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
Ticker Price Drug Stage Catalyst
BHVN
$54.50
-1.47  -2.63%
TRORILUZOLE
Generalized anxiety disorder (GAD)
Phase 3
Early-1Q 2020.
Phase 2/3 data due early-1Q 2020.
BHVN
$54.50
-1.47  -2.63%
Rimegepant
Migraine - preventative
Phase 3
Early-1Q 2020
Phase 3 top-line data due early-1Q 2020.
AIMT
$32.62
-0.38  -1.15%
AR101
Peanut Allergy
PDUFA
Late January 2020
Advisory Committee meeting September 13, 2019 voted in favor of supporting approval. PDUFA date late-January 2020.
MRK
$85.98
-2.58  -2.91%
DIFICID (fidaxomicin)
Clostridium difficile infections (CDI)
PDUFA
PDUFA date January 24, 2020
TROV
$1.72
-0.06  -3.37%
Onvansertib, Folfiri and Avastin (bevacizumab)
KRAS-Mutated Colorectal Cancer
Phase 1/2
Phase 1b/2 new data to be presented at ASCO-GI January 25, 2020.
FTSV
$39.03
-4.62  -10.58%
Magrolimab + cetuximab
Colorectal cancer
Phase 1/2
Phase 1b data due at ASCO-GI January 25, 2020.
MESO
$10.63
+0.06  +0.57%
Remestemcel-L (MSC-100-IV)
acute graft versus host disease (aGVHD) in children
BLA Filing
January 2020
BLA rolling submission has been initiated. Final part to be filed in January 2020.
MGEN
$0.97
+0.29  +42.67%
Cobomarsen MRG-106
Chronic Lymphocytic Leukemia (CLL); Diffuse Large B-Cell Lymphoma (DLBCL); Cutaneous T-cell Lymphoma (CTCL); Adult T-Cell Leukemia/Lymphoma (ATLL)
Phase 1
Phase 1 new ATLL biomarker analysis to be presented at the Annual T-Cell Lymphoma Forum, January 31, 2020 6:10PM-8:00PM PT.
KMPH
$0.36
-0.02  -4.97%
KP415
ADHD
NDA Filing
January 2020
NDA filing due by January 2020.
AQST
$3.88
-0.09  -2.27%
KP415
ADHD
NDA Filing
January 2020
NDA filing due by January 2020.
PTCT
$51.92
-1.41  -2.64%
Risdiplam - SUNFISH
Spinal Muscular Atrophy (SMA)
Phase 3
Phase 3 data met primary endpoint - November 11, 2019. Data to be presented at the International Scientific Congress on Spinal Muscular Atrophy. CC on February 6, 2020 at 9am EST.
RHHBY
$41.20
-1.19  -2.81%
Risdiplam - SUNFISH
Spinal Muscular Atrophy (SMA)
Phase 3
Phase 3 data met primary endpoint - November 11, 2019. Data to be presented at the International Scientific Congress on Spinal Muscular Atrophy. CC on February 6, 2020 at 9am EST.
FTSV
$39.03
-4.62  -10.58%
Magrolimab + Avelumab
Ovarian cancer
Phase 1
ASCO-SITC February 6-8, 2020
Phase 1b data due at ASCO-SITC February 6-8, 2020.
JNCE
$6.31
-0.22  -3.37%
Vopratelimab JTX-2011
Solid tumors - Cancer
Phase 1/2
Phase 1/2 new data to be presented at ASCO-SITC Clinical Immuno-Oncology Symposium Annual Meeting on February 6, 2020, 11:30 AM ET.
ADVM
$11.45
-0.19  -1.63%
ADVM-022
Wet age-related macular degeneration (Wet-AMD)
Phase 1
Cohort 1 long-term data and Cohort 2 24-week data due February 8, 2020 at the Angiogenesis, Exudation, and Degeneration 2020 symposium.
EXEL
$18.02
-1.55  -7.92%
Cabozantinib + atezolizumab (TECENTRIQ) COSMIC-021
Solid tumors
Phase 1b
Phase 1b data to be presented 11:30am PT, February 13, 2020 at ASCO GU.
RHHBY
$41.20
-1.19  -2.81%
Cabozantinib + atezolizumab (TECENTRIQ) COSMIC-021
Solid tumors
Phase 1b
Phase 1b data to be presented 11:30am PT, February 13, 2020 at ASCO GU.
