Drugs / narsoplimab
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Refused (EMA) | EU (EMA) | — | thrombotic microangiopathy | 2026-06-26 | “In June, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a negative opinion on our marketing authorization application...” omeros.com ↗ “Omeros was informed that the CHMP has adopted a negative opinion on the MAA for narsoplimab in TA-TMA.” omeros.com ↗ |
| Filed | EU (EMA) | — | thrombotic microangiopathy | 2025-06-27 | “In June 2025 , we submitted our marketing authorization application (“MAA”) for narsoplimab in TA-TMA to the European Medicines Agency (“EMA”).” omeros.com ↗ “today announced the recent submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for narsoplimab” omeros.com ↗ |
| Rejected (CRL) | US (FDA) | — | thrombotic microangiopathy | 2021-10-18 | “CRL from FDA indicating that the BLA for narsoplimab in TA-TMA could not be approved as submitted.” omeros.com ↗ |
| Filed | US (FDA) | — | thrombotic microangiopathy | 2021-01-19 | “BLA for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) has been accepted for filing” omeros.com ↗ |
| Filed | US (FDA) | — | thrombotic microangiopathy | 2020-11-18 | “has been submitted to the U.S. FDA for use of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy” omeros.com ↗ |
| Filed | US (FDA) | — | thrombotic microangiopathy | 2020-08-10 | “Omeros completed submission to FDA of the chemistry, manufacturing and controls (CMC) information for the Company’s rolling Biologic License Application (BLA) for narsoplimab” omeros.com ↗ |
| Filed | US (FDA) | — | thrombotic microangiopathy | 2020-05-11 | “Omeros submitted the second part of its rolling biologics license application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated...” omeros.com ↗ |
| Filed | US (FDA) | — | thrombotic microangiopathy | 2019-10-28 | “In March 2025 , we resubmitted to the U.S. Food and Drug Administration (“FDA”) our Biologics License Application (“BLA”) seeking regulatory approval for narsoplimab in...” omeros.com ↗ “is the subject of a biologics license application (BLA) pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA)” omeros.com ↗ “Omeros has initiated submission of a rolling biologics license application (BLA) to the FDA to be followed by a marketing authorization application for HSCT-TMA” omeros.com ↗ “Submitted to the U.S. Food and Drug Administration ( FDA ) the nonclinical sections of the Biologics License Application (BLA) for narsoplimab” omeros.com ↗ “The BLA for narsoplimab in HSCT-TMA was accepted for filing in January 2021 under FDA’s Priority Review program.” omeros.com ↗ “Earlier this month, we successfully resubmitted our biologics license application (“BLA”) for narsoplimab” omeros.com ↗ “The first drug candidate submitted to FDA for approval in TA-TMA, narsoplimab” omeros.com ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 24 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT05855083 | May 2023 → Dec 2025 overdue | disease related to hematopoietic stem cell transplant, thrombotic microangiopathy | Omeros Corporation | Recruiting | No outcome recorded |
| Phase 2 | NCT04488081 | Jul 2020 → Jul 2028 expected | COVID-19 | QuantumLeap Healthcare Collaborative | Active not recruiting | Missed primary |
| Phase 2 | NCT02682407 | Mar 2016 → Aug 2020 | IgA glomerulonephritis, complement 3 glomerulopathy | Omeros Corporation | Terminated | No outcome recorded |
| Phase 2 | NCT02222545 | Nov 2014 → Jan 2020 | thrombotic microangiopathy | Omeros Corporation | Completed | Met primary |
| Phase 32 trials | ||||||
| Phase 3 | NCT03205995 | May 2018 → Feb 2021 | atypical hemolytic-uremic syndrome | Omeros Corporation | Terminated | No outcome recorded |
| Phase 3 | NCT03608033 | Apr 2018 → Jan 2024 | IgA glomerulonephritis | Omeros Corporation | Terminated | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT02355782 | — | thrombotic microangiopathy | Michal Nowicki | Available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT04247906 Background | — | thrombotic microangiopathy | Omeros Corporation | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 69
| Date | Issuer | Release |
|---|---|---|
| 2026-08-03 | Omeros Corporation | Regulatory CMS Grants New Technology Add-On Payment (NTAP) Status to YARTEMLEA® omeros.com ↗
