
DPX-Survivac and epacadostat
Ovarian cancer
Phase 1/2
1Q 2019
Phase 1b/2 update due by end of 1Q 2019 with a further update in 2Q 2019.
ADXS
$0.49
+0.01  +2.19%
ADXS-PSA and Keytruda - KEYNOTE-046
Castrate-resistant prostate cancer
Phase 1/2
Phase 1 safety and immunogenicity data to be presented at AACR April 1, 2019 1:00 p.m.
UTHR
$119.81
-0.99  -0.82%
Esuberaprost - BEAT
Pulmonary arterial hypertension (PAH)
Phase 3
Late-March or 2Q 2019
Phase 3 unblinding of data likely late-March or 2Q 2019.
INCY
$85.53
+0.18  +0.22%
INCMGA0012
Solid tumors
Phase 1
Phase 1 poster presentation due at AACR April 1, 2019, 1pm.
NTGN
$5.14
-0.19  -3.56%
NEO-PV-01 + nivolumab NT-001
Melanoma, Lung Cancer or Bladder Cancer
Phase 1
AACR 2019
Phase 1b correlative data due at AACR April 2019. 52-week data due 1H 2019.
TROV
$3.99
+0.13  +3.37%
Onvansertib (PCM-075)
Acute Myeloid Leukemia (AML)
Phase 1/2
Phase 1/2 safety and preliminary anti-leukemic activity data to be presented at AACR April 1, 2019; 1pm
AUTL
$24.77
+0.39  +1.60%
AUTO1
Acute lymphoblastic leukemia (ALL)
Phase 1
Phase 1 data due at AACR meeting April 1, 2019, 1pm.
MNK
$21.87
-0.22  -1.00%
CPP-1X/sulindac
Familial Adenomatous Polyposis (FAP)
Phase 3
Late-1Q/early 2Q 2019
Phase 3 data due late 1Q or early 2Q 2019.
CNST
$12.06
+0.81  +7.24%
CPI-1205 - ProSTAR
Castration-resistant prostate cancer
Phase 1/2
Phase 2 interim data due 2H 2019. Phase 1b data April 1, 2019 at AACR.
CLDX
$4.85
-0.09  -1.82%
CDX-1140
Solid tumors
Phase 1
Phase 1 updated data due at AACR April 1, 2019.
EVOK
$1.43
+0.01  +0.50%
Gimoti - EVK-001
Female diabetic gastroparesis
PDUFA
PDUFA date April 1, 2019. Company noted March 4, 2019 that the FDA listed various clinical and chemistry concerns regarding the NDA. Meeting with FDA March 21, 2019.
ADRO
$3.75
+0.08  +2.18%
BION-1301
Multiple Myeloma
Phase 1/2
Phase 1/2 poster at AACR Apr 1, 2019 1pm.
FGEN
$53.02
+0.04  +0.08%
FG-3019
Duchenne muscular dystrophy
Phase 2
March/April 2019
Phase 2 initial data due estimated late-March/early April 2019.
TGTX
$6.98
+0.15  +2.20%
TG-1101 and TGR-1202 - UNITY-NHL study
Non-Hodgkin Lymphoma (NHL)
Phase 2/3
Phase 2/3 MZL cohort met ORR primary endpoint. Data presentation at AACR April 1, 2019; 3pm.
ADMA
$3.20
-0.11  -3.32%
RI-002
Primary Immune Deficiency Diseases
PDUFA
CRL issued July 29 2016. New PDUFA date April 2, 2019.
DVAX
$7.12
+0.03  +0.35%
DV281
Non-small Cell Lung Cancer (NSCLC)
Phase 1
Phase 1/2 safety data to be presented at AACR April 2, 2019, 1pm.
TROV
$3.99
+0.13  +3.37%
Onvansertib (PCM-075) and Zytiga
Prostate cancer
Phase 2
Phase 1/2 safety and initial efficacy data to be presented at AACR April 2, 2019; 8am.
CLVS
$23.27
-1.57  -6.32%
Opdivo and Rubraca ATHENA
Ovarian Cancer - First-line maintenance treatment
Phase 3
Phase 3 enrolment has commenced - noted August 8, 2018. Poster at AACR Apr 2, 2019 8:00 AM.
