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NVS | Paroxysmal nocturnal hemoglobinuria (PNH) | Phase 3 | 2023-06-09 00:00:00 | Phase 3 data presented at EHA showed that monotherapy significantly improved Hb levels vs. SoC without the need for RBCTs. By maintaining intravascular hemolysis control and reducing C3 deposition leading to EVH, IPTA monotherapy led to an expected increase in PNH RBC survival to the extent that they formed >90% of the total RBC population, noted June 9, 2023 | 1 |
AZN | COVID-19 vaccine | Phase 3 | 2021-03-22 00:00:00 | Data from U.S. trial noted 76% efficacy rate - March 24, 2021. | 0 |
BIIB | Mild Alzheimer's disease | Phase 1b | 2023-10-25 00:00:00 | Phase 1b data presented at CTAD showed favorable trends reported for the high-dose groups on multiple measures of cognition and function, noted October 25, 2023. | 1 |
LGND | Postpartum Depression - moderate | Approved | 2019-03-19 00:00:00 | FDA approval announced March 19, 2018. | 1 |
AERI | Glaucoma | Approved | 2017-12-18 00:00:00 | Approved December 18, 2017. | 1 |
VRCA | Genital warts | Phase 2 | 2020-11-10 00:00:00 | Phase 2 primary endpoint met - November 10, 2020. | 0 |
OCGN | COVID-19 (within U.S.) | Phase 2/3 | 2023-01-09 00:00:00 | Phase 2/3 Immuno-bridging and Broadening study met both co-primary endpoints, noted January 9, 2023. | 0 |
PCRX | Lower extremity nerve blocks | Phase 3 | 2021-05-26 00:00:00 | Phase 3 data released May 26, 2021. Did not demonstrate statistical significance for primary endpoint. | 1 |
BMY | Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia | Approved | 2019-01-02 00:00:00 | FDA Approval announced January 2, 2019. | 1 |
FHTX | Acute myeloid leukemia (AML) | Phase 1 | 2023-06-05 00:00:00 | Phase 1 is to be commenced in 3Q 2023, clinical hold lifted by FDA, noted June 5, 2023. | 0 |
JNJ | Plaque psoriasis | Phase 2b | 2023-07-05 00:00:00 | Phase 2b trial met all primary and secondary efficacy endpoints, noted July 5, 2023. | 0 |
MRK | Resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC) | Phase 3 | 2023-10-20 00:00:00 | Phase 3 data presented at ESMO 23 demonstrated statistically significant improvement in overall survival versus neoadjuvant placebo plus chemotherapy, noted October 20, 2023. | 1 |
MRK | Charcot-Marie-Tooth disease (CMT) | Phase 2 | 2020-03-09 00:00:00 | Phase 2 data did not meet primary endpoint - March 9, 2020. | 1 |
MRK | Pancreatic cancer | Approved | 2019-12-30 00:00:00 | FDA Approval announced December 30, 2019. | 1 |
PFE | Atopic Dermatitis | Approved | 2022-01-14 00:00:00 | Approved January 14, 2022. | 1 |
NVS | Wet age-related macular degeneration (AMD) | Approved | 2019-10-08 00:00:00 | FDA Approval announced October 8, 2019. | 1 |
ICVX | Respiratory syncytial virus (RSV) vaccine | Phase 1b | 2023-08-08 00:00:00 | Phase 1b 12 month extension trial in older adults, GMTs against RSV through day 365 persisted at ~45-70% of the GMTs at day 28 (for 75 and 250 µg unadjuvanted dosages), noted August 8, 2023. | 0 |
MOR | Rheumatoid Arthritis | Phase 2b | 2018-10-21 00:00:00 | Phase 2b released October 21, 2018 did not meet primary endpoint. | 1 |
MRNA | Heart Failure | Phase 2a | 2021-11-15 00:00:00 | Phase 2a study met the primary endpoint of safety and tolerability; numerical trends observed in endpoints in the heart failure efficacy domains compared with placebo, including increase in LVEF and patient reported outcomes, noted November 15, 2021. | 1 |
