ticker
stringlengths 2
5
| disease
stringlengths 3
196
| stage
stringclasses 15
values | date
stringlengths 19
19
| catalyst
stringlengths 18
760
| label
int64 -1
1
|
|---|---|---|---|---|---|
SGEN
|
HER2+ Metastatic Breast Cancer (MBC)
|
Approved
|
2020-04-17 00:00:00
|
FDA Approval announced April 17, 2020.
| 1 |
PFE
|
Ulcerative colitis
|
Approved
|
2023-10-13 00:00:00
|
FDA Approved on October 13, 2023.
| 1 |
MBIO
|
B-cell Non-Hodgkin Lymphoma & Chronic Lymphocytic Leukemia (CLL)
|
Phase 1/2
|
2023-08-16 00:00:00
|
Initial Phase 1/2 data reported clinical responses from four of four indolent lymphoma patients, including complete response in follicular lymphoma patient previously treated with CD19 CAR-T cell therapy, noted August 16, 2023.
| 1 |
ACHL
|
Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1/2
|
2022-12-06 00:00:00
|
Phase 1/2a data reported 1 partial response (PR), and 6 stable disease with overall durable clinical benefit at 12 weeks in 71% of evaluable patients, noted December 6, 2022.
| 1 |
SNDX
|
Relapsed/refractory (R/R) acute leukemias
|
Phase 2
|
2023-10-02 00:00:00
|
Phase 2 trial met its primary endpoint at the protocol-defined interim analysis stage with a complete remission (CR) or a CR with partial hematological recovery (CRh) rate of 23% among the 57 efficacy evaluable patients in the pooled KMT2Ar acute leukemia cohort, noted October 2, 2023.
| 1 |
SXTP
|
COVID-19 patients with mild-moderate symptoms and low risk of disease progression
|
Phase 1a
|
2023-09-18 00:00:00
|
IND withdrawn, noted September 18, 2023
| 0 |
RLAY
|
Cholangiocarcinoma (CCA)
|
Phase 1
|
2023-10-12 00:00:00
|
Phase 1 data from non-CCA expansion cohort presented at AACR-NCI-EORTC reported a 35% overall response rate (ORR), and nine of 26 patients experienced a partial response (PR), noted October 12, 2023.
| 1 |
MRK
|
Head and neck squamous cell carcinoma (HNSCC)
|
Approved
|
2019-06-11 00:00:00
|
FDA Approval announced June 11, 2019.
| 1 |
RHHBY
|
Wet age-related macular degeneration (nAMD) and diabetic macular edema (DME)
|
Approved
|
2022-01-31 00:00:00
|
Approved January 31, 2022.
| 1 |
BIVI
|
Ascites
|
Phase 2b
|
2023-03-13 00:00:00
|
Phase 2b data reported that treatment resulted in a 34% reduction in ascites fluid during the 28 days after treatment initiation compared to the 28 days prior to treatment, noted March 13, 2023.
| 1 |
AVDL
|
Clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia
|
Approved
|
2014-06-30 00:00:00
|
Approved June 30, 2014.
| 1 |
ANAB
|
Generalized pustular psoriasis
|
Phase 3
|
2023-10-09 00:00:00
|
Phase 3 top-line data met its primary endpoint in the study population achieving rapid clearance of pustulation, erythema and scaling through Week 4 after a single dose of 750mg IV imsidolimab. Top-line data also demonstrate a favorable safety and tolerability profile, noted October 9, 2023.
| 1 |
HOTH
|
Atopic Dermatitis (AD)
|
Phase 1b
|
2023-09-06 00:00:00
|
Phase 1b final results reported that 78% of patients reported that their overall health had improved since starting BioLexa as compared to 22% stating that there was no change in their health, or their health was worse, noted September 6, 2023.
| 1 |
PFE
|
Anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC)
|
Phase 3
|
2021-03-03 00:00:00
|
FDA approval announced March 3 2021.
| 1 |
BPTS
|
COVID-19
|
Phase 2/3
|
2023-05-25 00:00:00
|
Phase 2/3 data reported that at 28 days the adjusted difference in the proportion of patients with hospital discharge of 11% showed a trend towards a statistically significant difference in BIO101 group versus placebo in ITT population, noted May 25, 2023.
