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Catalyst Date | Ticker | Drug | Catalyst Type | Catalyst Details | Link |
---|---|---|---|---|---|
01/01/2021-12/31/2021 | ACET | ADI-001 | CT Interim Data | First-in-Human Phase I clinical trial of ADI-001 for the treatment of B cell non-Hodgkin's lymphoma (NHL). Adicet's Phase I trial is an open-label, multi-center study of ADI-001 enrolling adults diagnosed with B cell malignancies who have either relapsed, or are refractory to at least two prior regimens. The primary objectives of the trial are to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ADI-001, and to determine optimal dosing as a monotherapy. A combination of ADI-001 and interleukin 2 may also be evaluated in this trial. The trial is expected to enroll approximately 75 patients, with preliminary safety and tolerability data expected by the end of 2021, subject to the impact of COVID-19. For more information about the clinical trial design, please visit: www.clinicaltrials.gov (NCT04735471). | http://investor.adicetbio.com/news-releases/news-release-details/adicet-bio-announces-initiation-its-first-human-phase-1-trial |
5/6/2021 | ACET | Earnings | https://www.nasdaq.com/market-activity/stocks/acet/earnings | ||
3/31/2023 | ACET | ADI-001 | CT Estimated Primary Completion Date | A Phase 1 Safety and Efficacy Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma Delta T Cells in Adults With B Cell Malignancies, in Monotherapy and Combination With IL 2 | https://clinicaltrials.gov/ct2/show/NCT04735471 |
3/31/2024 | ACET | ADI-001 | CT Estimated Study Completion Date | A Phase 1 Safety and Efficacy Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma Delta T Cells in Adults With B Cell Malignancies, in Monotherapy and Combination With IL 2 | https://clinicaltrials.gov/ct2/show/NCT04735471 |
11/16/2022 | ADAG | ADG126 | CT Estimated Primary Completion Date | First-in-human (FIH), Open-Label, Phase I Dose Escalation Study of ADG126 in Patients With Advanced Malignancies | https://clinicaltrials.gov/ct2/show/NCT04645069 |
4/16/2023 | ADAG | ADG126 | CT Estimated Study Completion Date | First-in-human (FIH), Open-Label, Phase I Dose Escalation Study of ADG126 in Patients With Advanced Malignancies | https://clinicaltrials.gov/ct2/show/NCT04645069 |
9/23/2022 | ADAG | ADG116 | CT Estimated Primary Completion Date | A Phase 1, Open-Label, Dose Escalation Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors | https://clinicaltrials.gov/ct2/show/NCT04501276 |
2/28/2023 | ADAG | ADG116 | CT Estimated Study Completion Date | A Phase 1, Open-Label, Dose Escalation Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors | https://clinicaltrials.gov/ct2/show/NCT04501276 |
4/27/2021 | ADAG | ADG106 | CT Estimated Primary Completion Date | A Study of CD137 Agonist ADG106 Administered Intravenously in Patients With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma | https://clinicaltrials.gov/ct2/show/NCT03707093 |
9/27/2021 | ADAG | ADG106 | CT Estimated Study Completion Date | A Study of CD137 Agonist ADG106 Administered Intravenously in Patients With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma | https://clinicaltrials.gov/ct2/show/NCT03707093 |
2/1/2023 | ADAG | ADG106 | CT Estimated Primary Completion Date | A Multicenter, Open-Label, Phase Ib/II Study of ADG106 in Combination With PD-1 Antibody in Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma | https://clinicaltrials.gov/ct2/show/NCT04775680 |
7/1/2023 | ADAG | ADG106 | CT Estimated Study Completion Date | A Multicenter, Open-Label, Phase Ib/II Study of ADG106 in Combination With PD-1 Antibody in Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma | https://clinicaltrials.gov/ct2/show/NCT04775680 |
