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AZN | Heart failure | Approved | 2020-05-05 00:00:00 | FDA Approval announced May 5, 2020. | 1 |
BMY | Stage IIA to IIIB non-small cell lung cancer (NSCLC) | Phase 3 | 2023-10-21 00:00:00 | Phase 3 data presented at ESMO reported that NIVO + chemo/NIVO improved pCR rates (25.3% vs 4.7%; odds ratio, 6.64 [95% CI, 3.40–12.97]) and MPR rates (35.4% vs 12.1%; odds ratio: 4.01 [2.48–6.49]) vs chemo/PBO, noted October 21, 2023. | 1 |
FOLD | Pompe disease | Phase 1/2 | 2022-10-12 00:00:00 | Phase 1/2 trial long term followup data reported that ERT-experienced patients and ERT-naïve patients had durable mean improvements from baseline, noted October 12, 2022. | 1 |
LLY | Type 2 Diabetes | Phase 3 | 2020-12-09 00:00:00 | Phase 3 data released December 9, 2020 - significantly reduced A1C and body weight. | 1 |
KPTI | Relapsed/Refractory Acute Myeloid Leukemia (AML) | Phase 2 | 2017-03-02 00:00:00 | Data Safety Monitoring Board (DSMB) noted March 2, 2017 that trial will not meet primary endpoint. | 1 |
ZLAB | Ovarian cancer | Approved | 2020-04-29 00:00:00 | FDA Approval announced April 29, 2020. | 1 |
INZY | ENPP1 deficiency | Phase 2 | 2023-09-26 00:00:00 | Phase 2 interim data from cohort 1-3 reported an improvement in the Global Impression of Change (GIC) observed in all three dose cohorts in ABCC6 Deficiency (PXE) trial, noted September 26, 2023. | 1 |
HALO | Chronic inflammatory demyelinating polyneuropathy (CIDP) | Phase 2 | 2023-07-17 00:00:00 | Phase 2 trial met primary endpoints, noted July 17, 2023. | 0 |
AMAM | Breast cancer | Phase 2 | 2022-12-09 00:00:00 | Phase 2 safety and efficacy data demonstrated a 57.1% confirmed overall response rate (ORR) with 100% disease control rate (DCR), noted December 9, 2022. | 1 |
BIIB | C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) | Phase 1 | 2022-03-28 00:00:00 | Phase 1 study did not meet any secondary efficacy endpoints and it did not demonstrate clinical benefit. These results do not support further development, noted March 28, 2022. | 1 |
MRUS | Solid tumors - NRG1 | Phase 1/2 | 2023-10-23 00:00:00 | Phase 1/2 data update presented at ESMO showed a 37% ORR and 14.9 months median DOR in 78 evaluable NRG1+ NSCLC patients and 42% ORR and 9.1 months median DOR in 33 evaluable NRG1+ PDAC patients. Sufficient clinical data expected in 1H 2024 to support potential BLA submissions, noted October 23, 2023. | 1 |
CBIO | Hemophilia B | Phase 2b | 2020-06-15 00:00:00 | Phase 2b data noted after 28 days of daily SQ dosing of DalcA achieved protective target FIX levels of >12% in all participants, with FIX levels of up to 27% and a half-life of 2.5 to 5.1 days with no bleeds. | 1 |
FBIO | Menkes disease | Phase 1/2 | 2021-10-14 00:00:00 | Phase 1/2 data from both pre-specified primary and secondary efficacy analyses showed treatment with CUTX-101 demonstrated a significantly greater median overall survival (OS) compared to untreated historical control patients, noted October 14, 2021. | 1 |
MESO | Pediatric participants with acute graft versus host disease (aGVHD), following allogeneic hematopoietic stem cell transplant (HSCT) | Phase 3 | 2023-09-21 00:00:00 | Type A meeting noted the lack of a suitable potency assay for the RYONCIL product used during the Phase 3 trial, new potency assay data to be generated, noted September 21, 2023. | 1 |
MREO | Severe alpha-1 antitrypsin deficiency (AATD) | Phase 2 | 2022-05-09 00:00:00 | Phase 2 study demonstrated to be statistically significant inhibition of blood neutrophil elastase activity of up to 90% in patients in both high and low dose groups throughout the 12-week dosing period. | 1 |
