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PFE | Lyme disease vaccine for outdoor recreationists | Phase 3 | 2023-02-17 00:00:00 | Phase 3 study discontinued about 50% of patients enrolled following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator, noted February 17, 2023. | -1 |
ABBV | Botox in the cheeks | Approved | 2023-05-15 00:00:00 | FDA Approved on May 15, 2023. | 1 |
SPPI | Neutropenia | Approved | 2022-09-09 00:00:00 | Approved September 9, 2022. | 1 |
ALNY | Primary hyperoxaluria type 1 (PH1) | Phase 3 | 2021-11-05 00:00:00 | Phase 3 full results reported a 33 percent and 42 percent mean reduction in POx and predialysis POx from baseline to Month 6. Reduction in POx was evident by Month 1 and persisted through the end of the month 6, noted November 5, 2021. | 1 |
AMRX | Attention Deficit Hyperactivity Disorder (ADHD) | Approved | 2023-09-06 00:00:00 | ANDA approved September 6, 2023. | 1 |
SNGX | Cutaneous T-Cell Lymphoma (CTCL) cancer | Phase 3 | 2023-05-04 00:00:00 | Phase 3 data results confirm and extend response results, noted May 4, 2023. | 0 |
RGNX | MPS II (Hunter Syndrome) | BLA Filing | 2023-05-23 00:00:00 | FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation, noted May 23, 2023. | 0 |
IDYA | Solid tumors with MTAP deletion, NSCLC | Phase 1 | 2022-03-15 00:00:00 | Phase 1 updated data reported no drug-related SAE's or observed dose limiting toxicity (DLT) through Cohort 5, noted March 15, 2022. | 1 |
MRTX | Colorectal Cancer | Phase 1/2 | 2020-10-25 00:00:00 | Phase 1/2 updated data noted (23/51) 45% ORR in NSCLC patients. | 0 |
PFE | 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 |
BCTX | Early stage, newly diagnosed, high-risk triple negative breast cancer (TNBC) | Phase 2 | 2023-09-08 00:00:00 | Phase 2 trial enrollment completed with initial results of Median overall survival of 13.5 months in vs. 6.7-9.8 months for similar patients reported in the literature, noted September 8, 2023. | 0 |
AZN | Chronic obstructive pulmonary disease (COPD) | CRL | 2019-10-01 00:00:00 | CRL announced October 1, 2019. | 0 |
ARQT | Plaque psoriasis | Phase 3 | 2021-09-30 00:00:00 | Phase 3 data met its primary endpoint of Investigator Global Assessment Success rate at week 8 in 37.5% compared to a vehicle rate of 6.9%, noted September 30, 2021. | 0 |
MRK | Cancer - Third-line Gastric or Gastroesophageal Junction Adenocarcinoma | Phase 3 | 2017-12-14 00:00:00 | Approved Sept. 22, 2017 under accelerated approval in patients undergoing third-line treatment following data from Phase 2 Keynote-59 trial. Phase 3 data released December 14, 2017 in patients undergoing second-line treatment, did not meet the primary endpoint of overall survival, nor did it show a significant improvement in PFS. | 1 |
TEVA | Inflammatory conditions | CRL | 2023-10-12 00:00:00 | CRL received October 12, 2023. | 0 |
IXHL | Rheumatoid arthritis, inflammatory bowel disease and lung inflammation | Phase 1 | 2023-05-02 00:00:00 | Phase 1 results reported no adverse events of concern and no serious adverse events reported, noted May 2, 2023. | 0 |
AZN | Wilson disease | Phase 3 | 2022-06-23 00:00:00 | Phase 3 data reported at the International Liver Congress noted greater improvements in neurological scores for those treated with ALXN1840 compared to SoC, however, there were no significant differences between treatment groups observed at 48 weeks, noted June 23, 2022. | 1 |
TAK | Post-transplant Hodgkin lymphoma (HL) cancer | Approved | 2015-08-17 00:00:00 | Approved August 17, 2015 under priority review. | 1 |
FGEN | Duchenne muscular dystrophy | Phase 3 | 2023-06-07 00:00:00 | Phase 3 trial did not meet its primary endpoint, noted June 7, 2023. | 1 |
AXGN | Severed peripheral nerves | Phase 3 | 2022-05-04 00:00:00 | Phase 3 trial met primary endpoint, noted May 4, 2022. | 0 |
