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.

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.

NASDAQ and NYSE stocks only are shown. OTC stocks are not covered on BioPharmCatalyst. Overseas biotech companies are only displayed if they have a dual listing on NASDAQ.

Biotech Catalysts on the FDA Calendar are sourced using official company press releases, SEC filings and presentations. Press releases are generally checked on a daily basis while company websites are checked once a month for updated company presentations.

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-2018 or 4Q 2018). Exact dates for clinical data releases are only rarely issued.

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Showing 150 drugs
Ticker
Price
Drug
Stage
Catalyst
Ticker Price Drug Stage Catalyst
MNK
$34.69
+0.55  +1.61%
Stannsoporfin
Jaundice
PDUFA priority review
PDUFA data under priority review August 22, 2018. Advisory Committee Meeting May 3, 2018 voted 3-21 against approval.
KALA
$12.14
-0.32  -2.57%
INVELTYS
Post‑operative inflammation and pain following cataract surgery
PDUFA
PDUFA date August 24, 2018.
REGN
$374.26
+2.48  +0.67%
Praluent (alirocumab)
For use with apheresis
PDUFA
PDUFA date August 24, 2018.
PFE
$42.09
+0.67  +1.62%
Tafamidis
TTR amyloid cardiomyopathy
Phase 3
Phase 3 data to be presented at European Society of Cardiology Congress August 27, 2018.
BHC
$21.89
+0.2  +0.92%
IDP-121
Acne
PDUFA
PDUFA date August 27, 2018.
TTPH
$2.85
-0.1  -3.39%
Eravacycline (TP-434) - IGNITE4
cIAI (complicated intra-abdominal infections)
PDUFA priority review
Phase 3 data released July 25, 2017 - primary endpoint met. PDUFA date under priority review August 28, 2018.
IONS
$50.84
-0.58  -1.13%
Volanesorsen - APPROACH
Familial chylomicronemia syndrome (FCS)
PDUFA
PDUFA August 30, 2018. Advisory Committee Meeting May 10, 2018 voted 10-8 in favor.
AKCA
$35.89
+0.15  +0.42%
Volanesorsen - APPROACH
Familial chylomicronemia syndrome (FCS)
PDUFA
PDUFA August 30, 2018. Advisory Committee Meeting May 10, 2018 voted 10-8 in favor.
ESPR
$48.12
+1.45  +3.11%
Bempedoic Acid/ Ezetimibe (1002FDC-053)
Hypercholesterolemia
Phase 3
August 2018
Phase 3 initiation announced November 6, 2017. Data due August 2018.
TGTX
$11.55
+0.2  +1.76%
TG-1101 and TGR-1202 - UNITY-CLL study
Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin's Lymphoma (NHL)
Phase 3
Summer 2018
Phase 3 top-line data due by the end of summer 2018.
XENE
$11.45
-0.35  -2.97%
XEN1101
Epilepsy
Phase 1
August 2018
Phase 1b data to be presented at European Congress on Epileptology August 2018.
AGN
$185.60
+1.39  +0.75%
ESMYA (ulipristal acetate)
Uterine Fibroids
PDUFA
August 2018
Phase 3 data released January 18, 2017 - endpoints met. Noted February 28, 2018 that PDUFA date has been extended to August 2018.
AZN
$38.12
+0.16  +0.42%
Moxetumomab
Cancer - leukaemia
PDUFA priority review
3Q 2018
Phase 3 trial met primary endpoint. PDUFA date under priority review 3Q 2018.
ADMP
$2.45
-0.38  -13.27%
Symjepi - low dose
Anaphylaxis
PDUFA
sNDA filing to included lower dose. PDUFA date September 3, 2018.
AGLE
$9.20
-0.02  -0.22%
Pegzilarginase (AEB1102)
Arginase I deficiency
Phase 1/2
09/05/2018, 5:45 p.m EET
Phase 1/2 new data presented April 12, 2018. Updated data to be presented at SSIEM September 5, 5:45 p.m EET.
RHHBY
$30.12
+0.17  +0.57%
TECENTRIQ (atezolizumab) - IMpower150
Non-squamous non-small cell lung cancer (NSCLC)
Phase 3
PDUFA date under priority review 5 September 2018,
BLUE
$158.00
+1.8  +1.15%
Lenti-D - Starbeam
Childhood cerebral adrenoleukodystrophy (CCALD)
Phase 2/3
09/05/2018 2am EST
Phase 2/3 updated data due September 5, 2018, 2am EST at SSIEM.
