ticker
stringlengths
2
5
disease
stringlengths
3
196
stage
stringclasses
15 values
date
stringlengths
19
19
catalyst
stringlengths
18
760
label
int64
-1
1
BCAB
Solid Tumors
Phase 2
2023-01-10 00:00:00
Phase 2 part 1 interim results in PD-1 failure NSCLC continues to show strong antitumor activity in a highly refractory population with additional patients enrolled, noted January 10, 2023.
1
FREQ
Acquired Sensorineural Hearing Loss (SNHL)
Phase 2a
2021-03-23 00:00:00
Phase 2a trial did not show improvement versus placebo - March 23, 2021.
1
GILD
Refractory diffuse large B-cell lymphoma (DLBCL)
Approved
2022-04-01 00:00:00
Approved April 1, 2022.
1
MITO
Mitochondrial disease associated with pathogenic nDNA mutations (nPMD)
Phase 3
2019-12-20 00:00:00
Phase 3 data did not meet primary endpoint - December 20, 2019.
1
JNJ
Urothelial cancer
Approved
2019-04-12 00:00:00
FDA Approval announced April 12, 2019.
1
INVA
Asthma
Approved
2020-09-09 00:00:00
FDA approval announced September 9, 2020.
1
JNJ
Treatment resistant depression
Approved
2019-03-05 00:00:00
FDA approval announced March 5, 2019.
1
VTGN
Major depressive disorder (MDD)
Phase 1
2023-06-21 00:00:00
Phase 1 study results showed that dosing was well-tolerated and demonstrated a favorable safety and tolerability profile across single and multiple dose intranasal administrations, noted June 21, 2023.
1
ALPN
Lupus nephritis, IgA nephropathy
Phase 1/2
2023-11-02 00:00:00
Phase 1b/2a data presented at ASN reported that treatment reduced UPCR by greater than 50% in IgA nephropathy, noted November 2, 2023.
1
AQST
Allergic reactions (anaphylaxis)
Phase 2
2023-02-24 00:00:00
Phase 2 pharmacokinetic and pharmacodynamic data due presented at AAAAI reported rapid absorption following sublingual administration with the fastest observed median Tmax (12 min forAQST-109, 23 min for EpiPen, and 45 min for IM injection), noted February 24, 2023.
1
ALNY
Hereditary transthyretin-mediated (hATTR) amyloidosis
Approved
2022-06-14 00:00:00
Approved June 14, 2022.
1
NVS
Pegfilgrastim biosimilar
Approved
2019-11-05 00:00:00
FDA Approval announced November 5, 2019.
1
SLRN
Hidradenitis Suppurativa (HS)
Phase 2/3
2023-09-11 00:00:00
Phase 2b/3 data to did not meet statistical significance at week 16, noted Septemeber 11, 2023.
1
MGTX
X-linked retinitis pigmentosa (XLRP)
Phase 1/2
2022-10-01 00:00:00
Full Phase 1/2 data presented at AAO reported an improvement in mean retinal sensitivity in the treated eye compared to untreated eyes in the randomized concurrent control arm, noted October 1, 2022.
1
NVS
Gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
Phase 3
2023-09-25 00:00:00
Phase 3 trial met primary endpoint of improvement in progression-free survival (PFS) and key secondary endpoint of objective response rate (ORR), noted September 25, 2023.
1
VERU
COVID-19 / Severe Acute Respiratory Syndrome, SARS-CoV-2, Influenza A and B, Respiratory Syncytial Virus (RSV) and other viruses
Phase 3
2023-09-26 00:00:00
Phase 3 new study authorized by FDA, with an FDA meeting in September 2023 resulted in agreement with FDA on New Phase 3 Clinical Trial for Sabizabulin for Broader Indication, noted September 26, 2023.
1
TNXP
Post-traumatic stress disorder (PTSD)
Phase 3
2020-12-21 00:00:00
Phase 3 primary endpoint was not met - December 21, 2020.
0
IPHA
Solid tumors
Phase 1
2022-12-09 00:00:00
Phase 1 data reported that IPH5201 blocks ATP degradation and blocks CD39-mediated degradation of eATP released after chemotherapy treatment, noted December 8, 2022.
1
BLUE
Relapsed/refractory multiple myeloma
Approved
2021-03-26 00:00:00
FDA approval announced March 26, 2021.
1
ARDX
Serum phosphorus - chronic kidney disease (CKD) on dialysis
Approved
2023-10-17 00:00:00
Approved October 17, 2023.