PGEN | Type 1 diabetes | Phase 1/2 | 2021-10-01 00:00:00 | Phase 1b interim data showed HbA1c was below the 7% target for 100% of adult patients (9) and 92% of the patients aged 17+ (11). A stabilization of IDAA1c below 9 was demonstrated in 78% of adult patients (7) and in 75% of patients aged 17+ (9). Phase 2a interim data showed stabilization of HbA1c below the ADA target of 7% was demonstrated in 70% of adult patients (7). HbA1c levels were below target in 75% of the adolescent patients (3). Stabilization of IDAA1c was demonstrated in 100% of adult patients (10) and in 75% of adolescent patients (3), noted October 1, 2021. | 1 |
RARE | Mucopolysaccharidosis 7 (MPS 7) | Approved | 2017-11-15 00:00:00 | Approval announced November 15, 2017. | 1 |
SUPN | ADHD | Phase 3 | 2020-12-22 00:00:00 | Phase 3 trial met primary endpoint - December 22, 2020. | 0 |
IFRX | Hidradenitis Suppurativa | Phase 2b | 2019-06-05 00:00:00 | Phase 2b data June 5, 2019 did not meet primary endpoint. | 1 |
MTNB | Severe hypertriglyceridemia | Phase 2 | 2021-02-01 00:00:00 | Phase 2 data released February 1, 2021. Primary endpoint not met. | 0 |
BLUE | Cerebral Adrenoleukodystrophy (CALD) | Approved | 2022-09-17 00:00:00 | Approved September 17, 2022. | 1 |
IRWD | Gastroesophageal reflux disease (GERD) | Phase 3 | 2020-09-29 00:00:00 | Phase 3 trial did not meet primary endpoint - September 29, 2020. | 1 |
XERS | Hypoglycemia-Associated Autonomic Failure | Phase 2 | 2019-11-21 00:00:00 | Phase 2 data showed no statistically significant differences between the treatment arms. Program to be discontinued - November 21, 2019. | 1 |
BNTX | Resected pancreatic ductal adenocarcinoma (PDAC) | Phase 1 | 2022-06-05 00:00:00 | Phase 1 initial preliminary data readout from 16 vaccinated patients revealed that combination was well-tolerated. Only 1 of 16 patients (6%) developed a vaccine-related Grade 3 fever and hypertension, no other Grade 3 or higher adverse events were observed. In addition, the treatment induced de-novo, neoantigen-specific T cell response in half (8/16) of these patients from undetectable levels to large fractions of all blood T cells (median 2.9%). At an early median follow-up of 18 months, patients with de-novo immune response (n=8) had a significantly longer recurrence-free survival (RFS) as compared to those without vaccine-induced immune responses (n=8) (median not reached vs. 13.4 months, HR 0.08, 95% CI 0.01-0.4, P = 0.003)., noted June 5, 2022. | 1 |
VRTX | Sickle cell disease | Phase 1/2 | 2022-06-13 00:00:00 | Data presented at EHA reported that all 31 patients with severe SCD were free of VOCs after exa-cel infusion through duration of follow-up, with follow-up ranging from 2.0 to 32.3 months, noted June 13, 2022. | 1 |
MRK | Prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (D+/R-) | Approved | 2023-06-05 00:00:00 | Approved on June 5, 2023. | 1 |
BMY | Esophageal squamous cell carcinoma (ESCC) | Approved | 2022-05-27 00:00:00 | Approved May 27, 2022. | 1 |
AERI | Macular edema due to RVO (retinal vein occlusion) | Phase 2 | 2021-10-07 00:00:00 | Phase 2 data displayed that the implant achieved targeted 6-month duration of efficacy, with improvements in BCVA and macular edema demonstrated for at least 6 months. Adverse events were consistent with other corticosteroid treatments, noted October 7, 2021. | 1 |
VIR | HIV T cell vaccine | Phase 1 | 2023-05-08 00:00:00 | Phase 1 initial data reported that no safety signals and no vector shedding or viremia were reported, noted June 28, 2023. | 0 |
JNJ | Multiple myeloma | Approved | 2021-07-12 00:00:00 | FDA approval announced July 12, 2021. | 1 |
REGN | Osteoarthritis pain of the hip or knee | Phase 3 | 2020-08-05 00:00:00 | Phase 3 data achieved the co-primary endpoints for fasinumab 1 mg monthly. Fasinumab every two months did not reach statistical significance - August 5, 2020. | 1 |
BNOX | Social Anxiety Disorder (SAD) | Phase 3 | 2023-10-16 00:00:00 | End of Phase 2 meeting minutes resulted in favorable outcome for the company which confirmed agreement with the FDA on its Phase 3 clinical trial expected to commence in 1Q 2024. | 1 |
