MDS

Faron’s Financial Statement Release January 1 to December 31, 2023

Retrieved on: 
Wednesday, March 13, 2024
Head, Q&A, Survival, Immunotherapy, Patient, Medicine, Standard of care, CMML, Macrophage, Faron Pharmaceuticals, Neoplasm, EET, Rheumatology, PD-1, TME, PR, ASH, AML, Cancer, Johnson & Johnson, Safety, Azacitidine, MDS, BLA, Decitabine, Food, ODD, Nasdaq First North, PD, Tumor microenvironment, Manuscript, CRS, SICAV, MD, Interferon beta-1a, Haematopoietic system, GMT, FDA, AIM, Neurotoxicity, Infection, EUR, Sanofi, SOC, Metabolism, European Hematology Association, EDT, MBA, IPF, Facility, Treasury, Society, Cytokine release syndrome, CPA, Pharmaceutical industry

As at March 13, 2024, the Company is in compliance with all IPF financial covenants as agreed with the waiver letter.

Key Points: 
  • As at March 13, 2024, the Company is in compliance with all IPF financial covenants as agreed with the waiver letter.
  • Loss for the period for the financial year ended December 31, 2023, was EUR 30,9 million (2022: EUR 28,7 million).
  • In June 2023, Faron conducted a placement of 2,601,510 newly issued treasury shares to investors to raise EUR 6,6 million gross.
  • In October 2023, the Company successfully raised EUR 7,1 million gross through the issuance of 2,491,998 ordinary shares to investors.

European Commission Expands Approval of Bristol Myers Squibb’s Reblozyl® (luspatercept) to Include First-Line Treatment of Transfusion-Dependent Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (LR-MDS)

Retrieved on: 
Wednesday, April 3, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Civil service commission, BMY, Safety, Patient, Transfusion-dependent anemia, Bristol Myers Squibb, European Commission, Anemia, MDS, Epoetin alfa, Pharmaceutical industry

Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has expanded approval of Reblozyl® (luspatercept) to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS).

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has expanded approval of Reblozyl® (luspatercept) to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS).
  • This approval of Reblozyl covers all EU member states.
  • Safety results were consistent with previous MDS studies and were in line with expected symptoms in this patient population.
  • Reblozyl is also approved in the United States and Japan for the first-line treatment of anemia associated with lower-risk MDS.

Syros Reports Fourth Quarter and Full Year 2023 Financial Results and Provides a Corporate Update

Retrieved on: 
Wednesday, March 27, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Research, Aplastic anemia, Pfizer, AML, Webcast, Patient, Venetoclax, NDA, G&A, Azacitidine, ID, MDS, Bone marrow, RARA, Pharmaceutical industry

Gross proceeds to Syros were approximately $45.0 million, before underwriting discounts and commissions and offering expenses payable by Syros.

Key Points: 
  • Gross proceeds to Syros were approximately $45.0 million, before underwriting discounts and commissions and offering expenses payable by Syros.
  • Cash, cash equivalents and marketable securities as of December 31, 2023, were $139.5 million, as compared with $202.3 million on December 31, 2022.
  • ET to discuss the fourth quarter and full-year 2023 financial results and provide a corporate update.
  • A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com .

PhotoPharmics Launches Largest Phototherapy Trial for Parkinson’s Disease

Retrieved on: 
Tuesday, March 26, 2024
Biotechnology, Neurology, Medical Devices, Health, Clinical Trials, PDQ, Depression, Parkinson's disease, Disease, Sleep, Patient, URMC, Research, Anxiety, University, Telehealth, Hope, Quality of life, Eye, Chet, Light, Clinical trial, Retina, Cognition, MDS, Tremor, Fatigue, FDA, The, Pharmaceutical industry

The "Celeste Light for PD Trial" (found at lightforpd.com) represents a significant stride in Parkinson’s disease (PD) treatment, leveraging innovative Spectramax™ technology through the passive and non-invasive Celeste® phototherapy device.

Key Points: 
  • The "Celeste Light for PD Trial" (found at lightforpd.com) represents a significant stride in Parkinson’s disease (PD) treatment, leveraging innovative Spectramax™ technology through the passive and non-invasive Celeste® phototherapy device.
  • This pivotal trial will assess the efficacy of Celeste®, the company’s FDA Breakthrough phototherapy device to improve non-motor and motor function and quality of life in Parkinson’s disease (PD).
  • This 300-patient phototherapy trial will be the largest trial of its kind.
  • “A pivotal trial for medical devices is similar to a phase 3 trial drug trial,” said Dan Adams, chief science officer.

