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ZLAB | Non-small-cell lung cancer (NSCLC) and solid tumors | Phase 1/2 | 2022-04-12 00:00:00 | Phase 1/2 top-line data reported that in the ROS1-positive TKI-naïve advanced NSCLC population the cORR was 79%, with 4 patients receiving a complete response, and 52 having a partial response. With DOR ranging from 1.4+ to 35.1+ months and PFS ranging from 0+ to 40.4+ months, noted April 12, 2022. | 0 |
ABBV | Jawline definition | Approved | 2022-08-03 00:00:00 | Approved August 3, 2022. | 1 |
ACAD | Adjunctive treatment in patients with negative symptoms of schizophrenia | Phase 2 | 2019-11-25 00:00:00 | Phase 2 data released November 25, 2019. Primary endpoint met. Key secondary missed. | 0 |
MRK | Pulmonary arterial hypertension (PAH) | PDUFA | 2023-09-28 00:00:00 | PDUFA date on March 26, 2024. | 0 |
OTLK | Wet age-related macular degeneration (wet AMD) | Phase 3 | 2020-08-26 00:00:00 | Phase 3 data released August 26, 2020. No statistical differences between Lucentis (ranibizumab) and ONS-5010. | 0 |
TAK | Pouchitis | Phase 3 | 2023-03-30 00:00:00 | Phase 4 met primary endpoint, noted March 30, 2023. | 0 |
MRK | Renal cell carcinoma (RCC) | Phase 3 | 2023-11-01 00:00:00 | Phase 3 trial met its primary endpoint, noted November 1, 2023. | 0 |
ENTA | Primary biliary cholangitis (PBC) | Phase 2 | 2020-05-06 00:00:00 | Phase 2 top-line data did not meet primary endpoint - May 6, 2020. | 1 |
INCY | Hidradenitis suppurativa | Phase 2 | 2023-10-12 00:00:00 | Phase 2 secondary analysis presented at EADV reported that a large proportion of patients who received any dose of povorcitinib from Day 1 achieved T VASI50 (37.0% 45.2%) and F VASI75 (48.4% 58.6%) responses at Week 52, noted October 12, 2023. | 1 |
GSK | Covid-19 vaccine, omicron variant | Phase 1 | 2023-01-30 00:00:00 | Phase 1 immunogenicity data reported that on day 29 at the 12µg dose level, CV0501 generated a ratio of post-boost to pre-boost serum neutralizing titers against BA.1 of 13.3, noted January 30, 2023. | 0 |
AMGN | KRAS mutant non-small cell lung cancer (NSCLC) | Phase 1/2 | 2023-10-16 00:00:00 | Phase 1/2 initial data reported that the confirmed objective response rate (ORR) was 25% (3/12) across efficacy-evaluable patients and seen in both KRAS G12C inhibitor resistant (14.3%; 1/7) and naïve (40%; 2/5) patients, noted October 16, 2023. | 1 |
TCRT | Solid tumors | Phase 1 | 2018-06-18 00:00:00 | Phase 1 trial placed on clinical hold - June 18, 2018. | 0 |
PMVP | Solid tumors | Phase 1/2 | 2023-10-12 00:00:00 | Phase 1/2 updated results presented at AACR-NCI-EORTC reported that the overall response rate (ORR) was 38% (6/16 evaluable patients) at the Recommended Phase 2 Dose (RP2D) of 2000 mg daily and 34% (13/38) in the efficacious dose range, noted October 12, 2023. | 1 |
SIGA | Smallpox | Approved | 2022-05-19 00:00:00 | Approved May 19, 2022. | 1 |
OTIC | Ménière's disease | Phase 3 | 2021-02-22 00:00:00 | Phase 3 trial did not achieve the primary endpoint. | 1 |
GTHX | Urothelial carcinoma | Phase 2 | 2023-08-02 00:00:00 | Phase 2 PFS data reported that PFS was similar between patients receiving trilaciclib prior to gemcitabine/platinum + avelumab and patients receiving gemcitabine/platinum + avelumab alone (median PFS=6.0 months and 6.1 months), noted August 2, 2023. | 0 |
