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JAZZ | Tuberous Sclerosis Complex | Approved | 2020-08-03 00:00:00 | FDA approval announced August 3, 2020. | 1 |
GSK | HIV for adolescents 12 years and older | Approved | 2022-03-29 00:00:00 | Approved March 29, 2022. | 1 |
GILD | Hepatitis delta virus (HDV) | Phase 3 | 2023-06-23 00:00:00 | Phase 3 continued treatment with Bulevirtide showed clinical benefit and sustained viral decline with prolonged therapy in patients originally considered partial- or non-responders, noted June 23, 2023. | 1 |
RVMD | Solid Tumors | Phase 1 | 2023-10-13 00:00:00 | Phase 1 preliminary data shared at AACR-NCI-EORTC reported a median time to response of 1.3 months, and median time on treatment of 3.5 months in NSCLC, with a median time to response of 1.4 months, and median time on treatment of 2.4 months in CRC, noted October 13, 2023. | 1 |
PRLD | Solid tumors | Phase 1 | 2021-10-07 00:00:00 | Phase 1 interim data displayed a durable CR maintained for over 18 months in a patient with HRD+ ovarian cancer and prolonged SD persisting for over six months in five patients. The most common grade 3 or higher treatment-related adverse events (AE) occurring in at least 5% of patients were thrombocytopenia (27%) and anemia (12%), both of which were reversible upon treatment interruption, noted October 7, 2021. | 1 |
ARVN | Castration-resistant prostate cancer (CRPC) | Phase 1/2 | 2023-10-22 00:00:00 | Updated data from the ongoing Phase 1/2 trial presented at ESMO reported a median rPFS of 11.1 months in patients harboring AR 878/875 mutations and without co-occurring AR L702H mutations, and PSA50 rates of 54% in patients with tumors harboring AR 878/875 mutations and without co-occurring AR L702H, noted October 22, 2023. | 1 |
VINC | Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) | Phase 1 | 2022-12-12 00:00:00 | Phase 1 data reported that efficacy signals from the 5 newly enrolled pts include 1 stable disease (SD), 2 radiologic disease progression, and 2 on study and who have not yet had first tumor assessment, noted December 12, 2022. | 0 |
GLPG | Relapsed/refractory Non-Hodgkin Lymphoma (rrNHL) | Phase 1/2 | 2022-12-13 00:00:00 | Phase 1/2 data reported an ORR of 86% and all responding patients achieved complete response (CR), noted December 13, 2022. | 1 |
TAK | Type 3 von Willebrand Disease (VWD) | Approved | 2022-01-31 00:00:00 | Approved January 31, 2022. | 1 |
AGEN | Advanced Solid tumors, Colorectal cancer | Phase 1b | 2023-10-21 00:00:00 | Phase 1b data presented at ESMO reported an overall response rate (ORR) of 24% was observed, compared to 2.8% reported with standard of care (SOC), and a 12-month overall survival (OS) of 74% and median OS (mOS) not yet reached, noted October 21, 2023. | 1 |
MACK | Cancer - HER2-positive locally advanced or metastatic breast cancer | Phase 2 | 2016-12-21 00:00:00 | Phase 2 trial discontinued December 21, 2016 due to poor efficacy. | -1 |
MRK | Solid tumors - TMB-H ≥10 mutations/megabase | Approved | 2020-06-17 00:00:00 | FDA Approval June 17, 2020. | 1 |
EBS | Anthrax Vaccine Adsorbed | Approved | 2015-11-24 00:00:00 | Approved November 24, 2015. | 1 |
EXEL | Solid Tumors | Phase 1b | 2022-09-10 00:00:00 | Phase 1b data presented at ESMO demonstrated preliminary clinical activity similar to that observed with cabozantinib in Phase 1 across a range of solid tumors and dose levels, with a manageable safety profile, noted September 10, 2022. | 1 |