| 1 |
SNY
|
COVID-19 vaccine
|
Phase 3
|
2021-12-15 00:00:00
|
Phase 3 data reported that the vaccine is well tolerated, with a safety profile similar to currently approved COVID-19 vaccines, noted December 15, 2021.
| 1 |
TAK
|
Dengue Vaccine
|
Phase 3
|
2022-06-09 00:00:00
|
Phase 3 data reported that treatment prevented 84% of hospitalizations and 61% of symptomatic dengue illness overall, with identified safety risks, noted June 9, 2022.
| 1 |
RXDX
|
Ulcerative colitis
|
Phase 2
|
2023-03-01 00:00:00
|
Phase 2 trial met all ranked secondary endpoints, noted March 1, 2023.
| 0 |
LLY
|
Treatment-naïve RET fusion-positive non-small cell lung cancer (NSCLC)
|
Approved
|
2022-09-21 00:00:00
|
FDA Approval on September 21, 2022.
| 1 |
NAVB
|
Lymphatic-tissue tracing agent
|
Approved
|
2013-03-13 00:00:00
|
Approved March 13, 2013.
| 1 |
CNTX
|
ER+, HER2-, ESR1-mutated Breast Cancer
|
Approved
|
2023-01-31 00:00:00
|
Approved January 31, 2023.
| 1 |
APTO
|
Acute myeloid leukemia (AML)
|
Phase 1/2
|
2023-10-30 00:00:00
|
Phase 1/2 data demonstrated 44% ORR with TUS/VEN in Difficult-to-Treat VEN Failure R/R AML Patients, noted October 30, 2023.
| 1 |
GSK
|
Severe eosinophilic asthma - pediatric
|
Approved
|
2019-06-06 00:00:00
|
FDA Approval announced June 6, 2019.
| 1 |
COYA
|
Alzheimer’s Disease (AD)
|
Phase 2
|
2023-10-09 00:00:00
|
Phase 2 enrollment completed, noted October 9, 2023.
| 0 |
CMPS
|
Treatment Resistant Depression (TRD)
|
Phase 2b
|
2023-05-26 00:00:00
|
Phase 2b more than half of the patients demonstrated remission of depression at 18 months, after a single dose of 25mg investigational COMP360 psilocybin with psychological support, noted May 26, 2023.
| 1 |
SNY
|
Cystic fibrosis
|
Phase 1/2
|
2021-03-17 00:00:00
|
Phase 1/2 interim analysis March 17, 2021. Safe and well tolerated with no serious adverse events but no increase in lung function (ppFEV1) evident.
| 1 |
PLX
|
Fabry disease
|
Approved
|
2023-05-10 00:00:00
|
Approved May 10, 2023.
| 1 |
SNY
|
Sickle Cell Disease
|
Phase 1/2
|
2021-12-13 00:00:00
|
Phase 1/2 data reported that total hemoglobin stabilized by Week 26 after treatment in all four patients. Fetal hemoglobin level increased from 0.1-11% at screening to 14-39% in all four patients and was 38% in the longest-treated patient at 91 weeks, noted December 13, 2021.
| 1 |
KRYS
|
Epidermolysis Bullosa
|
Approved
|
2023-05-19 00:00:00
|
Approved May 19, 2023.
| 1 |
MRK
|
Ovarian Cancer
|
Phase 1/2
|
2022-06-06 00:00:00
|
Results from Phase 1 and Phase 2 expansion cohort presented at ASCO reported that G3/G2 immune-related AE and injection site reactions were observed in 1/1 and 1/3 pts treated at DL1, and in 1/0 and 2/2 pts at DL2, respectively. At Phase 1, one patient with MSI-High clear cell subtype had an ongoing CR after 26 months of follow-up, 2 patients had PR and 6 SD. There were 1 PR and 3 SD on P2EC, of which 1 and 2, respectively, achieved response greater than 12 weeks, noted June 6, 2022.
