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
VNDA
$15.19
+0.28  +1.88%
HETLIOZ (tasimelteon)
Jet Lag Disorder
PDUFA
PDUFA date August 16, 2019. However, noted July 22, 2019 that the FDA has identified deficiencies that preclude discussion of labeling.
NBRV
$2.28
+0.12  +5.56%
Lefamulin - Intravenous and Oral
Moderate to severe Community Acquired Bacterial Pneumonia (CABP)
PDUFA priority review
PDUFA date under priority review August 19, 2019.
SRPT
$124.95
+2.98  +2.44%
Golodirsen - Exon 53
Duchenne muscular dystrophy
PDUFA priority review
PDUFA date under priority review August 19, 2019 .
TROV
$2.09
+0.46  +28.22%
Onvansertib (PCM-075) and Zytiga
Prostate cancer
Phase 2
Phase 2 new data to be presented at Asia-Pacific Prostate Cancer Conference. August 24, 2019 1:00 pm (AEDT). Presentation also at ESMO September 27, 2019.
IPCIF
$0.21
  +0.00%
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 might be delayed.
NKTR
$18.10
-0.09  -0.49%
NKTR-181
Lower back pain
PDUFA
PDUFA date August 29, 2019. Company noted the date might not be met due to the postponement of an advisory committee meeting.
AVEO
$0.67
  +0.32%
TIVO-3 - tivozanib
Third line treatment of patients with renal cell cancer
Phase 3
August 2019
Noted January 31, 2019 that FDA recommended against filing an NDA with current OS data. Additional interim OS analysis due August 2019 with further OS data 4Q 2019.
ANAB
$49.20
-0.79  -1.58%
ANB019
Generalized pustular psoriasis
Phase 2
Mid-2019
Phase 2 data due mid-2019.
CELG
$94.74
+1.43  +1.53%
TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and Abraxane) - IMpower130
Squamous non-small cell lung cancer (NSCLC)
PDUFA
PDUFA date for sBLA September 2, 2019.
RHHBY
$34.70
+0.14  +0.41%
TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and Abraxane) - IMpower130
Squamous non-small cell lung cancer (NSCLC)
PDUFA
PDUFA date for sBLA September 2, 2019.
MYOK
$53.92
+0.57  +1.07%
Mavacamten (MYK-461) - PIONEER-OLE
Non-obstructive Hypertrophic cardiomyopathy (HCM)
Phase 2
Phase 2 interim positive data released March 4, 2019. Data to be presented at ESC August 31-September 4, 2019.
ALNY
$80.69
+2.32  +2.96%
Inclisiran - ORION 11
Cardiovascular disease (ASCVD)
Phase 3
Phase 3 data to be presented at ESC September 2, 2019 at 9:22 am CET.
MDCO
$32.71
+1.19  +3.78%
Inclisiran - ORION 11
Cardiovascular disease (ASCVD)
Phase 3
Phase 3 data to be presented at ESC September 2, 2019 at 9:22 am CET.
ORTX
$13.77
-0.34  -2.41%
OTL-200
Metachromatic leukodystrophy (MLD)
Phase 2
Phase 2 presentation at SSIEM September 4, 2019.
SYBX
$4.61
+0.09  +1.99%
SYNB1618
Phenylketonuria (PKU)
Phase 1
Sept 3-6, 2019
Phase 1/2 data released July 15, 2019 - well tolerated. Full data to be presented at SSIEM September 3-6, 2019.
CNCE
$10.46
+0.19  +1.85%
CTP-692
Schizophrenia
Phase 1
ECNP, Sept 7-10, 2019
Phase 2 trial to be initiated 4Q 2019. Phase 1 data to be presented at the ECNP Annual Congress, September 7-10, 2019.
XERS
$11.59
+0.78  +7.22%
Glucagon Rescue Pen
Severe hypoglycemia
PDUFA
PDUFA date extended by three months to September 10, 2019.
ATRA
$14.06
+0.71  +5.32%
ATA188
Multiple sclerosis
Phase 1
Phase 1 initial data to be presented at ECTRIMS September 11-13, 2019.
