FDA Calendar

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

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

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

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

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

Subscribe HERE to ensure you receive your weekly FREE copy of the BioPharmCatalyst Biotech Stock Watch list and/or our daily option of an end-of-day summary of the day's Biotech Stock Price Movers and Pipeline Database updates.

Premium users - Refer to FDA Calendar Abbreviations in the FDA Calendar Glossary for terms used in the columns and other parts of the FDA Calendar.

Showing 150 drugs
Ticker
Price
Drug
Stage
Catalyst
Last Updated
Ticker Price Drug Stage Catalyst Last Updated
BHVN
$44.49
-0.85  -1.87%
Rimegepant
Migraine - preventative
Phase 3
1Q 2020
Phase 3 top-line data due 1Q 2020.
02/22/2020
LLY
$138.15
-3.89  -2.74%
Ramucirumab
Non-small cell lung cancer
PDUFA
Advisory Committee 02/26/2020 (afternoon)
Advisory Committee Meeting for sBLA filing February 26, 2020.
02/03/2020
ESPR
$62.86
+1.1  +1.78%
Bempedoic Acid/ Ezetimibe
Hypercholesterolemia
PDUFA
PDUFA date February 26, 2020.
05/05/2019
GRTX
$14.69
-1.17  -7.38%
GC4419
Oral mucositis
Phase 2b
Phase 2b data to be presented February 28, 2020, 10:45 a.m. – 12:15 p.m. MST at the Multidisciplinary Head and Neck Cancers Symposium. Phase 3 data due 1H 2021.
02/24/2020
MNLO
$4.97
-0.23  -4.42%
Serlopitant
Chronic pruritus of unknown origin
Phase 2
February 2020
Phase 2 data due February 2020.
02/06/2020
KMPH
$0.32
-0.03  -7.49%
KP415
ADHD
NDA Filing
February 2020
NDA filing due by January 2020 (no update from company so moved to February 2020)
02/11/2020
AQST
$4.09
-0.13  -3.08%
KP415
ADHD
NDA Filing
February 2020
NDA filing due by January 2020 (no update from company so moved to February 2020)
02/11/2020
SRNE
$2.39
-0.15  -5.91%
Resiniferatoxin
Intractable Pain Associated with Cancer
Phase 1
Phase 1 data to be presented at American Academy of Pain Medicine in March 2020.
01/27/2020
BMY
$63.97
-1.66  -2.53%
Opdivo and Yervoy
Previously Treated Hepatocellular Carcinoma
PDUFA priority review
PDUFA date under priority review March 10, 2020.
11/11/2019
BPMC
$61.97
-5.66  -8.37%
Avapritinib BLU-285 - PIONEER
Indolent and smoldering systemic mastocytosis (SM)
Phase 2
Phase 2 updated data due at the AAAAI Annual Meeting March 14, 2020.
02/24/2020
ALLK
$65.35
-0.27  -0.41%
AK002
Severe Allergic Conjunctivitis
Phase 1b
Phase 1b poster at AAAAI meeting March 15, 4:45-6:15 pm.
02/24/2020
ETON
$5.98
-0.28  -4.47%
EM-105
Lennox-Gastaut syndrome, epilepsy
PDUFA
03/17/2020 (likely to be extended - see note below)
PDUFA date March 17, 2020. Noted February 19, 2020 that an additional required trial will unlikely be completed by the PDUFA date resulting in a likely extension of the PDUFA date.
02/19/2020
CNCE
$10.84
-0.21  -1.90%
CTP-543
Alopecia areata
Phase 2
Phase 2 trial met primary endpoint November 2019. Data to be presented March 21, 2020 at AAD meeting.
02/24/2020
INCY
$78.87
-2.02  -2.50%
Ruxolitinib - REACH 2
Steroid-refractory acute GVHD (Graft versus host disease)
Phase 3
EBMT, March 22-25, 2020
Phase 3 data met primary endpoint - October 16, 2019. Data to be presented at EBMT, March 22-25, 2020.
02/13/2020
NVS
$90.08
-6.68  -6.90%
Ruxolitinib - REACH 2
Steroid-refractory acute GVHD (Graft versus host disease)
Phase 3
EBMT, March 22-25, 2020
Phase 3 data met primary endpoint - October 16, 2019. Data to be presented at EBMT, March 22-25, 2020.
02/13/2020
ZGNX
$28.89
-1.27  -4.21%
FINTEPLA (ZX008)
Dravet syndrom
PDUFA priority review
Refusal to file Letter (RTF) issued April 8, 2019. NDA resubmitted with new PDUFA date under priority review March 25, 2020
11/25/2019
BMY
$63.97
-1.66  -2.53%
Ozanimod - RADIANCE
Relapsing Multiple Sclerosis
PDUFA
PDUFA date March 25, 2020.