NBIX | Uterine Fibroids | Approved | 2020-05-29 00:00:00 | FDA approval announced May 29, 2020. | 1 |
BIIB | Epilepsy | Phase 2 | 2020-04-22 00:00:00 | Phase 2 primary endpoint not met. | 0 |
RLAY | PIK3CA (PI3Kα) mutant tumors, including HR+/HER2- breast cancer | Phase 1 | 2023-04-18 00:00:00 | Phase 1 initial data reported that RLY-2608 reached selective target exposure at multiple doses, with a partial response in a breast cancer patient, noted April 18, 2023. | 1 |
BHC | Bowel cleansing | Approved | 2018-05-07 00:00:00 | Approval announced May 7, 2018. | 1 |
LLY | First-Line Nonsquamous Non-small cell lung cancer (NSCLC) | Approved | 2018-06-05 00:00:00 | FDA approval (label expansion) announced June 5, 2018. | 1 |
ACST | Subarachnoid hemorrhage (SAH) | Phase 3 | 2023-05-08 00:00:00 | PK study met all endpoints, noted May 18, 2022. Phase 3 trial to be initiated in 2H 2023. If the Phase 3 study meets the primary endpoint, an NDA filing for GTX-104 under Section 505(b)(2) is expected to follow, noted April 4, 2023. The company successfully submited GTX-104 Pivotal Phase 3 protocol IND amendment to the FDA with expectation for first patient dosed in calendar 4Q 2023, noted May 8, 2023. | 1 |
PRLD | Solid Tumors and Recurrent High-Grade Gliomas | Phase 1 | 2021-10-07 00:00:00 | Phase 1 data displayed a GBM patient who experienced a PR that later evolved into a durable CR for more than 13 months. Patients were largely able to remain on therapy with few AE-related dose interruptions (13%), reductions (4%), or discontinuations (3%), noted October 7, 2021. | 1 |
BGNE | Esophageal squamous cell carcinoma (ESCC) | Phase 3 | 2022-06-30 00:00:00 | Phase 3 data reported an improvement in overall survival (OS) for patients receiving treatment with a median OS of 17.2 months versus 10.6 months with placebo, noted June 30, 2022. | 1 |
LSTA | Type 1 diabetes | Phase 2 | 2019-02-13 00:00:00 | Phase 2 top-line data did not meet primary endpoint - February 13, 2019. | 1 |
AMGN | Heart failure with reduced ejection fraction (HFrEF) | Phase 3 | 2022-04-03 00:00:00 | Phase 3 results reported that there was no change in pVO2 in patients treated with omecamtiv mecarbil versus placebo, noted April 3, 2022. | 1 |
GILD | HR+/HER2- metastatic breast cancer | Approved | 2023-02-03 00:00:00 | Approved February 3, 2023. | 1 |
CRSP | Advanced clear cell renal cell carcinoma | Phase 1 | 2022-11-10 00:00:00 | Phase 1 result reported a 77% disease control rate in a heavily pretreated RCC patient population. The longest duration of stable disease achieved was observed for 7.8 months, noted November 10, 2022. | 1 |
GTHX | Metastatic colorectal cancer (mCRC) | Phase 3 | 2023-02-13 00:00:00 | Phase 3 topline data reported that achieved its co-primary endpoints related to severe neutropenia but failed to achieve a significant response in overall response rate (ORR) and preliminary measures of survival, noted February 13, 2023. | 1 |
PSTX | Multiple myeloma | Phase 2 | 2021-12-13 00:00:00 | Phase 2 results showed that dosage was well tolerated and demonstrated strong anti-tumor activity in advanced, late line R/R MM patients, with an overall response rate (ORR) of 78%, a VGPR/sCR rate of 43% and 100% overall survival at the time of the data cutoff, noted December 13, 2021. | 1 |
