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, Advisory Committee and Phase 2 & 3 trial data releases dates.
Refer to the Biotech Historical Catalyst Calendar for completed biotech stock catalysts.
The catalyst date is the LATEST expected date for the catalyst to occur by. For example, if the catalyst date is 12/31/17, the event is expected to occur BY 12/31/17. It does NOT necessarily mean that the catalyst will occur ON this date. In most cases it will occur BEFORE.
Please refer to the "FDA Calendar Glossary" for a list of terms used in the FDA Decision Calendar.
LARGE CAP CATALYSTS - generally only Phase 3 catalysts noted in company presentations and/or earnings releases are shown.
PDUFA DATES - biosimilars and sNDA/sBLA filings and resubmissions are only noted if a PDUFA date has been released by the company. No official PDUFA date = No entry (e.g. Saxagliptin and dapagliflozin resubmission). Standard reviews for NDA/BLA filings use a 10 month estimate following filing acceptance for a NEW MOLECULAR ENTITY if no PDUFA date has been announced.
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Showing 545 drugs
| Ticker | Price | Drug | Stage | Catalyst |
|---|---|---|---|---|
| GSK |
$39.80
-0.26 (-0.64%)
|
FF/UMEC/VI
Chronic obstructive pulmonary disease (COPD)
|
PDUFA |
Filing announced Novermber 21, 2016. PDUFA estimate September 21, 2017.
|
| INVA |
$13.97
+0.16 (+1.15%)
|
FF/UMEC/VI
Chronic obstructive pulmonary disease (COPD)
|
PDUFA |
Filing announced November 21, 2016. PDUFA estimate September 21, 2017.
|
| MRK |
$65.83
-0.16 (-0.25%)
|
Keytruda
Cancer - Third-line Gastric or Gastroesophageal Junction Adenocarcinoma
|
PDUFA priority review |
PDUFA date under priority review Sept. 22, 2017.
|
| JNJ |
$135.13
-0.26 (-0.19%)
|
Sirukumab
Rheumatoid arthritis
|
PDUFA |
BLA filing announced September 23, 2016. PDUFA estimate September 23, 2017. Advisory Committee Meeting August 2, 2017 voted 12-1 against that safety data is adequate to support approval. 13-0 in favor of efficacy.
|
| BMY |
$62.98
+0.28 (+0.44%)
|
Opdivo (CM-040)
Previously Treated Hepatocellular Carcinoma
|
PDUFA priority review |
PDUFA date under priority review September 24, 2017.
|
| IPCI |
$0.90
-0.02 (-1.98%)
|
Rexista
Pain relief
|
PDUFA |
PDUFA date September 25, 2017. Advisory Committee Meeting July 26, 2017 voted 22-1 against recommending approval. Note that the FDA is stayed from granting approval of Rexista until August 24, 2019 due to patent litigation.
|
| PRQR |
$5.80
-0.15 (-2.53%)
|
QR-010
Cystic Fibrosis
|
Phase 1b |
Phase 1b top-line data due September 25, 2017.
|
| PTCT |
$20.10
-0.31 (-1.52%)
|
Translarna
Duchenne muscular dystrophy caused by nonsense mutations (nmDMD)
|
PDUFA |
Received a Refusal to File letter for their NDA Filing - February 23 2016. Appeal rejected October 17, 2016. Decision made to resubmit NDA during 1Q 2017 under protest. New PDUFA date October 24, 2017. Advisory Committee Meeting September 28, 2017.
|
| NVO |
$48.65
-0.03 (-0.06%)
|
Fast-acting insulin aspart
Type 1 and type 2 diabetes
|
PDUFA |
NDA filing resubmission noted March 29, 2017 in response to CRL issued October 2016. Estimated latest possible PDUFA date - September 29, 2017 using 6-month timeline. Waiting for official date from company.
|
| ABUS |
$5.65
+0 (+0%)
|
Patisiran APOLLO
Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR
|
Phase 3 |
3Q 2017
Phase 3 top-line data due 3Q 2017 - entitled to low to mid-single-digit royalty payments on sales of patisiran by Alnylam.
|
| ABUS |
$5.65
+0 (+0%)
|
ARB-1467
Hepatitis B (HBV)
|
Phase 2 |
Sept 2017
Phase 2 Cohort 4 data due September 2017.
|
| ALNY |
$75.77
-0.23 (-0.31%)
|
Patisiran APOLLO
Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR
|
Phase 3 |
3Q 2017
Phase 3 top-line data due 3Q 2017.
|
| AXON |
$23.58
+0.69 (+3.03%)
|
Intepirdine - MINDSET
Alzheimer's disease
|
Phase 3 |
Late Sept 2017
Phase 3 data are due late September 2017.
|
| AZRX |
$4.20
-0.1 (-2.33%)
|
MS1819-SD
Exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis (CP)
|
Phase 2 |
Sept 2017
Phase 2a data from first six patients due September 2017.
|
| BCRX |
$5.40
-0.03 (-0.47%)
|
RAPIVAB (peramivir injection) | PDUFA |
Sept 2017
PDUFA date for sNDA for a pediatric indication due by the end of September, 2017. No date given.
|
| FCSC |
$3.44
-0.1 (-2.83%)
|
FCX-007
Recessive dystrophic epidermolysis bullosa
|
Phase 1/2 |
3Q 2017
Phase 1/2 initiation of dosing announced February 23, 2017. Phase 1 data due 3Q 2017.
|
| FOLD |
$13.77
+0.1 (+0.73%)
|
ATB200
Pompe Disease
|
Phase 1/2 |
Late-Sept 2017
Phase 1/2 additional data released February 15, 2017. Further data released May 15, 2017. Full data due late 3Q 2017.
|
| GILD |
$82.47
-0.5 (-0.6%)
|
GS-0976
Nonalcoholic steatohepatitis (NASH)
|
Phase 2 |
3Q 2017
Phase 2 trial to be completed 3Q 2017.
|
| GTXI |
$8.38
+0.34 (+4.22%)
|
Enobosarm
Breast cancer - metastatic or locally advanced, ER+/AR+ breast cancer
|
Phase 2 |
3Q 2017
Phase 2 initial data released December, 8 2016. Top-line data due 3Q 2017.
|
| RDHL |
$9.05
+0.15 (+1.68%)
|
BEKINDA
IBS-D
|
Phase 2 |
Sept 2017
Phase 2 top-line data due September 2017.
|
| SNY |
$49.10
+0.46 (+0.94%)
|
Patisiran APOLLO
Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR
|
Phase 3 |
3Q 2017
Phase 3 top-line data due 3Q 2017.
|
| VBLT |
$6.47
+0.67 (+11.47%)
|
VB-111
Recurrent glioblastoma (rGBM) cancer
|
Phase 3 |
Late-Sept 2017
Phase 3 completion of enrollment announced January 6, 2017. Interim analysis due late September 2017. Top-line data due 1Q 2018.
|
| VRX |
$13.74
-0.05 (-0.37%)
|
SAN-300
Rheumatoid Arthritis
|
Phase 2 |
3Q 2017 (est. only)
Phase 2 data due 1H 2017 according to latest company guidance. Timeline has passed so assume data release 3Q 2017.
|
| VSAR |
$19.80
+0.3 (+1.53%)
|
VRS-317 VELOCITY
Growth hormone deficiency, or GHD - pediatric
|
Phase 3 |
Late Sept '17
Phase 3 top-line data due late September 2017.
|
| ZGNX |
$14.05
-0.2 (-1.41%)
|
ZX008 - (Study 1)
Dravet syndrom
|
Phase 3 |
Sept 2017
Phase 3 data due 3Q 2017.
|
| ZYNE |
$6.33
-0.09 (-1.38%)
|
ZYN002
Fragile X syndrome
|
Phase 2 |
Sept 2017
Phase 2 trial initiation announced January 3, 2017. Data are due September 2017.
|
| CATB |
$1.66
+0.06 (+3.68%)
|
CAT-1004
Duchenne muscular dystrophy (DMD)
|
Phase 2 |
Phase 1/2 Part B top-line data released January 31, 2017 - endpoint not met. Part C open-label data to presented October 4, 2017 at the International Congress of the World Muscle Society.
|
| BLUE |
$130.80
-2.25 (-1.7%)
|
Lenti-D - Starbeam
Childhood cerebral adrenoleukodystrophy (CCALD)
|
Phase 2/3 |
Phase 2/3 trial initiated October 2013. Interim top-line data released June 26, 2017. Further data due October 5, 2017 at CNS 2017 meeting.
|
| FLXN |
$25.24
-0.06 (-0.24%)
|
Zilretta - FX006
Osteoarthritis of the knee
|
PDUFA |
PDUFA date October 6, 2017.
|
| MYL |
$31.18
-0.32 (-1.02%)
|
MYL-1401H
Neulasta biosimilar
|
PDUFA |
PDUFA date October 9, 2017.
|
| AGN |
$218.46
-3.08 (-1.4%)
|
Liletta
Prevention of pregnancy
|
PDUFA |
sNDA accepted January 4, 2017. PDUFA estimate September 4 - October 4, 2017.
|
| ACRX |
$3.23
+0.03 (+0.83%)
|
ARX-04 (SAP303)
Moderate-to-severe acute pain following a surgical procedure
|
PDUFA |
PDUFA date October 12, 2017. Noted June 7, 2017 that an Advisory Committee Meeting is no longer planned.
|
| ONCE |
$84.88
+2.04 (+2.47%)
|
Voretigene neparvovec (SPK-RPE65)
Inherited retinal dystrophies
|
PDUFA priority review |
PDUFA date January 12, 2018 under priority review. Advisory Committee Meeting October 12, 2017.
|
| FENC |
$10.75
-0.61 (-5.42%)
|
Sodium Thiosulphate
Cisplatin-induced ototoxicity
|
Phase 3 |
Phase 3 data due October 14th at SIOP conference. Preliminary data released September 13, 2017.
|
| NBIX |
$56.92
+0.23 (+0.4%)
|
INGREZZA
Tardive dyskinesia
|
PDUFA |
PDUFA date for sNDA 80 mg capsules October 14, 2017.
|
| AVEO |
$3.84
+0.07 (+1.85%)
|
TIVO-3 - tivozanib
Third line treatment of patients with renal cell cancer
|
Phase 3 |
Late Sept/Early Oct 2017
Phase 3 completion of enrollment noted June 20, 2017. Futility analysis due September or early October, 2017. Noted early August that outcome is due in 1-2 months. Top-line data due 1Q 2018.
|
| JNJ |
$135.13
-0.26 (-0.19%)
|
STELARA (USTEKINUMAB)
Plaque psoriasis
|
PDUFA |
sBLA filing announced December 15, 2016. PDUFA estimate October 15, 2017.
|
| ATRS |
$2.95
+0.02 (+0.68%)
|
Makena - auto injector
Preterm birth
|
PDUFA |
sNDA filing announced April 17, 2017. PDUFA date October 17, 2017 assuming 6-month priority review.
|
| LOXO |
$88.69
-0.03 (-0.04%)
|
LOXO-292
RET-fusion non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other tumors
|
Phase 1 |
Phase 1 initial data to be presented October 18, 2017.
|
| ATRS |
$2.95
+0.02 (+0.68%)
|
VIBEX QuickShot
Testosterone deficiency
|
PDUFA |
PDUFA date October 20, 2017.
|
| EIGR |
$11.31
-0.24 (-2.08%)
|
Pegylated Interferon Lambda (LIMT HDV)
Hepatitis delta virus (HDV)
|
Phase 2 |
Noted July 24, 2017 that enrollment has been completed. Interim data due at AASLD, October 20 -24, 2017.
|
| JNJ |
$135.13
-0.26 (-0.19%)
|
SIMPONI ARIA
Psoriatic arthritis (PsA)
|
PDUFA |
sBLA filing announced December 21, 2016. PDUFA date estimate October 21, 2017.
|
| JNJ |
$135.13
-0.26 (-0.19%)
|
SIMPONI ARIA
Ankylosing Spondylitis
|
PDUFA |
sBLA filing announced December 21, 2016. PDUFA date estimate October 21, 2017.
|
| ALXN |
$142.84
-0.8 (-0.56%)
|
Eculizumab
Refractory generalized myasthenia gravis (gMG)
|
PDUFA |
(sBLA) PDUFA date October 23, 2017.
|
| AGEN |
$4.20
+0.09 (+2.18%)
|
Shingrix
Shingles
|
PDUFA |
BLA filing announced October 24, 2016. PDUFA estimate October 24, 2017. Advisory Committee Meeting September 13, 2017 voted 11-0 in favor. Shingrix, containing Agenus' adjuvant, QS-21 Stimulon.
|
| GSK |
$39.80
-0.26 (-0.64%)
|
Shingrix
Shingles
|
PDUFA |
BLA filing announced October 24, 2016. PDUFA estimate October 24, 2017. Advisory Committee Meeting September 13, 2017 voted 11-0 in favor.
|
| TSRO |
$119.61
+1.17 (+0.98%)
|
Rolapitant - intravenous (IV)
Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients
|
PDUFA |
CRL January 11 2017. Resubmission noted with new PDUFA October 25, 2017.
|
| JNJ |
$135.13
-0.26 (-0.19%)
|
XARELTO (rivaroxaban)
Reduce the Risk of Recurrent Venous Thromboembolism (VTE)
|
PDUFA priority review |
PDUFA date under priority review October 28, 2017.
|
| MNOV |
$5.49
-0.08 (-1.44%)
|
MN-166
Progressive multiple sclerosis (progressive MS)
|
Phase 2b |
Phase 2b top-line data to be presented October 28, 2017 at Joint ECTRIMS – ACTRIMS meeting.
|
| EGRX |
$56.35
-1.41 (-2.45%)
|
Ready-to-dilute (RTD) Pemetrexed Injection
Nonsquamous Non-Small Cell Lung Cancer (NSCLC) and Mesothelioma
|
PDUFA |
PDUFA date October 30, 2017.
|
| DBVT |
$43.19
+0.08 (+0.18%)
|
Viaskin Peanut (PEPITES)
Peanut allergy
|
Phase 3 |
Phase 3 top-line data due October 2017.
|
| KPTI |
$10.45
-0.41 (-3.78%)
|
Selinexor - SEAL
Dedifferentiated liposarcoma
|
Phase 2/3 |
Phase 2/3 trial initiated January 2016. Top-line data for the Phase 2 portion due September or October 2017.
|
| PRTA |
$64.77
+0.14 (+0.21%)
|
PRX003
Psoriatic Arthritis
|
Phase 1b |
Phase 1b data due October 2017.
