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EVLO | Colorectal cancer; Triple-negative breast cancer | Phase 2 | 2020-12-09 00:00:00 | Phase 1/2 data to be presented at SABSC December 9, 2020 - objective response rate (ORR) of 18%. | 1 |
HRTX | Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV) | Approved | 2016-08-10 00:00:00 | CRL Mar 28 2013. Approved August 10, 2016. | 1 |
BMRN | Phenylketonuria (PKU) | Approved | 2018-05-24 00:00:00 | Approval announced May 24, 2018. | 1 |
ABEO | Recessive dystrophic epidermolysis bullosa (RDEB) | BLA Filing | 2023-07-28 00:00:00 | BLA filing package completed, noted July 28, 2023. FDA pre-BLA meeting in August 2023, and expected BLA submission on 3Q, 2023. | 1 |
ANIP | Menopause symptoms | Approved | 2023-09-12 00:00:00 | Approved September 12, 2023. | 1 |
PTPI | Erectile Dysfunction | Approved | 2012-04-27 00:00:00 | Approved April 27, 2012. | 1 |
CFRX | Serious infections caused by Staph aureus including MRSA | Phase 3 | 2022-07-13 00:00:00 | Phase 3 DSMB interim futility recommended the trial be stopped, noted July 13, 2022. | -1 |
BHC | Dry Eye Disease Associated With Meibomian Gland Dysfunction | Phase 3 | 2021-04-13 00:00:00 | Phase 3 trial met primary endpoints - April 13, 2021. | 0 |
NVO | Growth Hormone Deficiency (GHD) | Approved | 2023-04-28 00:00:00 | Approved April 28, 2023. | 1 |
FREQ | Sensorineural hearing loss progression (SNHL) | Phase 1b | 2023-02-13 00:00:00 | Phase 1b dosing completed, development to be discontinued, noted February 13, 2023. | -1 |
INO | Cervical dysplasia | Phase 3 | 2021-12-14 00:00:00 | Additional Phase 3 data reported that the safety profile observed at Week 36 remained well-tolerated through Week 88. In addition, participants who met the primary endpoint at Week 36 remained clear of HPV-16 and/or HPV-18 at Week 88, noted December 14, 2021. | 1 |
ERAS | Glioblastoma Multiforme | Phase 1 | 2023-06-22 00:00:00 | DA granted orphan drug designation (ODD), noted June 22, 2023. | 0 |
GILD | Indolent B-Cell Non-Hodgkin Lymphoma | Approved | 2021-03-05 00:00:00 | FDA approval announced March 5, 2021. | 1 |
CLLS | Large B-cell lymphoma | Phase 1 | 2023-06-15 00:00:00 | Additional data reported at ICML across all 33 patients the CR rate was 42% with 30% maintaining a CR at Month 6. Results indicated complete responses are more common with lymphodepletion regimens containing 90 mg of ALLO-647 (FCA90). Median duration of response for both the overall population and the patients treated with the Phase 2 regimen (n=12) was 23.1 months, noted June 15, 2023. | 1 |
FBIO | Gout | Phase 1 | 2023-06-29 00:00:00 | Phase 1 study dosing commenced, noted May 31, 2022. Phase 1 data show edcomparable pharmacokinetic, pharmacodynamic and safety profile between U.S. and Japanese healthy subjects, noted Jue 29, 2023. Phase 1b clinical trial in gout patients in the U.S. and expect to begin pivotal clinical trials in 2024. | 1 |
INO | Glioblastoma (GBM) | Phase 1/2 | 2019-11-05 00:00:00 | Phase 1/2 interim PFS data noted 80% (16/20) of MGMT gene promoter methylated patients and 75% (24/32) of unmethylated patients were progression-free at six months. | 0 |
