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 |
$1.75
+0.18 +11.46%
|
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 |
$56.15
-2.05 -3.52%
|
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 |
| ASND |
$121.36
-0.61 -0.50%
|
TransCon
Hypoparathyroidism
|
Phase 2 |
Mid-April 2020
Phase 2 top-line data due mid-April 2020.
|
04/01/2020 |
| ALNY |
$116.38
+4.99 +4.48%
|
ALN-HBV02 (VIR-2218)
Chronic hepatitis B virus (HBV)
|
Phase 1/2 | 04/08/2020 | |
| VIR |
$29.50
+0.4 +1.37%
|
ALN-HBV02 (VIR-2218)
Chronic hepatitis B virus (HBV)
|
Phase 1/2 | 04/08/2020 | |
| OGEN |
$0.76
+0.14 +21.64%
|
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 |
| VKTX |
$5.05
+0.13 +2.64%
|
VK2809
Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
|
Phase 2 | 02/26/2020 | |
| LGND |
$86.42
+3.41 +4.11%
|
VK2809
Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
|
Phase 2 | 02/26/2020 | |
| URGN |
$21.30
+1.25 +6.23%
|
MitoGel - UGN-101
Urothelial Carcinoma
|
PDUFA priority review | 12/19/2019 | |
| SNY |
$45.46
+0.28 +0.62%
|
MenQuadfi
Meningococcal meningitis
|
PDUFA | 06/27/2019 | |
| NBIX |
$96.68
+0.65 +0.68%
|
Opicapone
Parkinson's disease
|
PDUFA | 07/10/2019 | |
| CORV |
$0.37
+0.71%
|
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 |
$95.87
-0.72 -0.75%
|
Trevyent
Pulmonary Arterial Hypertension (PAH)
|
PDUFA | 01/07/2020 | |
| APLT |
$43.52
-2.41 -5.25%
|
AT-007
Galactosemia
|
Phase 2 | 01/08/2020 | |
| OVID |
$2.84
+0.01 +0.35%
|
OV935 ENDYMION
Developmental and Epileptic Encephalopathies (dEE)
|
Phase 2 | 03/05/2020 | |
| AMGN |
$218.21
-0.98 -0.45%
|
OTEZLA
Scalp Psoriasis
|
PDUFA |
April 2020
PDUFA date April 2020.
|
04/08/2020 |
| MYOV |
$9.60
+0.85 +9.71%
|
Relugolix - SPIRIT 2
Endometriosis-associated pain
|
Phase 3 |
April 2020
Phase 3 data due April 2020.
|
03/31/2020 |
| KNSA |
$16.99
+0.06 +0.35%
|
KPL-716
Prurigo nodularis
|
Phase 2 |
April 2020
Phase 2 data due by the end of April 2020.
|
02/26/2020 |
| SCYX |
$0.85
-0.02 -2.45%
|
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 |
$9.60
+0.85 +9.71%
|
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 |
$73.51
-1.48 -1.97%
|
Remdesivir GS-5734 - China trial
Coronavirus / COVID-19
|
Phase 3 |
April 2020
Phase 3 data due April 2020.
|
04/09/2020 |
| OVID |
$2.84
+0.01 +0.35%
|
OV101 (ROCKET)
Fragile X syndrome
|
Phase 2 |
Early-2Q 2020
Phase 2 top-line data due early 2Q 2020.
|
03/11/2020 |
| ITRM |
$2.89
+0.1 +3.58%
|
Sulopenem
Uncomplicated urinary tract infections (uUTI)
|
Phase 3 |
Early-2Q 2020
Phase 3 data due early-2Q 2020.
|
03/31/2020 |
| ITRM |
$2.89
+0.1 +3.58%
|
Sulopenem
Complicated urinary tract infections (cUTI)
|
Phase 3 |
Early-2Q 2020
Phase 3 data due early-2Q 2020.
|
03/31/2020 |
| LCTX |
$0.77
+0.01 +1.38%
|
OpRegen
Dry age-related macular degeneration (AMD)
|
Phase 1/2 | 12/19/2019 | |
| ADVM |
$11.16
+0.43 +4.01%
|
ADVM-022 (OPTIC)
Wet age-related macular degeneration (Wet-AMD)
|
Phase 1 | 03/11/2020 | |
| AZN |
$44.66
+0.81 +1.85%
|
Farxiga (Dapa-HF)
Heart failure
|
PDUFA priority review |
2Q 2020
PDUFA date under priority review 2Q 2020.