Omeros Corporation (Nasdaq: OMER) today announced that the Centers for Medicare & Medicaid Services (CMS) has granted New Technology Add-On Payment (NTAP) status for YARTEMLEA ® (narsoplimab-wuug) under the Fiscal Year (FY) 2027 Hospital Inpatient Prospective Payment System (IPPS) Final Rule. |
| 2026-06-26 | Omeros Corporation | Regulatory Omeros Corporation Announces Update on European Marketing Authorization Application for Narsoplimab in TA-TMA omeros.com ↗
Omeros was informed that the CHMP has adopted a negative opinion on the MAA for narsoplimab in TA-TMA. |
| 2026-04-16 | Omeros Corporation | Regulatory CMS Assigns Permanent Reimbursement J-Code for YARTEMLEA® (narsoplimab-wuug) omeros.com ↗ |
| 2025-12-24 | Omeros Corporation | Regulatory FDA Approves Omeros’ YARTEMLEA® – First and Only Therapy Indicated for TA-TMA omeros.com ↗
YARTEMLEA is the first and only approved lectin pathway inhibitor. |
| 2025-10-16 | Omeros Corporation | Results Omeros Announces Publication Highlighting Survival Benefits in TA-TMA Patients Treated with Narsoplimab Versus a Well-Matched External Control Group omeros.com ↗
Authored by an international panel of transplant experts, the manuscript – titled “ Survival in Adults with High Risk TA-TMA—A Comparative Analysis of Narsoplimab Versus Supportive Care ” – reports significant, multifold reductions in mortality risk across pivotal trial and EAP patient cohorts, individually and pooled, treated with narsoplimab compared to a well-matched external control group who did not receive narsoplimab. |
| 2025-09-02 | Omeros Corporation | Results Omeros Announces Publication Highlighting Survival Outcomes in TA-TMA Patients Treated with Narsoplimab Under Its Global Expanded Access Program omeros.com ↗
Omeros Corporation (Nasdaq: OMER) today announced the publication of a peer-reviewed manuscript in the American Journal of Hematology detailing survival outcomes in adult and pediatric patients with life-threatening transplant-associated thrombotic microangiopathy (TA-TMA) treated with narsoplimab through a global expanded access program (EAP). |
| 2025-06-27 | Omeros Corporation | Regulatory Omeros Submits Narsoplimab Marketing Authorization Application to the European Medicines Agency for the Treatment of TA-TMA omeros.com ↗ |
| 2025-05-06 | Omeros Corporation | Regulatory FDA Accepts Resubmission of BLA for Narsoplimab for Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (TA-TMA) and Assigns Late September PDUFA Date omeros.com ↗
Omeros Corporation (Nasdaq: OMER) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). |
| 2025-02-20 | Omeros Corporation | Results Omeros Announces Robust Results for Narsoplimab Expanded Access Program in TA-TMA omeros.com ↗
Narsoplimab reduced the risk of mortality in high-risk TA-TMA patients by over 2-fold (hazard ratio = 0.46 [95 percent confidence interval:0.30, 0.60]) to approximately 3-fold (hazard ratio = 0.34 [95 percent confidence interval: 0.21, 0.53]) |
| 2025-01-16 | Omeros Corporation | Results Omeros Announces Update on Statistical Analysis of Narsoplimab Pivotal Trial Primary Endpoint omeros.com ↗
Newly Completed Sensitivity Analyses Demonstrate Robustness of Previously Announced Survival Superiority Over External Control in Patients with TA-TMA |
| 2024-12-19 | Omeros Corporation | Results Omeros’ Narsoplimab Meets its Pivotal Trial Primary Endpoint – Statistical Analysis Shows Survival Superiority Over External Control in Patients with TA-TMA omeros.com ↗
Narsoplimab met its primary endpoint, with OMS721-TMA-001 patients demonstrating clinically meaningful and statistically significant superiority in overall survival |
| 2023-10-16 | Omeros Corporation | Results Omeros Corporation Provides Update on Interim Analysis of ARTEMIS-IGAN Phase 3 Trial of Narsoplimab in IgA Nephropathy omeros.com ↗
Topline results show that narsoplimab did not achieve statistically significant improvement over placebo. |
| 2022-11-08 | Omeros Corporation | Regulatory Omeros Corporation Receives Decision from FDA on Formal Dispute Resolution Request for Narsoplimab omeros.com ↗
Although that request was denied, the decision proposes a path forward for the resubmission of the BLA based on survival data from the completed pivotal trial versus an historical control group. |
