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.

ABBREVIATIONS USED FOR CATALYST DATES:

(1)Q = (First) quarter of calendar year. 

(1)H = (First) half of calendar year

YE = "Year end" - used when companies give guidance similar to "by the end of 2019" or "towards the end of 2019".

2018 - The year is used when companies only give guidance as to which year the catalyst is slated for, without mentioned which quarter or half.

Refer to the "FDA Calendar Glossary" for a list of terms used in the FDA Decision Calendar.

Refer to the Biotech Historical Catalyst Calendar for completed biotech stock catalysts.

LARGE CAP CATALYSTS - generally only Phase 3 catalysts noted in company presentations and/or earnings releases are shown.

Catalysts to feature are mainly in Phase 2 or 3 development. Phase 1 drugs are generally NOT included. Over time, this list will grow.

NASDAQ and NYSE stocks only are shown. OTC stocks are not covered on BioPharmCatalyst.

Click on the date for the source of the catalyst.

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Showing 150 drugs
Ticker
Price
Drug
Stage
Catalyst
Ticker Price Drug Stage Catalyst
RETA
$33.99
+0.76  +2.29%
Bardoxolone - PHOENIX
Chronic Kidney Disease
Phase 2
Phase 2 interim data at ERA-EDTA meeting May 25, 2018. Full data 3Q 2018.
ACHN
$3.64
-0.04  -1.09%
ACH-4471
C3 glomerulopathy (C3G)
Phase 2
Phase 2 interim data due 3Q 2018. Interim biomarker data to be presented at ERA-EDTA meeting May 26, 2018.
ABIO
$0.63
-0.02  -3.37%
Gencaro - GENETIC-AF trial
Chronic Heart Failure
Phase 2b
Phase 2b data released February 26, 2018 - no benefit shown in overall population. Intends to discuss Phase 3 plans with FDA. Oral presentation of data at European Society of Cardiology Heart Failure World Congress, May 27, 2018.
AIMT
$33.20
+0.41  +1.25%
AR101 PALISADE
Peanut Allergy
Phase 3
Phase 3 data released February 20, 2018 met primary endpoint but noted 20% discontinued treatment, 12% due to adverse event. Data to be presented at EAACI 37th Annual Congress May 28, 2018.
ANAB
$82.67
+0.69  +0.84%
ANB020
Moderate-to-severe adult atopic dermatitis
Phase 2a
Phase 2a positive data released October 10, 2017. Oral presentation of data due at EAACI May 29, 2018 10:30 a.m CEST. Phase 2b trial to be initiated 1H 2018 with data due 2019.
TXMD
$6.09
+0.14  +2.35%
Yuvvexy - TX-004HR
Moderate-to-severe vaginal pain
PDUFA
CRL announced May 8, 2017. Company noted that FDA cited a lack of long-term endometrial safety data. New PDUFA date May 29, 2018.
MDGL
$122.64
+1.33  +1.10%
MGL-3196
Non-alcoholic steatohepatitis (NASH)
Phase 2
May 2018
Phase 2 top-line data released December 6, 2017 - primary endpoint met. Biopsy data likely May.
KTOV
$2.03
-0.24  -10.57%
KIT-302
Osteoarthritis and Hypertension
PDUFA
PDUFA date May 31, 2018.
VKTX
$4.98
-0.16  -3.11%
VK2809
Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
Phase 2
BLUE
$187.00
-2.4  -1.27%
bb2121
Relapsed/refractory multiple myeloma
Phase 1
ASCO June 1, 2018, 2:45pm
Phase 1 data released at ASH 2017 - ORR 94%, CR 56%. Further data due at ASCO June 1, 2018, 2:45pm. Abstract 8007. Phase 3 trial to be initiated 2018.
CELG
$79.54
+1.88  +2.42%
bb2121
Relapsed/refractory multiple myeloma
Phase 1
ASCO June 1, 2018, 2:45pm
Phase 1 data released at ASH 2017 - ORR 94%, CR 56%. Further data due at ASCO June 1, 2018, 2:45pm. Abstract 8007. Phase 3 trial to be initiated 2018.
INCY
$66.67
+0.1  +0.15%
Ruxolitinib, Lenalidomide, and Methylprednisolone
Relapsed/Refractory Multiple Myeloma
Phase 1
ASCO June 1, 2018, 2:45pm
Phase 1 oral abstract June 1, 2018, 2:45p.m. CT. Abstract 8005.
CELG
$79.54
+1.88  +2.42%
MM-007 OPTIMISMM
Multiple Myeloma - refractory
Phase 3
ASCO June 1, 2018 2:57pm
Phase 3 data released February 6, 2018 - primary endpoint (PFS) met. Presentation at ASCO June 1, 2018 2:57pm. Abstract 8001.
AGIO
$88.62
-0.31  -0.35%
AG-881
Glioma
Phase 1
ASCO June 1, 2018 3:09pm
Phase 1 data to be presented at ASCO June 1, 2018 3:09pm. Abstract: 2002.
ZYME
$17.91
+0.11  +0.62%
ZW25
HER2-expressing Cancers - ovarian, breast, gastric
Phase 1
ASCO June 1, 2018 2:45 pm CT
Phase 1 oral presentation at ASCO Friday June 1, 2018 at 2:45 pm CT. Abstract 2500.
KPTI
$17.34
-1.72  -9.02%
Selinexor - SEAL
Dedifferentiated liposarcoma
Phase 2/3
ASCO June 2, 2018 8am
Phase 2/3 trial initiated January 2016.Topline data for the Phase 2 portion released September 20, 2017 - PFS HR 0.60. Phase 3 data due by the end of 2019. Presentation at ASCO June 2, 2018 8am, Abstract 11512.
