ticker
stringlengths 2
5
| disease
stringlengths 3
196
| stage
stringclasses 15
values | date
stringlengths 19
19
| catalyst
stringlengths 18
760
| label
int64 -1
1
|
|---|---|---|---|---|---|
PHAT
|
H. pylori
|
Approved
|
2023-10-30 00:00:00
|
Prior Approval Supplement (PAS) for the reformulation of vonoprazan tablets approved October 30, 2023.
| 1 |
BIIB
|
Painful Lumbosacral Radiculopathy (PLSR)
|
Phase 2
|
2018-09-30 00:00:00
|
Phase 2 data released September 2018 - primary endpoint not met.
| 0 |
AZN
|
Non-small cell lung cancer (NSCLC) without actionable genomic alterations
|
Phase 1b
|
2023-09-11 00:00:00
|
Phase 1b data reported an objective response rates of 77% and 50% and disease control rates of 92% and 93%, respectively, noted September 11, 2023.
| 0 |
MGTX
|
RPE65-Deficiency
|
Phase 1/2
|
2019-05-14 00:00:00
|
Phase 1/2 data met primary endpoint of safety and tolerability.
| 1 |
ENTX
|
Osteoporosis
|
Phase 2
|
2023-10-14 00:00:00
|
Phase 2 data presented at ASBMR showed that an increase in plasma ionized calcium should result in decreased secretion and plasma concentrations of endogenous PTH(1-84), noted October 14, 2023
| 1 |
CBAY
|
Primary biliary cholangitis (PBC)
|
Phase 3
|
2023-09-21 00:00:00
|
Phase 3/4 study initiated, noted September 21, 2023.
| 0 |
PFE
|
Relapsed or Refractory Acute Lymphoblastic Leukemia in Adults
|
Approved
|
2017-08-17 00:00:00
|
Approval announced August 17, 2017.
| 1 |
NVAX
|
Respiratory Syncytial Virus (RSV) in older adults
|
Phase 3
|
2016-09-15 00:00:00
|
Phase 3 released September 15, 2016 did not demonstrate efficacy.
| 1 |
TALS
|
Delayed tolerance kidney transplant
|
Phase 2
|
2023-02-16 00:00:00
|
Trial was discontinued due to the pace of enrollment and the associated timeline to critical milestones, noted February 16, 2023.
| -1 |
OTIC
|
Hearing loss
|
Phase 1/2
|
2020-12-17 00:00:00
|
Phase 1/2 data released December 17, 2020. 6 out of 9 (67%) patients demonstrated a clinically-meaningful improvement on at least one of the three SIN tests at both Days 57 and 85 versus 0 out of 8 (0%) for placebo.
| 1 |
AMGN
|
Ph+ R/R ALL
|
Approved
|
2017-07-11 00:00:00
|
PDUFA date under priority review August 14, 2017. Approval announced July 11, 2017.
| 1 |
BBIO
|
Canavan Disease
|
Phase 1/2
|
2023-05-22 00:00:00
|
Phase 1/2 data presented at AGSCT reported percent decreases in NAA from baseline ranged between 70% and 95% in cerebrospinal fluid (CSF), 29% and 88% in urine, and 8% and 75% in brain, noted May 22, 2023.
| 1 |
BMY
|
Non-small cell lung cancer (NSCLC)
|
Approved
|
2022-03-04 00:00:00
|
Approved March 4, 2022.
| 1 |
RHHBY
|
Solid tumors - NTRK gene fusion
|
Approved
|
2019-08-15 00:00:00
|
FDA approval announced August 15, 2019.
| 1 |
RHHBY
|
Huntington's Disease
|
Phase 3
|
2021-03-22 00:00:00
|
Phase 3 trial to be discontinued following review of data by an Independent Data Monitoring Committee.
| -1 |
HCM
|
Gastric cancer (GC) and gastroesophageal junction adenocarcinomas (GEJ)
|
Phase 2
|
2023-04-19 00:00:00
|
Phase 2 data reported a confirmed ORR by IRC was 45%, and reached 50% in 16 patients with MET GCN (high) while only 1 PR was observed in 4 patients with MET GCN, noted April 19, 2023.