ITRM | Uncomplicated urinary tract infections (uUTI) | CRL | 2021-07-26 00:00:00 | CRL announced July 26, 2021. | 0 |
ONCS | Triple negative breast cancer (TNBC) | Phase 2 | 2019-12-12 00:00:00 | Phase 2 interim data at SABCS December 12, 2019 noted ORR 28.5%. | 0 |
ASRT | Adrenocortical insufficiency screening | CRL | 2019-10-21 00:00:00 | CRL announced October 21, 2019. | 0 |
MDWD | Lower leg ulcers | Phase 2 | 2022-04-12 00:00:00 | Phase 2 top-line data presented at the SAWC 2022 showed treatment to debride wounds and promote wound area reduction, while reducing biofilm and bacterial bioburden safely and effectively, noted April 12, 2022. | 1 |
INCY | COVID-19 associated cytokine storm | Phase 3 | 2020-12-14 00:00:00 | Phase 3 top-line did not meet primary endpoint - December 14, 2020. | 1 |
LLY | Psoriatic Arthritis | Approved | 2017-12-01 00:00:00 | Approval announced December 1, 2017. | 1 |
TRDA | Duchenne Muscular Dystrophy (DMD) | Phase 1 | 2023-09-21 00:00:00 | Phase 1 trial initiated, noted September 21, 2023. | 0 |
HEPA | Non-alcoholic steatohepatitis (NASH) | Phase 2 | 2023-05-22 00:00:00 | Phase 2 topline data met primary and secondary endpoints, including improvement in liver function and multiple NASH biomarkers, noted May 22, 2023. | 1 |
BFRI | Actinic keratosis on the extremities, neck and trunk. | Phase 3 | 2023-01-09 00:00:00 | Phase 3 trial dosing initiated, noted January 9, 2023. | 0 |
PRTC | Healthy volunteers, neurological and neuropsychological conditions | Phase 1 | 2023-02-14 00:00:00 | Phase 1 study achieved blood levels of allopregnanolone at or above those associated with therapeutic effect in postpartum depression1 and was generally well-tolerated, noted February 14, 2023. | 1 |
AIMD | Oral warts in HIV-seropositive patients | Phase 3 | 2023-09-18 00:00:00 | Ainos plans to pursue a pre-IND meeting with the FDA in advance of planned Phase 3 clinical studies, noted September 18, 2023. | 1 |
ABBV | First line unfit AML | Approved | 2018-11-21 00:00:00 | FDA approval announced November 21, 2018. | 1 |
NVO | Obesity | Phase 3 | 2020-05-13 00:00:00 | Phase 3 data met primary endpoint - May 13, 2020. | 0 |
NVO | Type 1 diabetes | Phase 3 | 2022-06-03 00:00:00 | Phase 3a trial met its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 26 with insulin icodec compared to insulin degludec, noted June 3, 2022. | 1 |
SGEN | Urothelial cancer | Approved | 2023-04-03 00:00:00 | FDA Approved on April 3, 2023. | 1 |
ABBV | Waldenström’s Macroglobulinemia | Approved | 2018-08-27 00:00:00 | FDA approval announced August 27, 2018. | 1 |
ISEE | Geographic atrophy | Phase 3 | 2023-03-01 00:00:00 | Additional Phase 3 data reported that post-hoc time-to-event analysis signals up to 59% risk reduction in rate of vision loss compared to sham treatment at 12 months, noted March 1, 2023. | 1 |
REGN | Asthma - 6-11 year-olds | Approved | 2021-10-20 00:00:00 | Approved October 20, 2021. | 1 |
APLS | Paroxysmal Nocturnal Hemoglobinuria (PNH) | Approved | 2021-05-14 00:00:00 | FDA approval announced May 14, 2021. | 1 |
RDHL | COVID-19 | Phase 2 | 2020-12-31 00:00:00 | Phase 2 initial data released December 31, 2020. | 0 |
NVCR | Liver cancer | Phase 2 | 2021-07-01 00:00:00 | Phase 2 final data reported July 1, 2021. Objective response rate for the intent-to-treat population was 9.5%. | 1 |