11/21/2019
IGXT
$0.38
-0.02  -5.80%
RIZAPORT (RHB-103)
Migraine
PDUFA
PDUFA date March 26, 2020.
10/22/2019
DRRX
$2.09
-0.08  -3.69%
POSIMIR
Post-operative pain relief
PDUFA
Revised PDUFA not announced
CRL Feb 12 2014. Advisory Committee meeting voted 6-6 January 16, 2020 regarding approval. PDUFA date of December 27, 2019 was not met due to the meeting. No guidance announced regarding new timeline.
01/17/2020
RMTI
$3.23
+0.03  +0.94%
IV Triferic
Anemia
PDUFA
PDUFA date March 28, 2020.
12/10/2019
LPTX
$2.57
-0.03  -1.15%
DKN-01 and Paclitaxel
Endometrial Cancer
Phase 2
Phase 2 data presentation at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer on March 28, 2020.
02/19/2020
AZN
$47.59
-2.58  -5.14%
Imfinzi + tremelimumab (CASPIAN)
Small cell lung cancer (SCLC)
PDUFA priority review
PDUFA date under priority review announced November 29, 2019. No PDUFA date announced. Estimate March 29, 2019.
12/01/2019
NBIX
$96.93
-7.19  -6.91%
Crinecerfont (NBI-74788)
Congenital Adrenal Hyperplasia (CAH) - adults
Phase 2
ENDO 2020
Pivotal trial to be initiated mid-2020. Phase 2 data to be presented at at ENDO March 28–31, 2020.
01/12/2020
OVID
$3.46
-0.08  -2.26%
TAK-935/OV935 - ARCADE
CDKL5 Deficiency
Phase 1/2
1Q 2020
Phase 1b/2a data due 1Q 2020.
02/13/2020
NEOS
$1.56
-0.08  -4.88%
NT0502
Sialorrhea
Phase 1
1Q 2020
Phase 1 top-line pharmacokinetic data due 1Q 2020.
01/13/2020
ZEAL
$39.21
-1.27  -3.14%
Dasiglucagon
Severe hypoglycemia in diabetes - children
NDA Filing
Early 2020
NDA filing due early 2020.
01/06/2020
NVS
$90.08
-6.68  -6.90%
Entresto - PARADISE
AMI (acute myocardial infarction)
Phase 3
1Q 2020
Phase 3 interim analysis 1Q 2020 with full data due in 2021.
01/29/2020
AXSM
$88.51
-2.62  -2.88%
AXS-07 - INTERCEPT
Migraine
Phase 3
1Q 2020
Phase 3 completion of enrolment announced February 20, 2020 with data due 1Q 2020.
02/20/2020
MOR
$29.52
-1.39  -4.50%
BPS-804 (setrusumab)
Osteogenesis Imperfecta
Phase 2b
Early 2020
Phase 2b data due early 2020.
12/31/2019
IMVT
$14.83
-0.52  -3.39%
IMVT-1401
Graves Ophthalmopathy
Phase 2a
1Q 2020
Phase 2a initial data due 1Q 2020.
02/15/2020
INO
$3.96
+0.21  +5.74%
VGX-3100
HPV-related pre-cancers - Vulvar Intraepithelial Neoplasia (VIN)
Phase 2
1Q 2020
Phase 2 data to be presented 1Q 2020.
11/13/2019
ACER
$4.90
-0.26  -5.04%
ACER-001
Urea cycle disorder (UCD)
NDA Filing
Early 2020
NDA filing due early 2021.
02/24/2020
AKTX
$1.93
-0.04  -2.03%
Nomacopan
Atopic keratoconjunctivitis
Phase 1/2
1Q 2020
Phase 1/2 Part B data due 1Q 2020.
01/06/2020
KALA
$6.34
-0.16  -2.46%
KPI‑121 0.25% STRIDE 3
Dry eye disease
Phase 3
1Q 2020
Phase 3 data due 1Q 2020.
02/12/2020
RYTM
$17.93
-0.35  -1.91%
Setmelanotide
Leptin Receptor Deficiency Obesity
NDA Filing
1Q 2020
NDA filing due 1Q 2020.
01/06/2020
RYTM
$17.93
-0.35  -1.91%
Setmelanotide
POMC deficiency obesity
NDA Filing
1Q 2020
NDA filing due 1Q 2020.
01/06/2020
HALO
$21.43
-0.4  -1.83%
Efgartigimod (ARGX-113) and Enhanze
Healthy volunteers
Phase 1
1Q 2020
Phase 1 data due YE 2019. Moved to 1Q 2020 due to no update.