ARDX
$2.47
+0.32  +14.88%
Tenapanor (T3MPO-2)
Constipation-predominant irritable bowel syndrome (IBS-C)
PDUFA
PDUFA date September 12, 2019.
ADVM
$13.40
+0.93  +7.46%
ADVM-022
Wet age-related macular degeneration (Wet-AMD)
Phase 1
Phase 1 24-Week data from first cohort to be presented September 12, 2019.
AIMT
$22.43
+0.64  +2.94%
AR101
Peanut Allergy
PDUFA
Adcom 09/13/19; PDUFA late-January 2020.
PDUFA date late-January 2020. Advisory Committee meeting September 13, 2019.
ACHV
$1.81
+0.04  +2.26%
Cytisine
Smoking cessation
Phase 2b
Phase 2b data met primary endpoint in 3/4 arms - June 11, 2019. Data to be presented at SRNT-E Conference, September 12-14, 2019.
CYTK
$13.26
+0.77  +6.16%
CK-3773274
Healthy volunteers (hypertrophic cardiomyopathy (HCM))
Phase 1
HFSA Sept 13-16, 2019
Phase 1 data due at HFSA September 13-16, 2019.
LXRX
$1.37
+0.05  +3.79%
Sotagliflozin
Type 2 Diabetes
Phase 3
EASD Sept 16-20, 2019
SNY informed LXRX July 26, 2019 that it plans to terminate its agreement following insufficient efficacy across three Phase 3 trials. Presentation of new data due at EASD 16-20 September 2019.
MRK
$85.06
+1.6  +1.92%
DELSTRIGO (doravirine/lamivudine/tenofovir disoproxil fumarate)
HIV
PDUFA
PDUFA date for sNDA September 20, 2019.
NVO
$51.66
+1.37  +2.72%
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
$85.06
+1.6  +1.92%
PIFELTRO (doravirine)
HIV
PDUFA
FDA Approval announced August 30, 2018. PDUFA date for sNDA September 20, 2019.
LPTX
$1.46
+0.07  +5.04%
DKN-01 and Paclitaxel
Endometrial Cancer
Phase 2
Phase 2 updated data due September 20, 2019 at IGCS.
URGN
$32.01
+0.78  +2.50%
VesiGel UGN-102
Low grade non-muscle invasive bladder cancer (LG-NMIBC)
Phase 2b
Phase 2b initial data due September 24, 2019.
JNJ
$131.36
+0.82  +0.63%
Daratumumab + VTD
Multiple myeloma - candidates for autologous stem cell transplant (ASCT)
PDUFA priority review
PDUFA date September 26, 2019.
GMAB
$20.03
+0.14  +0.70%
Daratumumab + VTD
Multiple myeloma - candidates for autologous stem cell transplant (ASCT)
PDUFA priority review
PDUFA date September 26, 2019.
FPRX
$5.81
+0.08  +1.40%
FPA150
Solid tumors
Phase 1
ESMO 2019
Phase 1b initial data due at ESMO 27 September-1 October 2019.
AGIO
$42.40
-0.1  -0.24%
AG-120 Ivosidenib
IDH1 mutant positive cholangiocarcinoma - cancer
Phase 3
ESMO 2019
Phase 3 data released May 15, 2019 met primary endpoint. Data to be presented at ESMO September 27-October 1, 2019.
JNJ
$131.36
+0.82  +0.63%
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.
ASLN
$2.93
+0.23  +8.72%
Varlitinib + mFOLFIRI
Solid tumors
Phase 1
ESMO September 2019
Phase 1 presentation due at ESMO 27 September - 1 October 2019.
TROV
$2.09
+0.46  +28.22%
Onvansertib (PCM-075)
Acute Myeloid Leukemia (AML)
Phase 1/2
Phase 1/2 presentation at ESMO September 27, 2019.
ALRN
$0.59
+0.01  +1.55%
ALRN-6924 and IBRANCE (palbociclib)
Solid tumors
Phase 2a
ESMO September 2019
Phase 2a preliminary data due at ESMO Sept 27-Oct 1, 2019 with final data due 2H 2020.
