Decitabine

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.

Orphan designation: Cedazuridine / decitabine Treatment of myelodysplastic syndromes, 16/08/2023 Positive

Retrieved on: 
Sunday, February 4, 2024
COMP, IRIS, Syndrome, EMA, European Commission, Otsuka Pharmaceutical, Patient, Committee, Decitabine, Pharmaceutical industry

Key facts

Key Points: 
  • Key facts
    - Active substance
    - Cedazuridine / decitabine
    - Medicine name
    - Inaqovi
    - Intended use
    - Treatment of myelodysplastic syndromes
    - Orphan designation status
    - Positive
    - EU designation number
    - EU/3/23/2825
    - Date of designation
    - Sponsor
    Otsuka Pharmaceutical Netherlands B.V.
  • Patients' organisations
    For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
    European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:
    EMA list of opinions on orphan medicinal product designation
    EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:

Detailed Analysis of BEXMAB Data Provides Insights into Patient Profiles of Responding HMA-Failed MDS Population

Retrieved on: 
Thursday, January 25, 2024
AIM, Patient, SOC, MDS, Decitabine, Standard of care, Survival, Faron Pharmaceuticals, PD, Quality of life, Azacitidine, Nasdaq First North, Safety, Majesty of the Seas, Myelodysplastic syndrome, Myelocyte, Pharmaceutical industry

The new analysis of data from the Phase 1 part of the trial explores the 100% overall response rate (ORR) achieved among both the higher-risk frontline and HMA-failed MDS patients treated with a bexmarilimab/azacitidine combination – 5 out of 5 patients in each population – and examines previous therapies in the patients’ treatment pathways.

Key Points: 
  • The new analysis of data from the Phase 1 part of the trial explores the 100% overall response rate (ORR) achieved among both the higher-risk frontline and HMA-failed MDS patients treated with a bexmarilimab/azacitidine combination – 5 out of 5 patients in each population – and examines previous therapies in the patients’ treatment pathways.
  • “Patients with high-risk MDS who have failed HMA therapy face a poor prognosis and median overall survival in refractory MDS is just 4-6 months with no viable treatment options.
  • Yet here we have data showing that patients are surpassing anticipated survival rates and maintaining remission.
  • It is remarkable to see patients going into remission with bexmarilimab/azacitidine after showing disease progression on all the leading azacitidine combinations such as venetoclax, sabatolimab and magrolimab.

Bio-Path Holdings Reports Third Quarter 2023 Financial Results

Retrieved on: 
Wednesday, November 15, 2023
Acute myeloid leukemia, Clinical trial, Patient, Research, MD Anderson Cancer Center, D.O, Division, AML, Holding, Interim analysis, KOL, Pharmaceutical industry, Cryptocurrency, Decitabine

HOUSTON, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced its financial results for the third quarter ended September 30, 2023 and provided an update on recent corporate developments.

Key Points: 
  • HOUSTON, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced its financial results for the third quarter ended September 30, 2023 and provided an update on recent corporate developments.
  • Announced Positive Results from Interim Analysis of Phase 2 Clinical Trial of Prexigebersen in Acute Myeloid Leukemia.
  • As of September 30, 2023, the Company had cash of $2.4 million, compared to $10.4 million as of December 31, 2022.
  • ET to review these third quarter 2023 financial results and to provide a general update on the Company.

Schrödinger Presents Data Supporting Advancement of SGR-1505 and SGR-2921 at American Society of Hematology 2023 Annual Meeting

Retrieved on: 
Sunday, December 10, 2023
Oncology, Health, Technology, Health Technology, Software, Pharmaceutical, Biotechnology, Webcast, Cytokine, Decitabine, Safety, CDC7, Lymphoid leukemia, ASH, Acute myeloid leukemia, Harmonic pitch class profiles, B-cell lymphoma, Patient, Abstract, NF, Pharmacokinetics, Therapy, Venetoclax, Chronic lymphocytic leukemia, Significance, Trial of the century, Human, MALT1, AML, Potent, Cancer, Society, Myelodysplastic syndrome, NHL, CLL, Pharmaceutical industry, Vaccine

The preclinical data reported show that both SGR-1505 and SGR-2921 have multiple favorable attributes and the potential for combination activity with standard-of-care agents.

