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int64
-1
1
BMY
Urothelial Carcinoma
Approved
2021-08-20 00:00:00
FDA approval announced August 20, 2021.
1
HCM
Primary immune thrombocytopenia (ITP)
Phase 3
2023-08-21 00:00:00
Phase 3 trial met is primary endpoint, noted August 21, 2023.
0
MRK
Measles, Mumps, and Rubella Virus Vaccine Live
Approved
2023-03-06 00:00:00
Approved March 6, 2023.
1
AGIO
Advanced hematologic malignancies with an IDH2 mutation
Approved
2017-08-01 00:00:00
Approval announced August 1, 2017.
1
LLY
Alzheimer’s disease
Phase 3
2023-07-17 00:00:00
Phase 3 data presented at AAIC reported a 60% slowing of decline compared to placebo with nearly half of participants at earlier stage of disease on donanemab had no clinical progression at 1 year, noted July 17, 2023.
1
GILD
Adult patients with r/r ALL - cancer
Approved
2021-10-01 00:00:00
Approved October 1, 2021.
1
MRTX
Urothelial Carcinoma (Bladder)
Phase 2
2020-09-18 00:00:00
Phase 2 at ESMO September 2020 noted objective response rate of 37% (1 complete response and 10 partial responses)
0
ABBV
Crohn's disease (induction/maintenance)
Approved
2023-05-18 00:00:00
Approved May 18, 2023.
1
BIIB
Mitochondrial myopathies (MM)
Phase 2
2018-03-01 00:00:00
Phase 2 initial data released March 1, 2018 - endpoints not met.
0
RHHBY
Acute Myeloid Leukemia (AML)
Approved
2020-10-16 00:00:00
FDA approval announced October 16, 2020.
1
IVA
Nonalcoholic fatty liver disease (NAFLD)
Phase 2
2023-06-13 00:00:00
Phase 2 data of 800mg achieved the primary efficacy endpoint demonstrating a 44% reduction of hepatic fat measured by proton magnetic resonance spectroscopy (1H-MRS) following 24 weeks of treatment in patients with nonalcoholic fatty liver disease (NAFLD), noted June 13, 2023.
1
MTEM
Multiple Myeloma
Phase 1
2023-04-07 00:00:00
Partial clinical hold placed April 7, 2023.
0
CYAD
Multiple Myeloma
Phase 1
2022-12-21 00:00:00
Phase 1 additional data reported 5 partial responses, program has been discontinued, noted December 21, 2022.
-1
RHHBY
Paroxysmal nocturnal hemoglobinuria (PNH)
BLA Filing
2023-09-06 00:00:00
BLA accepted by FDA, noted Septemeber 6, 2023
0
GILD
Hepatitis C
Approved
2020-03-19 00:00:00
sNDA FDA Approval announced March 19, 2020.
1
GLSI
Breast cancer
Phase 2b
2022-05-26 00:00:00
Phase 2b abstract reported a DFS rate of 100% versus 89.4%, and just under 23% of subjects experienced an immune response to GP2 by DTH at baseline, noted May 26, 2022.
0
REGN
Chronic obstructive pulmonary disease (COPD)
Phase 3
2023-03-23 00:00:00
Phase 3 demonstrated clinically meaningful and highly significant reduction (30%) in moderate or severe acute exacerbations of COPD over 52 weeks, while also demonstrating significant improvements in lung function, quality of life and COPD respiratory symptoms, noted March 23, 2023. Data expected in 2025.
1
ABBV
Waldenström’s Macroglobulinemia
Approved
2015-01-29 00:00:00
Approved January 29, 2015 - PCYC
1
SUPN
ADHD
Approved
2021-04-02 00:00:00
FDA approval announced April 2, 2021.
1
VYNE
Papulopustular rosacea
Approved
2020-05-29 00:00:00
FDA Approval announced May 29, 2020.