TROV
$1.72
-0.06  -3.37%
Onvansertib (PCM-075) and Zytiga
Prostate cancer
Phase 2
Phase 2 data data to be presented February 13, 2020 with biomarker data to be presented at AACR April 24-29, 2020.
ACST
$0.67
-0.02  -3.37%
CaPre (TRILOGY 1 and 2)
Hypertriglyceridemia
Phase 3
Mid-February
Phase 3 TRILOGY 1 data did not meet primary endpoint - January 13, 2020. TRILOGY 2 data due mid-February 2020.
XXII
$1.06
-0.01  -0.93%
VLN cigarettes
MRTP application
NDA Filing
MRTP application Advisory Committee 02/14/2020 - SEE NOTE BELOW
FDA Tobacco Products Scientific Advisory Committee (TPSAC) to meet February 14, 2020, regarding MRTP application. Ignore "NDA filing" in the "stage" column to the left.
CRVS
$5.81
-0.12  -2.02%
CPI-444
Solid tumors - cancer
Phase 1b
ASCO GI February 2020
Phase 1b/2 updated data due at the ASCO Genitourinary Cancers Symposium (GU) February 13-15, 2020.
AGRX
$3.35
+0.27  +8.77%
Twirla
Contraceptive patch
PDUFA
CRLs issued 2013 and 2017. New PDUFA extended by three months to February 16, 2020. Advisory Committee Meeting October 30, 2019 voted 14 to 1 in favor.
MRK
$85.98
-2.58  -2.91%
Keytruda
6-week dosing for melanoma and other indications
PDUFA
PDUFA date February 18, 2020.
CLRB
$2.62
+0.08  +3.15%
CLR 131 - CLOVER-1
Various lymphoma
Phase 2
Phase 2 data update February 19, 2020, CC 10:30 am EST.
CLRB
$2.62
+0.08  +3.15%
CLR 131
Multiple myeloma
Phase 1
Phase 1 data update February 19, 2020, CC 10:30 am EST.
BXRX
$8.30
-0.15  -1.83%
Intravenous (IV) meloxicam
Acute pain following bunionectomy surgery
PDUFA
First CRL announced May 24, 2018. Second CRL issued March 22, 2019. New PDUFA date February 20, 2020
ESPR
$49.10
-2.74  -5.29%
Bempedoic acid
Hyperlipidemia whose LDL-C is not adequately controlled with low- and moderate-dose statins
PDUFA
PDUFA date February 21, 2020.
KDMN
$4.47
-0.01  -0.22%
KD025 - ROCKstar (KD025-213)
Chronic graft-versus-host disease (cGVHD)
Phase 2
Phase 2 trial met primary endpoint - November 11, 2019. Expanded data to be presented at TCT Meeting on February 23, 2020, 12:00 p.m. ET.
ESPR
$49.10
-2.74  -5.29%
Bempedoic Acid/ Ezetimibe
Hypercholesterolemia
PDUFA
PDUFA date February 26, 2020.
MNLO
$5.48
-0.52  -8.67%
Serlopitant
Chronic pruritus of unknown origin
Phase 2
January/February 2020
Phase 2 data due January/February 2020.
BMY
$64.16
-2.71  -4.05%
Opdivo and Yervoy
Previously Treated Hepatocellular Carcinoma
PDUFA priority review
PDUFA date under priority review March 10, 2020.
ETON
$6.44
-0.27  -4.02%
EM-105
Lennox-Gastaut syndrome, epilepsy
PDUFA
PDUFA date March 17, 2020.
ZGNX
$52.13
-2.19  -4.03%
FINTEPLA (ZX008)
Dravet syndrom
PDUFA priority review
Refusal to file Letter (RTF) issued April 8, 2019. NDA resubmitted with new PDUFA date under priority review March 25, 2020
BMY
$64.16
-2.71  -4.05%
Ozanimod - RADIANCE
Relapsing Multiple Sclerosis
PDUFA
PDUFA date March 25, 2020.
HRTX
$22.60
-0.8  -3.42%
HTX-011
Post operative pain
PDUFA
PDUFA date March 26, 2020.
