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.

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.

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

Financial data are delayed 15-25 minutes.

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Showing 150 drugs
Ticker
Price
Drug
Stage
Catalyst
Ticker Price Drug Stage Catalyst
PRTK
$11.00
-0.23  (-2%)
Omadacycline - oral
Acute bacterial skin and skin structure infections (ABSSSI)
 Phase 3
Phase 3 data released July 17, 2017 - all endpoints met. Oral presentation at ECCMID April 21, 2018.
TTPH
$3.23
0.09  (2.87%)
Eravacycline (TP-434) - IGNITE4
cIAI (complicated intra-abdominal infections)
 Phase 3
Presentation of data April 22; PDUFA August 28, 2018.
Phase 3 data released July 25, 2017 - primary endpoint met. PDUFA date under priority review August 28, 2018. Presentation of data April 22, 2018 at ECCMID.
BHVN
$27.18
-0.09  (-0.33%)
Rimegepant
Migraine
 Phase 3
Phase 3 data released March 26, 2018. Primary endpoint met but with competitive concerns. Additional data to be released April 22, 2018 at AAN meeting.
INCY
$68.43
-0.62  (-0.9%)
Baricitinib
Rheumatoid arthritis
 PDUFA
Adcom April 23; PDUFA June 2018
CRL received April 14, 2017. NDA resubmitted. Advisory Committee Meeting April 23, 2018. PDUFA date June 2018. Exact date unclear.
LLY
$79.06
-0.69  (-0.87%)
Baricitinib
Rheumatoid arthritis
 PDUFA
Adcom April 23; PDUFA June 2018
CRL received April 14, 2017. NDA resubmitted. Advisory Committee Meeting April 23, 2018. PDUFA date June 2018. Exact date unclear.
TOCA
$10.41
-0.07  (-0.67%)
Toca 511 & Toca FC
Glioma
 Phase 1
Phase 1 updated data due at AAN April 24, 2018.
ARGX
$88.90
-0.26  (-0.3%)
ARGX-113
Myasthenia gravis (MG)
 Phase 2
Phase 2 data released December 11, 2017 - 75% of patients showed meaningful improvement. Full data to be reported at American Academy of Neurology conference (April 24, 2018). Phase 3 trial to be initiated in 2018.
MNOV
$11.20
-0.36  (-3.11%)
MN-166
Amyotrophic lateral sclerosis (ALS)
 Phase 2
Phase 1b/2a abstract to be presented at AAN Meeting April 27, 2018.
BTX
$2.35
-0.04  (-1.26%)
OpRegen
Dry age-related macular degeneration (AMD)
 Phase 1/2
Data from first three cohorts to be presented at Association for Research in Vision and Ophthalmology (ARVO) conference Apr 29 - May 03, 2018.
NVS
$77.88
-1.13  (-1.42%)
RTH258 (brolucizumab)
Neovascular AMD
 Phase 3
Phase 3 data released June 20, 2017 - primary and key secondary endpoints met. Additional data to be presented at ARVO conference April 30, 2018.
KPTI
$14.59
-0.19  (-1.22%)
Selinexor - STORM
Quadruple Refractory Multiple Myeloma
 Phase 2b
April 2018
Phase 2b STORM Study Expansion data due April 2018.
NBRV
$5.23
0.18  (3.56%)
Lefamulin - LEAP 2
Moderate to severe Community Acquired Bacterial Pneumonia (CABP)
 Phase 3
Spring 2018
Phase 3 completion of enrollment announced December 4, 2017 with data due spring 2018.
AMGN
$171.56
-1.37  (-0.79%)
KYPROLIS (ENDEAVOR)
Relapsed Multiple Myeloma
 PDUFA
Phase 3 trial met PFS endpoint - March 2015. Announced February 28, 2017 that interim analysis met secondary endpoint of overall survival (OS). PDUFA date for sNDA April 30, 2018.
NVS
$77.88
-1.13  (-1.42%)
Kymriah (CTL019 )- JULIET
Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)
 PDUFA priority review
sBLA filing announced October 31, 2017. No PDUFA date given. Estimate April 30, 2018 using 6-month timeframe following receipt of sBLA by FDA.
IMGN
$10.27
0.03  (0.28%)
Mirvetuximab soravtansine - FORWARD I
Cancer - ovarian cancer and relapsed endometrial cancer
 Phase 3
April 2018
Phase 3 futility analysis April 2018. Enrollment to be completed mid-2018. Top-line data 1H 2019.
