ticker
stringlengths 2
5
| disease
stringlengths 3
196
| stage
stringclasses 15
values | date
stringlengths 19
19
| catalyst
stringlengths 18
760
| label
int64 -1
1
|
|---|---|---|---|---|---|
PMCB
|
Pancreatic cancer
|
Phase 2b
|
2020-10-30 00:00:00
|
Phase 2b IND placed on clinical hold - October 1, 2020.
| 0 |
GMAB
|
Cervical Cancer
|
Phase 3
|
2023-10-23 00:00:00
|
Additional data presented at ESMO that the overall survival (OS) was statistically significantly prolonged with TIVDAK, demonstrating a 30% reduction in the risk of death compared with chemotherapy, noted October 22, 2023.
| 1 |
NVS
|
Reduction of thrombotic cardiovascular events including stent thrombosis in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI)
|
CRL
|
2014-04-30 00:00:00
|
CRL April 30 2014.
| 0 |
BMY
|
Non-small cell lung cancer (NSCLC)
|
Phase 3
|
2023-10-23 00:00:00
|
Phase 3 data presented at ESMO reported that 3-y EFS and OS rates were 72% vs 47% and 85% vs 66%, respectively, noted October 23, 2023.
| 1 |
SVRA
|
Autoimmune pulmonary alveolar proteinosis (PAP)
|
Phase 3
|
2022-09-06 00:00:00
|
Additional Phase 3 data reported that patients treated with molgramostim after undergoing WLL had greater improvements in endpoint measures of gas exchange, noted September 6, 2022.
| 1 |
NVAX
|
Respiratory Syncytial Virus (RSV) in healthy pregnant women - protect infants via maternal immunization
|
Phase 3
|
2019-02-28 00:00:00
|
Phase 3 top-line data released March 28, 2019 - primary endpoint not met.
| 0 |
ALVR
|
AdV viremia (following allo-HSCT)
|
Phase 2
|
2023-04-26 00:00:00
|
Phase 2 study follow-up long-term data demonstrate dthat the high-risk allo-HCT patients who received posoleucel experienced continued low rates of clinically significant infections and end-organ disease and 0% non-relapse mortality, noted April 26, 2023.
| 1 |
PLRX
|
Idiopathic Pulmonary Fibrosis (IPF)
|
Phase 2a
|
2023-05-24 00:00:00
|
Phase 2a additional f\data presented at ATS 2023 showed that bexotegrast was well tolerated across all four dose groups with bexotegrast-treated participants experiencing a reduction in forced vital capacity (FVC) decline over 12 weeks versus placebo, on and off background therapy., noted May 24, 2023.
| 1 |
AIM
|
CFS
|
CRL
|
2013-02-04 00:00:00
|
CRL February 4, 2013.
| 0 |
BLU
|
Chronic pruritus associated with atopic dermatitis
|
Phase 2b
|
2021-12-13 00:00:00
|
Phase 2b top-line data reported that trial did not meet the primary endpoint. Development will not continue, noted December 13, 2021.
| 1 |
PFE
|
Oral Protease Inhibitor for COVID-19
|
Approved
|
2023-05-25 00:00:00
|
FDA approved on May 25, 2023.
| 1 |
CYTK
|
Amyotrophic lateral sclerosis (ALS)
|
Phase 2
|
2022-12-08 00:00:00
|
hase 2 data presented at Virtual 33rd International Symposium on ALS/MND demonstrated predicted survival risk score strongly correlated with decline in ALSFRS-R.
| 1 |
CALT
|
IgA nephropathy
|
Approved
|
2021-12-15 00:00:00
|
Approved December 15, 2021.
| 1 |
PFE
|
Acute myeloid leukemia (AML)
|
Approved
|
2017-09-01 00:00:00
|
Approval announced September 1, 2017.
| 1 |
BMY
|
Venous thromboembolism (VTE) prevention post total knee replacement (TKR) surgery
|
Phase 2
|
2021-11-15 00:00:00
|
Phase 2 trial met both primary endpoints; the dose response for efficacy was significant, and the 12% rate of VTE was significantly lower than the prespecified benchmark rate of 30%, noted November 15, 2021.
| 0 |
HGEN
|
COVID-19
|
Phase 2/3
|
2022-07-13 00:00:00
|
Phase 2/3 top-line data showed that trial did not achieve statistical significance on the primary endpoint. The data also showed a non-significant trend toward a reduction in mortality in the overall patient population, noted July 13, 2022.
