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MYOV | Contraception | Phase 3 | 2021-10-26 00:00:00 | Phase 3 trial resumed following clinical hold August 2021 after study protocol amendments, noted October 26, 2021. | 0 |
PHVS | Hereditary angioedema - on demand | Phase 2 | 2023-07-21 00:00:00 | Phase 2 data reported that trial met primary and all key secondary endpoints, noted July 21, 2023. | 0 |
ABBV | Hepatitis C virus (HCV) | Approved | 2017-08-03 00:00:00 | Approval announced August 3, 2017. | 1 |
RETA | Mitochondrial myopathies (MM) | Phase 2 | 2018-03-01 00:00:00 | Phase 2 initial data released March 1, 2018 - endpoints not met. | 0 |
GSK | Systemic lupus erythematosus (SLE) | Approved | 2017-07-21 00:00:00 | Approval announced July 21, 2017. | 1 |
ALIM | Non-infectious uveitis | Approved | 2018-10-15 00:00:00 | FDA approval announced October 15, 2018. | 1 |
TAK | NSCLC with EGFR exon 20 insertion mutations | Phase 3 | 2023-10-02 00:00:00 | Phase 3 trial withdrawn voluntarily after the confirmatory trial, which did not meet its primary endpoint, noted October 2, 2023. | 1 |
AMGN | Gastric and gastro-esophageal junction cancer | Phase 3 | 2023-07-14 00:00:00 | Trial in China initiated, noted July 14, 2023. | 0 |
SONN | Solid tumors | Phase 1 | 2023-04-18 00:00:00 | Phase 1 data presented at AACR reported no dose limiting toxicities, and 5 of the first 14 patients (36%) have evidence of clinical benefit, noted April 18, 2023. | 1 |
PHVS | Hereditary angioedema | Phase 1 | 2023-06-26 00:00:00 | Phase 1 clinical hold lifted by FDA on June 26, 2023. | 0 |
BMY | First-line Non-small cell lung cancer (NSCLC) | Approved | 2020-05-26 00:00:00 | FDA Approval announced May 26, 2020. | 1 |
ALKS | Schizophrenia | Approved | 2017-06-06 00:00:00 | Approved October 5 2015. sNDA filed for 2-month option with approval announced June 6, 2017. | 1 |
AZN | Head & neck cancer | Phase 3 | 2021-02-05 00:00:00 | Phase 3 trial did not meet the primary endpoint - February 5, 2021. | 1 |
BMY | Symptomatic Obstructive Hypertrophic Cardiomyopathy (HCM) | Approved | 2023-06-16 00:00:00 | FDA Approval on June 16, 2023 | 1 |
REGN | Cardiovascular events | Approved | 2019-04-26 00:00:00 | FDA approval announced April 26, 2019. | 1 |
AQST | Amyotrophic Lateral Sclerosis | Approved | 2019-11-23 00:00:00 | FDA Approval announced November 22, 2019. | 1 |
UTHR | Pulmonary arterial hypertension (PAH) | Phase 3 | 2021-10-21 00:00:00 | 78 week data noted an improved health-related quality of life at month six, noted October 21, 2021. | 1 |
CRNX | Acromegaly | Phase 2 | 2023-06-15 00:00:00 | Phase 2 2-year data presented at ENDO 2023 showed that treatment was well-tolerated, associated with stable IGF-I and symptom control relative to that achieved by iSRLs, and was preferred over injected therapy, noted June 15, 2023. | 1 |
ANIP | Tranxene generic | Approved | 2022-06-22 00:00:00 | Approved June 22, 2022. | 1 |
GMAB | Solid tumors | Phase 1/2 | 2021-11-10 00:00:00 | Phase 1/2 data demonstrated biologic and early antitumor activity with a favorable safety profile in patients with advanced solid tumors. Expansion cohorts, including combination therapy with PD-1 inhibitors, are currently enrolling, noted November 10, 2021. | 1 |
MGNX | Gastric cancer | Phase 2/3 | 2021-09-16 00:00:00 | Phase 2/3 results had 4 patients with confirmed complete responses and 17 confirmed partial responses, September 16, 2021. | 0 |
JNJ | Amyloidosis | Approved | 2021-01-15 00:00:00 | FDA approval announced January 15, 2021. | 1 |
TNXP | Pediatric obesity related binge eating disorder | Phase 2 | 2023-07-10 00:00:00 | Phase 2 trial initiated, noted July 10, 2022. | 0 |
