Red blood cell

Cerus Corporation Announces First Quarter 2024 Financial Results

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星期四, 五月 2, 2024
Medical Supplies, Health, Medical Devices, Hospitals, Health Technology, General Health, Biotechnology, FDA, Red blood cell, Investment, AUC, Cerus Corporation, Research, Canadian Blood Services, LED, Patient, Platelet, Government, GAAP, Growth, Pharmaceutical industry

The Company expects to report GAAP net loss attributable to Cerus Corporation for the full-year 2024 while also remains committed to adjusted EBITDA breakeven for the full-year 2024.

Key Points: 
  • The Company expects to report GAAP net loss attributable to Cerus Corporation for the full-year 2024 while also remains committed to adjusted EBITDA breakeven for the full-year 2024.
  • R&D expenses for the first quarter of 2024 were $14.5 million, compared to $17.4 million for the first quarter of 2023.
  • Net loss attributable to Cerus Corporation for the first quarter of 2024 was $9.7 million, or $0.05 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $15.6 million, or $0.09 per basic and diluted share, for the first quarter of 2023.
  • As discussed during prior quarters, the Company expects full-year 2024 non-GAAP adjusted EBITDA breakeven, though over the near term, results may not be consistent quarter by quarter.

The United States FDA Awards Orphan Drug Designation (ODD) to NM5072 for Treating Paroxysmal Nocturnal Hemoglobinuria (PNH)

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星期一, 四月 15, 2024
FDA, Pain, Mortality, Nephrology, Inflammation, Monocyte, Cell, Anemia, Alternative complement pathway, Safety, Ophthalmology, Red blood cell, Food, Hematology, Chelsea Handler, Dermatology, Half-life, Atypical hemolytic uremic syndrome, Blood, AP, Hyperlipidemia, Hemoglobinuria, Disease, Patient, Neurology, Fatigue, Platelet, Diagnosis, Infection, Hemolysis, Immune system, PNH, ODD, Quality of life, Chronic pain, LDH, Paroxysmal nocturnal hemoglobinuria, Pharmaceutical industry

The United States Food and Drug Administration (FDA) has awarded orphan drug designation (ODD) to NM5072 for the treatment of anemia in PNH patients.

Key Points: 
  • The United States Food and Drug Administration (FDA) has awarded orphan drug designation (ODD) to NM5072 for the treatment of anemia in PNH patients.
  • CLEVELAND, April 15, 2024 (GLOBE NEWSWIRE) -- NovelMed today announced that the Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to NM5072, an Alternative Pathway (AP) blocker anti-Properdin antibody, for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria (PNH).
  • NM5072 is another drug in our pipeline that has received Orphan Drug Designation in the United States.
  • Among these, Paroxysmal Nocturnal Hemoglobinuria (PNH) emerges as a prominent indication for complement blockers heading towards FDA approval.

Landmark New Publication: the Forgotten Biochemistry 101 of COVID-19

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星期一, 四月 22, 2024
Nobel Prize, ACE2, Coronavirus, Cell, Safety, Red blood cell, Risk, RBC, News, Human body, Diabetes, Biochemistry, Research, Therapy, Endothelium, Cardiovascular disease, Toxicity, COVID-19, Plasma, Vaccine

SALT LAKE CITY, April 22, 2024 /PRNewswire/ -- TrialSite News features a paper published today in Viruses (Basel), authored by an international team of researchers, including two fellows of their nations' academies of sciences (Colleen Aldous, senior author Wendy Hoy) and others who participated in Nobel prize-honored research (Thomas Borody, Morimasa Yagisawa). The publication reveals how coronavirus biochemistry well-established over past decades governs the morbidities of COVID-19, risk factors and therapeutic approaches.

Key Points: 
  • The publication reveals how coronavirus biochemistry well-established over past decades governs the morbidities of COVID-19, risk factors and therapeutic approaches.
  • The glycan monomer sialic acid, ubiquitous on eukaryotic cell surfaces, serves as the initial attachment point to host cells for the COVID–19 virus—SARS–CoV–2—as well as for other coronaviruses.
  • In the genetics-centric research environment of recent decades, however, most COVID–19 research ignored this older, well-established biochemistry, focusing instead on SARS–CoV–2 replication and its replication receptor, ACE2.
  • Three major risk factors for COVID–19 mortality—older age, diabetes and obesity—are each associated with significantly increased RBC aggregation and microvascular occlusion.

Cerus Corporation Announces Positive Topline Results for the Phase 3 Clinical Trial of the INTERCEPT Blood System for Red Blood Cells in Cardiovascular Surgery Patients

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星期二, 三月 19, 2024
Medical Supplies, Biotechnology, Practice Management, Other Health, Health, General Health, Health Technology, Medical Devices, Hospitals, Surgery, Clinical Trials, Red blood cell, STARS, Platelet, SPARC, Incidence, AKI, Patient, Corporation, Mitt, News, CERS, RBC, Acute kidney injury, Clinical trial, Antibody, Transfusion medicine, PMA, Safety, DSMB, Data, Food, FDA, Physician, Cerus Corporation, Pharmaceutical industry

Cerus Corporation (Nasdaq: CERS) today announced positive topline results for ReCePI, a pivotal Phase 3 clinical trial of pathogen reduced INTERCEPT Red Blood Cells (INTERCEPT RBCs) transfused to complex cardiac surgery patients.