1
BPMC
EGFR exon 20 insertion-positive NSCLC
Phase 1/2
2023-06-05 00:00:00
Phase 1/2 initial clinical data presented at ASCO reported a partial CNS response and a CNS complete response, noted June 5, 2023.
1
BGNE
Gastric or gastroesophageal junction (G/GEJ) adenocarcinoma
Phase 3
2023-10-21 00:00:00
Phase 3 data presented at ESMO reported that OS in the TIS arm was significantly improved compared with the PBO arm in the ITT population (median OS: 15.0 mo vs 12.9 mo, respectively; HR=0.80 [95% CI: 0.70, 0.92]; 1-sided P=0.0011), noted October 21, 2023.
1
CLNN
Amyotrophic Lateral Sclerosis (ALS)
Phase 2/3
2023-09-25 00:00:00
Phase 2/3 post hoc results showed significantly improved survival with a 49% decreased risk of death for the covariate risk-adjusted analyses compared to the largest U.S. clinical database of previous amyotrophic lateral sclerosis (ALS) trials (PRO-ACT), noted September 25, 2023.
1
VTRS
Trastuzumab biosimilar
Approved
2017-12-01 00:00:00
Approval announced December 1, 2017.
1
IDYA
Metastatic uveal melanoma (MUM)
Phase 2
2023-04-23 00:00:00
Phase 2 darovasertib and crizotinib combination data reported a cORR of 45%, DCR of 90% and median PFS of ~7 months in 20 evaluable First-Line MUM patients, noted April 23, 2023.
1
TTNP
Parkinson's disease
Phase 1/2
2018-07-02 00:00:00
DSMB recommended trial to continue - July 2, 2018 but further enrollment has been postponed due to lack of resources.
0
ACRX
Moderate-to-severe acute pain following a surgical procedure
Approved
2018-11-02 00:00:00
FDA Approval announced November 2, 2018.
1
CHRS
Cancer
CRL
2023-09-25 00:00:00
CRL issued September 25, 2023.
0
OKYO
Dry Eye Disease
Phase 2
2023-10-05 00:00:00
Phase 2 data reported a dropout rate at 5.4% and that treatment was well tolerated, noted October 5, 2023.
1
MRK
Ebola
Approved
2023-08-03 00:00:00
Approval in children aged 12 months and older on August 3, 2023.
1
ADAG
Solid tumors
Phase 1/2
2023-04-18 00:00:00
Phase 1/2 trial data presented at AACR demonstrated that combination was well-tolerated up to 10 mg/kg Q3W or Q6W and with repeat dosing beyond 4 cycles, noted April 18, 2023.
1
LLY
Atopic dermatitis
PDUFA
2021-07-16 00:00:00
Noted FDA will not meet assigned July 2021 PDUFA date - July 16, 2021
1
FGEN
Idiopathic pulmonary fibrosis
Phase 3
2023-06-26 00:00:00
Phase 3 study did not meet primary endpoints, noted June 26, 2023.
1
JNJ
COVID-19 vaccine - two-dose regimen
Approved
2021-10-20 00:00:00
EUA for second dose for adults aged 18 and older at least two months following primary vaccination with single-shot Johnson & Johnson COVID-19 vaccine; and for eligible individuals who received a different authorized or approved COVID-19 vaccine, noted October 20, 2021.
1
ARDS
Ventilator associated pneumonia (VAP) / Staphylococcus aureus
Phase 3
2023-06-20 00:00:00
FDA granted Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD), noted June 20, 2023. The official determination regarding using the LPAD pathway will be made after the Company's request following the filing of the biologics license application (BLA).
-1
FUSN
Solid tumors
Phase 1
2023-06-26 00:00:00
Phase 1 multi-dose safety and imaging data presented at SNMMI with Cold/Hot dosing regimen demonstrated potential to improve therapeutic index and safety profile, noted June 26, 2023.
1
NVS
Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis
Approved
2023-03-21 00:00:00
Approved March 21, 2023.