SGMO
$15.35
-0.1  -0.65%
SB-913 - CHAMPIONS
MPS Type 2
Phase 1/2
September 5, 2018, 2:30pm Eastern Europe time
Phase 1/2 initial data due September 5, 2018, 2:30pm Eastern Europe time.
PRQR
$7.65
  +0.00%
QR-010
Leber's Congenital Amaurosis (LCA) - Genetic blindness
Phase 1/2
09/05/2018 8:30 am GMT
Phase 1/2 commencement of dosing announced November 14, 2017. Interim analysis to be presented Sept. 5, 2018 at 8:30 am GMT with full 12 month data due 2019.
GSK
$41.25
+0.42  +1.03%
Mepolizumab
Chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype
PDUFA
Advisory Committee July 25, 2018 voted 3-16 against recommending approval. PDUFA date September 7, 2018.
INCY
$68.80
+0.95  +1.40%
Ruxolitinib
Atopic dermatitis
Phase 2
EADV 12-16 September 2018
Phase 2 data due at EADV 12-16 September 2018.
TEVA
$24.22
+0.11  +0.46%
Fremanezumab
Migraine
PDUFA
PDUFA date extended by three months to September 16, 2018.
NITE
$19.88
+0.37  +1.90%
NSR-RPGR
X-linked Retinitis Pigmentosa
Phase 1/2
09/22/2018 4:30pm
Phase 1/2 preliminary data due at EURETINA September 22, 2018 at 4:30 p.m.
CMRX
$4.05
-0.1  -2.41%
CMX521
Norovirus
Phase 1
Phase 1 data due 23-26 September 2018 at European Society for Clinical Virology.
LLY
$105.55
+1.19  +1.14%
(MK-3475-189/KEYNOTE-189)
First Line Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
PDUFA priority review
PDUFA date under priority review September 23, 2018.
MRK
$69.06
+0.21  +0.31%
(MK-3475-189/KEYNOTE-189)
First Line Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
PDUFA priority review
PDUFA date under priority review September 23, 2018.
SPPI
$22.78
-0.06  -0.26%
Poziotinib
Non-small cell lung cancer (NSCLC) with exon 20 insertion mutation in EGFR or HER2
Phase 2
Phase 2 updated data to be presented at the World Conference on Lung Cancer September 24, 2018.
FBIO
$1.91
-0.12  -5.91%
CK-101
Non-small cell lung cancer (NSCLC) and other solid tumors
Phase 1/2
Phase 1/2 preliminary data due at IASLC September 24, 2018.
CKPT
$3.81
-0.02  -0.52%
CK-101
Non-small cell lung cancer (NSCLC) and other solid tumors
Phase 1/2
Phase 1/2 preliminary data due at IASLC September 24, 2018.
LOXO
$158.34
-0.21  -0.13%
LOXO-292
RET-fusion non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other tumors
Phase 1
09/25/2018 3:15p.m. ET
Phase 1 updated data due at IASLC September 25, 2018, 3:15-4:45 p.m. ET. NDA filing due late-2019.
INSM
$20.99
+0.07  +0.33%
ALIS
Nontuberculous mycobacterial (NTM) lung disease
PDUFA priority review
PDUFA date under priority review September 28, 2018. Advisory Committee Meeting August 7, 2018 voted 12-2 supporting approval
ATRS
$3.39
+0.09  +2.73%
XYOSTED (testosterone enanthate)
Testosterone deficiency
PDUFA
PDUFA date September 29, 2018.
VTL
$9.00
-0.1  -1.10%
VTI-308
Alcohol-induced liver decompensation, or AILD
Phase 3
2H September 2018
Phase 3 VTI-208 trial failed. New VTI-308 trial initiated May 2016. Data due 2H September 2018.
MESO
$6.30
+0.39  +6.60%
MPC-150-IM
End-Stage Heart Failure with LVADs
Phase 2b
3Q 2018
Phase 2b 12-month data due 3Q 2018.
GALT
$3.87
+0.02  +0.52%
GR-MD-02 and pembrolizumab (KEYTRUDA)
Melanoma
Phase 1
3Q 2018 est (see note)
Phase 1 additional data due in the "near-term" - noted August 14, 2018.
LLY
$105.55
+1.19  +1.14%
Galcanezumab - EVOLVE-1, EVOLVE-2 and REGAIN
Migraine prevention
PDUFA
September 2018
PDUFA date September 2018. No exact date provided.