ECYT
$14.06
+0.05  +0.36%
Lu-PSMA-617
Metastatic castration-resistant prostate cancer (mCRPC)
Phase 3
ASCO June 2, 2018 1:15 p.m
Data to be presented at ASCO June 2, 2018 at 1:15 p.m, Abstract 5040.
SNDX
$9.12
+0.19  +2.13%
Entinostat
Solid tumors
Phase 1
ASCO June 2, 2018, 8am
Phase 1 ASCO poster ASCO June 2, 2018, 8am. Abstract 10556.
DCPH
$25.05
-0.8  -3.09%
DCC-2618
Gastrointestinal Stromal Tumors (GIST)
Phase 1
ASCO June 2, 2018 3pm
Phase 1 poster at ASCO June 2, 2018 3pm. Abstract 11511.
EXEL
$20.50
-0.08  -0.39%
CABOMETYX (cabozantinib) + Nivolumab and Ipilimumab
Urothelial Carcinoma
Phase 1
ASCO June 2, 2018 8am
Phase 1 abstract ASCO June 2, 2018 8am. Abstract 4528.
LOXO
$167.52
+1.43  +0.86%
LOXO-292
RET-fusion non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other tumors
Phase 1
ASCO June 2, 2018, 8am
Phase 1 data to be presented at ASCO June 2, 2018, 8am. Abstract 102.
INO
$4.84
-0.02  -0.41%
INO-5150
Prostate cancer
Phase 1b
ASCO June 2, 2018 1:15 PM
Phase 1b further data due at ASCO June 2, 2018 1:15 PM. Abstract 5078
RNN
$2.16
-0.02  -0.92%
RX-3117
Advanced bladder cancer - 3rd line
Phase 2a
ASCO June 2, 2018, 8am
Phase 2a data presented at ASCO GU February 9, 2018 noted 33% of patients had PFS of 2 months or more. Further data due at ASCO June 2, 2018; 8am. Abstract 4543.
GTHX
$51.17
+1.87  +3.79%
G1T38 plus Faslodex
ER+ breast cancer
Phase 1b
ASCO June 2, 2018 8am
Phase 1b preliminary data to be released at ASCO June 2, 8am. Abstract 1061.
CLDX
$0.64
-0.02  -3.35%
CDX-3379
Recurrent/metastatic head and neck squamous cell cancer
Phase 2
ASCO June 2, 2018, 1:15pm
Phase 2 trial initiation announced November 18, 2017. Enrollment to be completed 3Q 2018. Presentation at ASCO June 2, 2018, 1:15pm. TPS6091.
CLDX
$0.64
-0.02  -3.35%
Varlilumab and nivolumab
Solid tumors - cancer
Phase 2
ASCO June 2, 2018 3:12pm
Phase 2 initiated April 2016. Enrollment completed January 2018. Data to be presented at ASCO June 2, 2018 3:12pm. Abstract 3001.
RNN
$2.16
-0.02  -0.92%
Supinoxin RX-5902
Triple negative breast cancer
Phase 2a
ASCO June 2, 2018 8am
Phase 1b/2a poster at ASCO June 2, 2018; 8am. Abstract 1097.
SGEN
$55.37
-0.06  -0.11%
Enfortumab vedotin
Urothelial cancer
Phase 2
ASCO June 2, 2018 8am
Phase 2 pivotal trial initiation announced November 2017. Enrollment to be completed 3Q 2018. Presentation at ASCO June 2, 8am. Abstract #TPS4590.
AGIO
$88.62
-0.31  -0.35%
AG-120 Ivosidenib
R/R Acute Myeloid Leukemia (AML)
Phase 1
ASCO June 2, 2018 3pm
First data due from expansion trial at ASH December 11, 2017. Updated data due at ASCO June 2, 2018 3pm. Abstract 7000.
ODT
$23.33
-0.03  -0.13%
Tesetaxel - CONTESSA
Metastatic breast cancer (MBC)
Phase 3
ASCO June 2, 2018 8am
Phase 3 trial initiation announced December 28, 2017. Presentation at ASCO June 2, 2018 8am. Abstract TPS1106.
JNCE
$11.11
-0.49  -4.22%
JTX-2011
Solid tumors - Cancer
Phase 1/2
ASCO June 2, 2018 3PM
Phase 1/2 trial initiated September 2017.Phase 2 arm initiation announced April 21, 2017. Preliminary data due at ASCO June 2, 2018, 3pm. Abstract 3000.
STML
$19.65
+0.25  +1.29%
SL-701
Second line glioblastoma (GBM) cancer
Phase 2
ASCO June 2, 2018 1:15pm
Phase 2 abstract at ASCO June 2, 2018 1:15pm. Abstract 2058.
CLVS
$47.52
-0.75  -1.55%
Rucaparib - ATLAS
Urothelial carcinoma
Phase 2
ASCO June 2, 2018 8am
Phase 2 presentation at ASCO June 2, 2018 8am. Abstract TPS4592.
NKTR
$80.58
-2.22  -2.68%
NKTR-214 + OPDIVO (nivolumab) - PIVOT-02
Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancers
Phase 1/2
ASCO June 2, 2018, 5pm
Phase 1/2 preliminary data due at ASCO - presentation June 2, 2018, 5pm CT. Abstract 3006. Pivotal trials to be initiated mid-2018.
BMY
$52.69
+0.19  +0.36%
NKTR-214 + OPDIVO (nivolumab) - PIVOT-02
Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancers
Phase 1/2
ASCO June 2, 2018, 5pm
Phase 1/2 preliminary data due at ASCO - presentation June 2, 2018, 5pm CT. Abstract 3006. Pivotal trials to be initiated mid-2018.
