Granulocyte-macrophage colony-stimulating factor

Coya Therapeutics Provides a Corporate Update and Reports Fiscal 2023 Financial Results

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화요일, 3월 19, 2024
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Research, Pharmacology, LD, Survival, Serum, ALS, Science, PD, Houston Methodist Hospital, Patient, Regulatory affairs, Granulocyte-macrophage colony-stimulating factor, FD, GM-CSF, Nebraska Medicine, COYA, University, IPO, Senior, Society, IND, Commerce, Viral disease, Therapy, Frontotemporal dementia, FDA, FTD, Pharmaceutical industry

Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, provides a corporate update and announces its financial results for the year ended December 31, 2023.

Key Points: 
  • Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, provides a corporate update and announces its financial results for the year ended December 31, 2023.
  • COYA 302 is Coya’s combination of its proprietary LD IL-2 formulation with the immunomodulatory drug CTLA4-Ig.
  • “We believe that we have under-promised and over-delivered in executing on numerous deliverables in 2023 that have brought value to Coya,” commented Howard Berman, Ph.D., Chief Executive Officer of Coya.
  • Net loss was $8.0 million for the year ended December 31, 2023, compared to net loss of $12.2 million for the year ended December 31, 2022.

Partner Therapeutics' Leukine® (sargramostim) Receives Approval in Japan to Treat Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

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수요일, 4월 3, 2024
Monocyte, GM, Serum, Disease, Partnership, Patient, GM-CSF, DNA, PTX, Doctor of Philosophy, Respiratory failure, Pleasure, Trade name, Granulocyte-macrophage colony-stimulating factor, Pulmonary fibrosis, APAP, Therapy, Niigata University, Pulmonary alveolar proteinosis, Division, Partner, PMDA, PAGE, CEA, WLL, Hospital

LEXINGTON, Mass., April 3, 2024 /PRNewswire/ -- Partner Therapeutics, Inc. (PTx) announced that its partner Nobelpharma received approval from the Japanese Pharmaceuticals and Medical Device Agency (PMDA) for the inhaled use of Leukine (sargramostim), branded in Japan as Sargmalin, to treat aPAP. PTx licensed rights for certain indications in Japan to Nobelpharma in 2022. Leukine is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in yeast. Leukine is not approved outside Japan for aPAP or as an inhalation therapy. Partner Therapeutics will manufacture Sargmalin for Nobelpharma at its manufacturing facility in Lynnwood, WA.

Key Points: 
  • Leukine is not approved outside Japan for aPAP or as an inhalation therapy.
  • Partner Therapeutics will manufacture Sargmalin for Nobelpharma at its manufacturing facility in Lynnwood, WA.
  • Inhaled recombinant GM-CSF reduces the need for whole lung lavage and improves gas exchange in autoimmune pulmonary alveolar proteinosis patients.
  • Autoimmune pulmonary alveolar proteinosis.

Y-mAbs Reports Second Quarter 2023 Financial Results and Recent Corporate Developments

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목요일, 8월 10, 2023
Triple-negative breast cancer, Carcinoma, Interim, Melanoma, Cohort, American Society of Clinical Oncology, Cancer, American Association for Cancer Research, Research, EDT, MCI, ASCO, Sarcoma, Patient, Memorial Sloan Kettering Cancer Center, Yoy, Brazilian Health Regulatory Agency, Therapy, Society, Granulocyte-macrophage colony-stimulating factor, WEP, Naxitamab, Fine chemical, Pharmaceutical industry, Rare-earth element, Cryptocurrency, Drug, Electric power

On May 23, 2023, Y-mAbs announced that the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária (“ANVISA”) granted marketing authorization for DANYELZA (naxitamab-gqgk).

Key Points: 
  • On May 23, 2023, Y-mAbs announced that the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária (“ANVISA”) granted marketing authorization for DANYELZA (naxitamab-gqgk).
  • The DANYELZA net product revenues for the quarter ended June 30, 2023 represents an increase of 3% compared to the first quarter of 2023.
  • As of June 30, 2023, Y-mAbs has delivered DANYELZA to 56 centers across the U.S., a sequential increase of 6% in the number of centers since the first quarter of 2023.
  • During the second quarter of 2023, approximately 61% of the vials sold in the U.S. were sold outside of Memorial Sloan Kettering Cancer Center (“MSKCC”), which is in line with the first quarter of 2023.