SIGA
$6.19
-0.04  (-0.48%)
TPOXX
Smallpox
 PDUFA priority review
Adcom May 1; PDUFA August 8, 2018
PDUFA date August 8, 2018 under priority review. Advisory Committee Meeting May 1, 2018.
PTLA
$33.25
0.27  (0.82%)
Andexanet alfa
Factor Xa inhibitor reversal agent
 PDUFA
CRL August 17 2016. New PDUFA date initially set for February 2, 2018, extended by three months to May 4, 2018.
LPCN
$1.65
0.03  (1.85%)
LPCN 1021
Men with low testosterone (Low T)
 PDUFA
CRL issued June 2016. NDA resubmitted with PDUFA orginally scheduled for February 8, 2017 but delayed until May 8, 2017 due to submission of additional data. Advisory Committee meeting January 10, 2018 voted 6-13 against approval.
IONS
$48.51
2.66  (5.8%)
Volanesorsen - APPROACH
Familial chylomicronemia syndrome (FCS)
 PDUFA
Adcom May 10, 2018. PDUFA August 30.
PDUFA August 30, 2017. Advisory Committee Meeting scheduled for May 10, 2018.
AKCA
$26.18
2.11  (8.77%)
Volanesorsen - APPROACH
Familial chylomicronemia syndrome (FCS)
 PDUFA
Adcom May 10, 2018. PDUFA August 30.
PDUFA August 30, 2017. Advisory Committee Meeting scheduled for May 10, 2018.
VRX
$17.18
-0.16  (-0.87%)
Plenvu (NER1006)
Bowel cleansing
 PDUFA
Noted February 9, 2018 that PDUFA date has been extended to May 13, 2018 to allow review of additional data.
NVS
$77.88
-1.13  (-1.42%)
Erenumab
Migraine
 PDUFA
Phase 3 trial met primary endpoint September 2016. PDUFA date May 17, 2018.
RXII
$2.76
0.01  (0.18%)
RXI-109-1501
Dermal scarring
 Phase 2
Phase 2 completion of enrollment announced June 21, 2017. Data to be presented May 17, 2018.
AMGN
$171.56
-1.37  (-0.79%)
Erenumab
Migraine
 PDUFA
Phase 3 trial met primary endpoint September 2016. PDUFA date May 17, 2018.
GTXI
$17.12
0.42  (2.52%)
Enobosarm - open label
Stress urinary incontinence (SUI)
 Phase 2
Phase 2 updated open-label data to be presented May 18, 2018 at American Urological Association (AUA) Meeting.
RXII
$2.76
0.01  (0.18%)
Samcyprone - RXI-SCP-1502
Cutaneous warts
 Phase 2
Phase 2 enrollment completed - noted September 6, 2017. Data to be presented May 18, 2018.
JNJ
$126.66
-0.89  (-0.7%)
DARZALEX (Daratumumab) - ALCYONE
Frontline multiple myeloma (non-transplant)
 PDUFA priority review
PDUFA date under priority review for sBLA of May 21, 2018. LBA at ASH 2017 noted HR 0.50.
EBIO
$1.91
0.28  (17.89%)
Vicinium
Non-muscle invasive bladder cancer (NMIBC)
 Phase 3
Phase 3 completion of enrollment announced March 12, 2018 with preliminary data due May 21, 2018. 3-mth data due mid-2018. 12-month data due mid-2019.
DOVA
$25.33
0.38  (1.52%)
Avatrombopag
Thrombocytopenia in chronic liver disease (CLD) patients
 PDUFA priority review
PDUFA date under priority review May 21, 2018.
URGN
$56.85
-0.34  (-0.6%)
MitoGel - OLYMPUS
Urothelial Carcinoma
 Phase 3
Phase 3 enrollment commenced April 3, 2017. Interim analysis to be presented May 21, 2018. Top-line data due 3Q 2018.
INSY
$7.03
0.07  (1.01%)
Buprenorphine
Moderate to severe postoperative pain after bunionectomy
 PDUFA
Phase 3 data met primary endpoints - August 2016. PDUFA date July 28, 2018. Data to be submitted from safety trial, which might impact on PDUFA date (i.e. possible extension). Advisory Committee Meeting May 22, 2018.
AKAO
$13.38
0.38  (2.88%)
Plazomicin
Complicated urinary tract infections (cUTI)
 PDUFA priority review
Adcom May 2; PDUFA June 25, 2018.
