FDA Calendar

Biotech Stock Catalyst and FDA Calendar for your biotech stock investing. Use our tools on your road to profit in the stock market. Biotech stocks with key binary events/catalysts - FDA Approval/PDUFA dates, Advisory Committee and Phase 2 & 3 trial data releases dates are noted. Phase 1 catalysts for small-cap companies only are listed.

Refer to the FDA Calendar Glossary for a list of terms used in the FDA Decision Calendar and the Biotech Historical Catalyst Calendar for completed biotech stock catalysts.

NOTE: LARGE CAP CATALYSTS - generally only Phase 3 catalysts noted in company presentations and/or earnings releases are shown. Only NASDAQ and NYSE stocks are covered. Stocks listed on PINK/OTC exchanges are not covered.

The dates shown are provided by companies. A regulatory event, for example a PDUFA date or Advisory Committee Meeting, will be issued with an exact date by the FDA. However, most clinical release dates (i.e. Phase 1/2/3) are provided in a range format by companies (e.g, mid-2019 or 4Q 2019). Exact dates for clinical data releases are only rarely issued.

Click on the date for the source of the catalyst. Financial data are delayed 15-25 minutes.

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The public FDA Calendar is limited to 150 events in chronological order. The full calendar of approximately 1000 events is available to PREMIUM MEMBERS.

Showing 150 drugs
Ticker
Price
Drug
Stage
Catalyst
Ticker Price Drug Stage Catalyst
IPCIF
$0.18
+0.01  +3.17%
Rexista
Pain relief
PDUFA
CRL issued September 25, 2017. NDA resubmitted with new PDUFA date of August 28, 2019. Noted July 26, 2019 that PDUFA date will be delayed. No updated date provided.
NKTR
$20.00
-0.1  -0.50%
NKTR-181
Lower back pain
PDUFA
PDUFA date August 29, 2019. Company noted the date will not be met due to the postponement of an advisory committee meeting.
VTVT
$1.59
-0.13  -7.56%
TTP399
Type 1 Diabetes
Phase 1/2
Phase 1/2 new data to be presented September 18, 2019 1:15pm CEST. (Part 2) data due 1Q 2020.
MRK
$83.97
+0.95  +1.15%
DELSTRIGO (doravirine/lamivudine/tenofovir disoproxil fumarate)
HIV
PDUFA
PDUFA date for sNDA September 20, 2019.
NVO
$51.81
+0.84  +1.65%
Semaglutide - oral - PIONEER
Type 2 diabetes
PDUFA priority review
NDA filing announced March 20, 2019. Estimated PDUFA date September 20, 2019 assuming 6-month priority review.
MRK
$83.97
+0.95  +1.15%
PIFELTRO (doravirine)
HIV
PDUFA
FDA Approval announced August 30, 2018. PDUFA date for sNDA September 20, 2019.
LPTX
$1.48
  +-0.06%
DKN-01 and Paclitaxel
Endometrial Cancer
Phase 2
Phase 2 updated data due September 20, 2019 at IGCS.
URGN
$36.16
-0.08  -0.22%
VesiGel UGN-102
Low grade non-muscle invasive bladder cancer (LG-NMIBC)
Phase 2b
Phase 2b initial data due September 24, 2019.
RYTM
$24.30
+0.17  +0.70%
Setmelanotide (basket)
POMC Heterozygous Deficiency Obesity, Alstrom Syndrome, POMC Epigenetic Disorders
Phase 2
Phase 2 update due September 25, 2019.
JNJ
$130.68
+0.27  +0.21%
Daratumumab + VTD
Multiple myeloma - candidates for autologous stem cell transplant (ASCT)
PDUFA priority review
PDUFA date September 26, 2019.
GMAB
$20.36
-0.13  -0.63%
Daratumumab + VTD
Multiple myeloma - candidates for autologous stem cell transplant (ASCT)
PDUFA priority review
PDUFA date September 26, 2019.
JNJ
$130.68
+0.27  +0.21%
INVOKANA - CREDENCE
Diabetic Kidney Disease
PDUFA priority review
sNDA filing announced March 28, 2019. Priority review announced May 22, 2019. Estimated PDUFA date September 27, 2019.