| 1 |
IONS
|
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 |
BGNE
|
Gastric/gastroesophageal junction adenocarcinoma (G/GEJC)
|
Phase 1/2
|
2023-10-20 00:00:00
|
Phase 1b/2 data presented at ESMO reported that the confirmed objective response rate by investigator (INV) was 75.8% and median progression-free survival was 16.7 months, noted October 20, 2023.
| 1 |
ABBV
|
Neurogenic Detrusor Overactivity
|
Approved
|
2021-02-10 00:00:00
|
FDA approval announced February 10, 2021.
| 1 |
CPIX
|
Pain and fever in patients three months to six months of age
|
Approved
|
2023-05-15 00:00:00
|
Expanded label approval by FDA on May 15, 2023.
| 1 |
SNDX
|
Chronic Graft versus host disease (cGvHD)
|
Phase 2
|
2023-07-24 00:00:00
|
Phase 2 trial results met its primary endpoint across all cohorts with an overall response rate (ORR) of 74% at a dose of 0.3 mg/kg administered every two weeks, noted July 24, 2023.
| 0 |
RDHL
|
H. pylori
|
Approved
|
2023-09-18 00:00:00
|
https://www.biopharmcatalyst.com/company/RDHL/news/159168
| 0 |
ACIU
|
Alzheimer’s disease (AD)
|
Phase 2
|
2021-06-02 00:00:00
|
Phase 2 interim analysis June 2, 2021. Good safety confirmed.
| 0 |
PRAX
|
Early-seizure-onset SCN2A developmental and epileptic encephalopathy (DEE)
|
Phase 3
|
2023-10-02 00:00:00
|
Phase 3 results from preliminary analysis of PRAX-222 Part 1 showed 44% median reduction in seizures after three doses for SCN2A-gain-of-function pediatric patients, noted October 2, 2023.
| 1 |
IONS
|
Spinal muscular atrophy (SMA)
|
Approved
|
2016-12-23 00:00:00
|
Approved December 23, 2016.
| 1 |
FATE
|
B-cell Leukemias and Lymphomas
|
Phase 1
|
2022-12-10 00:00:00
|
Phase 1 interim data reported that 1 of 2 patients naïve to CAR T-cell therapy achieved an objective response (1 CR) at Day 30, and 2 of 6 patients previously treated with CAR T-cell therapy achieved an objective response (1 CR, 1 PR) at Day 30, noted December 12, 2022.
| 1 |
AZN
|
COVID-19
|
Phase 3
|
2023-01-26 00:00:00
|
FDA no longer allows treatment to be used as Emergency Use Authorization (EUA) due to the lack of effectiveness against the currently circulating variants, noted January 26, 2023.
| 1 |
INDV
|
Opioid Overdose
|
Approved
|
2023-05-23 00:00:00
|
Approved May 22, 2023.
| 1 |
GLUE
|
MYC-driven solid tumors
|
Phase 1/2
|
2023-10-17 00:00:00
|
Phase 1/2 initial data study demonstrated favorable tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles in heavily pre-treated patients with lung and high-grade neuroendocrine cancers., noted October 17, 2023
| 1 |
ZVRA
|
Urea cycle disorder (UCD)
|
Approved
|
2022-12-23 00:00:00
|
Approved December 23, 2022.
| 1 |
RHHBY
|
Ulcerative colitis
|
Phase 2b
|
2023-06-22 00:00:00
|
Additional Phase 2b data continue to support RVT-3101's potential as a first-in-class anti-TL1A antibody, demonstrating sustained efficacy across a broad dose range measured at 56 weeks, noted June 22, 2023
| 1 |
IPSEY
|
Glabellar and lateral canthal lines
|
CRL
|
2023-10-03 00:00:00
|
CRL received October 3, 2023.
| 0 |
LGND
|
Pneumococcal disease
|
Approved
|
2021-07-16 00:00:00
|
FDA approval announced July 16, 2021.
| 1 |
AMGN
|
Neuromyelitis Optica Spectrum Disorder
|
Approved
|
2020-06-11 00:00:00
|
FDA Approval announced June 11, 2020.