ABBV | Lower limb spasticity | Approved | 2019-10-24 00:00:00 | FDA Approval announced October 24, 2019. | 1 |
CWBR | Nonalcoholic Fatty Liver Disease / Obesity / Nonalcoholic steatohepatitis | Phase 1b | 2021-08-10 00:00:00 | Phase 1b top-line data met primary endpoint - August 10, 2021. | 0 |
BHVN | Generalized anxiety disorder (GAD) | Phase 3 | 2020-02-10 00:00:00 | Phase 3 trial did not meet primary endpoint. | 1 |
GILD | Non-small cell lung cancer (NSCLC) | Phase 2 | 2023-06-05 00:00:00 | Phase 2 presentation at ASCO reported one complete response in the monotherapy and in the DZ combo, noted June 5, 2023. | 1 |
RAIN | Liposarcoma | Phase 3 | 2023-05-22 00:00:00 | Phase 3 trial did not meet its primary endpoint, noted May 22, 2023. | 1 |
CYCC | Solid tumors | Phase 1/2 | 2022-06-30 00:00:00 | Phase 1/2 no dose limiting toxicities observed, noted June 30, 2022. | 1 |
PFE | Cardiovascular (CV) risk reduction and hypertriglyceridemia | Phase 2b | 2021-11-24 00:00:00 | Phase 2b updated data demonstrated that in the dose-ranging study in subjects with elevated non-HDL-C and triglycerides (TG), the study met its primary endpoint, achieving a statistically significant reduction in non-HDL-C at all doses tested at 24 weeks, compared to placebo, noted November 24, 2021. | 1 |
AZN | Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD) | Approved | 2019-06-27 00:00:00 | FDA Approval announced June 27, 2019. | 1 |
ATNXQ | 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 |
PFE | Serious Bacterial Infection | Phase 3 | 2023-06-01 00:00:00 | Phase 3 data reported that 5/12 (41.7%) of the ATM-AVI ± MTZ patients with infections due to confirmed MBL-producing Gram-negative bacteria were cured at TOC versus 0/3 (0%) of those on best available therapy (BAT), noted June 1, 2023. | 0 |
PGEN | HPV+ solid tumors | Phase 1 | 2023-06-03 00:00:00 | Phase 1 monotherapy and combination data presented at ASCO reported a 30% ORR in patients with heavily pre-treated HPV-associated cancers, noted June 3, 2023. | 1 |
BIIB | Biosimilar (ranibizumab) | Approved | 2021-09-20 00:00:00 | Approved September 20, 2021. | 1 |
BIIB | Acute ischemic stroke | Phase 2 | 2021-05-12 00:00:00 | Phase 2 trial met primary objective - May 12, 2021. | 0 |
INCY | Graft versus host disease | Approved | 2019-05-24 00:00:00 | FDA approval announced May 24, 2019. | 1 |
GMAB | Non-Hodgkin lymphoma (NHL) | Phase 1/2 | 2023-06-09 00:00:00 | Additional data shared at EHA reported an overall response rate (ORR) of 98 percent and complete metabolic response (CMR) of 87 percent in response evaluable patients, noted June 9, 2023. | 1 |
VACC | COVID-19 vaccine | Phase 3 | 2021-03-22 00:00:00 | Data from U.S. trial noted 76% efficacy rate - March 24, 2021. | 0 |
MEIP | Indolent B-cell Non-Hodgkin's Lymphoma (iB-NHL) without small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL), and Waldenström's macroglobulinemia (WM) | Phase 2 | 2022-11-17 00:00:00 | Phase 2 data reported a 75.4% objective response rate, and 24.6% of patients achieved a complete response, noted November 17, 2022. | 1 |
QTRX | Superoxide dismutase 1 amyotrophic lateral sclerosis (SOD1-ALS) | Approved | 2023-04-25 00:00:00 | Approved April 25, 2023. | 1 |
GILD | Ankylosing spondylitis | Phase 2 | 2018-09-05 00:00:00 | Phase 2 data released September 6, 2018. Primary endpoint met. | 0 |
VRTX | Cystic fibrosis (CF) ages 6 and older who have the R117H mutation | Approved | 2014-12-29 00:00:00 | Approved December 29, 2014. | 1 |