BMY
$47.49
-0.67  -1.38%
Opdivo and Rubraca ATHENA
Ovarian Cancer - First-line maintenance treatment
Phase 3
Phase 3 enrolment has commenced - noted August 8, 2018. Poster at AACR Apr 2, 2019 8:00 AM.
NLNK
$1.88
-0.03  -1.57%
NLG207 (CRLX101) and paclitaxel
Platinum-resistant ovarian cancer
Phase 2
Phase 2 data to be presented at AACR April 2, 2019 8am.
JNCE
$6.20
+0.19  +3.16%
JTX-2011
Solid tumors - Cancer
Phase 1/2
Phase 1/2 data at AACR - poster April 2, 2019 1pm.
AGLE
$7.88
+0.14  +1.74%
Pegzilarginase (AEB1102)
Arginase I deficiency
Phase 1/2
SIMD April 2019
Phase 1/2 data to be presented at SIMD April 6-9, 2019. Phase 3 trial to be initiated 2Q 2019 with data due 1Q 2021.
ICPT
$109.22
-0.63  -0.57%
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
$82.23
-0.06  -0.07%
Keytruda - KEYNOTE-042
Non-small cell lung cancer (NSCLC)
Phase 3
PDUFA date under priority review extended to April 11, 2019.
EIGR
$13.54
-0.36  -2.59%
Pegylated Interferon Lambda (LIMT HDV)
Hepatitis delta virus (HDV)
Phase 2
Phase 2 LIMT postive data released October 17, 2018. Late breaker presentation at Liver Congress April 11, 4:45 pm CET.
VKTX
$8.10
-0.16  -1.94%
VK2809
Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
Phase 2
EASL April 11-14, 2019
Phase 2 additional NAFLD data to be presented at EASL April 11-14, 2019 with Phase 2b trial to be initiated 2H 2019.
LGND
$122.59
-2.27  -1.82%
VK2809
Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
Phase 2
EASL April 11-14, 2019
Phase 2 additional NAFLD data to be presented at EASL April 11-14, 2019 with Phase 2b trial to be initiated 2H 2019.
CNAT
$1.20
-0.09  -6.64%
Emricasan
NASH cirrhosis - ENCORE-PH trial
Phase 2
Phase 2b data released December 5, 2018 did not meet primary endpoint. Late breaker at EASL April 13, 2019, 4:00 p.m. CEST. 48-week liver function data due mid-2019.
GSK
$41.17
-0.08  -0.19%
Dolutegravir + lamivudine
HIV
PDUFA priority review
NDA filing submitted October 18, 2018. PDUFA date April 17, 2019 assuming priority review.
ABBV
$79.25
-0.51  -0.64%
Risankizumab
Psoriasis
PDUFA
BLA filing announced April 25, 2018. PDUFA estimate April 24, 2019.
REGN
$393.53
+1.73  +0.44%
Praluent (alirocumab) ODYSSEY OUTCOMES
Cardiovascular events
PDUFA
PDUFA date for sBLA filing April 28, 2019.
SNY
$44.01
-0.26  -0.58%
Praluent (alirocumab) ODYSSEY OUTCOMES
Cardiovascular events
PDUFA
PDUFA date for sBLA filing April 28, 2019.
HRTX
$23.16
-0.62  -2.61%
HTX-011
Post operative pain
PDUFA priority review
PDUFA date under priority review April 30, 2019.
BTX
$1.42
-0.14  -9.29%
OpRegen
Dry age-related macular degeneration (AMD)
Phase 1/2
Phase 1/2 enrolment to be completed 2019. Updated data due April 30, 2019 at Ophthalmology Annual Meeting.
XLRN
$44.52
+0.36  +0.82%
Luspatercept - BELIEVE
b -thalassemia
BLA Filing
April 2019
BLA filing due April 2019.
CELG
$87.94
-0.21  -0.24%
Luspatercept - BELIEVE
b -thalassemia
BLA Filing
April 2019
BLA filing due April 2019.