MRK
$59.13
-0.04  -0.07%
Keytruda - KEYNOTE-042
Non-small cell lung cancer (NSCLC)
Phase 3
ASCO June 3, 2018 3:10pm
Phase 3 data released April 9, 2018. Overall survival endpoint met. Presentation at ASCO June 3, 2018 3:10pm. Abstract LBA4.
CELG
$79.54
+1.88  +2.42%
Lico-cel (CD-19 JCAR017) - TRANSCEND
r/r B cell non-Hodgkin lymphoma - cancer
Phase 1/2
ASCO June 3, 2018 11:09am
Phase 1 updated data to be presented at ASCO June 3, 2018 11:09am. Abstract 7505.
RHHBY
$27.62
+0.08  +0.29%
Tecentriq+cb+pac/nab-pac - IMpower131
Squamous non-small cell lung cancer (NSCLC)
Phase 3
ASCO June 4, 2018 3pm
Phase 3 PFS endpoint met - March 20, 2018. Trial to continue. OS benefit not evident. Presentation at ASCO June 4, 2018 3pm Abstract LBA9000.
TSRO
$48.58
+0.27  +0.56%
Niraparib and Keytruda (TOPACIO)
Triple-negative Breast Cancer or Ovarian Cancer
Phase 1/2
ASCO June 3, 2018 9:45am
Data presented at SGO March 26, 2018 showed ORR 25%, control rate 68%. Data to be presented at ASCO June 3, 2018, 9:45AM. Abstract 106.
CALA
$5.40
+0.2  +3.85%
CB-839 + Panitumumab
Colorectal cancer
Phase 1/2
ASCO June 3, 2018 8am
Phase 1/2 poster at ASCO June 3, 2018 8am. Abstract TPS3616.
MGNX
$21.81
-0.01  -0.05%
Margetuximab in combination with pembrolizumab
Gastric cancer
Phase 2
ASCO June 3, 2018 8am
Phase 2 data due at ASCO June 3, 2018. Abstract 4030.
INCY
$66.67
+0.1  +0.15%
DPX-Survivac Vaccine Therapy and Epacadostat
Recurrent Ovarian Cancer
Phase 1
ASCO June 3, 2018, 9:57am
Phase 1 ASCO abstract June 3, 2018, 9.57am. Abstract 5510.
ARMO
$49.93
+0.03  +0.06%
AM0010 (PEG-IL-10)
Solid tumors
Phase 1b
ASCO June 3, 2018 8am
Phase 1/1b trial ongoing. Data to be presented at ASCO June 3, 2018 8am. Abstract 9018.
LLY
$82.71
+0.03  +0.04%
KEYTRUDA + chemo (KEYNOTE-021)
First-Line Nonsquamous Non-small cell lung cancer (NSCLC)
Phase 2
ASCO June 3, 2018 8am
Phase 2 data presented at ESMO 2017 - ORR 57%, PFS 19 months, HR 0.54. 24mth overall survival data to be presented at ASCO June 3, 2018 8am. Abstract #9026.
MRK
$59.13
-0.04  -0.07%
KEYTRUDA + chemo (KEYNOTE-021)
First-Line Nonsquamous Non-small cell lung cancer (NSCLC)
Phase 2
ASCO June 3, 2018 8am
Phase 2 data presented at ESMO 2017 - ORR 57%, PFS 19 months, HR 0.54. 24mth overall survival data to be presented at ASCO June 3, 2018 8am. Abstract #9026.
MRK
$59.13
-0.04  -0.07%
KEYTRUDA + carboplatin-paclitaxel or nab-paclitaxel KEYNOTE-407
Squamous non-small cell lung cancer (sNSCLC)
BLA Filing
ASCO June 3, 2018. 10:09am
Noted May 3, 2018 that sBLA filing has been submitted. Met OS and PFS endpoints - presentation at ASCO June 3, 2018. 10:09am. Abstract 105.
IMMU
$22.58
+0.01  +0.04%
SACTUZUMAB GOVITECAN (IMMU-132)
HR+/HER2- metastatic breast cancer
Phase 2
ASCO June 3, 2018 9:12am
Presentation at ASCO June 3, 2018 9:12 a.m. Abstract # 1004.
EPZM
$18.40
+0.25  +1.38%
Tazemetostat
Adult patients with mesothelioma characterized by BAP1 loss-of-function
Phase 2
ASCO June 3, 2018; 8pm
Phase 2 dosing commenced August 2016. Noted April 23, 2018 that all Tazemetostat trials have been placed on partial clinical hold. Phase 2 presentation at ASCO June 3, 2018; 8pm. Abstract 8515.
EXEL
$20.50
-0.08  -0.39%
XL184 cabozantinib (CELESTIAL)
Advanced hepatocellular cancer (HCC)
Phase 3
ASCO June 3, 2018 8am
Phase 3 data released October 16, 2017 - primary endpoint met. Data to be presented at 2018 ASCO-GI Symposium, January 19, 2018 - OS 10.2 months vs 8 months placebo (HR 0.76, p=0.0049). Median PFS 5.2 months vs 1.9 months placebo (HR 0.44, p<0.0001). sNDA filing announced March 15, 2018. Detailed data due at ASCO June 3, 2018 8am
NLNK
$5.40
+0.07  +1.31%
Indoximod + gemcitabine and nab-paclitaxel
Pancreatic cancer
Phase 2
ASCO June 3, 8am
Phase 2 ASCO poster Jun 3, 8am. Abstract 4015.
ABBV
$103.14
-2.46  -2.33%
Venclexta (MURANO)
Relapsed or refractory Chronic Lymphocytic Leukemia (CLL)
Phase 3
ASCO June 3, 2018 11:57am
Phase 3 data released September 18, 2017 - PFS primary endpoint met. LBA at ASH data showed PFS of 85% after 24 months. Abstract at ASCO June 2018. Abstract 7508.