|
| KERX |
$7.26
-0.06 (-0.76%)
|
Auryxia
Iron deficiency anemia in non-dialysis dependent CKD patients
|
PDUFA |
(sNDA) PDUFA date November 6, 2017.
|
| BMY |
$62.98
+0.28 (+0.44%)
|
Sprycel (dasatinib)
Philadelphia Chromosome-Positive Chronic Phase Chronic Myeloid Leukemia
|
PDUFA priority review |
PDUFA date under priority review for sNDA of November 9, 2017.
|
| DVAX |
$20.80
+0.05 (+0.24%)
|
HEPLISAV-B
Hepatitis B
|
PDUFA |
CRL February 25, 2013 and November 14, 2016. Original PDUFA date set for August 10, 2017 but noted August 3, 2017 a 3-month extension to August 10.. Advisory Committee Meeting July 28, 2017 voted 21 -1 in favor of recommending approval.
|
| HRTX |
$15.00
-0.2 (-1.32%)
|
CINVANTI (HTX-019)
Prevention of chemotherapy-induced nausea and vomiting (CINV)
|
PDUFA |
PDUFA date November 12, 2017.
|
| ARDX |
$5.60
+0.05 (+0.9%)
|
Tenapanor (T3MPO-2)
Constipation-predominant irritable bowel syndrome (IBS-C)
|
Phase 3 |
Phase 3 data due early 4Q 2017. Estimate November 15, 2017 as latest possible date using company guidance of "early 4Q".
|
| RARE |
$51.77
-1.22 (-2.31%)
|
rhGUS
Mucopolysaccharidosis 7 (MPS 7)
|
PDUFA priority review |
Phase 3 data released July 2016. Primary endpoint hit. Secondary missed. PDUFA date under priority review November 16, 2017.
|
| KITE |
$179.41
+0.52 (+0.29%)
|
Axicabtagene ciloleucel (KTE-C19) - ZUMA-1
Refractory Non-Hodgkin's Lymphoma (NHL) - cancer
|
PDUFA priority review |
PDUFA date under priority review November 29, 2017.
|
| CLDX |
$2.56
+0.03 (+1.18%)
|
Glembatumumab vedotin, varlilumab, Opdivo or Keytruda
Cancer - melanoma
|
Phase 2 |
Phase 2 continues to enroll. Glembatumumab vedotin and varlilumab arm data due fall of 2017.
|
| AMGN |
$186.40
-0.08 (-0.04%)
|
Repatha
Cardiovascular disease
|
PDUFA |
Phase 3 cardiovascular outcomes study data released March 17, 2017 - endpoints met but down on expectations. PDUFA date under priority review December 2, 2017.
|
| MYL |
$31.18
-0.32 (-1.02%)
|
MYL-1401O - trastuzumab biosimilar
Trastuzumab biosimilar
|
PDUFA |
PDUFA date originally set for September 3 extended by three months to December 3, 2017. Advisory Committee Meeting July 13, 2017 voted 16-0 recommending approval.
|
| GSK |
$39.80
-0.26 (-0.64%)
|
Dolutegravir + rilpivirine:
HIV
|
PDUFA priority review |
Primary endpoint of non inferiority met - December 19, 2016. NDA filing announced June 5, 2017. Priority review requested - estimate PDUFA December 5, 2017 (6 month timeline) assuming priority review granted.
|
| JNJ |
$135.13
-0.26 (-0.19%)
|
Rilpivirine and Dolutegravir
HIV
|
PDUFA priority review |
Primary endpoint of non inferiority met - December 19, 2016. NDA filing announced June 5, 2017. Priority review requested - estimate PDUFA December 5, 2017 (6 month timeline) assuming priority review granted.
|
| NVO |
$48.65
-0.03 (-0.06%)
|
Semaglutide
Type 2 diabetes
|
PDUFA |
NDA filed December 5, 2016. PDUFA estimate December 5, 2017.
|
| ARGX |
$21.30
+0 (+0%)
|
ARGX-110
Relapsed/refractory cutaneous T-cell lymphoma (CTCL)
|
Phase 2 |
Phase 2 interim data due at ASH 2017 with top-line data due by the end of 2018.
|
| BLUE |
$130.80
-2.25 (-1.7%)
|
LentiGlobin - HGB-206
Sickle disease
|
Phase 1/2 |
Update at ASH 2016. Further data due at ASH 2017. Exact date TBC.
|
| IMDZ |
$10.20
+0.05 (+0.49%)
|
G100
Follicular non-Hodgkin Lymphoma - cancer
|
Phase 2 |
Phase 2 data at ASCO 2017 (June 2, 2017). Also due at ASH 2017.
|
| SGEN |
$51.70
-1.19 (-2.25%)
|
ADCETRIS
Cancer - ALCANZA trial for relapsed CD30-positive cutaneous T-cell lymphoma
|
PDUFA priority review |
PDUFA date under Priority review for sBLA filing December 16, 2017.
|
| ACRS |
$25.43
+0.08 (+0.31%)
|
A-101
Seborrheic keratosis (SK)
|
PDUFA |
PDUFA date is December 24, 2017
|
| AGRX |
$3.67
-0.06 (-1.5%)
|
Twirla
Contraceptive patch
|
PDUFA |
CRL issued 2013. Phase 3 top-line data released January 3, 2017 - poor data. NDA resubmitted with PDUFA date of December 26, 2017
|
| CORI |
$10.20
+0.04 (+0.39%)
|
Twirla
Contraceptive patch
|
PDUFA |
Phase 3 top-line data released January 3, 2017 - poor data. NDA resubmitted by partner Agile Therapeutics with PDUFA date of December 26, 2017
|
| VRX |
$13.74
-0.05 (-0.37%)
|
Luminesse
Eye Brightener
|
PDUFA |
PDUFA date December 27, 2017.
|
| AEZS |
$2.06
+0.09 (+4.57%)
|
Macimorelin Acetate - Macrilen
Adult Growth Deficiency
|
PDUFA |
CRL issued November 2014. Phase 3 data released January 4, 2017 - trial failed. NDA resubmitted with new PDUFA date of December 30, 2017.
|
| ABBV |
$86.38
+1.06 (+1.24%)
|
Imbruvica - PHOENIX
First-line Diffuse large B-cell lymphoma (DLBCL)
|
Phase 3 |
Phase 3 interim data possibly due 2H 2017.
|
| ABBV |
$86.38
+1.06 (+1.24%)
|
Risankizumab
Psoriasis
|
Phase 3 |
Phase 3 data due by the end of 2017.
|
| ABBV |
$86.38
+1.06 (+1.24%)
|
Elagolix
Uterine Fibroids
|
Phase 3 |
Phase 3 initiated in January 2016. Data due late 2017.
|
| ABBV |
$86.38
+1.06 (+1.24%)
|
Risankizumab
Psoriatic Arthritis
|
Phase 2b |
Phase 2b data due 2017.
|
| ABBV |
$86.38
+1.06 (+1.24%)
|
Rova-T (TRINITY)
Third-line Small Cell Lung Cancer
|
Phase 2 |
Phase 2 pivotal data due 2017.
|
| ADRO |
$11.00
-0.15 (-1.35%)
|
CRS-207 with pembrolizumab
Mesothelioma - cancer
|
Phase 2 |
Phase 2 trial to be initiated 2Q 2017 with early data due 2H 2017.
|
| ADXS |
$4.66
-0.29 (-5.86%)
|
Axalimogene filolisbac + durvalumab
Recurrent or refractory HPV-associated cervical cancer and head & neck cancer
|
Phase 1/2 |
Phase 1/2 updated data due 2H 2017.
|
| ADXS |
$4.66
-0.29 (-5.86%)
|
Axalimogene filolisbac
Anal cancer (FAWCETT)
|
Phase 2 |
Phase 2 initiated June 2016. Preliminary update due 2H 2017.
|
| AFMD |
$2.18
+0.03 (+1.16%)
|
AFM13 with Keytruda
Hodgkin Lymphoma - Cancer
|
Phase 1b |
Phase 1b update 2H 2017.
|
| AGN |
$218.46
-3.08 (-1.4%)
|
Cortisol Analog
Dry Eye disease
|
Phase 3 |
Phase 3 trial to be initiated 2H 2017.
|
| ALKS |
$51.07
-0.95 (-1.84%)
|
ALKS 8700
Multiple sclerosis (MS)
|
Phase 3 |
Phase 3 initiation announced March 16, 2017. Completion expected by end of 2017.
|
| ANAB |
$34.82
-0.98 (-2.74%)
|
ANB020
Moderate-to-severe adult atopic dermatitis
|
Phase 2 |
Phase 2a trial initiated 1Q 2017 with data due 2H 2017.
|
| ANAB |
$34.82
-0.98 (-2.74%)
|
ANB020
Severe adult peanut allergy
|
Phase 2a |
Phase 2a trial initiated 1Q 2017 with data due 2H 2017.
|
| ARDX |
$5.60
+0.05 (+0.9%)
|
RDX7675
Hyperkalemia
|
Phase 2 |
Onset of action trial data due 4Q 2017.
|
| ARGS |
$0.18
+0 (+2.8%)
|
rocapuldencel-T (AGS-003)
Early stage renal cell carcinoma (RCC) - cancer
|
Phase 2 |
Phase 2 trial initial data due 2H 2017.
|
| AST |
$3.25
+0 (+0%)
|
AST-OPC1 SCiSTAR
Cervical spinal cord injury
|
Phase 1/2 |
Phase 1/2 six and nine-month data released January 24, 2017. 10 and 20 million cell cohort 6-month top-line data due January 2018. Cohort 2 12-month data due later in 2017.
|
| ATNM |
$0.61
-0.02 (-3.19%)
|
Actimab-A
Acute Myeloid Leukemia (AML)
|
Phase 2 |
Phase 2 to initiated September 2016. Interim analysis due 2H 2017.
|
| ATNX |
$17.62
+0.59 (+3.46%)
|
Oraxol
Metastatic breast cancer
|
Phase 3 |
Phase 3 interim data due 2017.
|
| AXON |
$23.58
+0.69 (+3.03%)
|
Intepirdine - HEADWAY-DLB
Dementia with Lewy bodies (DLB)
|
Phase 2b |
Phase 2b data due 4Q 2017
|
| AXON |
$23.58
+0.69 (+3.03%)
|
Nelotanserin
Visual hallucinations in subjects with Lewy body dementia
|
Phase 2 |
Phase 2 preliminary data released February 13, 2017. Primary endpoint hit, secondary endpoints missed. Top-line data due 4Q 2017.
|
| AZN |
$32.68
+0.26 (+0.8%)
|
Tralokinumab (STRATOS2)
Severe, uncontrolled asthma
|
Phase 3 |
Phase 3 data due 2H 2017.
|
| AZN |
$32.68
+0.26 (+0.8%)
|
Moxetumomab
Cancer - leukaemia
|
Phase 3 |
Phase 3 data due 2H 2017.
|
| AZN |
$32.68
+0.26 (+0.8%)
|
Durvalumab +/- tremelimumab (ARCTIC)
Lung cancer
|
Phase 3 |
Phase 3 data 2H 2017.
|
| AZN |
$32.68
+0.26 (+0.8%)
|
Benralizumab
Severe, uncontrolled asthma
|
PDUFA |
PDUFA 4Q 2017. Exact data not confirmed. 12/31/2017 used solely for entry into the BioPharmCatalyst database. Actual date will most likely be BEFORE.
|
| BIIB |
$318.54
+0.36 (+0.11%)
|
BAN2401 (Aβ mAb)
Alzheimer’s disease
|
Phase 2 |
Phase 2 data due by the end of 2017.
|
| BIIB |
$318.54
+0.36 (+0.11%)
|
BG00011 (STX-100)
Idiopathic pulmonary fibrosis (IPF)
|
Phase 2 |
Phase 2 to be completed 2017.
|
| BLRX |
$1.07
+0 (+0%)
|
BL-8040 in combination with KEYTRUDA - COMBAT trial
Pancreatic cancer
|
Phase 2 |
Phase 2 initiated September 2016. Partial data due 2H 2017. Full data due 2H 2018.
|
| BLRX |
$1.07
+0 (+0%)
|
BL-8040
Mobilization and collection of bone marrow stem cells
|
Phase 2 |
Phase 2 trial initiated March 2016. Partial data released March 20, 2017 with topline results by the end of 2017 with Phase 2/3 trial to be initiated 2H 2017.
|
| BMY |
$62.98
+0.28 (+0.44%)
|
CM-459 – Opdivo
First-line Hepatocellular carcinoma (HCC) - cancer
|
Phase 3 |
Phase 3 data due 2H 2017.
|
| BMY |
$62.98
+0.28 (+0.44%)
|
CM-511 – Opdivo + Yervoy
First-line Melanoma
|
Phase 3 |
2H 2017
Phase 3 data due 2H 2017.
|
| BMY |
$62.98
+0.28 (+0.44%)
|
CM-227 – Opdivo + Yervoy
First-line Non-small cell lung cancer (NSCLC)
|
Phase 3 |
Phase 3 interim data due 4Q 2017. Primary completion 1Q 2018.
|
| BOLD |
$25.60
-0.15 (-0.59%)
|
AT342 - VALENS
Crigler-Najjar
|
Phase 1/2 |
Phase 1/2 preliminary data due 4Q 2017.
|
| BOLD |
$25.60
-0.15 (-0.59%)
|
AT132 - ASPIRO
X-Linked Myotubular Myopathy
|
Phase 1/2 |
Phase 1/2 preliminary data due 4Q 2017.
|
| BPTH |
$0.35
-0.03 (-8.35%)
|
BP-1001
Acute myeloid leukemia (AML)
|
Phase 2 |
Phase 2 first patient enrolled November 2016. Interim analysis due by the end of 2017.
|
| BTX |
$2.82
-0.04 (-1.23%)
|
AST-OPC1 - SCiStar
Cervical spinal cord injury
|
Phase 1/2 |
Phase 1/2 six and nine-month data released January 24, 2017. 10 and 20m cell cohort 6-month top-line data due January 2018. Cohort 2 12-month data due later in 2017.
|
| BYSI |
$38.17
+0.06 (+0.15%)
|
Plinabulin (Trial 106)
Prevention of neutropenia
|
Phase 2/3 |
First data due 2H 2017.
|
| BYSI |
$38.17
+0.06 (+0.15%)
|
Plinabulin (Trial 105)
Prevention of neutropenia
|
Phase 2/3 |
Phase 2/3 enrollment announced April 25, 2017. Data from Phase 2 portion due 2H 2017. Interim data from Phase 3 portion due 1H 2018.