XLRN
$44.52
+0.36  +0.82%
Luspatercept - MEDALIST
Myelodysplastic syndromes (MDS) cancer
BLA Filing
April 2019
BLA filing due April 2019.
CELG
$87.94
-0.21  -0.24%
Luspatercept - MEDALIST
Myelodysplastic syndromes (MDS) cancer
BLA Filing
April 2019
BLA filing due April 2019.
TCON
$1.41
-0.06  -4.08%
TRC105 (TAPPAS)
Angiosarcoma cancer
Phase 3
April 2019
Phase 3 interim analysis due April 2019 with top-line data due 2020.
NBRV
$2.91
-0.1  -3.28%
Contepo
Complicated urinary tract infections (cUTI)
PDUFA priority review
PDUFA date under priority review April 30, 2019.
SNY
$44.01
-0.26  -0.58%
Dengvaxia
Dengue
PDUFA priority review
PDUFA date under priority review May 1, 2019.
BOLD
$36.04
-0.86  -2.33%
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.
EYEN
$5.51
+0.21  +3.96%
MicroStat
Mydriasis - pupil dilation
Phase 3
Phase 3 trial met primary endpoint - January 31, 2019. Data from second trial also met primary endpoint - February 25, 2019. Detailed data due at (ASCRS) meeting May 3-7, 2019.
CYTK
$8.81
+0.07  +0.74%
Reldesemtiv (CK-2127107) - FORTITUDE-ALS
Amyotrophic lateral sclerosis (ALS)
Phase 2
Phase 2 data to be presented May 5, 2019, 1:11 PM.
ADAP
$3.77
+0.14  +3.86%
MAGE-A4
Soild tumors
Phase 1
Updated data on trials for solid tumors due 1Q earnings call - estimate May 9, 2019.
REGN
$393.53
+1.73  +0.44%
EYLEA - PANAROMA
Nonproliferative Diabetic Retinopathy
PDUFA
PDUFA date for sBLA May 13, 2019.
NVS
$93.01
-0.41  -0.44%
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
$85.53
+0.18  +0.22%
Ruxolitinib
Graft versus host disease
PDUFA priority review
PDUFA date under priority review extended by three months to May 24, 2019.
NVS
$93.01
-0.41  -0.44%
Ruxolitinib
Graft versus host disease
PDUFA priority review
PDUFA date under priority review extended by three months to May 24, 2019.
BMRN
$88.16
+0.11  +0.12%
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
$146.78
-2.52  -1.69%
Cariprazine
Bipolar I Depression
PDUFA
May 2019
PDUFA date for sNDA filing May 2019.
JAZZ
$136.35
-0.24  -0.18%
JZP-258
Cataplexy and Excessive Daytime Sleepiness in Narcolepsy
Phase 3
Spring 2019
Phase 3 data due spring 2019.
FPRX
$12.47
-0.59  -4.55%
FPA150
Solid tumors
Phase 1
ASCO 2019
Phase 1b commencement of dosing announced February 21, 2019. Initial data due at ASCO June 2019.
VCNX
$4.96
+0.04  +0.76%
VX15 and avelumab
Non-small cell lung cancer (NSCLC)
Phase 1/2
ASCO 2019
Phase 1/2 trial initial data due at ASCO 2019.
MRK
$82.23
-0.06  -0.07%
ZERBAXA(ceftolozane and tazobactam)
Hospital-acquired bacterial pneumonia (HABP)
PDUFA priority review
PDUFA date under priority review June 3, 2019.
OPK
$2.54
+0.01  +0.20%
OPK88003
Obesity and diabetes
Phase 2b
ADA June 2019
Phase 2b top-line data March 21, 2019 met primary endpoint. Data to be presented at ADA meeting June 7-11, 2019. Will evaluate Phase 3 options.
IMV
$3.75
+0.15  +4.15%
DPX-Survivac and pembrolizumab
Diffuse Large Cell Lymphoma
Phase 2
June 2019
Phase 2 top-line data due at ICML meeting June 9-15, 2019.
XERS
$10.00
  +0.00%
Glucagon Rescue Pen
Severe hypoglycemia
PDUFA
PDUFA date June 10, 2018.