Y-mAbs Announces Presentation of Naxitamab Data at ASCO

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금요일, 5월 26, 2023
Hypotension, American Society of Clinical Oncology, Bone marrow, Cancer, Outer ring road, CS, Naxitamab, Hives, Pain, Metastasis, Patient, Memorial Sloan Kettering Cancer Center, MSK, Therapy, Bronchospasm, Society, ORR, Granulocyte-macrophage colony-stimulating factor, Disease, Medical imaging, Pharmaceutical industry

The ongoing Phase 2 Trial 201 (NCT03363373) evaluates naxitamab in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”) in patients with relapsed or refractory HR-NB with residual disease limited to bone and/or bone marrow.

Key Points: 
  • The ongoing Phase 2 Trial 201 (NCT03363373) evaluates naxitamab in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”) in patients with relapsed or refractory HR-NB with residual disease limited to bone and/or bone marrow.
  • Curie Score (“CS”) is a semi-quantitative scoring system used to assess the extent of bone metastases and treatment response.
  • An interim analysis of Trial 201 (data cutoff December 31, 2021) included 52 patients in the efficacy group and 74 patients in the safety group.
  • Patients with refractory disease had a lower frequency of serious naxitamab related adverse events compared to patients with relapsed disease.

Y-mAbs Announces Partnership Regarding Early Access Program for DANYELZA (naxitamab-gqgk) in Europe

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수요일, 12월 21, 2022
Cancer, Bone marrow, Central nervous system, Therapy, WEP, MSK, Interim, GD2, Patient, Injection, FDA, Granulocyte-macrophage colony-stimulating factor, Memorial Sloan Kettering Cancer Center, Peripheral nervous system, Cell, Pharmaceutical industry

DANYELZA is a humanized, monoclonal antibody that binds to the glycolipid GD2.

Key Points: 
  • DANYELZA is a humanized, monoclonal antibody that binds to the glycolipid GD2.
  • GD2 is a disialoganglioside that is overexpressed on neuroblastoma cells and other cells of neuroectodermal origin, including the central nervous system and peripheral nerves.
  • DANYELZA is administered on days 1, 3, and 5 of each treatment cycle as an intravenous infusion after dilution.
  • “We are excited to be able to give European patients access to DANYELZA through this early access program with WEP,” said Thomas Gad, founder, President and Interim CEO.

Y-mAbs Announces Pipeline Update

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수요일, 12월 14, 2022
Squamous cell carcinoma, Neoplasm, Annual report, Sarcoma, Interim, Osteosarcoma, Security (finance), Marketing, MRCP, SVP, B7-H3, Growth, MBA, Research, MSK, COVID-19, DCH, FDA, Safety, Cancer, Bone marrow, Neuropathic pain, GD2, Melanoma, All India Mahila Congress, Granulocyte-macrophage colony-stimulating factor, MBBS, Cardiac arrest, Neurotoxicity, Transverse myelitis, Patient, Failure, Antibody, Government, Memorial Sloan Kettering Cancer Center, Anaphylaxis, Therapy, Vaccine, Pharmaceutical industry

Investors, analysts, members of the media and the public may access the event via a live webcast .

Key Points: 
  • Investors, analysts, members of the media and the public may access the event via a live webcast .
  • The presentation materials can be found on the Company’s website under the Presentations tab under the heading For Investors.
  • Dr. Rajah, will present an update on DANYELZA® (naxitamab-gqgk), including potential label expansion into osteosarcoma, and a planned multicenter Phase 2 trial in patients with newly diagnosed high-risk neuroblastoma.
  • The Company’s broad and advanced product pipeline includes one FDA-approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one product candidate at the registration-stage, OMBLASTYS® (omburtamab), which targets tumors that express B7-H3.

Y-mAbs’ DANYELZA® (naxitamab-gqgk) for the Treatment of High-Risk Neuroblastoma Approved in China

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목요일, 12월 8, 2022
Granulocyte-macrophage colony-stimulating factor, Sarcoma, Neoplasm, Annual report, Failure, Interim, Government, Marketing, FDA, Cardiac arrest, National Medical Products Administration, Safety, Cancer, Bone marrow, Memorial Sloan Kettering Cancer Center, Neurotoxicity, Neuropathic pain, B7-H3, Risk, GD2, Growth, Anaphylaxis, Transverse myelitis, Research, Therapy, MSK, Holding, COVID-19, Patient, Vaccine, Pharmaceutical industry

DANYELZA will be marketed in China by Y-mAbs’ partner SciClone Pharmaceuticals (Holdings) Limited (“SciClone Pharmaceuticals”).