|
| CALA |
$15.63
+0.03 (+0.16%)
|
CB-839 with paclitaxel
Triple negative breast cancer
|
Phase 2 |
Phase 2 data due 4Q 2017.
|
| CALA |
$15.63
+0.03 (+0.16%)
|
CB-839 + nivolumab
Renal cell carcinoma, malignant melanoma and non-small cell lung cancer
|
Phase 1/2 |
Phase 1/2 enrolment commenced August 2016. Initial data due 2H 2017.
|
| CAPR |
$1.90
+0.57 (+43.93%)
|
CAP-1002 HOPE-Duchenne
Duchenne Muscular Dystrophy (DMD)
|
Phase 1/2 |
Phase 1/2 data released April 25, 2017. Noted improvement in certain measures of cardiac and upper limb function. 12-month data due 4Q 2017.
|
| CBIO |
$4.00
-0.1 (-2.44%)
|
CB 2679d/ ISU304
Hemophilia B
|
Phase 1/2 |
Phase 1/2 completion of dosing announced June 14, 2017 with data due by the end of 2017.
|
| CDTX |
$6.90
-0.05 (-0.72%)
|
CD101 IV - STRIVE
Candidemia
|
Phase 2 |
Phase 2 initiated June 2016. Data due 4Q 2017.
|
| CELG |
$143.25
+0.41 (+0.28%)
|
REVLIMID - RELEVANCE
Newly Diagnosed Follicular Lymphoma
|
Phase 3 |
Phase 3 data due 2H 2017.
|
| CELG |
$143.25
+0.41 (+0.28%)
|
REVLIMID - AUGMENT NHL-007
Relapsed or Refractory Follicular Lymphoma
|
Phase 3 |
Phase 3 data due 2H 2017.
|
| CELG |
$143.25
+0.41 (+0.28%)
|
Ozanimod - SUNBEAM
Relapsing Multiple Sclerosis
|
Phase 3 |
Phase 3 data released February 17, 2017 - primary endpoint met. Full data 2H 2017.
|
| CELG |
$143.25
+0.41 (+0.28%)
|
OTEZLA - BCT-002 RELIEF
Behçet’s Disease
|
Phase 3 |
Phase 3 data due 2017.
|
| CELG |
$143.25
+0.41 (+0.28%)
|
ABRAXANE - PANC-003 apact
Adjuvant Therapy in Surgically Resected Pancreatic Cancer
|
Phase 3 |
Phase 3 data due 2H 2017.
|
| CELG |
$143.25
+0.41 (+0.28%)
|
ABRAXANE - NSCL-003 abound.sqm
First-line late stage Squamous Non-small cell lung cancer (NSCLC)
|
Phase 3 |
Phase data due 2017.
|
| CELG |
$143.25
+0.41 (+0.28%)
|
ABRAXANE - NSCL-003 abound.70+
Elderly Non-small cell lung cancer (NSCLC)
|
Phase 3 |
Phase 3 data due 2H 2017.
|
| CELG |
$143.25
+0.41 (+0.28%)
|
Ozanimod - RADIANCE
Relapsing Multiple Sclerosis
|
Phase 3 |
Phase 3 data due released May 22, 2017 - primary endpoint met, disability endpoint not met. Full data due 2H 2017.
|
| CELG |
$143.25
+0.41 (+0.28%)
|
OTEZLA
Ulcerative Colitis
|
Phase 2 |
Phase 2 data due 2H 2017. Phase 3 trial to be initiated 2018.
|
| CELG |
$143.25
+0.41 (+0.28%)
|
GED-0301
Ulcerative Colitis
|
Phase 2 |
Phase 2 data due 2H 2017.
|
| CEMP |
$3.13
+0.03 (+1.01%)
|
Taksta - Fusidic acid
Refractory infections in bones and joints
|
Phase 2/3 |
Phase 2/3 data due by the end of 2017.
|
| CLRB |
$1.81
-0.02 (-1.1%)
|
CLR 131
Various lymphoma
|
Phase 2 |
Phase 2 trial initiation announced March 30, 2017. Initial data due 2H 2017.
|
| CLSD |
$7.50
-0.1 (-1.32%)
|
Suprachoroidal CLS-TA - HULK
Diabetic macular edema (DME)
|
Phase 1/2 |
Phase 1/2 enrollment completion announced April 20, 2017. Preliminary data due 2H 2017.
|
| CPRX |
$2.42
-0.01 (-0.42%)
|
Firdapse
Lambert-Easton Myasthenic Syndrome (LEMS)
|
Phase 3 |
Refusal to file letter reported on February 17, 2016. Announced that enrollment had commenced in second Phase 3 trial on December 15, 2016. Noted August 30, 2017 that data are due 4Q 2017 with NDA resubmission delayed until early 2018.
|
| CRBP |
$6.84
-0.01 (-0.08%)
|
Anabasum (Resunab)
Dermatomyositis
|
Phase 2 |
Phase 2 data due 4Q 2017.
|
| CRMD |
$0.41
-0.01 (-3.05%)
|
Neutrolin - LOCK-IT 100
Hemodialysis patients with central venous catheters
|
Phase 3 |
Phase 3 data due 2H 2018 with interim analysis possibly due 4Q 2017.
|
| CYTK |
$14.20
-0.05 (-0.36%)
|
Tirasemtiv - VITALITY
Amyotrophic lateral sclerosis (ALS)
|
Phase 3 |
Phase 3 data are due 4Q 2017.
|
| DARE |
$2.95
-0.1 (-3.27%)
|
CRLX301
Solid tumours - cancer
|
Phase 2a |
Phase 2a portion of Phase 1/2a trial commenced dosing June 2016. Initial data due in 2017.
|
| DARE |
$2.95
-0.1 (-3.27%)
|
CRLX101, in combination with LYNPARZA
Solid tumors - cancer
|
Phase 1/2 |
Phase 1/2 trial commenced dosing May 2016. Top-line data due 2017.
|
| DARE |
$2.95
-0.1 (-3.27%)
|
CRLX101 and paclitaxel
Platinum-resistant ovarian cancer
|
Phase 2 |
Further data due in 2017.
|
| DBVT |
$43.19
+0.08 (+0.18%)
|
Viaskin Peanut (REALISE)
Peanut allergy
|
Phase 3 |
Phase 3 completion of enrollment announced March 10, 2017. Data due 2H 2017 - possibly late 3Q or early 4Q.
|
| DBVT |
$43.19
+0.08 (+0.18%)
|
Viaskin Milk
Cow’s milk protein allergy (CMPA)
|
Phase 1/2 |
Phase 1/2 data due 2H 2017.
|
| DCTH |
$0.09
+0.02 (+25.14%)
|
Melphalan Hepatic Delivery System (Melphalan HDS)
Hepatocellular carcinoma (HCC) - cancer
|
Phase 3 |
CRL issued September 13, 2013. New Phase 3 initiated February 2016. Ongoing as of November 2016. Interim safety analysis due 2H 2017.
|
| DMTX |
$5.82
-0.08 (-1.38%)
|
DTX301
Ornithine Transcarbamylase (OTC) Deficiency
|
Phase 1/2 |
Phase 1/2 initial data due late 2017.
|
| DRRX |
$1.62
-0.03 (-1.82%)
|
POSIMIR - PERSIST 3
Post-operative pain relief
|
Phase 3 |
CRL Feb 12 2014. Phase 3 commenced November 2015 in response to CRL. Enrollment originally expected to take one year but the company announced ammendments to the trial on April 7, 2016, which will result in time added to complete the trial. Noted June 22, 2017 that enrollment has been completed with top-line data due 4Q 2017.
|
| EARS |
$0.70
+0.01 (+1.09%)
|
AM-111 HEALOS
Acute inner ear hearing loss
|
Phase 3 |
Phase 3 HEALOS completion of enrollment announced June 5, 2017. Data due 4Q 2017.
|
| EGLT |
$1.44
-0.08 (-5.27%)
|
Egalet-002
Moderate to severe chronic pain
|
Phase 3 |
Phase 3 to be completed 4Q 2017. NDA planned for 2018.
|
| EVOK |
$3.37
+0.04 (+1.2%)
|
Gimoti - EVK-001
Female diabetic gastroparesis
|
Phase 3 |
Phase 3 data released July 2016. Primary endpoint not met. However, the company noted December 15, 2016 that following discussions with FDA regarding possible NDA submission, no new efficacy or safety study would be required, if bioequivalence criteria were met in a pharmacokinetic (PK) trial. PK data due 4Q 2017 with NDA filing to be submitted by late 2017 or early 2018.
|
| EXEL |
$27.75
+0.17 (+0.61%)
|
XL184 cabozantinib (CELESTIAL)
Advanced hepatocellular cancer (HCC)
|
Phase 3 |
Phase 3 initiated Sept 2013. Data due 2H 2017.
|
| EYEG |
$1.19
+0.04 (+3.47%)
|
EGP-437
Ocular inflammation and pain post cataract surgery
|
Phase 2b |
PPhase 1/2 top-line data released July 2016. Further data released December 5, 2016. Phase 2b commencement of enrollment announced August 1, 2017. Data due end of 2017.
|
| EYEG |
$1.19
+0.04 (+3.47%)
|
EGP-437
Non-infectious anterior uveitis
|
Phase 3 |
Phase 3 enrollment to be completed 3Q 2017. Top-line data due 4Q 2017
|
| FBIO |
$4.49
+0.03 (+0.67%)
|
CAEL‐101
AL amyloidosis
|
Phase 1/2 |
Phase 1/2 data due 2H 2017
|
| FBIO |
$4.49
+0.03 (+0.67%)
|
Triplex vaccine
Cytomegalovirus (CMV)
|
Phase 2 |
Phase 2 data due 2H 2017.
|
| FLKS |
$3.48
+0.03 (+0.72%)
|
FLX-787
Multiple Sclerosis
|
Phase 2 |
Phase 2 data due by the end of 2017.
|
| GALT |
$1.66
-0.03 (-1.49%)
|
GR-MD-02
Non-alcoholic steatohepatitis (NASH) with cirrhosis
|
Phase 2b |
Phase 2b top-line data due December 2017.
|
| GBT |
$28.20
+0.4 (+1.43%)
|
GBT440
Hypoxemia in patients with idiopathic pulmonary fibrosis (IPF) who are on supplemental oxygen at rest
|
Phase 2a |
Phase 2a initiated November 2016. Data due 4Q 2017.
|
| GBT |
$28.20
+0.4 (+1.43%)
|
GBT440 HOPE-KIDS 1
Sickle cell disease - children age 6-17.
|
Phase 1/2 |
Phase 2a initiated June 2016. Preliminary data released at European Hematology Association (EHA) - June 23, 2017. Noted July 10, 2017 that trial has been expanded to include a new single-dose cohort in children age 6 to 11 with data due by the end of 2017.
|
| GILD |
$82.47
-0.5 (-0.6%)
|
GS-9674
Nonalcoholic steatohepatitis (NASH)
|
Phase 2 |
Phase 2 data due 4Q 2017.
|
| GNMX |
$1.37
+0.03 (+2.23%)
|
AEVI-002 (Anti-LIGHT mAb)
Pediatric onset Crohn's disease
|
Phase 1/2 |
Phase 1/2 data due around end of 2017.
|
| GSK |
$39.80
-0.26 (-0.64%)
|
anti-SAP mAb
Amyloidosis
|
Phase 2b |
Phase 2b data likely due 4Q 2017.
|
| GSK |
$39.80
-0.26 (-0.64%)
|
GSK 165
Rheumatoid arthritis
|
Phase 3 |
Phase 2b data due 2H 2017.
|
| GSK |
$39.80
-0.26 (-0.64%)
|
Nucala
Chronic obstructive pulmonary disease (COPD)
|
Phase 3 |
Phase 3 data due 2017.
|
| GSK |
$39.80
-0.26 (-0.64%)
|
GSK 166
Rheumatoid arthritis
|
Phase 2b |
Phase 2b data due 2H 2017.
|
| GSK |
$39.80
-0.26 (-0.64%)
|
GSK 165
Osteoarthritis
|
Phase 2 |
Phase 2 data due 2H 2017.
|
| HALO |
$16.75
+0.03 (+0.17%)
|
PEGPH20 in combination with KEYTRUDA
Non-small cell lung cancer (NSCLC)
|
Phase 1b |
Phase 1b enrolment resumed July 2016 under revised protocol. Response rate data possible by end of 2017.
|
| IMRN |
$6.23
+0.48 (+8.34%)
|
IMM-124E
Nonalcoholic steatohepatitis (NASH)
|
Phase 2 |
Phase 2 top-line data due 4Q 2017. Interim analysis July 10, 2017 showed no statistical difference with placebo.
|
| IONS |
$59.05
-0.52 (-0.88%)
|
IONIS-HTT Rx
Huntington's Disease
|
Phase 1/2 |
Phase 1/2 completion of enrollment noted June 22, 2017. Top-line data due around the end of 2017.
|
| IRWD |
$15.51
-0.34 (-2.15%)
|
IW-1973
Type 2 diabetes
|
Phase 2a |
Phase 2a data due 2H 2017.
|
| IRWD |
$15.51
-0.34 (-2.15%)
|
IW-1973
Type 2 diabetes
|
Phase 2 |
Phase 2a data due 2H 2017.
|
| KDMN |
$3.14
+0.16 (+5.36%)
|
KD025
Idiopathic pulmonary fibrosis (IPF)
|
Phase 2 |
Phase 2 data due 4Q 2017.
|
| KDMN |
$3.14
+0.16 (+5.36%)
|
KD025
Moderate to severe chronic plaque psoriasis
|
Phase 2 |
Phase 2 first patient dosed September 2016. Data due 4Q 2017.
|
| KITE |
$179.41
+0.52 (+0.29%)
|
Axicabtagene ciloleucel - KTE-C19 (ZUMA-6)
Refractory diffuse large B-cell lymphoma (DLBCL)
|
Phase 1/2 |
Phase 1/2 initiated October 2016. Phase 1 data due 2017.
|
| KMDA |
$4.75
+0.1 (+2.15%)
|
Alpha-1 Antitrypsin (AAT)
Pediatric patients newly diagnosed with type 1 diabetes
|
Phase 2/3 |
Phase 2/3 data due 2H 2017.
|
| LLY |
$81.72
-0.8 (-0.97%)
|
Flortaucipir F 18 (Tau imaging agent)
Alzheimer's disease
|
Phase 3 |
Phase 3 ongoing. Data due 2017 (internal readout).