MRK
$82.23
-0.06  -0.07%
Keytruda KN-048
Head and neck squamous cell carcinoma (HNSCC)
Phase 3
PDUFA date under priority review June 10, 2019.
PFE
$41.91
+0.06  +0.13%
BAVENCIO (avelumab) and INLYTA (axitinib)
Renal cell carcinoma (RCC)
PDUFA priority review
PDUFA date under priority review June 2019. Exact date not provided.
SNSS
$1.19
-0.06  -4.80%
SNS-062
Advanced B-Cell Malignancies
Phase 1/2
EHA June 2019
Phase 1/2 update due at EHA meeting June 13-16, 2019.
MRK
$82.23
-0.06  -0.07%
Keytruda - KN-158
Small cell lung cancer (SCLC)
PDUFA priority review
PDUFA date under priority review June 17, 2019.
MRK
$82.23
-0.06  -0.07%
KEYTRUDA and Inlyta - KEYNOTE-426
Renal cell carcinoma
PDUFA priority review
PDUFA date under priority review June 20, 2019.
PFE
$41.91
+0.06  +0.13%
KEYTRUDA and Inlyta - KEYNOTE-426
Renal cell carcinoma
PDUFA priority review
PDUFA date under priority review June 20, 2019.
AGIO
$62.10
-0.19  -0.31%
Ivosidenib
Frontline AML with IDH1 mutation
PDUFA priority review
PDUFA date under priority review June 21, 2019.
AMAG
$12.06
-0.1  -0.82%
Vyleesi (Bremelanotide)
Female sexual dysfunction (FSD)
PDUFA
PDUFA date extended to June 23, 2019.
PTN
$0.96
-0.01  -0.71%
Vyleesi (Bremelanotide)
Female sexual dysfunction (FSD)
PDUFA
PDUFA date extended to June 23, 2019.
ACER
$22.96
+0.06  +0.26%
EDSIVO
Vascular Ehlers-Danlos Syndrome
PDUFA priority review
PDUFA date under priority review June 25, 2019.
REGN
$393.53
+1.73  +0.44%
Dupixent (dupilumab)
Nasal polyps
PDUFA priority review
PDUFA date under priority review June 26, 2019.
SNY
$44.01
-0.26  -0.58%
Dupixent (dupilumab)
Nasal polyps
PDUFA priority review
PDUFA date under priority review June 26, 2019.
CELG
$87.94
-0.21  -0.24%
REVLIMID - AUGMENT
Relapsed or Refractory Follicular Lymphoma
PDUFA priority review
PDUFA date under priority review June 27, 2019.
ALXN
$131.07
+0.86  +0.66%
Eculizumab
Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD)
PDUFA priority review
PDUFA date under priority review June 28, 2019.
ATRA
$36.80
-0.64  -1.71%
ATA 129 (tab-cel) - ALLELE
Epstein-Barr virus (EBV-PTLD) after solid organ transplant (SOT)
Phase 3
1H 2019
Phase 3 data due 1H 2019.
ARQL
$4.96
+0.14  +2.90%
ARQ 092
Overgrowth Diseases
Phase 1/2
1H 2019
Phase 1b data due 1H 2019.
SAGE
$157.98
+1.26  +0.80%
SAGE-718
Huntington's disease
Phase 1
1H 2019
Phase 1 biomarker data due 1H 2019 with Huntington’s Disease Phase 1 cohort data due 2H 2019.
BPMC
$77.59
-0.99  -1.26%
Avapritinib BLU-285 - NAVIGATOR
PDGFRα driven Gastrointestinal stromal tumors (GIST)
NDA Filing
2Q 2019
NDA filing due 2Q 2019.
ETTX
$6.57
-0.15  -2.18%
ETX0282CPDP
Complicated urinary tract infections (cUTI)
Phase 1
1H 2019
Phase 1 data due 1H 2019.
GILD
$63.38
-0.39  -0.61%
F/TAF (Descovy)
Pre-exposure prophylaxis
Phase 3
2Q 2019
Phase 3 data due 2Q 2019.
