ticker
stringlengths 2
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| disease
stringlengths 3
196
| stage
stringclasses 15
values | date
stringlengths 19
19
| catalyst
stringlengths 18
760
| label
int64 -1
1
|
|---|---|---|---|---|---|
KZIA
|
Glioblastoma (GBM)
|
Phase 2/3
|
2023-10-31 00:00:00
|
Phase 2/3 data reported that it did not perform better than the current standards of care in glioblastoma, noted October 31, 2023.
| 0 |
RYTM
|
Hypothalamic obesity
|
Phase 2
|
2023-06-19 00:00:00
|
Phase 2 data demonstrated a mean BMI reduction of 21.0% from baseline observed in 13 patients at six months, showing progression from 16.8% mean BMI reduction at 16 weeks, noted June 19 2023.
| 1 |
ALKS
|
Relapsing Remitting Multiple Sclerosis (RRMS)
|
Phase 3
|
2019-07-30 00:00:00
|
Phase 3 top-line data met primary endpoint - July 30, 2019.
| 0 |
KRTX
|
Acute psychosis in patients with schizophrenia
|
Phase 3
|
2022-08-08 00:00:00
|
Phase 3 trial met primary endpoint and secondary endpoints, demonstrating a statistically significant 9.6-point reduction in PANSS Total Score compared to placebo at Week 5, noted August 8, 2022.
| 1 |
JNJ
|
Relapsed or refractory multiple myeloma
|
Approved
|
2017-06-16 00:00:00
|
Approval announced June 16, 2017 - note: submitted by Janssen Biotech, Inc.
| 1 |
FATE
|
Acute graft-versus-host disease (GvHD) undergoing hematopoietic cell transplantation (HCT)
|
Phase 2
|
2021-05-05 00:00:00
|
Phase 2 trial did not meet primary endpoint.
| 1 |
AMGN
|
Palmoplantar pustulosis for Japanese patients
|
Phase 2
|
2022-03-27 00:00:00
|
Phase 2 data APR demonstrated shorter median time to PPPASI-50 response than PBO. The most common adverse events included gastrointestinal events and headache, noted March 27, 2022.
| 1 |
GMAB
|
Multiple myeloma - candidates for autologous stem cell transplant (ASCT)
|
Approved
|
2019-09-26 00:00:00
|
FDA Approval announced September 26, 2019.
| 1 |
BMY
|
Relapsing Multiple Sclerosis
|
Approved
|
2020-03-25 00:00:00
|
FDA Approval announced March 26, 2020.
| 1 |
IPHA
|
Head and neck squamous cell carcinoma of the head and neck (SCCHN)
|
Phase 3
|
2022-08-01 00:00:00
|
Phase 3 trial did not meet the futility interim analysis, noted August 1, 2022.
| 1 |
OCUP
|
Mydriasis in patients aged 3-11
|
Phase 3
|
2022-04-28 00:00:00
|
Phase 3 top-line data reported that trial met primary endpoint, noted April 28, 2022.
| 0 |
AMGN
|
Sjögren’s syndrome
|
Phase 2
|
2023-05-31 00:00:00
|
Additional Phase 2 data reported that all ESSDAI responder analyses (pre-specified and post-hoc) favored dazodalibep over placebo, with greater numerical differences for the highest levels of response and patients treated with dazodalibep experienced numerically greater improvements in ESSPRI score and fatigue compared to those who received placebo at Day 169, noted May 31, 2023.
| 1 |
EGRX
|
Breast, non-small cell lung, prostate gastric adenocarcinoma, and head and neck cancer
|
Approved
|
2015-12-24 00:00:00
|
Approved December 24, 2015.
| 1 |
AGEN
|
RSV vaccine
|
Approved
|
2023-05-03 00:00:00
|
FDA Approved on May 3, 2023.
| 1 |
BOLT
|
Solid Tumors
|
Phase 1/2
|
2023-10-17 00:00:00
|
Phase 1/2 initiated, noted October 17, 2023.
| 0 |
ALLK
|
Eosinophilic Gastritis and/or eosinophilic duodenitis (EoD)
|
Phase 3
|
2021-12-21 00:00:00
|
Phase 3 data reported that the trial met its histological primary endpoint but did not meet patient reported symptomatic primary endpoint, noted December 21, 2021.