VALN | Chikungunya Vaccine for adolecents | Phase 3 | 2023-08-28 00:00:00 | Phase 3 trial data reported that VLA1553 was generally safe and well tolerated in adolescents aged 12 to 17 years, regardless of previous CHIKV infection, noted August 28, 2023. | 1 |
GSK | RSV vaccine | Approved | 2023-05-03 00:00:00 | FDA Approved on May 3, 2023. | 1 |
AKTX | Paroxysmal nocturnal hemoglobinuria (PNH) | Phase 2/3 | 2020-12-11 00:00:00 | Additional data from Phase 2 and 3 trials released December 11, 2020 - reduced transfusion dependence by 79% in the 14 formerly transfusion dependent patients. | 1 |
TCON | Mesothelioma cancer | Phase 2 | 2021-10-07 00:00:00 | Phase 2 data reported that 9 patients reported stable disease as best response with Grade 3 TRAEs including lymphopenia (4) and anemia (1), noted October 7, 2021. | 0 |
RHHBY | Non-Small Cell Lung Cancer | Approved | 2021-10-15 00:00:00 | Approved October 15, 2021. | 1 |
GSK | Pediatric Lupus Nephritis | Approved | 2022-07-27 00:00:00 | Approved July 27, 2022. | 1 |
SNY | Coronavirus COVID-19 | Phase 3 | 2020-07-02 00:00:00 | Phase 3 trial did not meet primary endpoint - July 2, 2020. | 1 |
VTYX | Ulcerative Colitis (UC) | Phase 2 | 2023-10-09 00:00:00 | Phase 2 top-line data results showed that at 60 mg achieved the primary endpoint of clinical remission with a high rate of complete endoscopic remission, noted on October 9, 2023. | 1 |
PFE | BRAF mutant melanoma cancer | Approved | 2018-06-27 00:00:00 | Approval announced June 27, 2018. | 1 |
BDRX | Diffuse Midline Glioma (DMG) | Phase 1 | 2023-07-06 00:00:00 | Phase 1 trial reported a median overall survival (OS) of 26.1 month, noted July 6, 2023. | 0 |
PBYI | Glioblastoma (GBM) | Phase 2 | 2021-11-20 00:00:00 | Phase 2 results reported that in the intent-to-treat population, there was no significant improvement of PFS and OS. Median PFS with neratinib was 6.0 months versus 4.7 months and median OS was 13.8 months 14.7 months, noted November 20, 2021. | 1 |
PBYI | Rb-deficient head and neck squamous cell cancer | Phase 1/2 | 2023-10-16 00:00:00 | Phase 1/2 data reported that the median PFS was 1.4 months, and the median overall survival (OS) was 13.5 months, noted October 16, 2023. | 0 |
MRK | Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) | Phase 3 | 2017-07-24 00:00:00 | Phase 3 trial did not meet primary endpoint - July 24, 2017. Awarded accelerated approval in 2016. | 1 |
SAVA | Alzheimer's disease | Phase 3 | 2023-09-18 00:00:00 | Phase 3 Data and Safety Monitoring Board (DSMB) recommended that both of Cassava Sciences' Phase 3 studies of simufilam continue as planned, without modification, noted September 18, 2023. | 0 |
MRK | COVID-19 | Phase 3 | 2021-04-14 00:00:00 | Phase 3 development to be discontinued - April 15, 2021. | -1 |
DNLI | Frontotemporal dementia (FTD) caused by mutations in the granulin gene (GRN) | Phase 1/2 | 2022-11-01 00:00:00 | Phase 1/2 part A interim results showed that single doses of treatment result in substantial increases in CSF progranulin levels suggesting brain delivery of DNL593 was achieved and has the potential to address progranulin deficiency, noted November 1, 2022. | 1 |
REGN | Eosinophilic esophagitis (EoE) | Approved | 2022-05-20 00:00:00 | Approved May 20, 2022. | 1 |
ALT | COVID-19 | Phase 1/2 | 2021-06-29 00:00:00 | Phase 1/2 enrollment to be terminated - June 29, 2021. | -1 |
TVTX | Cystinuria | Approved | 2019-06-28 00:00:00 | FDA Approval announced June 28, 2019. | 1 |