RHHBY
$34.70
+0.14  +0.41%
Alecensa - ALEX
Anaplastic lymphoma kinase (ALK)-positive metastatic (advanced) non-small cell lung cancer (NSCLC)
Phase 3
ESMO September/October 2019
Phase 3 updated data due at 27 September-1 October 2019
IMGN
$2.83
+0.08  +2.91%
Mirvetuximab soravtansine - FORWARD II
Ovarian cancer and relapsed endometrial cancer
Phase 1/2
ESMO 2019
Phase 1b/2 initial data due at ESMO in late September, 2019.
GNCA
$3.12
  +0.00%
GEN-009 vaccine
Various cancers
Phase 1/2
ESMO 2019
Phase 1/2 additional immunogenicity data due at ESMO September 27-October 1, 2019. Preliminary data due mid-2020
CLVS
$5.60
+0.4  +7.69%
Rucaparib - TRITON2
Castrate-resistant prostate cancer (mCRPC)
Phase 2
ESMO September 2019
Phase 2 updated data due at ESMO late-September, 2019.
GTHX
$37.23
-0.17  -0.45%
Trilaciclib plus Tecentriq
First-line small-cell lung cancer
Phase 2
Phase 2 additional data due at ESMO September 29, 2019 (webcast).
GTHX
$37.23
-0.17  -0.45%
G1T48
ER+, HER2- breast cancer
Phase 1/2
Phase 1/2 preliminary data due at ESMO September 29, 2019 (webcast).
TYME
$1.03
+0.03  +3.00%
SM-88
Pancreatic cancer
Phase 2
Phase 2 presentation at ESMO September 29, 2019. 12:00 PM CET.
ZEAL
$21.15
-0.6  -2.75%
Dasiglucagon
Severe hypoglycemia in diabetes - children
Phase 3
September 2019
Phase 3 data due September 2019.
NVS
$89.47
+0.89  +1.00%
QVM149
Asthma
Phase 3
3Q 2019
Phase 3 trial to be completed 3Q 2019.
GILD
$63.14
+0.27  +0.43%
Filgotinib and GS-9876
Sjogren’s syndrome
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
NVS
$89.47
+0.89  +1.00%
OMB157 (ofatumumab)
Relapsing multiple sclerosis
Phase 3
3Q 2019
Phase 3 data due 3Q 2019.
GMAB
$20.03
+0.14  +0.70%
OMB157 (ofatumumab)
Relapsing multiple sclerosis
Phase 3
3Q 2019
Phase 3 data due 3Q 2019.
MRNS
$1.17
+0.06  +5.41%
Ganaxolone
Refractory status epilepticus (RSE)
Phase 2
3Q 2019
Data due by the end of 3Q 2019.
LGND
$94.94
+3.17  +3.45%
Ganaxolone
Refractory status epilepticus (RSE)
Phase 2
3Q 2019
Data due by the end of 3Q 2019.
SYBX
$4.61
+0.09  +1.99%
SYNB1020
Cirrhotic patients with elevated ammonia
Phase 1/2
3Q 2019
Phase 1/2 top-line data due 3Q 2019.
GLPG
$172.18
+2.61  +1.54%
Filgotinib and GS-9876
Cutaneous lupus erythematosus (CLE)
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
GILD
$63.14
+0.27  +0.43%
Filgotinib and GS-9876
Cutaneous lupus erythematosus (CLE)
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
IMUX
$13.51
+0.2  +1.50%
IMU-838
Ulcerative colitis
Phase 2
3Q 2019
Phase 2 interim dosing analysis expected 3Q 2019 and full data readout expected 1Q 2021.
EARS
$2.70
+0.01  +0.37%
AM-201
Healthy volunteers
Phase 1b
Late 3Q 2019
Phase 1b top-line data due late-3Q 2019.
RETA
$75.74
+2.75  +3.77%
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
$3.00
+0.11  +3.81%
RVL-1201
Blepharoptosis
NDA Filing
3Q 2019
NDA filing due 3Q 2019.
