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
MRK
$81.08
+0.12  +0.15%
Imipenem/ cilastatin
Complicated urinary tract infections (cUTI) and Complicated intra-abdominal infections (cIAI)
PDUFA priority review
PDUFA date under priority review July 16, 2019.
MRKR
$9.10
+0.16  +1.79%
MultiTAA-Specific T Cells
Pancreatic cancer
Phase 1
Phase 1/2 data to be presented July 20, 2019 at AACR.
CELG
$91.83
+0.07  +0.08%
OTEZLA
Behçet’s Disease
PDUFA
PDUFA date for sNDA July 21, 2019.
MRK
$81.08
+0.12  +0.15%
MK-8591
HIV
Phase 2
Phase 2b 48-week data to be presented July 24, 11:00-12:30 CDT at IAS 2019.
BHVN
$44.80
-0.92  -2.01%
BHV-0223
Amyotrophic lateral sclerosis (ALS)
PDUFA
NDA acceptance announced November 26, 2018. PDUFA date not supplied. Estimate July 25, 2019.
EVOK
$1.05
-0.07  -6.38%
Gimoti - EVK-001
Female diabetic gastroparesis
NDA Filing
CRL issued April 2, 2019. Meeting with FDA regarding NDA resubmission potentially to be held around July 26, 2019.
KOD
$13.95
-0.1  -0.71%
KSI-301
Wet age-related macular degeneration (AMD)
Phase 1b
Phase 2 trial planned 2H 2019 with interim data 2020 and final data 2021. Phase 1b data to be presented at ASRS meeting July 26-30, 2019.
SAGE
$183.20
-4.21  -2.25%
SAGE-718
Huntington's disease
Phase 1
July 2019
Phase 1 biomarker data due July 2019 with Huntington’s Disease Phase 1 cohort data due 2H 2019.
SAGE
$183.20
-4.21  -2.25%
SAGE-324
Essential tremor
Phase 1
July 2019
Phase 1 MAD data due July 2019. Top-line data due 2H 2019.
VERU
$2.31
-0.02  -0.86%
Zuclomiphene citrate
Hot flashes
Phase 2
Summer 2019
Phase 2 data due summer 2019.
ITCI
$11.58
+0.16  +1.40%
Lumateperone
Schizophrenia
PDUFA
Advisory Committee 07/31/2019; PDUFA 09/27/2019
PDUFA date September 27, 2019. Advisory Committee Meeting July 31, 2019.
IMUX
$14.00
+0.05  +0.36%
IMU-838
Ulcerative colitis
Phase 2
Mid-2019
Phase 2 interim dosing analysis expected mid-2019 and top-line data expected 2Q 2020.
CNAT
$0.32
  +-1.41%
Emricasan
NASH cirrhosis - ENCORE-PH trial
Phase 2
Mid-2019
Phase 2b data released December 5, 2018 did not meet primary endpoint. 48-week liver function data due mid-2019.
ALKS
$23.44
+0.1  +0.43%
Diroximel fumarate (BIIB098) - Head-to-head trial versus Tecfidera -
Relapsing Remitting Multiple Sclerosis (RRMS)
Phase 3
Mid-2019
Phase 3 top-line data due mid-2019.
ACAD
$26.48
-0.23  -0.88%
Pimavanserin - Enhance
Adjunctive treatment of schizophrenia
Phase 3
Mid-2019
Phase 3 data due mid-2019.
RIGL
$2.50
-0.01  -0.40%
R835
Autoimmune and inflammatory diseases
Phase 1
Mid-2019
Phase 1 trial to be completed mid-2019.
NBIX
$87.06
-0.49  -0.56%
Elagolix
Uterine Fibroids
NDA Filing
Mid-2019
NDA filing due mid-2019.
ABBV
$70.19
-0.08  -0.11%
Elagolix
Uterine Fibroids
NDA Filing
Mid-2019
NDA filing due mid-2019.
