Drug approval + hiring FDA novel approval for YARTEMLEA (BLA 761152, Dec 23, 2025); 11 manufacturing/quality or commercial roles open. FDA BLA 761152 (Dec 23, 2025)Evidence (1 event)
Dec 23, 2025 · FDA BLA 761152 openFDA drugsfda: application_number=BLA761152; sponsor_name='OMEROS CORP'; submission_type=ORIG; submission_number=1; submission_status=AP; submission_status_date=20251223; submission_class_code=TYPE 1; brand_name=['YARTEMLEA']
FDA FDA New drug/biologic (novel): YARTEMLEA (narsoplimab-wuug) — BLA761152, Dec 23, 2025. Applicant at approval: Omeros Corporation. source ↗
Partnership Partnership / licensing: $240M (upfront, as published); deal value up to $340M (kept separate from upfront), announced Dec 1, 2025. Source: SEC filing. source ↗
Partnership Partnership / licensing: $2.1B (upfront, as published), announced Oct 15, 2025. Source: SEC filing. source ↗
Grant Government grant — NIH U01: $4.46M (annual award, as published), announced Mar 11, 2025. Agency: NIH/NIDA. Source: government award database. source ↗
Trial start Phase 2: Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN source ↗
Trial start Phase 2: Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria source ↗
Trial start Phase 2: Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMA source ↗
Trial start Phase 2: Safety and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria Patients With a Sub-optimal Response to Ravulizumab source ↗
Trial start Phase 1: Study of the Safety and Efficacy of OMS906 in Patients With Paroxysmal Nocturnal Hemoglobinuria source ↗
Trial start Phase 3: Safety and Efficacy Study of OMS721 in Patients With Atypical Hemolytic Uremic Syndrome source ↗
Trial start Phase 3: Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy source ↗
Trial start Phase 2: Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721 source ↗
Trial start Phase 2: Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies source ↗
Trial start Phase 3: A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement source ↗
Trial start Phase 2: Safety and Efficacy of OMS643762 in Subjects With Huntington's Disease source ↗
Trial start Phase 2: Safety, Tolerability, and Pharmacokinetics of OMS643762 in Psychiatrically Stable Schizophrenia Subjects source ↗
Trial start Phase 3: Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification source ↗
Trial start Phase 3: Safety and Efficacy of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification source ↗
Trial start Phase 3: Safety and Efficacy of OMS103HP-S Administered in Joint Irrigation Solution to Subjects Undergoing Arthroscopic Meniscectomy source ↗
Trial start Phase 2: Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR) source ↗
Trial start Phase 1/Phase 2: Pharmacokinetic, Safety and Efficacy Study of OMS201 in Subjects Undergoing Retrograde Ureteroscopic Removal of Upper Urinary Tract Stones source ↗
Trial start Phase 1/Phase 2: Exploratory Study of OMS302 Injection in Subjects Undergoing Unilateral Cataract Extraction by Phacoemulsification. source ↗
Trial start Phase 2/Phase 3: Double-Blind, Multicenter, Study Comparing the Efficacy and Safety of OMS103HP With Vehicle Irrigation Solution in Subjects Undergoing Meniscectomy source ↗
Trial start Phase 1: Pharmacokinetic and Safety Study of OMS201 in Subjects Undergoing Ureteroscopic Treatment for Removal of Urinary Tract-Located Stones source ↗
Showing 25 of 28 dated events.
Upcoming milestones
2026-12 (ESTIMATED) · Phase 2 · Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria · NCT06298955
Estimated primary completion per ClinicalTrials.gov. Dates move.
Funding
Last 2 years.
Partnership / licensing: $240M (upfront, as published); deal value up to $340M (kept separate from upfront), announced Dec 1, 2025. Source: SEC filing. source ↗
Partnership / licensing: $2.1B (upfront, as published), announced Oct 15, 2025. Source: SEC filing. source ↗
Government grant — NIH U01: $4.46M (annual award, as published), announced Mar 11, 2025. Agency: NIH/NIDA. Source: government award database. source ↗
Pharmacokinetic and Safety Study of OMS201 in Subjects Undergoing Ureteroscopic Treatment for Removal of Urinary Tract-Located Stones
Phase 1
Completed
2007-12
Not listed
FDA records (last 2 years)
FDA New drug/biologic (novel): YARTEMLEA (narsoplimab-wuug) — BLA761152, Dec 23, 2025. Applicant at approval: Omeros Corporation. source ↗
NIH awards 24
Annual award amounts. Total $8.5M.