SNY | Atopic dermatitis 12-17 year-olds | Approved | 2019-03-11 00:00:00 | FDA approval announced March 11, 2019. | 1 |
BPMC | Gastrointestinal stromal tumors (GIST) | Phase 3 | 2020-04-28 00:00:00 | Phase 3 data did not meet primary endpoint - April 28, 2020. | 1 |
LVTX | Castration-resistant prostate cancer (mCRPC) | Phase 1/2 | 2023-06-14 00:00:00 | Phase 1/2 trial will continue as lead program, noted June 14, 2023. | 0 |
MEIP | Solid tumors | Phase 1 | 2018-06-04 00:00:00 | Phase 1 data presented at ASCO June 2018. Noted primary endpoint P=0.06. | 1 |
KRON | Solid tumors | Phase 1/2 | 2023-11-02 00:00:00 | Phase 2 initial data presented at Connective Tissue Oncology Society reported that treatment demonstrated on-mechanism, single agent anti-tumor activity and a manageable safety profile in heavily pre-treated patients with transcriptionally addicted solid tumors, noted November 2, 2023. | 1 |
OCUL | Ocular inflammation and pain following cataract surgery | Approved | 2018-12-03 00:00:00 | FDA approval announced December 3, 2018. | 1 |
BIVI | Alzheimer's disease | Phase 2 | 2022-12-05 00:00:00 | Phase 2 final data reported that improvements in QDRS scores were statistically significantly correlated with improvements on the ADCOMS assessment, noted December 2, 2022. | 1 |
VALN | Chikungunya vaccine | Phase 3 | 2022-12-05 00:00:00 | Phase 3 trial met primary endpoint, noted December 5, 2022. | 0 |
EGRX | Nonsquamous Non-Small Cell Lung Cancer (NSCLC) and Mesothelioma | Approved | 2017-10-27 00:00:00 | Tentative approval announced October 27, 2017. Full approval pending patent litigation with Eli Lilly. | 1 |
GSK | HIV | Approved | 2021-12-21 00:00:00 | Approved December 21, 2021. | 1 |
FNCH | C. difficile Infection | Phase 2 | 2022-10-24 00:00:00 | Phase 2 biomarker data presented at ACG 2022 showed that administration of treatment after standard-of-care (SOC) CDI antibiotics, there was a significant increase in microbiome diversity from baseline through week 8 and week 24, noted October 24, 2022. | 1 |
LMNL | Congenital plasminogen deficiency (C-PLGD) | Approved | 2021-06-04 00:00:00 | FDA approval announced June 4, 2021. | 1 |
UBX | Diabetic macular edema | Phase 1 | 2022-05-04 00:00:00 | Phase 1 24-week data presented at ARVO reported that treatment was well-tolerated with visual acuity was improved in 7/10 patients at 4 weeks and in 5 at Week 12, noted May 4, 2022 | 1 |
BGNE | Gastric / Gastroesophageal Junction Cancer | Phase 2 | 2023-06-05 00:00:00 | Phase 2 data shared at ASCO reported that the median overall survival (OS) was 19.5 months and median progression-free survival (PFS) was 11.3 months, noted June 5, 2023. | 0 |
LLY | Cancer pain | Phase 3 | 2021-07-28 00:00:00 | Phase 3 trial met primary endpoint - July 2021. | 0 |
VNDA | Motion sickness | Phase 3 | 2023-05-25 00:00:00 | Phase 3 data reported that the 170 mg and 85 mg tradipitant doses were shown to be superior to placebo in preventing vomiting with only 18.3% and 19.5% of participants experiencing vomiting on tradipitant 170 mg and 85 mg respectively, as compared to 44.3% of participants on placebo, noted May 25, 2023. | 1 |
VTGN | Social Anxiety Disorder (SAD) | Phase 3 | 2023-08-07 00:00:00 | Phase 3 topline data met its primary endpoint, noted August 7, 2023. | 0 |