RHHBY
$27.62
+0.08  +0.29%
Venclexta (MURANO)
Relapsed or refractory Chronic Lymphocytic Leukemia (CLL)
Phase 3
ASCO June 3, 2018 11:57am
Phase 3 data released September 18, 2017 - PFS primary endpoint met. LBA at ASH data showed PFS of 85% after 24 months. Abstract at ASCO June 2018. Abstract 7508.
SNDX
$9.12
+0.19  +2.13%
Entinostat plus Keytruda - ENCORE 601
Recurrent non-small cell lung cancer (NSCLC), colorectal cancer
Phase 1/2
ASCO June 3, 2018, 8:00AM CT
Phase 2 trial to advance to second stage of trial - noted May 16, 2017. ASCO poster June 3, 2018, 8am. Abstract 3557.
LLY
$82.71
+0.03  +0.04%
(MK-3475-189/KEYNOTE-189)
First Line Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
PDUFA priority review
ASCO 6/3/18 8am, PDUFA 9/23/18
PDUFA date under priority review September 23, 2018. Presentation June 3, 2018 8am. Abstract #9021.
MRK
$59.13
-0.04  -0.07%
(MK-3475-189/KEYNOTE-189)
First Line Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
PDUFA priority review
ASCO 6/3/18 8am, PDUFA 9/23/18
PDUFA date under priority review September 23, 2018. Presentation June 3, 2018 8am. Abstract #9021.
SPPI
$19.10
-0.41  -2.10%
SPI-2012 (ROLONTIS)
Chemotherapy-Induced Neutropenia
Phase 3
ASCO June 2018
Phase 3 ADVANCE trial met primary endpoint of non-inferiority in comparison to pegfilgrastim. Presentation at ASCO 2018. Abstract e12513 Additional Phase 3 RECOVER trial ongoing with BLA to be filed 4Q 2018.
SGEN
$55.37
-0.06  -0.11%
Enfortumab vedotin
Urothelial cancer
Phase 1
ASCO June 3, 2018 9:12 a.m
Phase 1 data to be presented at ASCO June 3, 9:12 a.m. Abstract #4504.
RHHBY
$27.62
+0.08  +0.29%
Alecensa - ALEX
Anaplastic lymphoma kinase (ALK)-positive metastatic (advanced) non-small cell lung cancer (NSCLC)
Phase 3
ASCO June 3, 2018 8am
Phase 3 updated data due at ASCO June 3, 2018 8am. Abstract #9043.
PFE
$35.89
-0.08  -0.22%
IBRANCE - PALOMA-3
Breast cancer
Phase 3
ASCO June 3, 2018 8am
Phase 3 presentation at ASCO June 3, 2018 8am. Abstract 1001.
PFE
$35.89
-0.08  -0.22%
IBRANCE (palbociclib)
Head and neck squamous cell carcinoma
Phase 2
ASCO June 3, 2018 8am
Phase 3 presentation at ASCO June 3, 2018 8am. Abstract 6008.
FGEN
$51.45
-2.05  -3.83%
Pamrevlumab (FG-3019)
Pancreatic cancer
Phase 1/2
ASCO June 3, 2018 8am
Phase 2 presentation at ASCO June 3, 2018 8am. Abstract 4016.
TYME
$3.87
+0.97  +33.45%
SM-88
Pancreatic cancer
Phase 2
ASCO June 3, 2018 8am
Phase 2 presentation due at ASCO June 3, 2018 8am. Abstract TPS4156.
FPRX
$18.41
+0.01  +0.05%
FPA144 + chemo (FIGHT)
Gastric and gastro-esophageal junction cancer
Phase 1
ASCO June 3, 2018 8am
Phase 3 portion of Phase 1/3 trial to be initiated 2H 2018. Poster at ASCO June 3, 2018am. Abstract TPS4135.
ZLAB
$22.19
+0.67  +3.11%
FPA144 + chemo (FIGHT)
Gastric and gastro-esophageal junction cancer
Phase 1
ASCO June 3, 2018 8am
Phase 3 portion of Phase 1/3 trial to be initiated 2H 2018. Poster at ASCO June 3, 2018am. Abstract TPS4135.
INFI
$2.04
+0.01  +0.74%
IPI-549 + Nivolumab
Solid tumors
Phase 1
ASCO June 4, 2018 8am
Data due be presented at ASCO June 4, 2018 8am. Abstract 3013.
RHHBY
$27.62
+0.08  +0.29%
TECENTRIQ (atezolizumab) - IMpower150
Non-squamous non-small cell lung cancer (NSCLC)
Phase 3
ASCO June 4 2018 3:45pm, PDUFA September 5, 2018.
Phase 3 overall survival endpoint met. Data to be presented at ASCO June 4, 2018 3:45pm. Abstract #9002. PDUFA date under priority review 5 September 2018,
AGEN
$3.47
-0.01  -0.29%
AGEN2034 (anti-PD-1)
Cervical cancer
Phase 1/2
ASCO June 4, 2018 8am
Phase 1/2 presentation at ASCO June 4, 2018 8am. Abstract 3086.
XLRN
$36.57
+0.23  +0.63%
Luspatercept Extension Study - PACE-MDS
Myelodysplastic Syndromes
Phase 2
ASCO June 4, 11:30am
Phase 2 updated data at ASCO June 4, 11:30am. Abstract 7018.
STML
$19.65
+0.25  +1.29%
SL-801
Solid tumors
Phase 1
ASCO June 4, 2018, 8am
Phase 1 abstract at ASCO June 4, 2018, 8am. Abstract 2560.
NKTR
$80.58
-2.22  -2.68%
NKTR-214 + TECENTRIQ + KEYTRUDA (PROPEL)
Solid tumors - cancer
Phase 1/2
ASCO June 4, 2018, 8am
Phase 1/2 commencement of dosing announced September 12, 2017. Presentation due at ASCO June 4, 2018, 8am. Abstract #TPS3115. Further data due 2H 2018.