|
| LLY |
$81.72
-0.8 (-0.97%)
|
Alimta + Keytruda (MK-3475-189/KEYNOTE-189)
First-Line Non-Squamous Non-Small Cell Lung Cancer
|
Phase 3 |
Phase 3 data due late 2017.
|
| LLY |
$81.72
-0.8 (-0.97%)
|
Abemaciclib - JUNIPER
Thrid line KRAS mutation positive Non-small cell lung cancer (NSCLC)
|
Phase 3 |
Phase 3 ongoing. Data due 2017 (internal readout).
|
| LOXO |
$88.69
-0.03 (-0.04%)
|
Larotrectinib (LOXO-101)
Solid tumors that harbor a TRK fusion.
|
Phase 2 |
Announced 76% ORR at ASCO - June 3, 2017. Primary analysis by the end of 2017 with NDA filing late 2017 or early 2018.
|
| MBVX |
$0.65
-0.03 (-4.4%)
|
MVT-1075
Pancreatic, colon and lung cancers
|
Phase 1 |
Phase 1 interim data due by the end of 2017.
|
| MCRB |
$14.99
-0.17 (-1.13%)
|
SER-287
Mild-to-Moderate Ulcerative Colitis
|
Phase 1b |
Phase 1b initiated December 2015. Completion of enrollment noted June 5, 2017. Data due 2H 2017
|
| MDGL |
$21.11
+1.31 (+6.61%)
|
MGL-3196
Heterozygous familial hypercholesterolemia (HeFH)
|
Phase 2 |
Phase 2 top-line data due by end of 2017.
|
| MDGL |
$21.11
+1.31 (+6.61%)
|
MGL-3196
Non-alcoholic steatohepatitis (NASH)
|
Phase 2 |
Phase 2 completion of enrollment announced August 1, 2017. Top-line data due end of 2017.
|
| MESO |
$5.45
+0.05 (+0.92%)
|
MSC-100-IV
acute graft versus host disease (aGVHD) in children
|
Phase 3 |
Phase 3 data due 2H 2017.
|
| MRK |
$65.83
-0.16 (-0.25%)
|
(MK-3475-189/KEYNOTE-189)
First Line Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
|
Phase 3 |
Phase 3 data due 4Q 2017.
|
| MRK |
$65.83
-0.16 (-0.25%)
|
Ertugliflozin
Type 2 diabetes
|
PDUFA |
PDUFA date set for December 2017 - exact date not provided. December 31 entered as latest possible date for calendar entry purposes only.
|
| MRNS |
$4.39
+0.09 (+1.97%)
|
Ganaxolone
Postpartum depression
|
Phase 2 |
Phase 2 data due in 2H 2017.
|
| MRSN |
$15.23
-0.69 (-4.34%)
|
XMT1522
HER2 - breast cancer
|
Phase 1 |
Phase 1 safety data due around the end of 2017.
|
| MRTX |
$10.80
+0 (+0%)
|
Mocetinostat and durvalumab
Non-small cell lung cancer (NSCLC)
|
Phase 2 |
Phase 2 combination trial initiated June 2016. Update due 2H 2017.
|
| MRTX |
$10.80
+0 (+0%)
|
Glesatinib (MGCD265)
Non-small cell lung cancer (NSCLC) patients with driver alterations in MET
|
Phase 2 |
Phase 2 initiated December 2015. Enrollment ongoing - update due 2H 2017.
|
| MRUS |
$16.06
-0.09 (-0.53%)
|
MCLA-128
Gastric cancer
|
Phase 1/2 |
Decision to support further development path expected 4Q 2017.
|
| MTFB |
$8.23
+0.05 (+0.61%)
|
Iclaprim - REVIVE-2
Acute bacterial skin and skin structure infections (ABSSSI)
|
Phase 3 |
Phase 3 data due 4Q 2017.
|
| NBIX |
$56.92
+0.23 (+0.4%)
|
Elagolix
Uterine Fibroids
|
Phase 3 |
Phase 3 initiated by partner Abbvie in January 2016. Data due late 2017.
|
| NKTR |
$22.03
-0.57 (-2.53%)
|
Inhaled Amikacin Solution (BAY41-6551T)
Gram-Negative Pneumonia (INHALE 1)
|
Phase 3 |
Phase 3 data due 4Q 2017.
|
| NLNK |
$11.88
-0.21 (-1.74%)
|
Indoximod + chemotherapy
Acute Myeloid Leukemia (AML)
|
Phase 1/2 |
Phase 1/2 data due 2H 2017.
|
| NLNK |
$11.88
-0.21 (-1.74%)
|
Indoximod + temozolomide
Glioblastoma multiforme cancer
|
Phase 2 |
Phase 2 data due 2H 2017.
|
| NLNK |
$11.88
-0.21 (-1.74%)
|
Indoximod + gemcitabine and nab-paclitaxel
Pancreatic cancer
|
Phase 2 |
Phase 2 data due 2H 2017.
|
| NVAX |
$1.13
+0.01 (+0.89%)
|
NanoFlu vaccine
Influenza
|
Phase 1/2 |
Phase 1/2 data due 4Q 2017.
|
| NVS |
$85.77
+0.66 (+0.77%)
|
LEE011: MONALEESA-3
Breast cancer - (post-menopausal)
|
Phase 3 |
Phase 3 trial completion 4Q 2017.
|
| OCRX |
$0.98
+0.02 (+2.27%)
|
OCR-002
Cirrhosis
|
Phase 2a |
Phase 2a trial initiation announced June 1, 2017. Top-line data due by the end of 2017.
|
| OGEN |
$0.34
+0.03 (+10.74%)
|
AG013
Oral mucositis (OM)
|
Phase 2 |
Phase 2 dosing announced August 30, 2017. Preliminary data due by the end of 2017 with completion and full results due by the end of 2018.
|
| ONCS |
$1.00
+0 (+0%)
|
ImmunoPulse IL-12
Melanoma - cancer
|
Phase 2 |
Phase 2 enrollment to commence June 2017 with data due 4Q 2017.
|
| ONTX |
$1.58
-0.02 (-1.25%)
|
IV Rigosertib - INSPIRE
2nd-line HR-MDS (high risk myelodysplastic syndromes)
|
Phase 3 |
Phase 3 enrolling. Interim analysis due 4Q 2017. Noted August 15, 2017 that enrollment has been slower than expected.
|
| PBYI |
$103.85
-1.11 (-1.05%)
|
Neratinib monotherapy with high dose loperamide prophylaxis - CONTROL
Extended adjuvant treatment of early stage HER2-positive breast cancer
|
Phase 2 |
Phase 2 additional data released December 8 2016 and April 4, 2017. Noted high rates of diarrhea. Additional data due 4Q 2017.
|
| PFE |
$35.41
-0.15 (-0.4%)
|
Xeljanz
Psoriatic arthritis
|
Phase 3 |
PDUFA date December 2017. No exact date given. December 31, 2017 noted as last possible date using guidance of "December 31". Advisory Committee Meeting August 3, 2017 voted 10-1 in favor of recommending approval.
|
| PFE |
$35.41
-0.15 (-0.4%)
|
Ertugliflozin
Type 2 diabetes
|
Phase 3 |
PDUFA date set for December 2017 - exact date not provided. December 31 entered as latest possible date for calendar entry purposes only.
|
| PFE |
$35.41
-0.15 (-0.4%)
|
BOSULIF
First-Line Treatment of Philadelphia Chromosome Positive Chronic Myeloid Leukemia
|
PDUFA priority review |
Phase 3 trial met primary endpoint - December 2016. PDUFA date under priority review for sNDA filing December 2017. Exact date not provided.
|
| PHMMF |
$4.20
-0.06 (-1.36%)
|
Zepsyre(PM1183)
Platinum resistant ovarian cancer
|
Phase 3 |
YE 2017
Phase 3 data readout due year end 2017.
|
| PLX |
$0.58
-0.04 (-6.42%)
|
OPRX-106
Ulcerative Colitis
|
Phase 2 |
Phase 2 trial initiation announced November 30, 2016. Data due around the end of 2017.
|
| PSTI |
$1.40
-0.02 (-1.26%)
|
PLX-PAD (stem cells)
Intermittent claudication, or IC
|
Phase 2 |
Phase 2 put on clinical hold Jun 2013. Lifted Sept 2013. Enrollment completed May 2016. Data are due late 2017.
|
| PTI |
$1.88
+0 (+0%)
|
PTI-428
Cystic fibrosis
|
Phase 2 |
Phase 2 28-day data due 4Q 2017.
|
| PULM |
$1.89
-0.06 (-3.08%)
|
PUR0200
COPD
|
Phase 2 |
Phase 2 data due 4Q 2017.
|
| RDUS |
$34.05
+0.34 (+0.99%)
|
Elacestrant
Vasomotor symptoms
|
Phase 2b |
Phase 2b data due 2H 2017.
|
| REGN |
$430.84
-3.8 (-0.88%)
|
EYLEA + nesvacumab
Diabetic macular edema (DME)
|
Phase 2 |
Phase 2 enrollment completed 4Q 2016. Data due 2H 2017.
|
| REGN |
$430.84
-3.8 (-0.88%)
|
EYLEA + nesvacumab
AMD - age-related macular degeneration
|
Phase 2 |
Phase 2 data due 2H 2017.
|
| RETA |
$31.50
-0.38 (-1.2%)
|
Bardoxolone methyl - LARIAT
Pulmonary hypertension due to interstitial lung disease - PH-ILD
|
Phase 2 |
Phase 2 enrollment commenced January 2017. Data due 2H 2017.
|
| RETA |
$31.50
-0.38 (-1.2%)
|
Omaveloxolone - MOTOR
Mitochondrial myopathies (MM)
|
Phase 2 |
Phase 2 initial data due 2H 2017.
|
| RETA |
$31.50
-0.38 (-1.2%)
|
Omaveloxolone - REVEAL
Metastatic melanoma
|
Phase 1/2 |
Phase 1b portion of trial due 2H 2017.
|
| RGLS |
$1.31
-0.03 (-1.88%)
|
RG-012
Renal biopsy study in Alport patients
|
Phase 1/2 |
Phase 1/2 data due year end 2017.
|
| RGNX |
$28.83
-0.97 (-3.28%)
|
RGX-501
Homozygous familial hypercholesterolemia (HoFH)
|
Phase 1/2 |
Phase 1/2 dosing initiated - March 8, 2017. Interim data due by the end of 2017.
|
| RIGL |
$2.47
-0.03 (-1.2%)
|
Fostamatinib
Autoimmune hemolytic anemia (AIHA)
|
Phase 2 |
Phase 2 data from Stage 1 of trial by end of 2017.
|
| RNN |
$2.32
+0 (+0%)
|
Supinoxin
Triple negative breast cancer
|
Phase 2a |
Phase 2a initial data due towards the end of 2017.
|
| RNN |
$2.32
+0 (+0%)
|
RX-3117
Relapsed and refractory pancreatic cancer
|
Phase 2 |
Updated Phase 2a data presented at ASCO GI January 20, 2017. Further data due 4Q 2017.
|
| RNN |
$2.32
+0 (+0%)
|
Archexin
Renal cell carcinoma (RCC) - cancer
|
Phase 2a |
Phase 2a second stage enrolment commenced February 2016. Noted May 4, 2017 an update due later this year.
|
| RVNC |
$23.95
-0.45 (-1.85%)
|
RT002 - SAKURA 2
Moderate to severe glabellar (frown) lines
|
Phase 2 |
Phase 3 completion of enrollment announced March 8, 2017. Data due 4Q 2017.
|
| RVNC |
$23.95
-0.45 (-1.85%)
|
RT002
Plantar fasciitis
|
Phase 2 |
Phase 2 data due 4Q 2017.
|
| RVNC |
$23.95
-0.45 (-1.85%)
|
RT002 - SAKURA 1
Moderate to severe glabellar (frown) lines
|
Phase 3 |
Phase 3 completion of enrollment announced March 8, 2017. Data due 4Q 2017.
|
| RXDX |
$12.18
-0.08 (-0.62%)
|
RXDX-105
Solid tumors - cancer
|
Phase 1b |
Phase 1b data update 2H 2017.
|
| RXDX |
$12.18
-0.08 (-0.62%)
|
STARTRK-2 entrectinib
Solid tumors - cancer
|
Phase 2 |
Phase 2 trial initiated September 2015. Updated data due 4Q 2017. NDA planned for 2H 2018.
|
| RXII |
$0.50
-0 (-0.48%)
|
RXI-109-1402
Connective tissue growth factor (CTGF)
|
Phase 2 |
Phase 2 final readout due 2H 2017.
|
| RXII |
$0.50
-0 (-0.48%)
|
Samcyprone - RXI-SCP-1502
Cutaneous warts
|
Phase 2 |
Phase 2 enrollment completed - noted September 6, 2017. Data read outs due before the end of 2017.
|
| SAGE |
$61.89
-0.81 (-1.3%)
|
Brexanolone - SAGE-547 (202C)
Postpartum Depression - moderate
|
Phase 3 |
Phase 2 data due 2H 2017.
|
| SAGE |
$61.89
-0.81 (-1.3%)
|
SAGE-217
Major Depressive Disorder (MDD)
|
Phase 2 |
Phase 2 initiation announced December 19, 2016. Part B data due 2H 2017.
|
| SAGE |
$61.89
-0.81 (-1.3%)
|
SAGE-217
Parkinson’s disease (PD)
|
Phase 2 |
Phase 2 initiation announced December 13, 2016. Data from Part A data released May 9, 2017. Part B data due 2H 2017.
|
| SAGE |
$61.89
-0.81 (-1.3%)
|
SAGE-217
Postpartum depression (PPD)
|
Phase 2 |
Phase 2 initiation 4Q 2016. Data due 2H 2017.
|
| SAGE |
$61.89
-0.81 (-1.3%)
|
Brexanolone - SAGE-547 (202B)
Postpartum Depression (Severe)
|
Phase 3 |
Phase 3 data due 2H 2017.
|
| SAGE |
$61.89
-0.81 (-1.3%)
|
SAGE-217
Essential tremor
|
Phase 2 |
Announced that screening has opened for Phase 2a trial - December 13, 2016. Data due 2H 2017.
|
| SNDX |
$11.59
-0.26 (-2.2%)
|
E2112
HR+, HER2- breast cancer
|
Phase 3 |
Phase 3 PFS data due by the end of 2017.
|
| SPPI |
$10.19
+0.09 (+0.89%)
|
Poziotinib
Non-small cell lung cancer (NSCLC)
|
Phase 2 |
Phase 2 initiation announced March 30, 2017 with preliminary data due by the end of 2017.