| 1 |
MRK
|
Type 2 Diabetes
|
CRL
|
2017-04-07 00:00:00
|
CRL issued April 7 2017. sNDA for approved drug requested to include data on cardiovascular effects
| 1 |
GSK
|
dMMR endometrial cancer
|
Approved
|
2023-02-10 00:00:00
|
Full approval granted February 10, 2023.
| 1 |
RHHBY
|
Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
|
Approved
|
2021-03-04 00:00:00
|
FDA approval announced March 4, 2021.
| 1 |
EIGR
|
Pulmonary arterial hypertension (PAH)
|
Phase 2
|
2018-01-16 00:00:00
|
Phase 2 trial did not meet endpoints - January 16, 2018.
| 1 |
CARA
|
Pruritus in patients with Atopic dermatitis
|
Phase 2
|
2022-03-28 00:00:00
|
Phase 2 presentation at AAD reported that within a sub-study treatment altered expression of multiple individual pruritus- and AD-related genes, noted March 28, 2022.
| 1 |
AZN
|
Solid tumors
|
Phase 1
|
2022-12-09 00:00:00
|
Phase 1 data reported that IPH5201 blocks ATP degradation and blocks CD39-mediated degradation of eATP released after chemotherapy treatment, noted December 8, 2022.
| 1 |
INFI
|
Triple negative breast cancer (TNBC) and ovarian cancer
|
Phase 1
|
2020-12-09 00:00:00
|
Phase 1 initial data due presented at SABCS Annual Meeting, December 9, 2020. 2/18 response rate (partial responses - PR) for doublet regimen. 5/12 responses for triplet (1 complete response, 4 had a PR).
| 1 |
AMGN
|
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 |
HALO
|
Testosterone deficiency
|
Approved
|
2018-10-01 00:00:00
|
FDA Approval announced October 1, 2018.
| 1 |
TNGX
|
Solid Tumors
|
Phase 1
|
2023-07-24 00:00:00
|
IND cleared by FDA, noted April 3, 2023. Phase 1/2 dosing initiated, noted July 24, 2023.
| 0 |
REGN
|
Atopic dermatitis
|
Approved
|
2017-03-28 00:00:00
|
Approved under priority review - March 28, 2017.
| 1 |
ASND
|
Mantle cell lymphoma (MCL)
|
Phase 1
|
2023-06-17 00:00:00
|
Phase 1 data presented at ICML showed that 86.5% of patients in the relapsed or refractory mantle cell lymphoma cohort achieved a response, with 74.3% achieving a complete response, noted June 17, 2023.
| 1 |
JAZZ
|
Acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL)
|
Approved
|
2022-11-18 00:00:00
|
Approved November 18, 2022.
| 1 |
IMCR
|
Solid tumors
|
Phase 1
|
2022-12-08 00:00:00
|
Phase 1 initial data reported that one patient had a durable Partial Response (PR), with a duration of 12.7 months, one patient who had a Stable Disease (SD) converted to an unconfirmed PR after the poster data cutoff date and is still ongoing, and 5 had SD, noted December 8, 2022.
| 0 |
AZN
|
Second-line ovarian cancer
|
Approved
|
2017-08-17 00:00:00
|
Approval announced August 17, 2017.
| 1 |
MRK
|
HIV-1
|
Approved
|
2017-05-30 00:00:00
|
Approval announced May 30, 2017.
| 1 |
MIST
|
Paroxysmal supraventricular tachycardia (PSVT)
|
Phase 3
|
2021-11-15 00:00:00
|
Phase 3 top-line data showed that the nasal dose significantly decreased heart rate during supraventricular tachycardia (SVT) episodes and independent of conversion to sinus rhythm (SR). Heart rate changes occurred within 5 minutes and were sustained for 60 minutes, noted November 15, 2021.
| 1 |
SESN
|
Non-muscle invasive bladder cancer (NMIBC)
|
CRL
|
2021-08-13 00:00:00
|
CRL announced August 13, 2021.