ARAV
$7.77
+0.83  +11.96%
AVB-S6-500
Ovarian cancer
Phase 1b
Phase 1b presentation at ESMO September 27, 2019, 4:15pm CEST.
TROV
$1.77
+0.06  +3.51%
Onvansertib (PCM-075)
Acute Myeloid Leukemia (AML)
Phase 1/2
Phase 1/2 presentation at ESMO September 27, 2019.
INCY
$78.44
-0.1  -0.13%
Pemigatinib (FIGHT-202)
Cholangiocarcinoma
Phase 2
NDA filing to be submitted 2H 2019. Phase 2 data to be presented at ESMO September 27, 2019, 9am ET.
AVXL
$3.36
+0.1  +3.07%
ANAVEX 2-73
Rett syndrome
Phase 2
Phase 2 preliminary data to be presented September 27-28 at European Rett Syndrome Conference.
AZN
$44.58
+1.01  +2.32%
Lynparza + Avastin- PAOLA-1
First-line ovarian cancer
Phase 3
Phase 3 data met primary endpoint - August 14, 2019. Presentation at ESMO September 28, 2019, 16:42 CEST.
MRK
$83.97
+0.95  +1.15%
Lynparza + Avastin- PAOLA-1
First-line ovarian cancer
Phase 3
Phase 3 data met primary endpoint - August 14, 2019. Presentation at ESMO September 28, 2019, 16:42 CEST.
AMGN
$195.66
+0.62  +0.32%
AMG 510
Solid tumors
Phase 1
Phase 1 presentation at ESMO September 28, 2019, 4:52pm CEST.
ASLN
$1.91
-0.04  -2.05%
Varlitinib + mFOLFIRI
Solid tumors
Phase 1
Phase 1 presentation due at ESMO September 28, 2019.
GSK
$41.41
+0.34  +0.84%
Niraparib - PRIMA
First-line ovarian cancer
Phase 3
Phase 3 data released July 15, 2019 met primary endpoint. Presentation at ESMO September 28, 2019, 4:30pm CEST.
ZLAB
$34.50
+0.12  +0.35%
Niraparib - PRIMA
First-line ovarian cancer
Phase 3
Phase 3 data released July 15, 2019 met primary endpoint. Presentation at ESMO September 28, 2019, 4:30pm CEST.
GTHX
$35.75
+0.2  +0.56%
Trilaciclib
Triple-negative breast cancer
Phase 2
Phase 2 data to be presented at ESMO September 28, 2019, 11:06am CEST.
CALA
$3.85
-0.12  -3.02%
CB-839 + AFINITOR (everolimus)‎ - ENTRATA
Clear cell renal cell carcinoma
Phase 2
Phase 2 data to be presented at ESMO September 28, 2019, 8:30am CET.
SGEN
$73.20
+0.37  +0.51%
Enfortumab vedotin and pembrolizumab
2nd-line Urothelial cancer
Phase 1b
Phase 1 initial data due at ESMO September 28, 8:30a.m. CEST.
IMMU
$17.30
+0.39  +2.31%
SACITUZUMAB GOVITECAN - TROPHY U-01
Urothelial cancer
Phase 2
Phase 1/2 interim data to be presented at ESMO September 28, 2019.
CKPT
$2.40
+0.04  +1.69%
Cosibelimab - CK-301
Lung and other solid tumors
Phase 1
Phase 1 updated data due at ESMO September 28, 2019, 12noon CEST.
ALRN
$0.94
-0.01  -1.39%
ALRN-6924 and IBRANCE (palbociclib)
Solid tumors
Phase 2a
Phase 2a preliminary data due at ESMO Sept 28, 2019 with final data due 2H 2020.
GNCA
$3.56
-0.02  -0.58%
GEN-009 vaccine
Various cancers
Phase 1/2
Phase 1/2 additional immunogenicity data due at ESMO September 28, 2019. Preliminary data due mid-2020
ABBV
$71.68
+0.41  +0.58%
Veliparib
Ovarian cancer
Phase 3
Phase 3 presentation at ESMO 28 September 2019, 5:08pm.
AZN
$44.58
+1.01  +2.32%
Tagrisso and Lerociclib (G1T38)
EGFR mutation-positive non-small cell lung cancer (NSCLC)
Phase 1/2
Phase 1/2 poster at ESMO September 28, 2019, 12pm CEST.