1
IMMP
Non-small cell lung cancer; Head and neck cancer
Phase 2
2023-11-03 00:00:00
Additional biomarker results shared at SITC showed statistically significant increases of Th1 biomarkers (IFN-gamma, CXCL-10), circulating immune cells (lymphocytes), and RNA levels of immune activating genes were observed and linked to improved clinical outcomes, noted November 3, 2023.
1
RARE
GNE Myopathy
Phase 3
2017-08-22 00:00:00
Phase 3 data released August 22, 2017 - endpoints not met.
0
PRTA
Parkinson's disease
Phase 2
2022-03-16 00:00:00
Phase 2 results presented showed that participants with PD who were treated for two years (early-start group) showed slower decline of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3 scores relative to participants treated with for one year (delayed-start group), noted March 16, 2022.
1
MOLN
Acute myeloid leukemia (AML)
Phase 1
2023-11-02 00:00:00
Phase 1 data from ASH abstract reported that one of the two patients evaluable for MP0533 antitumor activity in the third treatment cohort achieved a response, noted November 2, 2023.
1
AERI
Glaucoma
Approved
2019-03-13 00:00:00
FDA Approval announced March 12, 2019.
1
ZYME
3L+ HER2-positive, HR-positive breast cancer
Phase 2
2022-12-09 00:00:00
Phase 2 data reported a confirmed objective response rate (cORR) of 33%, disease control rate (DCR) of 92%, and median progression-free survival (mPFS) of 9.6 months, noted December 9, 2022.
0
MGTX
Xerostomia
Phase 1
2023-10-24 00:00:00
Phase 1 OLE data presented at ESGCT showed that dosing was safe and well-tolerated at all dose levels, with no treatment-related serious adverse events or dose limiting toxicity, noted October 24, 2023.
1
INBX
Chondrosarcoma and mesothelioma
Phase 1
2023-04-26 00:00:00
Clinical hold lifted, noted April 26, 2023. Phase 1 combination cohorts are expected to begin reading out by year end 2023 and data from the registration-enabling trial in unresectable or metastatic conventional chondrosarcoma is expected during the 2H 2024.
0
AGEN
Solid tumors, melanoma
Phase 1
2023-06-03 00:00:00
Phase 1 data at ASCO reported an overall response rate (ORR) was 11% (n=2); 37% had SD (n=7) resulting in a disease control rate (DCR) (CR, PR or SD) of 47%, noted June 3, 2023.
0
FGEN
Anaemia in Chronic Kidney Disease
CRL
2021-08-11 00:00:00
CRL announced August 11, 2021.
0
AVXL
Mild to moderate Alzheimer’s disease
Phase 2/3
2023-09-14 00:00:00
Phase 2b/3 full data reported that the least-squares mean (LSM) change from baseline to 48 weeks between the blarcamesine and placebo groups were −1.783; for ADAS-Cog13, and −0.456 for CDR-SB in patients with early Alzheimer's disease, noted September 14, 2023.
0
PFE
Early stage breast cancer
Phase 3
2020-05-29 00:00:00
Phase 3 trial unlikely to show a statistically significant improvement in the primary endpoint following futility analysis - May 29, 2020.
1
PBYI
Metastatic triple negative breast cancer with a HER2 mutation
Phase 2
2022-10-27 00:00:00
Phase 2 basket trial interim efficacy results showed that the objective response rate (ORR) was 35% overall, 30% in patients pretreated with TKIs, and 50% in patients not pretreated with TKIs. Response or stable disease lasting for ≥ 48 weeks was observed in 7 patients (6 PR, 1 SD), noted October 27, 2022.
1
TCDA
Chronic kidney disease
CRL
2020-08-24 00:00:00
CRL announced August 24, 2020.
0
MRK
Metastatic castration-resistant prostate cancer (mCRPC)
Phase 3
2022-08-03 00:00:00
Phase 3 trial results were not statistically significant, noted August 3, 2022.