Phase 3 data released December 12, 2016 - primary endpoint met. PDUFA date under priority review June 25, 2018. Advisory Committee Meeting May 2, 2018.
BMRN
$82.30
-1.32  (-1.58%)
Pegvaliase
Phenylketonuria (PKU)
 PDUFA priority review
Phase 3 data released March 2016. Primary endpoint hit. Key secondary endpoint missed. PDUFA date extended 3 months to May 25, 2018.
REPH
$11.49
-0.02  (-0.09%)
Intravenous (IV) meloxicam
Acute pain following bunionectomy surgery
 PDUFA
Phase 3 data from second trial released November 28, 2016. Primary endpoint met. NDA filing announced July 31, 2017. PDUFA date May 26, 2018.
AMGN
$171.56
-1.37  (-0.79%)
Prolia (denosumab)
Glucocorticoid-induced osteoporosis (GIOP)
 PDUFA
PDUFA date for sBLA filing May 28, 2017.
TXMD
$5.71
-0.15  (-2.39%)
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
$118.92
-0.08  (-0.07%)
MGL-3196
Non-alcoholic steatohepatitis (NASH)
 Phase 2
May 2018
Phase 2 top-line data released December 6, 2017 - primary endpoint met. Top-line 36-week data due 2Q 2018. Biopsy data likely May.
NVS
$77.88
-1.13  (-1.42%)
Tafinlar (dabrafenib) and Mekinist (trametinib)
Melanoma with BRAF V600E or V600K mutations
 PDUFA priority review
Estimate mid-2Q 2018
Priority review received December 22, 2017. No PDUFA date given. Estimate mid-2Q 2018.
ESPR
$73.69
-0.47  (-0.63%)
Bempedoic acid - CLEAR LDL-C Lowering Program 1002-046
Hypercholesterolemia - statin intolerance
 Phase 3
May 2018
Phase 3 initiation of efficacy trials announced January 8, 2017. Data due May 2018.
ESPR
$73.69
-0.47  (-0.63%)
Bempedoic acid (ETC-1002-040) - Clear Harmony
Hyperlipidemia whose LDL-C is not adequately controlled with low- and moderate-dose statins
 Phase 3
May 2018
Phase 3 long-term safety and tolerability trial initiated January 2016. Completion of enrollment announced January 25, 2017. Top-line results due May 2018.
KTOV
$2.55
-0.05  (-1.54%)
KIT-302
Osteoarthritis and Hypertension
 PDUFA
PDUFA date May 31, 2018.
BLUE
$170.50
0  (0%)
bb2121
Relapsed/refractory multiple myeloma
 Phase 1
ASCO 2018
Phase 1 data released at ASH 2017 - ORR 94%, CR 56%. Further data due at ASCO 2018. Phase 3 trial to be initiated 2018.
CELG
$88.95
-0.67  (-0.75%)
bb2121
Relapsed/refractory multiple myeloma
 Phase 1
ASCO 2018
Phase 1 data released at ASH 2017 - ORR 94%, CR 56%. Further data due at ASCO 2018. Phase 3 trial to be initiated 2018.
LOXO
$133.06
-0.39  (-0.3%)
LOXO-292
RET-fusion non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other tumors
 Phase 1
ASCO 2018
Phase 1 data to be presented at ASCO June 2018.
AGIO
$86.45
-1.84  (-2.08%)
Ivosidenib
R/R Acute Myeloid Leukemia (AML)
 Phase 1
ASCO 2018
First data due from expansion trial at ASH December 11, 2017. Updated data due at ASCO 2018.
AGIO
$86.45
-1.84  (-2.08%)
Enasidenib or ivosidenib with VIDAZA
Frontline AML with IDH1 or IDH2 mutation
 Phase 1/2
ASCO 2018
Phase 1/2 updated data due at ASCO 2018.
MRSN
$16.67
-0.18  (-1.01%)
XMT1522
HER2 - breast cancer
 Phase 1
ASCO 2018
Phase 1 dose escalation data due at ASCO 2018.
IDRA
$1.62
-0.1  (-5.81%)
IMO-2125 + ipilimumab - ILLUMINATE 204
Cancer - melanoma
 Phase 2
ASCO 2018
Phase 1/2 data released September 10, 2017. 6/9 disease control with one CR. Further data due at ASCO June 2018. Phase 3 initiation announced March 1, 2018.
TRPX
$4.80
-0.05  (-0.83%)
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.
PFE
$36.63
0.1  (0.27%)
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.