| 1 |
NVS
|
Multiple Sclerosis (MS)
|
Approved
|
2018-05-11 00:00:00
|
Approval announced May 11, 2018.
| 1 |
PTCT
|
Spinal Muscular Atrophy (SMA) Type 1
|
Approved
|
2020-08-07 00:00:00
|
FDA Approval announced August 7, 2020.
| 1 |
FMTX
|
Prostate cancer (CRPC)
|
Phase 1
|
2021-10-07 00:00:00
|
Phase 1 initial preliminary results reported include data as of Sept. 1, 2021, from eight men enrolled in the trial. The dose was administered in 28-day cycles, with 21 days of dosing followed by seven days of no dosing. (3/8) patients remain on study; (5/8) patients left the study (4 due to disease progression and 1 withdrawal of consent).
| 0 |
BMY
|
(dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC)
|
Approved
|
2017-08-01 00:00:00
|
Approval announced August 1, 2017.
| 1 |
REGN
|
Atopic dermatitis 12-17 year-olds
|
Approved
|
2019-03-11 00:00:00
|
FDA approval announced March 11, 2019.
| 1 |
BMRN
|
Batten Disease
|
Approved
|
2017-04-27 00:00:00
|
PDUFA date extended by three months to April 27 2017. Approval announced April 27, 2017.
| 1 |
NVS
|
Pre-symptomatic patients with spinal muscular atrophy (SMA) Types 1, 2 and 3
|
Phase 3
|
2019-05-05 00:00:00
|
Phase 3 data May 5, 2019 noted all patients (18/18) were alive and event-free
| 0 |
SUPN
|
Bipolar depression
|
Phase 3
|
2020-05-05 00:00:00
|
Phase 3 development has been terminated - May 5, 2020.
| -1 |
GMAB
|
Relapsed or refractory multiple myeloma
|
Approved
|
2017-06-16 00:00:00
|
Approval announced June 16, 2017 - note: submitted by Janssen Biotech, Inc.
| 1 |
VTRS
|
Multiple sclerosis - Tecfidera generic
|
Approved
|
2020-08-17 00:00:00
|
FDA approved August 17, 2020.
| 1 |
INO
|
COVID-19 vaccine
|
Phase 2
|
2021-05-10 00:00:00
|
Phase 2 data released May 10, 2021 - generally safe and well-tolerated.
| 1 |
EXEL
|
Advanced hepatocellular cancer (HCC)
|
Approved
|
2019-01-14 00:00:00
|
FDA Approval announced January 14, 2019.
| 1 |
AIM
|
Early-stage triple negative breast cancer
|
Phase 1
|
2023-09-11 00:00:00
|
Phase 1 complete topline results confirmed treatment was well tolerated, with promising clinical activity of pathologic complete response (pCR) + microinvasive residual disease (ypTmic) at 66%, comparable to pembrolizumab/neoadjuvant chemotherapy (NAC), noted September 11, 2023.
| 1 |
VTRS
|
Pediatric Formulation of Dolutegravir (DTG)
|
Approved
|
2020-11-23 00:00:00
|
FDA tentative approval announced November 23, 2020.
| 1 |
TEVA
|
Schizophrenia
|
Approved
|
2023-04-28 00:00:00
|
Approved April 28, 2023.
| 1 |
TNGX
|
Solid Tumors
|
Phase 1a
|
2023-09-06 00:00:00
|
IND cleared by FDA, noted September 6, 2023. Phase 1/2 clinical trial to commence 1H 2024.
| 0 |
ACAD
|
Rett Syndrome
|
Approved
|
2023-03-10 00:00:00
|
Approved March 10, 2023.
| 1 |
BCRX
|
Reduce or eliminate attacks in HAE patients
|
Approved
|
2020-12-03 00:00:00
|
FDA approval announced December 3, 2020
| 1 |
REGN
|
Chronic Spontaneous Urticaria (CSU)
|
Phase 3
|
2022-02-18 00:00:00
|
Phase 3 trial did not meet the primary endpoint, noted February 18, 2022.
| 1 |
GMAB
|
Relapsed or Refractory (R/R) Multiple Myeloma (MM).