|
01/06/2020 |
| ONCY |
$1.46
+0.01 +0.69%
|
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 |
$29.17
+1.34 +4.81%
|
Omburtamab
CNS/Leptomeningeal Metastases from Neuroblastoma
|
BLA Filing |
May 2020
Rolling BLA filing to be completed by early May 2020.
|
02/26/2020 |
| HALO |
$17.98
+0.29 +1.64%
|
DARZALEX (Daratumumab) using ENHANZE
Multiple myeloma
|
PDUFA | 07/18/2019 | |
| JNJ |
$141.23
-2.03 -1.42%
|
DARZALEX (Daratumumab) using ENHANZE
Multiple myeloma
|
PDUFA | 07/18/2019 | |
| GMAB |
$22.36
+0.66 +3.04%
|
DARZALEX (Daratumumab) using ENHANZE
Multiple myeloma
|
PDUFA | 07/18/2019 | |
| BPMC |
$66.20
-0.83 -1.24%
|
Avapritinib - Voyager
Gastrointestinal stromal tumors (GIST)
|
Phase 3 |
Early 2Q 2020
Phase 3 data due early 2Q 2020.
|
02/06/2020 |
| AZN |
$44.66
+0.81 +1.85%
|
Lynparza + Avastin- PAOLA-1
First-line ovarian cancer
|
PDUFA priority review |
2Q 2020
PDUFA date under priority review 2Q 2020.
|
01/13/2020 |
| MRK |
$82.49
+0.87 +1.07%
|
Lynparza + Avastin- PAOLA-1
First-line ovarian cancer
|
PDUFA priority review |
2Q 2020
PDUFA date under priority review 2Q 2020.
|
01/13/2020 |
| ARGX |
$143.58
+3.3 +2.35%
|
Efgartigimod (ARGX-113)
Pemphigus vulgaris (PV)
|
Phase 2 | 02/27/2020 | |
| BPMC |
$66.20
-0.83 -1.24%
|
Avapritinib
Fourth-line GIST
|
PDUFA priority review | 02/06/2020 | |
| EARS |
$0.83
+0.05 +6.35%
|
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 |
$58.91
+0.66 +1.13%
|
CM-227 – Opdivo + Yervoy
First-line Non-small cell lung cancer (NSCLC)
|
PDUFA priority review | 01/15/2020 | |
| CLVS |
$6.70
-0.23 -3.32%
|
Rubraca (rucaparib)
Castrate-resistant prostate cancer (mCRPC)
|
PDUFA priority review | 01/15/2020 | |
| ENTA |
$53.04
+0.87 +1.67%
|
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 |
$44.66
+0.81 +1.85%
|
Lynparza
Castration-Resistant Prostate Cancer
|
PDUFA priority review |
2Q 2020
PDUFA date under priority review 2Q 2020.
|
01/20/2020 |
| MRK |
$82.49
+0.87 +1.07%
|
Lynparza
Castration-Resistant Prostate Cancer
|
PDUFA priority review |
2Q 2020
PDUFA date under priority review 2Q 2020.
|
01/20/2020 |
| AQST |
$2.89
+0.31 +12.02%
|
APL-130277
Parkinson’s Disease with motor fluctuations
|
PDUFA | 01/10/2020 | |
| EVFM |
$5.21
+0.04 +0.77%
|
Amphora - AMPOWER
contraceptive vaginal gel
|
PDUFA | 01/06/2020 | |
| REGN |
$512.96
+0.63 +0.12%
|
Dupixent (dupilumab)
Atopic dermatitis 6-11 year-olds
|
PDUFA priority review | 01/28/2020 | |
| SNY |
$45.46
+0.28 +0.62%
|
Dupixent (dupilumab)
Atopic dermatitis 6-11 year-olds
|
PDUFA priority review | 01/28/2020 | |
| TRIL |
$3.96
-0.24 -5.71%
|
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 |
$0.91
+0.1 +12.47%
|
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 |
$1.46
+0.01 +0.69%
|
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 |
$11.47
-0.15 -1.29%
|
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 |
$1.22
+0.2 +19.61%
|
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 |
$86.81
-0.94 -1.07%
|
Pemigatinib (FIGHT-202)
Cholangiocarcinoma
|
PDUFA priority review | 11/27/2019 | |
| GILD |
$73.51
-1.48 -1.97%
|
Remdesivir (GS-5734) - Gilead trial
COVID-19 Coronavirus
|
Phase 3 |
May 2020
Phase 3 data due May 2020 (Gilead trial).