TEVA
$17.82
0.11  (0.62%)
Fremanezumab
Migraine
 PDUFA
PDUFA June 16, 2018.
VRX
$17.18
-0.16  (-0.87%)
IDP-118
Psoriasis
 PDUFA
PDUFA date June 18, 2018.
SCPH
$10.19
-0.57  (-5.21%)
Furoscix
Heart failure
 PDUFA
PDUFA June 23, 2018. Phase 3 trial did not meet FDA’s prespecified performance criteria.
DRRX
$2.11
-0.04  (-1.4%)
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
$7.83
-0.03  (-0.25%)
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
$132.43
-1.66  (-1.24%)
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
$58.83
0.19  (0.32%)
KEYTRUDA
Cervical cancer
 PDUFA priority review
PDUFA date under priority review June 28, 2018.
TEVA
$17.82
0.11  (0.62%)
CT-P6
Herceptin biosimilar
 PDUFA
1H 2018
PDUFA date 1H 2018.
DERM
$8.92
0.31  (3.6%)
Glycopyrronium tosylate
Primary axillary hyperhidrosis
 PDUFA
PDUFA date June 30, 2018.
EXEL
$20.87
-0.22  (-1.04%)
IMblaze370 - cobimetinib and atezolizumab
Third-line advanced or metastatic colorectal cancer
 Phase 3
1H 2018
Phase 3 data due 1H 2018.
GILD
$73.70
-0.74  (-0.99%)
Selonsertib (GS-4997)
Alcoholic Hepatitis
 Phase 2
2Q 2018
Phase 2 trial to be completed 2Q 2018.
GILD
$73.70
-0.74  (-0.99%)
GS-9674
Primary sclerosing cholangitis
 Phase 2
2Q 2018
Phase 2 data due 2Q 2018.
NVS
$77.88
-1.13  (-1.42%)
LEE011: MONALEESA-3
Breast cancer - (post-menopausal)
 Phase 3
2Q 2018
Phase 3 trial completion 4Q 2017, publication due 2Q 2018.
SGMO
$19.05
-0.16  (-0.78%)
SB-318
MPS Type 1
 Phase 1/2
1H 2018
Phase 1/2 data due 1H 2018.
INFI
$2.24
0.04  (1.81%)
IPI-549 + Nivolumab
Solid tumors
 Phase 1
2Q 2018
Late breaker at SITC November 8-12, 2017. Further data from monotherapy expansion component and combination due 2Q 2018.
KURA
$16.40
-0.4  (-2.38%)
Tipifarnib
Lower risk myelodysplastic syndromes (MDS) - cancer
 Phase 2
1H 2018
Phase 2 top-line data due 1H 2018.
CLSD
$11.42
0  (0%)
Suprachoroidal CLS-TA - HULK
Diabetic macular edema (DME)
 Phase 1/2
2Q 2018
Phase 1/2 enrollment completion announced April 20, 2017. Preliminary data due 2Q 2018.
RHHBY
$27.73
-0.15  (-0.48%)
TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and Abraxane) - IMpower132
Squamous non-small cell lung cancer (NSCLC)
 Phase 3
1H 2018
Phase 3 data due 1H 2018.
RHHBY
$27.73
-0.15  (-0.48%)
Tecentriq+cb+etoposide - IMpower133
Squamous non-small cell lung cancer (NSCLC)
 Phase 3
1H 2018
Phase 3 data due 1H 2018.
RYTM
$22.19
-0.23  (-1.03%)
Setmelanotide
POMC Heterozygous Deficiency Obesity, Alstrom Syndrome, POMC Epigenetic Disorders
 Phase 2
1H 2018
Phase 2 data due 1H 2018.
RHHBY
$27.73
-0.15  (-0.48%)
TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and Abraxane) - IMpower134
Squamous non-small cell lung cancer (NSCLC)
 Phase 3
1H 2018
Phase 3 data due 1H 2018.
CLSD
$11.42
0  (0%)
Suprachoroidal CLS-TA - TYBEE
Diabetic Macular Edema (DME)
 Phase 2
2Q 2018
Phase 2 completion of enrollment announced October 24, 2017 with preliminary data 2Q 2018.
RHHBY
$27.73
-0.15  (-0.48%)
TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and Abraxane) - IMpower130
Squamous non-small cell lung cancer (NSCLC)
 Phase 3
1H 2018
Phase 3 data due 1H 2018.
ARRY
$14.09
-0.35  (-2.42%)
Binimetinib - COLUMBUS
BRAF mutant melanoma cancer
 PDUFA
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.