RNA | Myotonic dystrophy type 1 (DM1) | Phase 1/2 | 2023-09-09 00:00:00 | Phase 1/2 topline data analysis presented at the Myotonic Dystrophy Foundation Annual Conference reported directional improvements in myotonia (vHOT) as early as 6 weeks after dosing with a sustained effect at Month 6, noted September 9, 2023. | 1 |
ARWR | Familial chylomicronemia syndrome (FCS), Hypertriglyceridemia | Phase 1/2 | 2021-11-15 00:00:00 | Phase 1/2 date reported APOC3 was reduced by 98% in FCS patients and 96% in MCM patients. Both groups showed similar maximum median reductions in TG of 91% and 90%, respectively, noted November 15, 2021. | 1 |
RLMD | Major depressive disorder (MDD) | Phase 3 | 2022-02-23 00:00:00 | Phase 3 top-line results showed that all three doses (25 mg, 75 mg, and 150 mg, the therapeutic, supratherapeutic and maximum tolerated doses, respectively) tested in recreational drug users, demonstrated a substantial (30+ points) and statistically significant difference vs. intravenous ketamine 0.5 mg/kg over 40 minutes, and were statistically equivalent to placebo, noted February 23, 2022. | 1 |
PFE | ER+/HER2- advanced breast cancer | Phase 3 | 2022-06-04 00:00:00 | Phase 3 trial did not meet the primary endpoint, noted June 4, 2022. | 1 |
NVO | Type 2 diabetes | Phase 2 | 2022-08-22 00:00:00 | Phase 2 trial data noted that treatment achieved a numerically higher HbA1c reduction of 2.18%-points compared to a reduction of 1.79%-points for people treated with semaglutide and 0.93%-points with cagrilintide alone, noted August 22, 2022. | 1 |
MRK | COVID-19 | Phase 3 | 2023-02-21 00:00:00 | Phase 3 trial did not meet statistical significance, noted February 21, 2023. | 1 |
TAK | Chronic Myeloid Leukemia | Approved | 2020-12-18 00:00:00 | FDA approval announced December 18, 2020. | 1 |
AVEO | Hepatocellular carcinoma (HCC) | Phase 1/2 | 2022-01-20 00:00:00 | Phase 1b/2 data reported a 27.8% partial response (PR) rate and disease control rate (PR + stable disease) of 67.8%, with a median PFS of 7.3 months and a 1-year OS of 76%, noted January 20, 2022. | 0 |
VTGN | Adjustment Disorder with Anxiety (AjDA) | Phase 2a | 2023-03-22 00:00:00 | Phase 2a top-line data demonstrated clinically meaningful reductions in fear, anxiety and avoidance of anxiety-provoking social and performance situations in daily life, as measured by the Liebowitz Social Anxiety Scale (LSAS) | 1 |
SAGE | Postpartum Depression | Approved | 2023-08-04 00:00:00 | Approved August 4, 2023. | 1 |
AEZS | Adult Growth Deficiency | Approved | 2017-12-20 00:00:00 | Approval announced December 20, 2017. | 1 |
ALDX | Proliferative vitreoretinopathy (PVR) | CRL | 2023-06-21 00:00:00 | CRL issued on June 21, 2023. Aldeyra plans to have a Type-C meeting on 2H 2023. | 1 |
CPRX | Lambert-Easton Myasthenic Syndrome (LEMS) | Approved | 2018-11-28 00:00:00 | FDA approval announced November 28, 2018. | 1 |
RHHBY | Diffuse large B-cell lymphoma (DLBCL) | Approved | 2019-06-10 00:00:00 | FDA approval announced June 10, 2019. | 1 |
SPRO | Complicated urinary tract infections (cUTI) | CRL | 2022-06-27 00:00:00 | CRL announced June 27, 2022. | 0 |
KPTI | Diffuse Large B-Cell Lymphoma (DLBCL) | Approved | 2020-06-22 00:00:00 | FDA Approval announced June 22, 2020. | 1 |
INCY | Atopic dermatitis | PDUFA | 2021-07-16 00:00:00 | Noted FDA will not meet assigned July 2021 PDUFA date - July 16, 2021 | 1 |