GTHX
$35.75
+0.2  +0.56%
Tagrisso and Lerociclib (G1T38)
EGFR mutation-positive non-small cell lung cancer (NSCLC)
Phase 1/2
Phase 1/2 poster at ESMO September 28, 2019, 12pm CEST.
ZYME
$26.07
+0.23  +0.91%
ZW25
HER2-expressing Cancers - ovarian, breast, gastric
Phase 1
Phase 1 updated data due at ESMO September 28, 2019, 5:36pm CEST. Phase 2 trial initiation announced April 15, 2019.
NVS
$86.53
+0.25  +0.29%
Kisqali plus fulvestrant: MONALEESA-3
Breast cancer - (post-menopausal)
Phase 3
Phase 3 data presented at ASCO 2018 - PFS 20.5 months v 12.8 months. Overall survival secondary endpoint met - July 31, 2019. Presentation at ESMO September 29, 2019; 4:45pm.
INCY
$78.44
-0.1  -0.13%
INCB001158
Solid tumors
Phase 1/2
Phase 1/2 data due at ESMO September 29, 2019.
CALA
$3.85
-0.12  -3.02%
INCB001158
Solid tumors
Phase 1/2
Phase 1/2 data due at ESMO September 29, 2019.
GTHX
$35.75
+0.2  +0.56%
Trilaciclib plus Tecentriq
First-line small-cell lung cancer
Phase 2
Phase 2 additional data due at ESMO September 29, 2019, 9:20am CEST.
GTHX
$35.75
+0.2  +0.56%
G1T48
ER+, HER2- breast cancer
Phase 1/2
Phase 1/2 preliminary data due at ESMO September 29, 2019 12pm CEST.
AZN
$44.58
+1.01  +2.32%
Tagrisso - FLAURA
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3 final OS data released August 9, 2019. Endpoint met. Presentation at ESMO September 29, 2019, 4:30pm CEST.
MRK
$83.97
+0.95  +1.15%
Keytruda KN-522
Triple negative breast cancer (TNBC)
Phase 3
Phase 3 data released July 29, 2019. First of two primary endpoints met (complete response). Trial to continue through to event-free survival (EFS) endpoint. Presentation at ESMO September 29, 2019, 5:15PM.
IMGN
$3.13
-0.02  -0.63%
Mirvetuximab soravtansine - FORWARD II
Ovarian cancer and relapsed endometrial cancer
Phase 1/2
Phase 1b/2 initial data due at ESMO September 29, 2019, 12noon CEST.
CLVS
$4.89
-0.25  -4.86%
Rucaparib - TRITON2
Castrate-resistant prostate cancer (mCRPC)
Phase 2
Phase 2 updated data due at ESMO September 29, 2019.
SGEN
$73.20
+0.37  +0.51%
Tucatinib - MOUNTAINEER
HER2 amplified metastatic colorectal cancer
Phase 2
Phase 2 poster at ESMO September 29, 3:00p.m. CEST.
RHHBY
$35.67
+0.38  +1.08%
Alecensa - ALEX
Anaplastic lymphoma kinase (ALK)-positive metastatic (advanced) non-small cell lung cancer (NSCLC)
Phase 3
Phase 3 updated data due at September 29, 2019
TYME
$1.71
+0.04  +2.40%
SM-88
Pancreatic cancer
Phase 2
Phase 2 presentation at ESMO September 29, 2019. 12:00 PM CET.
ZEAL
$24.88
  +0.00%
Dasiglucagon
Severe hypoglycemia in diabetes - children
Phase 3
September 2019
Phase 3 data due September 2019.
NVS
$86.53
+0.25  +0.29%
QVM149
Asthma
Phase 3
3Q 2019
Phase 3 trial to be completed 3Q 2019.
FPRX
$5.36
+0.02  +0.37%
FPA150
Solid tumors
Phase 1
Phase 1b initial data due at ESMO September 30, 2019.
GILD
$66.16
+0.44  +0.67%
Filgotinib and GS-9876
Sjogren’s syndrome
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
MRNS
$1.45
-0.12  -7.66%
Ganaxolone
Refractory status epilepticus (RSE)
Phase 2
3Q 2019
Data due by the end of 3Q 2019.