MACK
$8.49
0.03  (0.35%)
MM-141 - CARRIE
Cancer - front line pancreatic cancer
 Phase 2
1H 2018
Phase 2 completion of enrollment announced June 19, 2017. Data due 1H 2018.
AST
$1.30
-0.06  (-3.7%)
AST-OPC1 SCiSTAR
Cervical spinal cord injury
 Phase 1/2
Late 2Q/early 3Q through to 1Q 2019
Phase 1/2 further readouts due late 2Q/early 3Q through to 1Q 2019.
BTX
$2.35
-0.04  (-1.26%)
AST-OPC1 SCiSTAR
Cervical spinal cord injury
 Phase 1/2
Late 2Q/early 3Q through to 1Q 2019
Phase 1/2 further readouts due late 2Q/early 3Q through to 1Q 2019.
ALDR
$13.75
-0.45  (-3.17%)
ALD403 - PROMISE 2
Frequent episodic migraine
 Phase 3
1H 2018
Phase 3 PROMISE 2 data released January 8, 2017 - endpoints met. 6-mth data due 1H 2018 with BLA filing due 2H 2018.
AVEO
$2.59
-0.07  (-2.26%)
TIVO-3 - tivozanib
Third line treatment of patients with renal cell cancer
 Phase 3
2Q 2018
Phase 3 completion of enrollment noted June 20, 2017. Futility analysis released October 6, 2017 - trial to continue as planned. Top-line data due 2Q 2018.
MGNX
$23.61
0.05  (0.21%)
Margetuximab in combination with pembrolizumab
Gastric cancer
 Phase 2
1H 2018
Phase 2 data due 1H 2018.
GLPG
$96.71
-1.28  (-1.31%)
Filgotinib - TORTUGA
Ankylosing spondylitis
 Phase 2
2Q 2018
Phase 2 initiation announced April 4, 2017. Trial to be completed 2Q 2018.
JNJ
$126.66
-0.89  (-0.7%)
Esketamine
Treatment resistant depression
Phase 3
2018
Phase 3 ongoing. Data and regulatory filings likely due 2018.
GLPG
$96.71
-1.28  (-1.31%)
Filgotinib - EQUATOR
Psoriatic arthritis
 Phase 2
2Q 2018
Phase 2 initiation announced April 4, 2017. Trial to be completed 2Q 2018.
ABBV
$92.60
-0.41  (-0.44%)
ABT-494 upadacitinib
Rheumatoid arthritis
 Phase 3
1H 2018
Data from two additional Phase 3 trials due 1H 2018.
ZEAL
$14.90
-0.83  (-5.28%)
Dasiglucagon
Severe hypoglycemia in diabetes
 Phase 3
2Q 2018
Phase 3 trial initiated July 2017 with data due 2Q 2018.
ARGS
$0.29
-0.06  (-13.82%)
AGS-004 and vorinostat
HIV
 Phase 1
1H 2018
Decision to open planned investigator-initiated Phase 2 clinical trial for long-term viral control in pediatric patients expected in 1H 2018 pending positive data from Phase 1 trial.
MEIP
$2.15
-0.03  (-0.92%)
Pracinostat in combination with Vidaza
High-risk Myelodysplastic Syndrome (MDS)
 Phase 2
2Q 2018
Phase 2 commencement of dosing announced June 14, 2017 - data from first stage due 2Q 2018.
OGEN
$1.55
-0.07  (-3.79%)
AG013
Oral mucositis (OM)
 Phase 2
2Q 2018
Phase 2 preliminary data due 2Q 2018, full results due 2019.
CARA
$12.34
0  (0%)
IV CR845
Acute pain
 Phase 3
2Q 2018
Phase 3 initiated September 2015. Placed on clinical hold February 2016. Clinical hold released April 2016 with enrollment resuming June 2016. Noted March 15, 2018 that enrollment is nearing completion with data due 2Q 2018.
NVS
$77.88
-1.13  (-1.42%)
LJN452
Non-alcoholic steatohepatitis (NASH)
 Phase 2
1H 2018
Phase 2 readout due 1H 2018.
CELG
$88.95
-0.67  (-0.75%)
REVLIMID - AUGMENT NHL-007
Relapsed or Refractory Follicular Lymphoma
 Phase 3
1H 2018
Phase 3 data due 1H 2018.
GTHX
$38.93
0.53  (1.38%)
G1T38 plus Faslodex
ER+ breast cancer
 Phase 1b
2Q 2018
Phase 1b preliminary data due 2Q 2018.