LLY | Obesity or overweight with weight-related comorbidities | Phase 3 | 2023-07-27 00:00:00 | Phase 3 trial met primary endpoint, noted July 27, 2023. | 0 |
AZN | Thyroid cancer | Phase 3 | 2018-07-26 00:00:00 | Phase 3 trial did not meet primary endpoint - noted July 26, 2018. | 1 |
MRK | Pulmonary arterial hypertension (PAH) | Phase 3 | 2023-09-11 00:00:00 | Phase 3 interim results from OLE study represent longest safety and efficacy analysis of sotatercept to date; safety profile of sotatercept consistent with previous studies and efficacy improvements maintained after one year of therapy, noted September 11, 2023. | 1 |
BNTX | COVID-19 Vaccine (Omicron Booster) | Approved | 2023-09-11 00:00:00 | FDA booster approved on September 11, 2023. | 1 |
TOVX | Constipation-Predominant Irritable Bowel Syndrome (C-IBS) | Phase 2b | 2020-10-02 00:00:00 | Phase 2b interim futility analysis released October 2, 2020. Primary endpoint unlikely to be met. Trial to be discontinued. | -1 |
ABBV | Psoriasis | Approved | 2019-04-23 00:00:00 | FDA approval announced April 23, 2019. | 1 |
PBYI | Small Cell Lung Cancer (SCLC) | Phase 1a | 2023-08-08 00:00:00 | FDA IND Clearance on August 8, 2023. | 0 |
JAZZ | Fibromyalgia | CRL | 2010-10-11 00:00:00 | CRL received October 11, 2010. | 0 |
JAZZ | Sickle Cell Disease-Related Acute Chest Syndrome | Phase 2 | 2022-12-12 00:00:00 | Phase 2 data reported that among patients who underwent Day 30 CXR or CTA, 87.5% and 92%, respectfully, showed improvement or resolution of pulmonary consolidation, noted December 12, 2022. | 1 |
MAIA | Non-small cell lung cancer (NSCLC) | Phase 2 | 2023-10-31 00:00:00 | Phase 2 preliminary efficacy data reported a 100% Disease Control Rate (DCR), noted October 31, 2023. | 0 |
MRK | Renal Cell Carcinoma (RCC) - cancer | Phase 2 | 2017-06-12 00:00:00 | Phase 2 data released June 12, 2017 - primary endpoint not met. | 0 |
CADL | Non-small cell lung cancer (NSCLC) | Phase 2 | 2023-09-26 00:00:00 | Phase 2 initial data suggests 12-month survival is consistent with an increased tail on the maturing survival curve, noted September 26, 2023. | 0 |
APTX | Fibromyalgia | Phase 2b | 2022-08-12 00:00:00 | Phase 2b data reported that trial did not meet statistically significant, noted August 12, 2022. | 1 |
SNY | Non-small cell lung cancer (NSCLC) | Phase 3 | 2021-09-19 00:00:00 | Phase 3 data presented at ESMO September 19, 2021 showed trial met primary and all secondary endpoints, with an objective response rate of 43%. | 1 |
VSTM | KRAS mutant advanced solid tumors | Phase 1/2 | 2023-09-28 00:00:00 | Phase 1/2 data reported an overall response rate (ORR) of 42% (11 of 26) in evaluable patients with low grade serous ovarian cancer (LGSOC), noted September 28, 2023. | 1 |
AZN | COPD | Phase 3 | 2018-05-30 00:00:00 | Phase 3 data released May 30, 2018. Primary endpoint not met. | 0 |
ABUS | Hepatitis B (HBV) | Phase 1b | 2022-06-27 00:00:00 | Phase 1a/b data reported that all seven patients reached HBsAg levels <100 IU/ml during AB-729 treatment or follow-up and two patients reached HBsAg levels <LLOQ at one or more visits, noted June 27, 2022. | 1 |
RIGL | COVID-19 | Phase 2 | 2021-08-13 00:00:00 | Announced August 12, 2021 that data are insufficient for FDA emergency use authorization (EUA). | -1 |
SNGX | Oral Mucositis in Patients with Head & Neck Cancer | Phase 3 | 2020-12-22 00:00:00 | Phase 3 trial did not meet primary endpoint. | 1 |
BLCM | Metastatic castration-resistant prostate cancer (mCRPC) | Phase 1/2 | 2021-12-06 00:00:00 | Phase 1/2 data reported no dose-limiting toxicities, and 1 confirmed partial response, noted December 6, 2021. | 0 |
EYPT | Non-proliferative diabetic retinopathy (NPDR) | Phase 2 | 2023-09-11 00:00:00 | Phase 2 interim analysis of masked data showed that EYP-1901 is well tolerated with no reported drug-related ocular or systemic serious adverse events, noted September 11, 2023. | 1 |