|
04/09/2020 |
| GNFT |
$16.19
-0.31 -1.88%
|
Elafibranor - RESOLVE-IT
Non-alcoholic steatohepatitis (NASH)
|
Phase 3 |
May 2020
Phase 3 interim results due by the end of May 2020.
|
04/08/2020 |
| CLVS |
$6.70
-0.23 -3.32%
|
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 |
$1.46
+0.01 +0.69%
|
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 |
$1.20
+0.14 +13.21%
|
FMX103
Papulopustular rosacea
|
PDUFA | 03/09/2020 | |
| IMMU |
$19.64
+1.21 +6.57%
|
SACTUZUMAB GOVITECAN (IMMU-132)
Triple-negative breast cancer
|
PDUFA | 12/26/2019 | |
| NBIX |
$96.68
+0.65 +0.68%
|
Elagolix
Uterine Fibroids
|
PDUFA | 02/04/2020 | |
| ABBV |
$79.75
+1.19 +1.51%
|
Elagolix
Uterine Fibroids
|
PDUFA | 02/04/2020 | |
| MRK |
$82.49
+0.87 +1.07%
|
Imipenem/ cilastatin
Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)
|
PDUFA priority review | 02/03/2020 | |
| NBIX |
$96.68
+0.65 +0.68%
|
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 |
$69.26
+2.21 +3.30%
|
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 |
$1.50
+0.03 +2.04%
|
Nomacopan - CAPSTONE
Paroxysmal nocturnal hemoglobinuria (PNH)
|
Phase 3 | 01/10/2020 | |
| TROV |
$0.91
+0.1 +12.47%
|
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 |
$34.16
+1.76 +5.43%
|
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 |
$32.62
+1.46 +4.69%
|
Inebilizumab
Neuromyelitis Optica Spectrum Disorder
|
PDUFA | 10/05/2019 | |
| NVUS |
$0.37
+0.01 +2.69%
|
OP0201 - C-006
Acute Otitis Media - children
|
Phase 2a |
Early-June 2020
Phase 2a data due by early-June 2020.
|
03/17/2020 |
| AGIO |
$39.88
-0.78 -1.92%
|
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 |
$82.49
+0.87 +1.07%
|
Keytruda
Solid tumors - TMB-H ≥10 mutations/megabase
|
PDUFA priority review | 04/07/2020 | |
| RARE |
$52.50
-0.52 -0.98%
|
Burosumab
Tumor-induced osteomalacia (TIO)
|
PDUFA priority review | 02/27/2020 | |
| EPZM |
$17.66
+0.83 +4.93%
|
Tazemetostat
Follicular lymphoma
|
PDUFA priority review | 02/14/2020 | |
| NBRV |
$0.53
-0.01 -1.13%
|
Contepo
Complicated urinary tract infections (cUTI)
|
PDUFA | 01/08/2020 | |
| RHHBY |
$39.75
-0.6 -1.49%
|
Tecentriq - IMpower110
Non-small cell lung cancer (NSCLC)
|
PDUFA priority review | 02/19/2020 | |
| EVOK |
$1.10
+0.02 +1.85%
|
Gimoti - EVK-001
Female diabetic gastroparesis
|
PDUFA | 01/21/2020 | |
| KPTI |
$20.53
+1.25 +6.48%
|
Selinexor
Diffuse Large B-Cell Lymphoma (DLBCL)
|
PDUFA priority review | 02/19/2020 | |
| NVS |
$84.85
-0.77 -0.90%
|
OMB157 (ofatumumab)
Relapsing multiple sclerosis
|
PDUFA priority review |
June 2020
PDUFA date under priority review June 2020.
|
02/24/2020 |
| GMAB |
$22.36
+0.66 +3.04%
|
OMB157 (ofatumumab)
Relapsing multiple sclerosis
|
PDUFA priority review |
June 2020
PDUFA date under priority review June 2020.