NVO | Obesity | Phase 2 | 2020-06-18 00:00:00 | Phase 2 primary endpoint met - June 18, 2020. | 0 |
MRK | Localized muscle-invasive urothelial carcinoma (MIUC) | Phase 3 | 2023-10-05 00:00:00 | Phase 3 trial met one of its dual primary endpoints of disease-free survival (DFS), noted October 5, 2023. | 0 |
CYAD | Colorectal cancer | Phase 1 | 2022-08-05 00:00:00 | Phase 1 preliminary data noted 2/15 partial responses from the dose-escalation segment. Median progression-free survival (mPFS) and median overall survival (mOS) was 3.9 months and 10.6 months, respectively. | 0 |
MOR | Relapsed or refractory diffuse large B cell lymphoma | Approved | 2020-07-31 00:00:00 | FDA Approval announced July 31, 2020. | 1 |
MRUS | HNSCC , Solid Tumors | Phase 1 | 2023-04-14 00:00:00 | Phase 1 data from AACR reported antitumor activity among the 14 patients, with 1 partial response and 3 had stable disease, noted April 14 2023. | 0 |
INCY | Non-small cell lung cancer | Approved | 2020-05-06 00:00:00 | FDA Approval announced May 6, 2020. | 1 |
PTCT | Spinal Muscular Atrophy (SMA) in babies | Approved | 2022-05-31 00:00:00 | Approved May 31, 2022. | 1 |
CLSD | Neovascular age-related macular degeneration (wet AMD) | Phase 2b | 2023-11-01 00:00:00 | Phase 2b recruitment completed, noted November 1, 2023. | 0 |
LLY | Chronic and episodic migraine | Phase 3 | 2019-08-05 00:00:00 | Phase 3 trial met primary endpoint - August 5, 2019. | 0 |
OMER | Hematopoietic stem cell-associated TMA (HSCT-TMA) | CRL | 2021-10-18 00:00:00 | CRL announced October 18, 2021. | 0 |
AMGN | KRAS G12C-mutated solid tumors | Phase 1b | 2021-10-07 00:00:00 | Phase 1b results displayed that patients with CRC who were KRASG12C inhibitor naïve, 9% achieved PR (1 of 11), and 82% achieved disease control (9 of 11). In patients who were previously treated with a KRASG12C inhibitor, 14% achieved PR (1 of 7), and 86% achieved disease control (6 of 7). In patients with NSCLC who were KRASG12C inhibitor naïve, 20% achieved PR (3 of 15) and 87% achieved disease control (13 of 15). In patients who were previously treated with a KRASG12C inhibitor, 67% achieved disease control (2 of 3), noted October 7, 2021. | 1 |
EIGR | Hepatitis delta virus (HDV) | Phase 2 | 2019-11-12 00:00:00 | Phase 2 data presented at AASLD November 12, 2019 - Median HDV RNA decline was 3.4 log IU/mL (IQR: 2.9-4.5, p<0.0001). | 1 |
OCUL | Dry eye disease (DED) | Phase 2 | 2021-10-22 00:00:00 | Phase 2 data did not show separation between the OTX-CSI treated subjects and the vehicle treated subjects for the primary endpoint of increased tear production, noted October 22, 2021. | 1 |
MRK | Endometrial carcinoma | Phase 3 | 2023-03-23 00:00:00 | Additional Phase 3 data reported that KEYTRUDA plus chemotherapy reduced risk of disease progression or death by 46% in patients whose cancer was mismatch repair proficient (pMMR) and by 70% in patients whose cancer was mismatch repair deficient (dMMR), compared to chemotherapy alone, noted March 23, 2023. | 1 |
JNJ | Metastatic castration-sensitive prostate cancer (mCSPC). | Approved | 2019-09-18 00:00:00 | FDA Approval announced September 18, 2019. | 1 |
JAZZ | VOD in high-risk patients following hematopoietic stem cell transplantation | Phase 3 | 2022-12-12 00:00:00 | Phase 3 data reported that mortality from SOS was 33.3%, noted December 12, 2022. | 0 |
BIIB | Alport Syndrome | CRL | 2022-02-25 00:00:00 | CRL issued February 25, 2022. | 0 |
