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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Premium users - Refer to FDA Calendar Abbreviations in the FDA Calendar Glossary for terms used in the columns and other parts of the FDA Calendar.

Showing 150 drugs
Ticker
Price
Drug
Stage
Catalyst
Last Updated
Ticker Price Drug Stage Catalyst Last Updated
DRRX
$1.53
+0.08  +5.52%
POSIMIR
Post-operative pain relief
PDUFA
Revised PDUFA not announced
CRL Feb 12 2014. Advisory Committee meeting voted 6-6 January 16, 2020 regarding approval. PDUFA date of December 27, 2019 was not met due to the meeting. No guidance announced regarding new timeline.
01/17/2020
AXSM
$49.87
-3.68  -6.87%
AXS-05 ADVANCE-1
Agitation in patients with Alzheimer’s disease (AD)
Phase 2/3
Early 2Q 2020
Phase 2/3 top-line data due early 2Q 2020
04/04/2020
AMGN
$208.78
-2.8  -1.32%
OTEZLA
Scalp Psoriasis
PDUFA
April 2020
PDUFA date April 2020.
01/30/2020
ASND
$121.80
+3.47  +2.93%
TransCon
Hypoparathyroidism
Phase 2
Mid-April 2020
Phase 2 top-line data due mid-April 2020.
04/01/2020
OGEN
$0.57
-0.01  -1.56%
AG013
Oral mucositis (OM)
Phase 2
Early 2020
Phase 2 completion of enrolment announced December 2, 2019 with data due early 2020.
03/30/2020
PFE
$33.61
-0.96  -2.78%
Encorafenib and cetuximab - BEACON CRC
BRAF-Mutant Colorectal Cancer
PDUFA priority review
April 2020
PDUFA date under priority review for sNDA April 2020.
12/18/2019
VKTX
$4.57
-0.08  -1.72%
VK2809
Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
Phase 2
Phase 2b trial initiation announced November 19, 2019. Phase 2 additional data to be presented at EASL April 17, 2020.
02/26/2020
LGND
$78.23
+0.79  +1.02%
VK2809
Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
Phase 2
Phase 2b trial initiation announced November 19, 2019. Phase 2 additional data to be presented at EASL April 17, 2020.
02/26/2020
EIGR
$6.72
-0.14  -2.04%
Pegylated interferon lambda + ritonavir (RTV)-boosted lonafarnib (LNF) - LIFT
Hepatitis delta virus (HDV)
Phase 2
EASL 15-19 Apr 2020
Phase 2 additional data expected at EASL and AASLD 2020
01/06/2020
URGN
$19.88
-0.16  -0.80%
MitoGel - UGN-101
Urothelial Carcinoma
PDUFA priority review
PDUFA date under priority review April 18, 2020.
12/19/2019
SNY
$44.60
-1.52  -3.30%
MenQuadfi
Meningococcal meningitis
PDUFA
PDUFA date April 25, 2020.
06/27/2019
NBIX
$94.31
+3.09  +3.39%
Opicapone
Parkinson's disease
PDUFA
PDUFA date April 26, 2020.
07/10/2019
CORV
$0.37
  +-0.86%
Trevyent
Pulmonary Arterial Hypertension (PAH)
PDUFA
04/27/2020 - see note
PDUFA date April 27, 2020. NOTE: NDA was submitted by UTHR which holds rights to U.S. sales. CORV has rights to only European rights so will not be financially impacted by PDUFA decision but some stock price effect might be seen due to its upcoming European regulatory filing.
01/07/2020
UTHR
$95.06
-0.7  -0.73%
Trevyent
Pulmonary Arterial Hypertension (PAH)
PDUFA
PDUFA date April 27, 2020.
01/07/2020
APLT
$40.60
+5.59  +15.97%
AT-007
Galactosemia
Phase 2
Phase 2 data January 8, 2019 noted significant plasma galactitol reduction of ~50% (p<0.01). Full data to be presented at the Society for Inherited Metabolic Disorders Annual Meeting, April 26 – 29, 2020.
01/08/2020
OVID
$2.79
-0.07  -2.45%
OV935 ENDYMION
Developmental and Epileptic Encephalopathies (dEE)
Phase 2
Phase 2 open label additional data to be presented at AAN meeting April 28, 5:30 – 6:30 p.m. ET.