RHHBY | COVID-19 | Phase 3 | 2020-09-18 00:00:00 | Phase 3 trial met primary endpoint, with patients 44% less likely to progress to ventilation or death compared to patients who received placebo plus standard of care - September 18, 2020. No statistical difference in mortality. | 0 |
SPPI | Colorectal cancer | Approved | 2011-04-29 00:00:00 | Approved April 29, 2011. | 1 |
VAXX | COVID-19 prevention | Phase 3 | 2022-12-02 00:00:00 | Phase 3 trial met primary and key secondary endpoint, noted December 2, 2022. | 0 |
SNY | Pemphigus | Phase 3 | 2021-10-29 00:00:00 | Phase 3 trial did not meet primary or key secondary endpoints, noted October 29, 2021. | 1 |
PFE | Non-small cell lung cancer (NSCLC) | Phase 3 | 2018-09-28 00:00:00 | FDA Approval announced September 27, 2018. | 1 |
MRK | Locally advanced resectable gastric and gastroesophageal junction (GEJ) adenocarcinoma | Phase 3 | 2023-06-20 00:00:00 | Phase 3 study met one of its primary endpoints of pathological complete response (pCR) rate and demonstrated a statistically significant improvement in pCR rates compared with chemotherapy alone, noted June 20, 2023. | 1 |
JNJ | Psoriatic Arthritis | Approved | 2020-07-14 00:00:00 | FDA Approval announced July 14, 2020. | 1 |
GLPG | Rheumatoid Arthritis | Phase 2a | 2021-07-14 00:00:00 | Phase 2a data released July 14, 2021 - showed no differentiation from placebo. | 1 |
RIGL | IgA nephropathy | Phase 2 | 2018-04-03 00:00:00 | Phase 2 data released April 3, 2018. Primary endpoint not met. | 0 |
CPRX | MuSK-antibody positive myasthenia gravis (MuSK-MG) | Phase 3 | 2020-08-10 00:00:00 | Phase 3 trial did not meet primary endpoint - August 10, 2020. | 1 |
CADL | Pancreatic Cancer | Phase 2 | 2023-11-03 00:00:00 | Phase 2 initial overall survival and immunological biomarker data presented at SITC revealed notable improvements in patients with borderline resectable pancreatic ductal adenorcarcinoma (PDAC) after experimental treatment with CAN-2409, noted November 3, 2023. | 1 |
ALLK | Eosinophilic esophagitis | Phase 2/3 | 2021-12-21 00:00:00 | Phase 2/3 top-line data reported that the trial met its histologic co-primary endpoints, but did not achieve statistical significance on the patient reported symptomatic co-primary endpoints, noted December 21, 2021. | 1 |
NVS | Adjuvant breast cancer | Phase 3 | 2023-06-02 00:00:00 | Phase 3 data presented at ASCO significantly reduced the risk of recurrence by 25% across a broad population of patients with early breast cancer; clinically meaningful benefit was consistent across subgroups, noted June 2, 2023. | 1 |
ABUS | Coronavirus | Phase 1 | 2023-09-11 00:00:00 | Phase 1 trial discontinued, noted September 11, 2023. | -1 |
BMY | Kaposi’s sarcoma | Approved | 2020-05-15 00:00:00 | FDA Approval announced May 15, 2020. | 1 |
ORTX | Metachromatic leukodystrophy (MLD) | Phase 3 | 2023-08-31 00:00:00 | Announced long-term results from 39 patients that demonstrated that administration of one-time gene therapy resulted in statistically significant improvement in severe motor impairment-free survival with up to 12 years of follow-up (median 6.76 years), noted August 31, 2023. | 1 |
NKTR | Opioid-induced constipation (OIC) | Approved | 2014-09-16 00:00:00 | Approved September 16, 2014. | 1 |
JNJ | Diffuse large B-cell lymphoma (DLBCL) | Phase 3 | 2018-07-11 00:00:00 | Phase 3 trial did not meet primary endpoint - noted July 11, 2018. | 1 |
CORT | Long-standing antipsychotic-induced weight gain (APIWG) | Phase 2 | 2022-12-08 00:00:00 | Phase 2 data reported that AIWG did not reverse, noted December 8, 2022. | 0 |
MOLN | COVID-19 | Phase 2/3 | 2022-01-10 00:00:00 | Phase 2b/3 part A met primary endpoint, noted January 10, 2022. | 0 |
MRK | Myelofibrosis | Phase 2 | 2019-12-09 00:00:00 | Phase 2 data at ASH December 2019 noted primary endpoint met in 10%~32% of patients across four cohorts. | 0 |