LGND | Osteoporosis | Approved | 2019-10-07 00:00:00 | FDA approval announced October 7, 2019. | 1 |
NKTX | B-cell malignancies | Phase 1 | 2023-06-10 00:00:00 | Phase 1 data presented at EHA demonstrated that 7/10 patients treated with NKX019 monotherapy at 1 billion and 1.5 billion CAR NK cells per dose achieved complete response (70% CR rate). Early safety data support potential of allogeneic CD19 CAR NK to be administered on outpatient basis, noted June 10, 2023. | 1 |
BMY | Melanoma | Approved | 2022-03-18 00:00:00 | Approved March 18, 2022. | 1 |
MRNA | Propionic Acidemia | Phase 1/2 | 2023-05-19 00:00:00 | Phase 1/2 interim data presented at the 2023 ASGCT showed that mRNA-3927 has been generally well-tolerated at the doses administered, with encouraging early signs of dose-dependent pharmacology and potential clinical benefits, noted May 19, 2023. | 1 |
MRK | Nonsquamous non-small cell lung cancer (NSCLC) | Phase 3 | 2023-09-22 00:00:00 | Phase 3 trial did not meet its dual primary endpoints of overall survival (OS) and progression free survival (PFS), noted September 22, 2023. | 1 |
REGN | Homozygous familial hypercholesterolemia (HoFH) | Approved | 2021-02-11 00:00:00 | FDA approval announced February 11, 2021. | 1 |
PTCT | Duchenne muscular dystrophy (age 2-5) | Approved | 2019-06-07 00:00:00 | FDA Approval announced for label expansion June 7, 2019. | 1 |
BIIB | Multiple sclerosis (MS) | Phase 3 | 2021-10-13 00:00:00 | Phase 3b data displayed that the proportion of patients with No Evidence of Disease Activity (NEDA) was 70.0 percent for Q6W and 67.4 percent for Q4W. The proportion of patients free of disability worsening was 90.0 percent in the Q6W arm and 92.0 percent in the Q4W arm. Time to first relapse with the proportion who were relapse-free at 72 weeks at 96.9 percent for Q6W and 97.6 percent for Q4W, noted October 13, 2021 | 0 |
LXRX | Type 2 diabetes | Phase 3 | 2022-11-05 00:00:00 | Phase 3 data presented at ASN reported statistically significant reductions in UACR regardless of albuminuria status, noted November 5, 2022. | 1 |
YMAB | Neuroblastoma | Approved | 2020-11-25 00:00:00 | FDA approval announced November 25, 2020. | 1 |
NVS | HR+/HER2− metastatic breast cancer | Phase 2 | 2022-12-06 00:00:00 | Phase 2 data reported that treatment doubled the median PFS vs. combination CT at 24.0 months compared to 12.3 months, noted December 6, 2022. | 1 |
MNPR | Oral mucositis | Phase 2/3 | 2023-03-27 00:00:00 | Phase 2b/3 interim analysis conducted by an independent Data Safety Monitoring Board (DSMB), which informed the Company that the trial did not meet the pre-defined threshold for efficacy of a 15% absolute difference in SOM prevention between Validive and placebo. Based on not meeting the pre-specified efficacy threshold, the company will be discontinuing the study, noted March 27, 2023. | 1 |
ABBV | Mid-Face Injection Via Cannula | Approved | 2019-09-03 00:00:00 | FDA Approval announced September 3, 2019. | 1 |
AERI | Open Angle Glaucoma | Phase 3 | 2020-09-24 00:00:00 | Phase 3 top-line data released September 24, 2020. Non-inferiority to Ganfort achieved. | 1 |
AVRO | Fabry disease | Phase 2 | 2021-10-19 00:00:00 | Phase 2 safety data noted that no adverse events (AEs) or serious adverse events (SAEs) were reported, October 19, 2021. | 0 |
RHHBY | Neoadjuvant triple negative breast cancer | Phase 3 | 2020-06-18 00:00:00 | Phase 3 trial met primary endpoint - June 18, 2020. | 0 |