| 1 |
PFE
|
Gastric cancer
|
Phase 3
|
2017-11-28 00:00:00
|
Phase 3 data released November 28, 2017 - primary endpoint not met.
| 0 |
REGN
|
Ebola
|
Approved
|
2020-10-14 00:00:00
|
FDA Approval announced October 14, 2020.
| 1 |
PRVB
|
Ulcerative Colitis
|
Phase 1b
|
2019-05-08 00:00:00
|
Phase 1b top-line data May 8, 2019 noted primary safety and tolerability endpoint met but secondary efficacy endpoints were not met.
| 1 |
APTX
|
Post-traumatic stress disorder (PTSD)
|
Phase 2
|
2020-10-19 00:00:00
|
Phase 2 data released October 19, 2020. Primary endpoint met.
| 0 |
BMY
|
Melanoma
|
Phase 3
|
2022-03-14 00:00:00
|
Phase 3 data did not meet the primary endpoints, noted March 14, 2022.
| 1 |
INCY
|
Anemia and Post-essential Thrombocythemia Myelofibrosis
|
Phase 1/2
|
2022-12-12 00:00:00
|
Phase 1/2 data reported predominantly grade 1/2 TEAEs and no dose-limiting toxicities (DLTs), noted December 12, 2022.
| 0 |
NVAX
|
COVID-19 vaccine
|
Approved
|
2022-07-13 00:00:00
|
Emergency Use Authorization (EUA) granted July 13, 2022.
| 0 |
CLSD
|
Wet age-related macular degeneration
|
Phase 1/2
|
2023-10-16 00:00:00
|
Phase 1/2a results demonstrated the key benefits targeting the site of disease at the back of the eye, noted October 16, 2023.
| 1 |
GMAB
|
Metastatic cervical cancer
|
Phase 1/2
|
2022-06-06 00:00:00
|
Phase 1b/2 data reported an 41% objective response rate, noted June 6, 2022.
| 0 |
RCKT
|
Leukocyte Adhesion Deficiency-I (LAD-I)
|
Phase 1/2
|
2022-05-19 00:00:00
|
Phase 2 top-line data reported a 100% survival rate at 12-months post-infusion, with statistically significant reduction in the rate of all-cause hospitalizations and severe infections, noted May 19, 2022.
| 1 |
CALA
|
Non-small cell lung cancer (NSCLC) patients with genetic mutation NRF2/KEAP1
|
Phase 2
|
2021-11-05 00:00:00
|
Phase 2 interim analysis demonstrated lack of clinical benefit among patients treated. Trial termination, noted November 5, 2021.
| 1 |
AKBA
|
ARDS in subjects with COVID-19 and hypoxemia
|
Phase 2
|
2022-08-04 00:00:00
|
Phase 2 trial data reported that at Day 14, the proportions of subjects who had a 6, 7 or 8 on the NIAID-OS were 13.3% for vadadustat versus 16.9% for placebo, missing its primary endpoint, noted August 4, 2022.
| 0 |
IMVT
|
Myasthenia Gravis (MG)
|
Phase 2
|
2020-08-25 00:00:00
|
Phase 2 data released August 25, 2020.
| 0 |
INCY
|
Steroid-refractory chronic GVHD (Graft versus host disease)
|
Approved
|
2021-09-22 00:00:00
|
Approved September 22, 2021.
| 1 |
SWTX
|
Multiple Myeloma
|
Phase 1/2
|
2023-06-09 00:00:00
|
Phase 1/2 data presented at EHA Data from 34 patients with low-dose and 37 patients with monotherapy are presented. Patients had a median (range) age of 68 (48–81) years and a median (range) of 5 (3–14) prior lines of therapy. As of the data cutoff (Dec 9, 2022), patients received a median (range) of 4 (1–20) cycles of the combination and 3 (1–9) monotherapy cycles. For the combination and monotherapy arms, respectively, ORR was 29% (95% CI 15.1, 47.5) and 38% (22.5, 55.2) (Table). Incidence of Grade ≥3 adverse events was 76% and 65%, noted June 9, 2023.