ABLX
$54.62
-0.3  (-0.53%)
Vobarilizumab
Systemic lupus erythematosus (SLE)
 Phase 2
1H 2018
Phase 2 data due 1H 2018.
IMMP
$1.82
-0.04  (-1.62%)
Eftilagimod alpha and Keytruda
Melanoma
 Phase 1
1H 2018
Phase 1 data from all three cohorts is expected 1H 2018.
MTNB
$0.68
0.02  (3.53%)
MAT2501
Non-tuberculous mycobacterium (NTM)
 Phase 2
2Q 2018
Phase 2 trial to be initiated 2H 2018. Data from PK/tolerability trial due 2Q 2018.
ASNS
$15.51
0.05  (0.32%)
ASN100
Staphylococcus aureus
 Phase 2
1H 2018
Phase 2 top-line data due 2H 2018. Power analysis due 1H 2018.
BMY
$51.17
-0.44  (-0.85%)
CM-511 – Opdivo + Yervoy
First-line Melanoma
 Phase 3
1H 2018
Phase 3 data due 1H 2018.
PBYI
$61.25
-1.11  (-1.76%)
Neratinib
Third-line HER2-positive metastatic breast cancer
 Phase 3
1H 2018
Phase 3 data due 1H 2018.
TGTX
$14.40
-0.31  (-2.04%)
TG-1101 and TGR-1202 - UNITY-CLL study
Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin's Lymphoma (NHL)
 Phase 3
2Q 2018
Phase 3 completion of full enrollment announced October 16, 2017 with top-line data due 2Q 2018.
DNLI
$19.77
0.51  (2.65%)
DNL201
Parkinson’s disease
 Phase 1
1H 2018
Phase 1 data due 1H 2018.
BMY
$51.17
-0.44  (-0.85%)
CM-331– Opdivo
Second-line Small cell lung cancer (SCLC)
 Phase 3
1H 2018
Phase 3 data due 1H 2018.
FBIO
$4.20
-0.1  (-2.33%)
IV Tramadol
Post-operative Pain
 Phase 3
2Q 2018
Phase 3 initiation announced September 27, 2017 with data due 2Q 2018.
ATXI
$4.35
-0.06  (-1.11%)
IV Tramadol
Post-operative Pain
 Phase 3
2Q 2018
Phase 3 initiation announced September 27, 2017 with data due 2Q 2018.
PGNX
$7.00
-0.03  (-0.29%)
Azedra
Pheochromocytoma
 PDUFA priority review
Phase 2b primary endpoint met - March 2017. PDUFA date under priority review extended by three months to June 30, 2018 following submission of CMC material.
BMY
$51.17
-0.44  (-0.85%)
CM-548 - Opdivo+SOC
First-line Glioblastoma (GBM) cancer
 Phase 2
1H 2018
Phase 2 data due 1H 2018.
SPRO
$12.91
-0.25  (-1.9%)
SPR741
Healthy Volunteers (safety trial)
 Phase 1b
2Q 2018
Phase 1b top-line data due 2Q 2018.
CRMD
$0.22
0.01  (3.49%)
Neutrolin - LOCK-IT 100
Hemodialysis patients with central venous catheters
 Phase 3
2Q 2018
Phase 3 data due 2H 2018 with interim analysis due 2Q 2018.
PRTA
$36.84
1.87  (5.35%)
NEOD001 PRONTO
Previously-treated patients with AL amyloidosis and persistent cardiac dysfunction
 Phase 2b
2Q 2018
Phase 2b data due 2Q 2018.
AGN
$158.51
-0.08  (-0.06%)
UBROGEPANT - ACHIEVE II (UBR-MD-02)
Migraine
 Phase 3
1H 2018
Phase 3 data due 1H 2018.
ACRS
$17.73
0.13  (0.74%)
ATI-50002 - PK/safety
Alopecia areata
 Phase 2
1H 2018
Phase 2 data due 1H 2018.
RARE
$54.26
0.39  (0.72%)
KRN23 Burosumab
Tumor-induced osteomalacia (TIO)
 Phase 2
1H 2018
Interim data released April 2016. Additional data released September 2016 with full data due 1H 2018.
PSTI
$1.20
-0.05  (-3.23%)
PLX-PAD (stem cells)
Intermittent claudication, or IC
 Phase 2
2Q 2018
Phase 2 data due to be published 2Q 2018.