03/05/2020
SEEL
$0.45
-0.01  -2.95%
SLS-002-102
Healthy volunteers
Phase 1
Early 2Q 2020
Phase 1 data due early 2Q 2020.
03/24/2020
MYOV
$7.84
-0.72  -8.41%
Relugolix - SPIRIT 2
Endometriosis-associated pain
Phase 3
April 2020
Phase 3 data due April 2020.
03/31/2020
KNSA
$17.08
-0.71  -3.99%
KPL-716
Prurigo nodularis
Phase 2
April 2020
Phase 2 data due by the end of April 2020.
02/26/2020
SCYX
$0.86
+0.02  +2.09%
SCY-078 - oral ibrexafungerp - VANISH 306
Vulvovaginal candidiasis (VVC)
Phase 3
Early 2Q 2020
Phase 3 data due early 2Q 2020.
03/11/2020
MYOV
$7.84
-0.72  -8.41%
Relugolix - LIBERTY 1 and LIBERTY 2
Menstrual bleeding associated with uterine fibroids
NDA Filing
April 2020
NDA filing due April 2020.
02/10/2020
GILD
$74.67
-3.06  -3.94%
Remdesivir GS-5734
Coronavirus / COVID-19
Phase 3
April 2020
Phase 3 data due April 2020.
04/03/2020
OVID
$2.79
-0.07  -2.45%
OV101 (ROCKET)
Fragile X syndrome
Phase 2
Early-2Q 2020
Phase 2 top-line data due early 2Q 2020.
03/11/2020
ITRM
$2.67
+0.03  +0.94%
Sulopenem
Uncomplicated urinary tract infections (uUTI)
Phase 3
Early-2Q 2020
Phase 3 data due early-2Q 2020.
03/31/2020
ITRM
$2.67
+0.03  +0.94%
Sulopenem
Complicated urinary tract infections (cUTI)
Phase 3
Early-2Q 2020
Phase 3 data due early-2Q 2020.
03/31/2020
LCTX
$0.76
-0.03  -4.03%
OpRegen
Dry age-related macular degeneration (AMD)
Phase 1/2
Phase 1/2 enrolment to be completed 1Q 2020. Data due at ARVO May 3-7, 2020.
12/19/2019
ADVM
$9.86
-0.11  -1.10%
ADVM-022 (OPTIC)
Wet age-related macular degeneration (Wet-AMD)
Phase 1
Phase 1 updated data due at ARVO May 4, 2020 8:15 – 8:30 a.m. ET.
03/11/2020
AZN
$43.10
-1.21  -2.73%
Farxiga (Dapa-HF)
Heart failure
PDUFA priority review
2Q 2020
PDUFA date under priority review 2Q 2020.
01/06/2020
ONCY
$1.42
-0.04  -2.74%
Pelareorep and Tecentriq - AWARE-1
Breast cancer
Phase 1b
ESMO May 7-9, 2020
Phase 1b updated data to be presented at ESMO May 7-9, 2020 with final data due 2H 2020.
03/24/2020
YMAB
$27.15
+1.15  +4.42%
Omburtamab
CNS/Leptomeningeal Metastases from Neuroblastoma
BLA Filing
May 2020
Rolling BLA filing to be completed by early May 2020.
02/26/2020
HALO
$16.67
-0.59  -3.42%
DARZALEX (Daratumumab) using ENHANZE
Multiple myeloma
PDUFA
sBLA filing announced July 12, 2019. PDUFA estimate May 12, 2020.
07/18/2019
JNJ
$137.48
-2.28  -1.63%
DARZALEX (Daratumumab) using ENHANZE
Multiple myeloma
PDUFA
sBLA filing announced July 12, 2019. PDUFA estimate May 12, 2020.
07/18/2019
GMAB
$21.02
-0.52  -2.41%
DARZALEX (Daratumumab) using ENHANZE
Multiple myeloma
PDUFA
sBLA filing announced July 12, 2019. PDUFA estimate May 12, 2020.
07/18/2019
BPMC
$65.26
-0.37  -0.56%
Avapritinib - Voyager
Gastrointestinal stromal tumors (GIST)
Phase 3
Early 2Q 2020
Phase 3 data due early 2Q 2020.
02/06/2020
AZN
$43.10
-1.21  -2.73%
Lynparza + Avastin- PAOLA-1
First-line ovarian cancer
PDUFA priority review
2Q 2020
PDUFA date under priority review 2Q 2020.