Key Points: 
  • DANYELZA will be marketed in China by Y-mAbs’ partner SciClone Pharmaceuticals (Holdings) Limited (“SciClone Pharmaceuticals”).
  • DANYELZA is a humanized, monoclonal antibody that targets the ganglioside GD2, which is highly expressed in various neuroectoderm-derived tumors and sarcomas.
  • DANYELZA is administered to patients three times in a week in an outpatient setting and the treatment is repeated every four weeks.
  • “Today is an important day for children living with refractory/relapsed high-risk neuroblastoma in China.

Y-mAbs to Host Annual Research and Development Day in New York

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화요일, 12월 6, 2022
Granulocyte-macrophage colony-stimulating factor, Neoplasm, Annual report, Research, Failure, Interim, Osteosarcoma, MBBS, Government, Marketing, DCH, FDA, Cardiac arrest, PRV, Safety, Sale, Memorial Sloan Kettering Cancer Center, Bone marrow, MRCP, Neurotoxicity, SVP, Neuropathic pain, B7-H3, GD2, Growth, Anaphylaxis, MBA, Transverse myelitis, Therapy, MSK, COVID-19, Development, Patient, Pharmaceutical industry

NEW YORK, Dec. 06, 2022 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company today announced that it will host its annual Research and Development Day in New York, NY on December 14, 2022, at 9:00 am ET.

Key Points: 
  • NEW YORK, Dec. 06, 2022 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company today announced that it will host its annual Research and Development Day in New York, NY on December 14, 2022, at 9:00 am ET.
  • The event will feature presentations of the Company, its clinical development, and advanced product pipeline.
  • Thomas Gad (Founder, President, and Interim Chief Executive Officer at Y-mAbs Therapeutics) will give a corporate presentation.
  • Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic cancer products.

Protara Therapeutics Announces Trials in Progress Poster Presentation for the ADVANCED-1 Trial in NMIBC at the 23rd Annual Meeting of the Society of Urologic Oncology

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목요일, 12월 1, 2022
COVID-19, Microcystic lymphatic malformation, United, LM, IL-6, Degenerative disease, Food and Drug Administration, Urology, Granulocyte colony-stimulating factor, TNF, Streptococcus, Food, Safety, LMS, CIS, Therapy, Granulocyte-macrophage colony-stimulating factor, Lymphocyte, Patient, IL-8, Monocyte, Neutrophil, Society, Cytokine, Neoplasm, Date, Annual general meeting, Streptococcus pyogenes, IL-12, Cancer, Cyst, Bladder cancer, FDA, Pharmaceutical industry, Risk management, NMIBC

The ADVANCED-1 study is evaluating TARA-002, an investigational cell-based immunopotentiator, for the treatment of non-muscle invasive bladder cancer (NMIBC).

Key Points: 
  • The ADVANCED-1 study is evaluating TARA-002, an investigational cell-based immunopotentiator, for the treatment of non-muscle invasive bladder cancer (NMIBC).
  • In the initial dose escalation phase of the trial, patients will receive six weekly intravesical doses of TARA-002.
  • Bladder cancer is the 6th most common cancer inthe United States, with NMIBC representing approximately 80% of bladder cancer diagnoses.
  • Protara is committed to identifying and advancing transformative therapies for people with cancer and rare diseases with limited treatment options.

Savara Announces New Employment Inducement Grant

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화요일, 11월 22, 2022
Health, Other Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Inc., APAP, Employment, RSU, Degenerative disease, Granulocyte-macrophage colony-stimulating factor, Savara, Pulmonology, GM-CSF, Pharmaceutical industry

Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the grant of an employee inducement award.

Key Points: 
  • Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the grant of an employee inducement award.
  • The inducement award consists of options to purchase 375,000 shares of the Companys common stock and restricted stock units (RSUs) covering 150,000 shares of the Companys common stock.
  • This equity award was granted under the Savara Inc. 2021 Inducement Equity Incentive Plan pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules as an inducement material to the employees acceptance of employment with the Company.
  • The RSUs vest in full on the two-year anniversary of the employees first day of employment, subject to the employees continued employment on such vesting date.