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.
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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 |
|---|---|---|---|---|
| TGTX |
$9.00
-0.05 -0.55%
|
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.
|
| PFE |
$44.06
+0.31 +0.71%
|
Dacomitinib
Non-small cell lung cancer (NSCLC)
|
PDUFA priority review |
September 2018
PDUFA under priority review September 2018. Exact date not provided.
|
| NITE |
$25.50
-2.28 -8.21%
|
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 |
$3.97
+0.06 +1.53%
|
CMX521
Norovirus
|
Phase 1 | |
| SPPI |
$21.36
-0.16 -0.74%
|
Poziotinib
Non-small cell lung cancer (NSCLC) with exon 20 insertion mutation in EGFR or HER2
|
Phase 2 | |
| FBIO |
$1.58
-0.02 -1.25%
|
CK-101
Non-small cell lung cancer (NSCLC) and other solid tumors
|
Phase 1/2 | |
| CKPT |
$4.72
+0.33 +7.52%
|
CK-101
Non-small cell lung cancer (NSCLC) and other solid tumors
|
Phase 1/2 | |
| SNDX |
$6.77
-0.38 -5.31%
|
Entinostat plus Keytruda - ENCORE 601
Recurrent non-small cell lung cancer (NSCLC), colorectal cancer
|
Phase 1/2 |
09/24/2018 1:30PM
Phase 2 updated data to be presented September 24, 2018 1:30PM at WCLC.
|
| LOXO |
$159.27
+0.01 +0.01%
|
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.
|
| NVCR |
$48.65
-0.55 -1.12%
|
Tumor Treating Fields (TTFields) STELLAR
Mesothelioma
|
Phase 2 | |
| ADMP |
$3.10
+0.05 +1.64%
|
Symjepi - low dose
Anaphylaxis
|
PDUFA | |
| INSM |
$21.31
-0.42 -1.93%
|
ALIS
Nontuberculous mycobacterial (NTM) lung disease
|
PDUFA priority review | |
| ATRS |
$3.26
-0.11 -3.26%
|
XYOSTED (testosterone enanthate)
Testosterone deficiency
|
PDUFA | |
| MESO |
$6.70
+0.07 +1.06%
|
MPC-150-IM
End-Stage Heart Failure with LVADs
|
Phase 2b |
3Q 2018
Phase 2b 12 month database lock 3Q 2018 with data to be presented 4Q 2018.
|
| LLY |
$106.33
+0.26 +0.25%
|
Galcanezumab - EVOLVE-1, EVOLVE-2 and REGAIN
Migraine prevention
|
PDUFA |
September 2018
PDUFA date September 2018. No exact date provided.
|
| NVO |
$47.66
+0.16 +0.34%
|
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.
|
| ACOR |
$18.20
+0.05 +0.28%
|
BTT1023
Primary Sclerosing Cholangitis
|
Phase 2 |
3Q 2018
Phase 2 data due 2Q 2018 (overdue - shifted to 3Q in calendar).
|
| GLPG |
$113.31
-1.95 -1.69%
|
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.
|
| OMER |
$25.04
+0.73 +3.00%
|
OMS721
IgA nephropathy
|
Phase 2 |
September 2018
Phase 3 trial enrollment initiated February 2018. Phase 2 data due September 2018.
|
| INO |
$4.73
-0.17 -3.47%
|
INO-5150
Prostate cancer
|
Phase 1b |
3Q 2018
Phase 1b data due 3Q 2018.
|
| RETA |
$87.56
-4.19 -4.57%
|
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 |
$16.36
+0.78 +5.01%
|
RA101495 SC
Atypical hemolytic uremic syndrome (aHUS)
|
Phase 1b |
3Q 2018
Phase 1b PK data due 3Q 2018.
|
| UMRX |
$12.16
-0.11 -0.90%
|
ACTR707 + rituximab (ATTCK-20-03)
CD20+ Non-Hodgkin Lymphoma (NHL)
|
Phase 1 | |
| ENTX |
$5.24
-0.01 -0.19%
|
EB612
Hypoparathyroidism
|
Phase 2 |
September/October 2018
Phase 2 PK/PD data due in September/October 2018.
|
| LXRX |
$10.48
-0.23 -2.15%
|
LX2761
Type 2 diabetes
|
Phase 1b |
3Q 2018
Phase 1b data due 3Q 2018.
|
| SNDX |
$6.77
-0.38 -5.31%
|
E2112
HR+, HER2- breast cancer
|
Phase 3 |
3Q 2018
Phase 3 PFS data due 3Q 2018.