NVS
$93.01
-0.41  -0.44%
AIN457 (Cosentyx)
Psoriatic arthritis
Phase 3
2Q 2019
Phase 3 trial to be completed 2Q 2019.
CYAD
$20.61
+0.1  +0.46%
CYAD-01 - THINK
Various cancers - solid and hematologic cancers
Phase 1/2
1H 2019
Phase 1 additional data due 1H 2019.
MRNS
$3.81
-0.03  -0.78%
Ganaxolone
Refractory status epilepticus (RSE)
Phase 2
1H 2019
Phase 2 data due 1H 2019.
BGNE
$124.62
+0.16  +0.13%
Zanubrutinib (BGB-3111)
Waldenström’s macroglobulinemia
Phase 1/2
1H 2019
Phase 1 updated data due 1H 2019.
MRNS
$3.81
-0.03  -0.78%
Ganaxolone - Magnolia
Postpartum depression
Phase 2
1H 2019
Data due 1H 2019.
ARQL
$4.96
+0.14  +2.90%
Miransertib - ARQ 092
Solid tumors
Phase 1b
1H 2019
Phase 1b data due 1H 2019.
AGIO
$62.10
-0.19  -0.31%
AG-120 Ivosidenib
IDH1 mutant positive cholangiocarcinoma - cancer
Phase 3
1H 2019
Phase 3 top-line data due 1H 2019.
BYSI
$17.77
+0.05  +0.29%
Plinabulin (Trial 103)
Non small cell lung cancer - refractory
Phase 3
1H 2019
Phase 3 interim data due 1H 2019.
NVO
$51.31
+0.59  +1.16%
Anti-IL 21 GLP-1 T1D (NNc)
Type 1 diabetes
Phase 2
2Q 2019
Phase 2 data due 2Q 2019.
VRCA
$11.35
-0.19  -1.65%
VP-102
Common warts
Phase 2
2Q 2019
Phase 2 data due 2Q 2019.
ACHN
$2.90
-0.03  -0.85%
ACH-4471
Paroxysmal nocturnal hemoglobinuria (PNH)
Phase 2
2Q 2019
Phase 2 interim data due 2Q 2019.
PFE
$41.91
+0.06  +0.13%
PF-06939926
Duchenne muscular dystrophy (DMD)
Phase 1b
1H 2019
Phase 1b initiation announced April 12, 2018. Early data due 1H 2019.
RMTI
$5.78
-0.01  -0.17%
IV Triferic
Anemia
NDA Filing
2Q 2019
NDA filing due 2Q 2019.
ASMB
$17.80
-0.4  -2.20%
ABI-H0731
Hepatitis B virus (HBV)
Phase 2a
2Q 2019
Phase 2a interim data due 2Q 2019.
ARRY
$22.71
+0.22  +0.98%
Encorafenib and cetuximab - BEACON CRC
BRAF-Mutant Colorectal Cancer
Phase 3
1H 2019
Phase 3 interim analysis 1H 2019.
AKTX
$3.87
-0.23  -5.62%
Coversin
Atypical hemolytic-uremic syndrome (aHUS)
Phase 2
1H 2019
Phase 2 data due 1H 2019.
BPMC
$77.59
-0.99  -1.26%
BLU-667 - ARROW
RET-altered solid tumors
Phase 1
2Q 2019
Phase 1 updated data due 2Q 2019.
AXSM
$15.32
+2.32  +17.85%
AXS-12
Narcolepsy
Phase 2
2Q 2019
Phase 2 trial initiation announced January 30, 2019 with top-line data due 2Q 2019.
RYTM
$30.54
+0.6  +2.00%
Setmelanotide
POMC Heterozygous Deficiency Obesity, Alstrom Syndrome, POMC Epigenetic Disorders
Phase 2
1H 2019 est
Phase 2 updated data due "in the near future" - noted March 8, 2019.
ACRS
$5.95
-0.17  -2.78%
A-101 THWART-1 and THWART-2
Common warts (verruca vulgaris)
Phase 3
2H 2019
Phase 3 data due 2H 2019.