1
GTHX
Second/third-line treatment of NSCLC
Phase 2
2021-11-03 00:00:00
Phase 2 trial discontinued, noted November 3, 2021.
-1
LCTX
Non-small cell lung cancer (NSCLC)
Phase 1
2023-07-24 00:00:00
Phase 1 data reported that five of eight patients treated (62.5%) had a best response of immune-related stable disease, and three (37.5%) demonstrated immune-related progressive disease, noted July 24, 2023.
1
CRNX
Congenital adrenal hyperplasia and Cushing’s disease
Phase 1
2022-05-25 00:00:00
Data from MAD cohort results showed serum cortisol below normal levels and a marked reduction in 24-hour urine free cortisol excretion in the presence of sustained, disease-like ACTH concentrations, noted May 25, 2022.
1
ALBO
Alagille syndrome (ALGS)
Approved
2023-06-13 00:00:00
FDA Approved on June 13, 2023.
1
XERS
Endogenous Cushing’s syndrome
Phase 3
2022-05-12 00:00:00
Phase 3 presentation of data at AACE reported that mean total and LDL cholesterol levels were significantly increased with placebo versus treatment, noted May 12, 2022.
1
BDTX
Glioblastoma multiforme (GBM) and NSCLC
Phase 1
2023-10-14 00:00:00
Phase 1 clinical data presented at AACR-NCI-EORTC meeting reported that five of the 13 patients with either intrinsic driver, acquired resistance or complex mutations had a confirmed partial response (PR), noted October 14, 2023.
1
RHHBY
Neuromyelitis optica spectrum disorder (NMOSD)
Approved
2020-08-14 00:00:00
FDA approval announced August 14, 2020.
1
VTRS
Dry eye disease
Approved
2022-02-03 00:00:00
Approved February 3, 2022.
1
ABBV
Facial Erythema (Redness) Associated with Rosacea
Approved
2017-01-19 00:00:00
Approved January 19, 2017.
1
PFE
Acute treatment of migraine
Approved
2020-02-27 00:00:00
FDA Approval announced February 27, 2020.
1
SAGE
Major depressive disorder (MDD)
CRL
2023-08-04 00:00:00
CRL issued August 4, 2023.
0
AMGN
Immune Thrombocytopenia (Pediatric)
Approved
2018-12-14 00:00:00
FDA approval announced December 14, 2018.
1
STRO
Relapsed/refractory AML
Phase 1
2022-12-12 00:00:00
Phase 1 data presented at ASH reported that treatment was well-tolerated with 47% of the patients achieved complete remission and 53% of the patients achieved partial response or stable disease, noted December 12, 2022.
1
FULC
COVID-19
Phase 3
2021-03-04 00:00:00
Phase 3 trial to be discontinued - March 4, 2021.
-1
QURE
Hemophilia B
Approved
2022-11-22 00:00:00
Approved November 22, 2022.
1
PFE
Hemophilia A or B
Phase 3
2023-11-02 00:00:00
Phase 3 data from ASH abstract reported that OD group reported 12 (36.4%) adverse events (AEs) during ATP vs 9 (24.3%) in OP whereas the RP group reported 62 (74.7%) AEs in ATP vs 20 (22.0%) in OP, noted November 2, 2023.
0
NBIX
Tardive dyskinesia (TD)
Phase 3
2023-08-29 00:00:00
Phase 3 data reported that the mean AIMS total score at baseline was 14.6 and decreased over 48 weeks, with a mean change from baseline of -10.2 , noted August 29, 2023.
0
NKTR
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
KNSA
Giant cell arteritis (GCA)
Phase 2
2020-10-06 00:00:00
Phase 2 trial met endpoints - October 6, 2020.
0
PRVB
Coxsackievirus B (CVB) vaccine
Phase 1
2021-10-26 00:00:00
Phase 1 interim data met the primary endpoint and secondary efficacy endpoint as it induced high titers of viral-neutralizing antibodies against all CVB serotypes, noted October 26, 2021.
0
ERAS
Advanced solid tumors
Phase 1b
2023-04-18 00:00:00
Phase 1b data presented at AACR showed that dosing was well-tolerated with favorable pharmacokinetics and no apparent drug-drug interactions, noted April 18, 2023.
1
JNJ
Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Approved
2020-04-21 00:00:00
FDA Approval announced April 21, 2020.