Geron Announces FDA Oncologic Drugs Advisory Committee Votes in Favor of the Clinical Benefit/Risk Profile of Imetelstat for the Treatment of Transfusion-Dependent Anemia in Patients with Lower-Risk MDS

Retrieved on: 
Thursday, March 14, 2024
Research, Hospitals, FDA, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Bone marrow, Patient, Transfusion-dependent anemia, Corporation, Imetelstat, ODAC, Anemia, Geron Corporation, MDS, Food, Medicine, Pharmaceutical industry

“We are pleased with the Committee’s decision to recognize the positive clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in adult patients with lower-risk MDS.

Key Points: 
  • “We are pleased with the Committee’s decision to recognize the positive clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in adult patients with lower-risk MDS.
  • Additionally, a sustained increase in mean hemoglobin levels in imetelstat-treated patients was observed over time compared to placebo patients.
  • The ODAC provides the FDA with independent opinions and recommendations from outside medical experts, patients and caregivers, though the recommendations are not binding.
  • Geron plans to commercially launch imetelstat in the U.S. upon potential FDA approval.

PureTech Receives Orphan Drug Designation for LYT-200 in Acute Myeloid Leukemia

Retrieved on: 
Wednesday, March 13, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Diagnosis, Head, Survival, Massachusetts General Hospital, AML, Patient, Doctor of Philosophy, MD, PRTC, HMA, Hospital, Bone marrow, MDS, Immunoglobulin G, Food, Person, Pharmaceutical industry

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to LYT-200 for the treatment of AML.

Key Points: 
  • PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to LYT-200 for the treatment of AML.
  • LYT-200 is a fully human IgG4 monoclonal antibody (mAb) targeting galectin-9, a potent oncogenic driver in leukemia cells and an immunosuppressive protein.
  • “Orphan drug designation from the FDA validates our belief that targeting galectin-9 with LYT-200 is a novel, promising approach that may offer patients a better tolerated, more effective treatment,” notes Aleksandra Filipovic, MD, PhD, Head of Oncology at PureTech.
  • The FDA grants orphan drug designation to novel drug and biologic products for the treatment, diagnosis, or prevention of conditions affecting fewer than 200,000 persons in the U.S. Orphan drug designation qualifies PureTech for incentives under the Orphan Drug Act, including tax credits for some clinical trials and eligibility for seven years of market exclusivity in the U.S., if the drug is approved for AML.

AMERICAN SKIN ASSOCIATION ANNOUNCES NEW BOARD MEMBER JOSEPH F. MEROLA, MD, MMSc, FAAD, FACR

Retrieved on: 
Thursday, April 4, 2024
Cone Health Women's Hospital, Internal medicine, Patient, Skin, FAAD, Connective tissue, DSM-IV codes, Education, ASA, MDS, MMSc, Mass, Harvard Medical School, Associate, National Psoriasis Foundation, Psoriatic arthritis, Hospital, Public health, Atopic dermatitis, Dermatomyositis, Lupus, American Academy, Assessment, Management

NEW YORK, April 4, 2024 /PRNewswire/ -- American Skin Association (ASA) announced today that Joseph F. Merola, MD, MMSc, FAAD, FACR, will join its Board of Directors.

Key Points: 
  • NEW YORK, April 4, 2024 /PRNewswire/ -- American Skin Association (ASA) announced today that Joseph F. Merola, MD, MMSc, FAAD, FACR, will join its Board of Directors.
  • Distinguished Chair in Dermatology and is Professor at the Peter O'Donnell Jr. School of Public Health.
  • "We are proud to announce the addition of Dr. Joseph Merola to ASA's Board of Directors.
  • He was recently elected to the Board of the American Academy of Dermatology.