0
NVAX
COVID-19, COVID-19 vaccine, Influenza
Phase 2
2023-05-09 00:00:00
Phase 2 data reported that the highest dose stand-alone COVID vaccine candidate achieved statistically significant anti-S IgG and neutralization responses approximately 30% higher than Novavax's prototype COVID vaccine while maintaining comparable safety, noted May 9, 2023
1
MNOV
Idiopathic pulmonary fibrosis (IPF)
Phase 2
2021-08-12 00:00:00
Phase 2 data released August 12, 2021 - no clinically meaningful trends.
0
AMGN
Hematopoietic Syndrome of Acute Radiation Syndrome
Approved
2021-02-02 00:00:00
FDA approval announced in earnings release - February 2, 2021.
1
ATRA
Multiple sclerosis
Phase 2
2022-10-26 00:00:00
Phase 2 OLE data reported that all with stable EDSS remaining in the OLE continued to have a stable EDSS for a median of 41.2 months, noted October 26, 2022.
0
SVRA
MRSA in cystic fibrosis
Phase 3
2020-12-10 00:00:00
Phase 3 trial missed primary endpoint - December 10, 2020. Development to be stopped.
-1
ADMP
Anaphylaxis
Approved
2018-09-27 00:00:00
FDA Approval announced September 27, 2018.
1
NVO
Hemophilia A
Approved
2019-02-19 00:00:00
FDA Approval announced February 19, 2019.
1
TBPH
Acute Lung Injury (ALI) caused by COVID-19
Phase 2
2021-06-21 00:00:00
Phase 2 trial did not meet primary endpoint - June 21, 2021.
1
BLRX
Pancreatic ductal adenocarcinoma (PDAC)
Phase 2
2023-07-17 00:00:00
Phase 2b trial initiated, noted July 17, 2023.
0
MNKKQ
Hepatorenal syndrome (HRS) Type 1
CRL
2022-02-22 00:00:00
CRL reissued February 22, 2022.
0
ZYME
Solid Tumors
Phase 1
2023-04-18 00:00:00
Additional data reported that anti-tumor activity was observed in breast cancer and gastric cancer PDXs representing a range of HER2 expression, noted April 18, 2023.
1
BIIB
Alzheimer’s disease
Approved
2021-06-07 00:00:00
FDA approval announced June 7, 2021.
1
ADAG
Solid tumors
Phase 1/2
2023-04-18 00:00:00
Dose escalation data presented at AACR showed a compelling safety profile for ADG126, with no Grade 3 or higher TRAEs reported at repeat doses up to 20 mg/kg. Across all dose levels, the disease control rate was 37% among 27 evaluable patients, noted April 18, 2023.
1
GMAB
Multiple myeloma
Approved
2020-05-01 00:00:00
FDA Approval announced May 1, 2020.
1
NBRV
Cystic fibrosis (CF)
Phase 1
2022-11-28 00:00:00
Phase 1 top-line data reported that treatment was well-tolerated, noted November 28, 2022.
1
TERN
Nonalcoholic steatohepatitis (NASH)
Phase 2a
2023-08-08 00:00:00
Phase 2a topline data reported that the trial met all primary and secondary endpoints, noted August 8, 2023.
0
AVXL
Rett syndrome
Phase 2
2023-06-28 00:00:00
Phase 2 long-term clinical study results demonstrated disease modifying effect of ANAVEX2-73 (blarcamesine) for adult patients with Rett syndrome, noted June 28, 2023.
1
RVNC
Cervical dystonia
Phase 3
2021-11-09 00:00:00
Open label data reported a median duration of effect ranging from 19.9 weeks to 26.0 weeks across doses. The most common treatment-related adverse events were muscular weakness (4.9%), dysphagia (4.2%) and injection site pain (2.7%), noted November 9, 2021.