|
Phase 1/2
|
2022-12-12 00:00:00
|
Phase 1/2 preliminary data reported that treatment was well tolerated with no treatment related deaths or dose-limiting toxicities, noted December 12, 2022.
| 1 |
MRK
|
Head and neck squamous cell carcinoma (HNSCC)
|
Phase 3
|
2022-07-20 00:00:00
|
Phase 3 trial did not meet primary endpoint, noted June 20, 2022.
| 1 |
RHHBY
|
Alzheimer’s disease
|
Phase 3
|
2019-01-30 00:00:00
|
Phase 3 trial terminated following interim analysis indicating primary endpoint would not be met.
| -1 |
RCKT
|
Fanconi Anemia (FA)
|
Phase 2
|
2022-12-12 00:00:00
|
Phase 2 data reported that A seventh patient has displayed evidence of progressively increasing genetic correction as demonstrated by peripheral blood and BM vector copy numbers (VCNs), noted December 12, 2022.
| 1 |
AMGN
|
Coronary Artery Disease (CAD)
|
Phase 3
|
2023-03-04 00:00:00
|
Phase 3 data presented at the ACC.23/WCC reported that treatment significantly reduced both first and recurrent CV events, with more than double the number of total events prevented as compared with 1st events only, noted March 4, 2023.
| 1 |
ZNTL
|
Uterine serous carcinoma (USC)
|
Phase 1
|
2023-06-06 00:00:00
|
Phase 1 showed an ORR of 36.8% in heavily pretreated platinum-resistant ovarian cancer and USC patients treated with intermittent dosing, noted June 6, 2022.
| 1 |
JNCE
|
Second-line non-small cell lung cancer (NSCLC) patients
|
Phase 2
|
2022-08-30 00:00:00
|
Phase 2 trial did not meet its primary endpoint, noted August 30, 2022.
| 1 |
GILD
|
Large B-cell lymphoma (LBCL) after one prior line of therapy who were deemed ineligible for high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT)
|
Phase 2
|
2023-09-18 00:00:00
|
Phase 2 trial met its primary endpoint, noted September 18, 2023.
| 0 |
INO
|
HPV-associated squamous cell carcinoma of the head & neck (SCCHN)
|
Phase 1
|
2017-11-10 00:00:00
|
Presentation at SITC Meeting - November 10, 2017.
| 1 |
TXMD
|
Moderate-to-severe vaginal pain
|
Approved
|
2018-05-30 00:00:00
|
CRL announced May 8, 2017. NDA resubmitted with approval announced May 30, 2018.
| 1 |
DARE
|
Hormone replacement therapy
|
Phase 1/2
|
2023-04-18 00:00:00
|
Results of study published at the Menopause International Society demonstrated that the DARE-HRT1 IVRs, in general, were safe and well tolerated in healthy postmenopausal women and treatment emergent adverse events profiles were comparable between the DARE-HRT1 groups and the reference oral regimen group, noted April 18, 2023.
| 1 |
AUTL
|
Relapsed or refractory diffuse large B-celllymphoma (DLBCL)
|
Phase 2
|
2020-12-07 00:00:00
|
Phase 2 updated data at ASH December 7, 2020 noted objective response rate (ORR) of 65% and a CR rate of 51%.
| 0 |
INCY
|
Merkel cell carcinoma (MCC)
|
Approved
|
2023-03-22 00:00:00
|
FDA Approved on March 22, 2023.
| 1 |
AKBA
|
Anemia due to chronic kidney disease (CKD)
|
Phase 3
|
2023-04-03 00:00:00
|
Phase 3 study met primary and secondary endpoints, noted April 3, 2023.
| 0 |
AZN
|
Severe, uncontrolled asthma
|
Approved
|
2017-11-14 00:00:00
|
Approval announced November 14, 2017.
| 1 |
KURA
|
Relapsed or refractory acute myeloid leukemia (AML)
|
Phase 1/2
|
2023-06-10 00:00:00
|
Phase 1/2 data presented at EHA showed that 35% CR rate (7/20) among patients with relapsed/refractory NPM1-mutant AML treated at 600 mg dose (RP2D) and 33% (2/6) of patients with FLT3 co-mutations and 50% (4/8) of patients with IDH co-mutations achieved a CR on ziftomenib, noted June 10, 2023.