01/13/2020
MRK
$78.56
-1.75  -2.18%
Lynparza + Avastin- PAOLA-1
First-line ovarian cancer
PDUFA priority review
2Q 2020
PDUFA date under priority review 2Q 2020.
01/13/2020
ARGX
$138.15
+1.15  +0.84%
Efgartigimod (ARGX-113)
Pemphigus vulgaris (PV)
Phase 2
Phase 2 data to be presented at the Society for Investigative Dermatology Annual Meeting in May 13-16, 2020.
02/27/2020
BPMC
$65.26
-0.37  -0.56%
Avapritinib
Fourth-line GIST
PDUFA priority review
PDUFA date extended by three months to May 14, 2020 to allow for data from the Voyager trial.
02/06/2020
EARS
$0.81
+0.01  +1.02%
AM-201
Healthy volunteers
Phase 1b
Early-May 2020
Phase 1b data from second part of trial due early-May 2020.
04/03/2020
BMY
$56.90
-0.97  -1.68%
CM-227 – Opdivo + Yervoy
First-line Non-small cell lung cancer (NSCLC)
PDUFA priority review
PDUFA date under priority review May 15, 2020.
01/15/2020
CLVS
$6.79
-0.01  -0.15%
Rubraca (rucaparib)
Castrate-resistant prostate cancer (mCRPC)
PDUFA priority review
PDUFA date under priority review May 15, 2020.
01/15/2020
ENTA
$50.92
+0.15  +0.30%
EDP-305 INTREPID
Primary biliary cholangitis (PBC)
Phase 2
Early-2Q 2020
Phase 2 top-line data due by early-2Q 2020.
03/26/2020
AZN
$43.10
-1.21  -2.73%
Lynparza
Castration-Resistant Prostate Cancer
PDUFA priority review
2Q 2020
PDUFA date under priority review 2Q 2020.
01/20/2020
MRK
$78.56
-1.75  -2.18%
Lynparza
Castration-Resistant Prostate Cancer
PDUFA priority review
2Q 2020
PDUFA date under priority review 2Q 2020.
01/20/2020
AQST
$2.06
-0.05  -2.37%
APL-130277
Parkinson’s Disease with motor fluctuations
PDUFA
CRL issued January 30, 2019 through partner Sunovion (private company). NDA refiled. New PDUFA date May 21, 2020.
01/10/2020
EVFM
$5.09
-0.11  -2.12%
Amphora - AMPOWER
contraceptive vaginal gel
PDUFA
PDUFA date May 25, 2020.
01/06/2020
REGN
$501.51
-2.76  -0.55%
Dupixent (dupilumab)
Atopic dermatitis 6-11 year-olds
PDUFA priority review
PDUFA date May 26, 2020.
01/28/2020
SNY
$44.60
-1.52  -3.30%
Dupixent (dupilumab)
Atopic dermatitis 6-11 year-olds
PDUFA priority review
PDUFA date May 26, 2020.
01/28/2020
TRIL
$3.94
-0.06  -1.50%
TTI-622
Refractory lymphoma or multiple myeloma
Phase 1b
ASCO May 29, 2020 – Jun 2, 2020
Phase 1a/b update due at ASCO May 29, 2020 – Jun 2, 2020
03/10/2020
TROV
$0.80
+0.02  +2.22%
Onvansertib, Folfiri and Avastin (bevacizumab)
KRAS-Mutated Colorectal Cancer
Phase 1/2
ASCO May 29 – June 2
Phase 1b/2 data to be presented at ASCO May 29 – June 2.
04/01/2020
ONCY
$1.42
-0.04  -2.74%
Pelareorep and Carfilzomib /Dexamethasone
Multiple myeloma
Phase 1
ASCO May 29-June 2, 2020
Phase 1 interim data due at ASCO 2020.
03/05/2020
HARP
$11.49
-0.38  -3.20%
HPN424
Metastatic castration-resistant prostate cancer
Phase 1
ASCO May 29 - June 2, 2020
Phase 1 preliminary data due at ASCO May 29 - June 2, 2020.
03/12/2020
SBPH
$0.93
+0.02  +2.54%
SB 11285
Solid tumors
Phase 1
ASCO 2020
Phase 1 data to be presented at ASCO May 29 - June 2, 2020.
04/02/2020
INCY
$86.66
+1.55  +1.82%
Pemigatinib (FIGHT-202)
Cholangiocarcinoma
PDUFA priority review
PDUFA date under priority review May 30, 2020.