LLY
$82.71
+0.03  +0.04%
Ramucirumab REACH-2
Hepatocellular Carcinoma
Phase 3
ASCO June 4, 2018 4pm
Phase 3 data released April 4, 2018. Primary endpoint met. Presentation at ASCO June 4 4pm. Abstract 4003.
VSTM
$5.73
+0.4  +7.50%
Duvelisib
Peripheral T-Cell Lymphoma (PTCL)
Phase 2
ASCO June 4, 2018 8am
Phase 2 presentation due at ASCO June 4, 8am. Abstract TPS7590.
AGEN
$3.47
-0.01  -0.29%
AGEN1884 (anti-CTLA-4)
Solid cancers
Phase 1
ASCO June 4, 2018 8am
Phase 1 presentation at ASCO June 4, 2018 8am. Abstract 3075.
CTMX
$25.93
+0.19  +0.74%
CX 072
Solid tumors
Phase 1/2
ASCO June 4, 2018 8am
Phase 1/2 initial data due at ASCO June 4, 2018 at 8am. Abstract 3071.
ONCS
$1.59
+0.02  +1.27%
ImmunoPulse IL-12 - PISCES
Melanoma - cancer
Phase 2b
ASCO June 4, 2018 1:15pm
Phase 2 poster at ASCO June 4, 2018 1:15pm. Abstract TPS9601
CELG
$79.54
+1.88  +2.42%
ABRAXANE - IMpower 131 ( I/O Combo)
Non-small cell lung cancer (NSCLC)
Phase 3
ASCO June 4, 2018 3pm
Data presentation at ASCO June 4, 2018 3pm. Abstract LBA9000
IMGN
$10.58
+0.2  +1.93%
Mirvetuximab soravtansine - FORWARD II
Ovarian cancer and relapsed endometrial cancer
Phase 1/2
ASCO June 4, 2018 1:15pm
Phase 1b/2 updated data due at ASCO June 4, 2018 1:15pm. Abstract 5549.
BMY
$52.69
+0.19  +0.36%
CM-227 – Opdivo + Yervoy
First-line Non-small cell lung cancer (NSCLC)
Phase 3
ASCO June 4, 2018 3:12PM
Phase 3 interim data released February 5, 2018 - co-primary endpoint of PFS met. Presentation at ASCO June 4, 3:12PM. Abstract 9001.
CORT
$18.59
+0.59  +3.28%
CORT125134 Relacorilant
Solid tumors - cancer
Phase 2
ASCO June 4, 2018 8am
Phase 2 initiated 1Q 2016. Presentation at ASCO June 4, 2018 8am. Abstract 2554.
PLX
$0.43
  +-0.49%
OPRX-106
Ulcerative Colitis
Phase 2
Phase 2 data released March 13, 2018 - key endpoints met. New data to be presented at DDW Meeting June 4, 2018 5pm.
CLVS
$47.52
-0.75  -1.55%
Opdivo and Rubraca
Castration-resistant prostate cancer (mCRPC)
Phase 2
ASCO June 4, 2018 8am
Phase 2 presentation at ASCO June 4, 2018 8am. Abstract TPS3126.
BMY
$52.69
+0.19  +0.36%
Opdivo and Rubraca
Castration-resistant prostate cancer (mCRPC)
Phase 2
ASCO June 4, 2018 8am
Phase 2 presentation at ASCO June 4, 2018 8am. Abstract TPS3126.
MEIP
$3.16
+0.06  +1.94%
ME-401
Relapsed/refractory Follicular Lymphoma/Chronic Lymphocytic Leukemia (CLL)
Phase 1b
ASCO June 4, 2018 8am
Phase 1b data to be presented at ASCO June 4, 2018 8am. Abstract 7519.
MEIP
$3.16
+0.06  +1.94%
ME-344
HER2-negative Breast Cancer
Phase 1
ASCO June 4, 2018 8am
Phase 1 data to be presented at ASCO June 4, 2018 8am. Abstract 2552.
PTLA
$40.01
+0.52  +1.32%
Cerdulatinib (PRT2070)
Refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia - cancer
Phase 2
ASCO June 4, 2018 1:15pm
Phase 2 enrollment commenced May 2016. Interim data released June 15, 2017 - noted CLL/SLL 67% partial responese rate + two patient deaths. New interim data due at ASCO June 4, 2018 1:15pm. Abstract 7511.
AGIO
$88.62
-0.31  -0.35%
Enasidenib or ivosidenib with VIDAZA
Frontline AML with IDH1 or IDH2 mutation
Phase 1/2
ASCO June 4, 2018
Phase 1/2 updated data due at ASCO June 4, 2018. Abstract 7042.
MTEM
$6.76
-0.14  -2.03%
MT-3724 (targeting CD20)
Relapsed/refractory diffuse large B-cell lymphoma (DLBCL)
Phase 1b
ASCO June 4, 2018 8am
Phase 2 trial to be initiated 2H 2018. Phase 1 further data to be presented at ASCO June 4, 8am. Abstract 7580.
MRSN
$22.00
+0.33  +1.52%
XMT1522
HER2 - breast cancer
Phase 1
ASCO June 4, 2018 8am.
Phase 1 dose escalation data due at ASCO June 4, 2018 8am. Abstract 2546.
ADAP
$13.25
+0.05  +0.38%
MAGE-A10
Non-Small Cell Lung Cancer (NSCLC)
Phase 1
ASCO June 4, 2018 8am.
Phase 1 initial safety data to be presented at ASCO June 4, 2018 8am. Abstract 3056. Response data due 2H 2018.