NVO
$47.46
+0.16  +0.33%
Somapacitan (NN8640) - REAL 3
Adult Growth Hormone Deficiency (AGHD)
Phase 3
3Q 2018
Phase 2 GHD data due 2Q 2018. Extension AGHD data due 3Q 2018.
ATOS
$2.23
-0.08  -3.46%
Endoxifen
Male breast cancer and Gynecomastia
Phase 1
3Q 2018
Phase 1 completion of dosing announced June 20, 2018. Preliminary data due 3Q 2018.
ACOR
$28.20
+0.35  +1.26%
BTT1023
Primary Sclerosing Cholangitis
Phase 2
3Q 2018
Phase 2 data due 2Q 2018 (overdue - shifted to 3Q in calendar).
GLPG
$101.34
-0.4  -0.39%
GLPG 2451+2222+2737 - FALCON open label
Cystic fibrosis - homozygous F508del patients
Phase 2
3Q 2018
Phase 2 initiation announced April 24, 2018. Top-line data due 3Q 2018.
GLPG
$101.34
-0.4  -0.39%
Filgotinib - FINCH 2
Rheumatoid arthritis (RA)
Phase 3
3Q 2018
Phase 3 initiated August 2016. Data due 3Q 2018.
GILD
$72.92
-2.67  -3.53%
Filgotinib - FINCH 2
Rheumatoid arthritis (RA)
Phase 3
3Q 2018
Phase 3 initiated August 2016. Data due 3Q 2018.
OMER
$20.92
+0.39  +1.90%
OMS721
IgA nephropathy
Phase 2
September 2018
Phase 3 trial enrollment initiated February 2018. Phase 2 data due September 2018.
GLPG
$101.34
-0.4  -0.39%
Filgotinib - TORTUGA
Ankylosing spondylitis
Phase 2
3Q 2018
Phase 2 data due 3Q 2018.
GILD
$72.92
-2.67  -3.53%
Filgotinib - TORTUGA
Ankylosing spondylitis
Phase 2
3Q 2018
Phase 2 data due 3Q 2018.
ZEAL
$14.12
+0.47  +3.44%
Dasiglucagon
Severe hypoglycemia in diabetes
Phase 3
September 2018
Phase 3 data due September 2018.
INO
$4.43
-0.07  -1.56%
INO-5150
Prostate cancer
Phase 1b
3Q 2018
Phase 1b data due 3Q 2018.
RETA
$72.16
+1.61  +2.28%
Bardoxolone - PHOENIX
Chronic Kidney Disease
Phase 2
3Q 2018
Phase 2 data released July 23, 2018. Primary endpoint met. IgA nephropathy and T1D CKD cohort data due 3Q 2018.
RARX
$10.55
-0.01  -0.09%
RA101495 SC
Atypical hemolytic uremic syndrome (aHUS)
Phase 1b
3Q 2018
Phase 1b PK data due 3Q 2018.
SNNA
$15.18
+0.34  +2.29%
SNA-125
Psoriasis
Phase 1/2
3Q 2018
Phase 1/2 commencement of dosing announced February 14, 2018 with top-line data due 3Q 2018.
PFE
$42.09
+0.67  +1.62%
Dacomitinib
Non-small cell lung cancer (NSCLC)
PDUFA priority review
September 2018
PDUFA under priority review September 2018. Exact date not provided.
ENTX
$5.10
-0.2  -3.77%
EB612
Hypoparathyroidism
Phase 2
September/October 2018
Phase 2 PK/PD data due in September/October 2018.
LXRX
$10.39
-0.06  -0.57%
LX2761
Type 2 diabetes
Phase 1b
3Q 2018
Phase 1b data due 3Q 2018.
SNDX
$7.18
-0.09  -1.24%
E2112
HR+, HER2- breast cancer
Phase 3
3Q 2018
Phase 3 PFS data due 3Q 2018.
APLS
$17.49
-1.34  -7.12%
APL-2 subcutaneous
Auto-immune Hemolytic Anemia (AIHA)
Phase 2
3Q 2018
Phase 2 monotherapy data due 1H 2018 (overdue - shifted to 3Q in the calendar).
PGNX
$7.81
-0.08  -1.01%
1404
Help visualize prostate cancer by targeting prostate specific membrane antigen (PSMA)
Phase 3
3Q 2018
Phase 3 completion of enrollment announced January 2, 2017. Top-line data due 3Q 2018.