IGXT
$0.45
-0.02  -3.61%
RIZAPORT (RHB-103)
Migraine
PDUFA
PDUFA date March 26, 2020.
DRRX
$2.00
-0.1  -4.76%
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.
RMTI
$2.57
-0.03  -1.15%
IV Triferic
Anemia
PDUFA
PDUFA date March 28, 2020.
AZN
$49.28
-0.92  -1.83%
Imfinzi + tremelimumab (CASPIAN)
Small cell lung cancer (SCLC)
PDUFA priority review
PDUFA date under priority review announced November 29, 2019. No PDUFA date announced. Estimate March 29, 2019.
NBIX
$99.17
-3  -2.94%
Crinecerfont (NBI-74788)
Congenital Adrenal Hyperplasia (CAH) - adults
Phase 2
ENDO 2020
Pivotal trial to be initiated mid-2020. Phase 2 data to be presented at at ENDO March 28–31, 2020.
OVID
$3.55
-0.1  -2.74%
TAK-935/OV935 - ARCADE
CDKL5 Deficiency
Phase 1/2
1Q 2020
Phase 1b/2a data due 1Q 2020.
SNY
$48.73
-0.87  -1.75%
SAR442168 (PRN2246)
Multiple sclerosis
Phase 2
1Q 2020
Phase 2 data due 1Q 2020.
PRNB
$57.21
-2.99  -4.97%
SAR442168 (PRN2246)
Multiple sclerosis
Phase 2
1Q 2020
Phase 2 data due 1Q 2020.
NEOS
$1.76
+0.01  +0.57%
NT0502
Sialorrhea
Phase 1
1Q 2020
Phase 1 top-line pharmacokinetic data due 1Q 2020.
ZEAL
$36.25
-0.23  -0.64%
Dasiglucagon
Severe hypoglycemia in diabetes - children
NDA Filing
Early 2020
NDA filing due early 2020.
RGNX
$43.98
-1.16  -2.57%
RGX-121
MPS II
Phase 1/2
Early 2020
Phase 1/2 further data due early 2020.
NGM
$17.45
-0.95  -5.16%
NGM282
Non-alcoholic steatohepatitis (NASH)
Phase 2
1Q 2020
Phase 2 full Cohort 4 data due 1Q 2020.
AXSM
$85.20
-2.56  -2.92%
AXS-07 - INTERCEPT
Migraine
Phase 3
1Q 2020
Phase 3 data due 1Q 2020.
MOR
$32.81
-0.39  -1.17%
BPS-804 (setrusumab)
Osteogenesis Imperfecta
Phase 2b
Early 2020
Phase 2b data due early 2020.
KMDA
$6.77
-0.07  -1.02%
Alpha-1 antitrypsin (AAT)
Prevention of lung transplant rejection
Phase 1/2
Early 2020
Phase 2 top-line data due early 2020.
INO
$4.24
+0.4  +10.42%
VGX-3100
HPV-related pre-cancers - Vulvar Intraepithelial Neoplasia (VIN)
Phase 2
1Q 2020
Phase 2 data to be presented 1Q 2020.
VRTX
$229.06
-4.85  -2.07%
VX-147
Healthy volunteers
Phase 1
1Q 2020
Phase 1 trial to be completed in 4Q 2019. Moved to 1Q 2020 due to no update.
ACER
$4.23
-0.23  -5.16%
ACER-001
Urea cycle disorder (UCD)
Phase 2
1Q 2020
Pivotal bioavailability and bioequivalence trial Part B due 1Q 2020 with NDA filing 1Q 2021.
KPTI
$16.50
-0.84  -4.84%
Selinexor - BOSTON
Multiple myeloma
Phase 3
Early-2020
Phase 3 data due early 2020.
AKTX
$1.85
-0.02  -1.07%
Nomacopan
Atopic keratoconjunctivitis
Phase 1/2
1Q 2020
Phase 1/2 Part B data due 1Q 2020.
ENTA
$54.85
-1.15  -2.05%
EDP-514
Hepatitis B virus (HBV)
Phase 1
1Q 2020
Phase 1 data due 1Q 2020.
KALA
$7.25
+0.02  +0.28%
KPI‑121 0.25% STRIDE 3
Dry eye disease
Phase 3
1Q 2020
Phase 3 completion of enrolment announced January 15, 2020 with data due 1Q 2020.