| 0 |
GILD
|
Higher risk-Myelodysplastic Syndrome (MDS)
|
Phase 3
|
2023-07-21 00:00:00
|
Phase 3 ENHANCE study been discontinued due to futility based on a planned analysis, noted July 21, 2023.
| -1 |
AMGN
|
Cardiovascular disease
|
Approved
|
2021-09-24 00:00:00
|
Approved for pediatric patients 10 years and older September 24, 2021.
| 1 |
VBLT
|
Recurrent platinum resistant ovarian cancer
|
Phase 3
|
2022-07-19 00:00:00
|
Phase 3 trial did not meet the primary endpoint, noted July 19, 2022.
| 1 |
MRK
|
Gastric cancer
|
Phase 3
|
2019-04-25 00:00:00
|
Phase 3 data released April 25, 2019 noted that monotherapy arm met noninferiority primary endpoint. Combo arm did not meet OS/PFS endpoints.
| 1 |
MRK
|
House dust mite allergies
|
Approved
|
2017-03-01 00:00:00
|
Approved March 1, 2017.
| 1 |
JNJ
|
Psoriatic Arthritis in Pediatric Patients
|
Approved
|
2022-08-01 00:00:00
|
Approved August 1, 2022.
| 1 |
LGND
|
Postpartum depression
|
Phase 2
|
2019-07-23 00:00:00
|
Phase 2 negative data released July 23, 2019.
| 0 |
ANIP
|
Absence seizures that are refractory to other drugs
|
Approved
|
2023-05-15 00:00:00
|
ANDA approved May 15, 2023.
| 1 |
ATAI
|
Treatment Resistant Depression
|
Phase 1
|
2023-10-02 00:00:00
|
Phase 1 data reported that treatment was well-tolerated with a favorable safety profile, and dose-dependent increases in exposure were observed, noted October 02, 2023.
| 1 |
CGTX
|
Alzheimer's Disease
|
Phase 1/2
|
2023-03-28 00:00:00
|
Additional biomarker data revealed 28 biomarkers that were significantly altered as a result of treatment with CT1812, 11 of which are priority biomarkers of Alzheimer's biology, noted March 28, 2023.
| 1 |
RETA
|
Alport Syndrome
|
CRL
|
2022-02-25 00:00:00
|
CRL issued February 25, 2022.
| 0 |
NKTR
|
1L Non-small cell lung cancer (NSCLC)
|
Phase 2
|
2021-12-13 00:00:00
|
Phase 2 data reported an overall response rate (ORR) of 17%, including 2 complete responses (CR) in the highest PD-L1 status cohort, noted December 13, 2021.
| 0 |
ARWR
|
AATD-associated liver disease
|
Phase 2
|
2022-06-27 00:00:00
|
Phase 2 data showed noted a Fibrosis regression observed in 58% (7/12) of patients receiving 200 mg, a median reduction of 83% of Z-AAT accumulation in the liver and a reduction of 69% in histologic globule burden
| 1 |
ESPR
|
Hypercholesterolemia
|
Approved
|
2020-02-26 00:00:00
|
FDA Approval announced February 26, 2020.
| 1 |
ROIV
|
Atopic dermatitis (AD)
|
Phase 3
|
2023-05-16 00:00:00
|
Phase 3 data reported that the trial met its primary endpoint, noted May 16, 2023.
| 0 |
OCUP
|
Diabetic Retinopathy (DR) / Macular Edema (DME)
|
Phase 2
|
2023-08-28 00:00:00
|
Phase 2 data reported that APX3330 achieved statistical significance in preventing clinically meaningful progression of diabetic retinopathy, noted August 28, 2023.
| 1 |
STTK
|
Acute Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic Syndromes/Neoplasms (HR-MDS)
|
Phase 1
|
2023-11-02 00:00:00
|
Phase 1 data from ASH abstract reported that in 4 evaluable pts with UnTx TP53m-MDS, the ORs were 1 complete remission (CR), 1 marrow CR, and 2 stable disease. 2 of them proceeded to allo-HCT, noted November 2, 2023.