BNTX | Solid tumors | Phase 1/2 | 2023-10-23 00:00:00 | Phase 1/2 additional data presented at ESMO demonstrated that the application of CARVac increases the persistence of the adoptively transferred autologous CAR-T cells, noted October 23, 2023. | 1 |
IOVA | anti-PD-1 therapy for advanced (unresectable or metastatic) Non-small Cell Lung Cancer (NSCLC) | Phase 2 | 2023-07-10 00:00:00 | Phase 2 preliminary data in the trial showed that the median duration of response wasn't reached. Treatrdent-emergent adverse events were consistent with the underlying disease and known adverse event profiles of non-myeloablative lymphodepletion and interleukin-2, noted July 10, 2023. | 1 |
PFE | ER+ positive / HER2- negative breast cancer | Phase 1b | 2021-12-13 00:00:00 | Phase 1 dose escalation data reported that treatment was well tolerated with no DLTs at total daily doses up to 700mg, noted December 13, 2021. | 1 |
REGN | Wet age-related macular degeneration (AMD) | Phase 2 | 2023-08-10 00:00:00 | Phase 2 two-year longer-term data demonstrated that the vast majority of aflibercept 8 mg patients with wAMD could maintain or further extend their dosing intervals. Among those who completed the two-year follow-up, noted August 10, 2023. | 1 |
GMAB | Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | Approved | 2023-05-19 00:00:00 | Approved May 19, 2023. | 1 |
ALPN | Systemic lupus erythematosus (SLE) | Phase 1 | 2023-05-20 00:00:00 | Phase 1 data shared at the International Congress on Systemic Lupus Erythematosus reported that data demonstrated dose-dependent PK/PD. Coverage of free APRIL was maintained for 2–3 and ≥4 weeks with 80 and 240 mg, respectively, corresponding to reductions in serum Ig and antibody-secreting cells on May 20, 2023. | 1 |
STOK | Dravet Syndrome | Phase 1/2 | 2023-07-25 00:00:00 | Phase 1/2 data presented showed that patients treated with 2 or 3 initial doses experienced substantial and sustained reductions in convulsive seizure frequency; Median reductions at 3 months after last dose of 80% and 89% at 6 months after last dose, compared to baseline, noted July 25, 2023. | 1 |
HLVX | Prevention of Norovirus-Related Acute Gastroenteritis in Infants | Phase 2b | 2022-12-05 00:00:00 | Phase 2b immunogenicity results reported that Geometric Mean Titers (GMTs) of pan-IG antibodies 28 days following the second dose were 11,102.0 IU/mL and 2,185.5 IU/mL for GI.1 and GII.4, respectively, for HIL-214 compared to 59.6 IU/mL and 73.5 IU/mL for GI.1 and GII.4, respectively, for placebo, noted December 5, 2022. | 0 |
CLVS | Relapsed ovarian cancer patients with BRCA mutations | Phase 3 | 2020-12-21 00:00:00 | Phase 3 trial met primary endpoint - December 21, 2020. | 0 |
ASND | Growth hormone deficiency in children | Approved | 2021-08-25 00:00:00 | FDA approval announced August 25, 2021. | 1 |
NGM | Solid Tumors | Phase 1/2 | 2022-12-08 00:00:00 | Phase 1/2 data to be presented at the ESMO IO reported that treatment was well tolerated and six patients had reduced target lesion size including a maximum decrease in one patient of 70%, noted December 8, 2022. | 1 |
AZN | Non-small Cell Lung Carcinoma | Approved | 2020-12-21 00:00:00 | FDA approval announced December 21, 2020. | 1 |
FENC | Ototoxicity in non-metastatic, solid tumors | Approved | 2022-09-20 00:00:00 | Approved September 20, 2022. | 1 |
AMGN | Relapsed Multiple Myeloma | Approved | 2018-06-11 00:00:00 | sNDA approval announced June 11, 2018. | 1 |
CTMX | Breast cancer | Phase 2 | 2022-07-06 00:00:00 | Phase 2 initial data reported that trial met its primary endpoint. Arm B did not pass protocol-defined futility boundary (ORR was less than 10%) in patients with advanced triple-negative breast cancer (TNBC) and enrollment into Arms B and C will be discontinued, noted July 6, 2022. | -1 |