CNCE
$10.46
+0.19  +1.85%
CTP-543
Alopecia areata
Phase 2a
3Q 2019
Phase 2 8mg data released November 12, 2018 - primary endpoint met. 12mg data due 3Q 2019.
RTRX
$17.80
+0.8  +4.71%
RE-024 fosmetpantotenate
Pantothenate kinase-associated neurodegeneration (PKAN)
Phase 3
3Q 2019
Phase 3 top-line data due 3Q 2019.
GILD
$63.14
+0.27  +0.43%
GS-9131
HIV
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
GSK
$40.19
+0.23  +0.58%
Cabotegravir + rilpivirine - ATLAS2M
HIV
Phase 3
3Q 2019
Phase 3 8-week data due 3Q 2019.
IMMP
$1.48
+0.08  +5.71%
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
$49.63
+1.27  +2.63%
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
$80.69
+2.32  +2.96%
Inclisiran - ORION-9
Hypercholesterolemia
Phase 3
Latter half of 3Q 2019
Phase 3 data due second half of 3Q 2019.
MDCO
$32.71
+1.19  +3.78%
Inclisiran - ORION-9
Hypercholesterolemia
Phase 3
Latter half of 3Q 2019
Phase 3 data due second half of 3Q 2019.
JAGX
$1.11
-0.1  -8.26%
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
$34.70
+0.14  +0.41%
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.
TCDA
$34.64
+2  +6.13%
TRC 101
Chronic kidney disease
NDA Filing
3Q 2019
NDA filing due 3Q 2019.
SRPT
$124.95
+2.98  +2.44%
Casimersen (SRP-4045) - ESSENCE
Duchenne muscular dystrophy
NDA Filing
3Q 2019
NDA filing due 3Q 2019.
GLPG
$172.18
+2.61  +1.54%
Filgotinib
Rheumatoid arthritis (RA)
NDA Filing
3Q 2019
NDA filing due 3Q 2019.
GILD
$63.14
+0.27  +0.43%
Filgotinib
Rheumatoid arthritis (RA)
NDA Filing
3Q 2019
NDA filing due 3Q 2019.
ENTA
$71.93
+1.59  +2.26%
EDP-305 ARGON-1
Non-alcoholic steatohepatitis (NASH)
Phase 2
3Q 2019
Phase 2 initial data due 3Q 2019.
ETON
$5.66
  +0.00%
EM-104
Neurological indication
Phase 1
3Q 2019
Bioequivalence study data due 3Q 2019.
RARE
$58.65
+1.78  +3.13%
DTX401
GSD1
Phase 1/2
3Q 2019
Phase 1/2 data from second cohort due 3Q 2019.
VNDA
$15.19
+0.28  +1.88%
HETLIOZ (tasimelteon)
Smith-Magenis Syndrome
sNDA Filing
3Q 2019
sNDA filing due 3Q 2019.
AQST
$3.81
+0.29  +8.24%
AQST-108
Anaphylaxis
Phase 1
3Q 2019
Phase 1 data due 3Q 2019.
TLSA
$6.95
+0.76  +12.26%
Milciclib
Hepatocellular carcinoma (HCC)
Phase 2a
September 2019
Phase 2a objective tumor assessments due September 2019.
IGXT
$0.42
+0.03  +6.25%
RIZAPORT (RHB-103)
Migraine
NDA Filing
3Q 2019
NDA to be resubmitted 3Q 2019.
AGTC
$3.08
+0.08  +2.67%
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.
TBPH
$21.26
-0.01  -0.05%
TD-8236
Asthma
Phase 1
September 2019
Phase 1 data due September 2019.
ESPR
$38.41
+1.12  +3.00%
Bempedoic Acid/ Ezetimibe (1002-058)
LDL-C and type 2 diabetes
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
AGN
$158.25
+1.91  +1.22%
ABP 798
RITUXAN biosimilar - non-Hodgkin lymphoma
Phase 3
3Q 2019
Phase 3 data released January 24, 2019 - primary endpoint met in rheumatoid arthritis trial. Non-Hodgkin’s lymphoma data due 3Q 2019.