ASRT | Colorectal cancer | Approved | 2011-04-29 00:00:00 | Approved April 29, 2011. | 1 |
HRMY | Fragile X Syndrome in Children and Adolescents | Phase 3 | 2022-07-18 00:00:00 | Longterm data reported improvements in ABC-CFXS Social Avoidance in the full population, noted July 18, 2022. | 1 |
BCRX | Acute uncomplicated influenza to pediatric patients | Approved | 2017-09-21 00:00:00 | Approved September 21, 2017. | 1 |
TRVN | Diabetic neuropathic pain (DNP) | Phase 1 | 2023-09-06 00:00:00 | Phase 1 data demonstrated a statistically significant analgesic effect in the capsaicin-induced model, noted on September 6, 2023. | 1 |
GILD | Sjogren’s syndrome | Phase 2 | 2019-10-24 00:00:00 | Phase 2 trial did not meet primary endpoint. | 1 |
KALA | Post‑operative inflammation and pain following cataract surgery | Approved | 2018-08-23 00:00:00 | FDA approval announced August 23, 2018. | 1 |
INCY | Myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement | Approved | 2022-08-26 00:00:00 | Approved August 26, 2022. | 1 |
RHHBY | Non-small cell lung cancer (NSCLC) | Phase 2a | 2023-10-23 00:00:00 | Phase 2a data reported that the objective tumor responses (defined as partial responses per RECIST criteria 1.1) were observed in three of five patients (60%) who received GB1211 for at least three weeks, noted October 23, 2023 | 1 |
PLX | Fabry disease | Phase 3 | 2021-02-10 00:00:00 | Phase 3 final data presented February 10, 2021 - key objectives for safety and efficacy. | 1 |
ICPT | Primary biliary cholangitis | Phase 3 | 2022-11-06 00:00:00 | Phase 3/4 results from the EC group as-treated analysis showed statistical significance in both the original and the FDA-expanded primary endpoints comparing the OCA-treated subjects in COBALT with the non-OCA-treated patients in EC, noted November 6, 2022. | 1 |
GBT | Sickle cell disease | Approved | 2019-11-25 00:00:00 | FDA Approval announced November 25, 2019. | 1 |
JNJ | Reduce the Risk of Recurrent Venous Thromboembolism (VTE) | Approved | 2019-10-14 00:00:00 | FDA approval announced October 14, 2019. | 1 |
TAK | Hereditary angioedema (HAE) attacks in patients 2 to <6 yrs | Approved | 2023-02-03 00:00:00 | FDA approved on February 3, 2023. | 1 |
GSK | HIV | Approved | 2017-11-21 00:00:00 | Approval announced November 21, 2017. | 1 |
CLDX | Chronic spontaneous urticaria (CSU) | Phase 2 | 2023-07-11 00:00:00 | Phase 2 data ahead of schedule, enrollment completed, noted July 11, 2023. | 0 |
GNFT | Primary biliary cholangitis (PBC) | Phase 3 | 2023-06-30 00:00:00 | Phase 3 data reported that trial met primary endpoint, noted June 30, 2023. | 0 |
PFE | Respiratory syncytial virus (RSV) vaccine | Approved | 2023-06-01 00:00:00 | Approved June 1, 2023. | 1 |
RHHBY | Non-small cell lung cancer (NSCLC) | Phase 3 | 2023-10-18 00:00:00 | Phase 3 data reported that treatment reduces the risk of disease recurrence or death by 76%, noted October 18, 2023. | 1 |
MESO | Heart failure | Phase 3 | 2021-12-06 00:00:00 | Phase 3 results showed greatest treatment benefit in major adverse cardiovascular events (MACE) of cardiovascular mortality or irreversible morbidity (non-fatal heart attack or stroke) in patients with diabetes and/or myocardial ischemia (72% of total treated population) | 1 |
CRBP | Systemic Sclerosis | Phase 3 | 2020-09-08 00:00:00 | Phase 3 top-line data did not meet endpoints - September 8, 2020. | 1 |
AZN | Non-small Cell Lung Cancer (NSCLC) | Approved | 2022-08-12 00:00:00 | Approved August 12, 2022. | 1 |
EGRX | Severe Community-Acquired Bacterial Pneumonia (SCABP) | Phase 2/3 | 2023-06-14 00:00:00 | FDA granted Qualified Infectious Disease Product (QIDP) Designation under the Generating Antibiotic Incentives Now (GAIN) Act and Fast Track Designation, noted June 14, 2023. QIDP designation entitles Eagle to an additional five years of exclusivity upon NDA approval. | 1 |