| 2022-09-15 | Omeros Corporation | Results Omeros Corporation Reports Narsoplimab Treatment Results in Critically Ill COVID-19 Patients in I-SPY COVID Trial omeros.com ↗
Analysis in the randomized patient population shows that the addition of narsoplimab to treatment of critically ill patients with COVID-19 reduces the mortality risk (hazard ratio [HR]=0.81, with probability [HR <1] equal to 0.77). |
| 2022-09-15 | Omeros Corporation | Results I-SPY COVID Trial Sponsored by Quantum Leap Healthcare Collaborative Reports Assessment of Narsoplimab for Treatment of Critically Ill Patients With COVID-19 omeros.com ↗
The study did not identify any new safety signals for narsoplimab in the setting of critically ill COVID-19 patients. |
| 2022-08-17 | Omeros Corporation | Regulatory Omeros Corporation Receives Interim Response from FDA on Formal Dispute Resolution Request for Narsoplimab omeros.com ↗
the deciding official is collecting additional information |
| 2022-04-20 | Omeros Corporation | Results Omeros Announces Journal of Clinical Oncology Publication Detailing Pivotal Trial Results for Narsoplimab in HSCT-TMA omeros.com ↗
Omeros Corporation (Nasdaq: OMER) today announced the online publication of a manuscript detailing the results of its pivotal study assessing efficacy and safety of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), an often-lethal complication of stem-cell transplantation for which there is no approved treatment. |
| 2022-01-19 | Omeros Corporation | Regulatory Omeros Confirms Submission of Response to FDA Regarding the BLA for Narsoplimab in the Treatment of HSCT-TMA omeros.com ↗
Omeros Corporation (Nasdaq: OMER) today confirmed that earlier this month the company submitted to the U.S. Food and Drug Administration (FDA) its response to the Agency’s Complete Response Letter (CRL) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). |
| 2021-11-05 | Omeros Corporation | Results Omeros’ Narsoplimab Stabilized Kidney Function and Reduced Urinary Complement Proteins in a Patient with IgA Vasculitis omeros.com ↗
After one course of 12 weekly doses of narsoplimab, her kidney function stabilized and she was able to undergo successful renal transplantation without the need for dialysis. |
| 2021-11-05 | Omeros Corporation | Results Omeros Announces Results From Nearly Three-Year Follow-up of Patients in Phase 2 IgA Nephropathy Trial omeros.com ↗
Treatment with narsoplimab in this trial was associated with an unprecedented median reduction in proteinuria of 64.4 percent. |
| 2021-10-18 | Omeros Corporation | Regulatory Omeros Receives Complete Response Letter from FDA for Biologics License Application for Narsoplimab in the Treatment of HSCT-TMA omeros.com ↗
In the CRL, FDA expressed difficulty in estimating the treatment effect of narsoplimab in HSCT-TMA and asserted that additional information will be needed to support regulatory approval. |
| 2021-10-01 | Omeros Corporation | Regulatory Omeros Provides Regulatory Update on Biologics License Application for Narsoplimab in the Treatment of HSCT-TMA omeros.com ↗
FDA stated that the notification does not reflect a final decision on the information under review. |
| 2021-06-14 | Omeros Corporation | Results Omeros’ Narsoplimab Pivotal Trial Data Shared in Oral Presentation at 2021 Annual Congress of the European Hematology Association omeros.com ↗
The organ function improvement data presented underscore the potential of narsoplimab as a significant advance in the treatment of often fatal HSCT-TMA. |
| 2021-05-28 | Omeros Corporation | Results Omeros Announces Preliminary Results from Additional Critically Ill COVID-19 Patients Treated with Narsoplimab omeros.com ↗
The results in these patients are outstanding and further support what we have learned about the pathophysiology of COVID-19, the central role of endothelial damage in the disease, and the mechanism of action of narsoplimab. |
| 2021-05-20 | Omeros Corporation | Regulatory Omeros Announces Extension of FDA Review Period for Narsoplimab in HSCT-TMA omeros.com ↗
The new Prescription Drug User Fee Act (PDUFA) target action date is October 17, 2021 . |