SPRO
$10.62
+0.12  +1.14%
SPR994
Healthy Volunteers (safety trial)
Phase 1
3Q 2018
Phase 3 trial to be initiated year-end 2018. Final Phase 1 data due 3Q 2018.
BCRX
$7.10
+0.05  +0.71%
BCX7353 - ZENITH-1
Angioedema attacks in patients with hereditary angioedema (HAE)
Phase 2
3Q 2018
Phase 2 initiation announced August 2, 2017. Top-line data from first cohort due 3Q 2018.
ARNA
$35.74
-0.2  -0.56%
Olorinab (APD371)
Pain associated with Crohn's disease
Phase 2
Late-September
Phase 2 data due late-September 2018.
ATNX
$17.29
+0.62  +3.72%
Oraxol
Metastatic breast cancer
Phase 3
September 2018
Phase 3 second interim analysis due September 2018.
ESPR
$48.12
+1.45  +3.11%
Bempedoic acid - CLEAR LDL-C Lowering Program 1002-047
Hypercholesterolemia
Phase 3
September 2018
Phase 3 data due September, 2018.
NVO
$47.46
+0.16  +0.33%
Concizumab - explorer
Hemophilia A
Phase 2
3Q 2018
Phase 2 Explorer 5 data due 3Q 2018.
MESO
$6.30
+0.39  +6.60%
MSC-100-IV
acute graft versus host disease (aGVHD) in children
Phase 3
3Q 2018
Phase 3 data released February 22, 2018 - primary endpoint met. Day 180-day survival data due 3Q 2018.
CYTK
$7.20
+0.1  +1.41%
CK-2127107
Limited mobility
Phase 1b
3Q 2018
Phase 1b interim analysis 3Q 2018.
ANAB
$86.12
+0.54  +0.63%
ANB020
Severe adult eosinophilic asthma
Phase 2a
3Q 2018
Phase 2a data due 3Q 2018.
EYEG
$0.53
  +-0.17%
EGP-437
Non-infectious anterior uveitis
Phase 3
3Q 2018
Phase 3 data due 3Q 2018.
CLSN
$2.53
-0.02  -0.78%
GEN-1 OVATION 1
Ovarian cancer
Phase 1b
3Q 2018
Final Phase 1b PFS data to be reported 2Q 2018 (overdue - shifted to 3Q in calendar).
FOLD
$13.22
-0.24  -1.78%
ATB200
Pompe Disease
Phase 1/2
3Q 2018
Phase 1/2 additional data released February 15, 2017, May 15, 2017 and October 4, 2017. Further update February 8, 2018. US regulatory update due 3Q 2018.
DRNA
$14.92
-0.15  -1.00%
DCR-PHXC
Primary hyperoxaluria (PH)
Phase 1
3Q 2018
Phase 1 data due 3Q 2018.
FOMX
$5.84
+0.01  +0.17%
FMX101 - FX2017-22
Acne
Phase 3
3Q 2018
Third Phase 3 trial data due 3Q 2018.
ARGX
$84.94
+1.29  +1.54%
ARGX-113
Immune thrombocytopenia (ITP)
Phase 2
3Q 2018
Phase 2 data due 3Q 2018.
PTN
$0.96
-0.01  -0.99%
PL-8177
Inflammatory bowel diseases
Phase 1
3Q 2018
Phase 1 data due 3Q 2018.
CTIC
$1.83
-0.07  -3.68%
Pacritinib - PAC203
Myelofibrosis
Phase 2
3Q 2018
Enrollment to be completed by the end of 2018 with full data due 2Q 2019. Interim review due 3Q 2018.
NOVN
$2.45
-0.05  -2.00%
SB414
Atopic Dermatitis
Phase 1b
3Q 2018
Phase 1b data due 3Q 2018.
AMRN
$2.96
-0.06  -1.99%
Vascepa REDUCE-IT outcomes trial
High Triglycerides With Mixed Dyslipidemia
Phase 3
September 2018
Data due before the end of September 2018.
GERN
$3.92
-0.04  -1.01%
Imetelstat - IMbarkStudy
Myelofibrosis
Phase 2
3Q 2018
Phase 2 primary analysis due 3Q 2018.
JNJ
$134.47
+1.99  +1.50%
Imetelstat - IMbarkStudy
Myelofibrosis
Phase 2
3Q 2018
Phase 2 primary analysis due 3Q 2018.
