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NVS | Various blood cancers, rheumatoid arthritis. | CRL | 2018-05-02 00:00:00 | CRL issued May 2, 2018. | 0 |
PFE | Alopecia areata | Approved | 2023-06-23 00:00:00 | FDA Approved on June 23, 2023. | 1 |
MRSN | Ovarian Cancer, Non Small Cell Lung Cancer | Phase 1/2 | 2023-07-27 00:00:00 | Phase 1/2 trial did not meet its primary endpoint, noted July 27, 2023. | 1 |
MRK | Squamous non-small cell lung cancer (sNSCLC) | Approved | 2018-10-30 00:00:00 | FDA approval announced October 30, 2018. | 1 |
MOR | Diffuse Large B-Cell Lymphoma | Phase 3 | 2021-12-11 00:00:00 | Phase 3 data reported that trial met primary endpoint, with overall survival (OS) observed for tafasitamab plus lenalidomide at 20.1 months. The objective response rate (ORR) was 63.6% with a CR at 39.4%, noted December 11, 2021. | 1 |
DVAX | COVID-19 vaccine | Phase 3 | 2023-03-02 00:00:00 | Phase 3 data reported that the fold decline of neutralizing antibodies over six months after a second vaccination with VLA2001 was similar to the active comparator, and less pronounced than for other licensed COVID-19 vaccines, noted March 2, 2023. | 0 |
VNDA | Bipolar Disorder | Phase 3 | 2022-12-19 00:00:00 | Phase 3 trial results reported that treated patients showed a larger improvement than placebo treated patients, and this difference was highly statistically significant, noted December 19, 2022. | 1 |
CARA | Pruritus and Notalgia Paresthetica | Phase 2 | 2022-09-08 00:00:00 | Phase 2 data reported a WI-NRS score of 0 or 1 for 70% of the daily non-missing WI-NRS scores for the week., noted September 8, 2022. | 0 |
GSK | Head and Neck Squamous Cell Carcinoma | Phase 2 | 2021-04-14 00:00:00 | Phase 2 trial to be discontinued - April 14, 2021. | -1 |
AZN | Castration-resistant prostate cancer -first line | Approved | 2023-06-01 00:00:00 | FDA Approved on June 1, 2023. | 1 |
CMRX | H3 K27M-mutant Glioma | Phase 3 | 2023-08-16 00:00:00 | Phase 3 data from survival analyses published in Cancer Discovery reported that ONC201 frontline treatment, administered post-radiation therapy, demonstrated a statistically significant increase in mOS from diagnosis versus historical controls, noted August 16, 2023. | 1 |
AVIR | COVID-19 | Phase 3 | 2023-04-17 00:00:00 | Phase 3 presented at ECCMID reported a 71% relative reduction in risk of hospitalization with bemnifosbuvir versus placebo, noted April 17, 2023. | 1 |
BXRX | Hemophilia A | Phase 1/2 | 2023-09-28 00:00:00 | FDA granted Orphan Drug Designation, noted September 28, 2023. | 0 |
BNTX | Influenza and COVID-19, Omicron BA.4/BA.5-adapted bivalent | Phase 1/2 | 2023-10-26 00:00:00 | Phase 1/2 data demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains, noted October 26, 2023. | 1 |
BIIB | Mild cognitive impairment (MCI) due to Alzheimer's disease (AD) | Approved | 2023-07-06 00:00:00 | Traditional approval received July 6, 2023. | 1 |
FOLD | Fabry Disease | Approved | 2018-08-10 00:00:00 | FDA Approval announced August 10, 2018. | 1 |
AZN | Anaemia of myelodysplastic syndromes (MDS) | Phase 3 | 2023-10-20 00:00:00 | Phase 3 data presented at ESMO reported that treatment demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of pathologic complete response (pCR) versus neoadjuvant chemotherapy alone, noted October 20, 2023. | 1 |
MRK | Gastric or Gastroesophageal Junction Adenocarcinoma | Approved | 2021-05-05 00:00:00 | FDA approval announced May 5, 2021. | 1 |
GTHX | Early-stage triple negative breast cancer (TNBC) | Phase 2 | 2022-12-08 00:00:00 | Phase 2 data reported a trend toward an increased ratio of CD8+ T-cells to Tregs within the tumor microenvironment, indicating trilaciclib may favorably modulate the composition of immune cells to support antitumor immune responses, noted December 8, 2022. | 1 |