1
KPRX
Persistent epithelial defects
Phase 1
2023-04-26 00:00:00
Phase 1 interim results reported that 62.5% of patients achieved the primary endpoint of healing over the 4-week period , noted April 26, 2023.
1
NVS
HR + Metastatic breast cancer (MBC)
Phase 3
2018-08-23 00:00:00
Phase 3 trial met primary endpoint - August 23, 2018 with data to be presented at an upcoming medical congress.
1
BMY
Urothelial carcinoma, Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancers
Phase 1/2
2019-11-09 00:00:00
Phase 1/2 updated data at SITC November 9, 2019 noted ORR was 53% (20/38) with 34% (13/38) complete response (CR) rate.
0
BMY
First-line, lower-risk Myelodysplastic syndromes (MDS)
Approved
2023-08-28 00:00:00
Approved August 28, 2023.
1
ACER
induced Vasomotor Symptoms (iVMS) associated with menopause
Phase 1
2023-03-17 00:00:00
Phase 2a PoC did not meet its primary endpoint of ability to decrease the frequency or severity of hot flashes in postmenopausal women. As a result, the company is pausing the program until a full dataset review, noted March 17, 2023
1
VCNX
Huntington’s disease
Phase 2
2022-06-10 00:00:00
Phase 2 data reported that treatment restores the ability to benefit from experience, noted June 10, 2022.
1
EIGR
Hepatitis Delta Virus (HDV) infection
Phase 3
2023-09-12 00:00:00
Phase 3 LIMT-2 trial discontinued due to DSMB recommendation, noted September 12, 2023.
-1
NRSN
Parkinson's disease
Phase 1
2023-05-02 00:00:00
Biomarker data reported statistically significant decreased levels of novel biomarker AGO2 observed in newly diagnosed people living with Parkinson's disease (PD) compared to healthy individuals, noted May 2, 2023.
1
BNTX
Cancer, PD-(L)1-resistant non-small cell lung cancer
Phase 1/2
2023-06-02 00:00:00
Phase 1/2 data reported that the ORR was 29.6% and DCR was 70.4%, including one complete response, 7 partial responses and 11 patients with stable disease, noted June 2, 2023.
0
AADI
PEComa​
Approved
2021-11-23 00:00:00
Approved November 23, 2021.
1
CRSP
CD19+ B-cell malignancies
Phase 1
2021-10-12 00:00:00
Phase 1 data demonstrated 58% overall response rate (ORR) and 38% complete response (CR) rate with a single dose at Dose Level 2 (DL2) and above on an intent-to-treat (ITT) basis. Durable responses achieved with six-month CR rate of 21% and longest response on-going at over 18 months after initial infusion, noted October 12, 2021.
1
SRPT
Duchenne muscular dystrophy (DMD)
Phase 1b
2021-10-11 00:00:00
Phase 1b open label interim results from the first 11 participants in Cohort 1 (ambulatory boys aged 4-7 years) provided evidence of robust expression of micro-dystrophin and no new safety signals were identified, September 24, 2021. Functional results from study cohort 1 (n=11, ages 4-7) found participants improved 3.0 points on NSAA six months after treatment - noted October 11, 2021.
1
RHHBY
Chronic Lymphocytic Leukemia
Approved
2019-05-15 00:00:00
FDA approval announced May 15, 2019.
1
ALDX
Dry eye disease
Phase 3
2022-07-12 00:00:00
Phase 3 crossover results reported that met both primary endpoints, noted July 12, 2022.
0
CVAC
Solid tumors
Phase 1
2022-11-11 00:00:00
Phase 1 data reported that five out of 30 patients (17%) experienced a partial response and no objective responses were observed in the 10 patients of the single-agent cohort, noted November 11, 2022.
1
KROS
Iron deficiency anemia
Phase 2
2022-12-12 00:00:00
Phase 2 preliminary data reported that KER-047 was generally well tolerated by this patient, with no serious adverse events or dose-limiting toxicities, noted December 12, 2022.