|
| APLS |
$19.88
-0.09 -0.45%
|
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).
|
| SPRO |
$10.25
-0.58 -5.36%
|
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.
|
| ARNA |
$43.75
+0.67 +1.56%
|
Olorinab (APD371)
Pain associated with Crohn's disease
|
Phase 2 |
Late-September
Phase 2 data due late-September 2018.
|
| NVO |
$47.66
+0.16 +0.34%
|
Concizumab - explorer
Hemophilia A
|
Phase 2 |
3Q 2018
Phase 2 Explorer 5 data due 3Q 2018.
|
| MESO |
$6.70
+0.07 +1.06%
|
MSC-100-IV
acute graft versus host disease (aGVHD) in children
|
Phase 3 |
3Q 2018
Phase 3 - Day 180 data 3Q 2018.
|
| CYTK |
$8.50
+0.35 +4.29%
|
CK-2127107
Limited mobility
|
Phase 1b |
3Q 2018
Phase 1b interim analysis 3Q 2018.
|
| ANAB |
$92.80
+0.5 +0.54%
|
ANB020
Severe adult eosinophilic asthma
|
Phase 2a |
3Q 2018
Phase 2a data due 3Q 2018.
|
| CLSN |
$2.79
+0.09 +3.33%
|
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).
|
| CTIC |
$1.99
-0.02 -1.00%
|
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.
|
| AMRN |
$2.99
+0.06 +2.05%
|
Vascepa REDUCE-IT outcomes trial
High Triglycerides With Mixed Dyslipidemia
|
Phase 3 |
September 2018
Data due before the end of September 2018.
|
| GERN |
$5.46
-0.04 -0.73%
|
Imetelstat - IMbarkStudy
Myelofibrosis
|
Phase 2 |
3Q 2018
Phase 2 primary analysis due 3Q 2018.
|
| JNJ |
$142.88
+0.9 +0.63%
|
Imetelstat - IMbarkStudy
Myelofibrosis
|
Phase 2 |
3Q 2018
Phase 2 primary analysis due 3Q 2018.
|
| PTI |
$2.58
+0.12 +4.88%
|
PTI-801
Cystic fibrosis
|
Phase 1 |
3Q 2018
Phase 1 additional data released June 6, 2018. Final data due 3Q 2018.
|
| CYTK |
$8.50
+0.35 +4.29%
|
Reldesemtiv (CK-2127107)
Chronic obstructive pulmonary disease (COPD)
|
Phase 2 |
3Q 2018
Phase 2 data due 3Q 2018.
|
| TPIV |
$9.64
+0.21 +2.23%
|
TPIV200
Triple-negative breast cancer (TNBC) - second line
|
Phase 2 |
3Q 2018
Phase 2 interim response data due 3Q 2018.
|
| RDUS |
$17.93
-0.9 -4.78%
|
AB122
Solid tumors
|
Phase 1 |
3Q 2018
Phase 1 data due 3Q 2018.
|
| VKTX |
$18.20
-0.77 -4.06%
|
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.
|
| ALNY |
$94.57
-0.64 -0.67%
|
Givosiran
Acute hepatic porphyrias
|
Phase 3 |
Late-September 2018
Phase 3 completion of enrollment announced August 21, 2018 with interim analysis due late-September 2018. Full data due early 2019.
|
| ALDX |
$9.10
+0.6 +7.06%
|
ADX-102
Dry eye syndrome
|
Phase 2b |
Late 3Q or early 4Q 2018.
Phase 2b data due late 3Q or early 4Q 2018.
|
| BOLD |
$37.65
-2.03 -5.12%
|
AT132 - ASPIRO
X-Linked Myotubular Myopathy
|
Phase 1/2 | |
| PRTK |
$9.65
+0.4 +4.32%
|
Omadacycline
Community-acquired bacterial pneumonia (CABP)
|
PDUFA priority review | |
| PRTK |
$9.65
+0.4 +4.32%
|
Omadacycline
Acute bacterial skin and skin structure infections (ABSSSI)
|
PDUFA priority review | |
| RHHBY |
$30.62
+0.02 +0.07%
|
Hemlibra
Hemophilia
|
PDUFA priority review | |
| VSTM |
$8.65
-0.1 -1.14%
|
Duvelisib - DUO
Chronic lymphocytic leukemia (CLL)//Small Lymphocytic Lymphoma (SLL)/Follicular Lymphoma
|
PDUFA priority review | |
| PLX |
$0.72
+0.12 +20.83%
|
Pegunigalsidase alfa (PRX-102)
Fabry disease
|
Phase 3 |
10/05/2018 10:15 am ET
Phase 3 open label preliminary data to be presented October 5 at 10:15 am ET.