11/27/2019
CLVS
$6.79
-0.01  -0.15%
Lucitanib with Opdivo
Solid tumors
Phase 1/2
ASCO May 29-June 2, 2020
Phase 1b/2 initial data due at ASCO May 29-June 2, 2020.
01/31/2020
ONCY
$1.42
-0.04  -2.74%
Pelareorep with Keytruda
Pancreatic cancer
Phase 2
ASCO May 29-June 2, 2020
Phase 2 interim data due at ASCO May 29-June 2, 2020 with final data due 2H 2020.
03/05/2020
MNLO
$1.03
-0.37  -26.43%
FMX103
Papulopustular rosacea
PDUFA
PDUFA date June 2, 2020.
03/09/2020
IMMU
$18.91
+0.13  +0.69%
SACTUZUMAB GOVITECAN (IMMU-132)
Triple-negative breast cancer
PDUFA
PDUFA date June 2, 2020.
12/26/2019
NBIX
$94.31
+3.09  +3.39%
Elagolix
Uterine Fibroids
PDUFA
NDA filing announced August 5, 2019. PDUFA date 2Q 2020. Exact date not provided. Estimate June 4, 2020 based on 10-month timeline.
02/04/2020
ABBV
$75.39
-0.34  -0.45%
Elagolix
Uterine Fibroids
PDUFA
NDA filing announced August 5, 2019. PDUFA date 2Q 2020. Exact date not provided. Estimate June 4, 2020 based on 10-month timeline.
02/04/2020
MRK
$78.56
-1.75  -2.18%
Imipenem/ cilastatin
Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)
PDUFA priority review
PDUFA date under priority review June 4, 2020.
02/03/2020
NBIX
$94.31
+3.09  +3.39%
Crinecerfont (NBI-74788)
Congenital Adrenal Hyperplasia (CAH) - adults
Phase 2
ENDO Online meeting June 2020
Phase 2 full data to be presented at ENDO Online 2020 meeting June 08-22, 2020.
04/03/2020
ICPT
$62.91
+0.06  +0.10%
Ocaliva (Obeticholic acid (OCA)) - REGENERATE
Adult nonalcoholic steatohepatitis (NASH) patients.
PDUFA priority review
Advisory Committee 06/09/2020; PDUFA date 06/26/2020
Advisory Committee meeting June 9, 2020. PDUFA date June 26, 2020.
03/26/2020
AKTX
$1.44
+0.04  +2.86%
Nomacopan - CAPSTONE
Paroxysmal nocturnal hemoglobinuria (PNH)
Phase 3
Phase 3 interim data January 10, 2020 noted all patients achieved the primary endpoint of transfusion independence. Further data due at EHA June 11-14, 2020.
01/10/2020
TROV
$0.80
+0.02  +2.22%
Onvansertib (PCM-075)
Acute Myeloid Leukemia (AML)
Phase 1/2
EHA June 2020
Phase 1/2 efficacy data due at EHA June 11-14, 2020.
03/30/2020
CNST
$30.00
-1.26  -4.03%
CPI-0610 and ruxolitinib - Manifest
Myelofibrosis
Phase 2
EHA June 11-14, 2020
Phase 2 data at ASH December 9, 2019 noted (spleen volume response) SVR35 80%; (Total Symptom Score >50% improvement) TSS50 71%. Update due at EHA June 11-14, 2020.
03/10/2020
VIE
$29.90
-0.62  -2.03%
Inebilizumab
Neuromyelitis Optica Spectrum Disorder
PDUFA
PDUFA date June 11, 2020.
10/05/2019
NVUS
$0.35
+0.01  +1.88%
OP0201 - C-006
Acute Otitis Media - children
Phase 2a
Early-June 2020
Phase 2a data due by early-June 2020.
03/17/2020
AGIO
$38.18
-1.32  -3.34%
AG-348 - Mitapivat
Thalassemia
Phase 2
EHA June 11-14, 2020
Phase 2 updated data due at EHA June 11 - 14, 2020.
02/26/2020
MRK
$78.56
-1.75  -2.18%
Keytruda
Solid tumors - TMB-H ≥10 mutations/megabase
PDUFA priority review
PDUFA date under priority review June 16, 2020.
04/07/2020
RARE
$50.71
-0.75  -1.46%
Burosumab
Tumor-induced osteomalacia (TIO)
PDUFA priority review
PDUFA date under priority review June 18, 2020.