IMMP
$1.74
+0.03  +1.99%
Eftilagimod alpha and Keytruda - TACTI-002
Non-small cell lung cancer; Head and neck cancer
Phase 2
Mid-2019
Phase 2 initial data due mid-2019.
GNMX
$0.23
+0.03  +13.22%
AEVI-002 (Anti-LIGHT mAb)
Pediatric onset Crohn's disease
Phase 1b
Mid-2019
Phase 1b data due mid-2019. Possible delay due to slow enrolment.
SAGE
$183.20
-4.21  -2.25%
SAGE-217 - ARCHWAY
Bipolar depression
Phase 2
July 2019
Phase 2 Part A data due July 2019.
TCDA
$33.24
+0.19  +0.57%
TRC 101
Chronic kidney disease
Phase 3
Mid-2019
Phase 3 efficacy trial met endpoints June 2018. 12-month registration stability data due mid-2019. TRCA-301E data also met primary endpoint.
SRPT
$153.97
-2.94  -1.87%
Casimersen (SRP-4045) - ESSENCE
Duchenne muscular dystrophy
NDA Filing
Mid-2019
NDA filing due mid-2019.
CRIS
$2.48
+0.02  +0.89%
CA-4948
Relapsed or Refractory Non-Hodgkin Lymphoma
Phase 1
Mid-2019
Phase 1 data due mid-2019.
RARE
$58.51
-0.11  -0.19%
DTX401
GSD1
Phase 1/2
Mid-2019
Phase 1/2 data from second cohort due mid-2019.
ABUS
$2.26
-0.08  -3.42%
AB-506
Hepatitis B (HBV)
Phase 1
July 2019
Phase 1 data due July 2019.
BMY
$44.27
+0.09  +0.19%
CM-227 – Opdivo + Yervoy
First-line Non-small cell lung cancer (NSCLC)
Phase 3
Mid-2019
Phase 3 data due summer 2019.
BIIB
$233.60
-0.02  -0.01%
NSR-RPGR
X-linked Retinitis Pigmentosa
Phase 2/3
Mid-2019
Phase 1 6-Month data due 2Q 2019 with initial Phase 2/3 data due mid-2019.
TLSA
$6.79
  +0.00%
Milciclib
Hepatocellular carcinoma (HCC)
Phase 2a
July 2019
Phase 2a top-line data due July 2019.
RARE
$58.51
-0.11  -0.19%
UX007 (triheptanoin)
Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD)
NDA Filing
Mid-2019
NDA to be filed mid-2019.
ALLK
$35.16
-0.8  -2.21%
AK002
Eosinophilic Gastritis
Phase 2
Mid-2019
Phase 2 top-line data due mid-2019.
DCPH
$21.80
+0.02  +0.07%
DCC-2618 - INVICTUS
Gastrointestinal Stromal Tumors (GIST) - fourth-line
Phase 3
Mid-2019
Phase 3 data due mid-2019.
ZLAB
$36.51
+0.1  +0.26%
DCC-2618 - INVICTUS
Gastrointestinal Stromal Tumors (GIST) - fourth-line
Phase 3
Mid-2019
Phase 3 data due mid-2019.
MESO
$5.38
+0.04  +0.71%
MSC-100-IV
acute graft versus host disease (aGVHD) in children
BLA Filing
Mid-2019 est
BLA filing due following FDA meeting in April 2019.
ZEAL
$22.39
+0.43  +1.98%
Dasiglucagon
Obesity / diabetes
Phase 1b
Mid-2019
Phase 1b data due mid-2019.
ACRS
$2.19
-0.04  -1.79%
ATI-502 (AD-201 Topical)
Atopic dermatitis (AD)
Phase 2
Mid-2019
Phase 2 data due mid-2019.
ACRS
$2.19
-0.04  -1.79%
ATI-502 (VITI-201 Topical)
Vitiligo
Phase 2
Mid-2019
Phase 2 open label 6-month data due mid-2019.
ANAB
$54.84
-0.82  -1.47%
ANB019
Generalized pustular psoriasis
Phase 2
Mid-2019
Phase 2 data due mid-2019.