|
| BHC |
$24.92
-0.09 -0.36%
|
IDP-122
Psoriasis
|
PDUFA | |
| IONS |
$49.14
-1.66 -3.27%
|
Inotersen (IONIS-TTRRx)
NEURO-TTR - familial amyloid polyneuropathy (FAP).
|
PDUFA priority review | |
| PTCT |
$45.14
-1.17 -2.53%
|
Inotersen (IONIS-TTRRx)
NEURO-TTR - familial amyloid polyneuropathy (FAP).
|
PDUFA priority review | |
| AKCA |
$27.98
-0.94 -3.25%
|
Inotersen (IONIS-TTRRx)
NEURO-TTR - familial amyloid polyneuropathy (FAP).
|
PDUFA priority review | |
| MRK |
$71.10
+0.32 +0.45%
|
GARDASIL 9
Human Papilloma virus vaccine
|
PDUFA priority review | |
| TRVN |
$1.72
+0.08 +4.88%
|
Oliceridine (TRV130)
Moderate to severe acute pain
|
PDUFA |
Advisory Committee 10/11/2018; PDUFA 11/02/2018
PDUFA date November 2, 2018. Advisory Committee Meeting October 11, 2018.
|
| ACRX |
$3.95
+0.25 +6.76%
|
DSUVIA (ARX-04)
Moderate-to-severe acute pain following a surgical procedure
|
PDUFA |
Advisory Committee 10/12/2018; PDUFA 11/03/2018
CRL issued October 12, 2017. New PDUFA date November 3, 2018 with Advisory Committee Meeting October 12, 2018.
|
| NVS |
$85.46
-0.51 -0.59%
|
AIN457 (Cosentyx)
Psoriatic arthritis
|
Phase 3 | |
| TSRO |
$37.69
-0.12 -0.32%
|
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 |
$159.27
+0.01 +0.01%
|
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 |
$2.86
-0.03 -1.04%
|
Tivozanib + Opdivo
Renal cell cancer (RCC)
|
Phase 1/2 |
ESMO October 2018
Phase 2 data due at ESMO October 2018.
|
| DCPH |
$38.97
-0.34 -0.86%
|
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 |
$19.00
-0.36 -1.86%
|
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 |
$0.98
-0.1 -9.26%
|
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.
|
| CTMX |
$18.07
-0.77 -4.09%
|
CX 072
Solid tumors
|
Phase 1/2 |
ESMO October 2018
Phase 1/2 initial data released at ASCO 2018. 15% ORR. Update due ESMO October 19-23, 2018.
|
| NTGN |
$7.60
-0.47 -5.82%
|
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 |
$9.06
-0.18 -1.95%
|
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 |
$9.16
+0.43 +4.93%
|
Pegzilarginase (AEB1102)
Solid tumors
|
Phase 1 |
ESMO October 2018
Phase 1 data to be presented at ESMO October 19-23, 2018.
|
| PRTK |
$9.65
+0.4 +4.32%
|
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 |
$191.31
-1.2 -0.62%
|
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 |
$3.50
-0.05 -1.41%
|
CMB305
Cancer - soft tissue sarcoma
|
Phase 2 |
ESMO October 2018
Phase 2 monotherapy data due at ESMO October 2018.
|
| EPZM |
$10.25
-0.2 -1.91%
|
Tazemetostat
Epithelioid Sarcoma
|
Phase 2 |
ESMO October 19-23, 2018.
Phase 2 data due 2H 2018.
|
| KURA |
$17.10
+0.1 +0.59%
|
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 |
$15.65
-0.35 -2.19%
|
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 |
$390.28
+3.03 +0.78%
|
Dupixent (dupilumab) - LIBERTY ASTHMA QUEST
Asthma
|
PDUFA | |
| SNY |
$43.55
-0.6 -1.36%
|
Dupixent (dupilumab) - LIBERTY ASTHMA QUEST
Asthma
|
PDUFA | |
| NCNA |
$22.41
-1.37 -5.76%
|
NUC-1031 (Acelarin)
Front-Line Treatment of Advanced Biliary Tract Cancer
|
Phase 1b | |
| MRTX |
$59.30
-0.95 -1.58%
|
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 |
$32.38
-0.1 -0.31%
|
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.