1
ARQT
Plaque psoriasis
Phase 3
2022-03-25 00:00:00
Phase 3 pooled data reported that 40% of patients treated with roflumilast cream achieved IGA success and and 48% of patients treated with roflumilast cream achieved IGA status of clear, noted March 25, 2022.
1
HCM
Intrahepatic cholangiocarcinoma (IHCC)
Phase 2
2023-05-25 00:00:00
Phase 2 first in human data reported that the best overall response by investigator assessment was confirmed partial response in seven (31.8%) pts and stable disease in an additional 12 pts, noted May 25, 2023.
0
ALPMY
Nonmetastatic Prostate Cancer (nmCSPC)
Phase 3
2023-05-01 00:00:00
Additional Phase 3 data reported that treatment reduced the risk of metastasis or death by 58% versus placebo plus leuprolide, noted May 1, 202
1
ALXO
Head and neck squamous cell carcinoma (HNSCC)
Phase 2
2021-11-09 00:00:00
Phase 2 clinical data showed that patients with 1L HNSCC who have not received prior treatment for their advanced disease (n=13), the dose demonstrates an initial ORR of 38.5% with a 12-month OS rate of 87.5% and mOS not reached in combination with pembrolizumab + 5FU + platinum. These results compare favorably with benchmark survival data from standard pembrolizumab + chemotherapy, noted November 9, 2021.
1
EGRX
Percutaneous Coronary Intervention (PCI) and Percutaneous Transluminal Coronary Angioplasty (PTCA)
CRL
2016-03-18 00:00:00
CRL March 18 2016. FDA requested further characterization of bivalirudin-related substances in the drug product.
0
AZN
Type 2 diabetes (Pediatric)
Approved
2021-07-23 00:00:00
FDA approval announced July 23, 2021.
1
KNSA
COVID-19
Phase 2
2020-12-22 00:00:00
Phase 2 trial did not meet primary endpoint - December 22, 2020.
1
BMY
Non-Small Cell Lung Cancer (NSCLC)
Phase 3
2022-04-11 00:00:00
Phase 3 results reported that treatment reduced the risk of disease recurrence, progression or death by 37%, noted April 11, 2022.
1
ACIU
Alzheimer’s disease (AD)
Phase 2
2022-12-01 00:00:00
Phase 2 pharmacodynamic effects data presented at CTAD on December 1, 2022.
1
GLPG
Ankylosing spondylitis
Phase 2
2018-09-05 00:00:00
Phase 2 data released September 6, 2018. Primary endpoint met.
0
REGN
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
MRKR
Acute Myeloid Leukemia (AML)
Phase 2
2022-02-16 00:00:00
Phase 2 data reported that one MRD positive patient converted to MRD negative following treatment, with no reported dose limiting toxicities, noted February 16, 2022.
1
OPK
Obesity and diabetes
Phase 2b
2019-03-21 00:00:00
Phase 2b top-line data March 21, 2019 met primary endpoint.
0
MRK
Renal cell carcinoma (RCC)
Approved
2021-11-18 00:00:00
Approved November 18, 2021.
1
PGEN
Ovarian cancer
Phase 1
2023-06-05 00:00:00
Phase 1 data presented at ASCO demonstrated expansion and persistence when delivered via either intraperitoneal or intravenous infusion without lymphodepletion or via intravenous infusion after lymphodepletion demonstrating the effectiveness of mbIL15, noted June 5, 2023.
1
BIIB
CKD Patients at Risk of Rapid Progression
Phase 2
2023-05-10 00:00:00
Program discontinued, noted May 10, 2023.
-1
LLY
Heart failure with reduced ejection fraction
Approved
2021-08-18 00:00:00
FDA approval announced August 18, 2021.
1
PFE
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
ARWR
Alpha-1 Liver Disease
Phase 2
2023-06-24 00:00:00
Phase 2 data presented at EASL showed that at week 48, patients receiving 25, 100, or 200 mg fazirsiran achieved serum Z-AAT reductions of 74%, 89%, and 94%, respectively, versus an increase of 9% observed in patients receiving placebo, noted June 24, 2023.
1
CYDY
COVID-19 (Mild to Moderate)
Phase 2
2020-08-11 00:00:00
Phase 2 data released August 11, 2020 did not report primary endpoint data (TCSS at Day 14). Day 3 subgroup showed clinical improvement but not mentioned to be statistically significant. primary endpoint data for ALL treated patients NOT released. Secondary NEWS2 was met. No data on other secondary endpoints.
