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.
ABBREVIATIONS USED FOR CATALYST DATES:
(1)Q = (First) quarter of calendar year.
(1)H = (First) half of calendar year
YE = "Year end" - used when companies give guidance similar to "by the end of 2019" or "towards the end of 2019".
2018 - The year is used when companies only give guidance as to which year the catalyst is slated for, without mentioned which quarter or half.
Refer to the "FDA Calendar Glossary" for a list of terms used in the FDA Decision Calendar.
Refer to the Biotech Historical Catalyst Calendar for completed biotech stock catalysts.
LARGE CAP CATALYSTS - generally only Phase 3 catalysts noted in company presentations and/or earnings releases are shown.
Catalysts to feature are mainly in Phase 2 or 3 development. Phase 1 drugs are generally NOT included. Over time, this list will grow.
NASDAQ and NYSE stocks only are shown. OTC stocks are not covered on BioPharmCatalyst.
Click on the date for the source of the catalyst.
Financial data are delayed 15-25 minutes.
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Showing 150
drugs
Ticker
Price
Drug
Stage
Catalyst
| Ticker | Price | Drug | Stage | Catalyst |
|---|---|---|---|---|
| ARRY |
$19.39
-0.16 -0.82%
|
Encorafenib and cetuximab - BEACON CRC
BRAF-Mutant Colorectal Cancer
|
Phase 3 | |
| FBIO |
$3.24
+0.00%
|
CAEL‐101
AL amyloidosis
|
Phase 1/2 | |
| ZFGN |
$6.99
+0.28 +4.10%
|
ZGN-1061
Diabetes
|
Phase 2 |
06/25/2018 12noon
Update at American Diabetes Association meeting 12noon June 25, 2018. Phase 2 top-line data due mid-2018.
|
| AKAO |
$12.44
-0.01 -0.08%
|
Plazomicin
Complicated urinary tract infections (cUTI)
|
PDUFA priority review | |
| DRRX |
$1.95
-0.03 -1.52%
|
Remoxy
Chronic pain
|
PDUFA |
Adcom June 26; PDUFA August 7, 2018
CRL issued September 26, 2016. NDA refiled with PDUFA date of August 7, 2018. Advisory Committee Meeting June 26, 2018.
|
| PTIE |
$8.18
-1.1 -11.85%
|
Remoxy
Chronic pain
|
PDUFA |
Adcom June 26; PDUFA August 7, 2018
CRL issued September 26, 2016. NDA refiled with PDUFA date of August 7, 2018. Advisory Committee Meeting June 26, 2018.
|
| GWPH |
$151.20
+0.19 +0.13%
|
Epidiolex
Dravet Syndrome and Lennox-Gastaut syndrome
|
PDUFA priority review | |
| ALDR |
$16.80
-0.5 -2.89%
|
ALD403 - PROMISE 2
Frequent episodic migraine
|
Phase 3 |
06/29/2018 1:15pm
Phase 3 PROMISE 2 data released January 8, 2017 - endpoints met. 6-mth data to be presented 1:15 pm – 2:15 pm PT June 29, 2018 at American Headache Society Meeting. PK Comparability Study 4Q 2018. BLA filing due 1Q 2019.
|
| TEVA |
$23.98
-0.03 -0.11%
|
CT-P6
Herceptin biosimilar
|
PDUFA |
1H 2018
PDUFA date 1H 2018.
|
| DERM |
$10.48
-0.27 -2.51%
|
Glycopyrronium tosylate
Primary axillary hyperhidrosis
|
PDUFA | |
| NVO |
$46.90
+0.5 +1.08%
|
Somapacitan (NN8640) - REAL 3
Adult Growth Hormone Deficiency (AGHD)
|
Phase 3 |
2Q 2018
Phase 2 GHD data due 2Q 2018. Extension AGHD data due 3Q 2018.
|
| ACOR |
$29.45
-0.45 -1.50%
|
BTT1023
Primary Sclerosing Cholangitis
|
Phase 2 |
2Q 2018
Phase 2 data due 2Q 2018.
|
| RHHBY |
$27.79
+0.7 +2.58%
|
TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and Abraxane) - IMpower132
Squamous non-small cell lung cancer (NSCLC)
|
Phase 3 |
1H 2018
Phase 3 data due 1H 2018.
|
| RHHBY |
$27.79
+0.7 +2.58%
|
Tecentriq+cb+etoposide - IMpower133
Squamous non-small cell lung cancer (NSCLC)
|
Phase 3 |
1H 2018
Phase 3 data due 1H 2018.