ONCE
$98.34
+0.34  +0.35%
SPK-8011
Hemophilia A
Phase 1/2
Mid-2019
Phase 3 trial to be initiated late 2018. Phase 1/2 further data due mid-2019.
AKCA
$23.44
-0.04  -0.17%
Volanesorsen
Familial partial lipodystrophy (FPL)
Phase 3
Mid-2019
Phase 3 data due mid-2019.
FOMX
$2.28
  +0.00%
FMX103
Papulopustular rosacea
NDA Filing
Mid-2019
NDA filing due mid-2019.
CDTX
$1.61
  +0.00%
Rezafungin (CD101) STRIVE B
Candidemia
Phase 2
Mid-2019
Phase 2 STRIVE B readout due mid-2019.
LPTX
$2.05
+0.02  +0.99%
DKN-01 + KEYTRUDA
Esophagogastric adenocarcinoma
Phase 1/2
July 2019
Phase 1/2 data due July 2019.
RARE
$58.51
-0.11  -0.19%
DTX301
Ornithine Transcarbamylase (OTC) Deficiency
Phase 1/2
Mid-2019
Phase 1/2 third cohort data due mid-2019.
NTEC
$3.45
-0.19  -5.22%
AP-CDLD
Advanced Parkinson's Disease
Phase 3
July/August 2019
Phase 3 data due July/August 2019.
MRNS
$4.35
-0.1  -2.25%
Ganaxolone - Magnolia
Postpartum depression
Phase 2
3Q 2019 (first half)
Data due first half of 3Q 2019.
LGND
$117.36
+0.83  +0.72%
Ganaxolone - Magnolia
Postpartum depression
Phase 2
3Q 2019 (first half)
Data due first half of 3Q 2019.
KALA
$5.98
-0.1  -1.70%
KPI‑121 0.25%
Dry eye disease
PDUFA
PDUFA date August 15, 2019.
CHMA
$6.25
-0.26  -3.92%
Mycapssa - OPTIMAL
Acromegaly
Phase 3
Mid-3Q 2019
Phase 3 data due mid-3Q 2019.
MRNS
$4.35
-0.1  -2.25%
Ganaxolone - oral (Amaryllis)
Postpartum depression
Phase 2
3Q 2019 (first half)
Data due first half of 3Q 2019.
LGND
$117.36
+0.83  +0.72%
Ganaxolone - oral (Amaryllis)
Postpartum depression
Phase 2
3Q 2019 (first half)
Data due first half of 3Q 2019.
KMPH
$1.56
+0.04  +2.63%
KP415
ADHD
NDA Filing
Early-3Q 2019
NDA filing due early-3Q 2019.
VNDA
$13.58
+0.01  +0.07%
HETLIOZ (tasimelteon)
Jet Lag Disorder
PDUFA
PDUFA date August 16, 2019.
RHHBY
$33.63
+0.08  +0.24%
Entrectinib
Solid tumors and ROS1-positive non-small cell lung cancer (NSCLC)
PDUFA priority review
PDUFA date under priority review August 18, 2019.
NBRV
$2.40
-0.01  -0.41%
Lefamulin - Intravenous and Oral
Moderate to severe Community Acquired Bacterial Pneumonia (CABP)
PDUFA priority review
PDUFA date under priority review August 19, 2019.
ABBV
$70.19
-0.08  -0.11%
ABT-494 upadacitinib
Rheumatoid arthritis
PDUFA priority review
PDUFA date under priority review estimated at August 19, 2019.
SRPT
$153.97
-2.94  -1.87%
Golodirsen - Exon 53
Duchenne muscular dystrophy
PDUFA priority review
PDUFA date under priority review August 19, 2019 .
IPCIF
$0.20
-0.02  -7.23%
Rexista
Pain relief
PDUFA
CRL issued September 25, 2017. NDA resubmitted with new PDUFA date of August 28, 2019.
NKTR
$32.90
-0.31  -0.93%
NKTR-181
Lower back pain
PDUFA
PDUFA date extended three months to August 29, 2019.