BDRX | Recurrent Glioblastoma (GBM) | Phase 1 | 2023-10-03 00:00:00 | Phase 1 Cohort A enrollment completed, noted October 3, 2023. | 0 |
LLY | First-line gastric cancer | Phase 3 | 2017-12-08 00:00:00 | Phase 3 PFS data met primary endpoint but overall survival not improved. Will not seek regulatory approval. | 1 |
BIIB | X-linked Retinitis Pigmentosa | Phase 2/3 | 2021-10-20 00:00:00 | Phase 2/3 trial discontinued noted October 20, 2021. | -1 |
RHHBY | First-line BRAF wild-type metastatic or unresectable locally advanced melanoma | Phase 3 | 2019-06-20 00:00:00 | Phase 3 data did not meet primary endpoint - June 20, 2019. | 1 |
NGM | Non-alcoholic steatohepatitis (NASH) | Phase 2b | 2021-05-24 00:00:00 | Phase 2b top-line data released May 24, 2021. Primary endpoint not met. | 0 |
SAGE | Insomnia | Phase 1/2 | 2018-01-31 00:00:00 | Phase 1/2 trial met primary endpoint - January 31, 2018. | 0 |
BMEA | Acute myeloid leukemia (AML) | Phase 1 | 2023-10-17 00:00:00 | Phase 1 dosing initiated, noted October 17, 2023. | 0 |
SVRA | Nontuberculous mycobacteria (NTM) | Phase 2 | 2020-03-12 00:00:00 | Phase 2 top-line data released March 12, 2020. | 0 |
ABBV | Functional Constipation in pediatric patients aged 6-17 | Approved | 2023-06-12 00:00:00 | FDA Approved on June 12, 2023. | 1 |
IVVD | COVID-19 (treatment) | Phase 2/3 | 2021-09-29 00:00:00 | Phase 2/3 new data compiled to date suggest that the 300 mg IM regimen has a projected ability to rapidly achieve and maintain target concentrations at key tissue sites of viral replication, including the ability to attain near complete (> 90%) and durable (> 28-day) SARS-CoV-2 receptor occupancy across a range of baseline viral loads, noted September 29, 2021. | 1 |
ASND | Follicular lymphoma | Phase 2 | 2023-06-17 00:00:00 | Phase 2 data presented at ICML showed that 97% of patients with R/R FL treated with Breyanzi achieved a response, with 94% achieving a complete response, and 81.9% of responders in ongoing response at 12 months, noted June 17, 2023. | 1 |
AVTX | COVID-19 induced Acute Respiratory Distress Syndrome (ARDS) | Phase 2 | 2021-03-02 00:00:00 | Phase 2 data released March 2, 2021. At both the 28-day and the 60-day final timepoints, an approximately 50% trend in mortality reduction (22.5% vs 10.8% - placebo) was observed. | 1 |
VERA | IgA nephropathy (IgAN) | Phase 2a | 2022-11-05 00:00:00 | Phase 2a final data presented at the American Society of Nephrology Kidney Week reported that atacicept reduced immune complex levels in patients with IgA nephropathy (IgAN), noted November 5, 2022. | 1 |
SNDX | Triple negative breast cancer (TNBC) | Phase 2 | 2019-03-07 00:00:00 | Phase 2 top-line data March 7, 2019 failed to meet endpoints. | 1 |
GILD | HIV | Phase 2 | 2022-02-16 00:00:00 | Phase 2 data reported high rates of viral suppression by Week 54 with 90% achieving an undetectable viral load, noted February 16, 2022. | 1 |
AZN | Non-small cell lung cancer (NSCLC) | Phase 3 | 2022-12-19 00:00:00 | Phase 3 trial did not meet primary endpoint, noted December 19, 2022. | 1 |
PTN | Dry eye disease (DED) | Phase 2 | 2020-12-15 00:00:00 | Phase 2 trial met the primary endpoints in the moderate to severe patient population but not in the overall population including mild patients. | 0 |