BHC | Psoriasis | Approved | 2018-10-08 00:00:00 | Tentative FDA Approval announced October 8, 2018. Final approval expected November 2018 pending the expiration of exclusivity for a related product. | 1 |
MRK | Metastatic malignant pleural mesothelioma | Phase 2/3 | 2023-06-02 00:00:00 | Phase 2/3 data reported that mOS was 17.3m vs 16.1m for CP-pembro vs CP and mPFS was 7.13m vs 7.16m, noted June 2, 2023. | 0 |
IVA | Non-alcoholic steatohepatitis (NASH) | Phase 2b | 2023-06-24 00:00:00 | Phase 2b additional data presented on EASL showed that lanifibranor significantly increases the levels of adiponectin and that this increase is correlated with the improvements of cardiometabolic markers, including insulin resistance, glycemic control, lipid metabolism, and systemic inflammation, noted June 24, 2023. | 1 |
BHC | Open angle glaucoma (OAG) or ocular hypertension (OHT) | Approved | 2017-11-02 00:00:00 | Approval announced November 2, 2017. | 1 |
LGND | Pneumococcal conjugate vaccine | Phase 3 | 2023-07-27 00:00:00 | Phase 3 trial met primary endpoint, noted July 27, 2023. | 0 |
KNSA | Pericarditis | Approved | 2021-03-18 00:00:00 | FDA approval announced March 18, 2021. | 1 |
GMAB | Newly Diagnosed Multiple Myeloma (NDMM) | Approved | 2019-06-28 00:00:00 | FDA Approval announced June 28, 2019. | 1 |
LLY | Obesity | Phase 3 | 2023-06-24 00:00:00 | Phase 3 efficacy and safety data shared at ADA met both co-primary endpoints and all key secondary endpoints compared to placebo for both estimands, with those taking tirzepatide achieving a mean weight reduction of 13.4% on 10 mg and 15.7% on 15 mg compared to 3.3% on placebo for the efficacy estimand, noted June 24, 2023. | 1 |
SNY | Hidradenitis suppurativa / atopic dermatitis | Phase 1 | 2022-12-14 00:00:00 | Phase 1 data reported that a 37% mean reduction in EASI in AD and 42% of HS patients has AN Count 0/1/2, noted December 14, 2022. | 1 |
RHHBY | Hemophilia A | Phase 1/2 | 2022-12-12 00:00:00 | Phase 1/2 results reported a 92% reduction in ABR for all bleeds, with all-bleed ABR of 0.98 post-infusion compared to 11.62, noted December 12, 2022. | 1 |
ALLO | Clear cell renal cell carcinoma (ccRCC) | Phase 1 | 2023-04-17 00:00:00 | Phase 1 presentation at AACR reported early anti-tumor activity with deepening responses over time, noted April 17, 2023. | 1 |
XNCR | Systemic Lupus Erythematosus (SLE) | Phase 2 | 2018-10-08 00:00:00 | Phase 2 top-line data released October 5, 2018. Primary endpoint not met. | 0 |
ROIV | Plaque psoriasis | Approved | 2022-05-24 00:00:00 | Approved May 24, 2022. | 1 |
KYMR | Diffuse large B-cell lymphoma (DLBCL) | Phase 1 | 2023-06-14 00:00:00 | Phase 1 patient dose escalation data cohorts show target knockdown at or near levels associated with clinical efficacy in preclinical tumor models, with no dose limiting toxicities (DLTs) observed, noted June 14, 2023. | 1 |
PTGX | Beta-thalassemia | Phase 2 | 2021-10-11 00:00:00 | Phase 2 clinical hold lifted October 11, 2021. | 0 |
ENSC | Severe Pain Relief | Phase 3 | 2023-09-26 00:00:00 | Phase 3 data presented at the PAINWeek on September 7, 2023. Phase 3 completion of site initiation visit, noted September 26, 2023. | 1 |