02/27/2020
EPZM
$15.05
-0.23  -1.51%
Tazemetostat
Follicular lymphoma
PDUFA priority review
PDUFA date June 18, 2020 under priority review.
02/14/2020
NBRV
$0.56
+0.03  +6.52%
Contepo
Complicated urinary tract infections (cUTI)
PDUFA
CRL issued April 30, 2019. New PDUFA date June 19, 2020.
01/08/2020
RHHBY
$40.02
-1.63  -3.91%
Tecentriq - IMpower110
Non-small cell lung cancer (NSCLC)
PDUFA priority review
PDUFA date under priority review June 19, 2020.
02/19/2020
EVOK
$1.06
-0.02  -1.85%
Gimoti - EVK-001
Female diabetic gastroparesis
PDUFA
CRL issued April 2, 2019. NDA resubmitted with new PDUFA date of June 19, 2020.
01/21/2020
KPTI
$18.58
-0.56  -2.93%
Selinexor
Diffuse Large B-Cell Lymphoma (DLBCL)
PDUFA priority review
PDUFA date under priority review June 23, 2020.
02/19/2020
NVS
$83.99
-1.74  -2.03%
OMB157 (ofatumumab)
Relapsing multiple sclerosis
PDUFA priority review
June 2020
PDUFA date under priority review June 2020.
02/24/2020
GMAB
$21.02
-0.52  -2.41%
OMB157 (ofatumumab)
Relapsing multiple sclerosis
PDUFA priority review
June 2020
PDUFA date under priority review June 2020.
02/24/2020
ZGNX
$23.82
+0.74  +3.21%
FINTEPLA (ZX008)
Dravet syndrom
PDUFA priority review
PDUFA date under priority review extended by three months to June 25, 2020
02/27/2020
HRTX
$13.52
+0.74  +5.78%
HTX-011
Post operative pain
PDUFA
PDUFA date extended by three months to June 26, 2020.
02/19/2020
CHMA
$3.53
-0.26  -6.86%
Mycapssa - OPTIMAL
Acromegaly
PDUFA
PDUFA date June 26, 2020.
01/13/2020
PLX
$2.40
+0.07  +3.00%
Pegunigalsidase alfa (PRX-102)
Fabry disease
BLA Filing
2Q 2020
BLA filing due 2Q 2020.
03/12/2020
ARVN
$41.14
-1.44  -3.38%
ARV-110
Castration-resistant prostate cancer (CRPC)
Phase 1
2Q 2020
Phase 1 initial data presented October 23, 2019. Further data due 2Q 2020.
03/16/2020
MRNA
$32.02
-2.62  -7.56%
mRNA-1273
Coronavirus COVID-19 vaccine
Phase 1
2Q 2020
Phase 1 initiation of dosing announced March 16, 2020. Potential initial safety data due late-2Q 2020 with Phase 2 trial to commence in mid-2020.
04/04/2020
BYSI
$12.87
-0.13  -1.00%
Plinabulin (Trial 105)
Chemotherapy-induced neutropenia (CIN)
Phase 3
1H 2020
Phase 3 final data due 1H 2020.
03/17/2020
SLGL
$6.93
+0.01  +0.14%
VERED (Epsolay)
Papulopustular rosacea
NDA Filing
2Q 2020
NDA filing due 2Q 2020.
03/24/2020
NVS
$83.99
-1.74  -2.03%
Entresto - PARADISE
AMI (acute myocardial infarction)
Phase 3
1H 2020
Phase 3 interim analysis 1H 2020 with full data due in 2021.
03/25/2020
BIIB
$301.21
-10.18  -3.27%
Natalizumab - OPUS
Epilepsy
Phase 2
1H 2020
Phase 2 data due 1H 2020.
03/24/2020
BHVN
$30.23
-1.85  -5.77%
TRORILUZOLE
Obsessive compulsive disorder (OCD)
Phase 2/3
2Q 2020
Phase 2/3 top-line data due 2Q 2020.
02/25/2020
IMVT
$14.52
+0.65  +4.69%
IMVT-1401
Myasthenia Gravis (MG)
Phase 2
1H 2020
Phase 2 top-line data due 1H 2020.
02/14/2020
BTAI
$19.67
-0.45  -2.24%
BXCL501
Agitation in patients with schizophrenia
Phase 2
2Q 2020
Phase 2 data due 2Q 2020.