SGEN | HER2+ Metastatic Breast Cancer (MBC) | Phase 3 | 2023-08-19 00:00:00 | Phase 3 trial met primary endpoint, noted August 19, 2023 | 0 |
VYNE | Acne | Phase 2 | 2020-06-02 00:00:00 | Phase 2 data released June 2, 2020. | 0 |
OPTN | Chronic sinusitis | Phase 3 | 2022-07-08 00:00:00 | Additional Phase 3 analysis reported a greater improvement on the sinonasal outcomes test at week 24 for patients receiving XHANCE then placebo comparator, noted July 8, 2022. | 1 |
ACER | Urea cycle disorder (UCD) | Approved | 2022-12-23 00:00:00 | Approved December 23, 2022. | 1 |
ANAB | Endometrial Cancer | Approved | 2023-07-31 00:00:00 | FDA approved on July 31, 2023. Ahead of PDUFA on Sept. 23, 2023. | 1 |
BMY | Previously Treated Hepatocellular Carcinoma | Approved | 2020-03-11 00:00:00 | FDA Approval announced March 11, 2020. | 1 |
SWTX | Desmoid tumors | Phase 3 | 2022-09-10 00:00:00 | Phase 3 data presented at ESMO resulted in rapid, sustained and statistically significant Improvements in primary and all Key secondary efficacy endpoints, noted September 10, 2022. | 1 |
LLY | Pediatric type 2 diabetes | Approved | 2023-06-21 00:00:00 | FDA approved for 10 mg and 25 mg tablets on June 21, 2023. | 1 |
REGN | Basal cell carcinoma (BCC) | Approved | 2021-02-09 00:00:00 | FDA approval announced February 9, 2021. | 1 |
HOOK | HPV16+ Squamous cell head and neck cancers (HNSCC) | Phase 1 | 2023-11-03 00:00:00 | Phase 1 biomarker results demonstrated a robust increase in tumor-specific CD8+ T cells in all evaluable patients with HPV16+ head and neck cancers, noted November 3, 2023. Randomized trial planned for 2024. | 1 |
BMY | Advanced hematologic malignancies with an IDH2 mutation | Approved | 2017-08-01 00:00:00 | Approval announced August 1, 2017. | 1 |
ABBV | Age-related macular degeneration (AMD) | CRL | 2020-06-26 00:00:00 | CRL issued June 26, 2020. | 0 |
ALEC | Frontotemporal Dementia | Phase 2 | 2023-08-03 00:00:00 | Additional Phase 2 data considered to be uninformative regarding treatment effect, noted August 3, 2023. | 1 |
SNY | 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 |
RHHBY | Coronavirus COVID-19 | Phase 3 | 2020-07-29 00:00:00 | Phase 3 trial did meet primary endpoint - July 29, 2020. | 1 |
NVS | Chronic myeloid leukemia (CML) | Phase 3 | 2023-06-10 00:00:00 | Additional Phase 3 data reported at EHA poster showed that overall MMR rates at wk 96 were higher with ASC than BOS regardless of the last prior TKI received, noted on June 9, 2023 | 1 |
BPMC | Indolent and smoldering systemic mastocytosis (SM) | Phase 2 | 2023-02-27 00:00:00 | Phase 2 data presented at AAAAI reported a statistically significant and clinically meaningful improvement in total symptom score that deepened over time, noted February 27, 2023. | 1 |
BMY | First-line Non-small cell lung cancer (NSCLC) | Approved | 2020-05-15 00:00:00 | FDA Approval announced May 15, 2020. | 1 |
FGEN | 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 |
SGEN | Previously untreated high risk classical Hodgkin lymphoma (cHL) | Approved | 2022-11-10 00:00:00 | Approved November 10, 2022. | 1 |
GLPG | Inflammatory Bowel Disease | Phase 2 | 2021-03-04 00:00:00 | Phase 2 interim data released March 4, 2021. | 0 |
CLDX | Metastatic triple negative breast cancers that overexpress gpNMB | Phase 2b | 2018-04-16 00:00:00 | Phase 2b data released April 16, 2018 - primary endpoint not met. | 0 |
LLY | Systemic lupus erythematosus (SLE) | Phase 2 | 2023-04-27 00:00:00 | Phase 2 to be moved to from Lupus to Atopic dermatitis after disappointing results, noted April 27, 2023. | 0 |