CLLS | Acute myeloid leukemia (AML) | Phase 1 | 2023-05-17 00:00:00 | Phase 1 preliminary data presented at ASGCT showed that adding alemtuzumab to the FC LD regimen was associated with sustained lymphodepletion and significantly higher UCART123 cell expansion, which correlated with improved anti-tumor activity, noted on May 17, 2023. | 1 |
AMPH | Radionuclide myocardial perfusion imaging (MPI) | Approved | 2022-05-24 00:00:00 | Approved May 24, 2022. | 1 |
BMY | Multiple Myeloma | Phase 1 | 2022-12-12 00:00:00 | Phase 1 results reported that cytokine release syndrome (CRS) occurred in 80.0% of all treated pts, with most experiencing grade 1 (63.6%) or grade 2 (14.5%); only 1 pt experienced ≥ grade 3 (grade 4) CRS, noted December 12, 2022. | 1 |
MRK | Metastatic non-small cell lung cancer (NSCLC) | Phase 1b | 2023-06-05 00:00:00 | Phase 1b presented at ASCO demonstrated objective response rates of 57% and 50%, respectively, with a disease control rate of 91% across cohorts, noted June 6, 2023 | 1 |
ENDP | Men diagnosed with hypogonadism | Approved | 2014-03-06 00:00:00 | Approved March 6, 2014. | 1 |
CYBN | Major Depressive Disorder (MDD) and Alcohol use disorder (AUD) | Phase 1/2 | 2023-10-31 00:00:00 | Phase 1/2a topline data reported that the reduction in major depressive disorder ("MDD") symptoms, defined as change from baseline in MADRS total score, was superior in participants assigned to CYB003 compared to the participants who received placebo by 14.08 points, noted October 31, 2023. | 1 |
AZN | Anaemia in Chronic Kidney Disease | CRL | 2021-08-11 00:00:00 | CRL announced August 11, 2021. | 0 |
PTCT | Duchenne muscular dystrophy caused by nonsense mutations (nmDMD) | Phase 3 | 2022-06-21 00:00:00 | Trial data reported a significant benefit across 6MWD, NSAA and Timed function test endpoints, with no adverse events leading to discontinuation, noted June 21, 2022. NDA planned. | -1 |
AYTU | Attention deficit hyperactivity disorder (ADHD) | Approved | 2017-06-19 00:00:00 | Approval announced June 19, 2017. | 1 |
MRK | MSI-H/dMMR Advanced Endometrial Carcinoma | Approved | 2022-03-21 00:00:00 | Approved March 21, 2022. | 1 |
NVS | Asthma | Phase 3 | 2019-12-16 00:00:00 | Phase 3 trial did not meet primary endpoint - December 16, 2019. | 1 |
PBYI | Third-line HER2-positive metastatic breast cancer | Approved | 2020-02-26 00:00:00 | FDA Approval announced February 26, 2020. | 1 |
LGND | Maintenance treatment of COPD | Phase 2 | 2019-08-05 00:00:00 | Phase 2 data met primary endpoint - August 5, 2019. | 0 |
SGEN | Post-transplant Hodgkin lymphoma (HL) cancer | Approved | 2015-08-17 00:00:00 | Approved August 17, 2015 under priority review. | 1 |
ELOX | Alport syndrome | Phase 2 | 2023-09-18 00:00:00 | Phase 2 additional independent confirmation reported that all three patients treated with ELX-02 showed a visual improvement in podocyte foot process effacement post-treatment in kidney biopsies demonstrating the disease modifying effect of ELX-02, noted September 18, 2023. | 1 |
APRE | TP53 mutant Myelodysplastic syndromes (MDS), Acute Myeloid Leukemia (AML) | Phase 2 | 2021-12-14 00:00:00 | Phase 2 long-term data reported that at data-cutoff by ITT analysis, ORR was 69% and CR was 43% with a median follow up of 27.8 months, median OS was 11.8 months. Biallelic TP53 mutation or complex karyotype was significantly associated with higher CR rate, and the combination therapy was well tolerated in treated patients, noted December 14, 2021. | 1 |