AMGN
$204.02
+4.71  +2.36%
ABP 798
RITUXAN biosimilar - non-Hodgkin lymphoma
Phase 3
3Q 2019
Phase 3 data released January 24, 2019 - primary endpoint met in rheumatoid arthritis trial. Non-Hodgkin’s lymphoma data due 3Q 2019.
NERV
$6.78
+0.28  +4.31%
MIN-202 (seltorexant) vs quetiapine
Major Depressive Disorder
Phase 2b
3Q 2019
Phase 2b data due 3Q 2019.
ARDX
$2.47
+0.32  +14.88%
Tenapanor - AMPLIFY
Hyperphosphatemia - adjunctive therapy to phosphate binders
Phase 3
3Q 2019
Phase 3 data due 3Q 2019.
ALNY
$80.69
+2.32  +2.96%
Inclisiran - ORION-10
Cardiovascular disease (ASCVD)
Phase 3
Second half of 3Q 2019
Phase 3 data due second half of 3Q 2019.
MDCO
$32.71
+1.19  +3.78%
Inclisiran - ORION-10
Cardiovascular disease (ASCVD)
Phase 3
Second half of 3Q 2019
Phase 3 data due second half of 3Q 2019.
SNGX
$1.10
+0.05  +4.76%
SGX942 (dusquetide)
Oral Mucositis in Patients with Head & Neck Cancer
Phase 3
September 2019
Phase 3 interim analysis due September 2019 with top-line data due 1H 2020.
NTRP
$5.67
+0.1  +1.80%
Bryostatin
Alzheimer's disease
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
ASLN
$2.93
+0.23  +8.72%
ASLAN003
Acute Myeloid Leukemia (AML)
Phase 2
3Q 2019
Phase 2 Part 1 data due 2Q 2019. Timeline missed. Estimate 3Q 2019.
AZRX
$0.99
+0.03  +3.02%
MS1819-SD (OPTION)
Cystic fibrosis
Phase 2
September 2019
Phase 2 data due September 2019.
AZN
$44.34
+0.16  +0.36%
Tagrisso and Lerociclib (G1T38)
EGFR mutation-positive non-small cell lung cancer (NSCLC)
Phase 1/2
3Q 2019
Phase 1/2 preliminary data due 3Q 2019.
GTHX
$37.23
-0.17  -0.45%
Tagrisso and Lerociclib (G1T38)
EGFR mutation-positive non-small cell lung cancer (NSCLC)
Phase 1/2
3Q 2019
Phase 1/2 preliminary data due 3Q 2019.
CTIC
$0.65
  +-0.08%
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.
OBSV
$8.84
+0.06  +0.68%
OBE022 - PROLONG
Pre-term labor
Phase 2a
3Q 2019
Phase 2a Part B interim analysis due 2Q 2019. Timeline missed. Estimate 3Q.
ARDS
$7.75
+0.23  +3.06%
AR-105 (Aerucin)
Pseudomonas aeruginosa
Phase 2
3Q 2019
Phase 2 interim data due 3Q 2019.
ETON
$5.66
  +0.00%
EM-103
Hypothyroidism
Phase 3
3Q 2019
Bioequivalence study data due 3Q 2019.
TYME
$1.03
+0.03  +3.00%
SM-88
Prostate cancer
Phase 2
Phase 2 presentation at ESMO September 30, 2019. 12:00 PM CET.
ICPT
$64.00
-0.64  -0.99%
Ocaliva (Obeticholic acid (OCA)) - REGENERATE
Adult nonalcoholic steatohepatitis (NASH) patients.
Phase 3
3Q 2019
NDA filing due 3Q 2019.
ZYNE
$11.20
+0.58  +5.46%
ZYN002 BELIEVE 1
Developmental and Epileptic Encephalopathies (DEE)
Phase 2
September 2019
Phase 2 top-line data due September 2019.
OVID
$1.93
+0.07  +3.76%
OV935
Developmental and Epileptic Encephalopathies (dEE)
Phase 2
3Q 2019
Phase 2 open label data due 3Q 2019.