4/30/2021 | ADAG | ADG106 | CT Estimated Primary Completion Date | A Phase Ⅰ Study of ADG106 Administered in Patients With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma | https://clinicaltrials.gov/ct2/show/NCT03802955 |
12/31/2021 | ADAG | ADG106 | CT Estimated Study Completion Date | A Phase Ⅰ Study of ADG106 Administered in Patients With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma | https://clinicaltrials.gov/ct2/show/NCT03802955 |
6/1/2021 | ADAP | ADP-A2M4 | Data Update | preliminary data for SPEARHEAD-1 trial with ADP-A2M4 for people with synovial sarcoma at American Society of Clinical Oncology (ASCO) | https://www.adaptimmune.com/investors-and-media/news-events/press-releases/detail/188/adaptimmune-reports-fourth-quarter-full-year-2020 |
11/1/2021 | ADAP | ADP-A2M4 | Data Update | full update for SPEARHEAD-1 trial with ADP-A2M4 for people with synovial sarcoma at Connective Tissue Oncology Society (CTOS) | https://www.adaptimmune.com/investors-and-media/news-events/press-releases/detail/188/adaptimmune-reports-fourth-quarter-full-year-2020 |
9/1/2021 | ADAP | ADP-A2M4CD8 | Data Update | update for SURPASS Phase 1 trial with ADP-A2M4CD8 (next-generation product targeting MAGE-A4) at European Society for Medical Oncology (ESMO) | https://www.adaptimmune.com/investors-and-media/news-events/press-releases/detail/188/adaptimmune-reports-fourth-quarter-full-year-2020 |
9/1/2021 | ADAP | ADP-A2AFP | Data Update | update for ADP-A2AFP Phase 1 trial for people with liver cancer at International Liver Cancer Association (ILCA) conference | https://www.adaptimmune.com/investors-and-media/news-events/press-releases/detail/188/adaptimmune-reports-fourth-quarter-full-year-2020 |
10/1/2021 | ADAP | ADP-A2M4 | Data Update | update for radiation sub-study of the ADP-A2M4 Phase 1 trial at American Society for Radiation Oncology (ASTRO) | https://www.adaptimmune.com/investors-and-media/news-events/press-releases/detail/188/adaptimmune-reports-fourth-quarter-full-year-2020 |
11/1/2021 | ADAP | ADP-A2M4 | Data Update | update for ADP-A2M4 translational data at Society for Immunotherapy of Cancer (SITC) | https://www.adaptimmune.com/investors-and-media/news-events/press-releases/detail/188/adaptimmune-reports-fourth-quarter-full-year-2020 |
2022 | ADAP | ADP-A2M4 | BLA Filing | on track to file a Biologics License Application (BLA) for ADP-A2M4 in 2022 (for synovial sarcoma) | https://www.adaptimmune.com/investors-and-media/news-events/press-releases/detail/188/adaptimmune-reports-fourth-quarter-full-year-2020 |
01/01/2021-06/30/2021 | ADAP | ADP-A2M4CD8 | CT Initiation | initiate a Phase 2 trial, SURPASS-2, with ADP-A2M4CD8 (next-generation SPEAR T-cells targeting MAGE-A4 that co-express CD8α intended to increase potency) for patients with esophageal or EGJ cancers in 1H 2021 | https://www.adaptimmune.com/investors-and-media/news-events/press-releases/detail/188/adaptimmune-reports-fourth-quarter-full-year-2020 |
5/13/2021 | ADAP | Earnings | https://www.nasdaq.com/market-activity/stocks/adap/earnings | ||
2024 | ADAP | ADP-A2M4CD8 | BLA Filing | Plan to file a BLA with ADP-A2M4D8 in gastroesophageal cancers in 2024 | https://www.adaptimmune.com/investors-and-media/news-events/press-releases/detail/186/adaptimmune-to-showcase-market-potential-for-spear-t-cell |
01/01/2021-06/30/2021 | ADAP | ADP-A2M4CD8 | CT Initiation | On track to start a Phase 2 trial with ADP-A2M4CD8 in gastroesophageal cancers (gastric, esophageal, and esophagogastric junction) in the first half of 2021 | https://www.adaptimmune.com/investors-and-media/news-events/press-releases/detail/182/adaptimmune-reports-q3-financial-results-and-business-update |