XFOR | Renal Cell Carcinoma (RCC) | Phase 2a | 2019-09-30 00:00:00 | Phase 2a data presented at ESMO 2019 - TKI therapy PFS 7.4 months; ORR 18%. | 1 |
EYEN | Mydriasis - pupil dilation | Approved | 2023-05-08 00:00:00 | Approved May 8, 2023. | 1 |
LLY | HR+, HER2-, Node-Positive, High Risk Early Breast Cancer | Approved | 2023-03-03 00:00:00 | Approved March 3, 2023. | 1 |
RHHBY | Solid tumors and ROS1-positive non-small cell lung cancer (NSCLC) | Approved | 2019-08-15 00:00:00 | FDA approval announced August 15, 2019. | 1 |
CNTB | Ulcerative Colitis (UC) | Phase 2b | 2023-06-01 00:00:00 | Phase 2b maintenance data reported that 57% (12/21) of patients with clinical response at the end of the induction period achieved clinical remission at the end of the maintenance period, noted June 1, 2023. | 1 |
PRTA | Alzheimer’s disease | Phase 1 | 2023-07-17 00:00:00 | Phase 1 SAD data presented at AAIC met key pharmacokinetic (PK) and immunogenicity secondary endpoints, noted July 17, 2023 | 1 |
SNY | Non-small cell lung cancer (NSCLC) | Phase 3 | 2020-04-27 00:00:00 | Phase 3 trial stopped early due to significant improvement in overall survival - April 27, 2020. | 1 |
NRIX | Solid tumors | Phase 1a | 2022-11-10 00:00:00 | Phase 1a biomarker and safety reported dose-responsive target engagement and a mean half-life of 6 to 8 hours at doses ranging from 5 mg to 50 mg, noted November 10, 2022. | 0 |
PYPD | Abdominal (soft tissue) sternal surgical site infections | Phase 3 | 2022-09-02 00:00:00 | Phase 3 trial did not meet primary endpoint, noted September 2, 2022. | 1 |
BGNE | Ovarian Cancers or Triple-Negative Breast Cancer | Phase 1/2 | 2020-09-17 00:00:00 | Phase 1/2 data to be presented at ESMO September 2020. ORR 64.6% and 31.6% in cohorts 1 and 2, respectively. | 1 |
ROIV | Atopic Dermatitis | Phase 3 | 2023-03-15 00:00:00 | Phase 3 study met primary of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) and all secondary endpoints, noted March 15, 2023. | 0 |
HRTX | Prevention of chemotherapy-induced nausea and vomiting (CINV) | Approved | 2019-02-26 00:00:00 | FDA additional approval allowing IV injection in addition to current IV infusion. | 1 |
DRRX | Post-operative pain relief | CRL | 2014-02-12 00:00:00 | CRL issued February 12, 2014. | 0 |
ALNA | Enteric Hyperoxaluria | Phase 3 | 2019-11-07 00:00:00 | Phase 3 trial met primary endpoint, key secondary endpoint missed - November 7, 2019. | 0 |
IOVA | Solid Tumors | Phase 2 | 2023-09-12 00:00:00 | Phase 2 data presented at WCLC reported that the ORR was 42.1%, noted September 12, 2023. | 1 |
VRTX | Cystic Fibrosis (6-12 mths) | Approved | 2019-04-30 00:00:00 | FDA Approval announced April 30, 2019. | 1 |
WINT | Cardiogenic Shock in severe acute heart failure | Phase 2 | 2022-09-26 00:00:00 | Phase 2 dose response data demonstrated that study met its primary endpoint of significantly improved systolic blood pressure over the first 6 hours of study drug infusion. The study also met several other secondary endpoint assessments of cardiac function, noted on September 26, 2022. | 1 |
MRNA | Bivalent booster COVID-19 vaccine | Phase 2/3 | 2022-06-22 00:00:00 | Phase 2/3 trial data reported that neutralizing titers against BA.4/BA.5 were approximately 3-fold lower than previously reported neutralizing titers against BA.1. One month after an mRNA-1273.214 booster, neutralizing geometric mean titers (GMT) against BA.4/BA.5 were 941 (95% CI: 826, 1071) in all participants, and 727 (95% CI: 633, 836) in seronegative participants, noted June 22, 2022. | 0 |