RETA
$87.13
  +0.00%
RTA 1701
Healthy Volunteers
Phase 1
1H 2019
Phase 1 initiation announced June 20, 2018. Initial data due 1H 2019.
ITCI
$11.81
-0.23  -1.91%
ITI-007 - Monotherapy (Study 401)
Bipolar depression
Phase 3
2Q 2019
Phase 3 top-line data due 2Q 2019.
KPTI
$5.52
+0.08  +1.47%
Eltanexor
Solid tumors
Phase 2
1H 2019
Phase 2 data due 1H 2019.
OSMT
$6.24
-0.25  -3.85%
RVL-1201
Blepharoptosis
Phase 3
1H 2019
Phase 3 data due 1H 2019.
KPTI
$5.52
+0.08  +1.47%
KPT-9274
Non-Hodgkin Lymphoma
Phase 1/2
2Q 2019
Phase 1/2 updated tolerability data due 2Q 2019.
OSMT
$6.24
-0.25  -3.85%
Ontinua ER
Spasticity resulting from multiple sclerosis
Phase 3
1H 2019
Phase 3 data due 1H 2019.
ARGX
$124.40
-1.14  -0.91%
Efgartigimod (ARGX-113)
Pemphigus vulgaris (PV)
Phase 2
1H 2019
Phase 2 data due 1H 2019.
PRVB
$2.31
-0.07  -3.05%
PRV-300
Ulcerative Colitis
Phase 1b
2Q 2019
Phase 1b top-line data due 2Q 2019.
KZR
$17.72
+0.89  +5.29%
KZR-616
Lupus
Phase 1/2
2Q 2019
Initial Phase 1b top-line data due 2Q 2019.
VTGN
$1.17
-0.11  -8.28%
AV-101
Monotherapy Treatment Major Depressive Disorder
Phase 2
1H 2019
Phase 2 data due 1H 2019.
CORV
$3.13
  +0.00%
Brinavess
Atrial fibrillation (AF)
NDA Filing
2Q 2019
NDA filing to be resubmitted 2Q 2019.
CNCE
$15.11
-0.4  -2.58%
CTP-692 (single ascending dose)
Schizophrenia
Phase 1
1H 2019
Phase 1 data due 1H 2019.
XERS
$10.00
  +0.00%
Self administered glucagon
Post-Bariatric Hypoglycemia
Phase 2
1H 2019
Phase 2 data due 1H 2019.
APTX
$4.26
-0.1  -2.29%
NYX-458
Parkinson’s Disease Cognitive Impairment (healthy volunteers)
Phase 1
1H 2019
Phase 1 data due 1H 2019.
APTX
$4.26
-0.1  -2.29%
NYX-2925
Fibromyalgia
Phase 2
1H 2019
Phase 2 full data due 1H 2019.
MRK
$82.23
-0.06  -0.07%
Keytruda KN-361
Bladder cancer
Phase 3
1H 2019
Phase 3 data due 1H 2019.
MRK
$82.23
-0.06  -0.07%
Keytruda KN-057
NMIBC Bladder cancer
Phase 3
1H 2019
Phase 3 data due 1H 2019.
MRK
$82.23
-0.06  -0.07%
Keytruda KN-604
Small cell lung cancer (SCLC)
Phase 3
1H 2019
Phase 3 data due 1H 2019.
AXSM
$15.32
+2.32  +17.85%
AXS-05 STRIDE-1
Treatment resistant depression
Phase 3
2Q 2019
Phase 3 data due 2Q 2019.
VRTX
$182.74
+1.21  +0.67%
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
2Q 2019
Phase 3 data released March 6, 2019 - primary endpoint met. Further 24-week data due 2Q 2019.
CMTA
$25.86
-0.14  -0.54%
Palovarotene
Fibrodysplasia ossificans progressiva (FOP)
Phase 3
2Q 2019
Phase 3 first interim analysis due 2Q 2019. NDA filing due 2H 2019 based on Phase 2 data.
BCRX
$7.48
+0.1  +1.36%
BCX7353 - APeX-2
Reduce or eliminate attacks in HAE patients
Phase 3
2Q 2019
Phase 3 data due 2Q 2019.