1/15/2023 | ADXS | ADXS-503 | CT Estimated Primary Completion Date | A Phase 1/2, Open-Label Study of ADXS-503 Alone and in Combination With Pembrolizumab in Subjects With Metastatic Squamous or Non-Squamous Non-Small Cell Lung Cancer | https://clinicaltrials.gov/ct2/show/NCT03847519 |
3/17/2023 | ADXS | ADXS-503 | CT Estimated Study Completion Date | A Phase 1/2, Open-Label Study of ADXS-503 Alone and in Combination With Pembrolizumab in Subjects With Metastatic Squamous or Non-Squamous Non-Small Cell Lung Cancer | https://clinicaltrials.gov/ct2/show/NCT03847519 |
4/10/2021 | ADXS | ADXS-503 | Data Update | will present data on a) the development of a novel flow immunophenotyping assay to accurately evaluate total PD-1 expression as a pharmacodynamic biomarker during PD-1 blockade treatment with pembrolizumab and b) the correlation of changes in T cell populations with the clinical activity observed in the ongoing ADXS-503 clinical trial, in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2021, taking place virtually from April 10-15, 2021 | https://www.advaxis.com/news-releases/news-release-details/advaxis-present-american-association-cancer-research-aacr-2021 |
Dec-24 | AIM | Ampligen (rintatolimod) | CT Estimated Primary Completion Date | Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer | https://clinicaltrials.gov/ct2/show/NCT03734692 |
Dec-24 | AIM | Ampligen (rintatolimod) | CT Estimated Study Completion Date | Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer | https://clinicaltrials.gov/ct2/show/NCT03734692 |
9/4/2021 | AIM | Ampligen (rintatolimod) | CT Estimated Primary Completion Date | Phase 1/2A Study of Rintatolimod and IFN-Alpha Regimen in Cancer Patients With Mild or Moderate COVID-19 Infection | https://clinicaltrials.gov/ct2/show/NCT04379518 |
9/4/2021 | AIM | Ampligen (rintatolimod) | CT Estimated Study Completion Date | Phase 1/2A Study of Rintatolimod and IFN-Alpha Regimen in Cancer Patients With Mild or Moderate COVID-19 Infection | https://clinicaltrials.gov/ct2/show/NCT04379518 |
1/2/2022 | AIM | Ampligen (rintatolimod) | CT Estimated Primary Completion Date | Randomized Phase 2 Study: Neoadjuvant Conditioning of Prostate Cancer Tumor Microenvironment Using a Novel Chemokine-Modulating Regimen | https://clinicaltrials.gov/ct2/show/NCT03899987 |
1/2/2023 | AIM | Ampligen (rintatolimod) | CT Estimated Study Completion Date | Randomized Phase 2 Study: Neoadjuvant Conditioning of Prostate Cancer Tumor Microenvironment Using a Novel Chemokine-Modulating Regimen | https://clinicaltrials.gov/ct2/show/NCT03899987 |
2021 | ALEC | AL001 | Data Update | Alector plans to present updated data from the ongoing Phase 2 open-label study evaluating AL001, in 2021. The Company plans to present additional data in pre-symptomatic and symptomatic FTD-GRN participants at medical conferences in 2021. The data will include updated findings on safety, fluid and imaging biomarkers and clinical outcomes assessments, while also providing additional insights to the mechanism of action and safety of AL001 in this population. | https://investors.alector.com/node/7656/pdf |
2021 | ALEC | AL001 | CT Initiation | In January 2021, the Company announced plans to evaluate AL001 in people with amyotrophic lateral sclerosis (ALS) caused by C9orf72 repeats, which share TDP-43 pathology with FTD-GRN. The Phase 2 study is planned for 2021. | https://investors.alector.com/node/7656/pdf |
2021 | ALEC | AL001 | Data Update | In January 2020, a Phase 1a study evaluating AL101 was initiated in healthy volunteers. The U.S. Food and Drug Administration also granted Fast Track designation to AL101 for the treatment of patients with FTD-GRN in February 2020. The Company anticipates reporting preliminary findings from the Phase 1a study in 2021. | https://investors.alector.com/node/7656/pdf |