RYTM
$17.97
-0.41  -2.23%
Setmelanotide
Leptin Receptor Deficiency Obesity
NDA Filing
1Q 2020
NDA filing due 1Q 2020.
RYTM
$17.97
-0.41  -2.23%
Setmelanotide
POMC deficiency obesity
NDA Filing
1Q 2020
NDA filing due 1Q 2020.
HALO
$19.07
-0.59  -3.03%
Efgartigimod (ARGX-113) and Enhanze
Healthy volunteers
Phase 1
1Q 2020
Phase 1 data due YE 2019. Moved to 1Q 2020 due to no update.
ARGX
$144.43
-4.8  -3.22%
Efgartigimod (ARGX-113) and Enhanze
Healthy volunteers
Phase 1
1Q 2020
Phase 1 data due YE 2019. Moved to 1Q 2020 due to no update.
LLY
$139.07
-2.14  -1.52%
Tanezumab
Osteoarthritis
NDA Filing
Early 2020
Phase 3 data from second trial released January 29, 2019 - co-primary endpoints met. Data from trial April 18, 2019 met 2/3 primary endpoints in 5mg arm but failed to meet endpoints in 2.5mg arm. Regulatory filing due 4Q 2019 or early 2020.
PFE
$39.82
-0.89  -2.19%
Tanezumab
Osteoarthritis
NDA Filing
Early 2020
Phase 3 data from second trial released January 29, 2019 - co-primary endpoints met. Data from trial April 18, 2019 met 2/3 primary endpoints in 5mg arm but failed to meet endpoints in 2.5mg arm. Regulatory filing due 4Q 2019 or early 2020.
CHRS
$18.15
-0.57  -3.04%
Lucentis Biosimilar
Biosimilar
BLA Filing
1Q 2020
BLA filing due 4Q 2019. Moved to 1Q 2020 due to no update.
SNY
$48.73
-0.87  -1.75%
Isatuximab - IKEMA
Refractory Multiple Myeloma
Phase 3
1Q 2020
Phase 3 data due 1Q 2020.
PFNX
$11.14
-0.17  -1.50%
PCV-15 (V114)
Pneumococcal disease
Phase 3
Early 2020
Phase 3 data possibly due by end of 2019 or early 2020.
AVEO
$0.59
-0.01  -2.15%
TIVO-3 - tivozanib
Third line treatment of patients with renal cell cancer
NDA Filing
1Q 2020
NDA to be filed in 1Q 2020. Will withdraw if overall survival data in 2Q 2020 yields an OS HR above 1.00.
XERS
$5.75
-0.29  -4.80%
Self administered glucagon
Exercise-Induced Hypoglycemia
Phase 2
1Q 2020
Phase 2b data due 4Q 2019. Moved to 1Q 2020 due to no update.
XLRN
$52.05
-0.7  -1.34%
Sotatercept - PULSAR
Pulmonary arterial hypertension (PAH)
Phase 2
1Q 2020
Phase 2 data due 1Q 2020.
CERC
$4.61
-0.01  -0.22%
CERC-802
Healthy volunteers
Phase 1
Early 2020
PK data due early 2020.
BHC
$28.40
-0.79  -2.71%
Rifaximin
Overt hepatic encephalopathy
Phase 2
1Q 2020
Phase 2 interim analysis due 1Q 2020.
AXSM
$85.20
-2.56  -2.92%
AXS-05 STRIDE-1
Treatment resistant depression
Phase 3
1Q 2020
Phase 3 data due 1Q 2020.
ALNY
$120.00
+2.04  +1.73%
Lumasiran (ALN-GO1) ILLUMINATE-A
Primary Hyperoxaluria Type 1 (PH1)
NDA Filing
Early 2020
Rolling NDA filing has been initiated - January 10, 2020. To be completed early-2020.
MGNX
$10.80
-0.6  -5.26%
MGD007 and MGA012
Colorectal Cancer
Phase 1
1Q 2020
Phase 1 update due 1Q 2020.
XLRN
$52.05
-0.7  -1.34%
ACE-083
Charcot-Marie-Tooth disease (CMT)
Phase 2
1Q 2020
Phase 2 data due 1Q 2020.