03/09/2020
PFE
$33.61
-0.96  -2.78%
PF-06939926
Duchenne muscular dystrophy (DMD)
Phase 1b
1H 2020
Phase 1b data due 1H 2020.
04/03/2020
REGN
$501.51
-2.76  -0.55%
Cemiplimab
Basal cell carcinoma
Phase 2
1H 2020
Phase 2 pivotal data due 1H 2020.
02/06/2020
SNY
$44.60
-1.52  -3.30%
Cemiplimab
Basal cell carcinoma
Phase 2
1H 2020
Phase 2 pivotal data due 1H 2020.
02/06/2020
ASMB
$16.20
-0.75  -4.42%
ABI-H0731
Hepatitis B virus (HBV)
Phase 2
2Q 2020
Phase 2 additional interim analyses due 2Q 2020.
03/04/2020
KPTI
$18.58
-0.56  -2.93%
Selinexor - BOSTON
Multiple myeloma
sNDA Filing
2Q 2020
sNDA filing due 2Q 2020.
04/07/2020
SNY
$44.60
-1.52  -3.30%
THOR-707
Soild tumors
Phase 1/2
1H 2020
Phase 1 biomarker data from first cohort to be presented 1H 2020.
01/23/2020
AKTX
$1.44
+0.04  +2.86%
Nomacopan (Coversin)
Bullous Pemphigoid
Phase 2
2Q 2020
Phase 2 full data due 2Q 2020.
03/31/2020
MTEM
$13.95
+0.11  +0.79%
MT-5111
HER2-positive solid tumors
Phase 1
2Q 2020
Phase 1 interim data due 2Q 2020.
03/12/2020
RAPT
$15.65
-1.26  -7.45%
FLX475 + Keytruda
Advanced Cancer
Phase 1/2
2Q 2020
Phase 2 data due 2Q 2020.
01/09/2020
BPMC
$65.26
-0.37  -0.56%
BLU-667 - ARROW
RET-altered solid tumors
NDA Filing
2Q 2020
Phase 1 updated data noted 60% overall response rate and 18-month duration of response rate of 90%. NDA filing due 2Q 2020.
04/01/2020
CORT
$11.00
-0.54  -4.68%
Miricorilant
Healthy volunteers
Phase 1b
2Q 2020
Phase 1b 900g dose data due 2Q 2020.
02/20/2020
SRPT
$99.98
-1.09  -1.08%
MYO-101 (SRP-9003)
Duchenne muscular dystrophy - LGMD2E
Phase 1/2
2Q 2020
Expression and safety data due 2Q 2020. Dose selection decision due 3Q 2020.
02/26/2020
ALLO
$20.33
-0.78  -3.69%
ALLO-501 - ALPHA
Non-Hodgkin lymphoma (NHL)
Phase 1
2Q 2020
Phase 1 initial data due 2Q 2020.
03/27/2020
HOOK
$7.95
-0.35  -4.22%
HB-101
Cytomegalovirus (CMV)
Phase 2
1H 2020
Phase 2 safety and immunogenicity data due 1H 2020, with efficacy data due 2H 2020.
03/19/2020
ITCI
$15.29
-0.19  -1.23%
ITI-214-105
Heart failure
Phase 1/2
1H 2020
Phase 1/2 top-line data due 1H 2020.
03/02/2020
ASND
$121.80
+3.47  +2.93%
TransCon hGH
Growth hormone deficiency in children
BLA Filing
2Q 2020
BLA filing due 2Q 2020.
04/01/2020
SNY
$44.60
-1.52  -3.30%
Isatuximab - IKEMA
Refractory Multiple Myeloma
Phase 3
2Q 2020
Phase 3 data due 2Q 2020.
02/06/2020
AUPH
$14.50
-0.5  -3.33%
Voclosporin - AURORA
Lupus
NDA Filing
2Q 2020
NDA rolling submission has commenced - noted March 16, 2020. To be completed 2Q 2020.
03/18/2020
SRPT
$99.98
-1.09  -1.08%
Eteplirsen (PROMOVI)
Duchenne Muscular Dystrophy (DMD)
Phase 3
2Q 2020
Phase 3 open-label data to be released March 2020. Overdue. No update from company so moved to 2Q 2020.
04/03/2020
AVEO
$3.63
+0.06  +1.68%
TIVO-3 - tivozanib
Third line treatment of patients with renal cell cancer
Phase 3
June 2020
NDA filing announced March 31, 2020. Will withdraw if overall survival data to be reported by June 2020 yields an OS HR above 1.00.