|
02/24/2020 |
| ZGNX |
$23.92
-0.54 -2.21%
|
FINTEPLA (ZX008)
Dravet syndrom
|
PDUFA priority review | 02/27/2020 | |
| HRTX |
$14.44
+0.47 +3.36%
|
HTX-011
Post operative pain
|
PDUFA | 02/19/2020 | |
| CHMA |
$3.99
+0.00%
|
Mycapssa - OPTIMAL
Acromegaly
|
PDUFA | 01/13/2020 | |
| PLX |
$2.45
-0.02 -0.81%
|
Pegunigalsidase alfa (PRX-102)
Fabry disease
|
BLA Filing |
2Q 2020
BLA filing due 2Q 2020.
|
03/12/2020 |
| ARVN |
$45.79
+2.45 +5.65%
|
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 |
$31.86
-0.56 -1.73%
|
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 |
$13.31
+0.36 +2.78%
|
Plinabulin (Trial 105)
Chemotherapy-induced neutropenia (CIN)
|
Phase 3 |
1H 2020
Phase 3 final data due 1H 2020.
|
03/17/2020 |
| SLGL |
$7.12
-0.08 -1.11%
|
VERED (Epsolay)
Papulopustular rosacea
|
NDA Filing |
2Q 2020
NDA filing due 2Q 2020.
|
03/24/2020 |
| NVS |
$84.85
-0.77 -0.90%
|
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 |
$321.05
+4.1 +1.29%
|
Natalizumab - OPUS
Epilepsy
|
Phase 2 |
1H 2020
Phase 2 data due 1H 2020.
|
03/24/2020 |
| BHVN |
$36.24
+2.49 +7.38%
|
TRORILUZOLE
Obsessive compulsive disorder (OCD)
|
Phase 2/3 |
2Q 2020
Phase 2/3 top-line data due 2Q 2020.
|
02/25/2020 |
| IMVT |
$15.54
+0.7 +4.72%
|
IMVT-1401
Myasthenia Gravis (MG)
|
Phase 2 |
1H 2020
Phase 2 top-line data due 1H 2020.
|
02/14/2020 |
| BTAI |
$23.22
+1.91 +8.96%
|
BXCL501
Agitation in patients with schizophrenia
|
Phase 2 |
2Q 2020
Phase 2 data due 2Q 2020.
|
03/09/2020 |
| PFE |
$35.39
+0.79 +2.28%
|
PF-06939926
Duchenne muscular dystrophy (DMD)
|
Phase 1b |
1H 2020
Phase 1b data due 1H 2020.
|
04/03/2020 |
| REGN |
$512.96
+0.63 +0.12%
|
Cemiplimab
Basal cell carcinoma
|
Phase 2 |
1H 2020
Phase 2 pivotal data due 1H 2020.
|
02/06/2020 |
| SNY |
$45.46
+0.28 +0.62%
|
Cemiplimab
Basal cell carcinoma
|
Phase 2 |
1H 2020
Phase 2 pivotal data due 1H 2020.
|
02/06/2020 |
| ASMB |
$16.42
+0.16 +0.98%
|
ABI-H0731
Hepatitis B virus (HBV)
|
Phase 2 |
2Q 2020
Phase 2 additional interim analyses due 2Q 2020.
|
03/04/2020 |
| KPTI |
$20.53
+1.25 +6.48%
|
Selinexor - BOSTON
Multiple myeloma
|
sNDA Filing |
2Q 2020
sNDA filing due 2Q 2020.
|
04/07/2020 |
| SNY |
$45.46
+0.28 +0.62%
|
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 |
$1.50
+0.03 +2.04%
|
Nomacopan (Coversin)
Bullous Pemphigoid
|
Phase 2 |
2Q 2020
Phase 2 full data due 2Q 2020.
|
03/31/2020 |
| MTEM |
$15.06
+0.46 +3.15%
|
MT-5111
HER2-positive solid tumors
|
Phase 1 |
2Q 2020
Phase 1 interim data due 2Q 2020.
|
03/12/2020 |
| RAPT |
$17.19
+0.68 +4.12%
|
FLX475 + Keytruda
Advanced Cancer
|
Phase 1/2 |
2Q 2020
Phase 2 data due 2Q 2020.
|
01/09/2020 |
| BPMC |
$66.20
-0.83 -1.24%
|
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 |
$12.21
+0.55 +4.72%
|
Miricorilant
Healthy volunteers
|
Phase 1b |
2Q 2020
Phase 1b 900g dose data due 2Q 2020.