|
| NCNA |
$22.41
-1.37 -5.76%
|
NUC-3373
Solid tumors
|
Phase 1 | |
| MRTX |
$59.30
-0.95 -1.58%
|
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.
|
| ADMA |
$6.15
-0.42 -6.39%
|
BIVIGAM
Primary humoral immunodeficiency
|
PDUFA | |
| JAZZ |
$163.78
-0.58 -0.35%
|
Xyrem
Pediatric narcolepsy patients with cataplexy
|
PDUFA priority review | |
| BTX |
$2.63
+0.15 +6.05%
|
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 |
$69.35
-2.2 -3.07%
|
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 |
$6.62
-0.13 -1.93%
|
TX-001HR
Moderate to severe vasomotor symptoms (VMS)
|
PDUFA | |
| REGN |
$390.28
+3.03 +0.78%
|
Cemiplimab
Cutaneous squamous cell carcinoma
|
PDUFA priority review | |
| SNY |
$43.55
-0.6 -1.36%
|
Cemiplimab
Cutaneous squamous cell carcinoma
|
PDUFA priority review | |
| MRK |
$71.10
+0.32 +0.45%
|
KEYTRUDA + carboplatin-paclitaxel or nab-paclitaxel KEYNOTE-407
Squamous non-small cell lung cancer (sNSCLC)
|
PDUFA priority review | |
| XLRN |
$56.66
-1.81 -3.10%
|
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 |
$11.37
-0.21 -1.81%
|
Serlopitant
Refractory chronic cough
|
Phase 2 |
October 2018
Phase 2 data due October 2018.
|
| AZRX |
$2.65
+0.16 +6.43%
|
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 |
$10.17
-0.23 -2.21%
|
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 |
$56.62
-2.18 -3.71%
|
Trilaciclib plus Tecentriq
First-line small-cell lung cancer
|
Phase 2 |
ESMO October 2018.
Phase 2 data to be presented at ESMO October 2018. Myelopreservation results due 4Q 2018.
|
| ESPR |
$43.16
-2.59 -5.66%
|
Bempedoic acid - CLEAR LDL-C Lowering Program 1002-047
Hypercholesterolemia
|
Phase 3 |
October 2018
Phase 3 data due October, 2018.
|
| SNGX |
$1.54
-0.01 -0.65%
|
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 |
$5.97
+0.06 +1.02%
|
FMX103
Papulopustular rosacea
|
Phase 3 |
Early 4Q 2018
Phase 3 top-line data due early 4Q 2018.
|
| EGRX |
$67.39
-1.62 -2.35%
|
Fulvestrant
Breast cancer
|
Phase 3 |
Fall 2018
Pivotal trial initiation announced December 7, 2017. Data due fall of 2018.
|
| EARS |
$0.29
-0.01 -2.57%
|
AM-125
Vertigo
|
Phase 1 |
October 2018
Phase 1 data due October 2018.
|
| ALT |
$26.19
-0.04 -0.15%
|
HepTCell
Hepatitis B
|
Phase 1 |
Early 4Q 2018
Phase 1 data due early 4Q 2018.
|
| NVS |
$85.46
-0.51 -0.59%
|
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.
|
| CHRS |
$15.95
-0.4 -2.45%
|
CHS-1701
Pegfilgrastim biosimilar
|
PDUFA | |
| THERF |
$6.82
-0.08 -1.13%
|
Single vial formulation of EGRIFTA
Reduction of abdominal fat in HIV- patients
|
PDUFA | |
| EYPT |
$2.60
+0.1 +4.00%
|
YUTIQ
Non-infectious uveitis
|
PDUFA | |
| TSRO |
$37.69
-0.12 -0.32%
|
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 |
$37.69
-0.12 -0.32%
|
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 |
$59.00
+0.56 +0.96%
|
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.
|
| BMY |
$62.25
+0.5 +0.81%
|
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.
|
| MRK |
$71.10
+0.32 +0.45%
|
Keytruda - KEYNOTE-224
Hepatocellular carcinoma (HCC)
|
PDUFA priority review | |
| CRVS |
$8.86
-0.56 -5.94%
|
CPI-444
Solid tumors - cancer
|
Phase 1b |
SITC November 9-11, 2018
Phase 2 data due at SITC November 9-11, 2018.