01/06/2020
ARGX
$156.30
-4.8  -2.98%
Efgartigimod (ARGX-113) and Enhanze
Healthy volunteers
Phase 1
1Q 2020
Phase 1 data due YE 2019. Moved to 1Q 2020 due to no update.
01/06/2020
LPCN
$0.77
+0.31  +67.03%
TLANDO - LPCN 1021
Men with low testosterone (Low T)
NDA Filing
1Q 2020
CRL announced November 11, 2019. NDA to be resubmitted 1Q 2020.
02/24/2020
LLY
$138.15
-3.89  -2.74%
Tanezumab
Osteoarthritis
NDA Filing
Early 2020
Phase 3 data from second trial released January 29, 2019 - co-primary endpoints met. Data from trial April 18, 2019 met 2/3 primary endpoints in 5mg arm but failed to meet endpoints in 2.5mg arm. Regulatory filing due 4Q 2019 or early 2020.
01/06/2020
PFE
$34.67
-1.05  -2.94%
Tanezumab
Osteoarthritis
NDA Filing
Early 2020
Phase 3 data from second trial released January 29, 2019 - co-primary endpoints met. Data from trial April 18, 2019 met 2/3 primary endpoints in 5mg arm but failed to meet endpoints in 2.5mg arm. Regulatory filing due 4Q 2019 or early 2020.
01/06/2020
SRNE
$2.39
-0.15  -5.91%
Resiniferatoxin
Osteoarthritis Knee
Phase 1b
March 2020
Phase 3 trial to commence 2Q 2020. Phase 1b final data due March 2020.
01/27/2020
PFNX
$12.73
+0.04  +0.32%
PCV-15 (V114)
Pneumococcal disease
Phase 3
Early 2020
Phase 3 data possibly due early 2020.
02/04/2020
AVEO
$5.16
-0.16  -3.01%
TIVO-3 - tivozanib
Third line treatment of patients with renal cell cancer
NDA Filing
1Q 2020
NDA to be filed in 1Q 2020. Will withdraw if overall survival data in 2Q 2020 yields an OS HR above 1.00.
11/04/2019
XERS
$4.10
-0.28  -6.29%
Self administered glucagon
Exercise-Induced Hypoglycemia
Phase 2
1Q 2020
Phase 2b data due 4Q 2019. Moved to 1Q 2020 due to no update.
01/07/2020
CERC
$3.66
-0.39  -9.63%
CERC-802
Healthy volunteers
Phase 1
Early 2020
PK data due early 2020.
11/14/2019
BHC
$26.00
-0.5  -1.89%
Rifaximin
Overt hepatic encephalopathy
Phase 2
1Q 2020
Phase 2 interim analysis due 1Q 2020.
02/19/2020
AXSM
$88.51
-2.62  -2.88%
AXS-05 STRIDE-1
Treatment resistant depression
Phase 3
1Q 2020
Phase 3 data due 1Q 2020.
01/22/2020
ALNY
$122.29
-8.74  -6.67%
Lumasiran (ALN-GO1) ILLUMINATE-A
Primary Hyperoxaluria Type 1 (PH1)
NDA Filing
Early 2020
Rolling NDA filing has been initiated - January 10, 2020. To be completed early-2020. Full data from Phase 3 trial to be presented at the OxalEurope International Congress on March 31, 2020 in Amsterdam.
02/06/2020
MGNX
$11.07
-0.38  -3.32%
MGD007 and MGA012
Colorectal Cancer
Phase 1
1Q 2020
Phase 1 update due 1Q 2020.
07/31/2019
XLRN
$90.20
-4.31  -4.56%
ACE-083
Charcot-Marie-Tooth disease (CMT)
Phase 2
1Q 2020
Phase 2 data due 1Q 2020.
11/06/2019
BPMC
$61.97
-5.66  -8.37%
Pralsetinib (BLU-667)
First-line RET-fusion non-small cell lung cancer (NSCLC)
NDA Filing
1Q 2020
Rolling NDA has commenced. To be completed 1Q 2020.
02/13/2020
SLS
$2.25
+0.06  +2.74%
Nelipepimut-S (NPS)
Ductal Carcinoma in Situ (DCIS)
Phase 2
1Q 2020
Phase 2 initial data due 1Q 2020.
01/13/2020
OGEN
$0.60
-0.01  -2.33%
AG013
Oral mucositis (OM)
Phase 2
1Q 2020
Phase 2 completion of enrolment announced December 2, 2019 with data due early 2020.
01/16/2020
LCTX
$1.39
-0.06  -4.14%
VAC2
Non-small cell lung cancer (NSCLC)
Phase 1/2
1Q 2020
Phase 1 immunogenicity data due 1Q 2020.