|
| SPPI |
$10.19
+0.09 (+0.89%)
|
Poziotinib
Breast cancer
|
Phase 2 |
Phase 2 initiated March 2016. Data due by the end of 2017.
|
| STML |
$10.95
+0.2 (+1.86%)
|
SL-401
High Risk Myeloproliferative Neoplasms
|
Phase 2 |
Phase 2 ongoing. ASH oral presentation - December 2016. Update due later in 2017.
|
| STML |
$10.95
+0.2 (+1.86%)
|
SL-401
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) cancer
|
Phase 2 |
Phase 2 enrollment completed - noted March 23, 2017. Update on patients enrolled in Stages 1 and 2 at EHA June 23, 2017 with top-line data from Stage 3 due 2H 2017.
|
| STML |
$10.95
+0.2 (+1.86%)
|
SL-401
Cancer- adult relapsed or refractory acute myeloid leukemia (AML)
|
Phase 2 |
Phase 2 ongoing. ASH oral presentation - December 2016. Update due later in 2017.
|
| SVRA |
$8.31
-0.18 (-2.13%)
|
AIR001
Heart failure with preserved ejection fraction (HFpEF)
|
Phase 2 |
Phase 2 data due 4Q 2017.
|
| TBPH |
$32.43
+0.56 (+1.75%)
|
Closed Triple - IMPACT
COPD
|
Phase 3 |
Phase 3 data due 2017.
|
| TCON |
$3.68
-0.05 (-1.35%)
|
TRC105 and Inlyta
Renal Cell Carcinoma (RCC) - cancer
|
Phase 2 |
Phase 2 initiated Dec 2014. Completion of enrollment announced September 7, 2017. Top-line PFS data due later in 2017.
|
| TCON |
$3.68
-0.05 (-1.35%)
|
TRC105
Gestational Trophoblastic Neoplasia cancer
|
Phase 2 |
Phase 2 planned for 2016. Data due 4Q 2017.
|
| TCON |
$3.68
-0.05 (-1.35%)
|
TRC102
Mesothelioma cancer
|
Phase 2 |
Phase 2 initiated October 2015. Data are due in 2017.
|
| TSRO |
$119.61
+1.17 (+0.98%)
|
Niraparib - (QUADRA trial)
Cancer - ovarian
|
Phase 2 |
Phase 2 data due 2H 2017.
|
| VKTX |
$1.21
+0.03 (+2.54%)
|
VK5211
Acute Hip Fracture
|
Phase 2 |
Phase 2 completion of enrollment announced July 12, 2017 with data due 4Q 2017.
|
| VNDA |
$18.45
+0.25 (+1.37%)
|
HETLIOZ (tasimelteon)
Jet Lag Disorder
|
Phase 2 |
Phase 2 data due in 2H 2017.
|
| VRTX |
$152.87
-0.33 (-0.22%)
|
CTP-656
Cystic fibrosis
|
Phase 2 |
Phase 2 trial initiation announced December 21, 2016. Data due by end of 2017.
|
| VRTX |
$152.87
-0.33 (-0.22%)
|
Tezacaftor (VX-661) / ivacaftor
Cystic fibrosis - one copy of the F508del mutation and a second mutation that results in a gating mutation
|
Phase 3 |
Phase 3 data due 2H 2017.
|
| XBIT |
$4.43
-0.08 (-1.83%)
|
Xilonix
Pyoderma Gangrenosum
|
Phase 2 |
Noted November 2016 that Phase 2 trial has been completed and data is being finalized. Noted mid-March 2017 that data will be available soon. No definitive timeline given. Assume some time in 2017.
|
| XLRN |
$39.28
-0.1 (-0.26%)
|
ACE-083
Facioscapulohumeral muscular dystrophy
|
Phase 2 |
Phase 2 dosing initiation announced December 22, 2016. Initial data due late 2017.
|
| XNCR |
$22.31
+0.38 (+1.73%)
|
XmAb5871
IgG4-Related Disease (IgG4-RD)
|
Phase 2 |
Phase 2 top-line data due in 2017.
|
| XENT |
$30.55
-0.1 (-0.33%)
|
RESOLVE steroid-releasing implant
Recurrent sinus obstruction
|
PDUFA |
PDUFA January 7, 2018.
|
| EIGR |
$11.31
-0.24 (-2.08%)
|
Ubenimex - LIBERTY
Pulmonary arterial hypertension (PAH)
|
Phase 2 |
Phase 2 initiated July 2016. Enrollment completion announced May 15, 2017 with data due 1Q 2018 at JPM Conference - January 8-11, 2018.
|
| ARGX |
$21.30
+0 (+0%)
|
ARGX-110
Acute myeloid leukemia (AML)
|
Phase 1/2 |
Phase 1/2 interim data due at ASH 2017.
|
| LLY |
$81.72
-0.8 (-0.97%)
|
Abemaciclib - MONARCH 1 and 2
Second-line hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer and HR+, HER2- breast cancer
|
PDUFA priority review |
Phase 3 data released March 20, 2017 - PFS primary endpoint met. Noted July 10, 2017 PDUFA under priority review. No exact data released. Assume 6-month review rendering a PDUFA date on or around January 10, 2018.
|
| AXSM |
$5.49
+0.39 (+7.64%)
|
AXS-02 CREATE-1
Complex regional pain syndrome (CRPS)
|
Phase 3 |
Initiated July 2015. Interim efficacy analysis due late December 2017 or early January 2018.
|
| AXSM |
$5.49
+0.39 (+7.64%)
|
AXS-02 COAST-1
Knee Osteoarthritis Associated with Bone Marrow Lesions
|
Phase 3 |
Phase 3 commenced March 2016. Interim efficacy analysis due late December 2017 or early January 2018.
|
| SGYP |
$2.69
+0.01 (+0.37%)
|
Trulance (plecanatide)
Constipation-predominant irritable bowel syndrome (IBS-C)
|
PDUFA |
Phase 3 data from first and second trials met primary endpoints - December 9 and 22, 2016. PDUFA date January 24, 2018.
|
| AAAP |
$57.81
+0.18 (+0.31%)
|
Lutathera
Inoperable progressive midgut NETs
|
PDUFA |
CRL issued December 21, 2016. NDA to be resubmission announced July 27, 2017 with new PDUFA date January 26, 2018.
|
| PFE |
$35.41
-0.15 (-0.4%)
|
Talazoparib
BRCA-mutated breast cancer
|
Phase 3 |
Phase 3 data due January 2018.
|
| AZN |
$32.68
+0.26 (+0.8%)
|
Acalabrutinib
Relapsed or Refractory Mantle Cell Lymphoma
|
PDUFA priority review |
Priority Review announced August 2, 2017. Assume 6-month review rendering a PDUFA date on or around February 1, 2018.
|
| AMAG |
$19.03
-0.23 (-1.17%)
|
Feraheme
Adults with iron deficiency anemia (IDA)
|
PDUFA |
PDUFA date February 2, 2018 for sNDA filing.
|
| PTLA |
$51.87
-4.7 (-8.31%)
|
Andexanet alfa
Factor Xa inhibitor reversal agent
|
PDUFA |
CRL August 17 2016. New PDUFA date February 2, 2018.
|
| AMGN |
$186.40
-0.08 (-0.04%)
|
XGEVA
Multiple Myeloma
|
PDUFA |
sBLA filing announced April 4, 2017. Acceptance of filing announced June 19, 2017 - PDUFA February 3, 2018.
|
| LPCN |
$3.95
-0.04 (-0.88%)
|
LPCN 1021
Men with low testosterone (Low T)
|
PDUFA |
CRL issued June 2016. NDA resubmitted with new PDUFA February 8, 2017.
|
| GILD |
$82.47
-0.5 (-0.6%)
|
Bictegravir/F/TAF
HIV
|
PDUFA priority review |
PDUFA date under priority review February 12, 2018.
|
| AMAG |
$19.03
-0.23 (-1.17%)
|
Makena - auto injector
Reduce the risk of preterm birth in women with a singleton pregnancy
|
PDUFA |
sNDA filing announced April 17, 2017. PDUFA date February 14, 2018. 10-month review despite initial expectations of a 6-month review.
|
| APRI |
$1.77
+0 (+0%)
|
Vitaros
Erectile dysfunction
|
PDUFA |
PDUFA date for NDA resubmission February 17, 2018.
|
| KMPH |
$3.60
-0.2 (-5.27%)
|
KP201/APAP
Acute pain.
|
PDUFA |
PDUFA date February 23, 2018 - CRL issued June 13, 2016.
|
| AERI |
$58.65
-1.45 (-2.42%)
|
Rhopressa
Glaucoma
|
PDUFA |
PDUFA date February 28, 2018. Advisory Committee planned.
|
| LJPC |
$33.35
+0.53 (+1.61%)
|
LJPC-501
Hypotension
|
PDUFA priority review |
Phase 3 data released February 27, 2016 - primary endpoint hit. Data published May 21, 2017 confirmed primary endpoint was met but with lack of mortality improvement. PDUFA date under priority review February 28, 2018. No Advisory Committee Meeting planned.
|
| SRNE |
$1.80
-0.05 (-2.71%)
|
ZTlido (lidocaine patch 1.8%)
Pain associated with post-herpetic neuralgia (PHN)
|
PDUFA |
PDUFA date for NDA resubmission February 28, 2017.
|
| VRTX |
$152.87
-0.33 (-0.22%)
|
Tezacaftor (VX-661) / ivacaftor
Cystic fibrosis - Two Copies of the F508del Mutation
|
PDUFA priority review |
Phase 3 data released March 28, 2017 - primary endpoint met. PDUFA date under priority review February 28, 2017.
|
| OTIC |
$3.25
-0.15 (-4.42%)
|
OTIPRIO
Acute otitis externa
|
Phase 3 |
Phase 3 trial met primary endpoint - January 5, 2017. PDUFA date for sNDA filing March 2, 2018.
|
| BMY |
$62.98
+0.28 (+0.44%)
|
Opdivo - 4 week applications | PDUFA |
PDUFA date March 5, 2018 for sBLA filings across all approved indications.
|
| PFE |
$35.41
-0.15 (-0.4%)
|
Xeljanz
Ulcerative colitis
|
PDUFA |
sNDA acceptance announced July 13, 2017. Exact PDUFA date not released by company. BioPharmCatalyst estimate March 13 using 8-month timeline.
|
| ABIO |
$1.17
+0.02 (+2.15%)
|
Gencaro - GENETIC-AF trial
Chronic Heart Failure
|
Phase 2b |
Phase 2b completion of enrollment announced August 16, 2017 - top-line data due late 1Q 2018.
|
| ACOR |
$23.18
+0.13 (+0.56%)
|
Tozadenant
Parkinson’s disease (PD)
|
Phase 3 |
Phase 3 data due 1Q 2018.
|
| AIMT |
$23.21
-0.03 (-0.13%)
|
AR101
Peanut Allergy
|
Phase 3 |
Phase 3 initiated January 2016. Enrollment completion announced November 28, 2016. Top-line data due 1Q 2018.
|
| ANTH |
$1.30
-0.02 (-1.52%)
|
Sollpura - RESULT
Exocrine pancreatic insufficiency
|
Phase 3 |
Phase 3 data due end of 2017 or early 2018.
|
| ARGX |
$21.30
+0 (+0%)
|
ARGX-113
Myasthenia gravis (MG)
|
Phase 2 |
Phase 2 data due 1Q 2018.
|
| ARNA |
$24.50
+0.19 (+0.78%)
|
APD371
Pain associated with Crohn's disease
|
Phase 2 |
Phase 2 data due year-end 2017 or 1Q 2018.
|
| ARNA |
$24.50
+0.19 (+0.78%)
|
Etrasimod
Ulcerative colitis
|
Phase 2 |
Phase 2 data due by end of 2017 or 1Q 2018.
|
| AXON |
$23.58
+0.69 (+3.03%)
|
Nelotanserin
DLB patients experiencing REM Behavior Disorder (RBD)
|
Phase 2 |
Phase 2 data due 1Q 2018.
|
| AXSM |
$5.49
+0.39 (+7.64%)
|
AXS-05 STRIDE-1
Treatment resistant depression
|
Phase 3 |
Phase 3 initiated March 2016. Top-line data due 1Q 2018.
|
| AZN |
$32.68
+0.26 (+0.8%)
|
Brilinta (THEMIS)
Type 2 Diabetes
|
Phase 3 |
Phase 3 data due 1Q 2018.
|
| BHVN |
$37.95
+0.6 (+1.59%)
|
BHV-4157 Trigriluzole
Spinocerebellar Ataxia
|
Phase 2/3 |
Phase 2b/3 enrollment commenced December 2016. Phase 2 top-line data due 1Q 2018.
|
| CLBS |
$3.92
+0.06 (+1.57%)
|
CLBS03
Type 1 diabetes
|
Phase 2 |
Phase 2 top-line data due 1Q 2018.
|
| CLSD |
$7.50
-0.1 (-1.32%)
|
Suprachoroidal CLS-TA - PEACHTREE
Macular edema associated with non-infectious uveitis
|
Phase 3 |
Phase 3 completion of enrollment noted August 7, 2017 with preliminary data due 1Q 2018.
|
| CORI |
$10.20
+0.04 (+0.39%)
|
Corplex Donepezil
Alzheimer's disease
|
Phase 3 |
Pilot bioequivalence data due released May 11, 2017. Pivotal trial to commence fall of 2017 with preliminary data due 1Q 2018.
|
| CORT |
$18.08
-0.35 (-1.9%)
|
CORT125134
Cushing’s syndrome
|
Phase 2 |
Phase 2 trial initiated 2Q 2016. Data due 1Q 2018.
|
| CYTK |
$14.20
-0.05 (-0.36%)
|
CK-2127107
Spinal muscular atrophy (SMA)
|
Phase 2 |
Phase 2 initiated January 2016. Baseline data from first cohort released June 5, 2017. Cohort 2 enrollment to be completed in 2017. Data due 1Q 2018.
|
| DERM |
$26.78
-0.74 (-2.69%)
|
Olumacostat glasaretil (DRM01)
Acne
|
Phase 3 |
Phase 3 trial initiation announced January 3, 2017. Data are due 1Q 2018.
|
| EARS |
$0.70
+0.01 (+1.09%)
|
Keyzilen (AM-101) - TACTT3
Acute inner ear tinnitus
|
Phase 3 |
Phase 3 TACTT3 enrollment resumption announced January 26, 2017 with top-line data 1Q 2018.
|
| ESPR |
$50.16
-0.35 (-0.7%)
|
Bempedoic Acid - 1002-039
Hypercholesterolemia
|
Phase 2 |
Phase 2 initiation announced July 26, 2017 - data due 1Q 2018.
