CRR

Viracta Therapeutics Announces Positive Topline Nana-val Results from Stage 1 of the NAVAL-1 Trial in Patients with Relapsed or Refractory Epstein-Barr Virus-Positive (EBV+) Peripheral T-Cell Lymphoma

Retrieved on: 
Lundi, avril 15, 2024
FDA, Patient, Safety, CRR, Nausea, PTCL, Peripheral T-cell lymphoma, Thrombocytopenia, Weight loss, Appetite, Fatigue, Diarrhea, ITT, Therapy, Valganciclovir, SAN, Anemia, Pharmaceutical industry

SAN DIEGO, April 15, 2024 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today reported positive topline results from Stage 1 of the pivotal Phase 2 NAVAL-1 trial from both arms of the relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) peripheral T-cell lymphoma (PTCL) cohort. Patients were randomized to either nanatinostat monotherapy (n=10) or to nanatinostat in combination with valganciclovir (Nana-val, n=10). These data were featured in an oral presentation during the 2024 Joint Annual Congress of Taiwan Society of Blood and Marrow Transplantation and The Hematology Society of Taiwan.

Key Points: 
  • Patients were randomized to either nanatinostat monotherapy (n=10) or to nanatinostat in combination with valganciclovir (Nana-val, n=10).
  • These data were featured in an oral presentation during the 2024 Joint Annual Congress of Taiwan Society of Blood and Marrow Transplantation and The Hematology Society of Taiwan.
  • Patients who did not respond to nanatinostat monotherapy after 6 weeks of treatment were offered the opportunity to cross over to receive Nana-val.
  • Five nanatinostat monotherapy patients crossed over to receive Nana-val, two of whom remain on Nana-val treatment with stable disease as of the data cutoff.

The EBA consults on draft technical standards on the specification of long and short positions under the derogations for market and counterparty risks

Retrieved on: 
Jeudi, avril 25, 2024
RTS, EBA, SA-CCR, Risk, CRR, Comment, Capital Requirements Regulation 2013, FRTB, European

The EBA consults on draft technical standards on the specification of long and short positions under the derogations for market and counterparty risks

Key Points: 
  • The EBA consults on draft technical standards on the specification of long and short positions under the derogations for market and counterparty risks
    The European Banking Authority (EBA) today launched a public consultation on its draft Regulatory Technical Standards (RTS) on the method for identifying the main risk driver and determining whether a transaction represents a long or a short position.
  • These RTS are part of the Phase 1 deliverables of the EBA roadmap on the implementation of the EU banking package in the area of market risk.
  • The Capital Requirements Regulation (CRR) includes some derogations for the calculation of the capital requirements for market and counterparty credit risks, for small trading book business, derivative business or business subject to market risk.
  • A position can be considered as long or short depending on how movements in its main risk driver affect the market value.

ALX Oncology Reports Encouraging Clinical Data of Evorpacept in Combination with Standard-of-Care in an Ongoing Phase 1/2 Clinical Trial in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (“R/R B-NHL”)

Retrieved on: 
Mardi, avril 9, 2024
Drug design, Rituximab, R2, ALT, Assistant, Patient, SAN, CRR, University, CD47, MD Anderson Cancer Center, Clinical trial, Anemia, Fatigue, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., April 09, 2024 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, today reported encouraging clinical data from the ongoing Phase 1/2 investigator-sponsored trial (“IST”) of evorpacept in combination with R2 in patients with indolent and aggressive R/R B-NHL. The new data were presented in an oral presentation at the 2024 American Association for Cancer Research (“AACR”) Annual Meeting.

Key Points: 
  • The new data were presented in an oral presentation at the 2024 American Association for Cancer Research (“AACR”) Annual Meeting.
  • Patients received evorpacept 30 mg/kg Q2W (n=3) or 60 mg/kg Q4W (n=17) in combination with standard R2 treatment.
  • “We are pleased evorpacept in combination with R2 demonstrated a favorable safety profile and encouraging response in this patient population.
  • We look forward to applying these and other clinical trial data to inform new evorpacept combinations in our expanding pipeline.