BIVI | Parkinson's disease | Phase 2a | 2023-08-28 00:00:00 | Phase 2a results reported that in comparison of Day 1 and Day 14 of treatment, PK parameters demonstrated that NE3107 administration did not affect the PK profile of levodopa, noted August 28, 2023. | 1 |
BLTE | Stargardt disease (STGD1) | Phase 1/2 | 2022-05-05 00:00:00 | Phase 1b/2 results reported that 69.2% of patients reported delayed dark adaptation (DDA), 61.5% reported a gain in BCVA (ETDRS score) in at least one eye, and reductions of RBP4 levels by 80-90%, noted May 5, 2022. | 1 |
IONS | Familial chylomicronemia syndrome (FCS) | CRL | 2018-08-27 00:00:00 | CRL issued August 27, 2018. | 0 |
GRTX | Non-Small Cell Lung Cancer (NSCLC) | Phase 1/2 | 2023-10-31 00:00:00 | Phase 1/2 halted after GRECO-2 failed futility analysis, so trial halted to preserve cash, noted October 31, 2023. | 1 |
ZVRA | Vascular Ehlers-Danlos Syndrome | CRL | 2019-06-25 00:00:00 | CRL issued June 25, 2019. | 0 |
BMY | Multiple Myeloma | Phase 3 | 2023-02-10 00:00:00 | Full Phase 3 data presented at EBMT-EHA 5th European CAR T-cell meeting demonstrated more than tripled progression-free survival (13.3 months vs. 4.4 months) compared with standard regimens for triple-class exposed multiple myeloma, risk of disease progression or death was reduced by 51% versus standard regimens, noted February 10, 2023. Phase 3 topline results reported that trial met primary endpoint, noted September 7, 2022. | 1 |
PFE | Herceptin biosimilar | Approved | 2019-03-15 00:00:00 | FDA Approval March 11, 2019. | 1 |
ALNY | Hypertension | Phase 2 | 2023-09-07 00:00:00 | Phase 2 study met the primary endpoint, noted September 7, 2023. | 0 |
KALV | Hereditary angioedema (HAE) | Phase 2 | 2022-10-04 00:00:00 | Phase 2 trial has been terminated based on the observation of liver enzyme (ALT/AST) elevations in multiple patients in all treatment groups of the trial and to prioritize the development of the KONFIDENT Phase 3 trial. | 1 |
PBYI | Extended adjuvant HER2-positive early stage breast cancer | Approved | 2017-07-17 00:00:00 | Approval announced July 17, 2017. | 1 |
LLY | Primary axillary hyperhidrosis | Approved | 2018-06-29 00:00:00 | Approval announced June 29, 2018. | 1 |
APLS | Geographic atrophy (GA) associated with age-related macular degeneration (AMD) | Phase 3 | 2022-09-30 00:00:00 | Phase 3 24-month data reported evidence that slowing GA lesion growth has the potential to preserve visual function, noted September 30, 2022. | 1 |
ZLAB | Myasthenia gravis (MG) | Approved | 2021-12-17 00:00:00 | Approved December 17, 2021. | 1 |
MRK | Ovarian cancer | Phase 1 | 2023-10-23 00:00:00 | Phase 1 data presented at ESMO reported that the confirmed overall response rate in patients with measurable disease was 38% (13 of 34): 67% (including 1 CR) at 4.8 mg/kg, 33% (5/15) at 6.4 mg/kg, and 31% (4/13) at 8.0 mg/kg, with two patients with unconfirmed partial responses were still on treatment, noted October 23, 2023. | 1 |
MNMD | Anxiety Disorders | Phase 2a | 2022-05-11 00:00:00 | Phase 2a data results demonstrated the significant, long-lasting beneficial effects of LSD and potential to safely mitigate symptoms of anxiety and depression, noted May 11, 2022. | 1 |