2021 | ALEC | AL003 | Data Update | Data from the Phase 1b study evaluating AL003 in participants with Alzheimer’s disease is expected in 2021. Alector initiated the Phase 1b study in January 2020 and completed enrollment in 2020. The AL003 clinical development program is also being developed in collaboration with AbbVie. Preliminary results from the study are expected to be presented at a scientific medical meeting in 2021 | https://investors.alector.com/node/7656/pdf |
6/30/2023 | ALEC | AL002 | CT Estimated Primary Completion Date | A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease | https://clinicaltrials.gov/ct2/show/NCT04592874 |
8/30/2023 | ALEC | AL002 | CT Estimated Study Completion Date | A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease | https://clinicaltrials.gov/ct2/show/NCT04592874 |
10/30/2023 | ALEC | AL001 | CT Estimated Primary Completion Date | A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene | https://clinicaltrials.gov/ct2/show/NCT04374136 |
12/30/2023 | ALEC | AL001 | CT Estimated Study Completion Date | A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene | https://clinicaltrials.gov/ct2/show/NCT04374136 |
8/19/2021 | ALEC | AL101 | CT Estimated Primary Completion Date | A Phase 1 Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Bioavailability of IV and SC AL101 | https://clinicaltrials.gov/ct2/show/NCT04111666 |
10/14/2021 | ALEC | AL101 | CT Estimated Study Completion Date | A Phase 1 Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Bioavailability of IV and SC AL101 | https://clinicaltrials.gov/ct2/show/NCT04111666 |
3/30/2023 | ALEC | AL001 | CT Estimated Primary Completion Date | A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9orf72 Mutations Causative of Frontotemporal Dementia | https://clinicaltrials.gov/ct2/show/NCT03987295 |
5/30/2023 | ALEC | AL001 | CT Estimated Study Completion Date | A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9orf72 Mutations Causative of Frontotemporal Dementia | https://clinicaltrials.gov/ct2/show/NCT03987295 |
5/12/2021 | ALEC | Earnings | https://www.nasdaq.com/market-activity/stocks/alec/earnings | ||
5/11/2021 | ADPT | Earnings | https://www.nasdaq.com/market-activity/stocks/adpt/earnings | ||
5/10/2021 | ALLK | Earnings | https://www.nasdaq.com/market-activity/stocks/allk/earnings | ||
09/01/2021-12/31/2021 | ALLK | Lirentelimab (AK002) | Data Update | Topline data from a randomized, double-blind, placebo-controlled Phase 3 study of lirentelimab in patients with EG and/or EoD expected in the fourth quarter of 2021. | https://investor.allakos.com/news-releases/news-release-details/allakos-reports-fourth-quarter-and-full-year-2020-financial |
09/01/2021-12/31/2021 | ALLK | Lirentelimab (AK002) | Data Update | Topline data from a randomized, double-blind, placebo-controlled Phase 2/3 study of lirentelimab in patients with eosinophilic esophagitis (EoE) expected in the fourth quarter of 2021. | https://investor.allakos.com/news-releases/news-release-details/allakos-reports-fourth-quarter-and-full-year-2020-financial |
04/01/2021-06/30/2021 | ALLK | Lirentelimab (AK002) | CT Initiation | Initiation of a randomized, double-blind, placebo-controlled Phase 3 study of lirentelimab in patients with EoD expected in the second quarter of 2021. | https://investor.allakos.com/news-releases/news-release-details/allakos-reports-fourth-quarter-and-full-year-2020-financial |
07/01/2021-12/31/2021 | ALLK | Lirentelimab (AK002) | CT Initiation | Initiation of a randomized, double-blind, placebo-controlled Phase 2/3 study of SC lirentelimab in patients with EG and/or EoD expected in the second half of 2021. | https://investor.allakos.com/news-releases/news-release-details/allakos-reports-fourth-quarter-and-full-year-2020-financial |