| 1 |
IMMP
|
Ulcerative Colitis
|
Phase 2
|
2021-01-21 00:00:00
|
Phase 2 trial discontinued following interim analysis - January 21, 2021.
| -1 |
DRRX
|
Schizophrenia
|
Approved
|
2018-07-27 00:00:00
|
FDA Approval announced July 27, 2018.
| 1 |
MRK
|
Crohn’s Disease
|
Phase 2a
|
2023-03-03 00:00:00
|
Phase 2a primary and secondary results reported efficacy in biologic-experienced subjects consistent with overall population and consistent across subgroups and irrespective of presence of ADA, noted March 3, 2023.
| 0 |
LLY
|
COVID-19
|
Phase 3
|
2021-04-08 00:00:00
|
Phase 3 trial did not meet primary endpoint - April 8, 2021.
| 1 |
MYOV
|
Endometriosis
|
Phase 3
|
2022-07-28 00:00:00
|
Phase 3 data reported that trials met both co-primary endpoints with 75% of women in the relugolix combination therapy group in both studies achieving a clinically meaningful reduction in dysmenorrhea compared with 27% and 30% of women in the placebo groups at Week 24, respectively, noted July 28, 2022.
| 1 |
PRTA
|
AL Amyloidosis
|
Phase 3
|
2022-12-12 00:00:00
|
Phase 3 VITAL data reported a significant improvement in time to all-cause mortality, noted December 12, 2022.
| 1 |
BHC
|
Ocular Inflammation
|
Approved
|
2019-02-25 00:00:00
|
FDA approval announced February 25, 2019.
| 1 |
PFE
|
Endometriosis
|
Phase 3
|
2022-07-28 00:00:00
|
Phase 3 data reported that trials met both co-primary endpoints with 75% of women in the relugolix combination therapy group in both studies achieving a clinically meaningful reduction in dysmenorrhea compared with 27% and 30% of women in the placebo groups at Week 24, respectively, noted July 28, 2022.
| 1 |
AZN
|
Type-2 diabetes
|
Approved
|
2017-02-28 00:00:00
|
Approval announced February 28, 2017.
| 1 |
LSTA
|
Solid Tumors
|
Phase 2a
|
2023-09-12 00:00:00
|
Phase 2a dosing initiated on head and neck squamous cell carcinoma cohort, noted Septemeber 12, 2023.
| 0 |
OMER
|
Cataract surgery
|
Approved
|
2014-06-02 00:00:00
|
Approved June 2, 2014.
| 1 |
KROS
|
Myelodysplastic syndromes (MDS)
|
Phase 2
|
2023-11-02 00:00:00
|
Phase 2 data from ASH abstract reported that the median treatment duration was 166 days (range 6 to 649). Most participants (89.8%) had at least 1 treatment-emergent adverse event (TEAE), and 32.2% had TEAEs considered treatment-related, noted November 2, 2023.
| 1 |
ORTX
|
MPS-IIIA
|
Phase 1/2
|
2023-05-19 00:00:00
|
Initial data shared at ASGCT reported that four out of five patients continued to gain cognitive skills in line with development in healthy children, noted May 20, 2023.
| 0 |
AZN
|
Hyperkalaemia
|
Approved
|
2018-05-18 00:00:00
|
Approval announced May 18, 2018.
| 1 |
RDHL
|
Crohn’s disease
|
Phase 3
|
2018-07-30 00:00:00
|
Phase 3 data released July 30, 2018. Primary endpoint met but further trial required.
| 0 |
AMGN
|
Relapsed Multiple Myeloma
|
Approved
|
2018-01-17 00:00:00
|
sNDA approved January 17, 2018.
| 1 |
CGTX
|
Geographic Atrophy Secondary to Dry Age-related Macular Degeneration (AMD)
|
Phase 1
|
2023-07-11 00:00:00
|
Phase 2 trial dosing initiated, noted July 11, 2023.
| 0 |
AYTU
|
Attention deficit hyperactivity disorder (ADHD)
|
Approved
|
2017-09-15 00:00:00
|
Approval announced September 15, 2017.