|
| RHHBY |
$27.79
+0.7 +2.58%
|
TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and Abraxane) - IMpower134
Squamous non-small cell lung cancer (NSCLC)
|
Phase 3 |
1H 2018
Phase 3 data due 1H 2018.
|
| RETA |
$37.47
-1.89 -4.80%
|
RTA 1701
Healthy Volunteers
|
Phase 1 |
1H 2019
Phase 1 initiation announced June 20, 2018. Initial data due 1H 2019.
|
| ARRY |
$19.39
-0.16 -0.82%
|
Binimetinib - COLUMBUS
BRAF mutant melanoma cancer
|
PDUFA | |
| MACK |
$9.11
-0.36 -3.80%
|
MM-141 - CARRIE
Cancer - front line pancreatic cancer
|
Phase 2 |
1H 2018
Phase 2 completion of enrollment announced June 19, 2017. Data due 1H 2018.
|
| GLPG |
$100.28
+2 +2.04%
|
Filgotinib - TORTUGA
Ankylosing spondylitis
|
Phase 2 |
2Q 2018
Phase 2 initiation announced April 4, 2017. Trial to be completed 2Q 2018.
|
| GILD |
$71.25
-0.27 -0.37%
|
Filgotinib - TORTUGA
Ankylosing spondylitis
|
Phase 2 |
2Q 2018
Phase 2 initiation announced April 4, 2017. Trial to be completed 2Q 2018.
|
| GBT |
$41.95
+0.6 +1.45%
|
GBT440 - HOPE
Sickle cell disease in adults
|
Phase 3 |
2Q 2018
Phase 3 top-line Part A data due 2Q 2018. Part B data due 1H 2019.
|
| ZEAL |
$14.58
+0.06 +0.41%
|
Dasiglucagon
Severe hypoglycemia in diabetes
|
Phase 3 |
2Q 2018
Phase 3 trial met primary endpoint - March 2018. Additional data due 2Q 2018.
|
| CARA |
$16.64
-0.23 -1.33%
|
IV CR845
Acute pain
|
Phase 3 |
2Q 2018
Phase 3 data due 2Q 2018.
|
| NVS |
$75.13
+1.15 +1.55%
|
LJN452
Non-alcoholic steatohepatitis (NASH)
|
Phase 2 |
1H 2018
Phase 2 readout due 1H 2018.
|
| ASNS |
$18.16
+1.63 +9.86%
|
ASN100
Staphylococcus aureus
|
Phase 2 |
Late-June 2018
Phase 2 top-line data due 2H 2018. Interim analysis due late-June 2018.
|
| BMY |
$55.22
+1.28 +2.37%
|
CM-331– Opdivo
Second-line Small cell lung cancer (SCLC)
|
Phase 3 |
1H 2018
Phase 3 data due 1H 2018.
|
| APLS |
$21.79
-0.16 -0.73%
|
APL-2 subcutaneous
Auto-immune Hemolytic Anemia (AIHA)
|
Phase 2 |
1H 2018
Phase 2 monotherapy data due 1H 2018.
|
| NVO |
$46.90
+0.5 +1.08%
|
Semaglutide - oral - PIONEER
Type 2 diabetes
|
Phase 3 |
2Q 2018 ~
Phase 3 data released February 22, 2018 - primary endpoint met. Data from nine further trials due 2018. PIONEER 2, 3, 4 and 7 data due 2Q 2018.
|
| AZN |
$35.08
-0.07 -0.21%
|
Lynparza
First-line ovarian cancer
|
Phase 3 |
2Q 2018
Phase 3 data 2Q 2018.
|
| CARA |
$16.64
-0.23 -1.33%
|
KORSUVA (CR845/difelikefalin)
Chronic Kidney Disease-Associated Pruritus
|
Phase 1 |
2Q 2018
Phase 1 top-line data due 2Q 2018.
|
| ZYNE |
$11.58
-0.81 -6.54%
|
ZYN001
Tourette Syndrome
|
Phase 1 |
1H 2018
Phase 1 trial to be completed 1H 2018 with a Phase 2 trial to be initiated 2H 2018.
|
| GLPG |
$100.28
+2 +2.04%
|
GLPG2737 - PELICAN
Adult CF patients who are homozygous for the Class II F508del mutation
|
Phase 2 |
1H 2018
Phase 2 top-line data due 1H 2018.
|
| MESO |
$5.78
-0.28 -4.62%
|
MSC-100-IV
acute graft versus host disease (aGVHD) in children
|
Phase 3 |
2Q 2018
Phase 3 data released February 22, 2018 - primary endpoint met. Day 100-day survival data due 2Q 2018.