EIGR | Hyperinsulinemic hypoglycemia after bariatric or other gastrointestinal surgeries | Phase 2b | 2022-06-13 00:00:00 | Phase 2b data reported that trial met primary and secondary endpoints, noted June 13, 2022. | 0 |
PTCT | Mitochondrial Epilepsy | Phase 2/3 | 2023-06-29 00:00:00 | Phase 2/3 data reported that trial did not meet the primary endpoint, noted June 29, 2023. | 1 |
CDTX | Candidemia | Phase 2 | 2019-07-29 00:00:00 | Phase 2 data released July 29, 2019 - noted all objectives met. | 0 |
SIOX | GM1 gangliosidosis | Phase 1/2 | 2021-10-21 00:00:00 | Phase 1/2 interim safety and biomarker data demonstrated consistent dose-dependent improvements across biomarker measures, normalization of serum beta-galactosidase activity and GM1 ganglioside in CSF in the high-dose cohort, no overt disease progression in (6/7) patients treated across low- and high-dose cohorts. No SAE reported in patients (10/10), noted October 21, 2021. | 1 |
SLRX | Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML) | Phase 1/2 | 2022-12-12 00:00:00 | Phase 1/2 data presented at ASH reported an ORR of 50% among eight myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML), noted December 12, 2022. | 1 |
JNJ | Plaque psoriasis | Phase 3 | 2022-09-18 00:00:00 | Phase 3b data reported that patients treated with guselkumab ≤2 years after disease onset (versus >2 years) are more likely to achieve super-respondera status, noted September 18, 2022. | 1 |
NVS | IgA nephropathy (IgAN) | Phase 3 | 2023-10-02 00:00:00 | Phase 3 data reported that met its pre-specified interim analysis primary endpoint, noted October 2, 2023. | 0 |
KPTI | Dedifferentiated liposarcoma | Phase 3 | 2020-11-02 00:00:00 | Phase 3 trial met primary endpoint - November 2, 2020. | 0 |
LIAN | Symptomatic Obstructive Hypertrophic Cardiomyopathy (HCM) | Approved | 2023-06-16 00:00:00 | FDA Approval on June 16, 2023 | 1 |
INBX | Alpha-1 Antitrypsin Deficiency (AATD) | Phase 1 | 2022-11-02 00:00:00 | Phase 1 data presented at ACoP noted that treatment demonstrated the potential to achieve and maintain normal levels of functional AAT. The 120 mg/kg Q4W regimen is predicted to achieve average trough values >21.1 µM, noted November 2, 2022. | 1 |
BMY | Second-line Small cell lung cancer (SCLC) | Phase 3 | 2018-10-12 00:00:00 | Phase 3 data released October 12, 2018 - primary endpoint not met. | 0 |
ALDX | Chronic Cough | Phase 2 | 2023-06-27 00:00:00 | Phase 2 trial demonstrated statistically significant reduction in cough frequency following administration of ADX‑629 relative to placebo, noted June 27, 2023. | 1 |
MDGL | Non-alcoholic steatohepatitis (NASH) with liver fibrosis | PDUFA priority review | 2023-09-13 00:00:00 | https://www.biopharmcatalyst.com/company/MDGL/news/158576 | 0 |
ACAD | Parkinson’s disease psychosis (PDP) | Approved | 2016-04-29 00:00:00 | Approved April 29, 2016. | 1 |
RHHBY | Relapsed/Refractory Multiple Myeloma (RRMM) | Phase 1 | 2022-12-12 00:00:00 | Phase 1 data reported that the best overall response (BOR) achieved was: stringent complete response (sCR) in 7 patients, CR in 3 patients, very good partial response (VGPR) in 5 patients, and PR in 1 patient, noted December 12, 2022. | 1 |
AGTC | Achromatopsia | Phase 1/2 | 2021-06-24 00:00:00 | Phase 1/2 12-month data presented June 24, 2021. Company noted at this time point consistent evidence not shown of biologic activity, patient-reported anecdotes continue to be encouraging. | 1 |