PTI
$2.35
+0.02  +0.86%
PTI-801
Cystic fibrosis
Phase 1
3Q 2018
Phase 1 additional data released June 6, 2018. Final data due 3Q 2018.
CYTK
$7.20
+0.1  +1.41%
Reldesemtiv (CK-2127107)
Chronic obstructive pulmonary disease (COPD)
Phase 2
3Q 2018
Phase 2 data due 3Q 2018.
TPIV
$7.79
-0.2  -2.50%
TPIV200
Triple-negative breast cancer (TNBC) - second line
Phase 2
3Q 2018
Phase 2 interim response data due 3Q 2018.
RDUS
$19.99
-1.29  -6.06%
AB122
Solid tumors
Phase 1
3Q 2018
Phase 1 data due 3Q 2018.
HSGX
$2.64
-0.07  -2.58%
NeoCart
Cartilage defects in the knee
Phase 3
3Q 2018
Phase 3 top-line data due 3Q 2018.
ALT
$0.33
-0.01  -2.94%
NasoVAX
Flu vaccine
Phase 2
3Q 2018
Phase 2 additional data due 3Q 2018.
VKTX
$10.45
-0.09  -0.85%
VK5211
Acute Hip Fracture
Phase 2
09/30/2018 - 10:15am
Phase 2 trial met endpoints - November 28, 2017. Data to be presented at ASBMR meeting September 30, 2018, 10:15am.
ALT
$0.33
-0.01  -2.94%
NASOSHIELD
Anthrax
Phase 1
3Q 2018
Phase 1 data due 3Q 2018.
ALNY
$94.58
+1.63  +1.75%
Givosiran
Acute hepatic porphyrias
Phase 3
September 2018
Phase 3 trial initiation announced November 7, 2017 with interim analysis due September 2018.
KNSA
$15.94
-0.42  -2.57%
KPL-716
Atopic dermatitis
Phase 1a
3Q 2018
Phase 1a preliminary data due 3Q 2018.
ALDX
$7.15
-0.1  -1.38%
ADX-102
Dry eye syndrome
Phase 2b
Late 3Q or early 4Q 2018.
Phase 2b data due late 3Q or early 4Q 2018.
BOLD
$33.04
-0.34  -1.02%
AT132 - ASPIRO
X-Linked Myotubular Myopathy
Phase 1/2
Phase 1/2 updated data due October 2–6, 2018.
PRTK
$10.20
+0.2  +2.00%
Omadacycline
Community-acquired bacterial pneumonia (CABP)
PDUFA priority review
PDUFA date under priority review estimated October 4, 2018. Advisory Committee Meeting August 8, 2018 voted 17-1 in support of approval.
PRTK
$10.20
+0.2  +2.00%
Omadacycline
Acute bacterial skin and skin structure infections (ABSSSI)
PDUFA priority review
PDUFA date under priority review estimated October 4, 2018. Advisory Committee Meeting August 8, 2018 voted 14-4 in support of approval.
RHHBY
$30.12
+0.17  +0.57%
Hemlibra
Hemophilia
PDUFA priority review
PDUFA date under priority review October 4, 2018.
VSTM
$8.28
-0.1  -1.19%
Duvelisib - DUO
Chronic lymphocytic leukemia (CLL)//Small Lymphocytic Lymphoma (SLL)/Follicular Lymphoma
PDUFA priority review
Phase 3 data released September 6, 2017 - PFS primary endpoint met. Noted at ASH 2017 that OS secondary endpoint not met. PDUFA date under priority review October 5, 2018.
ACOR
$28.20
+0.35  +1.26%
INBRIJA (CVT-301)
OFF episodes of Parkinson’s disease (PD)
PDUFA
Phase 3 data released February 9, 2017 - primary endpoint met. NDA filing announced June 29, 2017. However, FDA issued a Refuse-To-File letter August 30, 2017. New PDUFA date October 5, 2018.
BHC
$21.89
+0.2  +0.92%
IDP-122
Psoriasis
PDUFA
PDUFA date October 5, 2018.
IONS
$50.84
-0.58  -1.13%
Inotersen (IONIS-TTRRx)
NEURO-TTR - familial amyloid polyneuropathy (FAP).
PDUFA priority review
Phase 3 data released May 15, 2017 - primary endpoint met but with safety concerns. Data presented November 2, 2017. PDUFA date under priority review extended to October 6, 2018.
PTCT
$42.35
-0.34  -0.80%
Inotersen (IONIS-TTRRx)
NEURO-TTR - familial amyloid polyneuropathy (FAP).