GILD
$63.14
+0.27  +0.43%
Axicabtagene ciloleucel - (ZUMA-2)
Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL) - cancer
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
RARE
$58.65
+1.78  +3.13%
DTX301
Ornithine Transcarbamylase (OTC) Deficiency
Phase 1/2
3Q 2019
Phase 1/2 third cohort data due 3Q 2019.
MNK
$4.08
-0.01  -0.24%
StrataGraft skin tissue
Deep partial thickness severe burns - skin defects
Phase 3
Late-2Q / early 3Q 2019
Phase 3 data due late 2Q or early 3Q 2019.
BOLD
$33.88
+0.93  +2.82%
AT132 - ASPIRO
X-Linked Myotubular Myopathy
Phase 1/2
Phase 1/2 data to be presented at WMS October 1-5, 2019.
PIRS
$5.00
+0.1  +2.04%
PRS-060
Asthma
Phase 1
Phase 1 presentation at European Respiratory Society International Congress, October 1, 2019.
GILD
$63.14
+0.27  +0.43%
F/TAF (Descovy)
Pre-exposure prophylaxis
PDUFA priority review
sNDA filed April 5, 2019. Likely PDUFA date under priority review of October 4, 2019.
CLVLY
$17.32
-0.18  -1.03%
SCENESSE
Phototoxicity and anaphylactoid reactions in adult patients with erythropoietic protoporphyria (EPP)
PDUFA priority review
PDUFA date under priority review October 6, 2019.
PFNX
$6.95
+0.12  +1.76%
PF708 and Forteo
Osteoporosis
PDUFA
PDUFA date October 7, 2019.
RHHBY
$34.70
+0.14  +0.41%
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.
KOD
$11.03
+0.79  +7.71%
KSI-301
Diabetic macular edema (DME)
Phase 2
Phase 1b additional data due at AAO October 12-15, 2019.
JNJ
$131.36
+0.82  +0.63%
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
$10.99
+0.26  +2.42%
Zilretta - FX006 repeat
Osteoarthritis of the knee
PDUFA
PDUFA date for sNDA filing October 14, 2019.
NVS
$89.47
+0.89  +1.00%
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
$1.80
+0.1  +5.88%
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
$204.02
+4.71  +2.36%
Nplate (Romiplostim)
Immune thrombocytopenia (ITP)
PDUFA
sNDA filing announced December 19, 2018. Estimated PDUFA date October 18, 2019.
ALXN
$110.85
+1.81  +1.66%
ALXN1210
atypical Hemolytic Uremic Syndrome (aHUS)
PDUFA priority review
PDUFA data under priority review October 19, 2019.
CLSD
$1.18
+0.02  +1.72%
Suprachoroidal CLS-TA - PEACHTREE
Macular edema associated with non-infectious uveitis
PDUFA
PDUFA date October 19, 2019.
ASRT
$1.62
+0.01  +0.62%
Cosyntropin depot
Adrenocortical insufficiency screening
PDUFA
PDUFA date October 19, 2019.
FOMX
$3.10
+0.21  +7.27%
FMX101
Acne
PDUFA
PDUFA date October 20, 2019.
ETON
$5.66
  +0.00%
ET-202
Injectable hospital product
PDUFA
PDUFA date October 21, 2019.
AGN
$158.25
+1.91  +1.22%
Botox
Lower limb spasticity
PDUFA
4Q 2019
PDUFA date 4Q 2019.
MLNT
$2.36
+0.02  +0.85%
Baxdela
Community-acquired bacterial pneumonia (CABP)
PDUFA priority review
PDUFA date under priority review - October 24, 2019.
LGND
$94.94
+3.17  +3.45%
Baxdela
Community-acquired bacterial pneumonia (CABP)
PDUFA priority review
PDUFA date under priority review - October 24, 2019.
GSK
$40.19
+0.23  +0.58%
Niraparib - (QUADRA trial)
Ovarian cancer
PDUFA priority review
PDUFA date under priority review 24 October 2019.