EBS | Chikungunya virus | Phase 2 | 2019-11-22 00:00:00 | Phase 2 interim analysis noted 98% of study participants produced a neutralizing antibody response against the chikungunya virus (CHIKV) within seven days after vaccination - November 22, 2019. | 0 |
BIIB | Alzheimer’s disease | Phase 2 | 2021-06-16 00:00:00 | Phase 2 trial did not meet primary endpoint - June 16, 2021. | 1 |
ACET | Non-Hodgkin’s lymphoma | Phase 1 | 2023-06-26 00:00:00 | Phase 1 safety and efficacy data demonstrated 71% overall response rate (ORR) and 63% complete response (CR) rate across all dose levels in patients with median 4 prior lines of therapy, a Six-month CR rate consistent with autologous CAR T cell therapy, noted June 26, 2023. | 1 |
KPTI | Endometrial cancer | Phase 3 | 2023-07-25 00:00:00 | Phase 3 updated exploratory subgroup analysis reported a median PFS of 27.4 months compared to 5.2 months for patients with TP53 wild-type endometrial cancer receiving placebo, noted July 25, 2023. | 0 |
MESO | Chronic low back pain | Phase 3 | 2023-02-08 00:00:00 | Phase 3 FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation, noted February 8, 2023. | 0 |
ICPT | Primary Biliary Cholangitis (PBC) | Phase 2a | 2023-06-23 00:00:00 | Phase 2a data presented at EASL showed that the Combination was well-tolerated with lowest rates of pruritus observed in OCA 5-10 mg + bezafibrate 400 mg treatment arm, noted June 23, 2023. | 1 |
MRK | Small cell lung cancer (SCLC) | Phase 3 | 2020-01-06 00:00:00 | Phase 3 data met PFS primary endpoint; overall survival primary endpoint not met | 0 |
ABBV | Platysma prominence associated with platysma muscle activity (M21-310) | Phase 3 | 2023-09-18 00:00:00 | Phase 3 trial met all primary and secondary endpoints, noted September 18, 2023. | 0 |
RHHBY | Hepatocellular carcinoma | Approved | 2020-05-29 00:00:00 | FDA Approval announced May 29, 2020. | 1 |
AIM | Metastatic triple-negative breast cancer | Phase 1/2 | 2022-04-11 00:00:00 | Phase 1 data presented at AACR reported that trial met primary endpoint, noted April 11, 2022. | 1 |
PFE | Focal Epilepsy | Phase 1 | 2023-09-05 00:00:00 | Examination of EEG in healthy subjects administered single doses confirmed central nervous system (CNS) activity consistent with effects observed with other antiseizure medications, noted September 5, 2023. | 1 |
LLY | COVID-19 Antibody | Approved | 2020-11-09 00:00:00 | Emergency Use Authorization (EUA) announced November 9, 2020. | 0 |
ADCT | Solid tumors | Phase 1 | 2022-12-12 00:00:00 | Phase 1 presentation at ASH reported that 2 of 3 patients achieved MRD negative CR, noted December 12, 2022. | 1 |
INCY | Treatment-naïve acute GVHD | Phase 3 | 2020-01-02 00:00:00 | Phase 3 trial did not meet primary endpoint - January 2, 2020. | 1 |
FRTX | Primary Axillary Hyperhidrosis | Phase 3 | 2021-04-23 00:00:00 | Phase 3 open-label data announced April 23, 2021 - generally well-tolerated. Clinically meaningful improvement in axillary hyperhidrosis severity. | 1 |
BCTX | Breast cancer | Phase 1/2 | 2021-12-09 00:00:00 | Phase 1/2a data reported that the control rate was 25% and 30% for the monotherapy studies and 33% for the combination study, noted December 9, 2021. | 0 |
ETON | Epilepsy | Approved | 2022-07-18 00:00:00 | Approved July 18, 2022. | 1 |
NVS | Multiple sclerosis (MS) | Approved | 2023-08-25 00:00:00 | Approved August 25, 2023. | 1 |
AIM | Colorectal cancer | Phase 2 | 2022-04-11 00:00:00 | Phase 2 initial results presented at AACR reported that the primary endpoint was met, noted April 11, 2022. | 1 |
ABBV | Acute bacterial skin and skin structure infections (ABSSSI) - pediatric | Approved | 2021-07-23 00:00:00 | FDA approval announced July 23, 2021. | 1 |
KALV | Diabetic macular edema (DME) | Phase 2 | 2019-12-09 00:00:00 | Phase 2 data did not meet primary endpoint - December 9, 2019. | 1 |