1
MGTA
Acute myeloid leukemia and myelodysplasia-excess blasts
Phase 1/2
2023-01-25 00:00:00
Company voluntarily paused trial after a Grade 5 Serious Adverse Event (SAE) (respiratory failure and cardiac arrest resulting in death of patient), noted January 25, 2023.
-1
BIOR
Ulcerative Colitis (UC)
Phase 1a
2023-09-25 00:00:00
IND submitted to FDA, noted September 25, 2023.
0
SAVA
Mild-to-Moderate Alzheimer's Disease
Phase 3
2023-10-25 00:00:00
Phase 3 MRI data suggested that simufilam is not associated with treatment-emergent amyloid-related imaging abnormalities, or ARIA. MRIs were all analyzed for ARIA by board-certified neuroradiologists, noted October 25, 2023.
1
AZN
Paroxysmal nocturnal hemoglobinuria (PNH) and atypical Hemolytic Uremic Syndrome (aHUS)
Phase 3
2020-06-24 00:00:00
Phase 3 trial met primary endpoint - June 24, 2020
0
GSK
Cancer - ovarian
Approved
2017-03-27 00:00:00
PDUFA date under priority review was June 30, 2017. Approved March 27, 2017.
1
CTXR
Hemorrhoids
Phase 2b
2023-06-20 00:00:00
Phase 2b enrollment completed, noted April 3, 2023. Phase 2b data provided meaningful reduction in symptom severity when compared to individual components alone, noted June 20, 2023.
1
KPRX
Later-stage Retinitis Pigmentosa
Phase 2
2023-04-27 00:00:00
Phase 2 interim results presented at ARVO reported patient-reported improvement in the ability to perceive a contrast between light and dark at days seven 14 and 29, noted April 27, 2023.
1
BMY
Philadelphia Chromosome-Positive Chronic Phase Chronic Myeloid Leukemia
Approved
2017-11-10 00:00:00
Approval announced November 10, 2017.
1
NBTX
Pancreatic cancer
Phase 1
2023-09-28 00:00:00
Phase 1 data reported a 92.3% local disease control rate (12/13) and a median Overall Survival of 21 months, noted September 28, 2023.
0
CALT
Alport Syndrome
Phase 2
2023-09-27 00:00:00
Phase 2 to be intiated in 4Q 2023. FDA granted Orphan Drug Designation, noted September 27, 2023.
0
AFMD
EGFR-expressing solid tumors
Phase 1/2
2023-06-03 00:00:00
Phase 1/2 interim data presented at ASCO reported that 7 out of 15 heavily pre-treated patients with tumor reductions, including 2 confirmed partial responses and 5 patients exhibiting stable disease, noted June 3, 2023.
1
SLRX
Hematological cancers and solid tumors
Phase 1
2023-06-12 00:00:00
Phase 1 clinical trial data revealed that in Jeko-1 (lymphoma) cells, SP-3164 induces twice the degradation of target proteins I/A at 1/10th the dose of lenalidomide, providing further support for the development of SP-3164 in relapsed refractory non-Hodgkin lymphoma, noted June 12, 2023.
0
BMY
Chronic Lymphocytic Leukemia (CLL)
Phase 1/2
2023-01-26 00:00:00
Phase 1/2 study met the primary endpoint of complete response rate compared to historical control in the prespecified subset of patients, noted January 26, 2023.
0
TTNP
Opioid dependence
Approved
2016-05-26 00:00:00
CRL issued April 30, 2013. Approved May 26, 2016.
1
PRTA
Psoriatic Arthritis
Phase 1b
2017-09-28 00:00:00
Phase 1b data released September 28, 2017 - insufficient meaningful clinical effect for further development.
-1
FULC
Sickle Cell Disease
Phase 1
2023-02-24 00:00:00
IND placed on hold February 24, 2023.
0
LNTH
Help visualize prostate cancer by targeting prostate specific membrane antigen (PSMA)
Phase 3
2018-09-12 00:00:00
Phase 3 trial met one of two co-primary endpoints.
0
GANX
Parkinson's Disease
Phase 1
2023-10-04 00:00:00
Phase 1 trial dosing commenced, noted October 4, 2023.