| 1 |
IMUX
|
Relapsing-remitting multiple sclerosis (RMS)
|
Phase 2
|
2023-10-13 00:00:00
|
Phase 2 data presented at ECTRIMS reported that VidoCa was associated with a Nfl reduction from baseline up to W6 of -3% for the pooled 30 and 45mg VidoCa group compared to +2.5% for placebo, and up to W24 of -19% and +7%, respectively, noted October 13, 2023.
| 1 |
AZN
|
COVID-19
|
Phase 3
|
2021-04-12 00:00:00
|
Phase 3 trial did not achieve statistical significance for the primary endpoint.
| 1 |
ISEE
|
Wet age-related macular degeneration (Wet-AMD)
|
Phase 2a
|
2018-11-12 00:00:00
|
Phase 2a top-line data released November 12, 2018 noted that treatment was generally well tolerated.
| 1 |
XBIT
|
Rheumatoid Arthritis
|
Phase 2
|
2023-05-22 00:00:00
|
Phase 2 initiation authorized by FDA on May 22, 2023.
| 0 |
EXEL
|
BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma
|
Approved
|
2020-07-30 00:00:00
|
FDA approval announced July 30, 2020.
| 1 |
GLTO
|
Liver cirrhosis
|
Phase 1/2
|
2022-11-08 00:00:00
|
Phase 1b/2a top-line data reported that data showed statistically significant reductions in the liver enzymes ALT, AST and GGT, with encouraging reductions for ALP , after 12 weeks of treatment, noted November 8, 2022.
| 1 |
AZN
|
Ovarian cancer
|
Phase 3
|
2020-03-12 00:00:00
|
Phase 3 trial did not meet primary endpoint.
| 1 |
TBPH
|
COPD
|
Approved
|
2018-11-09 00:00:00
|
FDA Approval announced November 9, 2018.
| 1 |
AZN
|
BRCAm HER2-negative breast cancer
|
Approved
|
2022-03-11 00:00:00
|
Approved March 11, 2022.
| 1 |
ALT
|
Flu vaccine
|
Phase 2
|
2019-03-19 00:00:00
|
Phase 2 additional data released March 19, 2019 noted all patients remained seroprotected.
| 0 |
BYSI
|
Multiple Myeloma
|
Phase 2
|
2022-08-29 00:00:00
|
Phase 2 data reported that the median white blood count (WBC) on Day 0, 1 and 2 was 7.6. Six patients had fever at median of eight days post AHCT. Five patients with engraftment syndrome were treated with steroids, and there was one patient with non-engraftment-related neutropenic fever, noted August 29, 2022.
| 1 |
SAGE
|
Postpartum depression (PPD)
|
Phase 3
|
2019-01-07 00:00:00
|
Phase 3 data met primary endpoint - January 7, 2019.
| 0 |
MRK
|
Myelodysplastic syndromes (MDS) cancer
|
Approved
|
2020-04-03 00:00:00
|
FDA Approval announced April 3, 2020.
| 1 |
CPRX
|
Spinal Muscular Atrophy (SMA) Type 3
|
Phase 2
|
2021-01-06 00:00:00
|
Phase 2 trial met primary endpoint. Secondary endpoints not met. Will not pursue development further.
| 0 |
GLPG
|
Psoriatic arthritis
|
Phase 2
|
2018-05-30 00:00:00
|
Phase 2 data released May 30, 2018 - primary endpoint met.
| 0 |
AMGN
|
Plaque psoriasis in pediatric patients
|
Phase 3
|
2022-09-09 00:00:00
|
Phase 3 primary endpoint was met, noted September 8, 2022.
| 0 |
MRK
|
Non-transfusion-dependent beta-thalassemia
|
Phase 2
|
2021-06-11 00:00:00
|
Phase 2 data presented at EHA meeting June 11, 2021. 77.7% of patients achieved a hemoglobin increase compared to 0% in the placebo arm.