PDUFA priority review
Phase 3 data released May 15, 2017 - primary endpoint met but with safety concerns. Data presented November 2, 2017. PDUFA date under priority review extended to October 6, 2018.
AKCA
$35.89
+0.15  +0.42%
Inotersen (IONIS-TTRRx)
NEURO-TTR - familial amyloid polyneuropathy (FAP).
PDUFA priority review
Phase 3 data released May 15, 2017 - primary endpoint met but with safety concerns. Data presented November 2, 2017. PDUFA date under priority review extended to October 6, 2018.
MRK
$69.06
+0.21  +0.31%
GARDASIL 9
Human Papilloma virus vaccine
PDUFA priority review
PDUFA date for sBLA under priority review October 6, 2018.
NVS
$83.04
+0.85  +1.03%
AIN457 (Cosentyx)
Psoriatic arthritis
Phase 3
Phase 3 trial to be completed 2Q 2019. 52 week data; to be presented at ACR October 19 - 24, 2018.
TSRO
$28.78
+1.56  +5.73%
TSR-042 - GARNET
Solid tumors
Phase 1
ESMO 19-23 October 2018
Phase 1 preliminary data at AACR April 16, 2018. ORR 47%. Further data due at ESMO 19-23 October 2018.
LOXO
$158.34
-0.21  -0.13%
Larotrectinib (LOXO-101)
Solid tumors that harbor a TRK fusion.
PDUFA priority review
ESMO October 2018 + PDUFA 11/26/2018
PDUFA date under priority review November 26, 2018. Duration of Response Data to be Reported at ESMO October 2018.
AVEO
$2.33
+0.07  +3.10%
Tivozanib + Opdivo
Renal cell cancer (RCC)
Phase 1/2
ESMO October 2018
Phase 2 data due at ESMO October 2018.
DCPH
$34.96
-0.56  -1.58%
DCC-2618
Gastrointestinal Stromal Tumors (GIST)
Phase 1
ESMO October 2018
Phase 1 poster at ASCO June 2018 - ORR 9-24% in 2nd- >4th line patients. Update at ESMO October 2018.
MRUS
$19.10
-1.16  -5.73%
MCLA-128
Gastric cancer, ovarian, endometrial and non-small cell lung cancer
Phase 1/2
ESMO October 2018
Phase 1/2 data due at ESMO October 2018 with other cohort data due 4Q 2018.
BLRX
$0.89
  +0.11%
BL-8040 in combination with KEYTRUDA - COMBAT trial
Pancreatic cancer
Phase 2
ESMO October 2018
Phase 2 initiated September 2016. Top-line data due at ESMO October 2018 with data from additional cohort due 2019.
NTGN
$11.92
-0.23  -1.89%
NEO-PV-01 + nivolumab NT-001
Melanoma, Lung Cancer or Bladder Cancer
Phase 1
ESMO October 2018
Phase 1b data due at ESMO October 2018.
IMGN
$8.95
+0.1  +1.13%
Mirvetuximab soravtansine - FORWARD II
Ovarian cancer and relapsed endometrial cancer
Phase 1/2
ESMO 19-23 October 2018
Phase 1b/2 updated data due at ESMO 19-23 October 2018.
AGLE
$9.20
-0.02  -0.22%
Pegzilarginase (AEB1102)
Solid tumors
Phase 1
ESMO October 2018
Phase 1 data to be presented at ESMO October 19-23, 2018.
PRTK
$10.20
+0.2  +2.00%
Sarecycline
Severe acne vulgaris
PDUFA
4Q 2018 Est 10/19/2018
PDUFA date 4Q 2018. Exact date not provided by company. Estimate October 19, 2018 based on NDA acceptance date of December 20, 2017.
AGN
$185.60
+1.39  +0.75%
Sarecycline
Severe acne vulgaris
PDUFA
4Q 2018 Est 10/19/2018
PDUFA date 4Q 2018. Exact date not provided by company. Estimate October 19, 2018 based on NDA acceptance date of December 20, 2017.
IMDZ
$3.25
+0.1  +3.17%
CMB305
Cancer - soft tissue sarcoma
Phase 2
ESMO October 2018
Phase 2 monotherapy data due at ESMO October 2018.
EPZM
$10.55
-0.2  -1.86%
Tazemetostat
Epithelioid Sarcoma
Phase 2
ESMO October 19-23, 2018.
Phase 2 data due 2H 2018.