|
02/20/2020 |
| SRPT |
$108.75
+4.88 +4.70%
|
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 |
$22.69
+1.84 +8.82%
|
ALLO-501 - ALPHA
Non-Hodgkin lymphoma (NHL)
|
Phase 1 |
2Q 2020
Phase 1 initial data due 2Q 2020.
|
03/27/2020 |
| HOOK |
$7.98
+0.15 +1.92%
|
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 |
$16.47
-0.57 -3.35%
|
ITI-214-105
Heart failure
|
Phase 1/2 |
1H 2020
Phase 1/2 top-line data due 1H 2020.
|
03/02/2020 |
| ASND |
$121.36
-0.61 -0.50%
|
TransCon hGH
Growth hormone deficiency in children
|
BLA Filing |
2Q 2020
BLA filing due 2Q 2020.
|
04/01/2020 |
| KZR |
$4.20
+0.37 +9.66%
|
KZR-616
Lupus
|
Phase 1/2 |
2Q 2020
Phase 2 next data due by the end of 2Q 2020.
|
04/09/2020 |
| SNY |
$45.46
+0.28 +0.62%
|
Isatuximab - IKEMA
Refractory Multiple Myeloma
|
Phase 3 |
2Q 2020
Phase 3 data due 2Q 2020.
|
02/06/2020 |
| AUPH |
$15.18
+0.34 +2.29%
|
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 |
$108.75
+4.88 +4.70%
|
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 |
| BIIB |
$321.05
+4.1 +1.29%
|
Aducanumab (Aβ mAb) - EMERGE
Alzheimer’s disease
|
BLA Filing |
2Q 2020
Phase 3 trial discontinued due to futility - unlikely to meet primary endpoint upon completion - March 21, 2019. However, noted October 22, 2019 that it intends to submit a BLA filing early 2020 based on data that showed the primary endpoint was met. Data released December 5, 2019 noted rate of decline in CDR-SB of 23% on high dose (p=0.0101
); 14% on low dose (p=0.1171).
|
04/09/2020 |
| AVEO |
$3.75
+0.08 +2.18%
|
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 |
$1.96
+0.1 +5.38%
|
Self administered glucagon
Exercise-Induced Hypoglycemia
|
Phase 2 |
1H 2020
Phase 2b data 1H 2020.
|
03/11/2020 |
| DRNA |
$19.57
+0.57 +3.00%
|
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 |
$1.96
+0.1 +5.38%
|
Self administered glucagon
Post-Bariatric Hypoglycemia
|
Phase 2 |
1H 2020
Phase 2b outpatient data due 1H 2020.
|
03/11/2020 |
| AKBA |
$7.00
+0.05 +0.72%
|
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 |
$8.90
+0.03 +0.34%
|
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 |
$2.57
+0.15 +6.20%
|
CERC-802
Healthy volunteers
|
Phase 1 |
1H 2020
Phase 1 initial data due 1H 2020.
|
03/17/2020 |
| OBSV |
$2.35
+0.14 +6.33%
|
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 |
$29.75
+0.97 +3.37%
|
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 |
$12.10
+0.91 +8.13%
|
MCLA-117
Acute Myeloid Leukemia
|
Phase 1 |
1H 2020
Phase 1 readout due 1H 2020.
|
03/12/2020 |
| PFE |
$35.39
+0.79 +2.28%
|
Avelumab - Bavencio
Gastric cancer
|
Phase 3 |
1H 2020
Phase 3 data due 1H 2020.
|
09/11/2019 |
| LLY |
$145.73
-0.49 -0.34%
|
D1PAM
Dementia with Lewy bodies (DLB)
|
Phase 2 |
1H 2020
Phase 2 data due 1H 2020.
|
07/30/2019 |
| EYEG |
$5.28
+0.24 +4.76%
|
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 |
$35.39
+0.79 +2.28%
|
Avelumab - Bavencio
Urothelial Cancer
|
Phase 3 |
1H 2020
Phase 3 data due 1H 2020.
|
07/22/2019 |
| BYSI |
$13.31
+0.36 +2.78%
|
Plinabulin + TAC (Trial 106)
Chemotherapy-induced neutropenia (CIN)
|
Phase 3 |
1H 2020
Phase 3 final data due 1H 2020.