LLY | Ulcerative Colitis (Maintenance data) | Phase 3 | 2023-05-08 00:00:00 | Additional Phase 3 data reported that bowel urgency remission directly accounted for a 44.8% and 32.5% improvement in IBDQ total score, respectively; 22.7% and 39.1% improvement, respectively, was mediated by rectal bleeding remission, and 32.5% and 28.4%, respectively, mediated by stool frequency remission, noted May 8, 2023. | 1 |
CYBN | Major Depressive Disorder (MDD) | Phase 1b | 2023-09-27 00:00:00 | Phase 1b data reported that 100% of patients in the SSRI cohort responded to SPL026 (DMT) with 92% of patients in remission from depression, noted September 27, 2023. | 0 |
PFE | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Approved | 2021-02-12 00:00:00 | FDA approval announced February 12, 2021. | 1 |
XFOR | Waldenström macroglobulinemia | Phase 1b | 2021-12-13 00:00:00 | Phase 1b data of 16 patients enrolled demonstrated that 14 were evaluable as of the data cut, all at low- (200 mg) and mid-level (400 mg) dosing; median duration of treatment was 272.5 days (range 33-435 days); 12 patients remain on study. CXCR4 antagonism proof of concept established, with 100% overall response rate. | 1 |
LGND | Non-alcoholic steatohepatitis (NASH) and fibrosis | Phase 2b | 2023-05-16 00:00:00 | Phase 2b data reported that trial met primary endpoint, noted May 16, 2023. | 0 |
HCM | Neuroendocrine carcinoma | Phase 2 | 2021-09-29 00:00:00 | Updated Phase 2 data reported median OS was 10.3 months. PFS was 4.14 months. The confirmed ORR was 23.8% and DCR was 71.4%. All patients experienced TRAEs, including 9 (42.9%) who experienced Grade 3 or above TRAEs, noted September 29, 2021. | 0 |
AMYT | Maintenance treatment of adult acromegaly | Phase 3 | 2022-09-07 00:00:00 | Additional Phase 3 data reported that no new or increased safety signals were identified with a shorter time to initiation of Mycapssa, noted September 7, 2022. | 0 |
ASRT | Conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma | Approved | 2016-03-15 00:00:00 | Approved March 15 2016. | 1 |
MIRM | Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome | Phase 2 | 2022-11-08 00:00:00 | Phase 2 data reported that treatment was well tolerated in infants with ALGS aged <1 year, with body weight of ≥2.5 kg, and TEAEs were mostly grade 1 in severity and unrelated to MRX, noted November 8, 2022. | 1 |
LLY | COVID-19 antibody | Phase 3 | 2020-10-26 00:00:00 | Phase 3 trial discontinued - October 26, 2020. | -1 |
GLPG | Idiopathic pulmonary fibrosis (IPF) | Phase 2 | 2020-11-30 00:00:00 | Phase 2 data released November 30, 2020 - forced vital capacity (FVC) decline of 42mL across treatment groups at 26 weeks. Phase 2b trial planned. | 1 |
KDNY | IgA nephropathy | Phase 1/2 | 2023-06-12 00:00:00 | Phase 1/2 interim results demonstrated rapid and sustained reductions in mechanistic biomarkers, including IgA and Gd-IgA1 levels, which correspond to clinically meaningful proteinuria reductions in patients with IgAN across Cohorts 1 and 2 due, noted June 12, 2023. | 1 |
HRMY | Adult Epilepsy Patients with Refractory Focal Seizures | Phase 2 | 2017-08-07 00:00:00 | Phase 2 data released August 7, 2017 - endpoints not met. | 0 |
NVS | Post-acute myocardial infarction | Phase 3 | 2021-10-26 00:00:00 | Phase 3 did not meet primary endpoint, trial will not continue to regulatory submission, noted October 26, 2021. | 1 |
CRIS | Relapsed or Refractory Non-Hodgkin Lymphoma | Phase 1 | 2022-04-04 00:00:00 | Company voluntarily paused enrollment on April 4, 2022. Partial hold placed by FDA, noted April 11, 2022. | -1 |