01/13/2020
SEEL
$1.01
-0.04  -3.81%
SLS-002-102
Healthy volunteers
Phase 1
1Q 2020
Phase 1 commencement of PK/PD dosing announced November 27, 2019. Initial data due 1Q 2020.
11/27/2019
NOVN
$0.52
-0.03  -5.15%
SB206
Molluscum contagiosum skin infection
Phase 3
March 2020
Phase 3 data did not meet primary endpoint - January 2, 2020. Full data due March 2020.
02/06/2020
LGND
$100.08
-0.65  -0.65%
SB206
Molluscum contagiosum skin infection
Phase 3
March 2020
Phase 3 data did not meet primary endpoint - January 2, 2020. Full data due March 2020.
02/06/2020
SUPN
$23.95
-0.04  -0.17%
SPN-810 (P302)
Attention Deficit Hyperactivity Disorder (ADHD)
Phase 3
1Q 2020
Phase 3 data due 1Q 2020.
12/09/2019
CLBS
$2.95
-0.18  -5.77%
CLBS16 (CLBS14-CMD) - ESCaPE-CMD
Coronary microvascular dysfunction (CMD)
Phase 2
Early 2020
Phase 2 full data due early 2020.
12/11/2019
ASMB
$20.63
-0.6  -2.83%
ABI-H2158
Hepatitis B virus (HBV)
Phase 1a
1Q 2020
Full data due 1Q 2020.
11/11/2019
ORMP
$5.01
+0.09  +1.83%
ORMD-0801
Type 2 Diabetes
Phase 2b
1Q 2020
Phase 2b data noted 2/3 arms showed significant reductions. Data from second cohort due 1Q 2020.
01/13/2020
NVAX
$8.16
+0.45  +5.76%
NanoFlu vaccine
Influenza
Phase 3
1Q 2020
Phase 3 top-line data due 1Q 2020.
02/10/2020
ABUS
$3.03
-0.22  -6.77%
AB-729
Hepatitis B (HBV)
Phase 1
1Q 2020
Phase 1a/b data due late-1Q 2020.
02/10/2020
ASND
$135.83
-6.07  -4.28%
TransCon
Hypoparathyroidism
Phase 2
March 2020
Phase 2 top-line data due around the end of March 2020.
01/12/2020
TGTX
$15.25
-0.37  -2.37%
TG-1101 and TGR-1202 - UNITY-CLL study
Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin's Lymphoma (NHL)
Phase 3
Early 2020
Phase 3 PFS data due early 2020.
12/31/2019
EYPT
$1.42
-0.03  -2.07%
Yutiq
Non-infectious uveitis
sNDA Filing
1Q 2020
sNDA filing due 2019 for 6-month formulation. Moved to 1Q 2020 due to no update.
12/31/2019
VNDA
$11.76
-0.44  -3.61%
HETLIOZ (tasimelteon)
Smith-Magenis Syndrome
sNDA Filing
1Q 2020
sNDA filing due 4Q 2019. Moved to 1Q 2020 due to no update.
01/06/2020
VNDA
$11.76
-0.44  -3.61%
Tradipitant - EPIONE 1
Atopic dermatitis
Phase 3
1Q 2020
Phase 3 data due 1Q 2020.
11/06/2019
PRVB
$13.08
-1.92  -12.80%
PRV-3279
Systemic Lupus Erythematosus (SLE) and Lupus nephritis (LN)
Phase 1b
1Q 2020
Phase 1b data due 1Q 2020.
12/23/2019
IMRN
$3.77
-0.09  -2.33%
IMM-124E
Nonalcoholic fatty liver disease (NAFLD) - pediatric
Phase 2
1Q 2020
Phase 2 data due 1Q 2020.
07/03/2019
CYTK
$14.70
-0.58  -3.80%
Omecamtiv mecarbil GALACTIC-HF
Acute heart failure
Phase 3
1Q 2020
Phase 3 second interim analysis due 1Q 2020. Top-line data due 4Q 2020.
02/06/2020
AMGN
$217.88
-4.91  -2.20%
Omecamtiv mecarbil GALACTIC-HF
Acute heart failure
Phase 3
1Q 2020
Phase 3 second interim analysis due 1Q 2020. Top-line data due 4Q 2020.
02/06/2020
ONCY
$2.46
-0.17  -6.46%
Pelareorep and Tecentriq - AWARE-1
Breast cancer
Phase 1b
1Q 2020
Phase 1b interim data due end of 2019 (moved to 1Q 2020 due to no update) with final data due 1H 2020.