Key Points: 
  • The preclinical data reported show that both SGR-1505 and SGR-2921 have multiple favorable attributes and the potential for combination activity with standard-of-care agents.
  • The company will report additional data from the healthy subject study at its Pipeline Day on December 14, 2023.
  • “The pharmacological data for SGR-1505 and SGR-2921 demonstrate that our development candidates have favorable, differentiated profiles with best-in-class potential,” stated Karen Akinsanya, Ph.D., president of R&D therapeutics at Schrödinger.
  • “Our progress within these programs further validates our computational approach to designing therapies with the potential to address the limitations of current treatments.

Biomea Fusion Announces Two Poster Presentations at Upcoming ASH Annual Meeting 2023

Retrieved on: 
Thursday, November 2, 2023
Trae tha Truth, ECOG, Vomiting, CYP3A4, WT, Abstract, NPM1, KMT2A, OBD, PK, DLT, TKD, Cancer, Diabetes, ORR, Clinical study design, Safety, Patient, Cohort, HSCT, SETBP1, CR, DSM-IV codes, NUP214, DOR, Dicarboxylic acid, CRi, ASH, CD135, QT interval, RFS, FLT3, Arm, Cellular, FMS, Transplant, ALL, Toxic leukoencephalopathy, Gene family, Survival, Postcholecystectomy syndrome, DS, Trial of the century, Incidence, CRC, Infrared spectroscopy correlation table, AL, Osteopathic medicine in Canada, MN1, BID, CNS, KRAS, ATD, NUP98, Society, WBC, Pharmacokinetics, CLL, Acute leukemia, Common, ITD, Toxicity, AML, Cardiovascular disease, Pharmaceutical industry, Dentistry, Vaccine, Decitabine, DLBCL

Both BMF-219 and BMF-500 were originated in-house with Biomea’s proprietary FUSION™ system platform, which discovers and designs next-generation covalent-binding small molecule product candidates.

Key Points: 
  • Both BMF-219 and BMF-500 were originated in-house with Biomea’s proprietary FUSION™ system platform, which discovers and designs next-generation covalent-binding small molecule product candidates.
  • Methods: Doses of BMF-219 are escalated independently for each indication, initially in single-subject cohorts followed by a “3 + 3” design.
  • A subsequent amendment introduced quotas for KMT2Ar (MLL1r), NPM1 and other known menin-dependent mutations: CEBP/A, MLL1-PTD, MN1, NUP98, NUP214, PICALM-AF10, SETBP1.
  • The study was initiated in July 2023 and will enroll ~110 participants at approximately 30 sites.

Foghorn Therapeutics Provides Third Quarter 2023 Financial and Corporate Update

Retrieved on: 
Thursday, November 2, 2023
Research, NSCLC, EP300, IND, Thrombocytopenia, MDS, Preclinical development, Colorectal cancer, Merck, Chromatin, Factorization of polynomials, Prostate cancer, Hanson, LDAC, ARID1B, Clinical trial, CBP, BRG1, BRM, Safety, Investment, AR, Patient, Gene expression, BAF, Prostate, Mutation, State Administrative Expenses, Cancer, Pharmaceutical industry, Vaccine, Decitabine, Foghorn, AML

“During the third quarter, we continued to enroll patients in our FHD-286 combination study in AML and expect to have data in the second half of 2024.

Key Points: 
  • “During the third quarter, we continued to enroll patients in our FHD-286 combination study in AML and expect to have data in the second half of 2024.
  • Foghorn commenced a Phase 1 study of FHD-286 in combination with decitabine or low-dose cytarabine (LDAC) in relapsed and/or refractory AML patients, with the first patient dosed during the third quarter of 2023.
  • As of September 30, 2023, the Company had $259.9 million in cash, cash equivalents and marketable securities, which provides cash runway into the first half of 2026.
  • Net loss was $14.3 million for the three months ended September 30, 2023, compared to a net loss of $25.8 million for the three months ended September 30, 2022.