EXEL | Medullary thyroid cancer | Approved | 2012-11-29 00:00:00 | Approved November 29, 2012. | 1 |
AFMD | T-Cell, Cutaneous Lymphoma | Phase 1/2 | 2020-12-07 00:00:00 | Phase 1/2 data presented at ASH 2020. Objective Response Rate (ORR) of 42%(6/14). | 1 |
ELDN | Kidney transplant rejection | Phase 2 | 2023-11-02 00:00:00 | Phase 2 data from 11 participants demonstrates tegoprubart successfully prevented kidney transplant rejection and was generally safe and well-tolerated, noted November 2, 2023. | 1 |
MACK | Cancer - Heregulin Positive Non-Small Cell Lung Cancer | Phase 2 | 2018-10-19 00:00:00 | Phase 2 trial discontinued due to futility - noted October 19, 2018. | -1 |
MGNX | Localized Prostate Cancer | Phase 2 | 2021-09-16 00:00:00 | Phase 2 data showed 34% of patients had pre-prostatectomy PSA declines of >10%. At 1 year post-operatively, PSA0 rate was 66%. The median time to PSA recurrence was not reached, September 16, 2021. | 1 |
REGN | Various cancers | Phase 1 | 2023-11-04 00:00:00 | Phase 1 safety data reported that a total of 11 adverse events (including one serious adverse event not considered related to SNS-101) was reported in five patients, with no dose-limiting toxicities observed, noted November 4, 2023. | 1 |
GMAB | Multiple Myeloma | Approved | 2020-08-20 00:00:00 | FDA approval announced August 20, 2020. | 1 |
OPK | Secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) - Stage 5 | Phase 2 | 2023-11-02 00:00:00 | Phase 2 data presented at ASH indicated that early, sustained and effective treatment of secondary hyperparathyroidism (SHPT) with RAYALDEE is associated with significantly slower progression CKD in pre-dialysis patients, noted November 2, 2023. | 1 |
NVS | Fascioliasis | Approved | 2019-02-13 00:00:00 | FDA Approval announced February 13, 2019. | 1 |
JNJ | COVID-19 vaccine (single dose) | Phase 3 | 2021-09-21 00:00:00 | Phase 3 data showed 75 percent overall efficacy against severe/critical COVID-19, across all ages and countries. 74 percent efficacy in the U.S. against severe/critical COVID-19; 89 percent against hospitalization; 83 percent against COVID-19-related death, September 21, 2021. | 1 |
HALO | Overactive bladder | Approved | 2011-12-08 00:00:00 | Approved December 8, 2011. | 1 |
SGEN | Diffuse large B-cell lymphoma (DLBCL) | Approved | 2019-06-10 00:00:00 | FDA approval announced June 10, 2019. | 1 |
EBS | Zika vaccine | Phase 1 | 2018-11-19 00:00:00 | Phase 1 data released November 19, 2018 - primary endpoint met with favorable safety profile. | 1 |
VTRS | Children Living with HIV | Approved | 2023-09-05 00:00:00 | Tentative approval announced September 5, 2023. | 1 |
SYRS | Solid tumors | Phase 1b | 2023-05-25 00:00:00 | Phase 1/1b data from ASCO reported that in solid tumors, data demonstrated a 100% disease control rate (DCR) with 10 mg SY-5609 monotherapy, with the PDAC patient experiencing a 10% tumor reduction, noted May 25, 2023. | 1 |
RGNX | Diabetic retinopathy | Phase 2 | 2023-08-01 00:00:00 | Phase 2 additional data reported that 20% of patients achieved a >2-step improvement vs. 10% in control and 54% of patients achieved any DRSS improvement vs. 20% in control, noted August 1, 2023. | 1 |
NVS | Rheumatoid Arthritis | Approved | 2018-10-31 00:00:00 | FDA approval announced October 31, 2018. | 1 |
BMEA | Healthy volunteers, type 2 diabetes | Phase 2 | 2023-06-24 00:00:00 | Additional Phase 2 data presented at ADA of eight weeks after completing treatment with BMF-219, patients with type 2 diabetes (T2D) showed an increase of C-peptide and an improvement of HOMA-B, measured during oral glucose tolerance testing (OGTT), supporting improved beta cell function for these patients, June 24, 2023. | 1 |