| 1 |
MGNX
|
Anal cancer
|
Phase 2
|
2020-09-18 00:00:00
|
Phase 2 data noted objective response rate of 14% and disease control rate of 49%.
| 0 |
LLY
|
Obesity
|
Phase 2
|
2023-06-26 00:00:00
|
Phase 2 24-week data met the primary endpoint for the efficacy estimand in participants living with obesity or overweight without diabetes, demonstrating a mean weight reduction up to 17.5%. In a secondary endpoint, retatrutide showed a mean weight reduction up to 24.2% at 48 weeks, noted June 26, 2023.
| 1 |
AVDL
|
Neonate Patients Requiring Total Parental Nutrition (TPN)
|
Approved
|
2019-12-16 00:00:00
|
FDA Approval announced December 16, 2019.
| 1 |
FRLN
|
Fabry disease
|
Phase 1/2
|
2022-02-08 00:00:00
|
Phase 1/2 data to be presented at the Annual WORLDSymposium reported that treatment has been well tolerated with myocarditis observed in both patients, noted February 8, 2022.
| 1 |
BMY
|
Metastatic non-small cell lung cancer (NSCLC)
|
Phase 3
|
2023-06-05 00:00:00
|
Phase 3 data reported that the dual immunotherapy-based combination continued to enhance overall survival (OS), the trial's primary endpoint, with 21% of patients treated with Opdivo plus Yervoy with two cycles of chemotherapy alive compared to 16% of patients treated with chemotherapy alone at four years , noted June 5, 2023.
| 1 |
ATNM
|
Relapsed or refractory acute myeloid leukemia (AML)
|
Phase 1
|
2022-12-12 00:00:00
|
Phase 1 data reported a 59% 1-year overall survival and 32% 2-year overall survival in patients with prior Venetoclax treatment, noted December 12, 2022.
| 1 |
ATOS
|
Mammographic breast density (MBD)
|
Phase 2
|
2019-06-27 00:00:00
|
Phase 2 data met primary endpoint - June 27, 2019. High dropout rate noted.
| 0 |
MACK
|
Pancreatic cancer
|
Phase 3
|
2022-11-09 00:00:00
|
Phase 3 data met its primary endpoint demonstrating clinically meaningful and statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine in 770 previously untreated. Key secondary efficacy outcomes of progression-free survival (PFS) also showed significant improvement over the comparator arm, noted November 9, 2022.
| 1 |
UTHR
|
Small cell lung cancer
|
Phase 2/3
|
2020-02-03 00:00:00
|
Phase 2/3 trial did not meet primary endpoint - February 3, 2020.
| 1 |
EBS
|
Anthrax
|
PDUFA
|
2015-03-25 00:00:00
|
Approved March 25, 2015.
| 1 |
LIAN
|
Demodex Blepharitis
|
Approved
|
2023-07-25 00:00:00
|
FDA approved on July 25, 2023.
| 1 |
CALT
|
IgA Nephropathy
|
Phase 3
|
2023-06-21 00:00:00
|
Phase 3 data presented at ERA continue to show that study study met its primary endpoint with Nefecon demonstrating a highly statistically significant benefit over placebo. Additionally the company submitted its sNDA based on this results to the FDA, noted June 21, 2023.
| 1 |
NVO
|
Obesity
|
Phase 3
|
2023-08-08 00:00:00
|
Phase 3 trial met its primary endpoint, with statistically significant and superior reduction in MACE of 20% for people treated with semaglutide 2.4 mg compared to placebo, noted August 8, 2023.
| 1 |
GRTS
|
COVID-19 vaccine
|
Phase 1
|
2023-10-11 00:00:00
|
Data presented at IDweek reported that treatment was well tolerated in both HIV-negative participants and PLWH irrespective of SARS-CoV-2 serostatus at baseline, October 11, 2023.
| 1 |
LNTH
|
Pheochromocytoma
|
Approved
|
2018-07-30 00:00:00
|
FDA approval announced July 30, 2018.
| 1 |
AGTC
|
X-linked Retinitis Pigmentosa (XLRP)
|
Phase 1/2
|
2022-05-04 00:00:00
|
Phase 1/2 18-month data appear to show safety and efficacy signals similar to the study's 12-month findings, including improvements to the ellipsoid zone (EZ). In patients with XLRP, the EZ, a defined region within the photoreceptor layer of the retina, degenerates over time and is eventually lost.