CALA
$5.40
+0.2  +3.85%
CB-839 plus capecitabine
Solid tumors
Phase 1
ASCO June 4, 2018 8am
Phase 1 presentation at ASCO June 4, 8am. Abstract 2562.
MGEN
$6.86
-0.36  -4.99%
Cobomarsen MRG-106
Chronic Lymphocytic Leukemia (CLL); Diffuse Large B-Cell Lymphoma (DLBCL); Cutaneous T-cell Lymphoma (CTCL)
Phase 1
ASCO June 4, 2018, 8am
Phase 1 presentation at ASCO June 4, 2018, 8:00 a.m. Phase 2 trial to be initiated 2018. Abstract 2511.
ABBV
$103.14
-2.46  -2.33%
Rova-T (TRINITY)
Third-line Small Cell Lung Cancer
Phase 2
ASCO June 4, 2018 10:12am
Phase 2 pivotal data released March 22, 2018. ORR of 16% + overall survival 5.6 months noted. Data to be presented at ASCO June 4, 2018 10:12am. Abstract 8507.
DVAX
$16.45
+0.35  +2.17%
SD-101 + Pembrolizumab
Melanoma and head and neck squamous cell carcinoma (HNSCC)
Phase 1/2
ASCO June 4, 2018, 1:15pm
Data abstract at ASCO June 4, 2018, 1:15pm, Abstract 9513.
ZIOP
$4.51
+0.12  +2.73%
Ad-RTS-hIL-12 + veledimex
Glioblastoma Multiforme (GBM)
Phase 1
ASCO June 4, 2018 8am
Phase 1 presentation at ASCO June 4, 8am. Abstract 3038.
TSRO
$48.58
+0.27  +0.56%
Niraparib + bevacizumab OVARIO
Ovarian cancer
Phase 2
ASCO June 4, 2018, 1:15PM
Phase 2 presentation at ASCO June 4, 2018, 1:15PM, Abstract TPS5606
AZN
$36.88
+0.04  +0.11%
Lyparza + Keytruda
Castration-Resistant Prostate Cancer
Phase 2
ASCO June 4, 2018 4pm
Phase 2 presentation at ASCO June 4, 4pm. Abstract 5003.
MRK
$59.13
-0.04  -0.07%
Lyparza + Keytruda
Castration-Resistant Prostate Cancer
Phase 2
ASCO June 4, 2018 4pm
Phase 2 presentation at ASCO June 4, 4pm. Abstract 5003.
REGN
$294.61
-0.7  -0.24%
Cemiplimab
Non-small cell lung cancer (NSCLC)
Phase 1
ASCO June 2018
Phase 1 data to be presented at ASCO June 2018.
SNY
$38.64
+0.03  +0.08%
Cemiplimab
Non-small cell lung cancer (NSCLC)
Phase 1
ASCO June 2018
Phase 1 data to be presented at ASCO June 2018.
TGTX
$13.75
  +0.00%
TGR-1202
Chronic Lymphocytic Leukemia (CLL)
Phase 2
ASCO June 4, 2018 8am
Phase 2 presentation at ASCO June 4, 2018 8am. Abstract 7530.
SLS
$5.26
-0.44  -7.72%
Galinpepimut-S and nivolumab
Ovarian cancer
Phase 1/2
ASCO June 4, 2018, 1:15PM
Phase 1/2 presentation due at ASCO June 4, 2018, 1:15PM.
PFE
$35.89
-0.08  -0.22%
Dacomitinib ARCHER 1050
Non-small cell lung cancer (NSCLC)
Phase 3
ASCO June 4, 2018 8am
Phase 3 presentation at ASCO June 4, 2018 8am. Abstract 9004.
XLRN
$36.57
+0.23  +0.63%
Luspatercept
Myelofibrosis
Phase 2
ASCO June 4, 2018 8am
Phase 2 session at ASCO June 4, 2018 8am. Abstract TPS7083.
CELG
$79.54
+1.88  +2.42%
Luspatercept
Myelofibrosis
Phase 2
ASCO June 4, 2018 8am
Phase 2 session at ASCO June 4, 2018 8am. Abstract TPS7083.
TSRO
$48.58
+0.27  +0.56%
Niraparib - (QUADRA trial)
Cancer - ovarian
Phase 2
ASCO June 4, 4:45PM
Phase 2 top-line data released April 24, 2018. Primary endpoint met. sNDA to be potentially filed 2H 2018. Additional data due at ASCO June 4, 4:45PM, Abstract 5514.
IDRA
$1.89
-0.02  -1.05%
IMO-2125 + ipilimumab - ILLUMINATE 204
Cancer - melanoma
Phase 2
ASCO June 4, 2018, 1:15pm
Phase 2 abstract June 4, 2018, 1:15pm CT. Abstract 9515.
CDTX
$5.42
+0.23  +4.33%
Rezafungin (CD101) IV - STRIVE
Candidemia
Phase 2
Phase 2 data released March 19, 2018. Primary objectives met. Data to be presented at ASM Microbe June 8, 11a.m. Phase 3 trials to commence mid-2018.
CMRX
$4.56
-0.09  -1.94%
CMX521
Norovirus
Phase 1
June 11-15, 2018
Phase 1 presentation due June 11-15, 2018 at the International Conference on Antiviral Research (ICAR).
TRPX
$4.25
-0.28  -6.18%
THX-110
Tourette Syndrome
Phase 2a
Phase 2a data released April 9, 2018. Primary endpoint met. Full data to be released at European Society for the Study of Tourette syndrome meeting - June 13, 2018.
CRBP
$5.92
-0.12  -2.07%
Resunab
Systemic Sclerosis
Phase 2
EULAR June 13, 2018 3:30 PM CET
Phase 2 open label data to be presented at EULAR June 13, 2018 at 3:30 PM CET.