AVEO
$0.71
-0.02  -2.64%
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.
ATNX
$19.91
-0.09  -0.45%
Oraxol
Metastatic breast cancer
Phase 3
August 2019
Phase 3 top-line data due August 2019.
AZRX
$1.19
-0.03  -2.68%
MS1819-SD (OPTION)
Cystic fibrosis
Phase 2
Late-summer 2019
Phase 2 data due late-summer 2019.
GLYC
$12.74
-0.11  -0.86%
GMI-1070 (rivipansel)
Vaso-occlusive crisis of sickle cell disease
Phase 3
2H 2019 (possibly July/August)
Phase 3 data due 2H 2019 (possibly July/August)
PFE
$42.62
-0.13  -0.30%
GMI-1070 (rivipansel)
Vaso-occlusive crisis of sickle cell disease
Phase 3
2H 2019 (possibly July/August)
Phase 3 data due 2H 2019 (possibly July/August)
CERC
$4.78
-0.07  -1.44%
CERC 801
Phosphoglucomutase 1 (PGM1) deficiency
Phase 1
Summer 2019
Phase 1 Pharmacokinetic (PK) data due summer 2019.
CELG
$91.83
+0.07  +0.08%
TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and Abraxane) - IMpower130
Squamous non-small cell lung cancer (NSCLC)
PDUFA
PDUFA date for sBLA September 2, 2019.
RHHBY
$33.63
+0.08  +0.24%
TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and Abraxane) - IMpower130
Squamous non-small cell lung cancer (NSCLC)
PDUFA
PDUFA date for sBLA September 2, 2019.
MYOK
$49.88
-0.34  -0.68%
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.
CELG
$91.83
+0.07  +0.08%
Fedratinib
Myelofibrosis
PDUFA priority review
PDUFA date under priority review September 3, 2019.
XERS
$12.06
+0.09  +0.75%
Glucagon Rescue Pen
Severe hypoglycemia
PDUFA
PDUFA date extended by three months to September 10, 2019.
ARDX
$2.55
+0.01  +0.39%
Tenapanor (T3MPO-2)
Constipation-predominant irritable bowel syndrome (IBS-C)
PDUFA
PDUFA date September 12, 2019.
ADVM
$16.09
+0.63  +4.08%
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
$18.98
-0.01  -0.05%
AR101
Peanut Allergy
PDUFA
Adcom 09/13/19; PDUFA late-January 2020.
PDUFA date late-January 2020. Advisory Committee meeting September 13, 2019.
ACHV
$1.82
-0.03  -1.64%
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.
AVDL
$2.27
+0.08  +3.65%
AV001
Hospital product
PDUFA priority review
PDUFA date September 15, 2019.
MRK
$81.08
+0.12  +0.15%
DELSTRIGO (doravirine/lamivudine/tenofovir disoproxil fumarate)
HIV
PDUFA
PDUFA date for sNDA September 20, 2019.
NVO
$47.91
+0.26  +0.55%
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
$81.08
+0.12  +0.15%
PIFELTRO (doravirine)
HIV
PDUFA
FDA Approval announced August 30, 2018. PDUFA date for sNDA September 20, 2019.
FPRX
$5.59
  +0.00%
FPA150
Solid tumors
Phase 1
ESMO 2019
Phase 1b initial data due at ESMO 27 September-1 October 2019.
AGIO
$46.20
+0.03  +0.06%
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
$132.87
-1.84  -1.37%
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.
TROV
$2.16
+0.04  +1.89%
Onvansertib (PCM-075)
Acute Myeloid Leukemia (AML)
Phase 1/2
Phase 1/2 presentation at ESMO September 27, 2019.
TROV
$2.16
+0.04  +1.89%
Onvansertib (PCM-075) and Zytiga
Prostate cancer
Phase 2
Phase 1/2 presentation at ESMO September 27, 2019.
ALRN
$0.58
-0.02  -3.52%
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
$33.63
+0.08  +0.24%
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
AMRN
$21.61
-0.26  -1.19%
Vascepa
High Triglycerides With Mixed Dyslipidemia
PDUFA priority review
PDUFA date under priority review September 28, 2019.