RNXT | Locally advanced pancreatic cancer (LAPC) | Phase 3 | 2023-06-29 00:00:00 | Phase 3 interim data presented at ESMO GI demonstrated an eight-month median PFS benefit, 15 versus 7 months, in delaying the progression of cancer for patients receiving treatment with RenovoGem versus standard-of-care, noted June 29, 2023. | 1 |
CPRX | Duchenne Muscular Dystrophy (DMD) | Approved | 2023-10-26 00:00:00 | Approved October 26, 2023. | 1 |
SYBX | Phenylketonuria (PKU) | Phase 2 | 2023-03-19 00:00:00 | Phase 2 full data presentation at SIMD reported plasma Phe reduction of -53% among responders with a response rate was 60%, noted March 19, 2023. | 1 |
CCXI | Associated vasculitis (AAV) | Approved | 2021-10-08 00:00:00 | FDA approval announced October 8, 2021. | 1 |
ACHV | Smoking cessation | Phase 3 | 2023-03-03 00:00:00 | Additionnal Phase 3 data presented at the Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting confirmed that successful abstinence was observed in subgroups of smokers who received cytisinicline. Subjects who received either 6 or 12-weeks of cytisinicline treatment experienced consistently higher rates of abstinence, noted March 3, 2023. | 1 |
NVS | Psoriasis | Approved | 2018-02-08 00:00:00 | FDA approval announced February 8, 2018. | 1 |
AMGN | REMICADE biosimilar - rheumatoid arthritis | Approved | 2019-12-06 00:00:00 | FDA Approval announced December 6, 2019. | 1 |
RHHBY | Relapsed or refractory Chronic Lymphocytic Leukemia (CLL) | Approved | 2018-06-11 00:00:00 | Approval announced June 11, 2018. | 1 |
IONS | Dyslipidaemia | Phase 2b | 2022-04-04 00:00:00 | Phase 2b study met its primary and secondary endpoints; ION449 was generally well tolerated, noted April 4, 2022 | 1 |
BMRN | Children under age 5 with Achondroplasia | Approved | 2023-10-23 00:00:00 | Approved October 23, 2023. | 1 |
LLY | Hepatocellular Carcinoma | Approved | 2019-05-13 00:00:00 | FDA approval announced May 13, 2019. | 1 |
RVNC | Moderate to severe glabellar (frown) lines | Approved | 2022-09-08 00:00:00 | Approved September 8, 2022. | 1 |
BMY | Multiple myeloma (MM) - autologous stem cell transplant (ASCT) | Approved | 2017-02-22 00:00:00 | Approved February 22, 2017. | 1 |
REGN | Wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR) | Approved | 2023-08-18 00:00:00 | Approved August 18, 2023. | 1 |
LLY | Solid tumors that harbor a TRK fusion. | Approved | 2018-11-26 00:00:00 | FDA Approval announced November 26, 2018. | 1 |
DTIL | Relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) | Phase 1/2 | 2023-07-27 00:00:00 | Phase 1/2 Type B End of Phase 1 meeting with the FDA provided clarity and direction to advance to Phase 2, noted July 27, 2023. | 1 |
AZN | HER2-overexpressing/amplified (HER2+) metastatic colorectal cancer (mCRC) | Phase 2 | 2023-06-05 00:00:00 | Phase 2 primary results to be presented at ASCO demonstrated positive antitumour activity and consistent safety in patients with previously treated HER2-positive metastatic colorectal cancer, noted June 5, 2023. | 1 |
ADCT | Hodgkin lymphoma (HL) | Phase 2 | 2021-06-22 00:00:00 | Phase 2 interim data presented June 22, 2021. Overall response rate (ORR) was 66.3% (67/101 patients) with a complete response rate (CRR) of 27.7% and partial response rate (PRR) of 38.6%. Median duration of response has not been reached. | 1 |
GOVX | Covid-19 | Phase 2 | 2023-09-11 00:00:00 | Phase 2 target enrollment met, noted September 11, 2023. | 0 |
AZN | Castration-Resistant Prostate Cancer | Approved | 2020-05-19 00:00:00 | FDA Approval announced May 19, 2020. | 1 |
AQST | Epileptic seizures | Approved | 2022-08-31 00:00:00 | Tentative approval from FDA on August 31, 2022. The tentative approval was due to to an existing FDA regulatory grant of orphan drug market exclusivity for Valtoco, a diazepam nasal spray product, Libervant is not yet eligible for marketing in the United States. | 1 |