Veritext Legal Solutions Offers Webinar on “AI and the Record for Reporters and Videographers”

Retrieved on: 
Jeudi, mars 28, 2024
RDR, CMRS, RMR, Knowledge, CRR, Ethics, NVRA, EDT, RPR, AI, CEU, CSR, CRC, Journalist, NCRA, Record, Industrial design

The webinar will take place on Thursday, April 4, at 7:30 p.m. EDT and is a 90-minute presentation.

Key Points: 
  • The webinar will take place on Thursday, April 4, at 7:30 p.m. EDT and is a 90-minute presentation.
  • This webinar will provide attendees with an overview of the role of AI in legal settings, how it’s shaping portions of the legal landscape and critical considerations for ethical usage and practice.
  • “Technology can’t replace or replicate the value that a trained officer of the court provides,” states Murray.
  • “Our most technologically advanced solutions rely on trained professional reporters to create and preserve the record and certify its accuracy.

Capitalize Releases New 401(k) Statistics Tracker Providing Insights Into Broader 401(k) and Retirement Savings Trends Across the Country

Retrieved on: 
Mercredi, mars 20, 2024
Personal Finance, Data Analytics, Accounting, Professional Services, Fintech, Retirement, CRR, Research, Financial adviser

Capitalize , the award-winning platform to find and transfer retirement accounts, today released its new 401(k) Statistics Tracker in collaboration with the Center for Retirement Research (CRR).

Key Points: 
  • Capitalize , the award-winning platform to find and transfer retirement accounts, today released its new 401(k) Statistics Tracker in collaboration with the Center for Retirement Research (CRR).
  • The collaboration stems from shared missions: to facilitate data-driven discussion in the retirement savings market and empower workers to grow their retirement savings.
  • The new Capitalize 401(k) Statistics Tracker provides and analyzes data from a range of sources, including public, proprietary, and institutional data, in order to surface insights representative of the broader retirement savings landscape in one place.
  • “We hope the Capitalize 401(k) Statistics Tracker will foster dialogue leading to more positive outcomes in retirement.”
    To date, the Capitalize 401(k) Statistics Tracker has highlighted a range of metrics that underscore ongoing progress in 401(k) access, balances, and contributions.

Kezar Life Sciences Reports Fourth Quarter and Year End 2023 Financial Results and Provides Business Update

Retrieved on: 
Jeudi, mars 14, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Research, Week, Autoimmune hepatitis, NMPA, ALT, AIH, Patient, CRR, Cohort, G&A, CDE, UPCR, IND, Clinical trial, Therapy, KZR, Safety, Pharmacokinetics, Lupus nephritis, Total, Pharmaceutical industry

(Nasdaq: KZR), a clinical-stage biotechnology company developing breakthrough treatments for immune-mediated and oncologic disorders, today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a business update.

Key Points: 
  • (Nasdaq: KZR), a clinical-stage biotechnology company developing breakthrough treatments for immune-mediated and oncologic disorders, today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a business update.
  • Research and development (R&D) expenses for the fourth quarter of 2023 increased by $7.7 million to $22.6 million, compared to $14.9 million in the fourth quarter of 2022.
  • General and administrative (G&A) expenses for the fourth quarter of 2023 increased by $0.6 million to $5.8 million compared to $5.2 million in the fourth quarter of 2022.
  • Restructuring and impairment charges for the fourth quarter of 2023 were $6.2 million.

GenSight Biologics Announces Initial Results from New Meta-Analyses on Visual Outcomes with LUMEVOQ® Gene Therapy at NANOS 2024

Retrieved on: 
Mardi, mars 12, 2024
Research, Neurology, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, Optical, Science, Mutation, Disease, Nadir, Patient, CRR, Eye, Idebenone, Natural history, Phase, Multimedia, Neuro-ophthalmology, ND4, Interval (mathematics), AAC, Medical imaging

The meta-analyses are the first to focus solely on patients with the m.11778G>A ND4 mutation, which is the most common mutation and one with a poor visual prognosis1.