PFE
$35.89
-0.08  -0.22%
Xeljanz
Ulcerative colitis
PDUFA
sNDA acceptance announced July 13, 2017. 3-month extension announced December 13, 2017. PDUFA date not given. Estimate June 13 using 8 (+3) month timeline.
CRBP
$5.92
-0.12  -2.07%
Anabasum (Resunab)
Dermatomyositis
Phase 2
EULAR June 15, 2018 11:45 AM CET
Phase 2 data released October 19, 2017 - primary endpoint met. Presentation at EULAR June 15, 2018 at 11:45 AM CET.
RARX
$6.07
+0.02  +0.33%
RA101495
Paroxysmal nocturnal hemoglobinuria (PNH)
Phase 2
EHA June 15, 2018 5:30pm CET
Phase 2 data released December 4, 2017. Primary endpoint met but with competitive concerns. Data to be presented at EHA June 15, 2018 5:30pm CET. Phase 3 trial to be initiated 2H 2018.
KPTI
$17.34
-1.72  -9.02%
Selinexor - BOSTON
Multiple myeloma
Phase 3
EMA June 15, 2018 5:30pm CET (Phase 1/2 STOMP trial - NOT BOSTON)
Phase 3 trial initiation announced June 7, 2017. Enrollment to be completed 2018 with data due 2019. Phase 1/2 STOMP updated data at EHA June 15, 2018 5:30pm.
BLRX
$0.90
-0.02  -2.00%
BL-8040
Stem-cell mobilization for allogeneic transplantation
Phase 2
EHA June 15, 2018 5:30pm CET
Phase 2 data to be presented at EHA June 15, 2018 5:30pm CET
LJPC
$32.24
+0.47  +1.48%
LJPC-401
Beta thalassemia patients suffering from iron overload
Phase 3
EHA June 15, 2018 5:30pm CET (Phase 1)
Pivotal trial initiation announced December 4, 2017. Phase 1 presentation at EHA June 15, 2018 5:30 pm CET.
BPMC
$84.30
+3.62  +4.49%
Avapritnib BLU-285 - EXPLORER
Advanced Systemic mastocytosis (SM)
Phase 1
EHA June 15, 2018 5:30pm CET
Phase 1 updated data due at EHA June 15, 2018 5:30pm CET.
AFMD
$2.45
-0.03  -1.01%
AFM13 with Keytruda
Hodgkin Lymphoma - Cancer
Phase 1b
EHA June 15, 2018 5:30pm CET
Phase 1b preliminary data released February 1, 2018 - Objective response rate (ORR) of 89% (8/9), 4/9 CRs and 4/9 PRs. 3-month data due mid-2018. Next data to be presented at EHA June 15, 2018 5:30pm CET.
INCY
$66.67
+0.1  +0.15%
Baricitinib
Rheumatoid arthritis
PDUFA
PDUFA June 2018
CRL received April 14, 2017. NDA resubmitted. Advisory Committee Meeting April 23, 2018 voted for lower dose but against higher dose. PDUFA date June 2018. Exact date unclear.
LLY
$82.71
+0.03  +0.04%
Baricitinib
Rheumatoid arthritis
PDUFA
PDUFA June 2018
CRL received April 14, 2017. NDA resubmitted. Advisory Committee Meeting April 23, 2018 voted for lower dose but against higher dose. PDUFA date June 2018. Exact date unclear.
BGNE
$187.86
-5.12  -2.65%
Zanubrutinib (BGB-3111)
Waldenström’s macroglobulinemia
Phase 1/2
EHA June 15, 2018 5:30pm CET
Data to be presented EHA June 15, 2018 5:30pm CET
STML
$19.65
+0.25  +1.29%
SL-401
High Risk Myeloproliferative Neoplasms
Phase 2
EHA June 15, 2018 5:30pm CET
Phase 2 ongoing. ASH 2017 data showed 65% (11/17 evaluable) of CMML and MF patients had spleen reductions >25%. Updated data at EHA June 15, 2018 5:30pm CET.
STML
$19.65
+0.25  +1.29%
SL-401
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) cancer
BLA Filing
EHA June 15, 2018 11:45am CET
ASH data showed 54% (7/13) CR + CRc rate + 77% ORR. Rolling BLA initiation announced April 5, 2018. EHA presentation June 15, 2018 11:45am CET.
GBT
$46.75
-0.45  -0.95%
GBT440 HOPE-KIDS 1
Sickle cell disease - children age 6-17.
Phase 2a
EHA June 15, 2018 5:30pm CET
Phase 2a initiated June 2016. Presentation of Part B data at EHA June 15, 2018 5:30pm CET.
SELB
$12.28
+0.3  +2.50%
SEL-212
Tophaceous gout
Phase 2
EULAR June 15, 2018 CC 8.30 am
Phase 2 updated data released April 10, 2018. Noted 25% gout flares. Expanision data to be presented at EULAR June 15th, 2018. Five-monthly dose data due 3Q 2018.
EPZM
$18.40
+0.25  +1.38%
Tazemetostat
Diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma
Phase 2
EHA June 15, 2018; 11:30am CET
Phase 2 data released June 14, 2017 - ORR 29% below expectations. Phase 2 presentation at EHA June 15, 2018; 11:30am CET.
ATRA
$51.05
+1.35  +2.72%
ATA 129
Epstein-Barr virus (EBV-PTLD)
Phase 2
EHA June 15 2018; 5:30 p.m CET
Phase 2 presentation at EHA June 15 2018; 5:30 p.m CET
KDMN
$3.66
-0.03  -0.81%
KD025
Chronic graft-versus-host disease (cGVHD)
Phase 2
EHA June 16, 2018 4:30pm CET
Phase 2 interim data presented July 11, 2017. ORR 71%. Updated data at ASH December 10, 2017. Presentation of data due at EHA June 16, 2018 4:30pm CET.