| 2021-05-13 | Omeros Corporation | Results Omeros’ Narsoplimab Pivotal Trial Data to Be Shared as an Oral Presentation at the European Hematology Association Congress omeros.com ↗
The presentation, entitled Narsoplimab (OMS721) Treatment Contributes to Improvements in Organ Function in Adult Patients with High-Risk Transplant-Associated Thrombotic Microangiopathy , will be delivered by Miguel-Angel Perales , M.D., Chief of Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center . |
| 2021-01-19 | Omeros Corporation | Regulatory Biologics License Application for Narsoplimab in HSCT-TMA Accepted for Priority Review by U.S. FDA omeros.com ↗
The BLA has been granted Priority Review with an FDA action date of July 17, 2021 under the Prescription Drug User Fee Act (PDUFA). |
| 2020-11-18 | Omeros Corporation | Regulatory Omeros Submits its Biologics License Application to U.S. FDA for Narsoplimab in HSCT-TMA omeros.com ↗
Omeros Corporation (Nasdaq: OMER) announced that it has completed the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). |
| 2020-10-28 | Omeros Corporation | Results Omeros Participates in Investor Conference Focused on COVID-19 Therapeutics in Development omeros.com ↗
Five to six months following discharge, none of the patients showed any clinical or laboratory evidence of longer-term effects from COVID-19. |
| 2020-10-22 | Omeros Corporation | Results Omeros Reports Final Efficacy and Safety Data from the Narsoplimab Pivotal Trial in HSCT-TMA omeros.com ↗
Omeros previously presented preliminary data from its pivotal HSCT-TMA trial. |
| 2020-10-15 | Omeros Corporation | Results Omeros Schedules Webcast to Present Final Efficacy Results from Narsoplimab BLA for the Treatment of HSCT-TMA omeros.com ↗
The safety profile observed in the final data set remains consistent with data previously presented. |
| 2020-08-10 | Omeros Corporation | Results Omeros Corporation Reports Recovery and Survival of All Patients in Study Evaluating Narsoplimab for Treatment of COVID-19-Associated Acute Respiratory Distress Syndrome omeros.com ↗
All patients initially required mechanical ventilation, and all recovered and survived with narsoplimab treatment. |
| 2020-06-12 | Omeros Corporation | Results Omeros’ Narsoplimab Pivotal Trial Data Shared in Oral Presentation at Annual European Hematology Association Congress omeros.com ↗
Omeros Corporation (Nasdaq: OMER) today announced that the results of its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) were shared during an oral presentation at the virtual edition of the 25th Congress of the European Hematology Association (EHA) . |
| 2020-05-11 | Omeros Corporation | Regulatory Omeros Corporation Reports First Quarter 2020 Financial Results omeros.com ↗
Omeros submitted the second part of its rolling biologics license application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). |
| 2020-03-02 | Omeros Corporation | Results Omeros Corporation Reports Updated Results from Narsoplimab HSCT-TMA Clinical Trial and Highlights from Recent Clinical and CMC Meetings with FDA omeros.com ↗
Omeros Corporation (Nasdaq: OMER) today reports an update on clinical data from its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), markedly exceeding the FDA-agreed threshold for the primary efficacy endpoint. |
| 2019-12-04 | Omeros Corporation | Results Omeros Reports Positive Data Across Primary and Secondary Endpoints in Pivotal Trial of Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy Patients Treated with Narsoplimab omeros.com ↗
Omeros Corporation (Nasdaq: OMER) today announced positive data from its pivotal clinical trial of the company’s novel investigational complement inhibitor narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), a frequently lethal complication of HSCT. |
| 2019-11-12 | Omeros Corporation | Regulatory Omeros Corporation Reports Third Quarter 2019 Financial Results omeros.com ↗
Submitted to the U.S. Food and Drug Administration ( FDA ) the nonclinical sections of the Biologics License Application (BLA) for narsoplimab |
| 2019-10-29 | Omeros Corporation | Regulatory Omeros’ Narsoplimab Receives Positive Opinion from European Medicines Agency for Pediatric Investigation Plan Required for MAA Submission omeros.com ↗