APRE | Solid tumors | Phase 1/2 | 2023-10-16 00:00:00 | Phase 1/2a dose expansion cohort being on track to be initiated in 2Q 2024, additionally, data presented at AACR-NCI-EORTC reported that no dose-limiting toxicities have been reported to date with persistent tumor-reducing effect, noted October 16, 2023. | 1 |
NOVN | Human papillomavirus (HPV) | Phase 2 | 2016-11-29 00:00:00 | Phase 2 data released November 29, 2016. Primary endpoint met. | 0 |
ZYNE | 22q11.2 Deletion Syndrome | Phase 2 | 2023-04-13 00:00:00 | Additional Phase 2 data reported a statistically significant improvements in PARS-R, total score and all 5 subscales of ADAMS and all 5 subscales of ABC-C, noted April 13, 2023. | 1 |
ABBV | Chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) | Approved | 2019-01-28 00:00:00 | FDA approval announced January 28, 2019. | 1 |
AZN | Relapsed or Refractory Mantle Cell Lymphoma | Approved | 2017-10-31 00:00:00 | Priority Review announced August 2, 2017. Approval announced October 31, 2017. | 1 |
TAK | Medullary thyroid cancer | Approved | 2012-11-29 00:00:00 | Approved November 29, 2012. | 1 |
AMGN | Colorectal Cancer (CRC) | Phase 1b | 2022-09-12 00:00:00 | Phase 1b data presented at ESMO showed that treatment achieved a 30% confirmed objective response rate in patients with KRAS G12C-mutated metastatic colorectal cancer. Treatment response rates can be as low as 2% in this patient population, and the current standard of care offers a median progression-free survival benefit of 2 months, noted September 12, 2022. | 1 |
SNY | Chronic spontaneous urticaria (CSU) | CRL | 2023-10-20 00:00:00 | CRL issued by the FDA, noted October 20, 2023. | 0 |
AMPH | Opioid overdose | Approved | 2023-03-07 00:00:00 | Approved March 8, 2023. | 1 |
ATAI | Treatment Resistant Depression | Phase 1 | 2023-10-02 00:00:00 | Phase 1 completed, noted October 2, 2023. | 0 |
FGEN | Idiopathic pulmonary fibrosis (IPF) | Phase 3 | 2023-06-26 00:00:00 | Phase 3 after ZEPHYRUS-1 results, company decided to discontinue this study, noted June 26, 2023. | -1 |
IOBT | Metastatic solid tumors | Phase 2 | 2023-10-23 00:00:00 | Additional Phase 2 data presented at ESMO reported that 10 out of 18 evaluable NSCLC patients (56%) had achieved a partial response as their best overall response and 3 out of 6 evaluable SCCHN patients had achieved partial response as their best overall response, noted October 23, 2023. | 1 |
GILD | Nonalcoholic steatohepatitis (NASH) | Phase 2 | 2019-12-16 00:00:00 | Phase 2 trial did not meet primary endpoint - December 16, 2019. | 1 |
MNMD | Major Depressive Disorder (MDD) | Phase 2 | 2023-04-14 00:00:00 | Phase 2 topline data reported that trial met primary endpoint, noted April 14, 2023. | 0 |
RARE | Angelman Syndrome | Phase 1/2 | 2022-07-18 00:00:00 | Phase 1/2 UK data reported that treatment displayed a meaningful improvement in clinical disease and an acceptable safety profile, noted July 18, 2022. | 1 |
XFOR | WHIM syndrome | Phase 3 | 2023-05-16 00:00:00 | Phase 3 new data reported statistically significant reduction (~60%) in annualized infection rate versus placebo with 29% (5 of 17) of those on placebo experienced Grade 3 or higher infections, whereas only 7%, (1 of 14) of those on mavorixafor experiencing a Grade 3 or higher infection, noted May 16, 2023. | 1 |