|
| APLS |
$21.79
-0.16 -0.73%
|
APL-2 subcutaneous and eculizumab (Soliris)
Paroxysmal Nocturnal Hemoglobinuria (PNH)
|
Phase 1b |
June 2018
Phase 1b eculizumab add-on and monotherapy expansion updates due June 2018. Phase 3 trial to be initiated 2H 2018.
|
| GEMP |
$5.65
-0.64 -10.17%
|
Gemcabene - INDIGO-1
Severe Hypertriglyceridemia (SHTG)
|
Phase 2b |
2Q 2018
Phase 2b completion of enrollment announced January 17, 2018 with data due 2Q 2018.
|
| CLSN |
$3.27
+0.2 +6.51%
|
GEN-1 OVATION 1
Ovarian cancer
|
Phase 1b |
2Q 2018
Final Phase 1b PFS data to be reported 2Q 2018.
|
| SPHS |
$3.77
-0.04 -1.05%
|
Topsalysin (PRX302)
Localized low to intermediate risk prostate cancer
|
Phase 2 |
2Q 2018
Phase 2b initial biopsy data due by the end of 2Q 2018.
|
| ACRS |
$19.40
-0.52 -2.61%
|
ATI-502 AA-202 Topical - PK/safety
Alopecia areata
|
Phase 2 |
1H 2018
Phase 2 top-line data due 1H 2018.
|
| ALKS |
$44.19
+0.54 +1.23%
|
Aripiprazole Lauroxil NanoCrystal Dispersion (ALNCD)
Schizophrenia
|
PDUFA | |
| TTNP |
$1.08
-0.01 -0.92%
|
Ropinirole implant
Parkinson's disease
|
Phase 1/2 |
1H 2018
Phase 1/2 treatment has commenced - noted October 11, 2017. Data from first patient cohort due 1H 2018.
|
| LIFE |
$1.16
-0.01 -0.85%
|
ATYR1923
|
Phase 1 |
2Q 2018
Phase 1 data due 2Q 2018.
|
| NLNK |
$5.12
-0.04 -0.68%
|
Indoximod in combination with chemotherapy and radiation
Diffuse intrinsic pontine glioma (DIPG)
|
Phase 1 | |
| AST |
$1.65
-0.1 -5.71%
|
AST-OPC1 SCiSTAR
Cervical spinal cord injury
|
Phase 1/2 |
Late 2Q/early 3Q through to 1Q 2019
Phase 1/2 further readouts due late 2Q/early 3Q through to 1Q 2019. Noted June 5, 2018 Independent Data Monitoring Committee (DMC) advised trial to continue through to final readout.
|
| BTX |
$2.33
+0.03 +1.30%
|
AST-OPC1 SCiSTAR
Cervical spinal cord injury
|
Phase 1/2 |
Late 2Q/early 3Q through to 1Q 2019
Phase 1/2 further readouts due late 2Q/early 3Q through to 1Q 2019. Noted June 5, 2018 Independent Data Monitoring Committee (DMC) advised trial to continue through to final readout.
|
| ZGNX |
$44.85
-2.7 -5.68%
|
ZX008 - Study 1504
Dravet syndrom
|
Phase 3 |
Late June/Early July 2018
Phase 3 completion of enrollment announced January 31, 2018 with data due late June/early July 2018.
|
| ZYNE |
$11.58
-0.81 -6.54%
|
ZYN002
Fragile X syndrome
|
Phase 2 | |
| CBIO |
$10.52
+0.15 +1.45%
|
Marzeptacog alfa
Hemophilia
|
Phase 2 |
ISTH 07/18/2018 - 07/21/2018
Phase 2 commencement of Part 2 of Phase 2/3 trial announced January 4, 2018. Interim data due at ISTH July 18-21, 2018.
|
| GSK |
$40.95
+0.14 +0.33%
|
Mepolizumab
Chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype
|
BLA Filing |
Advisory Committee 07/25/2018 8am-4pm.