01/27/2020
YMAB
$31.19
-2.01  -6.05%
Naxitamab
Relapsed/Refractory High-Risk Neuroblastoma
BLA Filing
1Q 2020
Rolling BLA filing commenced November 29, 2019 and to be completed by 1Q 2020.
12/01/2019
YMAB
$31.19
-2.01  -6.05%
Omburtamab
CNS/Leptomeningeal Metastases from Neuroblastoma
BLA Filing
1Q 2020
BLA filing due 1Q 2020.
11/01/2019
MIST
$20.51
-0.92  -4.29%
Etripamil - NODE-301
Paroxysmal supraventricular tachycardia (PSVT)
Phase 3
1Q 2020
Phase 3 top-line data due around end of 1Q 2020.
11/13/2019
ATNX
$12.95
-1.04  -7.43%
Tirbanibulin ointment
Actinic keratosis
NDA Filing
1Q 2020
NDA filing due 1Q 2020.
11/07/2019
PRQR
$8.46
-0.58  -6.42%
QR-421a - STELLAR
Usher Syndrome Type 2
Phase 1/2
1Q 2020.
Phase 1/2 interim data due 1Q 2020.
11/06/2019
IMMP
$2.88
+0.07  +2.49%
Eftilagimod Alpha - Active Immunotherapy PAClitaxel (AIPAC)
Metastatic breast cancer (MBC)
Phase 2b
March 2020
Phase 2b PFS data due March 2020.
02/23/2020
ALNY
$122.29
-8.74  -6.67%
ALN-AAT02
alpha-1 anti-trypsin deficiency-associated liver disease
Phase 1/2
1Q 2020
Phase 1/2 data due late-2019. Moved to 1Q 2020 due to no update.
12/31/2019
MYOV
$11.17
-0.2  -1.76%
Relugolix - SPIRIT 2
Endometriosis-associated pain
Phase 3
1Q 2020
Phase 3 data due 1Q 2020.
02/20/2020
VBLT
$1.40
-0.05  -3.45%
VB-111
Recurrent platinum resistant ovarian cancer
Phase 3
1Q 2020
Phase 3 interim data due 1Q 2020.
01/08/2020
KZIA
$4.14
+0.08  +1.99%
Cantrixil
Ovarian cancer
Phase 1
Early 2020
Phase 1 Part B initial data due early 2020.
09/30/2019
DMAC
$5.40
-0.24  -4.26%
DM199
Chronic Kidney Disease (African Americans)
Phase 2
1Q 2020
Phase 2 initiation announced December 17, 2019 with interim analysis 1Q 2020.
01/06/2020
AXGT
$4.14
-0.32  -7.17%
AXO-Lenti-PD - SUNRISE-PD
Parkinson's disease
Phase 1/2
1Q 2020
Phase 1/2 6-month data from the first two patients in the second cohort due 1Q 2020.
01/13/2020
SNGX
$3.03
-0.13  -4.11%
SGX301 (synthetic hypericin)
Cutaneous T-Cell Lymphoma (CTCL) cancer
Phase 3
1Q 2020
Phase 3 top-line data due 1Q 2020.
01/14/2020
CRNX
$22.61
-0.97  -4.11%
CRN01941
Neuroendocrine tumors
Phase 1
Early 2020
Phase 1 top-line data due early 2020.
12/31/2019
ARDS
$7.66
+0.27  +3.65%
AR-501
Chronic bacterial lung infections in patients with cystic fibrosis (CF)
Phase 1/2
1Q 2020
Phase 1/2 data in healthy subjects due 1Q 2020 and from cystic fibrosis patients in 2Q 2021.
11/13/2019
LXRX
$2.77
+0.08  +2.97%
Sotagliflozin
Type 2 Diabetes
Phase 3
Early 2020
SNY informed LXRX July 26, 2019 that it plans to terminate its agreement following insufficient efficacy across three Phase 3 trials. Phase 3 data noted 400 mg achieved the primary endpoint of superiority - December 20, 2019. Further trial data due early-2020.
12/20/2019
EARS
$1.52
-0.02  -1.30%
AM-125
Vertigo
Phase 2
1Q 2020
Phase 2 interim analysis due 1Q 2020.
12/10/2019
VRNA
$6.51
-0.28  -4.12%
Ensifentrine (RPL554) - Metered Dose Inhaler
Maintenance treatment of COPD
Phase 2
1Q 2020
Phase 2 MDI single dose data due 1Q 2020.
02/24/2020
LGND
$100.08
-0.65  -0.65%
Ensifentrine (RPL554) - Metered Dose Inhaler
Maintenance treatment of COPD
Phase 2
1Q 2020
Phase 2 MDI single dose data due 1Q 2020.