| 1 |
FDMT
|
Cystic fibrosis
|
Phase 2
|
2023-11-01 00:00:00
|
Phase 2 Dose Expansion interim data presented at the North American Cystic Fibrosis Conference showed that it was generally well tolerated with no inflammation in any lung biopsy across Cohorts 1 and 2 (1E15 & 2E15 vg; n=7) with up to 17 months follow-up November 1, 2023.
| 1 |
SRNE
|
Acute lower back pain (LBP)
|
Phase 2
|
2023-09-14 00:00:00
|
Phase 2 data reported that none of the subjects in the active group and 3 (8.1%) subjects in placebo group had AEs of special interest, with a meaningful reduction of pain over the first week, noted September 14, 2023.
| 1 |
JNJ
|
Frontline multiple myeloma (non-transplant)
|
Approved
|
2018-05-07 00:00:00
|
Approval announced May 7, 2018.
| 1 |
ALDX
|
Dry eye disease
|
Phase 3
|
2022-06-08 00:00:00
|
Phase 3 topline results reported that trial met both primary endpoints, noted June 8, 2022.
| 0 |
AZN
|
Asthma
|
Phase 3
|
2022-05-16 00:00:00
|
Phase 3 results reported that treatment reduced the risk of a severe exacerbation by 27%, noted May 16, 2022.
| 1 |
SCPH
|
Heart failure
|
CRL
|
2020-12-07 00:00:00
|
CRL announced December 7, 2020.
| 0 |
RYTM
|
Alstrom Syndrome
|
CRL
|
2022-06-16 00:00:00
|
CRL issued for sNDA application for Alstrom Syndrome issued June 16, 2022.
| 0 |
GRCL
|
B-cell acute lymphoblastic leukemia (B-ALL)
|
Phase 1
|
2023-06-10 00:00:00
|
Phase 1 study of the donor-derived allogeneic presented at EHA showed 100% ORR and a favorable safety profile for treatment of r/r B-ALL, noted June 10, 2023.
| 1 |
INCY
|
Myelofibrosis
|
CRL
|
2023-03-23 00:00:00
|
CRL issued by the FDA on March 23, 2023.
| 0 |
ALKS
|
Solid tumors
|
Phase 1/2
|
2022-06-01 00:00:00
|
Phase 1/2 monotherapy data reported that six patients achieved a partial response (PR), of which three were confirmed, with stable disease (SD) observed in 31 patients. Combination data reported two patients achieved a CR, four patients achieved a PR and SD was observed in 14 patients, noted June 1, 2022.
| 1 |
VYGR
|
Parkinson's Disease
|
Phase 2
|
2020-12-22 00:00:00
|
Phase 2 trial placed on clinical hold - December 22, 2020.
| 0 |
ENTA
|
Non-alcoholic steatohepatitis (NASH)
|
Phase 2b
|
2021-10-04 00:00:00
|
Phase 2b interim analysis showed 1.0 mg as the optimal dose. The monontherapy has been discontinued and priority is placed on the combinations, noted October 4, 2021.
| 1 |
INCY
|
Chronic Graft versus host disease (cGvHD)
|
Phase 2
|
2023-07-24 00:00:00
|
Phase 2 trial results met its primary endpoint across all cohorts with an overall response rate (ORR) of 74% at a dose of 0.3 mg/kg administered every two weeks, noted July 24, 2023.
| 0 |
AUPH
|
Lupus Nephritis
|
Phase 3
|
2023-11-03 00:00:00
|
Phase 3 data from ASN reported that treated patients in the overall AURORA 2 cohort maintained stable renal function over the last two years of the study, as measured by eGFR analysis and experienced numerically greater mean reductions in urine protein creatinine ratio (UPCR), compared to patients in the control arm, noted November 3, 2023.
| 1 |
BMY
|
Psoriatic Arthritis (PsA)
|
Approved
|
2017-07-06 00:00:00
|
Approval announced July 6, 2017.
| 1 |
AZN
|
HPV-associated squamous cell carcinoma of the head & neck (SCCHN)
|
Phase 1
|
2017-11-10 00:00:00
|
Presentation at SITC Meeting - November 10, 2017.
| 1 |
EQRX
|
1L metastatic non-small cell lung cancer (NSCLC)
|
Phase 3
|
2022-05-26 00:00:00
|
Phase 3 data reported that the median OS was 25.4 months versus 16.9 months in placebo, noted May 26, 2022.
| 0 |
BMY
|
Relapsed/refractory multiple myeloma
|
Approved
|
2021-03-26 00:00:00
|
FDA approval announced March 26, 2021.