ZEAL
$22.39
+0.43  +1.98%
Dasiglucagon
Severe hypoglycemia in diabetes - children
Phase 3
September 2019
Phase 3 data due September 2019.
NVS
$89.23
-0.04  -0.04%
QVM149
Asthma
Phase 3
3Q 2019
Phase 3 trial to be completed 3Q 2019.
GILD
$67.67
-0.4  -0.59%
Filgotinib and GS-9876
Sjogren’s syndrome
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
MRNS
$4.35
-0.1  -2.25%
Ganaxolone
Refractory status epilepticus (RSE)
Phase 2
3Q 2019
Data due by the end of 3Q 2019.
LGND
$117.36
+0.83  +0.72%
Ganaxolone
Refractory status epilepticus (RSE)
Phase 2
3Q 2019
Data due by the end of 3Q 2019.
SYBX
$8.15
-0.11  -1.33%
SYNB1020
Cirrhotic patients with elevated ammonia
Phase 1/2
3Q 2019
Phase 1/2 top-line data due 3Q 2019.
GLPG
$172.31
+1.55  +0.91%
Filgotinib and GS-9876
Cutaneous lupus erythematosus (CLE)
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
GILD
$67.67
-0.4  -0.59%
Filgotinib and GS-9876
Cutaneous lupus erythematosus (CLE)
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
NVO
$47.91
+0.26  +0.55%
Anti-IL 21 GLP-1 T1D (NNc)
Type 1 diabetes
Phase 2
3Q 2019
Phase 2 data due 2Q 2019. Timeline missed. Estimate 3Q 2019.
RYTM
$20.48
+0.04  +0.20%
Setmelanotide
Leptin Receptor Deficiency Obesity
Phase 3
3Q 2019
Phase 3 top-line data due 3Q 2019.
RYTM
$20.48
+0.04  +0.20%
Setmelanotide
POMC deficiency obesity
Phase 3
3Q 2019
Phase 3 initial data due 3Q 2019.
RETA
$85.79
-0.11  -0.13%
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
$3.64
+0.02  +0.55%
RVL-1201
Blepharoptosis
NDA Filing
3Q 2019
Phase 3 data May 6, 2019 met primary endpoint. NDA filing due 3Q 2019.
CNCE
$11.32
-0.12  -1.09%
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
$21.13
-0.09  -0.42%
RE-024 fosmetpantotenate
Pantothenate kinase-associated neurodegeneration (PKAN)
Phase 3
3Q 2019
Phase 3 top-line data due 3Q 2019.
VRTX
$176.62
+0.24  +0.14%
VX-445 in combination with tezacaftor and ivacaftor
Cystic fibrosis (CF) who have one copy of the F508del mutation and one minimal function mutation
NDA Filing
3Q 2019
NDA filing due 3Q 2019.
GILD
$67.67
-0.4  -0.59%
GS-9131
HIV
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
ARAV
$5.71
  +0.00%
AVB-S6-500
Ovarian cancer
Phase 1b
3Q 2019
Phase 1b initial safety data due 3Q 2019.
OMER
$15.25
-0.04  -0.26%
OMS527
Nicotine Addiction
Phase 1
3Q 2019
Phase 1 trial to be completed 3Q 2019.
AGN
$165.95
-0.13  -0.08%
Bimatoprost
Open-angle glaucoma or ocular hypertension
NDA Filing
3Q 2019
NDA filing due estimate 3Q 2019.
GSK
$41.27
+0.38  +0.92%
Dolutegravir + lamivudine (GEMINI 2)
Phase 3 trial met primary endpoint - June 14, 2018. 96-week data due 3Q 2019.
Phase 3
3Q 2019
Phase 3 trial met primary endpoint - June 14, 2018. 96-week data due 3Q 2019.
GSK
$41.27
+0.38  +0.92%
Cabotegravir + rilpivirine - ATLAS2M
HIV
Phase 3
3Q 2019
Phase 3 8-week data due 3Q 2019.