02/24/2020
OPK
$1.50
-0.13  -7.98%
RAYALDEE
Secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) - Stage 5
Phase 2
1Q 2020
Phase 2 initial open label data due 1Q 2020.
11/06/2019
AIM
$1.06
-0.01  -0.93%
Ampligen plus Intron A
Ovarian cancer
Phase 1/2
1Q 2020
Phase 1 interim data to be presented 1Q 2020.
02/24/2020
SELB
$4.22
  +0.00%
SEL-212 (COMPARE) - Head to head trial vs Krystexxa
Tophaceous gout
Phase 2
1Q 2020
Phase 2 interim data due 1Q 2020 and full data mid-2020.
11/08/2019
SVRA
$2.55
-0.12  -4.49%
Molgradex - IMPALA
Autoimmune pulmonary alveolar proteinosis (PAP)
Phase 3
1Q 2020
Phase 3 data June 12, 2019 did not meet primary endpoint. Noted October 2, 2019 that the FDA has recommended that a BLA not be filed. Open label data due 1Q 2020.
11/07/2019
ARDS
$7.66
+0.27  +3.65%
AR-301 (Salvecin)
Staphylococcus aureus
Phase 3
1Q 2020
Phase 3 interim data due 1Q 2020 with final data due early 2021.
11/13/2019
ASLN
$1.96
-0.06  -2.97%
ASLAN004
Atopic dermatitis
Phase 1
March 2020
Phase 1 interim data due early 2020 when earnings are released (expected March).
02/04/2020
ETON
$5.98
-0.28  -4.47%
EM-103
Hypothyroidism
NDA Filing
1Q 2020
NDA filing due 1Q 2020.
11/14/2019
SVRA
$2.55
-0.12  -4.49%
Molgradex - OPTIMA
Nontuberculous mycobacteria (NTM)
Phase 2a
1Q 2020
Phase 2 top-line data due 1Q 2020.
11/07/2019
INO
$3.96
+0.21  +5.74%
VGX-3100
Human papilloma virus (HPV)-related anal dysplasia
Phase 2
1Q 2020
Phase 2 data to be presented 1Q 2020.
11/13/2019
MRUS
$17.35
-1.64  -8.64%
MCLA-158
Colorectal cancer
Phase 1
1Q 2020
Phase 1 emerging data due YE 2019. Moved to 1Q 2020 due to no update.
12/31/2019
EIGR
$11.28
-0.54  -4.57%
Lonafarnib
Hutchinson-Gilford Progeria Syndrome (HGPS)
NDA Filing
1Q 2020
NDA rolling submission commenced December 16, 2019. To be completed 1Q 2020.
01/06/2020
ORMP
$5.01
+0.09  +1.83%
ORMD-0801
Non-alcoholic steatohepatitis (NASH)
Phase 2
1Q 2020
Phase 2 data due 1Q 2020.
01/20/2020
AKRO
$24.15
+1.56  +6.91%
AKR-001
Nonalcoholic steatohepatitis (NASH)
Phase 2a
1Q 2020
Phase 2a data due 1Q 2020 (MRI‐PDFF).
01/17/2020
OVID
$3.46
-0.08  -2.26%
OV935 ENDYMION
Developmental and Epileptic Encephalopathies (dEE)
Phase 2
1Q 2020
Phase 2 open label data released September 23, 2019. Additional data due 1Q 2020.
02/13/2020
ITRM
$3.06
+0.03  +0.99%
Sulopenem
Uncomplicated urinary tract infections (uUTI)
Phase 3
1Q 2020
Phase 3 data due 1Q 2020.
01/02/2020
ITRM
$3.06
+0.03  +0.99%
Sulopenem
Complicated urinary tract infections (cUTI)
Phase 3
1Q 2020
Phase 3 data due 1Q 2020.
01/02/2020
CANF
$1.46
-0.04  -2.67%
Namodenoson (CF102)
Non-alcoholic steatohepatitis (NASH)
Phase 2
1Q 2020
Phase 2 data due 1Q 2020.
02/18/2020
SRNE
$2.39
-0.15  -5.91%
Anti-CD38 CAR-T
Multiple Myeloma
Phase 1
1Q 2020
Phase 1 data due 1Q 2020.
12/31/2019
XLRN
$90.20
-4.31  -4.56%
Luspatercept
Myelodysplastic syndromes (MDS) cancer
PDUFA
PDUFA date April 4, 2020. Advisory Committee meeting originally set for December 18, 2019 is no longer required - noted December 6, 2019.
12/06/2019
BMY
$63.97
-1.66  -2.53%
Luspatercept
Myelodysplastic syndromes (MDS) cancer
PDUFA
PDUFA date April 4, 2020. Advisory Committee meeting originally set for December 18, 2019 is no longer required - noted December 6, 2019.