| 1 |
CLRB
|
Various lymphoma
|
Phase 2
|
2023-06-28 00:00:00
|
Phase 2 data from MM cohort reported an overall response rate (ORR) of 32%, a clinical benefit rate (CBR) of 75% and a disease control rate (DCR) of 85.7%, noted June 28, 2023.
| 0 |
IBRX
|
Acute myeloid leukemia (AML)
|
Phase 1
|
2023-07-10 00:00:00
|
Phase 1 results presented at the AHNS indicated the potential for a new treatment approach for the disease in advanced cases that currently have extremely poor prognoses, noted July 10, 2023.
| 1 |
JNJ
|
Prostate Cancer
|
Phase 3
|
2021-09-16 00:00:00
|
Phase 3 data showed OS was improved by abiraterone both in the overall population (HR: 0.83; medians: 5.7 vs 4.7 yrs) and in the ADT+ docetaxel population (HR: 0.75; medians: NR vs 4.4 yrs), noted September 16, 2021.
| 1 |
NVCR
|
Gastric cancer
|
Phase 2
|
2022-06-03 00:00:00
|
Phase 2 data reported a confirmed objective response rate of 50%, with a 10.3 month duration of response and 72% one-year survival rate, noted June 3, 2022.
| 0 |
ADGI
|
COVID-19 (prevention)
|
Phase 2/3
|
2023-03-23 00:00:00
|
Phase 2/3 study suggests clinically meaningful protection can be achieved at low neutralizing antibody titers, noted March 23, 2023.
| 1 |
HALO
|
Subcutaneous treatment for patients with primary immunodeficiency (PI)
|
Approved
|
2014-09-12 00:00:00
|
Approved September 12, 2014.
| 1 |
ACST
|
Ataxia-Telangiectasia (A-T)
|
Phase 3
|
2022-12-28 00:00:00
|
Phase 3 pharmacokinetic(PK) study met all outcome measures, noted December 28, 2022.
| 0 |
CLDX
|
Recurrent/metastatic head and neck squamous cell cancer
|
Phase 1/2
|
2019-06-01 00:00:00
|
Phase 2 data ASCO June 1, 2019 noted 2/19 CRs + one PR.
| 0 |
LUMO
|
Ebola
|
Approved
|
2023-08-03 00:00:00
|
Approval in children aged 12 months and older on August 3, 2023.
| 1 |
ABBV
|
Migraine
|
Approved
|
2019-12-23 00:00:00
|
FDA Approval announced December 23, 2019.
| 1 |
BGNE
|
Hepatocellular carcinoma (HCC)
|
Phase 3
|
2023-06-05 00:00:00
|
Phase 3 additional data presented at ASCO reported that treatment demonstrated numerically longer median overall survival (OS) versus sorafenib in the biomarker subgroups of ALBI grade 1 (19.9 months vs. 16.9 months), PLR ≤141 (19.4 months vs. 14.5 months), and NLR ≤3 (20.9 months vs. 15.2 months, noted June 5, 2023.
| 1 |
LGND
|
Refractory status epilepticus (RSE)
|
Phase 2
|
2019-09-26 00:00:00
|
Phase 2 data met primary endpoint - September 26, 2019.
| 0 |
ABIO
|
COVID-19
|
Phase 2b
|
2022-03-31 00:00:00
|
Phase 2b top-line data reported that neither doses met the primary endpoint, noted March 31, 2022.
| 0 |
VNDA
|
Gastroparesis
|
Phase 3
|
2022-02-04 00:00:00
|
Phase 3 data reported that the trial did not meet its primary endpoint, noted February 4, 2022.
| 1 |
OPK
|
Mild-to-moderate COVID-19
|
Phase 2
|
2021-12-23 00:00:00
|
Phase 2 top-line data reported that mean serum 25D levels increased with treatment and remained elevated for the duration of the trial, with 88% of subjects attaining the targeted level. Three symptoms related to respiratory function resolved more quickly when serum 25D was elevated at Days 7 and 14, with resolution of chest congestion occurring 3.4 days sooner, noted December 23, 2021.
| 1 |
AMYT
|
Epidermolysis Bullosa
|
Phase 3
|
2022-03-28 00:00:00
|
Phase 3 trial demonstrated that body surface area percentage of partial thickness wounds reduced from 12.1% to 5.4% after at least 15 months of treatment with no new safety signals observed, noted March 28, 2022.
| 1 |
HLVX
|
GI.1/GII.4 virus-like particle (VLP) vaccine
|
Phase 2
|
2022-07-20 00:00:00
|
Phase 2 data reported that Pan-Ig and HBGA blocking antibody responses persisted to year 5 and no adverse events reported were determined to be related to treatment, noted July 20, 2022.