|
| FGEN |
$53.55
+0.8 (+1.51%)
|
Pamrevlumab (FG-3019)
Pancreatic cancer
|
Phase 2 |
Phase 2 ongoing. Data due late 2017 or 1Q 2018.
|
| GALE |
$0.36
+0 (+0.95%)
|
NeuVax in combination with Herceptin
Breast cancer
|
Phase 2b |
Phase 2b enrollment due to be completed in a few weeks (noted July 12, 2017) with interim efficacy analysis due 6 months following - i.e. likely 1Q 2018.
|
| GEMP |
$9.51
+0.4 (+4.39%)
|
Gemcabene - INDIGO-1
Severe Hypertriglyceridemia (SHTG)
|
Phase 2b |
Phase 2b data due 1Q 2018.
|
| GERN |
$2.20
+0 (+0%)
|
Imetelstat - IMbarkStudy
Myelofibrosis
|
Phase 2 |
Phase 2 clinical hold lifted Nov 2014. Phase 2 initiated September 2015. Internal review conducted September 2016. Low dose discontinued, high dose enrollment suspended. Further internal data review due 1Q 2018.
|
| GSK |
$39.80
-0.26 (-0.64%)
|
Dolutegravir + lamivudine (GEMINI 1)
HIV
|
Phase 3 |
Phase 3 trial commenced August 2016. Data likely due 1Q 2018.
|
| GTHX |
$24.30
-0.47 (-1.9%)
|
Trilaciclib
First-line small-cell lung cancer
|
Phase 2 |
Phase 2a top-line data due 1Q 2018.
|
| GTHX |
$24.30
-0.47 (-1.9%)
|
Trilaciclib
First-line small-cell lung cancer
|
Phase 2 |
Phase 2a top-line data due 1Q 2018.
|
| GTHX |
$24.30
-0.47 (-1.9%)
|
Trilaciclib
First-line small-cell lung cancer
|
Phase 2 |
Phase 2a top-line data due 1Q 2018.
|
| GWPH |
$110.30
+1.33 (+1.22%)
|
GWP42006 (CBDV)
Epilepsy
|
Phase 2 |
Phase 2 initiated May 2015. Data due late 2017 or early 2018.
|
| MBIO |
$12.42
+0.17 (+1.38%)
|
MB-102
Acute myeloid leukemia
|
Phase 1 |
Phase 1 data due early 2018.
|
| MBIO |
$12.42
+0.17 (+1.38%)
|
MB-101
Glioblastoma
|
Phase 1 |
Phase 1 data due early 2018.
|
| MCRB |
$14.99
-0.17 (-1.13%)
|
SER-262
Primary Clostridium Difficile infection (CDI)
|
Phase 1b |
Phase 1b initiated July 2016. Data due early 2018.
|
| MEIP |
$2.68
-0.01 (-0.38%)
|
Pracinostat in combination with Vidaza
High-risk Myelodysplastic Syndrome (MDS)
|
Phase 2 |
Phase 2 dosing commenced June 2017 - data from first stage due 1Q 2018.
|
| MESO |
$5.45
+0.05 (+0.92%)
|
MPC-150-IM
Chronic heart failure (CHF)
|
Phase 2b |
Phase 2b data due 1Q 2018.
|
| MYOK |
$47.35
+2.65 (+5.92%)
|
MYK-461 - PIONEER-HCM
Hypertrophic cardiomyopathy (HCM)
|
Phase 2 |
Phase 2 top-line data released August 7, 2017 - primary endpoint met. Data from low dose cohort due 1Q 2018.
|
| OBSV |
$7.13
-0.01 (-0.14%)
|
OBE001 - IMPLANT2
IVF
|
Phase 2 |
Phase 2 trial did not meet primary endpoint in 2016. Phase 3 completion of patient recruitment announced September 6, 2017. Data due 1Q 2018.
|
| OHRP |
$0.70
-0.01 (-1.65%)
|
OHR-102 (MAKO)
Neovascular (Wet) Age-related Macular Degeneration (AMD)
|
Phase 3 |
Phase 3 data due early 2018.
|
| PFE |
$35.41
-0.15 (-0.4%)
|
Tanezumab
Chronic low back pain
|
Phase 3 |
Phase 3 ongoing. Estimate data due late 2017 or early 2018 using clinicaltrials.gov data.
|
| PFE |
$35.41
-0.15 (-0.4%)
|
Tanezumab
Osteoarthritis
|
Phase 3 |
Phase 3 ongoing. Estimate data late 2017 or early 2018 using clinicaltrials.gov data.
|
| PTGX |
$16.12
-0.42 (-2.54%)
|
PTG-100
Ulcerative colitis
|
Phase 2b |
Phase 2b initiation announced January 17, 2017. Interim futility analysis early 2018 with top-line data due 2018.
|
| REGN |
$430.84
-3.8 (-0.88%)
|
Praluent (alirocumab) ODYSSEY OUTCOMES
Cardiovascular events
|
Phase 3 |
Phase 3 data due 1Q 2018.
|
| RXII |
$0.50
-0 (-0.48%)
|
RXI-109-1501
Retinal scarring
|
Phase 1/2 |
Phase 2 completion of enrollment announced June 21, 2017. Data due early 2018.
|
| SGMO |
$14.35
-0.4 (-2.72%)
|
SB-318
MPS Type 1
|
Phase 1/2 |
Phase 1/2 trial initiated early 2017 with data due late 2017 or early 2018.
|
| SGMO |
$14.35
-0.4 (-2.72%)
|
SB-FIX
Hemophilia B
|
Phase 1/2 |
Phase 1/2 data due late 2017 or early 2018.
|
| SGMO |
$14.35
-0.4 (-2.72%)
|
SB-913
MPS Type 2
|
Phase 1/2 |
Phase 1/2 trial initiated early 2017 with data due late 2017 or early 2018.
|
| SMMT |
$12.19
-0.06 (-0.49%)
|
Ezutromid
Duchenne muscular dystrophy
|
Phase 2 |
Phase 2 completion of enrollment announced May 15, 2017. 24-week data due 1Q 2018.
|
| SNY |
$49.10
+0.46 (+0.94%)
|
SAR439684 (PD-1)
Cutaneous squamous cell carcinoma
|
Phase 2 |
Phase 2 data due 1Q 2018.
|
| SNY |
$49.10
+0.46 (+0.94%)
|
Praluent (alirocumab) ODYSSEY OUTCOMES
Cardiovascular events
|
Phase 3 |
Phase 3 data due 1Q 2018.
|
| SPHS |
$2.34
+0.02 (+0.77%)
|
Topsalysin (PRX302)
Localized low to intermediate risk prostate cancer
|
Phase 2 |
Phase 2b six-month biopsy data for all patients in 1Q 2018 with final biopsy data due 4Q 2018.
|
| SPPI |
$10.19
+0.09 (+0.89%)
|
SPI-2012 (ROLONTIS)
Chemotherapy-Induced Neutropenia
|
Phase 3 |
Phase 3 completion of enrollment announced August 1, 2017 with top-line data due 1Q 2018.
|
| TCON |
$3.68
-0.05 (-1.35%)
|
TRC105 and Nexavar
Hepatocellular carcinoma (HCC) - cancer
|
Phase 2 |
Phase 2 dosing initiated May 2016 with data due early 2018.
|
| TTPH |
$6.98
-0.13 (-1.83%)
|
Eravacycline (TP-434) - IGNITE3
cUTI - complicated urinary tract infections
|
Phase 3 |
Phase 3 trial did not meet endpoints September 2015. Additional Phase 3 trial initiation announced January 17, 2016. Completion of enrollment announced September 11, 2017. Data due 1Q 2018.
|
| VICL |
$2.41
-0.04 (-1.64%)
|
VCL-HB01 HSV-2 Therapeutic Vaccine
Genital Herpes in Adults
|
Phase 2 |
Phase 2 trial initiated September 2016. Enrollment completion announced April 19, 2017 with data due 2Q 2018.
|
| VICL |
$2.41
-0.04 (-1.64%)
|
ASP0113 Vaccine
Hematopoietic cell transplant recipients
|
Phase 3 |
Initiated Phase 3 Jun 2013. Enrollment due to be completed 3Q 2016. Topline data due 1Q 2018.
|
| VTVT |
$5.99
+0.03 (+0.5%)
|
Azeliragon - STEADFAST
Mild Alzheimer’s disease
|
Phase 3 |
Phase 3 initiated 2Q 2015. Part A enrollment completed September 2016. Part B enrollment completion announced June 1, 2017. Data from Part A due early 2018. Part B due late 2018
|
| RIGL |
$2.47
-0.03 (-1.2%)
|
Fostamatinib
Immune Thrombocytopenic Purpura (ITP)
|
PDUFA |
Phase 3 data from the first trial released August 30 2016. Primary endpoint met. Data from second trial did not meet the primary endpoint. PDUFA date April 17, 2018.
|
| AMGN |
$186.40
-0.08 (-0.04%)
|
KYPROLIS (ENDEAVOR)
Relapsed Multiple Myeloma
|
PDUFA |
Phase 3 trial met PFS endpoint - March 2015. Announced February 28, 2017 that interim analysis met secondary endpoint of overall survival (OS). PDUFA date for sNDA April 30, 2018.
|
| KPTI |
$10.45
-0.41 (-3.78%)
|
Selinexor - STORM
Quadruple Refractory Multiple Myeloma
|
Phase 2b |
Phase 2b STORM Study Expansion data due April 2018.
|
| NBRV |
$9.70
+0.83 (+9.35%)
|
Lefamulin - LEAP 2
Moderate to severe Community Acquired Bacterial Pneumonia (CABP)
|
Phase 3 |
Spring 2018
Phase 3 data due spring 2018.
|
| AMGN |
$186.40
-0.08 (-0.04%)
|
Erenumab
Migraine
|
PDUFA |
Phase 3 trial met primary endpoint September 2016. PDUFA date May 17, 2018.
|
| NVS |
$85.77
+0.66 (+0.77%)
|
Erenumab
Migraine
|
PDUFA |
Phase 3 trial met primary endpoint September 2016. PDUFA date May 17, 2018.
|
| AGN |
$218.46
-3.08 (-1.4%)
|
ATOGEPANT
Prophylaxis (migraine)
|
Phase 2b |
Phase 2b top-line data due 1H 2018.
|
| AGN |
$218.46
-3.08 (-1.4%)
|
UBROGEPANT
Acute (migraine)
|
Phase 3 |
Phase 3 initiated July 2016. Data due 1H 2018.
|
| ALRN |
$11.81
+0.22 (+1.88%)
|
ALRN-6924
Peripheral T-cell lymphoma (PTCL)
|
Phase 2a |
Phase 2a interim data due 1H 2018.
|
| ALXN |
$142.84
-0.8 (-0.56%)
|
ALXN1210
Paroxysmal nocturnal hemoglobinuria (PNH)
|
Phase 3 |
Phase 3 data due 2Q 2018.
|
| AMGN |
$186.40
-0.08 (-0.04%)
|
ABP 798
RITUXAN biosimilar - non-Hodgkin lymphoma
|
Phase 3 |
Phase 3 enrolling. Estimate data 1H 2018 using clinicaltrials.gov data.
|
| ANAB |
$34.82
-0.98 (-2.74%)
|
ANB020
Severe adult eosinophilic asthma
|
Phase 2a |
Phase 2a data due 1H 2018.
|
| ARRY |
$11.58
+0.28 (+2.52%)
|
Binimetinib - COLUMBUS
BRAF mutant melanoma cancer
|
PDUFA |
Phase 3 data released September 26, 2016 met primary endpoint. PDUFA date June 30, 2018 - no Adcom anticipated.
|
| AVIR |
$0.68
-0.04 (-6.08%)
|
BTA074 5% topical gel
Condyloma
|
Phase 2 |
Phase 2 enrollment to be completed 2H 2017 with data due 1H 2018.
|
| AZN |
$32.68
+0.26 (+0.8%)
|
Lynparza
First-line ovarian cancer
|
Phase 3 |
Phase 3 data due 1H 2018.
|
| AZN |
$32.68
+0.26 (+0.8%)
|
Durvalumab +/- tremelimumab (MYSTIC)
Lung cancer
|
Phase 3 |
Phase 3 data released July 27, 2017 - primary endpoint not met. Overall survival data due 1H 2018.
|
| AZN |
$32.68
+0.26 (+0.8%)
|
Durvalumab +/- tremelimumab (KESTREL)
Head & neck cancer
|
Phase 3 |
Phase 3 data due 1H 2018.
|
| AZN |
$32.68
+0.26 (+0.8%)
|
Durvalumab +/- tremelimumab (EAGLE)
Head & neck cancer
|
Phase 3 |
Phase 3 data due 1H 2018.
|
| BHVN |
$37.95
+0.6 (+1.59%)
|
Rimegepant
Migraine
|
Phase 3 |
Phase 3 trial initiation announced July 24, 2017 with top-line data due 1H 2018.
|
| BMY |
$62.98
+0.28 (+0.44%)
|
CM-651 – Opdivo + Yervoy
First-line Head and Neck Cancer
|
Phase 3 |
Phase 3 data due 1H 2018.
|
| BMY |
$62.98
+0.28 (+0.44%)
|
CM-451 – Opdivo + Yervoy
First-line Small cell lung cancer (SCLC)
|
Phase 3 |
Phase 3 data due 1H 2018.
|
| BMY |
$62.98
+0.28 (+0.44%)
|
CM-331– Opdivo
Second-line Small cell lung cancer (SCLC)
|
Phase 3 |
Phase 3 data due 1H 2018.
|
| BMY |
$62.98
+0.28 (+0.44%)
|
CM-078 – Opdivo
Second-line Non-small cell lung cancer (NSCLC)
|
Phase 3 |
Phase 3 data due 1H 2018.
|
| BMY |
$62.98
+0.28 (+0.44%)
|
CM-548 - Opdivo+SOC
First-line Glioblastoma (GBM) cancer
|
Phase 2 |
Phase 2 data due 1H 2018.
|
| CLDX |
$2.56
+0.03 (+1.18%)
|
Glembatumumab vedotin
Metastatic triple negative breast cancers that overexpress gpNMB
|
Phase 2b |
Phase 2b completion of enrollment announced August 23, 2017. Data likely 2Q 2018.
|
| CLSD |
$7.50
-0.1 (-1.32%)
|
Suprachoroidal CLS-TA - TYBEE
Diabetic Macula Edema (DME)
|
Phase 2 |
Phase 2 trial initiation announced July 11, 2017 with three-month preliminary data 1H 2018.