| 1 |
ABCL
|
COVID-19 Antibody
|
Approved
|
2020-11-09 00:00:00
|
Emergency Use Authorization (EUA) announced November 9, 2020.
| 0 |
PTGX
|
Hereditary hemochromatosis
|
Phase 2
|
2021-11-15 00:00:00
|
Phase 2 data released November 15, 2021. Phase 2 trial met primary endpoint, rusfertide-treated patients had 0.009 phlebotomies per month during the study compared to 0.28 phlebotomies per month pre-study. The average TSAT during treatment was 31.4% compared to 45.0% pre-study and the serum iron was 101 mcg/dl compared to 137 mcg/dl.
| 1 |
TARA
|
Non-muscle invasive bladder cancer (NMIBC)
|
Phase 1b
|
2023-04-28 00:00:00
|
Phase 1a data indicated that TARA-002 was generally well tolerated and showed anti-tumor activity in high-grade NMIBC patients, noted April 28, 2023.
| 1 |
RDHL
|
COVID-19 (outpatients)
|
Phase 2/3
|
2023-01-03 00:00:00
|
Phase 2 trial met primary endpoint, noted January 3, 2023.
| 0 |
BFRI
|
Actinic Keratosis
|
Phase 1
|
2022-11-21 00:00:00
|
Phase 1 Pharmacokinetics study and results discussed with FDA; to be submitted to FDA along with 3 tubes safety study. Phase 3 study launched, noted November 21, 2022.
| 0 |
ADVM
|
Wet age-related macular degeneration (AMD)
|
Phase 2
|
2023-09-26 00:00:00
|
Phase 2 14-week data reported that has been generally well-tolerated, with 90% of subjects were still receiving corticosteroid prophylactic taper, noted September 26, 2023.
| 1 |
SAGE
|
Parkinson Disease
|
Phase 2a
|
2022-03-15 00:00:00
|
Phase 2a data reported that sustained effects and improving trends were seen out to Day 28, noted March 15, 2022.
| 1 |
LPCN
|
Non-alcoholic fatty liver disease (NAFLD) / Non-alcoholic steatohepatitis (NASH)
|
Phase 2
|
2022-05-12 00:00:00
|
OLE extension study results reported that treatment was well-tolerated with liver injury markers reduced, noted May 12, 2022.
| 1 |
RHHBY
|
Hemophilia
|
Approved
|
2018-10-04 00:00:00
|
FDA Approval announced October 4, 2018.
| 1 |
ICPT
|
Fibrosis due to nonalcoholic steatohepatitis (NASH)
|
CRL
|
2023-06-23 00:00:00
|
Study to be discontinued, noted JUne 23, 2023.
| -1 |
CARA
|
Pruritus associated primary biliary cholangitis (PBC)
|
Phase 2
|
2022-11-07 00:00:00
|
Phase 2 data reported no unexpected adverse events, noted November 7, 2022.
| 0 |
GRCL
|
Diffuse large B-cell lymphoma (DLBCL)
|
Phase 1
|
2023-09-27 00:00:00
|
Additional Phase 1 data presented at IMS reported an 100% overall response rate (ORR) and a 100% MRD- sCR rate among 19 transplant-eligible, high-risk NDMM patients, noted September 27, 2023.
| 1 |
PTCT
|
Phenylketonuria (PKU)
|
Phase 3
|
2023-05-17 00:00:00
|
Phase 3 results met primary endpoint, noted May 17, 2023.
| 0 |
LGND
|
Chronic obstructive pulmonary disease (COPD)
|
Phase 3
|
2022-12-20 00:00:00
|
ENHANCE-1 Phase 3 topline data met its primary and key secondary endpoints, noted December 20, 2022.
| 0 |
REGN
|
Cutaneous squamous cell carcinoma
|
Approved
|
2018-09-28 00:00:00
|
FDA Approval announced September 28, 2018.
| 1 |
ZYME
|
HER2-positive breast cancer
|
Phase 1/2
|
2022-05-26 00:00:00
|
Phase 1b/2 data released in abstract reported that the cORR was 90.5% and the six-month progression-free survival rate was 95.2%, noted May 26, 2022.
| 0 |
BMY
|
First-line Small cell lung cancer (SCLC)
|
Phase 3
|
2018-11-26 00:00:00
|
Phase 3 trial did not meet primary endpoint - November 26, 2018.