KURA
$18.45
-0.95  -4.90%
Tipifarnib
Head and neck squamous cell carcinomas (HNSCC)
Phase 3
ESMO October 2018
Phase 3 pivotal trial to be initiated 2H 2018. Phase 2 updated data due at ESMO October 2018.
SELB
$12.70
-0.21  -1.63%
SEL-212
Tophaceous gout
Phase 2
October 19 - 24, 2018
Phase 2 five-monthly dose data due at ACR Meeting, October 19 - 24, 2018. Pivotal trial to commence 4Q 2018.
REGN
$374.26
+2.48  +0.67%
Dupixent (dupilumab) - LIBERTY ASTHMA QUEST
Asthma
PDUFA
Phase 3 data released September 11, 2017 - primary endpoints met. 46% improvement after 52 weeks in 300 mg group. PDUFA date October 20, 2018.
SNY
$42.04
+0.79  +1.92%
Dupixent (dupilumab) - LIBERTY ASTHMA QUEST
Asthma
PDUFA
Phase 3 data released September 11, 2017 - primary endpoints met. 46% improvement after 52 weeks in 300 mg group. PDUFA date October 20, 2018.
MRTX
$59.95
+1.1  +1.87%
Sitravatinib
Non-small cell lung cancer (NSCLC)
Phase 1b
10/21/2018 11:00am CEST
Phase 1b update due at ESMO October 21, 2018 at 11:00am CEST.
CLVS
$35.25
-0.12  -0.34%
Rucaparib - TRITON2
Castrate-resistant prostate cancer (mCRPC)
Phase 2
ESMO October 21, 2018
Phase 2 initial data to be presented at ESMO October 21, 2018.
MRTX
$59.95
+1.1  +1.87%
Sitravatinib plus nivolumab
Non-small cell lung cancer (NSCLC)
Phase 2
10/22/2018 12:06 p.m CEST
Phase 2 update due at ESMO October 22, 2018 12:06 p.m CEST.
MRK
$69.06
+0.21  +0.31%
Doravirine (MK-1439)
HIV
PDUFA
Phase 3 trial met primary endpoint - February 14, 2017. PDUFA date October 23, 2018.
ADMA
$5.60
+0.08  +1.45%
BIVIGAM
Primary humoral immunodeficiency
PDUFA
PDUFA date October 25, 2018.
JAZZ
$173.81
+0.69  +0.40%
Xyrem
Pediatric narcolepsy patients with cataplexy
PDUFA priority review
PDUFA date for sNDA filng under priority review October 27, 2018.
BTX
$2.45
-0.06  -2.39%
OpRegen
Dry age-related macular degeneration (AMD)
Phase 1/2
AAO 10/27-10/30/2018
Interim readout 2018 - cohort 4 at AAO Oct. 27 - 30, 2018.
RGNX
$65.95
+0.95  +1.46%
RGX-314
Wet age-related macular degeneration (wet AMD)
Phase 1/2
October 27-30, 2018
Phase 1 data due at AAO meeting October 27-30, 2018. Phase 2 trial planned for 2019.
TXMD
$5.39
-0.16  -2.88%
TX-001HR
Moderate to severe vasomotor symptoms (VMS)
PDUFA
PDUFA date October 28, 2018.
REGN
$374.26
+2.48  +0.67%
Cemiplimab
Cutaneous squamous cell carcinoma
PDUFA priority review
PDUFA data under priority review October 28, 2018.
SNY
$42.04
+0.79  +1.92%
Cemiplimab
Cutaneous squamous cell carcinoma
PDUFA priority review
PDUFA data under priority review October 28, 2018.
MRK
$69.06
+0.21  +0.31%
KEYTRUDA + carboplatin-paclitaxel or nab-paclitaxel KEYNOTE-407
Squamous non-small cell lung cancer (sNSCLC)
PDUFA priority review
PDUFA date under priority review October 30, 2018.
XLRN
$48.39
+0.44  +0.92%
ACE-083
Facioscapulohumeral muscular dystrophy
Phase 2
October 2018
Phase 2 dosing initiation announced December 22, 2016. Part 1 data to be released October 2018 with Part 2 data due 2H 2019.
MNLO
$7.71
-0.2  -2.53%
Serlopitant
Refractory chronic cough
Phase 2
October 2018
Phase 2 data due October 2018.
AZRX
$2.33
-0.01  -0.43%
MS1819-SD
Exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis (CP)
Phase 2
Fall 2018
Phase 2a data and Phase 2b initiation due fall of 2018.