BMY | First-line renal cell carcinoma | Phase 3 | 2021-09-16 00:00:00 | Additional Phase 3 data presented at ESMO September 16, 2021. At a median follow-up of 23.5 months, progression free survival (PFS) and objective response rate (ORR) benefits were observed regardless of prior nephrectomy status. The magnitudes of PFS and ORR benefits were greater in the subgroup with prior nephrectomy. | 1 |
ALXO | Myelodysplastic syndromes (MDS) | Phase 1b | 2023-08-10 00:00:00 | Phase 1b data reported that the evorpacept combination did not substantially improve upon the historical activity of azacitidine alone, noted August 10, 2023. | 1 |
NVS | Non-small cell lung cancer (NSCLC) | Phase 3 | 2021-10-25 00:00:00 | Phase 3 trial did not meet primary endpoints, noted October 25, 2021. | 1 |
ABVC | Attention Deficit Hyperactivity Disorder (ADHD) | Phase 2a | 2022-09-23 00:00:00 | Part 1 of Phase 2 study found that the active ingredient of ABV-1505, PDC-1421, was safe, well-tolerated and efficacious during the treatment and follow-up period with six adult patients, noted September 23, 2022. | 1 |
BGNE | Chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) | Phase 2 | 2023-06-15 00:00:00 | Phase 2 long-term follow-up demonstrated high rates of durable undetectable minimal residual disease (MRD) in CLL/SLL patients administered BOVen. Of the 46 patients meeting MRD criteria to cease treatment, median time from end of treatment to MRD conversion was 29.8 months, noted June 15, 2023. | 1 |
MRK | Hypercholesterolemia | Phase 2b | 2023-03-06 00:00:00 | Phase 2b trial data presented at ACC showed that study was generally well tolerated and reduced LDL-C across all dose levels compared to placebo, noted March 6, 2023. | 1 |
SWTX | Neurofibromas | Phase 2b | 2021-02-25 00:00:00 | Phase 2b interim data noted 10/20 Patients (50%) achieved an Objective Response | 1 |
LGND | Acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) | Phase 1b | 2023-07-18 00:00:00 | Phase 1b expansion trial data reported that one patient remained on study with sustained complete response for 8 cycles, noted July 18, 2023. | 0 |
IGXT | Acute migraine | Approved | 2023-04-17 00:00:00 | Approved April 17, 2023. | 1 |
PFE | HIV for adolescents 12 years and older | Approved | 2022-03-29 00:00:00 | Approved March 29, 2022. | 1 |
AZN | Chronic lymphocytic leukaemia | Approved | 2019-11-21 00:00:00 | FDA Approval announced November 21, 2019. | 1 |
MRTX | Non-small cell lung cancer (NSCLC) with a KRASG12C Mutation | Approved | 2022-12-13 00:00:00 | Approved December 13, 2022. | 1 |
AZN | Chronic Lymphocytic Leukemia (CLL), small lymphocytic lymphoma (SLL) and refractory mantle cell lymphoma (MCL) | Approved | 2022-08-05 00:00:00 | Approved August 5, 2022. | 1 |
SRNE | Non-small cell lung cancer (NSCLC) | Phase 3 | 2021-11-12 00:00:00 | Phase 3 top-line data reported an overall response rate (ORR) of 52.2%, and overall survival (OS) of 24.9 months, noted November 12, 2021. | 0 |
ADMA | Primary Immune Deficiency Diseases | Approved | 2022-12-13 00:00:00 | FDA supplemental approval for room temperature (25°C) storage conditions for up to 4 weeks during the first 24 months of the 36-month approved shelf life. | 1 |
ALXO | 2nd line or greater gastric/gastroesophageal junction cancer | Phase 2 | 2023-10-03 00:00:00 | Phase 2 data reported a confirmed overall response rate for evorpacept combination treatment was 52% compared to 22% for control treatment, noted October 3, 2023. | 1 |
CLSD | Uveal melanoma including choroidal melanoma | Phase 2 | 2023-02-16 00:00:00 | Phase 2 safety and efficacy data presented with an average of nine months of follow-up for patients treated with three cycles of therapy showed response to the therapy with 89-100% tumor control, noted February 16, 2023. | 1 |
IONS | End-stage renal disease (ESRD) | Phase 2b | 2022-11-04 00:00:00 | Additional Phase 2b data reported that treatment also achieved dose-dependent and sustained median reductions in steady-state FXI levels of 53.1%, 72.2% and 86.6% in the 40 mg, 80 mg, and 120 mg doses of fesomersen, respectively, administered once every 4 weeks, noted November 4, 2022. | 1 |