GRCL | Relapsed/refractory multiple myeloma (RRMM) | Phase 1 | 2023-09-10 00:00:00 | Phase 1 updated data at EHA demonstrated 100% minimal residual disease (MRD) negativity and 82.8% MRD negative stringent complete response (sCR) in a predominantly high-risk RRMM population, noted June 10, 2023. | 1 |
CALC | Wet age-related macular degeneration | Phase 2b | 2021-11-15 00:00:00 | Additional Phase 2b data reported that the anatomical control was similar to aflibercept over 18 months with BCVA maintained in extension study, noted November 15, 2021. | 0 |
ALEC | Frontotemporal Dementia | Phase 3 | 2023-10-27 00:00:00 | Phase 3 target enrollment achieved, noted October 27, 2023. | 1 |
BGNE | Waldenström’s macroglobulinemia | Phase 1/2 | 2020-06-12 00:00:00 | Phase 1/2 updated data at EHA 2020 noted overall response rate (ORR) was 80%, with a complete response (CR) rate of 15% and a partial response (PR) rate of 65%. | 0 |
ALNA | Enteric Hyperoxaluria | Phase 3 | 2022-03-18 00:00:00 | Phase 3 interim analysis due late 1Q 2022. Based on the results by an independent DSMB has recommended that the trial size be increased from the maximum allowed number of 400 subjects under the pre-specified rules. However, even with this maximum recommended sample size increase, the power to detect an effect vs. placebo would still be less than 80% based on the available data. Based upon this recommendation, the company has decided to terminate the study and plans to promptly initiate the process of closing the study. | -1 |
BLPH | Pulmonary hypertension associated with Fibrotic Interstitial Lung Disease | Phase 3 | 2023-06-05 00:00:00 | Phase 3 enrollment completed, noted January 18, 2023. Phase 3 study did not meet the primary endpoint with iNO45 performing worse than placebo by 5.49 minutes per day, noted June 5, 2023. | 1 |
TMBR | Rosacea | Phase 2b | 2019-06-25 00:00:00 | Phase 2b data June 25, 2019 met endpoints. | 0 |
ELEV | Solid tumors | Phase 1 | 2023-06-03 00:00:00 | Phase 1 data presented at ASCO reported a 47.1% ORR in patients with resistant/refractory gastric cancer expressing Claudin 18.2, with a well-tolerated safety profile, noted June 3, 2023. | 1 |
IOBT | Non-muscle invasive bladder cancer (NMIBC) | Phase 1 | 2023-07-28 00:00:00 | Phase 1 dosing initiated, noted July 28, 2023. | 0 |
DMAC | Acute ischaemic stroke (AIS) | Phase 2/3 | 2023-06-21 00:00:00 | Clinical hold removed, noted June 21, 2023. | 0 |
AMGN | B-Cell Acute Lymphoblastic Leukemia (B-All) | Approved | 2023-06-21 00:00:00 | FDA Approval on June 21, 2023. | 1 |
SNY | Cold agglutinin disease | CRL | 2020-11-13 00:00:00 | CRL issued November 13, 2020. | 0 |
ENSC | Overdose Protection | Phase 1 | 2023-05-09 00:00:00 | Phase 1 was completed with final part B data showing that a 25 mg dose of PF614-MPAR, delivered oxycodone as designed for what may be a prescribed dose of one to two capsules, noted May 9, 2023. | 1 |
NVO | Type 2 diabetes | Approved | 2019-09-20 00:00:00 | FDA approval announced September 20, 2019. | 1 |
SYRS | Pancreatic Cancer | Phase 1 | 2022-11-14 00:00:00 | Phase 1 safety data reported that treatment was generally safe, noted November 14, 2022. | 1 |