Key Points: 
  • Cerus Corporation (Nasdaq: CERS) today announced positive topline results for ReCePI, a pivotal Phase 3 clinical trial of pathogen reduced INTERCEPT Red Blood Cells (INTERCEPT RBCs) transfused to complex cardiac surgery patients.
  • There was no clinical significance related to treatment-emergent RBC antibodies observed in five patients receiving INTERCEPT RBCs.
  • This safety endpoint is also being explored in the Company’s ongoing RedeS Phase 3 clinical trial of INTERCEPT RBCs.
  • “We are extremely pleased by the positive topline results of the ReCePI clinical trial,” stated Richard Benjamin, M.D., Ph.D., Cerus’ chief medical officer and principal investigator for the ReCePI clinical trial.

Cerus Corporation Announces Fourth Quarter and Full-Year 2023 Financial Results

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星期二, 三月 5, 2024
Medical Supplies, Health, Hospitals, Health Technology, Other Health, General Health, Biotechnology, Red blood cell, Investment, Growth, Government, Adjustment, Cerus Corporation, Research, Pharmaceutical industry

Product gross margin for the fourth quarter of 2023 was relatively stable year over year at 55.5% compared to 55.7% for the fourth quarter of 2022.

Key Points: 
  • Product gross margin for the fourth quarter of 2023 was relatively stable year over year at 55.5% compared to 55.7% for the fourth quarter of 2022.
  • R&D expenses for the fourth quarter of 2023 were $14.3 million, compared to $18.6 million for the fourth quarter of 2022.
  • Selling, general, and administrative (SG&A) expenses narrowed for the fourth quarter of 2023 and totaled $17.3 million, compared to $23.2 million for the fourth quarter of 2022.
  • Net loss attributable to Cerus Corporation for the fourth quarter of 2023 was $1.3 million, or $0.01 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $13.6 million, or $0.08 per basic and diluted share, for the fourth quarter of 2022.

Beta-thalassemia Market to Witness Upsurge in Growth During the Study Period (2019-2032), Evaluates DelveInsight | Leading Companies - Vertex Pharmaceuticals, CRISPR Therapeutics, Agios Pharmaceuticals, Celgene, Forma Therapeutics

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星期三, 一月 17, 2024
Vertex Pharmaceuticals, Patient, Biologics license application, Therapy, Endocrine system, TGF, Heart, LAS, HBA, Spleen, Diagnosis, Anemia, Mouse, Thalassemia, Beta thalassemia, HB, CBC, RBC, Pharmacosmos, Disease, Iron overload, TDT, EU4, FDA, Blas, Prevalence, Liver, Novo Nordisk, PDUFA, Red blood cell, CRISPR Therapeutics, Hemoglobin A, Cell, Iron, Pharmaceutical industry

LAS VEGAS, Jan. 17, 2024 /PRNewswire/ -- DelveInsight's Beta-thalassemia Market Insights report includes a comprehensive understanding of current treatment practices, beta-thalassemia emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].

Key Points: 
  • According to DelveInsight's analysis, the market size for beta-thalassemia across the 7MM is expected to grow with a significant CAGR by 2032.
  • The promising beta-thalassemia therapies in the pipeline include CTX001, EDIT-301, Mitapivat, ACE-536, Panobinostat, Etavopivat tablets, and others.
  • In September 2023, Pharmacosmos has initiated a Phase II trial of SP-420 in patients with transfusion-dependent β-thalassemia.
  • In June 2023, FDA accepted the Biologics License Application (BLAs) of exagamglogene autotemcel (exa-cel) for transfusion-dependent beta thalassemia (TDT).

Beta-thalassemia Market to Witness Upsurge in Growth During the Study Period (2019-2032), Evaluates DelveInsight | Leading Companies - Vertex Pharmaceuticals, CRISPR Therapeutics, Agios Pharmaceuticals, Celgene, Forma Therapeutics

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星期三, 一月 17, 2024
Vertex Pharmaceuticals, Patient, Biologics license application, Therapy, Endocrine system, TGF, Heart, LAS, HBA, Spleen, Diagnosis, Anemia, Mouse, Thalassemia, Beta thalassemia, HB, CBC, RBC, Pharmacosmos, Disease, Iron overload, TDT, EU4, FDA, Blas, Prevalence, Liver, Novo Nordisk, PDUFA, Red blood cell, CRISPR Therapeutics, Hemoglobin A, Cell, Iron, Pharmaceutical industry

LAS VEGAS, Jan. 17, 2024 /PRNewswire/ -- DelveInsight's Beta-thalassemia Market Insights report includes a comprehensive understanding of current treatment practices, beta-thalassemia emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].