| 1 |
ADPT
|
Newly Diagnosed Multiple Myeloma
|
Phase 2a
|
2022-12-10 00:00:00
|
Cohort 2a efficacy and safety data presented at ASH demonstrated complete and durable responses in a significant proportion of patients, noted on December 10, 2022.
| 1 |
NTLA
|
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 |
SNY
|
COVID-19 vaccine
|
Phase 1/2
|
2021-09-28 00:00:00
|
Phase 1/2 interim data noted neutralizing antibody seroconversion in 91% to 100% of study participants. No safety concern has been observed, noted September 28, 2021.
| 1 |
GRTS
|
COVID-19 booster (60+)
|
Phase 1
|
2023-10-11 00:00:00
|
Additional Phase 1 data reported at IDweek noted that durable binding and high neutralizing antibodies were induced and sustained for up to at least 12 months, noted October 11, 2023.
| 0 |
AADI
|
Soft Tissue Sarcoma
|
Phase 1
|
2023-06-05 00:00:00
|
Phase 1 data at ASCO reported that 3 of the 18 evaluable patients having achieved a partial response, and 13 achieving stable disease, noted June 5, 2023.
| 1 |
INCY
|
COVID-19
|
Approved
|
2022-05-11 00:00:00
|
FDA approval on May 11, 2022.
| 1 |
BIIB
|
Small Fiber Neuropathy
|
Phase 2
|
2021-09-16 00:00:00
|
Phase 2 200mg dosing data met primary endpoint, did not meet statistical significance for secondary endpoints. Phase 2 330 mg dosing data did not meet the primary endpoint or secondary endpoints, September 16, 2021.
| 1 |
IMMP
|
Metastatic breast cancer (MBC)
|
Phase 2b
|
2022-05-04 00:00:00
|
Phase 2b biomarker data reported a statistically significant increase in innate and adaptive immune response biomarkers and six patient subgroups with improvements in Overall Survival (OS), noted May 4, 2022.
| 1 |
SVRA
|
Heart failure with preserved ejection fraction (HFpEF)
|
Phase 2
|
2018-03-11 00:00:00
|
Phase 2 top line data presented March 11, 2018 failed to meet primary endpoint.
| 1 |
MRK
|
Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
|
Approved
|
2018-06-13 00:00:00
|
Approval announced June 13, 2018.
| 1 |
NVO
|
Type 2 diabetes
|
Phase 3
|
2022-06-03 00:00:00
|
Phase 3a trial met primary endpoint, noted June 3, 2022.
| 0 |
ZLDPF
|
Short bowel syndrome (SBS)
|
Phase 3
|
2022-09-30 00:00:00
|
Phase 3 trial results reported that trial met its primary endpoint, noted September 30, 2022.
| 0 |
TVTX
|
Focal segmental glomerulosclerosis (FSGS)
|
Phase 3
|
2023-11-03 00:00:00
|
Phase 3 presentations at ASN showed that sparsentan delivered a clinically meaningful benefit at 108 weeks with significant proteinuria reduction, higher rates of partial and complete remission, and lower rates of end-stage kidney disease, noted November 3, 2023.
| 1 |
PFE
|
Ulcerative colitis
|
Approved
|
2018-05-30 00:00:00
|
Approval announced May 30, 2018.
| 1 |
PCRX
|
Post surgical pain
|
Approved
|
2018-04-06 00:00:00
|
Approval announced April 6, 2018.
| 1 |
INCY
|
Rheumatoid arthritis
|
Approved
|
2018-06-01 00:00:00
|
FDA approval announced for low dose only - June 1, 2018.
| 1 |
AVIR
|
COVID-19
|
Phase 2
|
2023-04-25 00:00:00
|
Fast Track Designation granted on April 25, 2023.
| 0 |
MRK
|
HER2 amplified metastatic colorectal cancer
|
Approved
|
2023-01-19 00:00:00
|
Approved January 19, 2023.
| 1 |
SYRS
|
Acute myeloid leukemia (AML)
|
Phase 2
|
2022-12-10 00:00:00
|
Phase 2 data reported a 83% composite complete response rate in newly diagnosed unfit AML patients with RARA gene overexpression, noted December 10, 2022.
| 0 |
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