CBIO
$10.33
-0.03  -0.29%
CB 2679d/ ISU304
Hemophilia B
Phase 1/2
Late-3Q/early-4Q 2018
Cohort 6 patients (2) safety concerns - presence of neutralizing antibodies - noted June 18, 2018. Update likely late 3Q or early 4Q 2018.
GTHX
$57.42
-0.33  -0.57%
Trilaciclib plus Tecentriq
First-line small-cell lung cancer
Phase 2
ESMO October 2018.
Phase 2 data to be presented at ESMO October 2018.
GTXI
$18.34
-0.02  -0.11%
Enobosarm
Postmenopausal women with stress urinary incontinence (SUI)
Phase 2
Early 4Q 2018
Phase 2 top-line data due early 4Q 2018.
SNGX
$1.34
-0.03  -2.19%
SGX301 (synthetic hypericin)
Cutaneous T-Cell Lymphoma (CTCL) cancer
Phase 3
October 2018
Phase 3 interim analysis October 2018 with top-line data 1H 2019.
FOMX
$5.84
+0.01  +0.17%
FMX103
Papulopustular rosacea
Phase 3
Early 4Q 2018
Phase 3 top-line data due early 4Q 2018.
EGRX
$78.14
-2.47  -3.06%
Fulvestrant
Breast cancer
Phase 3
Fall 2018
Pivotal trial initiation announced December 7, 2017. Data due fall of 2018.
EARS
$0.24
  +1.92%
AM-125
Vertigo
Phase 1
October 2018
Phase 1 data due October 2018.
ALT
$0.33
-0.01  -2.94%
HepTCell
Hepatitis B
Phase 1
Early 4Q 2018
Phase 1 data due early 4Q 2018.
NVS
$83.04
+0.85  +1.03%
Promacta (eltrombopag)
Severe aplastic anemia (SAA)
PDUFA priority review
Early 4Q 2018 - estimate only
Announced May 30, 2018 that sNDA accepted for priority review. No PDUFA date given. Estimate early 4Q 2018.
ABBV
$98.81
+0.59  +0.60%
IMBRUVICA (ibrutinib)
Waldenström’s Macroglobulinemia
PDUFA priority review
PDUFA early 4Q 2018
sNDA accepted June 25, 2018. PDUFA date under priority review granted.
JNJ
$134.47
+1.99  +1.50%
IMBRUVICA (ibrutinib)
Waldenström’s Macroglobulinemia
PDUFA priority review
PDUFA early 4Q 2018
sNDA accepted June 25, 2018. PDUFA date under priority review granted.
TRVN
$1.57
-0.04  -2.48%
Oliceridine (TRV130)
Moderate to severe acute pain
PDUFA
PDUFA date November 2, 2018. Advisory Committee Meeting likely in October.
CHRS
$19.00
+0.25  +1.33%
CHS-1701
Pegfilgrastim biosimilar
PDUFA
CRL announced June 12, 2017. BLA resubmission announced May 3, 2018 with new PDUFA date of November 3, 2018.
ACRX
$3.05
-0.05  -1.61%
DSUVIA (ARX-04)
Moderate-to-severe acute pain following a surgical procedure
PDUFA
CRL issued October 12, 2017. NDA resubmission announced May 9, 2018 with new PDUFA date November 3, 2018.
EYPT
$1.99
-0.07  -3.40%
YUTIQ
Non-infectious uveitis
PDUFA
PDUFA date of November 5, 2018
TSRO
$28.78
+1.56  +5.73%
TSR-022 + TSR-042 AMBER
Solid tumors
Phase 1
SITC Novemeber 7 - 11, 2018
Phase 1 data due at SITC Novemeber 7 - 11, 2018.
TSRO
$28.78
+1.56  +5.73%
TSR-033 - CITRINO
Solid tumors
Phase 1
SITC November 7 - 11, 2018
Phase 1 monotherapy dose-escalation data due at SITC November 7 - 11, 2018.
NKTR
$60.03
+0.08  +0.13%
NKTR-214 + OPDIVO (nivolumab) - PIVOT-02
Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancers
Phase 1/2
SITC 11/7/2018-11/11/2018
Phase 1/2 preliminary data at ASCO 2018. PR rates - Melanoma 50%; RCC 46%; Urothelial Carcinoma 60%. Updated data likely at SITC meeting November 7-11, 2018.