Omeros Corporation (Nasdaq: OMER) today announced that the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) has issued a positive opinion for the company’s pediatric investigation plan (PIP) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). |
| 2019-10-28 | Omeros Corporation | Regulatory Omeros Corporation Initiates BLA Submission for Narsoplimab for the Treatment of HSCT-TMA omeros.com ↗
Omeros Corporation (Nasdaq: OMER) has submitted the first sections of the rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration ( FDA ) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), a far-too-often deadly complication of stem-cell transplantation. |
| 2019-04-03 | Omeros Corporation | Results Omeros Corporation Announces EBMT Case Report of Resolution of Gastrointestinal Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy Following Narsoplimab Treatment omeros.com ↗
The patient received narsoplimab, her TMA resolved, and all transfusions have been discontinued. |
| 2019-02-14 | Omeros Corporation | Regulatory Omeros Corporation Streamlines Path to Biologics License Application for OMS721 in HSCT-TMA Following Meeting with FDA omeros.com ↗
Patient data from the existing single-arm OMS721 HSCT-TMA trial will form the clinical basis for the BLA, and Omeros will collect additional data from patients currently in the trial for inclusion in the BLA. |
| 2019-01-17 | Omeros Corporation | Regulatory Omeros Finalizes with FDA Clinical Plan for OMS721 Approval in IgA Nephropathy omeros.com ↗
The Phase 3 trial’s primary endpoint of assessment of proteinuria was extended from 24 to 36 weeks at the company’s request to allow for additional OMS721 dosing, if needed. |
| 2018-12-06 | Omeros Corporation | Regulatory Omeros Announces Clinical Strategy to Accelerate Pediatric Development of OMS721 for the Treatment of Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (HSCT-TMA) omeros.com ↗
Omeros Corporation (Nasdaq: OMER) today announced that it has submitted a pediatric investigational plan (PIP) for the use of OMS721 for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) to the European Medicines Association (EMA). |
| 2018-11-08 | Omeros Corporation | Results Omeros Corporation Reports Third Quarter 2018 Financial Results omeros.com ↗
demonstrated significant reductions in proteinuria ranging from greater than 50% to approximately 70% following extended treatment with OMS721 |
| 2018-10-23 | Omeros Corporation | Regulatory FDA Grants Orphan Drug Designation to Omeros’ OMS721 for Treatment of Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy omeros.com ↗
Omeros Corporation (NASDAQ:OMER) today announced that OMS721 has received orphan drug designation from the U.S. Food and Drug Administration ( FDA ) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). |
| 2018-10-01 | Omeros Corporation | Results Omeros Corporation Announces Additional Positive Data for OMS721 in IgA Nephropathy omeros.com ↗
Omeros Corporation (NASDAQ: OMER) today announced positive data from the company’s ongoing Phase 2 clinical trial of OMS721 for the treatment of renal diseases. |
| 2018-08-28 | Omeros Corporation | Regulatory European Commission Designates OMS721 as an Orphan Medicinal Product for Treatment in Hematopoietic Stem Cell Transplantation omeros.com ↗
Omeros Corporation (Nasdaq: OMER) today announced that the European Commission (EC) has adopted a decision designating OMS721 as an Orphan Medicinal Product in the European Union (EU) for treatment in hematopoietic stem cell transplantation (HSCT). |
| 2018-07-25 | Omeros Corporation | Regulatory Omeros’ OMS721 Receives European Orphan Drug Designation Positive Opinion for Treatment in Hematopoietic Stem Cell Transplantation omeros.com ↗
Omeros Corporation (Nasdaq: OMER) announced today that the European Medicines Agency’s (EMA’s) Committee for Orphan Medicinal Products (COMP) issued a positive opinion recommending orphan drug designation of OMS721 for treatment in hematopoietic stem cell transplantation. |
| 2018-04-26 | Omeros Corporation | Regulatory FDA Grants Breakthrough Therapy Designation to Omeros’ MASP-2 Inhibitor OMS721 for the Treatment of High-Risk Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy omeros.com ↗
This is the second breakthrough therapy drug designation for OMS721, which last year received the designation from FDA for the treatment of Immunoglobulin A (IgA) nephropathy. |