|
| ARWR |
$17.77
-1.11 -5.88%
|
ARO-AAT
Healthy volunteers
|
Phase 1 |
11/09/18 - 11/03/18
Phase 1 completion of dosing announced August 31, 2018. Initial data due at AASLD meeting November 9-13, 2018.
|
| VKTX |
$18.20
-0.77 -4.06%
|
VK2809
Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
|
Phase 2 |
11/9/2018-11/13/2018
Phase 2 data released September 18, 2018 met primary and secondary endpoints. Data to be presented at AASLD November 9-13, 2018.
|
| ARWR |
$17.77
-1.11 -5.88%
|
ARO-HBV
Hepatitis B (HBV)
|
Phase 1/2 |
November 9-13, 2018
Phase 1/2 completion of dosing in for single dose portion of trial announced May 30, 2018. Initial data due at Liver Meeting November 9-13, 2018.
|
| MDGL |
$211.38
-5.32 -2.46%
|
MGL-3196
Non-alcoholic steatohepatitis (NASH)
|
Phase 2 |
11/12/2018 8:15 AM
Phase 2 top-line data released December 6, 2017 - primary endpoint met. Top-line 36-week data released May 31, 2018 also met primary endpoint. Presentation of data November 12, 2018, at 8:15 AM.
|
| TBPH |
$29.04
+0.89 +3.16%
|
Revefenacin
COPD
|
PDUFA | |
| MYL |
$38.99
+0.26 +0.67%
|
Revefenacin
COPD
|
PDUFA | |
| NVS |
$85.46
-0.51 -0.59%
|
Adalimumab
Rheumatoid Arthritis
|
PDUFA |
Nov 16, 2018 est only
BLA filing acceptance announced January 16, 2018. No PDUFA date given - estimate November 16, 2018.
|
| CPRX |
$3.15
+0.01 +0.32%
|
Firdapse
Lambert-Easton Myasthenic Syndrome (LEMS)
|
PDUFA priority review | |
| PFE |
$44.06
+0.31 +0.71%
|
Lorlatinib
ALK+ NSCLC
|
PDUFA |
November 2018
PDUFA date November 2018.
|
| CBIO |
$10.17
-0.23 -2.21%
|
Marzeptacog alfa
Hemophilia
|
Phase 2/3 |
ASH 2018
Phase 2 interim data released July 18, 2018. Final Phase 2 data due at ASH 2018.
|
| BLUE |
$140.35
-1.55 -1.09%
|
LentiGlobin - HGB-206
Sickle disease
|
Phase 1/2 |
ASH 2018
Data due at ASH December 2018.
|
| MOR |
$26.81
-0.91 -3.28%
|
Lenalidomide + MOR208 - L-MIND
Relapsed or refractory diffuse large B cell lymphoma
|
Phase 2 |
ASH December 2018
Phase 2 data due at ASH December 2018 with final data due mid-2019.
|
| BLUE |
$140.35
-1.55 -1.09%
|
LentiGlobin - HGB-207 Northstar-2
non-β0/β0 transfusion-dependent thalassemia (TDT)
|
Phase 3 |
ASH 2018
Data due at ASH December 2018.
|
| SNSS |
$2.11
+0.1 +4.98%
|
SNS-062
Advanced B-Cell Malignancies
|
Phase 1/2 |
ASH December 2018
Phase 1/2 update at ASH December 2018.
|
| AGIO |
$73.56
-0.41 -0.55%
|
Ivosidenib or enasidenib
Frontline AML with IDH1 or IDH2 mutation
|
Phase 1 |
ASH 2018
Phase 1 first data presented at ASH 2017 with updated data due at ASH 2018. Phase 3 trial to be initiated 4Q 2018.
|
| BLUE |
$140.35
-1.55 -1.09%
|
LentiGlobin - HGB-212
TDT and the β0/β0genotype
|
Phase 3 |
ASH 2018
Phase 3 first patient treated - noted November 16, 2017. Data due at ASH 2018.
|
| RHHBY |
$30.62
+0.02 +0.07%
|
TECENTRIQ (atezolizumab) - IMpower150
Non-squamous non-small cell lung cancer (NSCLC)
|
Phase 3 | |
| PFE |
$44.06
+0.31 +0.71%
|
Talazoparib
BRCA-mutated breast cancer
|
PDUFA priority review |
12/7/2018 estimate only
PDUFA date under priority review December 2018. Exact date not provided. Estimate December 7, 2018 based on 6-month timeline.