03/31/2020
XERS
$1.71
-0.28  -14.07%
Self administered glucagon
Exercise-Induced Hypoglycemia
Phase 2
1H 2020
Phase 2b data 1H 2020.
03/11/2020
DRNA
$18.10
-1.71  -8.63%
DCR-PHXC - PHYOX3
Primary hyperoxaluria (PH)
Phase 1
June 2020
Phase 1 multi-dose data presented March 31, 2020. More detailed data due June 2020.
03/31/2020
XERS
$1.71
-0.28  -14.07%
Self administered glucagon
Post-Bariatric Hypoglycemia
Phase 2
1H 2020
Phase 2b outpatient data due 1H 2020.
03/11/2020
AKBA
$6.70
-0.39  -5.50%
Vadadustat - INNO2VATE
Anemia related to chronic kidney disease who are undergoing dialysis (DD-CKD)
Phase 3
2Q 2020
Phase 3 data due 2Q 2020.
03/10/2020
KALA
$8.50
-0.36  -4.06%
KPI‑121 0.25%
Dry eye disease
NDA Filing
1H 2020
CRL issued August 8, 2019. NDA to be resubmitted 1H 2020.
02/12/2020
CERC
$2.15
-0.19  -8.12%
CERC-802
Healthy volunteers
Phase 1
1H 2020
Phase 1 initial data due 1H 2020.
03/17/2020
OBSV
$2.12
-0.13  -5.78%
Linzagolix OBE2109 - PRIMROSE 2
Uterine fibroids
Phase 3
2Q 2020
Phase 3 data met primary endpoint - December 9, 2019. 12 month data due 2Q 2020.
03/23/2020
MNTA
$26.49
-1.51  -5.39%
M254
Immune Thrombocytopenic Purpura (ITP)
Phase 1/2
2Q 2020
Phase 1/2 additional data due 2Q 2020 may not be released on time due to COVID-19.
04/02/2020
MRUS
$11.00
-0.53  -4.60%
MCLA-117
Acute Myeloid Leukemia
Phase 1
1H 2020
Phase 1 readout due 1H 2020.
03/12/2020
PFE
$33.61
-0.96  -2.78%
Avelumab - Bavencio
Gastric cancer
Phase 3
1H 2020
Phase 3 data due 1H 2020.
09/11/2019
LLY
$141.88
+0.27  +0.19%
D1PAM
Dementia with Lewy bodies (DLB)
Phase 2
1H 2020
Phase 2 data due 1H 2020.
07/30/2019
EYEG
$4.87
-0.32  -6.17%
Ocular Bandage Gel eye drop
Dry eye disease
Phase 1
1H 2020
Data from follow-on pilot trial due 1H 2020.
03/04/2020
PFE
$33.61
-0.96  -2.78%
Avelumab - Bavencio
Urothelial Cancer
Phase 3
1H 2020
Phase 3 data due 1H 2020.
07/22/2019
BYSI
$12.87
-0.13  -1.00%
Plinabulin + TAC (Trial 106)
Chemotherapy-induced neutropenia (CIN)
Phase 3
1H 2020
Phase 3 final data due 1H 2020.
12/24/2019
APLS
$25.51
-1.6  -5.90%
APL-2 subcutaneous PEGASUS
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Phase 3
2Q 2020
Phase 3 data met primary endpoint - January 7, 2020. 48-week data due 2Q 2020.
02/27/2020
JAZZ
$105.22
-0.55  -0.52%
Defibrotide
VOD in high-risk patients following hematopoietic stem cell transplantation
Phase 3
1H 2020
Phase 3 interim analysis due 1H 2020.
03/28/2020
ACIU
$6.81
-0.43  -5.94%
RG6100 (Anti-Tau RO7105705)
Alzheimer’s disease
Phase 2
2Q 2020
Phase 2 primary completion 2Q 2020.
03/30/2020
NERV
$5.50
-0.2  -3.51%
Roluperidone (MIN-101)
Schizophrenia
Phase 3
2Q 2020
Phase 3 data due 2Q 2020.
03/09/2020
NVAX
$14.90
-1.2  -7.45%
Matrix-M
Malaria vaccine
Phase 2b
2Q 2020
Phase 2b data due 2Q 2020.