EIGR | Chronic hepatitis delta virus (HDV) | Phase 3 | 2023-06-29 00:00:00 | Phase 3 data presented at EASL showed that at week 48 the trial met its primary endpoint in both lonafarnib arms vs placebo, also 24-week post-treatment data demonstrated that both lonafarnib arms showed a statistically significant difference in composite response rate compared to placebo, noted June 24, 2023. | 1 |
LPCN | Postpartum Depression | Phase 1 | 2023-05-16 00:00:00 | Pilot clinical PK bridge study data reported that treatment is well-tolerated with no hypoxia or sedation-related adverse events, noted May 16, 2023. | 1 |
DSGN | Friedreich ataxia (FA) | Phase 1 | 2023-08-14 00:00:00 | Phase 1 ascending dose data reported that DT-216 was generally well-tolerated and achieved a statistically significant and dose-related increase in frataxin (FXN) mRNA levels in skeletal muscle biopsies, noted August 14, 2023. | 1 |
BGNE | Marginal Zone Lymphoma | Approved | 2021-09-15 00:00:00 | Approved September 15, 2021. | 1 |
AMGN | Obesity and without diabetes | Phase 1 | 2022-12-01 00:00:00 | Phase 1 results presented at the 20th World Congress of Insulin Resistance, Diabetes and Cardiovascular Disease (WCIRDC) showed up to 14.5% reduction in body weight at the highest dose after 12 weeks, noted December 1, 2022. | 1 |
AZN | Multiple HER2-expressing advanced solid tumors | Phase 2 | 2023-10-23 00:00:00 | Phase 2 data presented at ESMO 23 continued to demonstrate clinically meaningful and durable responses with a a median progression-free survival of 6.9 months and median overall survival of 13.4 months in the overall trial population, noted October 23, 2023. | 1 |
FDMT | Wet Age-Related Macular Degeneration (wet AMD) | Phase 2 | 2023-09-07 00:00:00 | Phase 2 enrollment commenced, noted September 7, 2023. | 0 |
PGEN | Recurrent Respiratory Papillomatosis (RRP) | Phase 2 | 2023-06-20 00:00:00 | Received Breakthrough Therapy Designation (BTD) by FDA on June 20, 2023. | 0 |
SEEL | Acute Suicidal Ideation and Behavior in patients with Major Depressive Disorder (ASIB in MDD) | Phase 2 | 2023-09-20 00:00:00 | Phase 2 Part 2 cohort data readout demonstrated early and persistent clinically meaningful reductions in symptoms of depression and acute suicidality, noted September 20, 2023. | 1 |
AZN | Head & neck cancer | Phase 3 | 2018-12-07 00:00:00 | Phase 3 data released December 7, 2018 - primary endpoints not met. | 0 |
LBPH | Developmental and epileptic encephalopathies (DEEs) | Phase 1 | 2022-12-05 00:00:00 | Phase 1 initial data reported favorable safety and tolerability results were observed in this study, with adverse events (AEs) generally consistent with previous clinical studies, noted December 5, 2022. | 1 |
ANIX | Ovarian Cancer | Phase 1 | 2023-10-13 00:00:00 | Phase 1 completed treatment of the first patient cohort, noted October 13, 2023. | 1 |
AGIO | IDH1 mutant cholangiocarcinoma - cancer | Phase 3 | 2019-09-30 00:00:00 | Data presented at ESMO 2019 PFS HR HR=0.37. | 1 |
RIGL | COVID-19 | Phase 2/3 | 2023-10-11 00:00:00 | Phase 2/3 trial enrollment ceased based on the recommendations of DSMB, noting that here was an extremely low likelihood of fostamatinib providing benefits related to the primary outcome, noted October 11, 2023. | 0 |
RHHBY | Immunoglobulin A nephropathy (IgAN) | Phase 2 | 2022-11-07 00:00:00 | IONIS-FB-LRx achieved a 44% mean reduction in proteinuria in patients treated for 6 months | 1 |
SRPT | Duchenne Muscular Dystrophy | Approved | 2023-06-22 00:00:00 | FDA acelerated Approval on June 22, 2023. | 1 |
BLUE | TDT and the β0/β0genotype | Phase 3 | 2020-06-11 00:00:00 | Phase 3 updated data at EHA June 12, 2020. Six of eight evaluable patients achieved transfusion independence, | 1 |