BLUE
$187.00
-2.4  -1.27%
LentiGlobin - HGB-207 Northstar-2
non-β0/β0 transfusion-dependent thalassemia (TDT)
Phase 3
EHA June 16, 2018 11:45 a.m CET
Noted on December 14, 2016 that Phase 3 dosing has commenced. Data due at EHA June 16, 2018 11:45 a.m CET.
CYTK
$8.75
+0.05  +0.57%
CK-2127107
Spinal muscular atrophy (SMA)
Phase 2
Phase 2 data to be presented at Annual Cure SMA Conference in Dallas on June 16, 2018.
GERN
$4.82
+0.14  +2.99%
Imetelstat - IMerge Study
Myelodysplastic syndromes
Phase 2/3
EHA June 17, 2018 8:30am CET
Enrollment in expanded Part 1 of IMerge trial completed February 2018. Presentation of data at EHA June 17 8:30am CET.
JNJ
$121.35
-1.2  -0.98%
Imetelstat - IMerge Study
Myelodysplastic syndromes
Phase 2/3
EHA June 17, 2018 8:30am CET
Enrollment in expanded Part 1 of IMerge trial completed February 2018. Presentation of data at EHA June 17 8:30am CET.
BLUE
$187.00
-2.4  -1.27%
LentiGlobin - HGB-206
Sickle disease
Phase 1/2
EHA June 16, 2018, 12:30pm CET
Update at ASH 2016/2017. Further data due at EHA June 16, 2018, 12:30pm CET.
VRX
$22.22
+0.02  +0.09%
IDP-118
Psoriasis
PDUFA
PDUFA date June 18, 2018.
ARRY
$15.64
-0.12  -0.76%
Encorafenib and cetuximab - BEACON CRC
BRAF-Mutant Colorectal Cancer
Phase 3
June 20-23, 2018.
Data at ESMO September 2017. ORR 41%. Median duration of treatment was 5.6 months. Updated data due at World Congress on Gastrointestinal Cancer June 20-23, 2018.
ZFGN
$6.57
+0.28  +4.45%
ZGN-1061
Diabetes
Phase 2
ADA meeting late June, 2018.
Phase 2 top-line data due mid-2018. Update at American Diabetes Association meeting June 22-26, 2018.
SCPH
$13.96
+0.01  +0.07%
Furoscix
Heart failure
PDUFA
PDUFA June 23, 2018. Phase 3 trial did not meet FDA’s prespecified performance criteria.
AKAO
$11.73
-0.08  -0.68%
Plazomicin
Complicated urinary tract infections (cUTI)
PDUFA priority review
PDUFA date under priority review June 25, 2018. Advisory Committee Meeting May 2, 2018 voted for in favor of cUTI but against for the treatment of bloodstream infections in patients with limited or no treatment options.
DRRX
$1.88
-0.02  -1.05%
Remoxy
Chronic pain
PDUFA
Adcom June 26; PDUFA August 7, 2018
CRL issued September 26, 2016. NDA refiled with PDUFA date of August 7, 2018. Advisory Committee Meeting June 26, 2018.
PTIE
$9.66
-0.21  -2.13%
Remoxy
Chronic pain
PDUFA
Adcom June 26; PDUFA August 7, 2018
CRL issued September 26, 2016. NDA refiled with PDUFA date of August 7, 2018. Advisory Committee Meeting June 26, 2018.
GWPH
$159.96
+1.74  +1.10%
Epidiolex
Dravet Syndrome and Lennox-Gastaut syndrome
PDUFA priority review
PDUFA date under priority review June 27, 2018. Advisory Committee Meeting April 19, 2018 unanimously voted to support approval.
MRK
$59.13
-0.04  -0.07%
KEYTRUDA
Cervical cancer
PDUFA priority review
PDUFA date under priority review June 28, 2018.
ARRY
$15.64
-0.12  -0.76%
Binimetinib - COLUMBUS
BRAF mutant melanoma cancer
PDUFA
ASCO 6/4/2018; PDUFA 6/30/18
Phase 3 data released September 26, 2016 met primary endpoint. PDUFA date June 30, 2018 - no Adcom anticipated. Noted February 6, 2018 33.6 month overall survival HR=0.61. Oral presentation at ASCO June 4, 2018. Abstract 223875.
TEVA
$21.63
+0.48  +2.27%
CT-P6
Herceptin biosimilar
PDUFA
1H 2018
PDUFA date 1H 2018.
VTVT
$1.69
+0.05  +3.05%
Azeliragon - STEADFAST
Mild Alzheimer’s disease
Phase 3
Data from Part A released April 9, 2018 did not meet endpoints. Noted Part B to be discontinued. However, company noted May 8, 2018 that data from Part B will be released in June 2018 following a revised statistical analyses plan.
DERM
$8.11
-2.37  -22.61%
Glycopyrronium tosylate
Primary axillary hyperhidrosis
PDUFA
PDUFA date June 30, 2018.
GILD
$67.53
-0.64  -0.94%
Selonsertib (GS-4997)
Alcoholic Hepatitis
Phase 2
2Q 2018
Phase 2 trial to be completed 2Q 2018.
GILD
$67.53
-0.64  -0.94%
GS-9674
Primary sclerosing cholangitis
Phase 2
2Q 2018
Phase 2 data due 2Q 2018.
NVS
$76.17
-0.26  -0.34%
LEE011: MONALEESA-3
Breast cancer - (post-menopausal)
Phase 3
2Q 2018
Phase 3 trial completion 4Q 2017, publication due 2Q 2018.
AZN
$36.88
+0.04  +0.11%
Benralizumab - TERRANOVA
COPD
Phase 3
2Q 2018
Phase 3 data due 2Q 2018.