LGND
$101.53
+2.26  +2.28%
Ganaxolone
Refractory status epilepticus (RSE)
Phase 2
3Q 2019
Data due by the end of 3Q 2019.
GLPG
$160.27
+2.16  +1.37%
Filgotinib and GS-9876
Cutaneous lupus erythematosus (CLE)
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
GILD
$66.16
+0.44  +0.67%
Filgotinib and GS-9876
Cutaneous lupus erythematosus (CLE)
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
AGIO
$36.56
+0.06  +0.16%
AG-120 Ivosidenib
IDH1 mutant positive cholangiocarcinoma - cancer
Phase 3
Phase 3 data released May 15, 2019 met primary endpoint. Data to be presented at ESMO September 30, 2019, 4:30pm CEST.
EARS
$3.06
-0.02  -0.74%
AM-201
Healthy volunteers
Phase 1b
Late 3Q 2019
Phase 1b top-line data due late-3Q 2019.
RETA
$91.59
+1.43  +1.59%
RTA 1701
Healthy Volunteers
Phase 1
3Q 2019
Phase 1 initiation announced June 20, 2018. Initial data due 2Q 2019. Timeline missed. Estimate 3Q.
OSMT
$3.56
-0.04  -1.11%
RVL-1201
Blepharoptosis
NDA Filing
3Q 2019
NDA filing due 3Q 2019.
GILD
$66.16
+0.44  +0.67%
GS-9131
HIV
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
IMMP
$1.62
+0.14  +9.60%
Eftilagimod alpha and Keytruda - TACTI-002
Non-small cell lung cancer; Head and neck cancer
Phase 2
3Q 2019
Phase 2 initial data due 3Q 2019.
ZGNX
$41.77
+0.19  +0.46%
FINTEPLA (ZX008)
Dravet syndrom
NDA Filing
September 2019
Refusal to file Letter (RTF) issued April 8, 2019. Intends to resubmit NDA in September 2019.
ALNY
$85.25
-0.24  -0.28%
Inclisiran - ORION-9
Hypercholesterolemia
Phase 3
Latter half of 3Q 2019
Phase 3 data due second half of 3Q 2019.
MDCO
$47.98
+0.65  +1.37%
Inclisiran - ORION-9
Hypercholesterolemia
Phase 3
Latter half of 3Q 2019
Phase 3 data due second half of 3Q 2019.
JAGX
$1.38
-0.08  -5.55%
Mytesi (crofelemer) HALT-D
Cancer related diarrhea (CRD)
Phase 2
3Q 2019
Phase 2 interim data due 3Q 2019 with final data due 1Q 2020.
RHHBY
$35.67
+0.38  +1.08%
Mytesi (crofelemer) HALT-D
Cancer related diarrhea (CRD)
Phase 2
3Q 2019
Phase 2 interim data due 3Q 2019 with final data due 1Q 2020.
ENTX
$2.46
-0.12  -4.47%
EB612
Hypoparathyroidism
Phase 2b
September 2019
Phase 2b results to be presented September 2019.
SRPT
$83.96
+0.29  +0.35%
Casimersen (SRP-4045) - ESSENCE
Duchenne muscular dystrophy
NDA Filing
3Q 2019
NDA filing due 3Q 2019.
GLPG
$160.27
+2.16  +1.37%
Filgotinib
Rheumatoid arthritis (RA)
NDA Filing
3Q 2019
NDA filing due 3Q 2019.
GILD
$66.16
+0.44  +0.67%
Filgotinib
Rheumatoid arthritis (RA)
NDA Filing
3Q 2019
NDA filing due 3Q 2019.
ENTA
$71.12
+0.42  +0.59%
EDP-305 ARGON-1
Non-alcoholic steatohepatitis (NASH)
Phase 2
3Q 2019
Phase 2 initial data due 3Q 2019.
VNDA
$13.42
+0.23  +1.74%
HETLIOZ (tasimelteon)
Smith-Magenis Syndrome
sNDA Filing
3Q 2019
sNDA filing due 3Q 2019.
AQST
$3.42
-0.07  -2.01%
AQST-108
Anaphylaxis
Phase 1
3Q 2019
Phase 1 data due 3Q 2019.
IGXT
$0.53
+0.02  +3.92%
RIZAPORT (RHB-103)
Migraine
NDA Filing
3Q 2019
NDA to be resubmitted 3Q 2019.