12/06/2019
AMGN
$217.88
-4.91  -2.20%
OTEZLA
Scalp Psoriasis
PDUFA
April 2020
PDUFA date April 2020.
01/30/2020
PFE
$34.67
-1.05  -2.94%
Encorafenib and cetuximab - BEACON CRC
BRAF-Mutant Colorectal Cancer
PDUFA priority review
April 2020
PDUFA date under priority review for sNDA April 2020.
12/18/2019
EIGR
$11.28
-0.54  -4.57%
Pegylated interferon lambda + ritonavir (RTV)-boosted lonafarnib (LNF) - LIFT
Hepatitis delta virus (HDV)
Phase 2
EASL 15-19 Apr 2020
Phase 2 additional data expected at EASL and AASLD 2020
01/06/2020
URGN
$29.33
-0.95  -3.14%
MitoGel - UGN-101
Urothelial Carcinoma
PDUFA priority review
PDUFA date under priority review April 18, 2020.
12/19/2019
ICPT
$90.89
-4.1  -4.32%
Ocaliva (Obeticholic acid (OCA)) - REGENERATE
Adult nonalcoholic steatohepatitis (NASH) patients.
PDUFA priority review
Advisory Committee 04/22/2020; PDUFA date 06/26/2020
Advisory Committee meeting April 22, 2020. PDUFA date originally set for March 26, 2020 extended to June 26, 2020.
01/17/2020
TROV
$1.56
-0.1  -6.02%
Onvansertib (PCM-075)
Acute Myeloid Leukemia (AML)
Phase 1/2
AACR 2020
Phase 1/2 biomarker data to be presented at AACR April 24-29, 2020. Efficacy data due at EHA June 11-14, 2020.
01/24/2020
TROV
$1.56
-0.1  -6.02%
Onvansertib (PCM-075) and Zytiga
Prostate cancer
Phase 2
AACR April 24-29, 2020
Phase 2 biomarker data to be presented at AACR April 24-29, 2020.
02/13/2020
DMPI
$0.56
-0.01  -2.54%
VAL-083
MGMT-unmethylated newly diagnosed Glioblastoma Multiforme (GBM)
Phase 2
AACR 2020
Phase 2 further data due at AACR April 24 - 29, 2020. Top-line data due August 2020.
02/19/2020
DMPI
$0.56
-0.01  -2.54%
VAL-083
MGMT-unmethylated Recurrent Glioblastoma Multiforme (GBM)
Phase 2
AACR April 24-29, 2020
Phase 2 further data due at AACR April 24-29, 2020.
02/13/2020
SNY
$49.84
-1.01  -1.99%
MenQuadfi
Meningococcal meningitis
PDUFA
PDUFA date April 25, 2020.
06/27/2019
NBIX
$96.93
-7.19  -6.91%
Opicapone
Parkinson's disease
PDUFA
PDUFA date April 26, 2020.
07/10/2019
CORV
$0.47
+0.18  +61.12%
Trevyent
Pulmonary Arterial Hypertension (PAH)
PDUFA
04/27/2020 - see note
PDUFA date April 27, 2020. NOTE: NDA was submitted by UTHR which holds rights to U.S. sales. CORV has rights to only European rights so will not be financially impacted by PDUFA decision but some stock price effect might be seen due to its upcoming European regulatory filing.
01/07/2020
UTHR
$115.35
+8.39  +7.84%
Trevyent
Pulmonary Arterial Hypertension (PAH)
PDUFA
PDUFA date April 27, 2020.
01/07/2020
APLT
$40.97
-1.81  -4.23%
AT-007
Galactosemia
Phase 2
Phase 2 data January 8, 2019 noted significant plasma galactitol reduction of ~50% (p<0.01). Full data to be presented at the Society for Inherited Metabolic Disorders Annual Meeting, April 26 – 29, 2020.
01/08/2020
PLX
$3.64
-0.23  -5.94%
Pegunigalsidase alfa (PRX-102)
Fabry disease
BLA Filing
April 2019
BLA filing due April 2020.
01/30/2020
KPTI
$14.79
-1.3  -8.08%
Selinexor - BOSTON
Multiple myeloma
Phase 3
April 2020
Phase 3 data due by the end of April 2020.
02/13/2020
EARS
$1.52
-0.02  -1.30%
AM-201
Healthy volunteers
Phase 1b
Early-2Q 2020
Phase 1b data from second part of trial due early-2Q 2020.
01/09/2020
MNLO
$4.97
-0.23  -4.42%
Serlopitant
Pruritus associated with prurigo nodularis
Phase 3
March/April 2020
Phase 3 data due March/April 2020.