03/11/2020
TNXP
$0.70
-0.03  -3.97%
Tonmya (TNX-102 SL)
Post-traumatic stress disorder (PTSD)
Phase 3
2Q 2020
Phase 3 enrolment to be stopped due to futility - February 5, 2020. Top-line data to be reported 2Q 2020.
03/24/2020
SGEN
$121.87
-2.6  -2.09%
Tisotumab Vedotin (innovaTV 204 )
Cervical Cancer
Phase 2
1H 2020
Phase 2 data due 1H 2020.
02/06/2020
GMAB
$21.02
-0.52  -2.41%
Tisotumab Vedotin (innovaTV 204 )
Cervical Cancer
Phase 2
1H 2020
Phase 2 data due 1H 2020.
02/06/2020
GMDA
$2.99
+0.2  +7.17%
NiCord (omidubicel)
Acute myeloid leukemia
Phase 3
2Q 2020
Phase 3 top-line data due 2Q 2020.
02/25/2020
MIRM
$13.30
-0.13  -0.97%
Volixibat
Phase 1
2Q 2020
Phase 1 data due 2Q 2020.
03/12/2020
ACIU
$6.81
-0.43  -5.94%
ACI-35.030
Alzheimer’s Disease
Phase 1/2
2Q 2020
Phase 1b/2 interim analysis 2Q 2020.
03/30/2020
CAPR
$1.18
+0.08  +7.27%
CAP-1002 HOPE-2
Duchenne Muscular Dystrophy (DMD)
Phase 2
2Q 2020
Phase 2 12-month data due 2Q 2020.
03/18/2020
ALXN
$94.72
-1.19  -1.24%
ULTOMIRIS (ravulizumab-cwvz) subcutaneous
Paroxysmal nocturnal hemoglobinuria (PNH) and atypical Hemolytic Uremic Syndrome (aHUS)
Phase 3
1H 2020
Phase 3 PK data due 1H 2020.
01/30/2020
KNSA
$17.08
-0.71  -3.99%
KPL-716
Chronic Pruritus
Phase 2
1H 2020
Phase 2 interim data due 1H 2020.
02/26/2020
NYMX
$2.12
-0.01  -0.47%
NX-1207 Fexapotide
BPH
NDA Filing
1H 2020
NDA filing planned for 1H 2020.
01/28/2020
GILD
$74.67
-3.06  -3.94%
Axicabtagene ciloleucel (ZUMA-6)
Refractory diffuse large B-cell lymphoma (DLBCL)
Phase 1/2
1H 2020
Phase 1/2 data due 1H 2020.
12/13/2019
CBIO
$4.36
+0.03  +0.69%
Marzeptacog alfa
Hemophilia
Phase 1
2Q 2020
Phase 1 PK data due 2020.
02/24/2020
RVNC
$15.00
-0.55  -3.54%
DAXI (RT002)
Forehead lines
Phase 2
2Q 2020
Phase 2 top-line data due 2Q 2020.
03/26/2020
NVS
$83.99
-1.74  -2.03%
LJN452
Non-alcoholic steatohepatitis (NASH)
Phase 2
1H 2020
Phase 2 trial to be completed 1H 2020.
02/25/2020
CPRX
$3.72
-0.2  -5.10%
Firdapse
MuSK-antibody positive myasthenia gravis (MuSK-MG)
Phase 3
2Q 2020
Phase 3 data due 2Q 2020.
03/16/2020
BVXV
$7.68
+0.38  +5.21%
M-001
Universal flu vaccine
Phase 2
2Q 2020
Phase 2 data due 2Q 2020.
02/05/2020
CTXR
$0.67
-0.02  -3.48%
Mino-Lok
Catheter related blood stream infection
Phase 3
1H 2020
Phase 3 75% interim analysis for superior efficacy expected 1H 2020.
02/04/2020
OTIC
$1.96
-0.01  -0.51%
OTO-313
Tinnitus
Phase 1/2
2Q 2020
Phase 1/2 data due 2Q 2020.
02/27/2020
MYOV
$7.84
-0.72  -8.41%
Relugolix - HERO
Advanced prostate cancer
NDA Filing
2Q 2020
NDA filing due 2Q 2020.
02/10/2020
CCXI
$42.60
-0.9  -2.07%
CCX140 - LUMINA-1
Focal Segmental Glomerulosclerosis
Phase 2
2Q 2020
Phase 2 data due 2Q 2020.
03/10/2020

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