|
| CNAT |
$5.61
-0.08 (-1.41%)
|
Emricasan
Liver fibrosis post-orthotopic liver transplant due to Hepatitis C virus infection (HCV-POLT)
|
Phase 2b |
Phase 2b initiated May 2014. Topline data due 1H 2018.
|
| CPRX |
$2.42
-0.01 (-0.42%)
|
Firdapse
Congenital Myasthenic Syndromes (CMS)
|
Phase 3 |
Phase 3 data due 1H 2018.
|
| CTIC |
$3.25
+0 (+0.12%)
|
PIXUVRI - PIX306 Trial
B-cell non-Hodgkin lymphoma
|
Phase 3 |
Phase 3 data due 1H 2018. Noted August 2, 2017 that enrollment has completed.
|
| EIGR |
$11.31
-0.24 (-2.08%)
|
Ubenimex - ULTRA
Secondary lymphedema
|
Phase 2 |
Phase 2 dosing commenced July 2016. Enrollment to be completed 4Q 2017. Data due 2Q 2018.
|
| ESPR |
$50.16
-0.35 (-0.7%)
|
Bempedoic acid - CLEAR LDL-C Lowering Program 1002-046, 1002-047 and 1002-048
Hypercholesterolemia - statin intolerance
|
Phase 3 |
Phase 3 initiation of efficacy trials announced January 8, 2017. Data due 2Q and 3Q 2018.
|
| ESPR |
$50.16
-0.35 (-0.7%)
|
Bempedoic acid (ETC-1002-040) - Clear Harmony
Hyperlipidemia whose LDL-C is not adequately controlled with low- and moderate-dose statins
|
Phase 3 |
Phase 3 long-term safety and tolerability trial initiated January 2016. Completion of enrollment announced January 25, 2017. Top-line results due 2Q 2018.
|
| FBIO |
$4.49
+0.03 (+0.67%)
|
CEVA101
Severe Traumatic Brain Injury
|
Phase 2 |
Phase 2 data in children due 1H 2018.
|
| FBIO |
$4.49
+0.03 (+0.67%)
|
Pepvax vaccine
Cytomegalovirus (CMV)
|
Phase 2 |
Phase 2 data due 1H 2018.
|
| FBIO |
$4.49
+0.03 (+0.67%)
|
IV Tramadol
Post-operative Pain
|
Phase 3 |
Phase 3 to be initiated in 3Q 2017 with data due 2Q 2018.
|
| FLKS |
$3.48
+0.03 (+0.72%)
|
FLX-787
Amyotrophic lateral sclerosis (ALS)
|
Phase 2 |
Phase 2 initiated September 2016. Readout due 2017/18.
|
| FOMX |
$5.52
-0.08 (-1.35%)
|
FMX101 - FX2017-22
Acne
|
Phase 3 |
Phase 3 data released March 27, 2017 - three of four primary endpoints met across two trials. Third Phase 3 trial to be initiated with commencement of dosing announced August 3. 2017 with data due mid-2018.
|
| GLMD |
$8.27
+0.28 (+3.63%)
|
Aramchol - ARREST
Non-Alcoholic Steatohepatitis (NASH)
|
Phase 2b |
Phase 2b enrollment complettion announced January 9, 2017. Data due 2Q 2018.
|
| GTHX |
$24.30
-0.47 (-1.9%)
|
G1T38 plus Faslodex
ER+ breast cancer
|
Phase 1b |
Phase 1b preliminary data due 2Q 2018.
|
| IDRA |
$2.34
+0.11 (+4.88%)
|
IMO-8400
Dermatomyositis
|
Phase 2 |
Phase 2 initiated November 2015. Enrollment to be completed by the end of 2017 with data due 1H 2018.
|
| JNCE |
$15.37
-0.03 (-0.2%)
|
JTX-2011
Solid tumors - Cancer
|
Phase 1/2 |
Phase 1/2 trial initiated September 2017.Phase 2 arm initiation announced April 21, 2017. Efficacy data due 1H 2018.
|
| JNJ |
$135.13
-0.26 (-0.19%)
|
Esketamine
Treatment resistant depression
|
Phase 3 |
Phase 3 ongoing. Data and regulatory filings likely due 2018.
|
| KURA |
$12.50
-0.35 (-2.73%)
|
Tipifarnib
Chronic myelomonocytic leukemia (CMML) - cancer
|
Phase 2 |
Phase 2 first dosing announced January 17, 2016 with data due 1H 2018.
|
| KURA |
$12.50
-0.35 (-2.73%)
|
Tipifarnib
Lower risk myelodysplastic syndromes (MDS) - cancer
|
Phase 2 |
Phase 2 top-line data due 1H 2018.
|
| MACK |
$14.60
+0.03 (+0.2%)
|
MM-141 - CARRIE
Cancer - front line pancreatic cancer
|
Phase 2 |
Phase 2 completion of enrollment announced June 19, 2017. Data due 1H 2018.
|
| MDWD |
$5.05
-1 (-16.53%)
|
NexoBrid
Severe burns
|
Phase 3 |
Phase 3 initiated mid April 2015. Data due 1H 2018.
|
| MTNB |
$1.29
+0 (+0%)
|
MAT2501
Non-tuberculous mycobacterium (NTM)
|
Phase 2 |
Phase 2 trial to be initiated 2H 2018. Data from PK/tolerability trial due 2Q 2018.
|
| NVCR |
$21.75
+0.4 (+1.87%)
|
Tumor Treating Fields (TTFields) STELLAR
Mesothelioma
|
Phase 2 |
Phase 2 enrollment completion announced March 31, 2017. Data likely 2Q 2018.
|
| OCUL |
$6.19
-0.09 (-1.44%)
|
OTX-TP
Glaucoma and ocular hypertension
|
Phase 3 |
Phase 3 initiated October 2016. Data due 1H 2018.
|
| PBYI |
$103.85
-1.11 (-1.05%)
|
Neratinib
Third-line HER2-positive metastatic breast cancer
|
Phase 3 |
Phase 3 data due 1H 2018.
|
| PRTA |
$64.77
+0.14 (+0.21%)
|
NEOD001 PRONTO
Previously-treated patients with AL amyloidosis and persistent cardiac dysfunction
|
Phase 2b |
Phase 2b data due 2Q 2018.
|
| RNN |
$2.32
+0 (+0%)
|
RX-3117 in combination with Abraxane
First-line pancreatic cancer
|
Phase 2a |
Phase 2 data due 2Q 2018.
|
| SBBP |
$7.20
+0.05 (+0.69%)
|
COR-003 (levoketoconazole) - SONICS
Endogenous Cushing’s syndrome
|
Phase 3 |
Phase 3 completion of enrollment announced June 27, 2017 with top-line data due 2Q 2018.
|
| SNGX |
$2.25
+0 (+0%)
|
SGX301 (synthetic hypericin)
Cutaneous T-Cell Lymphoma (CTCL) cancer
|
Phase 3 |
Phase 3 data due 1H 2018.
|
| SVRA |
$8.31
-0.18 (-2.13%)
|
Aironite - INDIE
Pulmonary hypertension (PH)
|
Phase 2 |
Phase 2 enrollment to be completed 4Q 2017 with top-line data due 1H 2018.
|
| TBPH |
$32.43
+0.56 (+1.75%)
|
TD-9855
nOH
|
Phase 2a |
Phase 2a data due 1H 2018.
|
| TGTX |
$11.63
-0.12 (-1.07%)
|
TG-1101 and TGR-1202 - UNITY-CLL study
Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin's Lymphoma (NHL)
|
Phase 3 |
Phase 3 completion of target enrollment announced September 5, 2017. Enrollment to continue through to mid-October with top-line data due 2Q 2018.
|
| TNXP |
$4.26
+0.01 (+0.23%)
|
TNX-102 SL
Post-traumatic stress disorder (PTSD)
|
Phase 3 |
Initiation of first of two Phase 3 trials announced March 28, 2017 in military-related PTSD 1Q 2017. Interim analysis due 1H 2018 with top-line data due 2H 2018.
|
| TOCA |
$12.90
-0.2 (-1.53%)
|
Toca 511 & Toca FC
Recurrent brain cancer
|
Phase 2/3 |
Data from Phase 2 portion are due 1H 2018.
|
| VKTX |
$1.21
+0.03 (+2.54%)
|
VK2809
Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
|
Phase 2 |
Phase 2 data due 1H 2018.
|
| VNDA |
$18.45
+0.25 (+1.37%)
|
Tradipitant
Gastroparesis
|
Phase 2 |
Phase 2 data due 1H 2018.
|
| ZFGN |
$3.40
-0.06 (-1.74%)
|
ZGN-1061
Diabetes
|
Phase 2 |
Phase 2 initiation announced September 12, 2017. Interim data due 1H 2018.
|
| ALNY |
$75.77
-0.23 (-0.31%)
|
Givosiran
Acute hepatic porphyrias
|
Phase 3 |
Phase 3 trial to be initiated late 2017 with interim analysis data available in mid-2018.
|
| CELG |
$143.25
+0.41 (+0.28%)
|
Luspatercept - BELIEVE
b -thalassemia
|
Phase 3 |
Phase 3 enrollment completion announced June 1, 2017 with data due mid-2018.
|
| CELG |
$143.25
+0.41 (+0.28%)
|
Luspatercept - MEDALIST
Myelodysplastic syndromes (MDS) cancer
|
Phase 3 |
Phase 3 enrollment completion announced June 1, 2017 with data due mid-2018.
|
| EBIO |
$1.70
+0.25 (+17.24%)
|
Vicinium
Non-muscle invasive bladder cancer (NMIBC)
|
Phase 3 |
Phase 3 enrollment to be completed 1Q 2018, with 3-month top-line data due mid-2018 and 12-month data due 2Q 2019.
|
| FOMX |
$5.52
-0.08 (-1.35%)
|
FMX103
Papulopustular rosacea
|
Phase 3 |
Phase 2 top-line data released September 12, 2016. Endpoints met. Phase 3 trial to be initiation announced June 12, 2017 with top-line data due mid-2018.
|
| GNMX |
$1.37
+0.03 (+2.23%)
|
AEVI-001 (NFC-1)
ADHD - 9-Gene subset
|
Phase 2 |
Phase 2 trial to be initiated 2H 2017 with data due mid-2018.
|
| LLY |
$81.72
-0.8 (-0.97%)
|
Ramucirumab
Second-line bladder cancer
|
Phase 3 |
Phase 3 PFS data released May 31, 2017 - primary endpoint met. Final OS results are currently expected in mid-2018.
|
| OBSV |
$7.13
-0.01 (-0.14%)
|
OBE2109 - EDELWEISS
Endometriosis
|
Phase 2b |
Phase 2b data due mid 2018.
|
| RGLS |
$1.31
-0.03 (-1.88%)
|
RG-012 - HERA
Alport Syndrome
|
Phase 2 |
Phase 2 interim data due mid-2018.
|
| SCYX |
$2.21
+0.08 (+3.75%)
|
SCY-078 - oral
Vulvovaginal candidiasis (VVC)
|
Phase 2 |
Phase 2 initation of dosing annunced August 3, 2017 - data due mid-2018.
|
| VTL |
$4.65
-0.05 (-1.07%)
|
VTI-308
Alcohol-induced liver decompensation, or AILD
|
Phase 3 |
Phase 3 VTI-208 trial failed. New VTI-308 trial initiated May 2016. Data due mid 2018.
|
| XLRN |
$39.28
-0.1 (-0.26%)
|
Luspatercept - MEDALIST
Myelodysplastic syndromes (MDS) cancer
|
Phase 3 |
Phase 3 enrollment completion announced June 1, 2017 with data due mid-2018.
|
| XLRN |
$39.28
-0.1 (-0.26%)
|
Luspatercept - BELIEVE
b -thalassemia
|
Phase 3 |
Phase 3 enrollment completion announced June 1, 2017 with data due mid-2018.
|
| PFE |
$35.41
-0.15 (-0.4%)
|
Sutent (Sunitinib)
Renal cell carcinoma (RCC)
|
PDUFA priority review |
PDUFA date January 2018. Specific date not released. BPC estimate late January. Advisory Committee Meeting September 19, 2017.
|
| AGTC |
$3.70
-0.05 (-1.34%)
|
rAAV-hRS1
X-linked retinoschisis (XLRS)
|
Phase 1/2 |
Phase 1/2 completion of enrollment due 1Q 2018 with data due after the last patient has been followed for six months (est 3Q 2018).
|
| AMRN |
$3.25
+0 (+0%)
|
Vascepa REDUCE-IT outcomes trial
High Triglycerides With Mixed Dyslipidemia
|
– |
Interim analysis announced September 12, 2016 - trial to proceed. Second interim analysis August 14, 2017 also recommended trial to continue. Final data due 2Q or 3Q 2018.
|
| AQXP |
$13.94
+0.11 (+0.79%)
|
AQX-1125 LEADERSHIP
Bladder pain syndrome/interstitial cystitis (BPS/IC).
|
Phase 3 |
Phase 2 trial did not meet endpoints - June 2015 but postive secondary endpoint data - August 2015. Phase 3 trial commenced September 2016. Data due 3Q 2018.
|
| HSGX |
$2.05
+0 (+0%)
|
NeoCart
Cartilage defects in the knee
|
Phase 3 |
Phase 3 completion of enrollment announced June 27, 2017. Top-line data and potential BLA filing 3Q 2018.
|
| SBBP |
$7.20
+0.05 (+0.69%)
|
COR-003 (levoketoconazole) - LOGICS
Endogenous Cushing’s syndrome
|
Phase 3 |
Phase 3 enrollment from second trial to begin 3Q 2017 with top-line data expected in 3Q 2018.
|
| CNCE |
$15.00
+0.12 (+0.8%)
|
AVP-786
Agitation in patients with Alzheimer's disease
|
Phase 3 |
Phase 3 initiated December 2015. Trial to be completed 3Q 2018
|
| AGLE |
$4.52
-0.12 (-2.57%)
|
AEB1102
Arginase I deficiency
|
Phase 1/2 |
Phase 1/2 dosing in repeat dose part (Part 2) announced September 6, 2017. Top-line data due 2H 2018.
|
| AGN |
$218.46
-3.08 (-1.4%)
|
Brazikumab
Crohn's disease
|
Phase 2b |
Phase 2b data due 2018.
|
| AGN |
$218.46
-3.08 (-1.4%)
|
Cariprazine
Major depressive disorder (MDD)
|
Phase 3 |
Phase 3 data due 2H 2018.