AZN | Non-squamous non-small cell lung cancer (NSCLC) | Phase 2 | 2022-09-11 00:00:00 | Phase 2 data to be presented at ESMO demonstrated continued durable activity across patient subtypes, noted September 11, 2022. | 1 |
LIAN | Demodex blepharitis | Phase 3 | 2023-10-30 00:00:00 | Phase 3 results demonstrated statistically significant mite eradication in patients treated compared to vehicle, noted October 30, 2023. | 1 |
BCLI | Progressive Multiple Sclerosis (MS) | Phase 2 | 2021-03-24 00:00:00 | Phase 2 top-line data released March 24, 2021 - safety primary endpoint met. | 0 |
AZN | Advanced Hematological Malignancies | Phase 1/2 | 2022-12-12 00:00:00 | Phase 1/2 preliminary results reported that treatment has been well tolerated, with no DLTs to date and no discontinuations due to treatment-related AEs, noted December 12, 2022. | 1 |
ITCI | Bipolar depression | Approved | 2021-12-20 00:00:00 | Approved December 20, 2021. | 1 |
VCEL | Severe burns | CRL | 2021-06-29 00:00:00 | CRL announced June 29, 2021. | 0 |
AGLE | Classical Homocystinuria | Phase 1/2 | 2023-04-12 00:00:00 | Phase 1/2 data reported that treatment with pegtarviliase lowered total homocysteine levels in participants when compared to baseline values, and in the third cohort (1.35 mg/kg) did not show a consistent reduction in total homocysteine levels compared to baseline, noted April 12, 2023. | 1 |
YMAB | High-risk neuroblastoma (HR-NB) commonly | Phase 2 | 2023-06-06 00:00:00 | Phase 2 interim data presented at ASCO reported that the ORR was 58% in patients with refractory disease and 42% in patients with relapsed disease, noted June 6, 2023. | 1 |
KOD | Wet age-related macular degeneration (AMD) | Phase 2/3 | 2022-05-03 00:00:00 | Phase 2b/3 primary results reported durability with nearly 60% on Q20W dosing, however trial did not meet primary endpoint, noted May 3, 2022. | 1 |
NVCR | Non-small cell lung cancer (NSCLC) | Phase 3 | 2023-10-16 00:00:00 | Phase 3 data from ESMO abstract reported that quality of life data showed no statistically significant difference between patients who received TTFields therapy together with standard systemic therapies, noted October 16, 2023. | 1 |
ANNX | Retinal vein occlusion (RVO) | Phase 2 | 2023-08-11 00:00:00 | Phase 2 data reported a long duration of effect with a single dose of standard of care anti-VEGF treatment in two of five treated patients. These two patients also had some positive effects on visual acuity and the retina already during the four weeks before standard of care treatment was used, noted August 11, 2023. | 1 |
TNGX | MTAP-deleted tumors | Phase 1/2 | 2023-05-09 00:00:00 | Safety and efficacy data reported dose-dependent decreases in tumor SDMA with minimal or no decrease in normal tissue, noted May 9, 2023. | 0 |
VTRS | Neulasta biosimilar | Approved | 2018-06-04 00:00:00 | Approval announced June 4, 2018. | 1 |
MLTX | Hidradenitis suppurativa | Phase 2 | 2023-10-16 00:00:00 | Phase 2 24-week topline data reported that 57% of patients continuously treated with 120mg achieved a HiSCR75 response and 38% achieved HiSCR90, noted October 16, 2023. | 1 |
HCM | Solid Tumors | Phase 2 | 2023-05-25 00:00:00 | Additional data from ASCO reported that among evaluable radioactive iodine-refractory differentiated thyroid cancer patients, median PFS was 10.9 months and median OS was not reached, and in endometrial cancer patients, the median PFS was 5.4 months and 12-month OS rate was 71.0%, noted May 25, 2023. | 1 |
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