TRVN | Moderate to severe acute pain | Approved | 2020-08-07 00:00:00 | FDA Approval announced August 7, 2020. | 1 |
GILD | Refractory metastatic triple-negative breast cancer (TNBC) | Phase 3 | 2022-06-06 00:00:00 | Phase 3 final results reported that Trodelvy improved median progression-free survival versus physicians' choice of chemotherapy to 4.8 vs. 1.7 months and extended median overall survival (OS) by almost five months, noted June 6, 2022. | 1 |
WINT | COVID-19 / Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) | Phase 2 | 2022-03-22 00:00:00 | Phase 2 data reported that treatment was safe and well tolerated with fast administration and considered feasible, noted March 22, 2022. | 1 |
SGEN | Solid Tumors | Phase 1 | 2023-06-03 00:00:00 | Phase 1 data at ASCO reported that treatment-emergent adverse events (TEAEs) were observed in 88.5% of pts: 50.7% were Grade ≥ 3 (21.6% related), and 37.2% were serious (8.1% related); 6.1% of pts discontinued treatment due to TEAEs, noted June 3, 2023. | 1 |
VALN | Lyme disease vaccine for outdoor recreationists | Phase 3 | 2023-02-17 00:00:00 | Phase 3 study discontinued about 50% of patients enrolled following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator, noted February 17, 2023. | -1 |
RMTI | Anemia | Approved | 2015-01-26 00:00:00 | Approved January 26, 2015. | 1 |
GBT | Sickle cell disease (SCD) | Phase 2/3 | 2023-11-02 00:00:00 | Phase 2/3 data from ASH abstract reported that safety data showed GBT021601 was well tolerated. For 27 patients with VOC at baseline, the baseline annualized VOC rate was 2.30, noted November 2, 2023. | 1 |
PFE | Juvenile idiopathic arthritis (JIA) | Phase 3 | 2020-09-28 00:00:00 | FDA approval announced September 28, 2020. | 1 |
EVFM | Chlamydia and gonorrhea | Phase 3 | 2022-10-12 00:00:00 | Phase 3 trial did not meet its primary endpoint, noted October 12, 2022. | 1 |
EPZM | Follicular lymphoma | Approved | 2020-06-18 00:00:00 | FDA approval announced June 18, 2020. | 1 |
GBT | Hypoxemia in patients with idiopathic pulmonary fibrosis (IPF) who are on supplemental oxygen at rest | Phase 2a | 2017-10-23 00:00:00 | Phase 2a discontinuation announced October 23, 2017 due to lack of efficacy. | -1 |
OPT | Wet age-related macular degeneration (AMD) | Phase 2b | 2022-05-05 00:00:00 | Phase 2b Polypoidal Choroidal Vasculopathy subgroup data reported that the combination achieved superior visual acuity gains and anatomic improvements, noted May 5, 2022. | 1 |
REGN | Melanoma | Phase 1 | 2023-05-25 00:00:00 | Additional Phase 1 data from ASCO reported an ORR of 63% (25 of 40 patients), including 6 complete responses (CR) and 19 partial responses (PR) in the initial cohort, with a ORR of 63% in the confirmatory cohort, and 56% in the Prior neo/adjuvant systemic therapy cohort, noted May 25, 2023. | 0 |
BIIB | Alzheimer's disease | Phase 1/2 | 2023-03-29 00:00:00 | Phase 1b trial of 1b/2 study met its primary objective of safety and tolerability. Phase 1b LTE study results showed that dosing reduced biomarkers of soluble tau in CSF (t-tau and p-tau181) in a dose-dependent and sustained manner, with all dose groups showing approximately a 60% reduction from baseline CSF tau levels by the end of the LTE .Phase 2 trial in progress, noted March 29, 2023. | 1 |