TNXP
$1.63
+0.24  +17.27%
Tonmya
Post-traumatic stress disorder (PTSD)
Phase 3
1Q 2020
Phase 3 interim analysis 1Q 2020 with top-line data due 2Q 2020.
BPMC
$65.58
-1.61  -2.40%
Pralsetinib (BLU-667)
First-line RET-fusion non-small cell lung cancer (NSCLC)
NDA Filing
1Q 2020
Rolling NDA has commenced. To be completed 1Q 2020.
IMMP
$1.99
-0.02  -1.12%
Eftilagimod alpha and Keytruda - TACTI-002
Non-small cell lung cancer; Head and neck cancer
Phase 2
1Q 2020
Phase 2 data due 1Q 2020. Noted January 8, 2020 that enrolment in the head and neck cohort has been expanded due to meeting the required number of responses.
VTVT
$2.33
-0.2  -7.91%
TTP399
Type 1 Diabetes
Phase 1/2
Late-1Q 2020
Phase 2 Part 2 data due late-1Q 2020.
ZGNX
$52.13
-2.19  -4.03%
ZX008 - (Study 1601)
Lennox-Gastaut syndrome
Phase 3
1Q 2020
Phase 3 data due 1Q 2020.
MEIP
$2.33
-0.02  -0.85%
Pracinostat in combination with Vidaza
High-risk Myelodysplastic Syndrome (MDS)
Phase 2
1Q 2020
Phase 2 updated data due by the end of 2019. Moved to 1Q 2020 due to no update.
SLS
$2.94
-0.04  -1.34%
Nelipepimut-S (NPS)
Ductal Carcinoma in Situ (DCIS)
Phase 2
1Q 2020
Phase 2 initial data due 1Q 2020.
OGEN
$0.45
-0.01  -2.55%
AG013
Oral mucositis (OM)
Phase 2
1Q 2020
Phase 2 completion of enrolment announced December 2, 2019 with data due early 2020.
INCY
$76.74
-1.5  -1.92%
INC280 - capmatinib
Non-small cell lung cancer
NDA Filing
1Q 2020
NDA filing due 2019. Moved to 1Q 2020 due to no update.
NVS
$93.87
-1.05  -1.11%
INC280 - capmatinib
Non-small cell lung cancer
NDA Filing
1Q 2020
NDA filing due 2019. Moved to 1Q 2020 due to no update.
LCTX
$1.04
+0.09  +9.50%
VAC2
Non-small cell lung cancer (NSCLC)
Phase 1/2
1Q 2020
Phase 1 immunogenicity data due 1Q 2020.
SEEL
$1.22
-0.02  -1.61%
SLS-002-102
Healthy volunteers
Phase 1
1Q 2020
Phase 1 commencement of PK/PD dosing announced November 27, 2019. Initial data due 1Q 2020.
CTXR
$1.25
-0.05  -3.85%
Mino-Lok
Catheter related blood stream infection
Phase 3
March 2020
Phase 3 interim analysis December 19, 2019 noted continuation of the trial with no changes. 75% superiority analysis due March 2020. Test for superiority likely due 2Q 2020.
SUPN
$23.57
-0.64  -2.64%
SPN-810 (P302)
Attention Deficit Hyperactivity Disorder (ADHD)
Phase 3
1Q 2020
Phase 3 data due 1Q 2020.
FENC
$6.12
-0.09  -1.45%
Pedmark (sodium thiosulfate)
Cisplatin-induced ototoxicity
NDA Filing
Early-2020
Rolling NDA to be completed early 2020.
CLBS
$3.04
  +0.00%
CLBS16 (CLBS14-CMD) - ESCaPE-CMD
Coronary microvascular dysfunction (CMD)
Phase 2
Early 2020
Phase 2 full data due early 2020.
ASMB
$16.71
-0.31  -1.82%
ABI-H2158
Hepatitis B virus (HBV)
Phase 1a
1Q 2020
Full data due 1Q 2020.
ORMP
$5.08
-0.1  -1.93%
ORMD-0801
Type 2 Diabetes
Phase 2b
1Q 2020
Phase 2b data noted 2/3 arms showed significant reductions. Data from second cohort due 1Q 2020.