Advisory Committee meeting July 25, 2018 8am-4pm to discuss sBLA filing.
|
| NBIX |
$101.80
-1.65 -1.60%
|
Elagolix
Endometriosis
|
PDUFA priority review |
Late July/Early August 2018
Phase 3 trials met both co-primary endpoints - Jan 2015. Priority review announced October 27, 2017. Announced April 10, 2018 that PDUFA date has been extended by three months. New date likely late July/early August 2018. Exact PDUFA date not announced.
|
| ABBV |
$93.91
-1.64 -1.72%
|
Elagolix
Endometriosis
|
PDUFA priority review |
Late July/Early August 2018
Phase 3 trials met both co-primary endpoints - Jan 2015. Priority review announced October 27, 2017. Announced April 10, 2018 that PDUFA date has been extended by three months. New date likely late July/early August 2018. Exact PDUFA date not announced.
|
| INSY |
$8.11
-0.3 -3.57%
|
Buprenorphine
Moderate to severe postoperative pain after bunionectomy
|
PDUFA | |
| DRRX |
$1.95
-0.03 -1.52%
|
RBP-7000
Schizophrenia
|
PDUFA | |
| PGNX |
$8.47
+0.01 +0.06%
|
Azedra
Pheochromocytoma
|
PDUFA priority review | |
| GALT |
$7.66
-0.05 -0.65%
|
GR-MD-02 and pembrolizumab (KEYTRUDA)
Melanoma
|
Phase 1 |
Mid-2018
Phase 1 additional data due mid-2018 at which point a decision will be made whether or not to proceed to Phase 2.
|
| RARX |
$9.22
+0.06 +0.66%
|
RA101495 SC
Atypical hemolytic uremic syndrome (aHUS)
|
Phase 1b |
Mid-2018
Phase 1b PK data due mid-2018.
|
| ACRS |
$19.40
-0.52 -2.61%
|
ATI-502 AUATB-201 - open label
Alopecia areata - regrowth of eyebrows
|
Phase 2 |
Mid-2018
Phase 2 data due mid-2018.
|
| LPTX |
$8.99
-0.05 -0.55%
|
DKN-01
Biliary tract cancer (BTC)
|
Phase 1 |
Mid-2018
Phase 1 data due mid-2018.
|
| TCON |
$2.85
+0.1 +3.64%
|
TRC253
Prostate cancer
|
Phase 1/2 |
Mid-2018
Phase 1/2 dosing commenced May 24, 2017. Completion of dose escalation phase due mid-2018.
|
| XLRN |
$37.37
+0.32 +0.86%
|
Luspatercept - BELIEVE
b -thalassemia
|
Phase 3 |
Mid-2018
Phase 3 data due mid-2018.
|
| CELG |
$78.90
-0.24 -0.30%
|
Luspatercept - BELIEVE
b -thalassemia
|
Phase 3 |
Mid-2018
Phase 3 data due mid-2018.
|
| XLRN |
$37.37
+0.32 +0.86%
|
Luspatercept - MEDALIST
Myelodysplastic syndromes (MDS) cancer
|
Phase 3 |
Mid-2018
Phase 3 enrollment completion announced June 1, 2017 with data due mid-2018.
|
| CELG |
$78.90
-0.24 -0.30%
|
Luspatercept - MEDALIST
Myelodysplastic syndromes (MDS) cancer
|
Phase 3 |
Mid-2018
Phase 3 enrollment completion announced June 1, 2017 with data due mid-2018.
|
| PULM |
$0.57
+0.06 +11.58%
|
Pulmazole (PUR1900)
Allergic bronchopulmonary aspergillosis in patients with asthma.
|
Phase 1 |
Mid-2018
Phase 1 dosing to commence early February with data due mid-2018 with Phase 2a trial to be initiated 4Q 2018.
|
| DNLI |
$17.89
+0.89 +5.24%
|
DNL201
Parkinson’s disease
|
Phase 1 |
Mid-2018
Phase 1 data due 1H 2018.
|
| SPRO |
$14.64
+1.34 +10.08%
|
SPR994
Healthy Volunteers (safety trial)
|
Phase 1 |
Mid-2018
Phase 1 data due mid-2018. Phase 3 trial to be initiated year-end 2018 pending positive data from Phase 1 trial.
|
| CRMD |
$0.24
+1.21%
|
Neutrolin - LOCK-IT 100
Hemodialysis patients with central venous catheters
|
Phase 3 |
July 2018
Phase 3 data due 2H 2018 with interim analysis due July 2018.
|
| GSK |
$40.95
+0.14 +0.33%
|
anti-SAP mAb (dezamizumab)
Amyloidosis
|
Phase 2b |
Mid-2018
Phase 2b data likely due mid-2018.
|
| RARE |
$84.40
+2.05 +2.49%
|
KRN23 Burosumab
Tumor-induced osteomalacia (TIO)
|
Phase 2 |
Mid-2018
Interim data released April 2016. Additional data released September 2016 with full data due mid-2018.
|
| SBPH |
$12.79
+0.78 +6.49%
|
SB 9200
Hepatitis B (HBV)
|
Phase 2a |
Mid-2018
Phase 2a initial data released May 23, 2017. Additional data from first cohort to be presented September 7, 2017. Second cohort top-line data released November 15, 2017. Data from third cohort due mid-2018 with fourth-cohort data due late 2018.