| 1 |
JNJ
|
HIV
|
Approved
|
2018-07-18 00:00:00
|
FDA Approval announced July 17, 2018.
| 1 |
ADPT
|
Multiple Myeloma
|
Approved
|
2023-08-14 00:00:00
|
FDA Approved on August 14, 2023.
| 1 |
DVAX
|
Asthma
|
Phase 2a
|
2018-11-29 00:00:00
|
Phase 2a trial did not meet primary endpoint - November 29, 2018.
| 1 |
TPST
|
Hepatocellular Carcinoma (HCC), Solid tumors
|
Phase 1
|
2023-04-17 00:00:00
|
Additional biomarker data presented at AACR reported on-target changes in gene signatures in the peripheral blood that were dependent upon drug exposure levels, noted April 17, 2023.
| 1 |
LBPS
|
Solid tumors
|
Phase 1/2
|
2022-03-23 00:00:00
|
Phase 1/2 part B data reported that the renal cell carcinoma (RCC) group met the primary endpoint, noted March 23, 2022.
| 0 |
CKPT
|
Cutaneous squamous cell carcinoma (CSCC)
|
BLA Filing
|
2023-01-04 00:00:00
|
Phase 1 pivotal top-line data reported that the trial met the primary endpoint, noted January 25, 2022. Phase 1 interim efficacy results reported an objective response rate of 54.8%, noted June 16, 2022. BLA submitted to FDA, noted January 4, 2022.
| 0 |
AURA
|
Indeterminate lesions (ILs) and choroidal melanoma (CM)
|
Phase 1/2
|
2022-06-22 00:00:00
|
Phase 1b/2 reported results from retrospective matched case control study, treatment achieved statistically significant vision preservation compared current standard of care, noted June 22, 2022.
| 1 |
CGEM
|
Solid tumors
|
Phase 1
|
2023-11-03 00:00:00
|
Phase 1 Initial clinical biomarker data demonstrated that CLN-619 increases MICA expression on the tumor cell surface, consistent with previously reported preclinical data and supporting the proposed mechanism of action, noted November 3, 2023.
| 1 |
JNJ
|
Non- Small Cell Lung Cancer
|
Phase 3
|
2023-10-24 00:00:00
|
Phase 3 data presented at ESMO reported that PFS was significantly improved with ami-chemo (HR, 0.48; 95% CI, 0.36–0.64) and ami-laz-chemo (HR, 0.44; 95% CI, 0.35–0.56) vs chemo (median PFS, 6.3 and 8.3 vs 4.2 mo), noted October 24, 2023.
| 1 |
SUPN
|
Motor fluctuations in Parkinson’s disease (PD)
|
CRL
|
2022-10-10 00:00:00
|
CRL announced October 10, 2022.
| 0 |
SIOX
|
Parkinson's disease
|
Phase 1/2
|
2020-10-06 00:00:00
|
Two evaluable patients in Cohort 2 demonstrated a 21-point mean improvement in the UPDRS Part III “OFF” score, representing a 40% improvement from the baseline average score of 52 in these patients. Two other patients not evaluated.
| 1 |
VRTX
|
Acute Pain following bunionectomy or abdominoplasty surgery
|
Phase 2
|
2022-03-31 00:00:00
|
Phase 2 trial met primary endpoint, noted March 31, 2022.
| 0 |
BNTX
|
COVID-19 vaccine
|
Approved
|
2022-06-17 00:00:00
|
EUA approval for children 4 years - 6 months, noted June 17, 2022.
| 1 |
NVS
|
CV risk reduction
|
CRL
|
2018-10-18 00:00:00
|
CRL announced October 18, 2018.
| 0 |
LLY
|
Early Alzheimer's disease
|
Phase 3
|
2018-06-11 00:00:00
|
Announced discontinuation of trial due to futility.
| -1 |
ASLN
|
Gastric cancer
|
Phase 2
|
2019-01-13 00:00:00
|
Phase 2 trial did not meet primary endpoint - January 13, 2019.
| 1 |
AMGN
|
RITUXAN biosimilar - non-Hodgkin lymphoma
|
Approved
|
2020-12-17 00:00:00
|
FDA approval announced December 17, 2020.