NVAX
$7.80
+0.14  +1.83%
NanoFlu vaccine
Influenza
Phase 3
1Q 2020
Phase 3 top-line data due 1Q 2020.
ABUS
$2.89
-0.23  -7.37%
AB-729
Hepatitis B (HBV)
Phase 1
1Q 2020
Phase 1a/b data due late-1Q 2020.
CLSN
$1.52
-0.05  -3.18%
GEN-1 OVATION 2
Ovarian cancer
Phase 1/2
1Q 2020
Phase 1/2 data due 4Q 2019. Moved to 1Q 2020 due to no update.
ASND
$135.80
-1.2  -0.88%
TransCon
Hypoparathyroidism
Phase 2
March 2020
Phase 2 top-line data due around the end of March 2020.
ABUS
$2.89
-0.23  -7.37%
AB-452
Hepatitis B
Phase 1
Early 2020
Decision regarding clinical development due early 2020.
TGTX
$13.50
-0.05  -0.37%
TG-1101 and TGR-1202 - UNITY-CLL study
Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin's Lymphoma (NHL)
Phase 3
Early 2020
Phase 3 PFS data due early 2020.
ADXS
$0.89
-0.08  -8.08%
ADXS-HOT 503
Non-small cell lung cancer (NSCLC)
Phase 1/2
1Q 2020
Phase 1/2 immune response data from Part A monotherapy due 1Q 2020.
EYPT
$1.93
-0.06  -3.02%
Yutiq
Non-infectious uveitis
sNDA Filing
1Q 2020
sNDA filing due 2019 for 6-month formulation. Moved to 1Q 2020 due to no update.
BHC
$28.40
-0.79  -2.71%
EM-100
Allergic conjunctivitis
NDA Filing
1Q 2020
CRL issued July 12, 2019. NDA to be resubmitted in December 2019. Moved to 1Q 2020 due to no update.
ETON
$6.44
-0.27  -4.02%
EM-100
Allergic conjunctivitis
NDA Filing
1Q 2020
CRL issued July 12, 2019. NDA to be resubmitted in December 2019. Moved to 1Q 2020 due to no update.
VNDA
$14.29
-0.71  -4.73%
HETLIOZ (tasimelteon)
Smith-Magenis Syndrome
sNDA Filing
1Q 2020
sNDA filing due 4Q 2019. Moved to 1Q 2020 due to no update.
VNDA
$14.29
-0.71  -4.73%
Tradipitant - EPIONE 1
Atopic dermatitis
Phase 3
1Q 2020
Phase 3 data due 1Q 2020.
PRVB
$15.96
-0.56  -3.39%
PRV-3279
Systemic Lupus Erythematosus (SLE) and Lupus nephritis (LN)
Phase 1b
1Q 2020
Phase 1b data due 1Q 2020.
IMRN
$3.46
  +0.00%
IMM-124E
Nonalcoholic fatty liver disease (NAFLD) - pediatric
Phase 2
1Q 2020
Phase 2 data due 1Q 2020.
NVS
$93.87
-1.05  -1.11%
PDR001
BRAFV600 mutant metastatic melanoma
Phase 3
1Q 2020
Phase 3 data due 4Q 2019. Moved to 1Q 2020 due to no update.
CYTK
$12.01
-0.65  -5.13%
Omecamtiv mecarbil GALACTIC-HF
Acute heart failure
Phase 3
1Q 2020
Phase 3 second interim analysis due 1Q 2020. Top-line data due 4Q 2020.
AMGN
$225.59
-9.45  -4.02%
Omecamtiv mecarbil GALACTIC-HF
Acute heart failure
Phase 3
1Q 2020
Phase 3 second interim analysis due 1Q 2020. Top-line data due 4Q 2020.
ONCY
$3.27
-0.19  -5.49%
Pelareorep and Tecentriq - AWARE-1
Breast cancer
Phase 1b
1Q 2020
Phase 1b interim data due end of 2019 (moved to 1Q 2020 due to no update). with final data due 1H 2020.
YMAB
$35.16
+0.2  +0.57%
Naxitamab
Relapsed/Refractory High-Risk Neuroblastoma
BLA Filing
1Q 2020
Rolling BLA filing commenced November 29, 2019 and to be completed by 1Q 2020.