|
| SCYX |
$1.71
+0.00%
|
SCY-078 - oral
Vulvovaginal candidiasis (VVC)
|
Phase 2b |
July 2018
Phase 2b initiation of dosing announced August 3, 2017 - data due by July 2018. Phase 3 trial to be initiated 4Q 2018.
|
| RCUS |
$15.21
-0.81 -5.06%
|
AB928
Healthy volunteers
|
Phase 1 |
Mid-2018
Phase 1 data following unblinding of data mid-2018.
|
| LPTX |
$8.99
-0.05 -0.55%
|
DKN-01 + KEYTRUDA
Esophagogastric adenocarcinoma
|
Phase 1/2 |
Mid-2018
Monotherapy data released March 14, 2018. 2/16 PRs, 5/16 SD. Gastric interim data due 2H 2018. Esophagogastric interim ORR due mid-2018.
|
| TBPH |
$23.98
-0.12 -0.48%
|
TD-9855
nOH
|
Phase 2a |
July 2018
Phase 2a data due July 2018.
|
| KMPH |
$6.50
+0.25 +4.00%
|
KP415
ADHD
|
Phase 3 |
Mid-2018
Pivotal final data due mid-2018.
|
| BLPH |
$2.87
-0.05 -1.71%
|
INOpulse delivery device
Pulmonary Arterial Hypertension (PAH)
|
Phase 3 |
Mid-2018
Phase 3 commenced enrollment June 2016. Interim analysis due mid-2018 with and top-line data towards the end of 2018.
|
| BLRX |
$0.92
+0.01 +0.84%
|
BL-8040 GENESIS
Stem-cell mobilization for autologous transplantation
|
Phase 3 |
Mid-2018
Phase 3 trial initiation announced December 21, 2017. Data from lead-in stage due mid-2018 with top-line data due 2020.
|
| ALT |
$0.58
+0.09%
|
NASOSHIELD
Anthrax
|
Phase 1 |
Early 3Q 2018
Phase 1 data due early 3Q 2018.
|
| SBBP |
$6.17
-0.12 -1.98%
|
COR-003 (levoketoconazole) - SONICS
Endogenous Cushing’s syndrome
|
Phase 3 |
Mid 2018
Phase 3 completion of enrollment announced June 27, 2017 with top-line data due mid-2018.
|
| RDHL |
$7.95
+0.11 +1.40%
|
RHB-104 MAP US
Crohn’s disease
|
Phase 3 |
August 2018 est
Noted May 7, 2018 that top-line data due in approximately three months - i.e. around early August 2018.
|
| INSM |
$26.44
-0.47 -1.75%
|
ARIKAYCE
Non-tuberculous Mycobacterial Lung Disease
|
PDUFA priority review |
Advisory Committee 08/07/2018; PDUFA 09/28/2018
PDUFA date September 28, 2018 under priority review. Advisory Committee meeting August 7, 2018.
|
| PRTK |
$10.65
-0.15 -1.39%
|
Omadacycline
Community-acquired bacterial pneumonia (CABP)
|
PDUFA priority review | |
| SIGA |
$6.93
+0.22 +3.28%
|
TPOXX
Smallpox
|
PDUFA priority review | |
| PRTK |
$10.65
-0.15 -1.39%
|
Omadacycline
Acute bacterial skin and skin structure infections (ABSSSI)
|
PDUFA priority review | |
| ABUS |
$6.67
+0.3 +4.71%
|
Patisiran APOLLO
Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR
|
PDUFA priority review | |
| ALNY |
$103.94
+1.25 +1.22%
|
Patisiran APOLLO
Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR
|
PDUFA priority review | |
| SNY |
$39.99
+0.96 +2.47%
|
Patisiran APOLLO
Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR
|
PDUFA priority review | |
| REGN |
$332.08
+3.04 +0.92%
|
EYLEA
Wet AMD
|
PDUFA | |
| FOLD |
$15.80
-0.71 -4.30%
|
Migalastat
Fabry Disease
|
PDUFA priority review | |
| CRIS |
$2.08
-0.06 -2.80%
|
CA170
Solid Tumors and Lymphomas
|
Phase 1 |
Mid-3Q 2018
Phase 1 updated data due mid-3Q 2018.
|
| AZN |
$35.08
-0.07 -0.21%
|
Moxetumomab
Cancer - leukaemia
|
PDUFA priority review |
3Q 2018
Phase 3 trial met primary endpoint. PDUFA date under priority review 3Q 2018.