Dec-21 | ALLK | Lirentelimab (AK002) | CT Estimated Primary Completion Date | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AK002 in Patients With Moderately to Severely Active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis) | https://clinicaltrials.gov/ct2/show/NCT04322604 |
Dec-21 | ALLK | Lirentelimab (AK002) | CT Estimated Study Completion Date | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AK002 in Patients With Moderately to Severely Active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis) | https://clinicaltrials.gov/ct2/show/NCT04322604 |
Dec-21 | ALLK | Lirentelimab (AK002) | CT Estimated Primary Completion Date | A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lirentelimab (AK002) in Adult and Adolescent Patients With Active Eosinophilic Esophagitis | https://clinicaltrials.gov/ct2/show/NCT04322708 |
May-22 | ALLK | Lirentelimab (AK002) | CT Estimated Study Completion Date | A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lirentelimab (AK002) in Adult and Adolescent Patients With Active Eosinophilic Esophagitis | https://clinicaltrials.gov/ct2/show/NCT04322708 |
Jul-22 | JNCE | JTX-8064 | CT Estimated Primary Completion Date | Phase 1 First-in-Human (FIH) Study of Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2) Inhibitor Monoclonal Antibody (mAb) JTX-8064, as Monotherapy and in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumor Malignancies | https://clinicaltrials.gov/ct2/show/NCT04669899 |
Sep-22 | JNCE | JTX-8064 | CT Estimated Study Completion Date | Phase 1 First-in-Human (FIH) Study of Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2) Inhibitor Monoclonal Antibody (mAb) JTX-8064, as Monotherapy and in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumor Malignancies | https://clinicaltrials.gov/ct2/show/NCT04669899 |
12/1/2021 | JNCE | JTX-4014 | CT Estimated Primary Completion Date | Phase 2 Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab, an ICOS Agonist, in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen | https://clinicaltrials.gov/ct2/show/NCT04549025 |
Mar-23 | JNCE | JTX-4014 | CT Estimated Study Completion Date | Phase 2 Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab, an ICOS Agonist, in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen | https://clinicaltrials.gov/ct2/show/NCT04549025 |
4/30/2024 | JNCE | Vopratelimab (JTX-2011) | CT Estimated Primary Completion Date | An Open-label, Multi-center, Rollover Study in Subjects With Advanced Solid Tumor Malignancies After Participation in a Vopratelimab (JTX-2011) Clinical Study | https://clinicaltrials.gov/ct2/show/NCT04319224 |
7/31/2024 | JNCE | Vopratelimab (JTX-2011) | CT Estimated Study Completion Date | An Open-label, Multi-center, Rollover Study in Subjects With Advanced Solid Tumor Malignancies After Participation in a Vopratelimab (JTX-2011) Clinical Study | https://clinicaltrials.gov/ct2/show/NCT04319224 |
4/10/2021 | JNCE | JTX-8064 | Data Update | preclinical data informing indication selection for the clinical development of its lead macrophage program, JTX-8064, will be presented in a poster session at the upcoming 2021 American Association for Cancer Research (AACR) Virtual Annual Meeting being held April 10- 15, 2021. | https://ir.jouncetx.com/news-releases/news-release-details/jounce-therapeutics-present-preclinical-data-jtx-8064-program |
2022 | JNCE | JTX-4014 | Data Update | In October 2020, Jounce initiated enrollment in the randomized Phase 2 SELECT trial to evaluate vopratelimab in combination with JTX-4014 versus JTX-4014 alone in immunotherapy naïve TISvopra biomarker-selected, second line non-small cell lung cancer patients. COVID-19 related delays are currently impacting patient enrollment, and Jounce now anticipates reporting data from the SELECT trial in 2022. | https://ir.jouncetx.com/news-releases/news-release-details/jounce-therapeutics-reports-fourth-quarter-and-full-year-2020 |