| 1 |
KOD
|
Retinal vein occlusion (RVO)
|
Phase 3
|
2023-10-13 00:00:00
|
Phase 3 one year primary data from the Retina Society meeting reported that Tarcocimab treated patients had a ~30% higher chance of not requiring any additional doses versus aflibercep, noted October 13, 2023.
| 1 |
SAGE
|
Postpartum depression (PPD)
|
Phase 3
|
2022-10-17 00:00:00
|
Additional Phase 3 data reported that a total of two participants (all in the zuranolone group) experienced four serious adverse events all of which were assessed by the investigator as unrelated to the therapy, noted October 17, 2022.
| 0 |
REGN
|
Coronavirus COVID-19
|
Phase 3
|
2020-07-02 00:00:00
|
Phase 3 trial did not meet primary endpoint - July 2, 2020.
| 1 |
AMLX
|
Amyotrophic Lateral Sclerosis (AML)
|
Phase 3
|
2023-02-02 00:00:00
|
Phase 3 trial enrollment completed, noted February 2, 2023.
| 0 |
PLUR
|
Intermittent claudication, or IC
|
Phase 2
|
2018-06-12 00:00:00
|
Phase 2 data released June 12, 2018 - primary endpoint met.
| 0 |
VRTX
|
Beta-thalassemia
|
Phase 1/2
|
2021-06-11 00:00:00
|
Phase 1/2 data presented at EHA meeting June 11, 2021. All 15 patients were transfusion independent with follow-up ranging from 4 to 26 months after CTX001 infusion and had clinically meaningful improvements in total hemoglobin from 8.9 to 16.9 g/dL and fetal hemoglobin from 67.3% to 99.6% at last visit.
| 1 |
BNTX
|
Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine
|
Approved
|
2022-12-08 00:00:00
|
EUA granted for children under 5 December 8, 2022.
| 0 |
ABBV
|
Marginal zone lymphoma
|
Approved
|
2017-01-19 00:00:00
|
sNDA filing under priority review approved January 19, 2017.
| 1 |
LLY
|
Non-small cell lung cancer, medullary thyroid cancer and thyroid cancer.
|
Approved
|
2020-05-08 00:00:00
|
FDA Approval announced May 8, 2020.
| 1 |
EQ
|
Celiac disease
|
Phase 1
|
2023-05-15 00:00:00
|
Phase 1 data suggested that selective blockade of IL-15 and IL-21 inhibits the synergistic signaling that mediates NK and T cell responses in multiple immune disorders including celiac disease, noted May 15, 2023.
| 0 |
QNCX
|
Alzheimer’s disease
|
Phase 2/3
|
2021-11-11 00:00:00
|
Phase 2/3 data reported that the 40 mg demonstrated equivalent or better efficacy compared 80 mg, as well as a superior safety profile. Benefits were shown in ADAS-Cog11, CDR-SB, MMSE, and NPI, with increasing separation from placebo throughout the study consistent with disease modification. Benefits were not seen on ADCS-ADL at either dose, noted November 11, 2021.
| 1 |
GSK
|
Lupus Nephritis
|
Approved
|
2020-12-17 00:00:00
|
FDA approval announced December 17, 2020.
| 1 |
VCNX
|
Non-small cell lung cancer (NSCLC)
|
Phase 1/2
|
2020-04-27 00:00:00
|
Phase 1/2 updated data presented April 27, 2020 at AACR noted 81% of immunotherapy-naïve patients (17/21) experienced disease control - partial response (5/21 patients) or stable disease (12/21 patients)
| 1 |
TNXP
|
Fibromyalgia
|
Phase 3
|
2022-03-21 00:00:00
|
Second Phase 3 trial did not meet primary endpoint, noted March 21, 2022.
| 1 |
GLPG
|
Ulcerative colitis
|
Phase 2/3
|
2020-05-20 00:00:00
|
Phase 2b/3 data released May 20, 2020. 200mg dose met primary endpoint. 100mg did not meet clinical remission endpoint.
| 1 |
BIIB
|
Chronic Kidney Disease
|
Phase 2
|
2023-05-10 00:00:00
|
Program discontinued, noted May 10, 2023.