|
| BMY |
$55.22
+1.28 +2.37%
|
CM-32 - Opdivo+chemo
Small cell lung cancer (SCLC)
|
PDUFA priority review | |
| MNK |
$19.30
-0.14 -0.72%
|
Stannsoporfin
Jaundice
|
PDUFA priority review | |
| KALA |
$13.73
-0.21 -1.51%
|
INVELTYS
Post‑operative inflammation and pain following cataract surgery
|
PDUFA | |
| REGN |
$332.08
+3.04 +0.92%
|
Praluent (alirocumab)
For use with apheresis
|
PDUFA | |
| VRX |
$24.33
-0.39 -1.58%
|
IDP-121
Acne
|
PDUFA | |
| TTPH |
$4.00
+0.01 +0.38%
|
Eravacycline (TP-434) - IGNITE4
cIAI (complicated intra-abdominal infections)
|
PDUFA priority review | |
| IONS |
$42.85
+0.68 +1.61%
|
Volanesorsen - APPROACH
Familial chylomicronemia syndrome (FCS)
|
PDUFA | |
| AKCA |
$26.23
+0.31 +1.18%
|
Volanesorsen - APPROACH
Familial chylomicronemia syndrome (FCS)
|
PDUFA | |
| ESPR |
$38.94
+0.66 +1.72%
|
Bempedoic Acid/ Ezetimibe (1002FDC-053)
Hypercholesterolemia
|
Phase 3 |
August 2018
Phase 3 initiation announced November 6, 2017. Data due August 2018.
|
| TGTX |
$13.68
-0.17 -1.26%
|
TG-1101 and TGR-1202 - UNITY-CLL study
Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin's Lymphoma (NHL)
|
Phase 3 |
Summer 2018
Phase 3 top-line data due by the end of summer 2018.
|
| AGN |
$173.38
+0.89 +0.52%
|
ESMYA (ulipristal acetate)
Uterine Fibroids
|
PDUFA |
August 2018
Phase 3 data released January 18, 2017 - endpoints met. Noted February 28, 2018 that PDUFA date has been extended to August 2018.
|
| SGMO |
$16.48
+0.35 +2.17%
|
SB-913 - CHAMPIONS
MPS Type 2
|
Phase 1/2 |
Late-summer 2018
Phase 1/2 commencement of dosing announced November 15, 2017 with data due late summer 2018.
|
| SGMO |
$16.48
+0.35 +2.17%
|
SB-525 cDNA gene therapy
Hemophilia A
|
Phase 1/2 |
Late-summer 2018
Phase 1/2 dosing has commenced - noted August 25, 2017. Preliminary data due late-summer 2018.
|
| NBIX |
$101.80
-1.65 -1.60%
|
NBI-74788
Congenital Adrenal Hyperplasia (CAH) - adults
|
Phase 2a |
Summer 2018
Phase 2a data due summer 2018.
|
| ADMP |
$3.38
-0.2 -5.59%
|
Symjepi - low dose
Anaphylaxis
|
PDUFA | |
| RHHBY |
$27.79
+0.7 +2.58%
|
TECENTRIQ (atezolizumab) - IMpower150
Non-squamous non-small cell lung cancer (NSCLC)
|
Phase 3 | |
| TEVA |
$23.98
-0.03 -0.11%
|
Fremanezumab
Migraine
|
PDUFA | |
| LLY |
$86.06
-0.01 -0.01%
|
(MK-3475-189/KEYNOTE-189)
First Line Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
|
PDUFA priority review | |
| MRK |
$61.46
+0.28 +0.46%
|
(MK-3475-189/KEYNOTE-189)
First Line Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
|
PDUFA priority review | |
| ATRS |
$2.68
-0.01 -0.19%
|
XYOSTED (testosterone enanthate)
Testosterone deficiency
|
PDUFA | |
| ACHN |
$2.83
-0.01 -0.18%
|
ACH-4471
C3 glomerulopathy (C3G)
|
Phase 2 |
3Q 2018
Phase 2 interim data due 3Q 2018.
|
| VTL |
$6.40
+0.6 +10.34%
|
VTI-308
Alcohol-induced liver decompensation, or AILD
|
Phase 3 |
September 2018
Phase 3 VTI-208 trial failed. New VTI-308 trial initiated May 2016. Completion of enrollment noted March 22, 2018 with data due 3Q 2018 (likely September).
|
| MESO |
$5.78
-0.28 -4.62%
|
MPC-150-IM
End-Stage Heart Failure with LVADs
|
Phase 2b |
3Q 2018
Phase 2b 12-month data due 3Q 2018.