Key Points: 
  • The meta-analyses are the first to focus solely on patients with the m.11778G>A ND4 mutation, which is the most common mutation and one with a poor visual prognosis1.
  • This gradient of recovery, based on the CRR measure of visual improvement, is observed at both eye level and patient level (response in one or both eyes).
  • There is no overlap in confidence intervals when LUMEVOQ® is compared to idebenone and to natural history, indicating a positive difference in visual outcomes.
  • Follow-up of patients in the Phase III REFLECT study of LUMEVOQ® is ongoing, with topline results at Year 4 of follow-up expected this month.

Cboe Clear Europe Secures Support of Additional Key Participants for Launch of Securities Financing Transactions Clearing Service

Retrieved on: 
Jeudi, avril 4, 2024
Bank of America, Clearing house (finance), Growth, Rural sociology, Risk, CRR, CRD, Bank, CCP, SFT, UCITS, Capital Requirements Regulation 2013, Capital Requirements Directives, State Street, ETF, State, Security (finance)

Brings total number of launch participants to nine, comprising a broad range of key market participants, including banks, clearing firms, asset managers and custodians

Key Points: 
  • Brings total number of launch participants to nine, comprising a broad range of key market participants, including banks, clearing firms, asset managers and custodians
    Launch on track for Q3 2024, subject to regulatory approvals
    AMSTERDAM and LONDON, April 4, 2024 /PRNewswire/ -- Cboe Clear Europe, Cboe's Amsterdam-based pan-European clearing house, today announced that it has secured the support of additional participants to support the launch of its Central Counterparty (CCP) clearing service for securities financing transactions (SFTs).
  • Their commitment brings the total number of launch participants for the SFT clearing service to nine, comprising a broad range of key market participants, including banks, clearing firms, asset managers and custodians.
  • Alessandro Cozzani, Managing Director, Bank of America, said: "We are excited to embark on this journey with Cboe Clear Europe.
  • At launch, Cboe Clear Europe will be the only pan-European CCP offering these consolidated services for SFTs in European cash equities and ETFs."

Complementary cost-benefit assessment of the Integrated Reporting Framework - Additional analytical value and operational aspects

Retrieved on: 
Vendredi, avril 5, 2024
Pillar, Reproduction, NACE, European Banking Authority, Exercise, A3, Integration, Frankfurt, OJ, Climate, Carbon, Statistics, Chart, Council, European, Prudential, BIRD, Legislation, Annex, PDF, ITS, ECB, Risk, ESCB, CRR, Scenario, A5, A10, Section 4, IRB, A4, EBA, Content, CRM, Climate change, A9, Section 3, A6, A1, Classification, CBA, Publication, Feedback, Section 2, European Central Bank, Element, NCBS, INSPIRE, Central bank, European Parliament, WDS, Section 1, Record, Instrument, Data collection, Analysis, Capital Requirements Regulation 2013, Data, AnaCredit, Collection, Risk management
Key Points: 

    Complementary cost-benefit assessment on the Integrated Reporting Framework - Closer alignment with FINREP solo

    Retrieved on: 
    Vendredi, avril 5, 2024
    Reproduction, The, European Banking Authority, Level, Exercise, Integration, Frankfurt, OJ, Sale, Council, Prudential, BIRD, PDF, ITS, ECB, Chapter Three, International, ESCB, CRR, Feasibility study, Data collection, A5, Collection, Financial instrument, Person, A4, EBA, Content, Part, Classification, Chapter Four, Commission, CBA, Publication, Chapter Five, Chapter Six, Fair value, European Central Bank, NCBS, Central bank, Chapter Two, European Parliament, Analysis, Capital Requirements Regulation 2013, Data, BAD, AnaCredit, Risk management

    Complementary cost-benefit assessment on the Integrated Reporting Framework ?

    Key Points: 
      • Complementary cost-benefit assessment on the Integrated Reporting Framework ?
        Executive summary

        2

        towards closer alignment of the two frameworks, rather than implementing all
        changes at once.

      • Complementary cost-benefit assessment on the Integrated Reporting Framework ?
        Executive summary

        3

        1

        Introduction
        The complementary IReF cost-benefit assessment (CBA) followed an earlier
        consultation on an initial CBA that was launched in 2020.