| 2018-02-15 | Omeros Corporation | Results Omeros Reports Significant Improvement in Overall Survival Data in OMS721-Treated Patients with Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy omeros.com ↗
The data demonstrate an increase in median overall survival in HCT-TMA patients treated with OMS721 compared to a matched historical control (347 days vs. 21 days, respectively, by Kaplan-Meier analysis; p < 0.0001 by log-rank test). |
| 2018-01-22 | Omeros Corporation | Regulatory European Medicines Agency Issues Orphan Drug Designation Positive Opinion for Omeros’ OMS721 in the Treatment of IgA Nephropathy omeros.com ↗
Omeros Corporation (Nasdaq: OMER) announced today that the European Medicines Agency’s (EMA’s) Committee for Orphan Medicinal Products (COMP) issued a positive opinion on Omeros’ application for orphan drug designation of OMS721 in the treatment of primary Immunoglobulin A nephropathy (IgAN). |
| 2018-01-03 | Omeros Corporation | Regulatory Omeros Corporation Reaches Agreement with FDA on OMS721 Phase 3 Trial Protocol for IgA Nephropathy omeros.com ↗
Omeros Corporation (Nasdaq: OMER) today announced that it has reached agreement with the US Food and Drug Administration ( FDA ) on Omeros’ protocol for its Phase 3 clinical trial evaluating OMS721 in patients with IgA nephropathy (IgAN). |
| 2017-11-06 | Omeros Corporation | Results Extended Improvement in OMS721-Treated Patients with IgA Nephropathy Presented at American Society of Nephrology Annual Meeting omeros.com ↗ |
| 2017-10-26 | Omeros Corporation | Results Omeros Reports Additional and Consistently Positive Data for OMS721 in Patients with Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy omeros.com ↗
Omeros Corporation (NASDAQ: OMER) today announced further positive data from the company's ongoing Phase 2 study of OMS721 evaluating patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HCT-TMA). |
| 2017-10-20 | Omeros Corporation | Results Report of Successful OMS721 Treatment of Patient with Both Stem Cell Transplant-Associated Thrombotic Microangiopathy and Graft-versus-Host Disease Presented at EBMT Annual Meeting omeros.com ↗
Omeros Corporation (NASDAQ: OMER) today announced the presentation of a case report of a patient having co-existing hematopoietic stem cell transplant-associated thrombotic microangiopathy (HCT-TMA) and graft-versus-host disease (GvHD), which both resolved following OMS721 treatment. |
| 2017-08-14 | Omeros Corporation | Results Omeros Data Show Continued Improvement in Patients with IgA Nephropathy Treated with OMS721 omeros.com ↗
Omeros Corporation (NASDAQ: OMER) today announced additional follow-up data from patients with immunoglobulin A (IgA) nephropathy treated with OMS721 in the Phase 2 clinical trial of glomerulonephropathy. |
| 2017-08-04 | Omeros Corporation | Regulatory FDA Grants Orphan Drug Designation to Omeros’ OMS721 for Treatment of IgA Nephropathy omeros.com ↗
Omeros Corporation (NASDAQ:OMER) today announced that OMS721 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of Immunoglobulin A (IgA) nephropathy. |
| 2017-06-13 | Omeros Corporation | Regulatory FDA Grants Breakthrough Therapy Designation to Omeros’ MASP-2 Inhibitor OMS721 for the Treatment of IgA Nephropathy omeros.com ↗
Omeros Corporation (NASDAQ: OMER) today announced that the US Food and Drug Administration ( FDA ) has granted breakthrough therapy designation to OMS721 for the treatment of Immunoglobulin A (IgA) nephropathy. |
| 2017-06-01 | Omeros Corporation | Results Omeros Announces OMS721 Presentation at 54th ERA-EDTA Congress omeros.com ↗
The presentation further describes data demonstrating statistically and clinically significant improvement in proteinuria after 12 weeks of treatment with OMS721 in IgA nephropathy patients. |
| 2017-05-17 | Omeros Corporation | Results Omeros Announces Completion of IgA Nephropathy Cohort in OMS721 Phase 2 Clinical Trial omeros.com ↗
The additional Phase 2 results in IgA nephropathy patients expand on the data reported earlier this year and further demonstrate marked and statistically significant improvement in urine protein levels (proteinuria). |
| 2017-03-30 | Omeros Corporation | Results Omeros Reports More Positive Data in OMS721 Phase 2 Trial in Renal Diseases omeros.com ↗