10/29/2019
PBYI
$12.55
-1.05  -7.72%
Neratinib - NALA
Third-line HER2-positive metastatic breast cancer
PDUFA
Late-April 2020
PDUFA date late-April 2020.
02/21/2020
SCYX
$1.05
-0.05  -4.55%
SCY-078 - oral ibrexafungerp - VANISH 306
Vulvovaginal candidiasis (VVC)
Phase 3
Early 2Q 2020
Phase 3 data due early 2Q 2020.
02/13/2020
MYOV
$11.17
-0.2  -1.76%
Relugolix - LIBERTY 1 and LIBERTY 2
Menstrual bleeding associated with uterine fibroids
NDA Filing
April 2020
NDA filing due April 2020.
02/10/2020
SNY
$49.84
-1.01  -1.99%
Isatuximab
Refractory Multiple Myeloma
PDUFA
PDUFA date April 30, 2020.
07/10/2019
GILD
$72.90
+3.2  +4.59%
Remdesivir GS-5734
Coronavirus
Phase 2
April 2020
Clinical trials have been initiated in China. Data due April 2020.
02/24/2020
OVID
$3.46
-0.08  -2.26%
OV101 (ROCKET)
Fragile X syndrome
Phase 2
Early-2Q 2020
Phase 2 top-line data due early 2Q 2020.
02/13/2020
LCTX
$1.39
-0.06  -4.14%
OpRegen
Dry age-related macular degeneration (AMD)
Phase 1/2
Phase 1/2 enrolment to be completed 1Q 2020. Data due at ARVO May 3-7, 2020.
12/19/2019
AZN
$47.59
-2.58  -5.14%
Farxiga (Dapa-HF)
Heart failure
PDUFA priority review
2Q 2020
PDUFA date under priority review 2Q 2020.
01/06/2020
HALO
$21.43
-0.4  -1.83%
DARZALEX (Daratumumab) using ENHANZE
Multiple myeloma
PDUFA
sBLA filing announced July 12, 2019. PDUFA estimate May 12, 2020.
07/18/2019
JNJ
$145.91
-3.07  -2.06%
DARZALEX (Daratumumab) using ENHANZE
Multiple myeloma
PDUFA
sBLA filing announced July 12, 2019. PDUFA estimate May 12, 2020.
07/18/2019
GMAB
$24.66
-0.56  -2.22%
DARZALEX (Daratumumab) using ENHANZE
Multiple myeloma
PDUFA
sBLA filing announced July 12, 2019. PDUFA estimate May 12, 2020.
07/18/2019
BPMC
$61.97
-5.66  -8.37%
Avapritinib - Voyager
Gastrointestinal stromal tumors (GIST)
Phase 3
Early 2Q 2020
Phase 3 data due early 2Q 2020.
02/06/2020
AZN
$47.59
-2.58  -5.14%
Lynparza + Avastin- PAOLA-1
First-line ovarian cancer
PDUFA priority review
2Q 2020
PDUFA date under priority review 2Q 2020.
01/13/2020
MRK
$81.33
-1.01  -1.23%
Lynparza + Avastin- PAOLA-1
First-line ovarian cancer
PDUFA priority review
2Q 2020
PDUFA date under priority review 2Q 2020.
01/13/2020
BPMC
$61.97
-5.66  -8.37%
Avapritinib
Fourth-line GIST
PDUFA priority review
PDUFA date extended by three months to May 14, 2020 to allow for data from the Voyager trial.
02/06/2020
AGN
$198.17
-1.98  -0.99%
Bimatoprost
Open-angle glaucoma or ocular hypertension
PDUFA
1H 2020
PDUFA date 1H 2020. No exact date announced.
02/10/2020
BMY
$63.97
-1.66  -2.53%
CM-227 – Opdivo + Yervoy
First-line Non-small cell lung cancer (NSCLC)
PDUFA priority review
PDUFA date under priority review May 15, 2020.
01/15/2020
CLVS
$9.92
-1.08  -9.82%
Rubraca (rucaparib)
Castrate-resistant prostate cancer (mCRPC)
PDUFA priority review
PDUFA date under priority review May 15, 2020.
01/15/2020
DBVT
$9.61
-0.32  -3.22%
Viaskin Peanut
Peanut allergy
PDUFA
Advisory Committee 05/15/2020; PDUFA 08/05/2020
PDUFA date August 5, 2020. Advisory Committee meeting May 15, 2020.
02/21/2020

The public FDA Calendar is limited to 150 events in chronological order. The full calendar of approximately 800 events is available to PREMIUM MEMBERS which you can access through our 14-day FREE TRIAL.