BLU | Refractory Chronic Cough | Phase 2b | 2023-02-26 00:00:00 | Phase 2b data shared at AAAAI reported that similar burdens are also reported across all three LCQ subdomains in the main vs exploratory populations, noted February 26, 2023. | 0 |
LUMO | Pediatric Growth Hormone Deficiency (PGHD) | Phase 2 | 2023-09-26 00:00:00 | Phase 2 interim data analysis reported that LUM-201 restored GH secretion to similar levels seen in normally growing children, noted September 26, 2023. | 0 |
MOLN | COVID-19 | Phase 2a | 2021-12-06 00:00:00 | Phase 2a data reported an infectivity of virus extracted through nasopharyngeal swabs was reduced to zero within 3-5 days post treatment in patients with positive titers at baseline, noted December 6, 2021. | 1 |
CLVS | Ovarian Cancer - First-line maintenance treatment | Phase 3 | 2022-06-06 00:00:00 | Additional Phase 3 data reported that median PFS for the HRD-positive patient population treated with rucaparib was 28.7 months, noted June 6, 2022. | 1 |
TBPH | Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) | Approved | 2013-06-21 00:00:00 | Approved June 21, 2013. | 1 |
ALZN | Dementia related to Alzheimer's | Phase 2a | 2023-06-22 00:00:00 | Phase 2a topline results identified a safe & appropriate dose to explore the potential to distribute more lithium to the brain but at lower systemic exposure, resulting in an improved safety profile compared to currently marketed lithium, noted June 22, 2023 | 1 |
EOLS | Glabellar lines | Approved | 2019-02-01 00:00:00 | FDA Approval announced February 1, 2019. | 1 |
MRK | Triple negative breast cancer (TNBC) | Phase 3 | 2021-09-19 00:00:00 | Phase 3 overall survival data showed risk of death reduced by 27%, and an increase of 6.9 months in median OS with KEYTRUDA plus chemotherapy. OS with treatment was 23 months, versus 16.1 months with chemotherapy, September 19, 2021. | 1 |
BPMC | CCNE-aberrant cancers | Phase 1/2 | 2023-06-05 00:00:00 | Phase 1/2 data presented at ASCO reported a confirmed partial response, noted June 5, 2023. | 1 |
PASG | GM1 gangliosidosis (GM1) | Phase 1/2 | 2023-08-07 00:00:00 | Phase 1/2 initial safety data from cohorts 1-4 up to 28 months showed Dose 1 and 2 of PBGM01 were well tolerated and had a favorable safety and immunological profile, noted August 7, 2023. | 1 |
DARE | Bacterial Vaginosis | Approved | 2021-12-07 00:00:00 | FDA Approval on December 7, 2021. | 1 |
CNTA | Kidney Disease | Phase 3 | 2021-12-14 00:00:00 | Phase 3 data reported that ALT elevation peaked between 1.8x and 3.5x ULN and did not return to below ULN until 23 to 140 days after tolvaptan use was discontinued. Four patients were successfully titrated to a maintenance dose of lixivaptan of either 100 mg BID or 200 mg BID, noted December 14, 2021. | -1 |
HALO | Rheumatoid arthritis (RA) | Approved | 2013-10-14 00:00:00 | Approved Oct 14, 2013. | 1 |
SMMT | Duchenne muscular dystrophy | Phase 2 | 2018-06-27 00:00:00 | Phase 2 top-line data released June 27, 2018. Primary endpoint not met. | 0 |
LMNL | Idiopathic pulmonary fibrosis (IPF) | Phase 2 | 2021-05-28 00:00:00 | Phase 2 trial will no longer be initiated - May 28, 2021. | 0 |
CMPI | Lymphoma | Phase 1/2 | 2022-05-26 00:00:00 | Phase 1/2 data released in an abstract at ASCO reported no significant adverse effects (AEs) and clinical activity in 5 of 7 patients, noted May 26, 2022. | 0 |