AGTC
$3.80
  +0.00%
AAV-based gene therapy
X-linked Retinitis Pigmentosa (XLRP)
Phase 1/2
3Q 2019
Phase 1/2 dose escalation data due 3Q 2019. Expansion data due 4Q 2019.
DCPH
$35.67
-0.24  -0.67%
Ripretinib DCC-2618 - INVICTUS
Gastrointestinal Stromal Tumors (GIST) - fourth-line
Phase 3
Phase 3 data met PFS primary endpoint - August 13, 2019. Secondary ORR endpoint not achieved. Presentation at ESMO September 30, 2019, 2:25pm CEST.
ZLAB
$34.50
+0.12  +0.35%
Ripretinib DCC-2618 - INVICTUS
Gastrointestinal Stromal Tumors (GIST) - fourth-line
Phase 3
Phase 3 data met PFS primary endpoint - August 13, 2019. Secondary ORR endpoint not achieved. Presentation at ESMO September 30, 2019, 2:25pm CEST.
MRK
$83.97
+0.95  +1.15%
Pembrolizumab vs chemotherapy
Malignant pleural mesothelioma (MPM)
Phase 3
Phase 3 data to be presented at ESMO September 30, 2019, 10:15am CEST.
ATOS
$2.08
+0.07  +3.48%
Endoxifen
Healthy volunteers
Phase 1
3Q 2019
Phase 1 data due within 30 days - noted September 3, 2019.
NERV
$8.45
+0.03  +0.36%
MIN-202 (seltorexant) vs quetiapine
Major Depressive Disorder
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
ANAB
$42.47
-0.19  -0.45%
ANB019
Generalized pustular psoriasis
Phase 2
3Q 2019
Phase 2 data due mid-2019.
ALNY
$85.25
-0.24  -0.28%
Inclisiran - ORION-10
Cardiovascular disease (ASCVD)
Phase 3
Second half of 3Q 2019
Phase 3 data due second half of 3Q 2019.
MDCO
$47.98
+0.65  +1.37%
Inclisiran - ORION-10
Cardiovascular disease (ASCVD)
Phase 3
Second half of 3Q 2019
Phase 3 data due second half of 3Q 2019.
AZRX
$1.02
+0.02  +2.00%
MS1819-SD (OPTION)
Cystic fibrosis
Phase 2
September 2019
Phase 2 data due September 2019.
CTIC
$0.85
-0.01  -0.85%
Pacritinib - PAC203
Myelofibrosis
Phase 2/3
3Q 2019
Phase 2 data to be presented 3Q 2019 with Phase 3 trial to commence also in 3Q 2019 with data due mid-2021.
AZN
$44.58
+1.01  +2.32%
Lynparza
Castration-Resistant Prostate Cancer
Phase 3
Phase 3 trial met primary endpoint. Presentation at ESMO September 30, 2019, 5:09pm CEST.
MRK
$83.97
+0.95  +1.15%
Lynparza
Castration-Resistant Prostate Cancer
Phase 3
Phase 3 trial met primary endpoint. Presentation at ESMO September 30, 2019, 5:09pm CEST.
BFRA
$14.00
  +0.00%
Ameluz
Actinic keratosis
sNDA Filing
3Q 2019
Phase 3 data met primary endpoint - March 20, 2019. sNDA filing due 3Q 2019.
TYME
$1.71
+0.04  +2.40%
SM-88
Prostate cancer
Phase 2
Phase 2 presentation at ESMO September 30, 2019. 12:00 PM CET.
ICPT
$70.42
+1.18  +1.70%
Ocaliva (Obeticholic acid (OCA)) - REGENERATE
Adult nonalcoholic steatohepatitis (NASH) patients.
NDA Filing
3Q 2019
NDA filing due 3Q 2019.
IONS
$62.62
-0.49  -0.78%
AKCEA-ANGPTL3-LRx
Rare hyperlipidemias
Phase 2
3Q 2019
Pilot study data due mid-2019.
AKCA
$22.01
+0.07  +0.32%
AKCEA-ANGPTL3-LRx
Rare hyperlipidemias
Phase 2
3Q 2019
Pilot study data due mid-2019.
OVID
$2.17
-0.09  -3.98%
OV935
Developmental and Epileptic Encephalopathies (dEE)
Phase 2
3Q 2019
Phase 2 open label data due 3Q 2019.