Key Points: 
  • According to DelveInsight's analysis, the market size for beta-thalassemia across the 7MM is expected to grow with a significant CAGR by 2032.
  • The promising beta-thalassemia therapies in the pipeline include CTX001, EDIT-301, Mitapivat, ACE-536, Panobinostat, Etavopivat tablets, and others.
  • In September 2023, Pharmacosmos has initiated a Phase II trial of SP-420 in patients with transfusion-dependent β-thalassemia.
  • In June 2023, FDA accepted the Biologics License Application (BLAs) of exagamglogene autotemcel (exa-cel) for transfusion-dependent beta thalassemia (TDT).

bluebird bio Announces FDA Approval of LYFGENIA™ (lovotibeglogene autotemcel) for Patients Ages 12 and Older with Sickle Cell Disease and a History of Vaso-Occlusive Events

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星期五, 十二月 8, 2023
FDA, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Red blood cell, Sickle cell disease, Patient, Anemia, Quality of life, Bangladesh Technical Education Board, Qualification, Webcast, Priority review, Lung, Vasculitis, Food, Incidence, Pain, Priapism, Acute myeloid leukemia, Bluebird, PIN, Genetic disorder, Regenerative medicine, Division, Ronas Voe, DSM-IV codes, Hematology, Vaso-occlusive crisis, Courage, Adolescence, Hemolytic anemia, Stomatitis, Cellular, Febrile neutropenia, History, Leukopenia, Thrombocytopenia, Neutropenia, University, QTC, Life, NHLBI, Bone marrow, Research, HBA, Bluebird bio, Telephone, Disease, Acute chest syndrome, Caregiver, NIH, MD, Blood transfusion, Pharmaceutical industry, Vaccine, Online shopping

LYFGENIA is a one-time gene therapy that has the potential to resolve vaso-occlusive events and is custom-designed to treat the underlying cause of sickle cell disease.

Key Points: 
  • LYFGENIA is a one-time gene therapy that has the potential to resolve vaso-occlusive events and is custom-designed to treat the underlying cause of sickle cell disease.
  • “LYFGENIA has the potential to have a transformational impact for patients who currently live under the shadow of unpredictable and debilitating vaso-occlusive events.
  • The burden associated with VOEs is pervasive and can affect every aspect of life for patients and their families and caregivers.
  • A replay of the webcast will be available on the bluebird website for 90 days following the event.

Cerus Corporation Announces Third Quarter 2023 Financial Results

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星期四, 十一月 2, 2023
Medical Supplies, Health, Hospitals, Health Technology, Other Health, General Health, Biotechnology, CERS, Government, Red blood cell, SG, EBITDA, Research, R, Growth, Corporation, Transfusion medicine, Investment, Patient, Cryptocurrency, Video game, Pharmaceutical industry, Renting, Bookkeeping, Canadian Blood Services, Cerus Corporation

Cerus Corporation (Nasdaq: CERS) today announced financial results for the third quarter ended September 30, 2023.

Key Points: 
  • Cerus Corporation (Nasdaq: CERS) today announced financial results for the third quarter ended September 30, 2023.
  • Product gross margin for the third quarter of 2023 was 54.9% compared to 55.4% for the third quarter of 2022.
  • R&D expenses for the third quarter of 2023 were $16.8 million, compared to $16.2 million for the third quarter of 2022.
  • Net loss attributable to Cerus Corporation for the third quarter of 2023 was $7.3 million, or $0.04 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $8.5 million, or $0.05 per basic and diluted share, for the third quarter of 2022.

Cellectis to Present Pre-Clinical Data on HSPC Gene Therapy Program and Comprehensive Analysis of TALE-BE at the ESGCT 30th Annual Congress

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星期二, 十月 24, 2023
Knowledge, Gene editing, ISCB Senior Scientist Award, TC, AAV, Therapy, HBB, SCD, Y RNA, Architecture, Euronext Growth, Genome, Cell, Risk, Gene, Integrin alpha M, Congress, ESGCT, European Society of Gene and Cell Therapy, Red blood cell, Myelocyte, DNA, Vaccine, HSPC

The data will be presented in three posters:

Key Points: 
  • The data will be presented in three posters:
    Presenter: Eduardo Seclen, Senior Scientist & Team Leader, Gene Editing
    Intronic editing enables lineage specific expression of therapeutics relevant for HSPC gene therapy.
  • TALEN®-mediated intron editing of the CD11b locus results in the lineage-specific expression of a reporter transgene in myeloid cells, with negligible expression in HSPC or other cellular subsets in vitro and in vivo.
  • We believe this intron editing approach could be disruptive in HSPC gene therapy and brain delivery of multiple therapeutics.
  • Using a combination of scRNA sequencing and multiple genomic read out methodologies, we demonstrate that the mutant HBB gene can be efficiently corrected in HSPCs by TALEN®-mediated gene editing coupled to non-viral gene delivery (ssODN) with a low risk of generating β-thalassemic RBCs.