1
OBSV
Endometriosis
Phase 3
2021-01-10 00:00:00
Phase 3 trial discontinued due to enrollment challenges.
-1
HOTH
Aggressive systemic mastocytosis (ASM), mast cell leukemia (MCL), and systemic mastocytosis with associated hematological neoplasm (SM-AHN).
Phase 1a
2023-09-13 00:00:00
Preclinical Results of Novel HT-KIT Therapeutic Performed at NC State University demonstrated that gastrointestinal Stromal Tumors Cells Rapidly Died Between 48 and 72 Hours After Exposure to HT-KIT. HT-KIT Shows Positive Results in AML, noted September 13, 2023.
1
STTK
Ovarian Cancer
Phase 1a
2023-06-05 00:00:00
Phase 1a monotherapy data shared at ASCO reported that the best response was stable disease in 6/27 response evaluable (22%) pts, noted June 5, 2023.
1
LLY
Axial Spondyloarthritis
Approved
2019-08-26 00:00:00
FDA Approval announced August 26, 2019.
1
IONS
Hypertriglyceridemia
Phase 3
2021-11-13 00:00:00
Phase 3 data reported a significant reduction in total TRL particle (TRLP) concentration by 51%. Total LDL particle (LDLP) concentration was not changed, small LDLP numerically decreased by 39% while medium LDLP increased by 187%, noted November 13, 2021.
1
GOVX
Head and neck squamous cell carcinoma (HNSCC)
Phase 1/2
2023-07-10 00:00:00
Phase 1/2 study data presented at AHNS resulted on impairment of tumor growth (i.e., "stable disease" using RECIST 1.1 evaluation criteria) in targeted lesions was seen in 5 of 7 patients; tumor response assessment in one patient remains under study, noted July 10, 2023.
1
LEGN
Molluscum Contagiosum
Phase 3
2021-09-23 00:00:00
Phase 3 safety data showed TEAEs reported in greater than 5% of subjects in the SB206 treated groups were all at the application site (pain, erythema, pruritis, exfoliation, and dermatitis) with the high majority of these TEAEs being mild or moderate by severity, noted September 23, 2021.
1
CYTK
Hypertrophic cardiomyopathy (HCM)
Phase 2
2023-05-22 00:00:00
Cohort 4 data reported that overall, 58% of patients experienced a clinical reduction in symptom burden: 12.5% had a small improvement (≥ 5-10 points), 20% had a moderate to large improvement (≥ 10-20 points), and 25% had a large to very large improvement, noted May 22, 2023.
1
VECT
Short bowel syndrome - colon-in-continuity
Phase 2
2023-10-16 00:00:00
Additional Phase 2 data reported that 33% of the patients achieving clinical response and PS volume reduction reached a statistically significant 40% at week 24 and the effect was maintained with a 52% volume reduction at week 52, noted October 16, 2023.
1
EXEL
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
EGRX
Supraventricular tachycardia (SVT) - atrial fibrillation and atrial flutter
CRL
2023-05-31 00:00:00
CRL received on May 31, 2023.
0
ABCL
COVID-19 Anti-body
Approved
2021-12-03 00:00:00
Emergency Use Authorization (EUA) expanded for children under 12 years old, noted December 3, 2021.
0
INCY
Myelfibrosis
Phase 2
2022-12-12 00:00:00
Phase 2 data reported that 28.1% (9), 3.1% (1) and 0% of patients who received daily followed by weekly dosing experienced ≥10%, ≥25% and ≥35% reduction in spleen volume, respectively, noted December 12, 2022,
1
EPIX
Metastatic castration-resistant prostate cancer (mCRPC)
Phase 1
2023-10-22 00:00:00
Phase 1 updated data presented at ESMO reported a PSA50 of 88%, PSA90 of 69%, and PSA <0.2 ng/mL of 56%, noted October 22, 2023.
1