|
| TORC |
$9.79
-0.74 -7.03%
|
RTB101 and Everolimus
Respiratory Tract Infections
|
Phase 2b |
3Q 2018
Phase 2b dosing completed - noted May 9, 2018 with top-line data due 3Q 2018.
|
| MRNS |
$6.78
+0.2 +3.12%
|
Ganaxolone
Postpartum depression
|
Phase 2 |
3Q 2018
Phase 2 data due 3Q 2018.
|
| AGLE |
$10.74
+0.26 +2.48%
|
Pegzilarginase (AEB1102)
Arginase I deficiency
|
Phase 1/2 |
3Q 2018
Phase 1/2 new data presented April 12, 2018. Top-line data due 3Q 2018.
|
| ATOS |
$2.43
-0.08 -3.19%
|
Endoxifen
Male breast cancer and Gynecomastia
|
Phase 1 |
3Q 2018
Phase 1 completion of dosing announced June 20, 2018. Preliminary data due 3Q 2018.
|
| GLPG |
$100.28
+2 +2.04%
|
GLPG 2451+2222+2737 - FALCON open label
Cystic fibrosis - homozygous F508del patients
|
Phase 2 |
3Q 2018
Phase 2 initiation announced April 24, 2018. Top-line data due 3Q 2018.
|
| AVEO |
$2.40
+0.1 +4.57%
|
TIVO-3 - tivozanib
Third line treatment of patients with renal cell cancer
|
Phase 3 |
3Q 2018
Phase 3 top-line data due 3Q 2018.
|
| AXON |
$2.44
-0.23 -8.43%
|
Nelotanserin
DLB patients experiencing REM Behavior Disorder (RBD)
|
Phase 2 |
3Q 2018
Phase 2 data due 3Q 2018.
|
| SNNA |
$15.90
+0.32 +2.05%
|
SNA-001
Acne
|
Phase 3 |
3Q and 4Q 2018
Phase 3 data due 3Q and 4Q 2018.
|
| ZEAL |
$14.58
+0.06 +0.41%
|
Dasiglucagon
Severe hypoglycemia in diabetes
|
Phase 3 |
3Q 2018
Phase 3 completion of dosing announced May 29, 2018. Data due 3Q 2018.
|
| RETA |
$37.47
-1.89 -4.80%
|
Bardoxolone - PHOENIX
Chronic Kidney Disease
|
Phase 2 |
3Q 2018
Phase 2 full data for primary endpoint due 3Q 2018.
|
| WVE |
$34.10
-1.32 -3.74%
|
WVE-210201
Duchenne muscular dystrophy - Exon 51
|
Phase 1 |
3Q 2018
Phase 1 top-line safety data due 3Q 2018.
|
| FLXN |
$27.55
+0.45 +1.66%
|
Zilretta - FX006 repeat
Osteoarthritis of the knee
|
Phase 3 |
3Q 2018
Phase 3 data due 3Q 2018.
|
| AQXP |
$15.54
+0.82 +5.60%
|
AQX-1125 LEADERSHIP
Bladder pain syndrome/interstitial cystitis (BPS/IC)
|
Phase 3 |
3Q 2018
Phase 2 trial did not meet endpoints - June 2015 but positive secondary endpoint data - August 2015. Phase 3 trial commenced September 2016. Data due 3Q 2018.
|
| SNNA |
$15.90
+0.32 +2.05%
|
SNA-125
Psoriasis
|
Phase 1/2 |
3Q 2018
Phase 1/2 commencement of dosing announced February 14, 2018 with top-line data due 3Q 2018.
|
| PFE |
$36.50
+0.2 +0.55%
|
Dacomitinib
Non-small cell lung cancer (NSCLC)
|
PDUFA priority review |
September 2018
PDUFA under priority review September 2018. Exact date not provided.
|
| TNXP |
$4.63
-0.19 -3.94%
|
TNX-102 SL
Post-traumatic stress disorder (PTSD)
|
Phase 3 |
3Q 2018
Initiation of first of two Phase 3 trials announced March 28, 2017 in military-related PTSD 1Q 2017. Interim analysis due 3Q 2018 with top-line data due 1Q 2019.
|
| ONTX |
$0.47
-0.03 -5.55%
|
Oral Rigosertib and azacitidine
First-line HR-MDS (high risk myelodysplastic syndromes)
|
Phase 2 |
3Q 2018
Phase 2 expansion trial enrolment to be completed March 2018. Initial data due 3Q 2018.
|
| IMNP |
$0.19
+-1.97%
|
Bertilimumab
Bullous pemphigoid (BP)
|
Phase 2 |
3Q 2018
Phase 2/3 trial planned for 2019. Phase 2a PK data due 3Q 2018.