YMAB
$35.16
+0.2  +0.57%
Omburtamab
CNS/Leptomeningeal Metastases from Neuroblastoma
BLA Filing
1Q 2020
BLA filing due 1Q 2020.
MIST
$21.33
-0.15  -0.70%
Etripamil - NODE-301
Paroxysmal supraventricular tachycardia (PSVT)
Phase 3
1Q 2020
Phase 3 top-line data due around end of 1Q 2020.
ATNX
$14.33
-0.68  -4.53%
Tirbanibulin ointment
Actinic keratosis
NDA Filing
1Q 2020
NDA filing due 1Q 2020.
REGN
$345.28
-11.32  -3.17%
Dupixent (dupilumab)
Atopic dermatitis 6-11 year-olds
sNDA Filing
1Q 2020
sBLA filing due 4Q 2019. Moved to 1Q 2020 due to no update.
SNY
$48.73
-0.87  -1.75%
Dupixent (dupilumab)
Atopic dermatitis 6-11 year-olds
sNDA Filing
1Q 2020
sBLA filing due 4Q 2019. Moved to 1Q 2020 due to no update.
PRQR
$8.25
+0.02  +0.24%
QR-421a - STELLAR
Usher Syndrome Type 2
Phase 1/2
1Q 2020.
Phase 1/2 interim data due 1Q 2020.
IMMP
$1.99
-0.02  -1.12%
Eftilagimod Alpha - Active Immunotherapy PAClitaxel (AIPAC)
Metastatic breast cancer (MBC)
Phase 2b
March 2020
Phase 2b PFS data due March 2020.
ALNY
$120.00
+2.04  +1.73%
ALN-AAT02
alpha-1 anti-trypsin deficiency-associated liver disease
Phase 1/2
1Q 2020
Phase 1/2 data due late-2019. Moved to 1Q 2020 due to no update.
MYOV
$12.96
-0.44  -3.28%
Relugolix - SPIRIT 2
Endometriosis-associated pain
Phase 3
1Q 2020
Phase 3 data due 1Q 2020.
VBLT
$1.48
+0.05  +3.58%
VB-111
Recurrent platinum resistant ovarian cancer
Phase 3
1Q 2020
Phase 3 interim data due 1Q 2020.
KZIA
$4.25
-0.1  -2.30%
Cantrixil
Ovarian cancer
Phase 1
Early 2020
Phase 1 Part B initial data due early 2020.
DMAC
$4.19
+0.15  +3.71%
DM199
Chronic Kidney Disease (African Americans)
Phase 2
1Q 2020
Phase 2 initiation announced December 17, 2019 with interim analysis 1Q 2020.
AXGT
$3.96
-0.17  -4.12%
AXO-Lenti-PD - SUNRISE-PD
Parkinson's disease
Phase 1/2
1Q 2020
Phase 1/2 6-month data from the first two patients in the second cohort due 1Q 2020.
SNGX
$2.96
-0.02  -0.67%
SGX301 (synthetic hypericin)
Cutaneous T-Cell Lymphoma (CTCL) cancer
Phase 3
1Q 2020
Phase 3 top-line data due 1Q 2020.
EVLO
$6.01
  +0.00%
EDP1066
Psoriasis or atopic dermatitis
Phase 1
1Q 2020
Phase 1b data due 1Q 2020.
CRNX
$22.57
-0.24  -1.05%
CRN01941
Neuroendocrine tumors
Phase 1
Early 2020
Phase 1 top-line data due early 2020.
ARDS
$7.61
+0.2  +2.74%
AR-501
Chronic bacterial lung infections in patients with cystic fibrosis (CF)
Phase 1/2
1Q 2020
Phase 1/2 data in healthy subjects due 1Q 2020 and from cystic fibrosis patients in 2Q 2021.
LXRX
$3.36
-0.09  -2.47%
Sotagliflozin
Type 2 Diabetes
Phase 3
Early 2020
SNY informed LXRX July 26, 2019 that it plans to terminate its agreement following insufficient efficacy across three Phase 3 trials. Phase 3 data noted 400 mg achieved the primary endpoint of superiority - December 20, 2019. Further trial data due early-2020.
LQDA
$6.52
-0.63  -8.81%
LIQ861 - INSPIRE
Pulmonary arterial hypertension
NDA Filing
1Q 2020
NDA filing due 1Q 2020.