Syndax Announces Updated Data Supporting Impressive Clinical Profile of Revumenib in Genetically-Defined Acute Leukemias to Be Presented at the 65th ASH Annual Meeting

Retrieved on: 
Thursday, November 2, 2023
CR, CRP, Acute myeloid leukemia, Food, Trae Waynes, Thrombocytopenia, Decitabine, Febrile neutropenia, Safety, CRH, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Phenotype, Maintenance, Poster, Society, IDMC, ASH, DLT, Abstract, MRD, QT interval, ORR, SNDX, SAVE, NDA, Acute leukemia, Cellular, Transplant, ALL, AML, Neutropenia, Phase 1, HSCT, Pharmaceutical industry, Dentistry, Patient

WALTHAM, Mass., Nov. 2, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that updated data from multiple trials across its clinical program for revumenib, the Company's highly selective, oral menin inhibitor, will be featured in three poster presentations at the 65th American Society of Hematology (ASH) Annual Meeting being held December 9-12, 2023, in San Diego, California. Copies of the abstracts are now available online via the ASH website at www.hematology.org.

Key Points: 
  • The Company previously announced positive topline data from the protocol-defined pooled analysis of the pivotal Phase 2 portion of the AUGMENT-101 trial.
  • Based on the Independent Data Monitoring Committee (IDMC) recommendation, the Company stopped the trial to further accrual in the KMT2Ar cohorts.
  • Full data from the pivotal portion of the study will be reported at the meeting.
  • Title: Revumenib Monotherapy in Patients with Relapsed/Refractory KMT2Ar Acute Leukemias: Efficacy and Safety Results from the Augment-101 Phase 1/2 Study
    Session Name: 616.

RegCell Appoints Experienced Life Science Executive and Entrepreneur Michael McCullar, Ph.D., MBA, as its New Chief Executive Officer

Retrieved on: 
Thursday, October 19, 2023
Osaka University, FDA, Immune tolerance, Food, Biotechnology, Business development, Acquisition, MBA, Regulation of tobacco by the U.S. Food and Drug Administration, Research, Otsuka Pharmaceutical, Supergene, Syndrome, Drug development, Senior, U.S. Department of Defense Strategy for Operating in Cyberspace, Technical advisor, Immune system, Business, Sumitomo Pharma, Kyoto University, Patient, Astex Pharmaceuticals, Toxic epidermal necrolysis, Pharmaceutical industry, Vaccine, Regulatory T cell, Decitabine

"I am honored to join this remarkable team at an exciting time for RegCell as we prepare to enter the clinical stage and to support the company's mission to discover innovative treatments for autoimmune diseases," said Dr. Michael McCullar, Chief Executive Officer of RegCell.

Key Points: 
  • "I am honored to join this remarkable team at an exciting time for RegCell as we prepare to enter the clinical stage and to support the company's mission to discover innovative treatments for autoimmune diseases," said Dr. Michael McCullar, Chief Executive Officer of RegCell.
  • "In an era where the increasingly aging population is facing an escalating burden of autoimmune disorders, Treg-based cellular therapies are opening the doors to exciting new treatment possibilities.
  • Dr. McCullar has a wealth of experience in the biotech and pharmaceutical industries, spanning more than two decades.
  • Dr. McCullar has held several high-level executive positions at SuperGen, showcasing his commitment and upward career path within the company.

Otsuka and Astex announce that the European Commission has approved INAQOVI® (oral decitabine and cedazuridine) for the treatment of adults with newly diagnosed acute myeloid leukaemia

Retrieved on: 
Tuesday, September 19, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, EEA, IV, Civil service commission, Acute leukemia, Fatigue, Astex Pharmaceuticals, European Medicines Agency, Clinical trial, Multimedia, EMA, Induction chemotherapy, AML, Patient, European Economic Area, Physician, EC, European Commission, Nursing, Vaccine, Decitabine, EU

Otsuka Pharmaceutical Europe Ltd. (Otsuka) and Astex Pharmaceuticals, Inc. (Astex) today announce that the European Commission (EC) has approved INAQOVI® (oral decitabine and cedazuridine) as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy.

Key Points: 
  • Otsuka Pharmaceutical Europe Ltd. (Otsuka) and Astex Pharmaceuticals, Inc. (Astex) today announce that the European Commission (EC) has approved INAQOVI® (oral decitabine and cedazuridine) as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy.
  • The EC decision applies to the European Economic Area (EEA), which includes the EU member states, Iceland, Liechtenstein and Norway.
  • INAQOVI® is the first and only oral hypomethylating agent licensed in the EEA in this patient population.
  • Safety findings for the fixed-dose combination of decitabine and cedazuridine were generally consistent with those anticipated for IV decitabine1.