NVS | Secondary progressive multiple sclerosis | Approved | 2019-03-26 00:00:00 | FDA approval announced March 26, 2019. | 1 |
RHHBY | Multiple sclerosis (MS) or primary progressive MS | Phase 3 | 2023-10-11 00:00:00 | Phase 3 data reported that treatment was comparable to IV infusion in providing rapid and sustained depletion of B cells and near-complete suppression of MRI lesion activity in the brain over 24 weeks, noted October 11, 2023. | 1 |
PLUR | Critical limb ischemia (CLI) | Phase 3 | 2020-12-09 00:00:00 | Phase 3 trial to be terminated following interim analysis that trial is unlikely to meet primary endpoint. | 1 |
CVAC | COVID-19 vaccine | Phase 2/3 | 2021-10-12 00:00:00 | CVnCoV withdrawn from regulatory review due to focus on second generation candidate, noted October 12, 2021. | 0 |
ABBV | Glioblastoma (rGBM) | Phase 3 | 2019-05-17 00:00:00 | Phase 3 trial did not meet primary endpoint at interim analysis - May 17, 2019. | 1 |
SAGE | Postpartum Depression (Severe) | Phase 3 | 2017-11-09 00:00:00 | Phase 3 data released November 9, 2017. Primary endpoint met. | 0 |
SNDX | Recurrent non-small cell lung cancer (NSCLC), colorectal cancer | Phase 2 | 2018-09-24 00:00:00 | Phase 2 updated data to be presented September 24, 2018 did not meet prespecified ORR endpoint. | 1 |
SDGR | B-cell lymphoma | Phase 1 | 2023-11-02 00:00:00 | Phase 1 data from ASH abstract reported that treatment showed excellent potency in the biochemical assay and strong anti-proliferative effects on ABC-DLBCL cells, noted November 2, 2023. | 1 |
CMRX | Adenovirus Infection | Phase 3 | 2017-02-22 00:00:00 | Phase 3 interim analysis released May 2016. Final data released February 22, 2017. | 0 |
AVDL | Excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy | Approved | 2023-05-01 00:00:00 | Final approval granted by FDA on May 1, 2023. | 1 |
SNY | Pompe disease | Approved | 2021-08-06 00:00:00 | FDA approval announced August 6, 2021. | 1 |
EFTR | Solid Tumors RTK BC and KRAS NSCLC | Phase 1/2 | 2022-06-06 00:00:00 | Phase 1/2 presentation at ASCO reported 2 partial responses, noted June 6, 2022. | 1 |
KPRX | Retinitis Pigmentosa (RP) | Phase 1 | 2023-05-01 00:00:00 | Phase 1 abstract presented at ASNR23 on May 1, 2023 | 1 |
EBS | Anthrax Vaccine | Approved | 2012-05-17 00:00:00 | Approved May 17, 2012. | 1 |
ARGX | Immune thrombocytopenia (ITP) | Phase 3 | 2022-05-05 00:00:00 | Phase 3 top-line data reported that trial met primary endpoint, noted May 5, 2022. | 0 |
EVLO | Mild to moderate psoriasis | Phase 2 | 2022-03-28 00:00:00 | Phase 2 data reported that treatment was well tolerated, and the primary endpoint analysis showed that treatment was superior to placebo with 80-90% probability across each cohort, noted March 28, 2022. | 1 |
APRE | TP53 mutated myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) - post transplant | Phase 2 | 2021-12-13 00:00:00 | Phase 2 data from 33 patients enrolled demonstrated a 60% relapse free survival and 79% overall survival, both at 1 year post-transplant. Median overall survival was 20.6 months. | 1 |
CRBP | Cystic Fibrosis | Phase 2b | 2020-10-06 00:00:00 | Phase 2b trial did not meet primary endpoint - October 6, 2020. | 1 |
AMPE | Osteoarthritis of the Knee (OAK) | Phase 3 | 2022-03-02 00:00:00 | Phase 3 data reported that in the modified Intent-to-Treat (mITT) population treatment demonstrated a statistically significant reduction in pain and trended favorably toward improvement in function versus saline control, noted March 2, 2022. | 1 |