ZGNX
$46.95
-0.29  -0.61%
FINTEPLA (ZX008)
Dravet syndrom
NDA Filing
3Q 2019
Refusal to file Letter (RTF) issued April 8, 2019. Intends to resubmit NDA in 3Q 2019.
ALNY
$73.26
+0.47  +0.65%
Inclisiran - ORION-9
Hypercholesterolemia
Phase 3
3Q 2019
Phase 3 data 3Q 2019.
MDCO
$36.59
-0.04  -0.11%
Inclisiran - ORION-9
Hypercholesterolemia
Phase 3
3Q 2019
Phase 3 data 3Q 2019.
AUTL
$16.10
  +0.00%
AUTO3 - (ALEXANDER)
Relapsed or refractory diffuse large B-celllymphoma (DLBCL)
Phase 1/2
3Q 2019
Phase 1/2 data update due 3Q 2019.
GILD
$67.67
-0.4  -0.59%
GS-9688
HBV
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
TBIO
$9.68
-0.14  -1.38%
MRT5005
Cystic fibrosis
Phase 1/2
3Q 2019
Phase 1/2 interim data 3Q 2019.
FOLD
$12.73
+0.2  +1.64%
CLN6 Gene Therapy
Batten disease
Phase 1/2
3Q 2019
Phase 1/2 preliminary data due 3Q 2019.
JAGX
$2.63
-0.19  -6.67%
Mytesi (crofelemer) HALT-D
Cancer related diarrhea (CRD)
Phase 2
3Q 2019
Phase 2 interim data due 1H 2019. Timeline missed. Assume 3Q 2019 release.
RHHBY
$33.63
+0.08  +0.24%
Mytesi (crofelemer) HALT-D
Cancer related diarrhea (CRD)
Phase 2
3Q 2019
Phase 2 interim data due 1H 2019. Timeline missed. Assume 3Q 2019 release.
GTHX
$26.12
-1.01  -3.74%
Trilaciclib plus Tecentriq
First-line small-cell lung cancer
Phase 2
3Q 2019
Phase 2 additional data due 3Q 2019.
GTHX
$26.12
-1.01  -3.74%
G1T48
ER+, HER2- breast cancer
Phase 1/2
3Q 2019
Phase 1/2 preliminary data due 3Q 2019.
VNDA
$13.58
+0.01  +0.07%
Tradipitant
Motion sickness
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
VRTX
$176.62
+0.24  +0.14%
VX-445 in combination with tezacaftor and ivacaftor
Cystic fibrosis (CF) who have two copies of the F508del mutation
NDA Filing
3Q 2019
NDA filing due 3Q 2019.
ENTA
$82.08
+0.29  +0.35%
EDP-305 ARGON-1
Non-alcoholic steatohepatitis (NASH)
Phase 2
3Q 2019
Phase 2 initial data due 3Q 2019.
ETON
$7.16
+0.16  +2.29%
ET-203
Injectable hospital product
NDA Filing
3Q 2019
NDA filing due 3Q 2019.
VNDA
$13.58
+0.01  +0.07%
HETLIOZ (tasimelteon)
Smith-Magenis Syndrome
sNDA Filing
3Q 2019
Phase 3 data released December 10, 2018 - one of two primary endpoints met. sNDA filing due 3Q 2019.
AQST
$4.20
+0.05  +1.20%
AQST-108
Anaphylaxis
Phase 1
3Q 2019
Phase 1 data due 3Q 2019.
IGXT
$0.50
  +-0.03%
RIZAPORT (RHB-103)
Migraine
NDA Filing
3Q 2019
NDA to be resubmitted 3Q 2019.
AGTC
$3.75
-0.05  -1.32%
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.
DBVT
$10.17
-0.13  -1.26%
Viaskin Peanut
Peanut allergy
BLA Filing
3Q 2019
BLA to be resubmitted 3Q 2019.
TBPH
$17.51
  +0.00%
TD-8236
Asthma
Phase 1
3Q 2019
Phase 1 data due 3Q 2019.