| 1 |
BOLT
|
HER2-Expressing Solid Tumors, gastric cancer, including gastroesophageal junction cancer
|
Phase 2
|
2023-10-23 00:00:00
|
Phase 2 updated safety data presented at ESMO supports the selection of 20 mg/kg q2w as the recommended Phase 2 dose (RP2D), noted October 23, 2023.
| 1 |
XNCR
|
COVID-19 antibody
|
Approved
|
2021-05-26 00:00:00
|
FDA Emergency Use Authorization filing approval announced May 26, 2021.
| 1 |
EPZM
|
Epithelioid Sarcoma
|
Approved
|
2020-01-23 00:00:00
|
FDA approval announced January 23, 2020.
| 1 |
AMRX
|
Acute symptomatic hypocalcemia in pediatric and adult patients
|
Approved
|
2023-09-06 00:00:00
|
FDA ANDA Approved based on FDA's Competitive Generic Therapy (CGT) designation with 180-day exclusivity on September 6, 2023.
| 1 |
SNY
|
Atopic dermatitis
|
Phase 2a
|
2021-09-30 00:00:00
|
Phase 2a data noted 80% improvement in average EASI, and patients treated with amlitelimab-HD showed 70% improvement in average EASI, compared to 49% for the placebo group. The overall rate of TEAEs was 35% for amlitelimab-LD, 17% for amlitelimab-HD and 31% for placebo. One serious adverse event was reported in the amlitelimab-LD group related by the investigator; the event was resolved, and the patient was able to complete the study. No hypersensitivity reactions were reported, noted September 30, 2021.
| 1 |
ALPMY
|
Claudin-18 isoform 2-positive (CLDN18.2+), HER2−, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma
|
Phase 3
|
2023-10-21 00:00:00
|
Phase 3 data presented at ESMO reported that median PFS was 11.0 vs 8.9 mo and median OS was 18.2 vs 15.6 mo, noted October 21, 2023.
| 1 |
ZLDPF
|
Severe hypoglycemia in diabetes
|
Approved
|
2021-03-22 00:00:00
|
FDA approval announced March 22, 2021.
| 1 |
DMAC
|
Chronic Kidney Disease
|
Phase 2
|
2021-11-04 00:00:00
|
Phase 2 data presented November 4, 2021 reported statistically significant reductions (over 30% decrease) in albuminuria and early signals of potential disease modification with the APRIL and IgA1 biomarkers decreasing 35% and 22%, respectively.
| 1 |
PLXP
|
Liquid-filled aspirin capsule
|
Approved
|
2021-03-01 00:00:00
|
FDA approval announced March 1, 2021.
| 1 |
REGN
|
Retinopathy of Prematurity (ROP)
|
Approved
|
2023-02-08 00:00:00
|
FDA approval on February 8, 2023.
| 1 |
PFE
|
HIV
|
Approved
|
2021-12-21 00:00:00
|
Approved December 21, 2021.
| 1 |
SLS
|
Hematologic malignancies, acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and lymphoma
|
Phase 2a
|
2023-10-30 00:00:00
|
FDA granted fast track designation, noted October 30, 2023.
| 0 |
ENTX
|
Hypoparathyroidism
|
Phase 2b
|
2019-09-22 00:00:00
|
Phase 2b results presented September 22, 2019.
| 1 |
TPST
|
Solid Tumors
|
Phase 1
|
2023-05-25 00:00:00
|
Phase 1 monotherapy and combination data from abstract reported a disease control rate (DCR) by RECIST v1.1 was 44% for patients on monotherapy TPST-1495 and 40.9% for patients on TPST-1495 with pembrolizumab, noted May 25, 2023.
| 0 |
PRAX
|
Healthy volunteers
|
Phase 1
|
2022-12-04 00:00:00
|
Phase 1 data reported that there were no clinically significant safety findings in vital signs, clinical laboratory results, physical exams, ECGs, or C-SSRS. TEAEs were mostly mild or moderate, noted December 4, 2022.
| 0 |
MTEM
|
Solid tumors
|
Phase 1
|
2023-06-03 00:00:00
|
Phase 1 interim efficacy and safety data from ASCO reported that all cohorts had reductions in peripheral PD-L1+ MDSCs, monocytes and dendritic cells after MT-6402 without effect on PD-L1- cells with the most depletion at the highest doses, noted June 3, 2023.