IONS | ATTR Amyloidosis | Phase 3 | 2023-03-27 00:00:00 | Phase 3 66-week data reported that trial met all three primary endpoints, noted March 27, 2023. | 0 |
LLY | Rheumatoid arthritis | Approved | 2018-06-01 00:00:00 | FDA approval announced for low dose only - June 1, 2018. | 1 |
AZN | Lupus | Phase 3 | 2021-08-02 00:00:00 | FDA approval announced August 2, 2021. | 1 |
LPTX | Gastric / Gastroesophageal Junction Cancer | Phase 2 | 2023-06-05 00:00:00 | Phase 2 data shared at ASCO reported that the median overall survival (OS) was 19.5 months and median progression-free survival (PFS) was 11.3 months, noted June 5, 2023. | 0 |
TEVA | Tardive dyskinesia (TD) | Approved | 2023-02-17 00:00:00 | FDA Approval on February 17, 2023. | 1 |
GMDA | Severe aplastic anemia | Phase 2 | 2020-12-06 00:00:00 | Phase 2 data presented at ASH 2020 - sustained early engraftment shown. | 1 |
EVFM | contraceptive vaginal gel | Approved | 2020-05-22 00:00:00 | FDA Approval announced May 22, 2020. | 1 |
BMY | First-line Head and Neck Cancer | Phase 3 | 2021-07-16 00:00:00 | Phase 3 trial did not meet primary endpoints - July 16, 2021. | 1 |
RHHBY | Influenza | Approved | 2019-10-18 00:00:00 | FDA Approval announced October 18, 2019. | 1 |
MIST | Paroxysmal supraventricular tachycardia (PSVT) | Phase 3 | 2022-11-07 00:00:00 | Phase 3 additional data reported that median time to conversion was 17 minutes for patients treated with etripamil, three times faster than placebo, noted November 7, 2022. | 1 |
CANF | Pancreatic Cancer | Phase 1a | 2023-06-13 00:00:00 | Preclinical studies demonstrated robust effect reached 90% inhibition of pancreatic cancer growth, IND underway, noted June 13, 2023. | 1 |
MRK | First-line ovarian cancer | Approved | 2020-05-08 00:00:00 | FDA Approval announced May 8, 2020. | 1 |
VTVT | Mild Alzheimer’s disease | Phase 3 | 2018-06-12 00:00:00 | Phase 3 data from Part A released April 9, 2018 did not meet endpoints. Part B data released June 12, 2018 also did not meet endpoints. | 1 |
EDAP | Rectal endometriosis | Phase 2 | 2023-01-31 00:00:00 | Phase 2 data reported that 3.3% of treated patients presenting Clavien 2 complications and zero patients presenting Clavien 3 complications, with significant decrease of the symptoms level from the first post-treatment evaluation, and the reduction of symptoms was maintained at three and six months following HIFU treatment, noted January 31, 2023. | 1 |
GTHX | ER+, HER2- breast cancer | Phase 1/2 | 2021-06-04 00:00:00 | Phase 1/2 initial data presented at ASCO June 4, 2021. 65% of patients experienced stable disease. Median progression-free survival was 7.4 months. | 1 |
ANIP | Carnitine supplement | Approved | 2022-12-20 00:00:00 | Approved December 20, 2022. | 1 |
SNY | Non-small cell lung cancer (NSCLC) | Approved | 2021-02-22 00:00:00 | FDA approval announced February 22, 2021. | 1 |
BIIB | Parkinson's disease | Phase 2 | 2021-02-03 00:00:00 | Phase 2 trial did not meet primary endpoint - February 3, 2021. | 1 |
NVS | Pediatric BRAF V600E low-grade glioma | Approved | 2023-03-17 00:00:00 | Approved March 17, 2023. | 1 |
ATAI | Cognitive Impairment Associated with Schizophrenia | Phase 2a | 2021-12-14 00:00:00 | Full Phase 2a results reported dose-related improvements on exploratory cognitive endpoints. A dose dependent response in qEEG was observed, with the greatest increases seen in 20mg and 40mg doses of RL-007, noted December 14, 2021. | 1 |