NIH award 5U01DA058541-02 FY2024: $845,252 awarded for that fiscal year; activity U01 (OTHER_NIH); PI GAITANARIS, GEORGE; recipient as written: OMEROS CORPORATION, SEATTLE, WA. PDE7 Inhibitor for the Treatment of Coc source ↗
NIH award 1U01DA058541-01 FY2023: $1,382,131 awarded for that fiscal year; activity U01 (OTHER_NIH); PI GAITANARIS, GEORGE; recipient as written: OMEROS CORPORATION, SEATTLE, WA. PDE7 Inhibitor for the Treatment of C source ↗
NIH award 5R43MH097383-02 FY2013: $348,510 awarded for that fiscal year; activity R43 (SBIR); PI GRAY, PAT W; recipient as written: OMEROS CORPORATION, SEATTLE, WA. Monoclonal Antibodies for Orphan GPCRs in the CNS source ↗
NIH award 5R44DA023290-03 FY2013: $517,024 awarded for that fiscal year; activity R44 (SBIR); PI CUTSHALL, NEIL; recipient as written: OMEROS CORPORATION, SEATTLE, WA. Development of NMUR2 Antagonists as Novel Analge source ↗
NIH award 1R43MH097383-01 FY2012: $348,510 awarded for that fiscal year; activity R43 (SBIR); PI GRAY, PAT W; recipient as written: OMEROS CORPORATION, SEATTLE, WA. Monoclonal Antibodies for Orphan GPCRs in the CNS source ↗
NIH award 1R43NS077735-01A1 FY2012: $193,002 awarded for that fiscal year; activity R43 (SBIR); PI DUDLER, THOMAS ANTON; recipient as written: OMEROS CORPORATION, SEATTLE, WA. MASP-2 Antibodies for Diabetic Neuropath source ↗
NIH award 2R44DA023290-02 FY2012: $524,835 awarded for that fiscal year; activity R44 (SBIR); PI CUTSHALL, NEIL; recipient as written: OMEROS CORPORATION, SEATTLE, WA. Development of NMUR2 Antagonists as Novel Analge source ↗
NIH award 5R44EY018017-03 FY2011: $173,661 awarded for that fiscal year; activity R44 (SBIR); PI DUDLER, THOMAS ANTON; recipient as written: OMEROS CORPORATION, SEATTLE, WA. MASP-2 Therapy for Macular Degeneration source ↗
NIH award 1R43DK089907-01 FY2010: $198,383 awarded for that fiscal year; activity R43 (SBIR); PI DUDLER, THOMAS ANTON; recipient as written: OMEROS CORPORATION, SEATTLE, WA. Development of MASP-2 MoAbs for the treatm source ↗
NIH award 5R43MH085368-02 FY2010: $239,449 awarded for that fiscal year; activity R43 (SBIR); PI BERGMANN, JOHN EISENHARDT; recipient as written: OMEROS CORPORATION, SEATTLE, WA. Universal High Throughput GPCR Scree source ↗
NIH award 2R44EY018017-02A1 FY2010: $487,011 awarded for that fiscal year; activity R44 (SBIR); PI DUDLER, THOMAS ANTON; recipient as written: OMEROS CORPORATION, SEATTLE, WA. MASP-2 Therapy for Macular Degeneration source ↗
NIH award 3R43AR056911-01S1 FY2009: $334,600 awarded for that fiscal year; activity R43 (SBIR); PI MOORE, EMMA E.; recipient as written: OMEROS CORPORATION, SEATTLE, WA. A novel therapeutic target for OA that restore source ↗
NIH award 1R43AG034696-01 FY2009: $193,888 awarded for that fiscal year; activity R43 (SBIR); PI MOORE, EMMA E.; recipient as written: OMEROS CORPORATION, SEATTLE, WA. Novel therapy for osteoporosis source ↗
NIH award 1R43MH085368-01A1 FY2009: $237,427 awarded for that fiscal year; activity R43 (SBIR); PI BERGMANN, JOHN EISENHARDT; recipient as written: OMEROS CORPORATION, SEATTLE, WA. Universal High Throughput GPCR Scr source ↗
NIH award 1R43AR056911-01 FY2009: $148,400 awarded for that fiscal year; activity R43 (SBIR); PI MOORE, EMMA E.; recipient as written: OMEROS CORPORATION, SEATTLE, WA. A Novel Therapeutic Target for OA that Restores source ↗
NIH award 5R44MH070241-04 FY2008: $450,000 awarded for that fiscal year; activity R44 (SBIR); PI GRAGEROV, ALEXANDER; recipient as written: OMEROS CORPORATION, SEATTLE, WA. G-Protein-Coupled Receptors As Drug Targets source ↗
NIH award 1R43DA023290-01 FY2008: $107,050 awarded for that fiscal year; activity R43 (SBIR); PI GRAGEROV, ALEXANDER; recipient as written: OMEROS CORPORATION, SEATTLE, WA. Development of Novel Analgesics Targeting a source ↗
NIH award 1R43AR055821-01 FY2008: $146,600 awarded for that fiscal year; activity R43 (SBIR); PI MOORE, EMMA E.; recipient as written: OMEROS CORPORATION, SEATTLE, WA. MASP-2: A Potential New Target for Treatment of source ↗
NIH award 6R44MH070241-03 FY2004: $450,000 awarded for that fiscal year; activity R44 (SBIR); PI ZENG, HONGKUI; recipient as written: OMEROS CORPORATION, SEATTLE, WA. G-Protein-Coupled Receptors As Drug Targets for A source ↗
NIH award 1R43EY018017-01 FY2007: $142,140 awarded for that fiscal year; activity R43 (SBIR); PI TEDFORD, CLARK E; recipient as written: OMEROS CORPORATION, SEATTLE, WA. MASP-2 Therapy for Macular Degeneration source ↗
NIH award 5R44DA016496-03 FY2006: $358,143 awarded for that fiscal year; activity R44 (SBIR); PI TEDFORD, CLARK E; recipient as written: OMEROS CORPORATION, SEATTLE, WA. Novel 5-HT treatments for METH post-addiction source ↗
NIH award 1R43HL082004-01 FY2005: $127,000 awarded for that fiscal year; activity R43 (SBIR); PI TEDFORD, CLARK E; recipient as written: OMEROS CORPORATION, SEATTLE, WA. MASP-2 MoAB therapeutics for MI/RP injury source ↗
NIH award 2R44DA016496-02A1 FY2005: $425,631 awarded for that fiscal year; activity R44 (SBIR); PI TEDFORD, CLARK E; recipient as written: OMEROS CORPORATION, SEATTLE, WA. Novel 5-HT treatments for METH post-addictio source ↗
NIH award 1R43HD038204-01 FY1999: $99,640 awarded for that fiscal year; activity R43 (SBIR); PI SIMPSON, PAUL J; recipient as written: OMEROS CORPORATION, SEATTLE, WA. INTRA-ARTICULAR DELIVERY OF PEPTIDES AND PROTEIN source ↗
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