| 1 |
NVO
|
haemophilia B
|
Approved
|
2017-05-31 00:00:00
|
Approval announced May 31, 2017.
| 1 |
RARE
|
Osteogenesis Imperfecta
|
Phase 2
|
2023-10-14 00:00:00
|
Additional Phase 2 data reported that the annualized fracture rate across all 24 patients in the Phase 2 portion of the study was reduced by 67%, noted October 14, 2023.
| 1 |
AMRX
|
Neulasta biosimilar
|
Approved
|
2022-05-27 00:00:00
|
Approved May 27, 2022.
| 1 |
EFTR
|
COVID-19
|
Phase 1b
|
2023-02-21 00:00:00
|
Phase 1b data reported that only Grade 1 or 2 events were reported, noted February 21, 2023.
| 0 |
KTRA
|
Glioblastoma (GBM)
|
Phase 2/3
|
2023-10-31 00:00:00
|
Phase 2/3 data reported that it did not perform better than the current standards of care in glioblastoma, noted October 31, 2023.
| 0 |
NBRV
|
Complicated urinary tract infections (cUTI)
|
CRL
|
2020-06-19 00:00:00
|
CRL issued April 30, 2019. Further CRL received June 19, 2020.
| 0 |
VRNA
|
COPD
|
Phase 2
|
2019-01-14 00:00:00
|
Phase 2 trial did not meet primary endpoint - January 13, 2019.
| 1 |
AMGN
|
Cardiovascular disease / Elevated Lipoprotein
|
Phase 2
|
2023-08-28 00:00:00
|
Phase 2 data reported at ESC noted that results from the off-treatment extension period show that patients previously dosed with ≥75 mg of olpasiran sustained a ~40-50% placebo-adjusted percent reduction in Lp(a) nearly a year after the last dose, noted August 28, 2023.
| 1 |
HRMY
|
Osteoarthritis
|
Phase 2
|
2017-08-14 00:00:00
|
Phase 2 data released August 14, 2017 - primary endpoint not met. However, company still intends to initiate Phase 3 trial pending discussions with FDA.
| 0 |
ENTA
|
Respiratory Syncytial Virus (community-acquired)
|
Phase 2b
|
2023-10-12 00:00:00
|
Phase 2b data shared at IDWeek 2023 reported that EDP-938 has a high barrier to clinical resistance, a single resistant mutation was detected in 1 of 37 sequenced EDP-938-treated participants October 12, 2023.
| 1 |
ZYME
|
HER2-amplified biliary tract cancers
|
Phase 2
|
2023-06-05 00:00:00
|
Phase 2 pivotal trial recruitment completed, noted April 28, 2022. Phase 2 full data presented at ASCO reported a confirmed objective response rate (cORR) of 41.3%, median duration of response (DOR) of 12.9 months, and median progression-free survival (PFS) of 5.5 months, noted June 5, 2023.
| 1 |
CYDY
|
HIV
|
BLA Filing
|
2020-07-13 00:00:00
|
Refusal to file letter announced July 13, 2020.
| 0 |
LLY
|
Type 2 Diabetes
|
Approved
|
2022-05-13 00:00:00
|
Approved May 13, 2022.
| 1 |
ARDX
|
Constipation-predominant irritable bowel syndrome (IBS-C)
|
Phase 3
|
2017-05-12 00:00:00
|
Phase 3 data released May 12, 2017. Primary endpoint met - however, competitive concerns raised.
| 0 |
EXAI
|
Advanced Solid Tumors
|
Phase 1/2
|
2023-07-10 00:00:00
|
Phase 1/2 first patient enrolled, noted July 10, 2023.
| 0 |
FBIO
|
Cutaneous squamous cell carcinoma (CSCC)
|
BLA Filing
|
2023-01-04 00:00:00
|
Phase 1 pivotal top-line data reported that the trial met the primary endpoint, noted January 25, 2022. Phase 1 interim efficacy results reported an objective response rate of 54.8%, noted June 16, 2022. BLA submitted to FDA, noted January 4, 2022.
| 0 |
BMEA
|
Acute myeloid leukemia (AML) / acute lymphocytic leukemia (ALL) / Diffuse large B-cell lymphoma (DLBCL) / Multiple myeloma (MM)
|
Phase 1
|
2023-07-24 00:00:00
|
Phase 1 clinical update of AML cohort revealed 2 complete responses (CRs) out of 5 relapsed/refractory AML patients carrying menin-dependent mutations treated at Dose Level 4, noted July 24, 2023.
| 1 |
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