|
| LXRX |
$13.61
+0.54 +4.09%
|
LX2761
Type 2 diabetes
|
Phase 1b |
3Q 2018
Phase 1b data due 3Q 2018.
|
| SNDX |
$7.68
-0.1 -1.29%
|
E2112
HR+, HER2- breast cancer
|
Phase 3 |
3Q 2018
Phase 3 PFS data due 3Q 2018.
|
| PGNX |
$8.47
+0.01 +0.06%
|
1404
Help visualize prostate cancer by targeting prostate specific membrane antigen (PSMA)
|
Phase 3 |
3Q 2018
Phase 3 completion of enrollment announced January 2, 2017. Top-line data due 3Q 2018.
|
| NITE |
$14.80
-0.28 -1.86%
|
NSR-RPGR
X-linked Retinitis Pigmentosa
|
Phase 1/2 |
3Q 2018
Phase 1/2 preliminary data due 3Q 2018.
|
| ARNA |
$43.50
-1.04 -2.34%
|
Olorinab (APD371)
Pain associated with Crohn's disease
|
Phase 2 |
3Q 2018
Phase 2 data due 3Q 2018.
|
| ENTA |
$119.70
+0.71 +0.60%
|
EDP-938
Respiratory Syncytial Virus
|
Phase 1 |
3Q 2018
Phase 2 trial to be initiated in 4Q 2018. Phase 1 data due 3Q 2018.
|
| ATNX |
$19.04
+0.42 +2.26%
|
KX-01 (KX2-391) Ointment
Actinic keratosis
|
Phase 3 |
3Q 2018
Phase 3 completion of enrollment announced February 14, 2018. Data due 3Q 2018.
|
| ATNX |
$19.04
+0.42 +2.26%
|
Oraxol
Metastatic breast cancer
|
Phase 3 |
3Q 2018
Phase 3 second interim analysis due 3Q 2018.
|
| ESPR |
$38.94
+0.66 +1.72%
|
Bempedoic acid - CLEAR LDL-C Lowering Program 1002-047
Hypercholesterolemia
|
Phase 3 |
September 2018
Phase 3 data due September, 2018.
|
| NVO |
$46.90
+0.5 +1.08%
|
Concizumab - explorer
Hemophilia A
|
Phase 2 |
3Q 2018
Phase 2 Explorer 5 data due 3Q 2018.
|
| ANAB |
$74.50
+2.95 +4.12%
|
ANB020
Severe adult eosinophilic asthma
|
Phase 2a |
3Q 2018
Phase 2a data due 3Q 2018.
|
| EYEG |
$0.56
-0.01 -1.39%
|
EGP-437
Non-infectious anterior uveitis
|
Phase 3 |
3Q 2018
Phase 3 data due 3Q 2018.
|
| SMMT |
$12.49
-0.86 -6.44%
|
Ezutromid
Duchenne muscular dystrophy
|
Phase 2 |
3Q 2018
Phase 2 completion of dosing announced April 19, 2018 with 48-week top-line data due 3Q 2018.
|
| ONCE |
$90.04
+1.55 +1.75%
|
SPK-8011
Hemophilia A
|
Phase 1/2 |
3Q 2018
Phase 1/2 data released at ASH 2017 - promising reductions in bleeding shown but lower levels of Factor VII. Updated data due 3Q 2018.
|
| FOLD |
$15.80
-0.71 -4.30%
|
ATB200
Pompe Disease
|
Phase 1/2 |
3Q 2018
Phase 1/2 additional data released February 15, 2017, May 15, 2017 and October 4, 2017. Further update February 8, 2018. US regulatory update due 3Q 2018.
|
| FOMX |
$5.15
+0.1 +1.98%
|
FMX103
Papulopustular rosacea
|
Phase 3 |
Late 3Q/Early 4Q2018
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 late 3Q or early 4Q 2018.
|
| FOMX |
$5.15
+0.1 +1.98%
|
FMX101 - FX2017-22
Acne
|
Phase 3 |
3Q 2018
Phase 3 data released March 27, 2017 - three of four primary endpoints met across two trials. Enrollment of third Phase 3 trial completed - noted May 7, 2018, with data due 3Q 2018.
|
| PTN |
$1.01
+0.07 +7.45%
|
PL-8177
Inflammatory bowel diseases
|
Phase 1 |
3Q 2018
Phase 1 data due 3Q 2018.
|
| NOVN |
$2.88
-0.03 -1.03%
|
SB414
Atopic Dermatitis
|
Phase 1b |
3Q 2018
Phase 1b data due 3Q 2018.
|