GILD
$66.16
+0.44  +0.67%
Axicabtagene ciloleucel - (ZUMA-2)
Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL) - cancer
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
XFOR
$14.03
-0.01  -0.11%
Mavorixafor and axitinib
Renal Cell Carcinoma (RCC) - cancer
Phase 2a
Phase 2a data to be presented at ESMO September 30, 2019; 8:45 AM CEST.
RARE
$43.69
+0.15  +0.34%
DTX301
Ornithine Transcarbamylase (OTC) Deficiency
Phase 1/2
3Q 2019
Phase 1/2 third cohort data due 3Q 2019.
BOLD
$31.02
+0.3  +0.98%
AT132 - ASPIRO
X-Linked Myotubular Myopathy
Phase 1/2
Phase 1/2 data to be presented at WMS October 1-5, 2019.
PIRS
$5.57
-0.02  -0.36%
PRS-060
Asthma
Phase 1
Phase 1 presentation at European Respiratory Society International Congress, October 1, 2019.
SVRA
$2.48
-0.04  -1.59%
Molgradex - IMPALA
Autoimmune pulmonary alveolar proteinosis (PAP)
Phase 3
Phase 3 data June 12, 2019 did not meet primary endpoint. Data to be presented at ERS October 2, 2019, 5:30 AM ET.
ENTA
$71.12
+0.42  +0.59%
EDP-938
Respiratory Syncytial Virus
Phase 2
Phase 2b trial to commence by end of 2019. Phase 2a new data to be presented at IDWeek October 3, 2019, 2:35pm.
GILD
$66.16
+0.44  +0.67%
F/TAF (Descovy)
Pre-exposure prophylaxis
PDUFA priority review
sNDA filed April 5, 2019. Likely PDUFA date under priority review of October 4, 2019.
CAPR
$2.92
+0.07  +2.46%
CAP-1002 HOPE-2
Duchenne Muscular Dystrophy (DMD)
Phase 2
Phase 2 expanded interim data due at the International Congress of the World Muscle Society October 5, 2019.
CLVLY
$17.54
-0.46  -2.56%
SCENESSE
Phototoxicity and anaphylactoid reactions in adult patients with erythropoietic protoporphyria (EPP)
PDUFA priority review
PDUFA date under priority review October 6, 2019.
PFNX
$9.99
+0.27  +2.77%
PF708 and Forteo
Osteoporosis
PDUFA
PDUFA date October 7, 2019.
AKTX
$1.91
-0.01  -0.52%
Coversin
Bullous Pemphigoid
Phase 2
Phase 2 further data due at EADV Congress, October 10, 2019.
RGNX
$40.19
+1.57  +4.08%
RGX-314
Wet age-related macular degeneration (wet AMD)
Phase 1/2
Phase 1/2a data due at AAO October 11, 2019, 4:18 p.m. PT. Phase 2b trial to be initiated late 2019.
RHHBY
$35.67
+0.38  +1.08%
MabThera/ Rituxan (rituximab)
Granulomatosis with polyangiitis (GPA) / microscopic polyangiitis (MPA)
PDUFA priority review
PDUFA date under priority review, sBLA accepted June 12, 2019. No PDUFA date released. Estimate October 11, 2019 assuming sBLA was filed two months prior to acceptance.
CNCE
$10.95
-0.05  -0.45%
CTP-543
Alopecia areata
Phase 2a
Phase 2 data to be presented at EADV October 12, 2019 at 9:15am GMT.
LCTX
$1.15
+0.15  +15.00%
OpRegen
Dry age-related macular degeneration (AMD)
Phase 1/2
Phase 1/2 updated data due at AAO October 12-15, 2019
JNJ
$130.68
+0.27  +0.21%
XARELTO (rivaroxaban)
Reduce the Risk of Recurrent Venous Thromboembolism (VTE)
PDUFA
Approval announced October 30, 2017. sNDA flled December 14, 2018. Estimated PDUFA date October 13, 2019.
FLXN
$14.87
+0.33  +2.27%
Zilretta - FX006 repeat
Osteoarthritis of the knee
PDUFA
PDUFA date for sNDA filing October 14, 2019.