|
12/24/2019 |
| APLS |
$28.15
+0.43 +1.55%
|
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 |
$109.69
+1.22 +1.12%
|
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 |
$6.98
-0.02 -0.29%
|
RG6100 (Anti-Tau RO7105705)
Alzheimer’s disease
|
Phase 2 |
2Q 2020
Phase 2 primary completion 2Q 2020.
|
03/30/2020 |
| NERV |
$5.85
+0.13 +2.27%
|
Roluperidone (MIN-101)
Schizophrenia
|
Phase 3 |
2Q 2020
Phase 3 data due 2Q 2020.
|
03/09/2020 |
| NVAX |
$17.05
-0.13 -0.76%
|
Matrix-M
Malaria vaccine
|
Phase 2b |
2Q 2020
Phase 2b data due 2Q 2020.
|
03/11/2020 |
| TNXP |
$0.72
+0.02 +2.57%
|
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 |
$120.32
+0.64 +0.53%
|
Tisotumab Vedotin (innovaTV 204 )
Cervical Cancer
|
Phase 2 |
1H 2020
Phase 2 data due 1H 2020.
|
02/06/2020 |
| GMAB |
$22.36
+0.66 +3.04%
|
Tisotumab Vedotin (innovaTV 204 )
Cervical Cancer
|
Phase 2 |
1H 2020
Phase 2 data due 1H 2020.
|
02/06/2020 |
| GMDA |
$3.37
-0.02 -0.59%
|
NiCord (omidubicel)
Acute myeloid leukemia
|
Phase 3 |
2Q 2020
Phase 3 top-line data due 2Q 2020.
|
02/25/2020 |
| MIRM |
$14.75
+0.66 +4.68%
|
Volixibat
|
Phase 1 |
2Q 2020
Phase 1 data due 2Q 2020.
|
03/12/2020 |
| ACIU |
$6.98
-0.02 -0.29%
|
ACI-35.030
Alzheimer’s Disease
|
Phase 1/2 |
2Q 2020
Phase 1b/2 interim analysis 2Q 2020.
|
03/30/2020 |
| CAPR |
$1.63
-0.15 -8.43%
|
CAP-1002 HOPE-2
Duchenne Muscular Dystrophy (DMD)
|
Phase 2 |
2Q 2020
Phase 2 12-month data due 2Q 2020.
|
03/18/2020 |
| ALXN |
$96.23
-2.33 -2.36%
|
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 |
$16.99
+0.06 +0.35%
|
KPL-716
Chronic Pruritus
|
Phase 2 |
1H 2020
Phase 2 interim data due 1H 2020.
|
02/26/2020 |
| NYMX |
$2.16
+0.04 +1.89%
|
NX-1207 Fexapotide
BPH
|
NDA Filing |
1H 2020
NDA filing planned for 1H 2020.
|
01/28/2020 |
| GILD |
$73.51
-1.48 -1.97%
|
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 |
$4.98
-0.01 -0.20%
|
Marzeptacog alfa
Hemophilia
|
Phase 1 |
2Q 2020
Phase 1 PK data due 2020.
|
02/24/2020 |
| RVNC |
$16.37
+1.22 +8.05%
|
DAXI (RT002)
Forehead lines
|
Phase 2 |
2Q 2020
Phase 2 top-line data due 2Q 2020.
|
03/26/2020 |
| NVS |
$84.85
-0.77 -0.90%
|
LJN452
Non-alcoholic steatohepatitis (NASH)
|
Phase 2 |
1H 2020
Phase 2 trial to be completed 1H 2020.
|
02/25/2020 |
| CPRX |
$4.41
+0.25 +6.01%
|
Firdapse
MuSK-antibody positive myasthenia gravis (MuSK-MG)
|
Phase 3 |
2Q 2020
Phase 3 data due 2Q 2020.
|
04/08/2020 |
| BVXV |
$7.51
+0.11 +1.46%
|
M-001
Universal flu vaccine
|
Phase 2 |
2Q 2020
Phase 2 data due 2Q 2020.
|
02/05/2020 |
| SEEL |
$0.45
-0.01 -1.67%
|
SLS-002-102
Healthy volunteers
|
Phase 1 |
2Q 2020
Phase 1 data due 2Q 2020.
|
04/08/2020 |
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