| 1 |
BHVN
|
Spinocerebellar Ataxia (SCA)
|
Phase 3
|
2023-07-27 00:00:00
|
The FDA informed Biohaven that it would not review the recently submitted NDA application for troriluzole given that the study's primary endpoint was not met and thus, would not permit a substantive review. The communication from the FDA indicated that the Company may request a Type A meeting within 30 days, noted July 27, 2023.
| 1 |
AUTL
|
Pediatric Acute lymphoblastic leukemia (ALL)
|
Phase 1
|
2023-09-05 00:00:00
|
Phase 1 data presented at the Blood journal showed that of 10 responding patients, 5 had emergence of MRD (2) or frank relapse (3) with CD19 and CD22 expressing disease associated with loss of CAR T-cell persistence. Importantly, there were no cases of relapse due to antigen-negative escape, with a median follow-up of 8.7 months. Overall survival was 75% at 6 and 12 months. Six and 12-month event free survival (EFS) were 75% and 60% respectively, noted September 5, 2023.
| 1 |
ACER
|
Vascular Ehlers-Danlos Syndrome
|
CRL
|
2019-06-25 00:00:00
|
CRL issued June 25, 2019.
| 0 |
AYLA
|
Desmoid tumors
|
Phase 2/3
|
2023-10-23 00:00:00
|
Phase 2 data presented at ESMO showed that 1.2 mg once daily treatment achieved Overall Response Rate of 83% in the evaluable population, AL102 1.2 mg once daily treatment resulted in 88% reduction in tumor volume and 85% reduction in T2W signal intensity, noted October 23, 2023.
| 1 |
ARAV
|
Platinum Resistant Ovarian Cancer (PROC)
|
Phase 3
|
2023-08-02 00:00:00
|
Phase 3 topline data did not meet primary endpoint of progression-free survival, noted August 2, 2023.
| 1 |
AZN
|
Asthma and comorbid nasal polyps
|
Phase 3
|
2021-09-05 00:00:00
|
Phase 3 data showed an 86% reduction in the annualized asthma exacerbation rate (AAER) September 5, 2021.
| 1 |
MRK
|
Hepatocellular Carcinoma
|
CRL
|
2020-07-08 00:00:00
|
CRL issued July 8, 2020.
| 0 |
BMY
|
Stroke prevention (SSP)
|
Phase 2
|
2022-08-28 00:00:00
|
Phase 2 trial results reported that a a dose response was not observed and a relative risk reduction of approximately 30% in symptomatic ischemic stroke, noted August 28, 2022.
| 1 |
JNCE
|
Non-small cell lung cancer and bladder cancer
|
Phase 2
|
2020-11-02 00:00:00
|
Phase 2 interim analysis noted the trial will not meet pre-specified interim criteria for continuation of enrollment - November 2, 2020.
| 1 |
SRRK
|
Spinal muscular atrophy (SMA)
|
Phase 2
|
2023-06-30 00:00:00
|
Phase 2 36-month extension data presented at the Cure SMA Conference showed that continued treatment with apitegromab over the extended treatment period was associated with substantial and sustained improvement in motor function, noted June 30, 2023.
| 1 |
INVA
|
Uncomplicated gonorrhea
|
Phase 3
|
2023-11-01 00:00:00
|
Phase 3 data met the primary endpoint when compared against the combination of injectable ceftriaxone and oral azithromycin, noted November 1, 2023.
| 0 |
SRNE
|
Pain associated with post-herpetic neuralgia (PHN)
|
Approved
|
2018-02-28 00:00:00
|
Approval announced February 28, 2018.
| 1 |
MRK
|
Castration-resistant prostate cancer -first line
|
Approved
|
2023-06-01 00:00:00
|
FDA Approved on June 1, 2023.
| 1 |
AZN
|
Amyotrophic lateral sclerosis (ALS)
|
Phase 3
|
2021-08-20 00:00:00
|
Phase 3 trial discontinued due to lack of efficacy.
| -1 |
CHRS
|
Esophageal Squamous Cell Carcinoma
|
Phase 3
|
2021-09-17 00:00:00
|
Phase 3 trial met the co-primary endpoints of progression free survival (PFS) and overall survival (OS) for patients treated with the toripalimab and chemotherapy combination compared to chemotherapy alone, September 17, 2021.
| 1 |
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