|
| AGN |
$218.46
-3.08 (-1.4%)
|
ABICIPAR
Age-related macular degeneration (AMD)
|
Phase 3 |
Phase 3 data due 2H 2018.
|
| AKBA |
$17.55
+0.27 (+1.56%)
|
Vadadustat - TRILO2GY
Three-times-weekly dosing regimen for vadadustat
|
Phase 3 |
Phase 3 trial to be initiated 2H 2017 with data due by the end of 2018.
|
| AKBA |
$17.55
+0.27 (+1.56%)
|
Vadadustat - FO2RWARD
Renal anemia
|
Phase 2 |
Phase 2 data due by the end of 2018.
|
| ALDX |
$7.38
-1.73 (-18.96%)
|
ADX-102
Noninfectious anterior uveitis
|
Phase 3 |
Phase 3 trial initiation announced April 27, 2017 with data due 2H 2018.
|
| ALDX |
$7.38
-1.73 (-18.96%)
|
ADX-102
Sjögren-Larsson Syndrome (SLS)
|
Phase 2 |
Phase 3 trial initial data due 2H 2018.
|
| ALKS |
$51.07
-0.95 (-1.84%)
|
ALKS 3831 - ENLIGHTEN-2
Schizophrenia
|
Phase 3 |
Pivotal trial initiated February 2016. Data due 2018.
|
| ALXN |
$142.84
-0.8 (-0.56%)
|
Eculizumab
Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD)
|
Phase 3 |
Phase 3 enrollment to be completed in 2017 with data due 2018.
|
| ANIK |
$56.00
-0.11 (-0.2%)
|
Cingal
Osteoarthritis
|
Phase 3 |
Additional Phase 3 trial commenced enrollment - May 25 2017. Trial to be completed in 2018.
|
| ARGX |
$21.30
+0 (+0%)
|
ARGX-113
Immune thrombocytopenia (ITP)
|
Phase 2 |
Phase 2 data due 2H 2018.
|
| AZN |
$32.68
+0.26 (+0.8%)
|
Dapagliflozin - DECLARE
Type-2 diabetes
|
Phase 3 |
Cardiovascular outcome data due 2H 2018.
|
| AZN |
$32.68
+0.26 (+0.8%)
|
Benralizumab - TERRANOVA
COPD
|
Phase 3 |
Phase 3 data due 2H 2018.
|
| AZN |
$32.68
+0.26 (+0.8%)
|
Farxiga - DECLARE
Cardiovascular Outcomes
|
Phase 3 |
Phase 3 data due 2H 2018.
|
| AZN |
$32.68
+0.26 (+0.8%)
|
Selumetinib - ASTRA
Thyroid cancer
|
Phase 3 |
Phase 3 data due 2018.
|
| AZN |
$32.68
+0.26 (+0.8%)
|
Roxadustat - ANDES
Anaemia
|
Phase 3 |
Phase 3 data due 2018.
|
| AZN |
$32.68
+0.26 (+0.8%)
|
PT010
Chronic obstructive pulmonary disease (COPD)
|
Phase 3 |
Phase 3 data due 2018.
|
| AZN |
$32.68
+0.26 (+0.8%)
|
Durvalumab +/- tremelimumab (NEPTUNE)
Lung cancer
|
Phase 3 |
Phase 3 data due 2H 2018.
|
| AZN |
$32.68
+0.26 (+0.8%)
|
Durvalumab +/- tremelimumab (DANUBE)
Bladder cancer
|
Phase 3 |
Phase 3 data due 2H 2018.
|
| AZN |
$32.68
+0.26 (+0.8%)
|
Anifrolumab
Lupus
|
Phase 3 |
Phase 3 data due 2H 2018.
|
| BIIB |
$318.54
+0.36 (+0.11%)
|
Raxatrigine - BIIB074 (Nav1.7 inhibitor)
Painful Lumbosacral Radiculopathy (PLSR)
|
Phase 2 |
Phase 2 initiated 2016. Data due in 2018.
|
| BLPH |
$1.07
-0.03 (-2.73%)
|
INOpulse delivery device
Pulmonary Arterial Hypertension (PAH)
|
Phase 3 |
Phase 3 commenced enrollment June 2016. Interim analysis and top-line data due 2018.
|
| BLRX |
$1.07
+0 (+0%)
|
BL-8040
Consolidation treatment for AML cancer patients
|
Phase 2b |
Phase 2b initiated August 2015. Interim analysis due in 2018, with top-line results expected in 2019.
|
| BMY |
$62.98
+0.28 (+0.44%)
|
CM-602 – Opdivo + Elo + SOC
Myeloma
|
Phase 3 |
Phase 3 data due 2H 2018. Noted September 6, 2017 that trial has been placed on partial hold.
|
| BYSI |
$38.17
+0.06 (+0.15%)
|
Plinabulin
Non small cell lung cancer - refractory
|
Phase 3 |
Phase 3 trial initiated 2016. Interim data due 2018. Final data due 1Q 2019.
|
| CELG |
$143.25
+0.41 (+0.28%)
|
REVLIMID - ROBUST
First-line ABC Diffuse large B-cell lymphoma (DLBCL)
|
Phase 3 |
Phase 3 data due 2018.
|
| CELG |
$143.25
+0.41 (+0.28%)
|
MM-007 OPTIMISMM
Multiple Myeloma - refractory
|
Phase 3 |
Phase 3 data due 2018.
|
| CELG |
$143.25
+0.41 (+0.28%)
|
Ozanimod - TRUE NORTH
Ulcerative Colitis
|
Phase 3 |
Phase 3 enrolling. Data due 2018.
|
| CELG |
$143.25
+0.41 (+0.28%)
|
GED-0301 (CD-003)
Crohn’s disease
|
Phase 3 |
Phase 3 enrolling. Data due 2018.
|
| CELG |
$143.25
+0.41 (+0.28%)
|
GED-0301 (CD-002)
Crohn’s disease
|
Phase 3 |
Phase 3 enrolling. Data due 2018.
|
| CELG |
$143.25
+0.41 (+0.28%)
|
Oral Azacitidine - CC-486-AML-001
Post induction AML Maintenance
|
Phase 3 |
Phase 3 data due 2018.
|
| CELG |
$143.25
+0.41 (+0.28%)
|
ABRAXANE - IMpower 131 ( I/O Combo)
Non-small cell lung cancer (NSCLC)
|
Phase 3 |
Phase 3 data due 2018.
|
| CELG |
$143.25
+0.41 (+0.28%)
|
ABRAXANE - IMpower 130 ( I/O Combo)
Non-small cell lung cancer (NSCLC)
|
Phase 3 |
Phase 3 data due 2018.
|
| CELG |
$143.25
+0.41 (+0.28%)
|
ABRAXANE - IMPassion ( I/O Combo)
Triple Negative Metastatic Breast Cancer
|
Phase 3 |
Phase 3 data due 2018.
|
| CFRX |
$0.99
-0.03 (-3.24%)
|
CF-301
Serious infections caused byStaph aureus including MRSA
|
Phase 2 |
Phase 2 initiation announced May 25, 2017 - data due 4Q 2018.
|
| CNAT |
$5.61
-0.08 (-1.41%)
|
Emricasan
NASH cirrhosis - ENCORE-PH trial
|
Phase 2 |
Phase 2b initiated November 2016. Data due 2018.
|
| CNCE |
$15.00
+0.12 (+0.8%)
|
CTP-543
Alopecia areata
|
Phase 2a |
Phase 2 clinical hold placed May 17, 2017 lifted July 10, 2017. Trial completion due 2H 2018.
|
| EARS |
$0.70
+0.01 (+1.09%)
|
AM-111 ASSENT
Acute inner ear hearing loss
|
Phase 3 |
Phase 3 ASSENT data due 2H 2018.
|
| EPZM |
$18.85
+1 (+5.6%)
|
Tazemetostat
Adult patients with mesothelioma characterized by BAP1 loss-of-function
|
Phase 2 |
Phase 2 dosing commenced August 2016. Enrollment completed June 2017 with data due 2018.
|
| FGEN |
$53.55
+0.8 (+1.51%)
|
Roxadustat - ANDES
Anaemia
|
Phase 3 |
Phase 3 data due 2018.
|
| GEMP |
$9.51
+0.4 (+4.39%)
|
Gemcabene - AZURE-1
Nonalcoholic steatohepatitis (NASH) / Nonalcoholic fatty liver disease (NAFLD)
|
Phase 2 |
Phase 2 trial to be initiated in 2H 2017 with data due 2H 2018.
|
| GSK |
$39.80
-0.26 (-0.64%)
|
Closed Triple - CAPTAIN
Asthma
|
Phase 3 |
Phase 3 data due 2H 2018.
|
| GWPH |
$110.30
+1.33 (+1.22%)
|
Epidiolex
Tuberous Sclerosis Complex
|
Phase 3 |
Phase 3 data due 2018.
|
| IMGN |
$6.62
-0.15 (-2.08%)
|
Kadcyla (KATHERINE).
HER2-positive breast cancer - residual invasive disease
|
Phase 3 |
Phase 3 data due in 2018.
|
| IMRN |
$6.23
+0.48 (+8.34%)
|
IMM-529
C. difficile infection
|
Phase 1/2 |
Phase 1/2 trial enrollment to commence mid-September 2017 with data due 4Q 2018.
|
| INCY |
$117.23
-1.17 (-0.99%)
|
Epacadostat with Keytruda - ECHO-301
Cancer - first-line metastatic melanoma.
|
Phase 3 |
Phase 3 initiated June 2016. Initial data due 2018
|
| INVA |
$13.97
+0.16 (+1.15%)
|
Closed Triple
Asthma
|
Phase 3 |
Phase 3 data due 2H 2018.
|
| IOVA |
$8.45
+0.2 (+2.42%)
|
LN-145
Cervical cancer
|
Phase 2 |
Phase 2 dosing has commenced - noted August 16, 2017. Initial data due 2018.
|
| JNJ |
$135.13
-0.26 (-0.19%)
|
STELARA (USTEKINUMAB)
Ulcerative colitis
|
Phase 3 |
Phase 3 trial to be completed in 2018.
|
| JNJ |
$135.13
-0.26 (-0.19%)
|
DARZALEX (Daratumumab)
Frontline multiple myeloma (non-transplant)
|
Phase 3 |
Phase 3 data likely due 2018.
|
| KALA |
$20.86
-1.13 (-5.14%)
|
KPI‑121 0.25%
Phase 3 data due by the end of 2017.
|
Phase 3 |
YE 2017
Phase 3 data due by the end of 2017.
|
| KALA |
$20.86
-1.13 (-5.14%)
|
KPI‑121 0.25%
Dry eye disease
|
Phase 3 |
YE 2017
Phase 3 data due by the end of 2017.
|
| KITE |
$179.41
+0.52 (+0.29%)
|
Axicabtagene ciloleucel - KTE-C19 (ZUMA-2)
Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL) - cancer
|
Phase 2 |
Phase 2 pivotal initiated November 2015. Data due 2018.
|
| KITE |
$179.41
+0.52 (+0.29%)
|
Axicabtagene ciloleucel - KTE-C19 (ZUMA-3)
Adult patients with r/r ALL - cancer
|
Phase 1/2 |
Phase 1 data released at ASCO June 5, 2017. Complete remission 73%. Phase 2 data due 2018.
|
| KITE |
$179.41
+0.52 (+0.29%)
|
Axicabtagene ciloleucel - KTE-C19 (ZUMA-4)
Pediatric and young adult patients with r/r ALL - cancer
|
Phase 1/2 |
Phase 2 data due 2018.
|
| KPTI |
$10.45
-0.41 (-3.78%)
|
Selinexor - SADAL
Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)
|
Phase 2b |
Phase 2b additional interim data released June 23, 2017 at EHA. Final top-line data due 2H 2018.
|
| MACK |
$14.60
+0.03 (+0.2%)
|
MM-121
Cancer - Heregulin Positive Non-Small Cell Lung Cancer
|
Phase 2 |
Phase 2 initiated mid Feb 2015. Data due 2H 2018.
|
| MBRX |
$2.44
-0.08 (-2.67%)
|
Annamycin
Acute myeloid leukemia (AML) - cancer
|
Phase 1/2 |
Phase 1/2 data due 2018.
|
| MRK |
$65.83
-0.16 (-0.25%)
|
Epacadostat with Keytruda - ECHO-301
Cancer - first-line metastatic melanoma.
|
Phase 3 |
Phase 3 initiated June 2016. Initial data due 2018.
|
| NVS |
$85.77
+0.66 (+0.77%)
|
QVM149
Asthma
|
Phase 3 |
Phase 3 data due 2018.
|
| NVS |
$85.77
+0.66 (+0.77%)
|
LEE011: MONALEESA-7
Breast cancer - (pre-menopausal)
|
Phase 3 |
Phase 3 trial completion 4Q 2017.
|
| NVS |
$85.77
+0.66 (+0.77%)
|
Entresto - PIONEER
In-hospital initiation vs. enalapril following ADHF (acute decompensated heart failure)
|
Phase 3 |
Phase 3 trial completion due 2018.
|
| NVS |
$85.77
+0.66 (+0.77%)
|
Entresto - PARAGON
HF-pEF (heart failure with preserved ejection fraction)
|
Phase 3 |
Phase 3 interim analysis due 2018. Filing 2019.
|
| NVS |
$85.77
+0.66 (+0.77%)
|
AIN457 (Cosentyx)
Non-radiographic axial SpA
|
Phase 3 |
Phase 3 data due 2018.
|
| OBSV |
$7.13
-0.01 (-0.14%)
|
OBE022 - PROLONG
Pre-term labor
|
Phase 2a |
Phase 2a to commence 4Q 2017, with top line data expected around year end 2018.
|
| PFE |
$35.41
-0.15 (-0.4%)
|
Tanezumab
Cancer pain
|
Phase 3 |
Phase 3 ongoing. Estimate data due 2018 using clinicaltrials.gov data.
|
| PLX |
$0.58
-0.04 (-6.42%)
|
PRX-102
Fabry disease
|
Phase 3 |
Phase 3 dosing commenced October 2016. Enrollment to be completed 2H 2017 with data in 2018.
|
| PULM |
$1.89
-0.06 (-3.08%)
|
PUR1800
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD)
|
Phase 2 |
Phase 2 data due 4Q 2018.
|
| RETA |
$31.50
-0.38 (-1.2%)
|
Bardoxolone methyl - CATALYST
Pulmonary arterial hypertension associated with connective tissue disease - CTD-PAH
|
Phase 3 |
Phase 3 commenced enrollment October 2016 with data due 2H 2018.
|
| RIGL |
$2.47
|