Omeros Corporation (NASDAQ: OMER) today announced additional positive data from the company’s Phase 2 clinical trial of OMS721 for the treatment of serious kidney disorders, which frequently lead to end-stage renal disease and dialysis. |
| 2017-03-28 | Omeros Corporation | Results Omeros Announces OMS721 Presentation at Annual Meeting of the European Society for Blood and Marrow Transplantation omeros.com ↗
Following OMS721 treatment, the patient was able to discontinue hemodialysis and to decrease substantially her platelet transfusion requirements. |
| 2017-03-01 | Omeros Corporation | Results Omeros Reports Additional Positive Results from OMS721 Phase 2 Trial in Patients with Stem Cell Transplant-Associated Thrombotic Microangiopathy omeros.com ↗
Omeros Corporation (NASDAQ: OMER) today announced additional positive data from the ongoing Phase 2 clinical trial evaluating OMS721 in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HCT-TMA). |
| 2016-12-06 | Omeros Corporation | Results Omeros Extending Compassionate Use for Pediatric Patient No Longer Requiring Dialysis after OMS721 Treatment omeros.com ↗
The patient’s treating physician requested extended access to OMS721 for his 15 year-old patient given her positive results with OMS721 treatment, including discontinuation of dialysis. |
| 2016-11-03 | Omeros Corporation | Regulatory Omeros Files Orphan Drug Application for OMS721 in Immunoglobulin A Nephropathy omeros.com ↗
Omeros Corporation (NASDAQ: OMER) today announced that it has filed an application for orphan drug designation with the U.S. Food and Drug Administration ( FDA ) for OMS721 in the treatment of immunoglobulin A (IgA) nephropathy (also known as Berger’s disease). |
| 2016-10-20 | Omeros Corporation | Results Omeros Announces Positive Data from OMS721 Phase 2 Trial in Patients with Stem Cell Transplant-Associated Thrombotic Microangiopathy omeros.com ↗ |
| 2016-10-17 | Omeros Corporation | Results Omeros Announces Positive Data from OMS721 Phase 2 Clinical Trial in Renal Diseases omeros.com ↗
Statistical significance (p ≤ 0.017) was achieved on key endpoints of improvement in renal function. |
| 2016-09-08 | Omeros Corporation | Results Omeros’ MASP-2 Antibody Preserves Brain Tissue and Function in Stroke Models omeros.com ↗
In well-established animal models of ischemic brain injury or stroke, MASP-2 deficiency or inhibition significantly limited brain infarct size and protected against functional loss. |
| 2016-02-24 | Omeros Corporation | Regulatory Physicians Increasingly Seek Access to OMS721 Compassionate Use Program omeros.com ↗
Based on review of OMS721 data, Finnish physicians requested access to OMS721 under a Special License, granted by the Finnish regulatory authorities, to treat a patient with aHUS. |
All press releases naming this drug 92 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | narsoplimab | “The purpose of this study is to evaluate the efficacy and safety of narsoplimab (OMS721) compared to placebo on proteinuria and whether narsoplimab has the ability to slow...” NCT03608033 ↗4“Narsoplimab (OMS721), an inhibitor of mannan-binding lectin-associated serine protease-2 (MASP-2), was evaluated for safety and efficacy in adults with HSCT-TMA.” PMID 35439028 ↗ Apr 2022 |
| Known as | Masp-2 antibody | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298195 ↗ |
| Known as | OMS00620646 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298195 ↗ |
| Known as | OMS620646 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298195 ↗ |
| Known as | OMS721 | “Narsoplimab (OMS721), an inhibitor of mannan-binding lectin-associated serine protease-2 (MASP-2), was evaluated for safety and efficacy in adults with HSCT-TMA.” PMID 35439028 ↗ Apr 2022 |
| Action | Inhibit | “an inhibitor of mannan-binding lectin-associated serine protease-2 (MASP-2)” PMID 35439028 ↗ Apr 2022 |
| Modality | Monoclonal antibody | “Human IgG4 MASP-2 Monoclonal Antibody” NCT02355782 ↗ |
| Route | Intravenous | “patients received intravenous narsoplimab once weekly for 4-8 weeks” PMID 35439028 ↗ Apr 2022 |
| Target | MASP2 | “an inhibitor of mannan-binding lectin-associated serine protease-2 (MASP-2)” PMID 35439028 ↗ Apr 2022 |