REGN | Chaple | Approved | 2023-08-18 00:00:00 | Approved August 18, 2023. | 1 |
VSTM | Chronic lymphocytic leukemia (CLL)//Small Lymphocytic Lymphoma (SLL)/Follicular Lymphoma | Approved | 2018-09-24 00:00:00 | FDA Approval announced September 24, 2018. | 1 |
ACAD | Alzheimer’s disease psychosis (ADP) | CRL | 2022-08-05 00:00:00 | CRL announced August 5, 2022. | 0 |
CANF | Advanced liver cancer, hepatocellular carcinoma | Phase 2 | 2021-12-20 00:00:00 | Phase 2 data reported a complete response with that patient surviving 5 years, noted December 20, 2021. | 0 |
RMTI | Anemia | Approved | 2020-03-27 00:00:00 | FDA approval announced date March 27, 2020. | 1 |
IMVT | Graves Ophthalmopathy | Phase 2a | 2020-03-30 00:00:00 | Phase 2a initial data March 30, 2020 noted 65% mean reduction in total IgG. | 1 |
ABBV | Plaque psoriasis | Phase 3 | 2023-03-18 00:00:00 | Phase 3 long-term data reported that short- and long-term efficacy of psoriasis signs and symptoms (sPGA 0/1) at week 16 and week 52 in a difficult-to-treat population, with no new safety signals observed, noted March 18, 2023. | 1 |
VRNA | 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 |
SNY | Prurigo nodularis (PN) | Approved | 2022-09-28 00:00:00 | Approved September 28, 2022. | 1 |
ZLAB | Non-Small Cell Lung Cancer | Phase 1/2 | 2021-12-16 00:00:00 | Updated Phase 1/2a reported that 14 patients achieved a confirmed PR for a 39% confirmed response rate and one additional patient had a PR that was pending confirmation at the time of the data cut-off. The median duration of response was >15 months and the median progression free survival was 12 months in the initial cohort of Phase 1 patients, noted December 16, 2021. | 1 |
MOR | Membranous nephropathy (MN) | Phase 1/2 | 2021-11-04 00:00:00 | Phase 1b/2a data reported that creatinine ratio (UPCR) results at 6 months of treatment showed a decrease in 6 of 10 patients, with 4 patients having a decrease of >=50% from baseline. The first patient who reached the 12-month time point showed a complete immunologic response and a partial clinical response, noted November 4, 2021. | 1 |
PFE | Metastatic Castration-Sensitive Prostate Cancer (mCSPC) | Approved | 2023-06-20 00:00:00 | FDA Approved on June 20, 2023 | 1 |
TCDA | Chronic Kidney Disease | Phase 3 | 2022-10-24 00:00:00 | Phase 3 top-line data reported that trial did not meet its primary endpoint, noted October 24, 2022. | 1 |
LLY | Chronic kidney disease (CKD) | Approved | 2023-09-22 00:00:00 | FDA Approval on September 22, 2023. | 1 |
FDMT | Choroideremia | Phase 1 | 2021-10-25 00:00:00 | Phase 1 initial data from 6 patients enrolled in one of two dose cohorts: 3E11 vg/eye (cohort 1; n=3) and 1E12 vg/eye (cohort 2; n=3). The study showed that at the 3E11 vg/eye dose (Cohort 1), 4D-110 was well-tolerated with no dose-limiting toxicities or serious adverse events. At the 1E12 vg/eye dose, pigment dispersion (iris transillumination) was observed in 3 patients in the 1E12 vg/eye cohort ~7 to 9 months following treatment, 2 cases were asymptomatic and 1 patient reported mild glare. | 1 |
AMGN | Wild-Type RAS Metastatic Colorectal Cancer | Approved | 2017-06-29 00:00:00 | sBLA approval announced June 29, 2017. | 1 |