NVS
$86.53
+0.25  +0.29%
RTH258 (brolucizumab)
Neovascular AMD
PDUFA priority review
PDUFA date under priority review estimated October 15, 2019 using six-month timeline. Exact date not provided by company.
CLSN
$1.74
  +0.00%
ThermoDox - OPTIMA
Hepatocellular carcinoma - liver cancer
Phase 3
Mid-October 2019
Phase 3 interim efficacy analysis due by mid-October 2019 with second interim analysis due 1H 2020.
AMGN
$195.66
+0.62  +0.32%
Nplate (Romiplostim)
Immune thrombocytopenia (ITP)
PDUFA
sNDA filing announced December 19, 2018. Estimated PDUFA date October 18, 2019.
ALXN
$105.12
+2.14  +2.08%
ALXN1210
atypical Hemolytic Uremic Syndrome (aHUS)
PDUFA priority review
PDUFA data under priority review October 19, 2019.
CLSD
$0.73
  +0.11%
Suprachoroidal CLS-TA - PEACHTREE
Macular edema associated with non-infectious uveitis
PDUFA
PDUFA date October 19, 2019. Noted August 22, 2019 that a CRL is expected and will resubmit in 1Q 2020 with requested stability data.
ASRT
$1.34
+0.01  +0.75%
Cosyntropin depot
Adrenocortical insufficiency screening
PDUFA
PDUFA date October 19, 2019.
FOMX
$3.65
+0.11  +3.11%
FMX101
Acne
PDUFA
PDUFA date October 20, 2019.
ETON
$6.78
-0.04  -0.59%
ET-202
Injectable hospital product
PDUFA
PDUFA date October 21, 2019.
AGN
$165.93
-0.07  -0.04%
Botox
Lower limb spasticity
PDUFA
4Q 2019
PDUFA date 4Q 2019.
MLNT
$3.20
-0.03  -0.93%
Baxdela
Community-acquired bacterial pneumonia (CABP)
PDUFA priority review
PDUFA date under priority review - October 24, 2019.
LGND
$101.53
+2.26  +2.28%
Baxdela
Community-acquired bacterial pneumonia (CABP)
PDUFA priority review
PDUFA date under priority review - October 24, 2019.
GSK
$41.41
+0.34  +0.84%
Niraparib - (QUADRA trial)
Ovarian cancer
PDUFA priority review
PDUFA date under priority review 24 October 2019.
AGIO
$36.56
+0.06  +0.16%
AG-270
Solid tumors
Phase 1
Phase 1 data to be presented at AACR-NCI-EORTC International Conference October 26-30, 2019
AGRX
$1.25
-0.04  -3.10%
Twirla
Contraceptive patch
PDUFA
Advisory Committee 10/30/2019; PDUFA 11/16/2019
CRLs issued 2013 and 2017. New PDUFA date November 16, 2019. Advisory Committee Meeting October 30, 2019.
VERU
$1.90
  +0.00%
Zuclomiphene citrate
Hot flashes
Phase 2
Summer/Fall 2019
Phase 2 data due summer/fall of 2019.
MNK
$2.52
-0.01  -0.40%
StrataGraft skin tissue
Deep partial thickness severe burns - skin defects
Phase 3
Late 3Q/early 4Q 2019
Phase 3 data due late 3Q/early 4Q 2019
ELOX
$6.63
+0.15  +2.39%
ELX-02
Cystinosis
Phase 2
Early 4Q 2019
Phase 2 data due early 4Q 2019.
FGEN
$40.98
+0.02  +0.05%
Roxadustat
Anaemia in Chronic Kidney Disease
NDA Filing
October 2019
NDA filing due October 2019.
AZN
$44.58
+1.01  +2.32%
Roxadustat
Anaemia in Chronic Kidney Disease
NDA Filing
October 2019
NDA filing due October 2019.
RVNC
$14.22
+0.22  +1.57%
DAXI (RT002)
Moderate to severe glabellar (frown) lines
BLA Filing
Fall 2019
BLA filing due fall of 2019.
NBRV
$2.28
+0.02  +0.88%
Contepo
Complicated urinary tract infections (cUTI)
NDA Filing
Early 4Q 2019
CRL issued April 30, 2019. NDA resubmission due early 4Q 2019.
APLT
$9.76
-0.12  -1.21%
AT-007
Galactosemia
Phase 1
Fall 2019
Phase 1 additional data due fall of 2019.