|
| SAGE |
$146.01
-1.03 -0.70%
|
Brexanolone - SAGE-547 (202C)
Postpartum Depression - moderate
|
PDUFA priority review | |
| JAZZ |
$163.78
-0.58 -0.35%
|
JZP-110
Excessive sleepiness associated with narcolepsy
|
PDUFA | |
| SUPN |
$48.90
-1 -2.00%
|
Oxtellar XR
Epilepsy
|
PDUFA |
December 2018
sNDA to expand label to include monotherapy treatment. PDUFA date by the end of December 2018. NO EXACT DATE GIVEN.
|
| RHHBY |
$30.62
+0.02 +0.07%
|
Baloxavir marboxil
Influenza
|
PDUFA priority review | |
| BMY |
$62.25
+0.5 +0.81%
|
Empliciti (elotuzumab) - ELOQUENT-3
Relapsed/refractory multiple myeloma
|
PDUFA priority review | |
| PFE |
$44.06
+0.31 +0.71%
|
Glasdegib
Acute myeloid leukemia (AML)
|
PDUFA priority review | |
| OCUL |
$6.45
+0.02 +0.31%
|
DEXTENZA
Ocular inflammation and pain following cataract surgery
|
PDUFA | |
| MRK |
$71.10
+0.32 +0.45%
|
Keytruda KN-17
Merkel Cell Carcinoma
|
PDUFA priority review | |
| BMY |
$62.25
+0.5 +0.81%
|
Sprycel (dasatinib)
Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
|
PDUFA | |
| ACHN |
$3.51
-0.03 -0.85%
|
ACH-4471
C3 glomerulopathy (C3G)
|
Phase 2 |
December 2018
Phase 2 interim data due December 2018.
|
| SYRS |
$12.92
+0.15 +1.17%
|
SY-1425
Relapsed or refractory Acute myeloid leukemia (AML) and relapsed high-risk Myelodysplastic Syndrome (MDS) - cancer
|
Phase 2 |
4Q 2018
Phase 2 data at ASH showed 1 complete response from 48 patients. Initial data from combination arms due 4Q 2018.
|
| CASI |
$5.70
+0.01 +0.18%
|
ENMD-2076
Cancer - fibrolamellar carcinoma (FLC)
|
Phase 2 |
2018
Phase 2 initiated October 2015. Data due 2018.
|
| ATHX |
$1.94
+0.08 +4.30%
|
Multistem
Acute Respiratory Distress Syndrome
|
Phase 1/2 |
2018
Phase 1/2 trial to be completed in 2018.
|
| AXSM |
$3.25
+0.00%
|
AXS-05 ASCEND
Major Depressive Disorder
|
Phase 2 |
4Q 2018
Phase 2 data due 4Q 2018.
|
| DVAX |
$12.00
-0.2 -1.64%
|
SD-101
Low-grade, B cell lymphoma
|
Phase 1/2 |
2H 2018
Phase 1/2 updated data due 2H 2018 with Phase 3 trial to be initiated YE 2018.
|
| EIGR |
$11.60
-0.25 -2.11%
|
Ubenimex - ULTRA
Secondary lymphedema
|
Phase 2 |
2H 2018
Phase 2 data due 2H 2018.
|
| BPMC |
$69.61
-2.01 -2.81%
|
Avapritnib BLU-285 - NAVIGATOR
PDGFRα driven Gastrointestinal stromal tumors (GIST)
|
Phase 1 |
2H 2018
Phase 1 updated data due 2H 2018 with potential NDA filing 1H 2019.
|
| BYSI |
$25.00
+0.00%
|
Plinabulin (Trial 105)
Chemotherapy-induced neutropenia (CIN)
|
Phase 2/3 |
4Q 2018
Phase 3 initiation announced March 19, 2018. Interim data due 4Q 2018.
|
| HALO |
$17.53
+0.27 +1.56%
|
Eribulin In Combination With PEGPH20
High-Hyaluronan (HA) HER2-negative breast cancer
|
Phase 1/2 |
2H 2018
Phase 1/2 initiated July 2016. Data due 2H 2018. No further clinical development planned on the Phase 2 portion of study
|
| EIGR |
$11.60
-0.25 -2.11%
|
Exendin 9-39
Post-Bariatric Hypoglycemia (PBH)
|
Phase 2 |
2H 2018
Phase 2 completion of enrollment announced August 13, 2018 with top-line data due 2H 2018.
|
| VNDA |
$20.10
+0.05 +0.25%
|
Tradipitant
Gastroparesis
|
Phase 2 |
YE 2018
Phase 2 data due by end of 2018.
|