01/01/2021-06/30/2021 | JNCE | JTX-1811 | IND Filing | In October 2020, Jounce licensed to Gilead Sciences, Inc. (“Gilead”) the worldwide rights to JTX-1811, a potential first-in-class antibody designed to bind to CCR8 and selectively deplete immunosuppressive tumor-infiltrating T regulatory cells. Upon clearance of an investigational new drug application (“IND”), JTX-1811 will transition to Gilead for clinical development and potential commercialization. In addition to an $85.0 million upfront and a $35.0 million equity investment, Jounce has the potential to earn up to $685.0 million in milestones as well as royalties on worldwide sales. Jounce continues to progress JTX-1811 to IND clearance and remains on track for an IND filing in the first half of 2021. | https://ir.jouncetx.com/news-releases/news-release-details/jounce-therapeutics-reports-fourth-quarter-and-full-year-2020 |
Jul-23 | NKTX | NKX101 | CT Estimated Primary Completion Date | A Phase 1 Study of NKX101, an Activating Chimeric Receptor Natural Killer Cell Therapy, in Subjects With Hematological Malignancies or Dysplasias | https://clinicaltrials.gov/ct2/show/NCT04623944 |
Jul-38 | NKTX | NKX101 | CT Estimated Study Completion Date | A Phase 1 Study of NKX101, an Activating Chimeric Receptor Natural Killer Cell Therapy, in Subjects With Hematological Malignancies or Dysplasias | https://clinicaltrials.gov/ct2/show/NCT04623944 |
01/01/2021-03/31/2021 | NKTX | NKX019 | IND Filing | In 1Q 2021, Nkarta expects to file an Investigational New Drug (IND) Application for NKX019, an investigational NK cell therapy engineered to target tumors expressing CD19 antigen for the treatment of B-cell malignancies. | https://ir.nkartatx.com/news-releases/news-release-details/nkarta-reports-third-quarter-2020-financial-results |
01/08/2021-05/01/2021 | NLTX | NL-201 | IND Acceptance | Neoleukin Therapeutics, Inc., “Neoleukin” (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, today announced that on January 7, 2021, it received a clinical hold letter from the U.S. Food and Drug Administration (FDA) related to its Investigational New Drug (IND) Application to begin a Phase 1 clinical program of its immunotherapeutic candidate, NL-201. The FDA has informed Neoleukin that it needs to develop a new assay that more precisely measures the amount of protein being administered and demonstrate with this assay that dose and administration procedures will accurately deliver the intended dose of NL-201. The FDA also had additional requests not related to the clinical hold to be addressed by amendment of the IND. “We will work diligently to address the FDA’s questions as quickly as possible,” said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin. “We believe that we will be able to develop the requested assay and respond within the next several months. While we do not have a definitive timeline as to when we will be able to obtain clearance to proceed, we look forward to working with the FDA to satisfy their requests.” | http://investor.neoleukin.com/news-releases/news-release-details/neoleukin-therapeutics-receives-clinical-hold-letter-us-fda |
May-23 | NLTX | NL-201 | CT Estimated Primary Completion Date | A First-in-Human Phase 1 Study of NL-201 in Patients With Relapsed or Refractory Cancer | https://clinicaltrials.gov/ct2/show/NCT04659629 |
Dec-24 | NLTX | NL-201 | CT Estimated Study Completion Date | A First-in-Human Phase 1 Study of NL-201 in Patients With Relapsed or Refractory Cancer | https://clinicaltrials.gov/ct2/show/NCT04659629 |