0
GILD
Refractory Large B-cell Lymphoma (R-LBCL)
Phase 2
2022-06-06 00:00:00
Phase 2 data presented at ASCO reported a CR rate of 65% and ORR of 88%. With a median follow-up of 17 mo, 65% of the patients had ongoing response, with 57% ongoing in CR, noted June 6, 2022.
1
ACST
Hypertriglyceridemia
Phase 3
2020-08-31 00:00:00
TRILOGY 2 data August 31, 2020 also did not meet primary endpoint.
1
REGN
Homozygous familial hypercholesterolemia (HoFH)
Approved
2021-04-01 00:00:00
FDA approval announced April 1, 2021.
1
TVTX
Pantothenate kinase-associated neurodegeneration (PKAN)
Phase 3
2019-08-22 00:00:00
Phase 3 top-line data did not meet endpoints - August 22, 2019.
1
AXLA
Long COVID-19
Phase 2a
2023-04-17 00:00:00
Phase 2a data reported that fatigue responders showed significantly greater improvement in phosphocreatine recovery time, a marker of mitochondrial function, and a trend towards reductions in plasma FGF-21 and serum lactate at day 28 compared with placebo-treated patients, noted April 17, 2023.
1
SLNO
Prader-Willi syndrome (PWS)
Phase 3
2021-09-08 00:00:00
Phase 3 extension study data showed mean (SE) improvement in hyperphagia by a decrease in the HQ-CT total score, of -9.9 (0.77), was highly significant (p<0.0001) after receiving DCCR for 52 weeks, noted September 8, 2021.
1
URGN
Non-Muscle-Invasive Bladder Cancer
Phase 3
2023-07-27 00:00:00
Phase 3 trial met primary endpoint, noted July 27, 2023.
0
MBIO
X-linked Severe Combined Immunodeficiency (XSCID) - newly diagnosed infants
Phase 1/2
2019-04-17 00:00:00
Phase 1/2 trial ongoing. Initial data noted in NEJM.
0
BCYC
Solid tumors
Phase 1/2
2023-02-14 00:00:00
Phase 1/2 data reported a 50% ORR and 75% benefit rate, including one complete response, noted February 14, 2023.
0
AZN
Amyloidosis
Phase 2
2022-12-12 00:00:00
Phase 2 1-year study results reported that treatment has been generally well tolerated without evidence of organ toxicity. Organ response persisted even after cessation of anti-PCD treatment, noted December 12, 2022.
1
ERYP
Triple-Negative Breast Cancer (TNBC)
Phase 2
2022-09-19 00:00:00
Phase 2 data reported that no clinical benefit was demonstrated, noted September 19, 2022.
1
TNYA
Heart Failure with Preserved Ejection Fraction
Phase 1
2023-10-09 00:00:00
Phase 1 data presented at HFSA demonstrated safety and tolerability in healthy participants with dose-proportional pharmacokinetics and robust target engagement, noted October 9, 2023.
1
BMY
Stage IIB or IIC melanoma
Approved
2023-10-16 00:00:00
Approved October 13, 2023.
1
AYLA
Adenoid cystic carcinoma
Phase 2
2022-06-06 00:00:00
Phase 2 results reported an overall disease control rate of 69%, 14.6% in the 4mg group achieved a partial response, 8.3% in the 6 mg group, noted June 6, 2022.
1
MRK
High-Risk, Early-Stage ER+/HER2- Breast Cancer
Phase 3
2023-10-20 00:00:00
Phase 3 data presented at ESMO reported that treatment significantly improved pCR rate compared to neoadjuvant placebo plus chemotherapy (24.3% vs. 15.6%, respectively), noted October 20, 2023.
1
CHRS
Nasopharyngeal carcinoma (NPC)
Approved
2023-10-27 00:00:00
FDA Approval on October 27, 202
1
ACRS
Common warts (verruca vulgaris)
Phase 2
2019-10-24 00:00:00
Phase 3 data met all endpoints - second Phase 3 trial.
0
NVS
First-line use in patients with ALK+ metastatic NSCLC
Approved
2017-05-26 00:00:00
Priority review granted February 22, 2017. Approval announced May 26, 2017.
1
RHHBY
Diffuse Large B-Cell Lymphoma
BLA Filing
2023-03-10 00:00:00
Advisory committee meeting voted 11 to 2 in favor of approval, noted March 10, 2023.
1
VCEL
Focal chondral cartilage defects in the knee.
Approved
2016-12-13 00:00:00
FDA Approval announced December 13, 2016 ahead of PDUFA date of January 3 2017.
1