CYTK
$7.15
0.05  (0.7%)
CK-2127107
Spinal muscular atrophy (SMA)
 Phase 2
2Q 2018
Phase 2 initiated January 2016. Baseline data from first cohort released June 5, 2017. Cohort 2 enrollment to be completed in 2017. Data due 2Q 2018.
MEIP
$2.15
-0.03  (-0.92%)
ME-401
Relapsed/refractory Follicular Lymphoma/Chronic Lymphocytic Leukemia (CLL)
 Phase 1b
2Q 2018
Phase 1b data to be presented 2Q 2018.
AZN
$35.34
-0.07  (-0.18%)
Selumetinib - ASTRA
Thyroid cancer
 Phase 3
1H 2018
Phase 3 data due 1H 2018.
MEIP
$2.15
-0.03  (-0.92%)
ME-344
HER2-negative Breast Cancer
 Phase 1
2Q 2018
Phase 1 data due 2Q 2018.
AZN
$35.34
-0.07  (-0.18%)
Lynparza
First-line ovarian cancer
 Phase 3
1H 2018
Phase 3 data due 1H 2018.
ARNA
$39.69
0.42  (1.07%)
APD371
Pain associated with Crohn's disease
 Phase 2
2Q 2018
Phase 2 data due 2Q 2018.
AZN
$35.34
-0.07  (-0.18%)
Durvalumab +/- tremelimumab (KESTREL)
Head & neck cancer
Phase 3
1H 2018
Phase 3 data due 1H 2018.
CKPT
$4.12
0.11  (2.74%)
CK-101
Non-small cell lung cancer (NSCLC) and other solid tumors
 Phase 1/2
1H 2018
Potential clinical update 1H 2018.
ALRN
$5.84
-0.18  (-2.83%)
ALRN-6924
Peripheral T-cell lymphoma (PTCL)
 Phase 2a
1H 2018
Phase 2a interim data due 1H 2018.
AZN
$35.34
-0.07  (-0.18%)
Durvalumab +/- tremelimumab (EAGLE)
Head & neck cancer
Phase 3
1H 2018
Phase 3 data due 1H 2018.
AZN
$35.34
-0.07  (-0.18%)
Durvalumab +/- tremelimumab (ARCTIC)
Non-small cell lung cancer (NSCLC)
 Phase 3
1H 2018
Phase 3 data 1H 2018.
FBIO
$4.20
-0.1  (-2.33%)
CEVA101
Severe Traumatic Brain Injury
 Phase 2
1H 2018
Phase 2 data in children due 1H 2018.
MTEM
$8.60
-0.15  (-1.6%)
MT-3724 (targeting CD20)
Relapsed/refractory diffuse large B-cell lymphoma (DLBCL)
 Phase 1b
2Q 2018
Phase 2 (potentially pivotal) trial to be initiated 2H 2018. Phase 1b further data due 2Q 2018.
FBIO
$4.20
-0.1  (-2.33%)
Pepvax vaccine
Cytomegalovirus (CMV)
 Phase 2
1H 2018
Phase 2 data due 1H 2018.
ZGNX
$40.80
-0.1  (-0.24%)
ZX008 - Study 1504
Dravet syndrom
 Phase 3
Late 2Q 2018
Phase 3 completion of enrollment announced January 31, 2018 with data due late 2Q 2018.
AGN
$158.51
-0.08  (-0.06%)
Brimo DDS
Atrophic Age-related macular degeneration (AMD)
 Phase 2
1H 2018
Phase 2 top-line data due 1H 2018.
CORI
$10.77
0.17  (1.6%)
Corplex Donepezil
Alzheimer's disease
 Phase 1
1H 2018
Pilot bioequivalence data due released May 11, 2017. Pivotal trial commenced fall of 2017 with preliminary data due 1H 2018.
DBVT
$23.75
-0.41  (-1.7%)
Viaskin Milk
Cow’s milk protein allergy (CMPA)
 Phase 2b
1H 2018
Phase 2b data due 1H 2018.
GLPG
$96.71
-1.28  (-1.31%)
GLPG2737 - PELICAN
Adult CF patients who are homozygous for the Class II F508del mutation
 Phase 2
1H 2018
Phase 2 top-line data due 1H 2018.
MESO
$5.69
-0.19  (-3.23%)
MSC-100-IV
acute graft versus host disease (aGVHD) in children
 Phase 3
2Q 2018
Phase 3 data released February 22, 2018 - primary endpoint met. Day 100-day survival data due 2Q 2018.