SLS
$2.94
-0.04  -1.34%
NeuVax in combination with Herceptin
Breast cancer - 1+/2+
Phase 2b
1Q 2020
Waiting on further guidance from FDA regarding future development - likely 1Q 2020.
EARS
$1.48
+0.01  +0.68%
AM-125
Vertigo
Phase 2
1Q 2020
Phase 2 interim analysis due 1Q 2020.
VRNA
$5.80
-0.26  -4.29%
Ensifentrine (RPL554) - Metered Dose Inhaler
Maintenance treatment of COPD
Phase 2
1Q 2020
Phase 2 MDI single dose data due 1Q 2020.
LGND
$88.54
-1.4  -1.56%
Ensifentrine (RPL554) - Metered Dose Inhaler
Maintenance treatment of COPD
Phase 2
1Q 2020
Phase 2 MDI single dose data due 1Q 2020.
INSM
$20.09
-0.13  -0.64%
INS1007
Bronchiectasis
Phase 2
1Q 2020
Phase 2 top-line data due 1Q 2020.
OPK
$1.58
-0.04  -2.47%
RAYALDEE
Secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) - Stage 5
Phase 2
1Q 2020
Phase 2 initial open label data due 1Q 2020.
AIM
$1.14
-0.15  -11.63%
Ampligen plus Intron A
Ovarian cancer
Phase 1/2
1Q 2020
Phase 1 interim data to be presented 1Q 2020.
GNFT
$19.28
-0.12  -0.62%
Elafibranor - RESOLVE-IT
Non-alcoholic steatohepatitis (NASH)
Phase 3
1Q 2020
Phase 3 interim data due 1Q 2020.
SNY
$48.73
-0.87  -1.75%
Olipudase alfa
Acid sphingomyelinase deficiency (ASMD)
Phase 2/3
1Q 2020
Phase 3 data due 1Q 2020.
SELB
$3.08
-0.11  -3.45%
SEL-212 (COMPARE) - Head to head trial vs Krystexxa
Tophaceous gout
Phase 2
1Q 2020
Phase 2 interim data due 1Q 2020 and full data mid-2020.
SVRA
$3.14
-0.2  -5.99%
Molgradex - IMPALA
Autoimmune pulmonary alveolar proteinosis (PAP)
Phase 3
1Q 2020
Phase 3 data June 12, 2019 did not meet primary endpoint. Noted October 2, 2019 that the FDA has recommended that a BLA not be filed. Open label data due 1Q 2020.
ARDS
$7.61
+0.2  +2.74%
AR-301 (Salvecin)
Staphylococcus aureus
Phase 3
1Q 2020
Phase 3 interim data due 1Q 2020 with final data due early 2021.
ASLN
$2.18
-0.32  -12.80%
ASLAN004
Atopic dermatitis
Phase 1
Early 2020
Phase 1 interim data due early 2020.
ETON
$6.44
-0.27  -4.02%
EM-103
Hypothyroidism
NDA Filing
1Q 2020
NDA filing due 1Q 2020.
TRVN
$0.97
+0.07  +7.68%
Oliceridine (TRV130)
Moderate to severe acute pain
NDA Filing
1Q 2020
CRL issued November 2, 2018. NDA to be resubmitted 1Q 2020.
SVRA
$3.14
-0.2  -5.99%
Molgradex - OPTIMA
Nontuberculous mycobacteria (NTM)
Phase 2a
1Q 2020
Phase 2 top-line data due 1Q 2020.
INO
$4.24
+0.4  +10.42%
VGX-3100
Human papilloma virus (HPV)-related anal dysplasia
Phase 2
1Q 2020
Phase 2 data to be presented 1Q 2020.
BPMC
$65.58
-1.61  -2.40%
Avapritinib BLU-285 - PIONEER
Indolent and smoldering systemic mastocytosis (SM)
Phase 2
1Q 2020
Phase 2 initial data at ASH December 8, 2019 noted robust reductions in serum tryptase. Updated data due 1Q 2020.
MRUS
$17.02
+0.12  +0.71%
MCLA-158
Colorectal cancer
Phase 1
1Q 2020
Phase 1 emerging data due YE 2019. Moved to 1Q 2020 due to no update.

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