AGIO
$42.40
-0.1  -0.24%
AG-270
Solid tumors
Phase 1
Phase 1 data to be presented at AACR-NCI-EORTC International Conference October 26-30, 2019
AGRX
$1.12
+0.01  +0.90%
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
$1.89
-0.04  -2.07%
Zuclomiphene citrate
Hot flashes
Phase 2
Summer/Fall 2019
Phase 2 data due summer/fall of 2019.
ELOX
$6.24
+0.06  +0.97%
ELX-02
Cystinosis
Phase 2
Early 4Q 2019
Phase 2 data due early 4Q 2019.
FGEN
$44.60
+1.46  +3.38%
Roxadustat
Anaemia in Chronic Kidney Disease
NDA Filing
October 2019
NDA filing due October 2019.
AZN
$44.34
+0.16  +0.36%
Roxadustat
Anaemia in Chronic Kidney Disease
NDA Filing
October 2019
NDA filing due October 2019.
RVNC
$11.34
+0.44  +4.04%
DAXI (RT002)
Moderate to severe glabellar (frown) lines
BLA Filing
Fall 2019
BLA filing due fall of 2019.
NBRV
$2.28
+0.12  +5.56%
Contepo
Complicated urinary tract infections (cUTI)
NDA Filing
Early 4Q 2019
CRL issued April 30, 2019. NDA resubmission due early 4Q 2019.
RTTR
$0.92
+0.02  +2.60%
RP-G28
Lactose intolerance
Phase 3
Early 4Q 2019
Phase 3 data due early 4Q 2019.
RGNX
$37.18
+1.65  +4.64%
RGX-314
Wet age-related macular degeneration (wet AMD)
Phase 1/2
October 2019
Phase 1/2a data due in October 2019. Phase 2b trial to be initiated late 2019.
APLT
$9.54
+0.64  +7.19%
AT-007
Galactosemia
Phase 1
Fall 2019
Phase 1 additional data due fall of 2019.
ADMP
$1.08
+0.05  +4.85%
Higher Dose Naloxone Injection
Opioid overdose
PDUFA
PDUFA date October 31, 2019.
ZYME
$26.39
+1.39  +5.56%
ZW25
HER2-expressing Cancers - ovarian, breast, gastric
Phase 1
Fall 2019
Phase 1 updated data due fall of 2019. Phase 2 trial initiation announced April 15, 2019.
RDHL
$6.87
+0.17  +2.61%
RHB-105
H. pylori
PDUFA priority review
PDUFA date under priority review November 2, 2019.
RHHBY
$34.70
+0.14  +0.41%
Baloxavir marboxil
Influenza
PDUFA
PDUFA date for sNDA November 4, 2019.
APLS
$27.75
+0.83  +3.08%
APL-2 subcutaneous
Complement-dependent Nephropathies (CDN)
Phase 2
Phase 2 data due at ASN meeting November 05 - 10, 2019.
CRVS
$4.04
-0.11  -2.65%
CPI-006
Solid tumors
Phase 1b
SITC November 2019
Phase 1/1b updated data due at SITC November 7-10, 2019.
EIGR
$10.26
+0.49  +5.02%
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
$2.34
+0.2  +9.35%
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
$5.81
+0.08  +1.40%
FPT155
Solid tumors
Phase 1
SITC 2019
Phase 1 dosing announced November 14, 2018. Data due at SITC 2019.
AGN
$158.25
+1.91  +1.22%
UBROGEPANT
Migraine
PDUFA
NDA acceptance announced March 11, 2019. PDUFA 4Q 2019. No exact date provided.
LLY
$110.52
+0.29  +0.26%
Lasmiditan - SPARTAN
Migraine
PDUFA
NDA filing announced November 14, 2018. Estimated PDUFA date November 13, 2019.
AMRN
$15.15
+0.71  +4.92%
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 but will be extended, potentially to December 28, 2019 (unconfirmed).
EVFM
$4.97
-0.19  -3.68%
Amphora - AMPREVENCE
Prevention of urogenital Chlamydia trachomatis infection in women
Phase 2/3
November 2019
Phase 2b data due November 2019.

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