RTRX
$21.13
-0.09  -0.42%
CNSA-001
Phenylketonuria (PKU)
Phase 2
3Q 2019
Phase 2 data due 2Q 2019. Timeline missed. Estimate 3Q 2019.
CYTK
$11.13
+0.06  +0.57%
CK-3773274
Healthy volunteers (hypertrophic cardiomyopathy (HCM))
Phase 1
3Q 2019
Phase 1 data due 3Q 2019.
NERV
$6.42
-0.05  -0.77%
MIN-202 (seltorexant) vs quetiapine
Major Depressive Disorder
Phase 2b
3Q 2019
Phase 2b data due 3Q 2019.
ARDX
$2.55
+0.01  +0.39%
Tenapanor - AMPLIFY
Hyperphosphatemia - adjunctive therapy to phosphate binders
Phase 3
3Q 2019
Phase 3 data due 3Q 2019.
MYOV
$8.76
-0.07  -0.74%
Relugolix - LIBERTY 1 and LIBERTY 2
Menstrual bleeding associated with uterine fibroids
Phase 3
3Q 2019
Phase 3 LIBERTY 1 top-line data met primary endpoint - May 14, 2019. LIBERTY 2 data due 3Q 2019.
ALNY
$73.26
+0.47  +0.65%
Inclisiran - ORION-10
Cardiovascular disease (ASCVD)
Phase 3
3Q 2019
Phase 3 sata due 3Q 2019.
MDCO
$36.59
-0.04  -0.11%
Inclisiran - ORION-10
Cardiovascular disease (ASCVD)
Phase 3
3Q 2019
Phase 3 sata due 3Q 2019.
EVLO
$7.01
-0.61  -8.00%
EDP1066
Psoriasis or atopic dermatitis
Phase 1
3Q 2019
Phase 1b initial data due 3Q 2019.
SNGX
$0.98
  +0.00%
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.
ALNY
$73.26
+0.47  +0.65%
Inclisiran - ORION 11
Cardiovascular disease (ASCVD)
Phase 3
3Q 2019
Phase 3 data due 3Q 2019.
MDCO
$36.59
-0.04  -0.11%
Inclisiran - ORION 11
Cardiovascular disease (ASCVD)
Phase 3
3Q 2019
Phase 3 data due 3Q 2019.
NTRP
$6.50
-0.07  -1.07%
Bryostatin
Alzheimer's disease
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
ASLN
$3.44
+0.21  +6.50%
ASLAN003
Acute Myeloid Leukemia (AML)
Phase 2
3Q 2019
Phase 2 Part 1 data due 2Q 2019. Timeline missed. Estimate 3Q 2019.
AZN
$40.18
-0.04  -0.10%
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
$26.12
-1.01  -3.74%
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.
OBSV
$10.20
+0.05  +0.49%
OBE022 - PROLONG
Pre-term labor
Phase 2a
3Q 2019
Phase 2a Part B interim analysis due 2Q 2019. Timeline missed. Estimate 3Q.
VRNA
$4.25
  +0.00%
Ensifentrine (RPL554) - Metered Dose Inhaler
Maintenance treatment of COPD
Phase 2
3Q 2019
Phase 2 MDI data due 3Q 2019.
VRNA
$4.25
  +0.00%
RPL554 DPI formulation
Maintenance treatment of COPD
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
LGND
$117.36
+0.83  +0.72%
RPL554 DPI formulation
Maintenance treatment of COPD
Phase 2
3Q 2019
Phase 2 data due 3Q 2019.
APVO
$0.85
-0.02  -1.95%
APVO210
Healthy volunteers
Phase 1
3Q 2019
Phase 1 trial initiation announced March 20, 2019 with initial single ascending doses (SAD) data due 3Q and safety data 4Q 2019.
LPTX
$2.05
+0.02  +0.99%
DKN-01 and Paclitaxel
Endometrial Cancer
Phase 2
September 2019
Phase 2 updated data due September 2019.

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