ADMP
$0.76
+0.01  +1.84%
Higher Dose Naloxone Injection
Opioid overdose
PDUFA
PDUFA date October 31, 2019.
RDHL
$7.64
+0.01  +0.13%
RHB-105
H. pylori
PDUFA priority review
PDUFA date under priority review November 2, 2019.
RHHBY
$35.67
+0.38  +1.08%
Baloxavir marboxil
Influenza
PDUFA
PDUFA date for sNDA November 4, 2019.
APLS
$26.85
+0.6  +2.28%
APL-2 subcutaneous
Complement-dependent Nephropathies (CDN)
Phase 2
Phase 2 data due at ASN meeting November 05 - 10, 2019.
CRVS
$3.48
+0.07  +2.05%
CPI-006
Solid tumors
Phase 1b
SITC November 2019
Phase 1/1b updated data due at SITC November 7-10, 2019.
EIGR
$11.90
+0.35  +3.03%
Pegylated interferon lambda + ritonavir (RTV)-boosted lonafarnib (LNF) - LIFT
Hepatitis delta virus (HDV)
Phase 2
AASLD November 8-12, 2019
Phase 2 data to be presented at AASLD November 8-12, 2019.
LPCN
$2.94
+0.01  +0.34%
TLANDO - LPCN 1021
Men with low testosterone (Low T)
PDUFA
CRL issued June 2016. Further CRL issued May 9, 2018. PDUFA date November 9, 2019.
FPRX
$5.36
+0.02  +0.37%
FPT155
Solid tumors
Phase 1
SITC 2019
Phase 1 dosing announced November 14, 2018. Data due at SITC 2019.
AGN
$165.93
-0.07  -0.04%
UBROGEPANT
Migraine
PDUFA
NDA acceptance announced March 11, 2019. PDUFA 4Q 2019. No exact date provided.
LLY
$114.01
+1.29  +1.14%
Lasmiditan - SPARTAN
Migraine
PDUFA
NDA filing announced November 14, 2018. Estimated PDUFA date November 13, 2019.
AMRN
$16.96
+0.03  +0.18%
Vascepa
High Triglycerides With Mixed Dyslipidemia
PDUFA priority review
Adcom 11/14/2019; PDUFA (est) 12/28/2019
Advisory Committee meeting November 14, 2019. PDUFA date under priority review September 28, 2019 extended to December 28, 2019.
KNSA
$9.21
+0.04  +0.49%
Rilonacept
Pericarditis
Phase 2
Phase 2 open-label data to be presented at AHA November 16, 2019, 4:30 p.m.
DMPI
$0.60
-0.01  -1.79%
VAL-083
MGMT-unmethylated newly diagnosed Glioblastoma Multiforme (GBM)
Phase 2
Phase 2 enrolment to be completed 4Q 2020. Potential update due at the Society of Neuro-Oncology meeting November 20-24, 2019.
DMPI
$0.60
-0.01  -1.79%
VAL-083
MGMT-unmethylated Recurrent Glioblastoma Multiforme (GBM)
Phase 2
Phase 2 enrolment to be completed 4Q 2020. Potential update due at the Society of Neuro-Oncology meeting November 20-24, 2019.
EVFM
$5.53
-0.01  -0.18%
Amphora - AMPREVENCE
Prevention of urogenital Chlamydia trachomatis infection in women
Phase 2/3
November 2019
Phase 2b data due November 2019.
AQST
$3.42
-0.07  -2.01%
Exservan (riluzole) Oral Film
Amyotrophic Lateral Sclerosis
PDUFA
PDUFA date November 30, 2019.
CELG
$99.16
+0.49  +0.50%
TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and Abraxane) - IMpower130
Squamous non-small cell lung cancer (NSCLC)
PDUFA
PDUFA date for sBLA extended by three months to December 2, 2019.
RHHBY
$35.67
+0.38  +1.08%
TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and Abraxane) - IMpower130
Squamous non-small cell lung cancer (NSCLC)
PDUFA
PDUFA date for sBLA extended by three months to December 2, 2019.
XLRN
$43.90
+0.65  +1.50%
Luspatercept
Beta-thalassemia
PDUFA priority review
PDUFA date December 4, 2019 under priority review.

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