| -1 |
RUBY
|
Refractory Acute Myeloid Leukemia (AML) / Solid tumors
|
Phase 1/2
|
2021-03-15 00:00:00
|
Phase 1/2 data announced March 15, 2021. 1 partial response (PR), 1 unconfirmed PR.
| 0 |
SNY
|
Meningococcal meningitis
|
Approved
|
2020-04-24 00:00:00
|
FDA approval announced April 24, 2020.
| 1 |
LBPS
|
Asthma
|
Phase 1/2
|
2022-05-17 00:00:00
|
Phase 1/2 data reported that 83.3% of subjects receiving treatment had improved ACQ-6 scores compared to 56.3% of those receiving placebo, noted May 17, 2022.
| 1 |
INCY
|
Relapsed or refractory diffuse large B cell lymphoma
|
Approved
|
2020-07-31 00:00:00
|
FDA Approval announced July 31, 2020.
| 1 |
ADAP
|
Solid tumors
|
Phase 1
|
2021-11-21 00:00:00
|
Phase 1 preliminary data reported that all Cohort 1 patients had measurable persistence of transduced cells throughout the interventional phase of the trial with some maintaining high levels of persistence beyond 6 months post infusion. Median time to peak persistence was 1.1 weeks and median peak persistence was 218,827.9 copies/ug DNA, noted November 12, 2021.
| 0 |
GLSI
|
HER2/neu breast cancer
|
Phase 2b
|
2022-04-19 00:00:00
|
Phase 2b trial data reported that treatment safely elicited a potent immune response, as evidenced by injection site reactions that correlate to and may serve as a complement to immune response data such as DTH, noted April 19, 2022.
| 1 |
SLN
|
Cardiovascular diseases
|
Phase 1
|
2023-11-01 00:00:00
|
Phase 1 data showed very significant and durable reductions in lipoprotein(a) of up to 99%. Lp(a) levels remained around 90% lower than baseline at study endpoint, noted November 1, 2023.
| 1 |
KTRA
|
MGMT-unmethylated Recurrent Bevacizumab Naïve Glioblastoma Multiforme (GBM) or The Adjuvant
|
Phase 2
|
2021-11-18 00:00:00
|
Phase 2 data noted that In the adjuvant group PFS was 9.5 months and mOS was 16.5 months, noted November 18, 2021.
| 0 |
IMUX
|
Celiac disease, healthy volunteers
|
Phase 1
|
2023-10-16 00:00:00
|
Phase 1 data reported that treatment has been well tolerated, with no systematic clinically relevant findings relative to safety and tolerability, noted October 16, 2023.
| 1 |
ABBV
|
Presbyopia
|
Phase 3
|
2022-04-05 00:00:00
|
Phase 3 trial met primary endpoint, noted April 5, 2022.
| 0 |
AZN
|
Lung cancer
|
Phase 3
|
2021-09-17 00:00:00
|
Phase 3 median PFS of 16.9 months was observed, September 17, 2021.
| 1 |
ETNB
|
Nonalcoholic Steatohepatitis (NASH)
|
Phase 2b
|
2023-09-21 00:00:00
|
Phase 2b trial received Breakthrough Therapy Designation (BTD) granted by the FDA, noted September 21, 2023.
| 0 |
INCY
|
Cholangiocarcinoma
|
Approved
|
2020-04-17 00:00:00
|
FDA Approval announced April 17, 2020.
| 1 |
TAK
|
ALK+ Metastatic Non-Small Cell Lung Cancer
|
Approved
|
2020-05-22 00:00:00
|
FDA Approval announced May 22, 2020.
| 1 |
RCKT
|
Danon disease
|
Phase 1
|
2023-05-18 00:00:00
|
Phase 1 additional results reported that efficacy results continue to demonstrate sustained improvement or stabilization in all patients with preserved left ventricular systolic function at time of treatment, noted May 18, 2023.
| 1 |
MRNS
|
Refractory status epilepticus (RSE)
|
Phase 2
|
2019-09-26 00:00:00
|
Phase 2 data met primary endpoint - September 26, 2019.
| 0 |
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