ALVO | Inflammatory conditions | CRL | 2023-10-12 00:00:00 | CRL received October 12, 2023. | 0 |
VRTX | Children with cystic fibrosis (CF) ages 1 month to less than four months old | Approved | 2023-05-03 00:00:00 | FDA approved on May 3, 2023. | 1 |
RHHBY | Anaplastic lymphoma kinase (ALK)-positive metastatic (advanced) non-small cell lung cancer (NSCLC) | Phase 3 | 2019-09-29 00:00:00 | Phase 3 updated data at ESMO noted HR 0.43. PFS 34.8 months vs 10.9 months for crizotinib. | 0 |
SELB | Tophaceous gout | Phase 2 | 2020-09-30 00:00:00 | Phase 2 top-line data released September 30, 2020. Numerically higher response rate on the primary endpoint during months 3 and 6 combined, but did not meet the primary endpoint of statistical superiority. | 1 |
RYTM | Bardet-Biedl Syndrome | Approved | 2022-06-16 00:00:00 | Approved June 16, 2022. | 1 |
MNOV | Non-alcoholic fatty liver disease (NAFLD) with Type 2 Diabetes Mellitus and Hypertriglyceridemia | Phase 2 | 2022-12-07 00:00:00 | Additional Phase 2 data reported that T2DM group showed a greater reduction in serum triglyceride levels at Week 8 and Mean HDL increase was significantly greater in subjects with T2DM than subjects without T2DM at Week 8, noted December 7, 2022. | 1 |
SNY | Autosomal dominant polycystic kidney disease (ADPKD) | Phase 2/3 | 2021-06-01 00:00:00 | Phase 2/3 trial stopped due to futility - June 1, 2021. | -1 |
ANAB | dMMR endometrial cancer | Approved | 2023-02-10 00:00:00 | Full approval granted February 10, 2023. | 1 |
EDIT | Transfusion-Dependent Beta Thalassemia (TDT) | Phase 1/2 | 2023-06-09 00:00:00 | Phase 1/2 first patient demonstrated successful neutrophil and platelet engraftment, and, at one and a half months post-infusion, the patient's response resembles that of the first four RUBY patients, noted June 9, 2023. | 1 |
ARTL | Cancer-Related Anorexia and Weight Loss | Phase 1b | 2022-07-19 00:00:00 | Phase 1b safety review determined that treatment is well-tolerated, noted July 19, 2022. | 1 |
ORMP | Non-alcoholic steatohepatitis (NASH) | Phase 2 | 2020-06-15 00:00:00 | Phase 2 interim data presented at ADA 2020 Scientific Sessions - mean 6.9% reduction in liver fat content. | 1 |
BFRI | Actinic Keratosis on face & scalp | Phase 1 | 2023-08-28 00:00:00 | Phase 1 data reported that treatment was generally well tolerated and all TEAEs were transient, noted August 28, 2023. | 1 |
RARE | X-Linked Hypophosphatemia (XLH) | Approved | 2018-04-17 00:00:00 | Approval announced April 17, 2018. | 1 |
RVNC | Cervical Dystonia | Approved | 2023-08-14 00:00:00 | Approved on August 14, 2023. | 1 |
OLMA | HR+, HER2- Breast Cancer | Phase 1/2 | 2023-10-22 00:00:00 | Phase 1/2 monotherapy data presented at ESMO reported that the median PFS was 4.6 months with a CBR of 40%; in patients with ESR1 mutations at baseline, the median PFS was 5.6 months with a CBR of 52%, noted October 22, 2023. | 1 |
NBIX | Congenital Adrenal Hyperplasia (CAH) - adults | Phase 3 | 2023-09-12 00:00:00 | Phase 3 study met its primary endpoint at Week 24, Noted September 12, 2023 | 0 |
VAXX | Parkinson's disease | Phase 1 | 2023-07-17 00:00:00 | Additional Phase 1 data reported that antibodies derived from UB-312, slowed the seeding of alpha-synuclein (aSyn) in cerebrospinal fluid (CSF) of patients with PD as demonstrated using multiple target engagement assays, noted July 17, 2023. | 1 |