APLS
$24.52
0.31  (1.28%)
APL-2 subcutaneous and eculizumab (Soliris)
Paroxysmal Nocturnal Hemoglobinuria (PNH)
 Phase 1b
June 2018
Phase 1b eculizumab add-on and monotherapy expansion updates due June 2018. Phase 3 trial to be initiated 2H 2018.
CMTA
$17.63
-1.81  (-9.31%)
Palovarotene
Fibrodysplasia ossificans progressiva (FOP)
 Phase 2
2Q 2018
Data from Phase 2 Part B open-label extension due 2Q 2018.
GEMP
$5.86
-0.07  (-1.19%)
Gemcabene - INDIGO-1
Severe Hypertriglyceridemia (SHTG)
 Phase 2b
2Q 2018
Phase 2b completion of enrollment announced January 17, 2018 with data due 2Q 2018.
AGN
$158.51
-0.08  (-0.06%)
ATOGEPANT
Prophylaxis (migraine)
 Phase 2b
1H 2018
Phase 2b top-line data due 1H 2018.
JNCE
$19.46
-0.32  (-1.62%)
JTX-2011
Solid tumors - Cancer
 Phase 1/2
2Q 2018
Phase 1/2 trial initiated September 2017.Phase 2 arm initiation announced April 21, 2017. Efficacy data due 2Q 2018.
ANAB
$91.67
0.8  (0.88%)
ANB020
Severe adult eosinophilic asthma
 Phase 2a
2Q 2018
Phase 2a data due 2Q 2018.
PBYI
$61.25
-1.11  (-1.76%)
Neratinib plus Kadcyla (T-DM1)
HER2-positive metastatic breast cancer
 Phase 1/2
2Q 2018
Phase 1/2 updated data due 2Q 2018.
IONS
$48.51
2.66  (5.8%)
IONIS-HTT Rx
Huntington's Disease
 Phase 1/2
1H 2018
Phase 1/2 data to be presented 1H 2018.
NLNK
$4.49
-0.03  (-0.44%)
Indoximod + gemcitabine and nab-paclitaxel
Pancreatic cancer
 Phase 2
1H 2018
Phase 2 data due 1H 2018.
BOLD
$38.49
-0.44  (-1.11%)
AT342 - VALENS
Crigler-Najjar
 Phase 1/2
2Q 2018
Phase 1/2 commencement of dosing announced February 12, 2018 with preliminary data due 2Q 2018.
BOLD
$38.49
-0.44  (-1.11%)
AT132 - ASPIRO
X-Linked Myotubular Myopathy
 Phase 1/2
2Q 2018
Phase 1/2 dosing has commenced - noted September 21, 2017 with preliminary data released January 4, 2018. Additional data due 2Q 2018.
IDRA
$1.62
-0.1  (-5.81%)
IMO-8400
Dermatomyositis
 Phase 2
2Q 2018
Phase 2 initiated November 2015. Enrollment completed 3Q 2017 with data due 2Q 2018.
INCY
$68.43
-0.62  (-0.9%)
Ruxolitinib - REACH 1
Graft versus host disease
 Phase 3
1H 2018
Phase 2 pivotal trial dosing initiation announced December 30, 2016. Data due 1H 2018.
NVS
$77.88
-1.13  (-1.42%)
Ruxolitinib - REACH 1
Graft versus host disease
 Phase 3
1H 2018
Phase 2 pivotal trial dosing initiation announced December 30, 2016. Data due 1H 2018.
SPHS
$2.18
0.01  (0.35%)
Topsalysin (PRX302)
Localized low to intermediate risk prostate cancer
 Phase 2
Late-2Q 2018
Phase 2b initial biopsy data due late 2Q 2018.
SNDX
$11.03
0.17  (1.56%)
Entinostat plus Keytruda - ENCORE 601
Recurrent non-small cell lung cancer (NSCLC)
 Phase 1/2
2Q 2018
Phase 2 trial to advance to second stage of trial - noted May 16, 2017. Updated data due 2Q 2018.
TPIV
$2.91
-0.1  (-3.32%)
TPIV200
Second line triple-negative breast cancer (TNBC)
 Phase 2
1H 2018
Phase 2 enrollment commenced - noted December 13, 2017. Interim data due 1H 2018.
ACRS
$17.73
0.13  (0.74%)
ATI-502 (ATI-50002) - PK/safety
Alopecia areata
 Phase 2
1H 2018
Phase 2 top-line data due 1H 2018.