PRTC | Clostridioides difficile infection (CDI) | Phase 2 | 2023-05-09 00:00:00 | Phase 2 data reported that the high dose arm had an acceptable safety profile and compared with placebo, reduced the odds of developing rCDI through Week 8 by over 80%, noted May 9, 2023. | 1 |
INCY | COVID-19 | Phase 3 | 2021-04-08 00:00:00 | Phase 3 trial did not meet primary endpoint - April 8, 2021. | 1 |
ALNY | Wild-type ATTR amyloidosis patients with cardiomyopathy | CRL | 2023-10-09 00:00:00 | CRL issued by the FDA on October 9, 2023. As a result of the CRL, the Company will no longer pursue an expanded indication for patisiran in the US. | 0 |
OCUL | Glaucoma and ocular hypertension | Phase 3 | 2019-05-20 00:00:00 | Phase 3 data May 20, 2019 did not meet primary endpoint. | 1 |
AMGN | Immune thrombocytopenia (ITP) | Approved | 2019-10-18 00:00:00 | FDA Approval announced October 18, 2019. | 1 |
OPK | Children - growth hormone deficiency | Approved | 2023-06-28 00:00:00 | FDA Approved on June 28, 2023. | 1 |
LGND | Acute lymphoblastic leukemia (ALL) | Approved | 2021-06-30 00:00:00 | FDA approval announced June 30, 2021. | 1 |
SUPN | Migraine | Approved | 2017-04-05 00:00:00 | Tentative approval August 19 2016, subject to the pediatric exclusivity which expires March 28, 2017. Final approval announced April 6, 2017. | 1 |
ATNXQ | Angiosarcoma | Phase 2 | 2020-12-09 00:00:00 | Phase 2 poster at SABCS December 9, 2020 - Complete response (CR) 43% (3/7 pts), partial response (PR) 14% (1/7 pts). | 0 |
ABBV | Chronic Lymphocytic Leukemia | Phase 3 | 2022-12-10 00:00:00 | Phase 3 reported that treatment reduced the risk of progression or death by 79 percent among older and/or unfit patients with previously untreated chronic lymphocytic leukemia (CLL) compared to patients treated with chemoimmunotherapy, noted December 10, 2022. | 1 |
NVS | Acute postoperative pain | Approved | 2015-04-30 00:00:00 | Approved April 30, 2015. | 1 |
TAK | Hodgkin lymphoma and Anaplastic large cell lymphoma | Approved | 2011-08-19 00:00:00 | Approval announced August 19, 2011. | 1 |
VIGL | Healthy volunteers | Phase 1 | 2023-10-17 00:00:00 | Phase 1 trial dosing initiated, noted October 17, 2023. | 0 |
SGEN | 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 |
ARWR | Healthy volunteers and Asthma | Phase 1/2 | 2023-09-11 00:00:00 | Phase 1/2 preliminary clinical data achieved mean target gene knockdown of up to 90% with a maximum of 95% after a single inhaled administration, noted Septemeber 11, 2023. | 1 |
JNJ | Plaque psoriasis | Approved | 2017-07-13 00:00:00 | Approval announced July 13, 2017. | 1 |
ABBV | Rheumatoid arthritis | Approved | 2019-08-16 00:00:00 | FDA Approval announced August 16, 2019. | 1 |
RCUS | 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 |
AMTI | Ulcerative colitis | Phase 2 | 2022-07-06 00:00:00 | Phase 2 top-line data reported a remission rate of 31.8% in the treatment group, versus 33.3% in the placebo group, noted July 6, 2022. | 1 |
LNTH | Chronic pain | Approved | 2014-09-29 00:00:00 | Approved September 29, 2014. | 1 |
ABBV | Ulcerative colitis | Phase 3 | 2022-10-24 00:00:00 | Phase 3 data reported that after 52-weeks of maintenance treatment patients had less severe disease and were in clinical remission for approximately 1 additional month/year, noted October 24, 2022. | 1 |
NAVB | Head and Neck Cancer | Approved | 2014-06-13 00:00:00 | Approved June 13, 2014. | 1 |
CLSD | Macular edema associated with uveitis | Approved | 2021-10-25 00:00:00 | Approved October 25, 2021. | 1 |
RLMD | Major Depressive Disorder (MDD) | Phase 3 | 2022-10-13 00:00:00 | Phase 3 trial did not meet its primary endpoint, noted October 13, 2022. | 1 |