LLY | Pediatric Patients with Moderate to Severe Plaque Psoriasis | Approved | 2020-03-30 00:00:00 | FDA Approval announced March 30, 2020. | 1 |
XERS | Type 1 diabetes | Phase 2 | 2020-06-18 00:00:00 | Phase 2 data released June 18, 2020. 62% reduction of hyperglycemia after a glucose challenge. | 1 |
TEVA | Cluster headache | Phase 3 | 2018-06-15 00:00:00 | Phase 3 trial to be terminated due to lack of efficacy - noted June 15, 2018. | -1 |
FSTX | Advanced malignancies | Phase 1 | 2022-12-06 00:00:00 | Phase 1 interim data reported one complete response, 6 stable disease (SD), and 16 progressive disease, noted December 6, 2022. | 0 |
SGEN | Hodgkin lymphoma and Anaplastic large cell lymphoma | Approved | 2011-08-19 00:00:00 | Approval announced August 19, 2011. | 1 |
AZN | Paroxysmal nocturnal hemoglobinuria (PNH) | Approved | 2018-12-21 00:00:00 | FDA approval announced December 21, 2018. | 1 |
EDSA | Allergic contact dermatitis (ACD) | Phase 2b | 2023-03-18 00:00:00 | Phase 2b data presented at AAD reported a 60% average improvement in symptoms from baseline on the CDSI versus 39% for the vehicle treated patients, noted March 18, 2023. | 1 |
REGN | Transthyretin amyloidosis (ATTR) | Phase 1 | 2023-11-02 00:00:00 | Phase 1 updated data from over 60 patients showed consistent, deep and durable serum TTR reduction achieved with a single dose of NTLA-2001, including in 29 patients who have now reached 12 months or more of follow-up, noted November 2, 2023. | 1 |
GTHX | Neoadjuvant breast cancer | Phase 2 | 2022-12-20 00:00:00 | Phase 2 data reported that oral treatment was associated with less neuropathy and was not associated with an increase in febrile neutropenia, noted December 20, 2022. | 1 |
NKTR | Hemophilia A | Approved | 2015-11-16 00:00:00 | Approved November 16, 2015. | 1 |
GSK | Uncomplicated urinary tract infection (uUTI) | Phase 3 | 2023-04-17 00:00:00 | Both EAGLE-2 and EAGLE-3 phase 3 trials met primary endpoint of non-inferiority to nitrofurantoin; EAGLE-3 demonstrated statistical superiority, noted April 17, 2023. | 1 |
ABBV | Uterine Fibroids | Approved | 2020-05-29 00:00:00 | FDA approval announced May 29, 2020. | 1 |
AMAM | PSMA Expressing Tumors | Phase 1 | 2023-10-20 00:00:00 | Phase 1 data presented at ESMO reported that 52% (12/23) of patients experienced a ≥50% PSA reduction, and ≥90% PSA reduction observed in 6% (1/16) and 36% (5/14) of patients at 1.4 mg/kg (Cohort 4) and 2.0 mg/kg (Cohort 6), respectively, noted October 20, 2023. | 1 |
JAZZ | Rett syndrome | Phase 3 | 2020-11-12 00:00:00 | Phase 3 trial stopped due to COVID-19 - November 12, 2020. | -1 |
ABBV | Crohn's disease | Phase 3 | 2022-02-24 00:00:00 | Phase 3 trial met primary endpoint, noted February 24, 2022. | 0 |
RHHBY | Squamous non-small cell lung cancer (NSCLC) | Approved | 2019-12-03 00:00:00 | FDA Approval announced December 3, 2019. | 1 |
RHHBY | B-Cell Non-Hodgkin's Lymphoma | Approved | 2023-06-16 00:00:00 | FDA Approved on June 16, 2023. | 1 |
TAK | Crohn's Disease | Phase 3 | 2019-07-22 00:00:00 | Phase 3 trial met primary endpoint - July 22, 2020. | 0 |