07/01/2021-12/31/2021 | NXTC | NC410 | Data Update | the NC410 Phase 1 trial is advancing and we look forward to reporting initial data in the second half of the year "Enrollment is on track and the company expects to announce initial clinical data from the Phase 1 portion of the trial in the second half of 2021." | http://ir.nextcure.com/news-releases/news-release-details/nextcure-provides-business-update-and-reports-fourth-quarter-and |
04/01/2021-06/30/2021 | NXTC | NC762 | CT Initiation | we are very excited to introduce NC762, a B7-H4 antibody expected to enter the clinic next quarter "An investigational new drug (IND) application has been filed with the U.S. Food and Drug Administration (FDA) for NC762, a humanized monoclonal antibody targeting B7-H4, which is upregulated in multiple solid tumor types, and which we believe is differentiated from other B7-H4-targeted antibodies." | http://ir.nextcure.com/news-releases/news-release-details/nextcure-provides-business-update-and-reports-fourth-quarter-and |
01/01/2022-06/30/2022 | NXTC | NC318 | Data Update | the Yale University Phase 2 investigator-initiated trial of NC318 in NSCLC with anticipated initial data first half of 2022 | http://ir.nextcure.com/news-releases/news-release-details/nextcure-provides-business-update-and-reports-fourth-quarter-and |
04/01/2021-06/30/2021 | NXTC | NC318 | CT Initiation | Initiate in the second quarter of 2021, the Yale University Phase 2 investigator-initiated trial of NC318 in NSCLC with anticipated initial data first half of 2022 "Yale University plans to initiate in the second quarter of 2021, an investigator-initiated Phase 2 trial of NC318 as a monotherapy and in combination with pembrolizumab in patients with advanced non-small cell lung cancer." | http://ir.nextcure.com/news-releases/news-release-details/nextcure-provides-business-update-and-reports-fourth-quarter-and |
10/01/2021-12/31/2021 | NXTC | NC318 | Data Update | Report NC318 Phase 2 monotherapy data in the fourth quarter of 2021 | http://ir.nextcure.com/news-releases/news-release-details/nextcure-provides-business-update-and-reports-fourth-quarter-and |
5/5/2021 | JNCE | Earnings | https://www.nasdaq.com/market-activity/stocks/jnce/earnings | ||
5/6/2021 | NXTC | Earnings | https://www.nasdaq.com/market-activity/stocks/nxtc/earnings | ||
6/30/2022 | NXTC | NC318 | CT Estimated Primary Completion Date | A Phase 1/2 Study of NC318 in Combination With Chemotherapy for Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer | https://clinicaltrials.gov/ct2/show/NCT04430933 |
10/30/2022 | NXTC | NC318 | CT Estimated Study Completion Date | A Phase 1/2 Study of NC318 in Combination With Chemotherapy for Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer | https://clinicaltrials.gov/ct2/show/NCT04430933 |
1/9/2023 | NXTC | NC410 | CT Estimated Primary Completion Date | A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors | https://clinicaltrials.gov/ct2/show/NCT04408599 |
1/9/2023 | NXTC | NC410 | CT Estimated Study Completion Date | A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors | https://clinicaltrials.gov/ct2/show/NCT04408599 |
5/1/2021 | NXTC | NC318 | CT Estimated Primary Completion Date | A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors | https://clinicaltrials.gov/ct2/show/NCT03665285 |
5/1/2021 | NXTC | NC318 | CT Estimated Study Completion Date | A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors | https://clinicaltrials.gov/ct2/show/NCT03665285 |
Jun-25 | NXTC | NC318 | CT Estimated Primary Completion Date | The Study of NC318 Alone or in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer | https://clinicaltrials.gov/ct2/show/NCT04699123 |
Jun-25 | NXTC | NC318 | CT Estimated Study Completion Date | The Study of NC318 Alone or in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer | https://clinicaltrials.gov/ct2/show/NCT04699123 |