CASI PHARMACEUTICALS ANNOUNCES FOURTH QUARTER AND FULL-YEAR 2023 BUSINESS AND FINANCIAL RESULTS

Retrieved on: 
Thursday, March 28, 2024
Agreement, Transplant, CASI Pharmaceuticals, CASI, Patient, Travel, PTCL, Immunoglobulin G, CMC, Depreciation, Bone marrow, Therapy, VCP, Marketing, Research, Cleave, Pralatrexate, MCL, Rituximab, AML, Pembrolizumab, Trial of the century, Myelodysplastic syndrome, Melphalan, MDS, Clinical trial, Follicular lymphoma, Republic, Multiple myeloma, Acute myeloid leukemia, Annual report, National Medical Products Administration, Haematopoietic system, FDA, Cayman, CD19, NMPA, COVID-19, CTA, HKIAC, NHL, Non-Hodgkin lymphoma, MICL, Pharmaceutical industry

BEIJING, March 28, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported business and financial results for the year ended December 31, 2023, and provided an update on key highlights for 2023.

Key Points: 
  • BEIJING, March 28, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported business and financial results for the year ended December 31, 2023, and provided an update on key highlights for 2023.
  • CASI reported fourth quarter 2023 revenue of $6.9 million for EVOMELA®, 33% lower than the same period in 2022.
  • 2023 marks a major milestone for CASI and our partner Juventas; Inaticabtagene Autoleucel (CNCT-19 CAR-T cell therapy) was approved by National Medical Products Administration (NMPA) in November 2023.
  • As of December 31, 2023, CASI had cash, cash equivalents and short term investment of $29.1 million compared to $48.6 million as of December 31, 2022.

Flamingo Therapeutics Appoints Leading Medical Oncologist Ezra Cohen, MD to its Board of Directors

Retrieved on: 
Thursday, March 21, 2024
University, Science, AML, UCSD, Associate, HNSCC, Patient, RNA, Acute myeloid leukemia, Cancer, Doctor of Philosophy, MD, MBA, Myelodysplastic syndrome, Therapy, Division, MDS, Neck, Pharmaceutical industry

LEUVEN, Belgium and STRASBOURG, France and PHILADELPHIA, March 21, 2024 /PRNewswire/ -- Flamingo Therapeutics ("Flamingo") today announced the appointment of Ezra Cohen, MD to its Board of Directors.

Key Points: 
  • LEUVEN, Belgium and STRASBOURG, France and PHILADELPHIA, March 21, 2024 /PRNewswire/ -- Flamingo Therapeutics ("Flamingo") today announced the appointment of Ezra Cohen, MD to its Board of Directors.
  • Dr. Cohen is a leading medical oncologist and cancer researcher who brings unique and relevant expertise in the development of drugs, especially head and neck cancer, to the Flamingo board.
  • Ezra Cohen, MD currently serves as the Chief Medical Officer of Oncology for Tempus AI.
  • "His expertise in leading globally recognized cancer centers and helping many companies develop successful drugs enhances our Board and we look forward to Ezra's contribution," added Chris Mirabelli, PhD, Chairman of the Board of Flamingo.

DFI Collaborates with MDS to Showcase AI Embedded Solutions at Smart Factory + Automation World 2024

Retrieved on: 
Wednesday, March 20, 2024
Deep learning, DFI, DL Boost, SOC, Face, Acceleration, Intelligence, Xe, AI, VNNI, SBC, IMB, Xeon, MDS, Som, Smart

TAIPEI, March 20, 2024 /PRNewswire/ -- DFI, the world's leading brand in embedded motherboards and industrial computers, is thrilled to announce its collaboration with Korean distributor MDS for a groundbreaking co-exhibition at Smart Factory + Automation World 2024 in Seoul, Korea. The showcase will feature an exclusive demonstration of the TGH960 System-on-Module and its AI edge computing applications, highlighting its deep learning capabilities and face and object recognition features.

Key Points: 
  • TAIPEI, March 20, 2024 /PRNewswire/ -- DFI , the world's leading brand in embedded motherboards and industrial computers, is thrilled to announce its collaboration with Korean distributor MDS for a groundbreaking co-exhibition at Smart Factory + Automation World 2024 in Seoul, Korea.
  • Founded in 1990, Smart Factory + Automation World 2024 is a premier international exhibition in the Korean automation market that brings together industry leaders, innovators, and technology enthusiasts from around the world.
  • As leaders at the forefront of the embedded industry, DFI and MDS aim to leverage the platform to redefine the future of the smart manufacturing and industrial automation industry.
  • The AI BOX from MDS has received positive feedback from numerous customers in terms of its performance in deep learning.