      • The report summarises the feedback received from the banking industry on the
        possible closer alignment of the IReF with FINREP solo.
      • Complementary cost-benefit assessment on the Integrated Reporting Framework ?
        Introduction

        4

        2

        General question on closer alignment
        with FINREP solo
        Closer alignment between the IReF and FINREP solo could allow more substantial
        use of the IReF dataset for supervisory purposes, with the potential benefit of
        reducing ad hoc requests to reporting agents due to a more analytical and stable
        dataset.

      • The ECB legal framework for collecting FINREP solo information (Regulation (EU)
        2015/34)4 currently sets up four different levels of reporting for proportionality
        measures:
        ?

        FINREP data points;

        ?

        over-simplified FINREP;

        ?

        simplified FINREP;

        ?

        full FINREP.

      • Closer alignment does not mean that data
        under the IReF will be collected from reporting agents at the level of the legal entity
        in its entirety.
      • Complementary cost-benefit assessment on the Integrated Reporting Framework ? General
        question on closer alignment with FINREP solo

        5

        Chart 2.1
        General assessment on closer alignment between the IReF and FINREP solo

        Notes: The percentages are calculated for each driver as the simple average of the corresponding frequencies across euro area
        countries.

      • See Annex B of the report ?Complementary cost-benefit assessment of the Integrated Reporting Framework ? Extension of
        the IReF Regulation to cover country-specific requirements? published on the ECB?s website for information on how national results
        are calculated.
      • Members also raised the point that IReF
        information required for closer alignment with FINREP solo would only be collected
        from institutions that are currently subject to FINREP solo reporting.
      • The open text comments that were received in the complementary CBA show that
        different approaches to reporting at the level of the reporting agent may result in
        different expectations regarding closer alignment.
      • There
        were also several comments regarding the frequency and timeliness of the reporting
        of attributes needed for closer alignment with FINREP.
      • Many comments questioned which accounting standards will underpin IReF
        reporting, as those applicable to statistical reporting are often different from those
        relating to FINREP solo reporting.
      • Complementary cost-benefit assessment on the Integrated Reporting Framework ? General
        question on closer alignment with FINREP solo

        7

        3

        Extensions related to concepts already
        available in the IReF baseline scenario
        The IReF baseline scenario includes several accounting concepts that only apply to
        specific financial instruments.

      • See
        Annex B of the report ?Complementary cost-benefit assessment of the Integrated Reporting Framework ? Extension of the IReF
        Regulation to cover country-specific requirements? published on the ECB?s website for information on how national results are
        calculated.
      • See
        Annex B of the report ?Complementary cost-benefit assessment of the Integrated Reporting Framework ? Extension of the IReF
        Regulation to cover country-specific requirements? published on the ECB?s website for information on how national results are
        calculated.
      • See
        Annex B of the report ?Complementary cost-benefit assessment of the Integrated Reporting Framework ? Extension of the IReF
        Regulation to cover country-specific requirements? published on the ECB?s website for information on how national results are
        calculated.
      • See
        Annex B of the report ?Complementary cost-benefit assessment of the Integrated Reporting Framework ? Extension of the IReF
        Regulation to cover country-specific requirements? published on the ECB?s website for information on how national results are
        calculated.
      • See
        Annex B of the report ?Complementary cost-benefit assessment of the Integrated Reporting Framework ? Extension of the IReF
        Regulation to cover country-specific requirements? published on the ECB?s website for information on how national results are
        calculated.
      • See
        Annex B of the report ?Complementary cost-benefit assessment of the Integrated Reporting Framework ? Extension of the IReF
        Regulation to cover country-specific requirements? published on the ECB?s website for information on how national results are
        calculated.
      • See
        Annex B of the report ?Complementary cost-benefit assessment of the Integrated Reporting Framework ? Extension of the IReF
        Regulation to cover country-specific requirements? published on the ECB?s website for information on how national results are
        calculated.
      • See
        Annex B of the report ?Complementary cost-benefit assessment of the Integrated Reporting Framework ? Extension of the IReF
        Regulation to cover country-specific requirements? published on the ECB?s website for information on how national results are
        calculated.
      • Complementary cost-benefit assessment on the Integrated Reporting Framework ? Annex A
        Results by type and size of respondent

        57

        ? European Central Bank, 2024
        Postal address
        Telephone
        Website

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        +49 69 1344 0
        www.ecb.europa.eu

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