CRR | Jotup

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:

Tuesday, April 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:

Thursday, March 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:

Wednesday, March 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:

Thursday, March 14, 2024

(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:

Tuesday, March 12, 2024

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:

Thursday, April 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:

Friday, April 5, 2024

Key Points:

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

Retrieved on:

Friday, April 5, 2024

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

60640 Frankfurt am Main, Germany
+49 69 1344 0
www.ecb.europa.eu

All rights reserved.

The Eurosystem Integrated Reporting Framework ‒ an overview

Retrieved on:

Friday, April 5, 2024

The Eurosystem Integrated

Key Points:

The Eurosystem Integrated
Reporting Framework ? an overview
1
Background
European Union (EU) banks face a whole range of data reporting obligations,
including for statistical, resolution and prudential information.
Existing ECB statistical regulations specify the information that must be reported, but
not how the actual reporting process is to be carried out.
The Eurosystem Integrated Reporting Framework ? an overview
1

submitted by reporting agents to NCBs.
This arrangement dates back to when the ECB was set up in 1998 and was justified
at the time, as it meant that statistical reporting could be founded on well-established
national reporting frameworks.
Figure 1
Current Eurosystem approach to collecting statistical information from banks
Banks

NCBs

ECB

Transformations by banks

Transformations by NCBs
Country A

BSI & MIR

Integrated approach
?

SHS

Country B

Operational
systems

Monetary data

b.o.p., i.i.p &
sector accounts

Credit register
Sector accounts

AnaCredit
b.o.p.
Under the new paradigm, cross-border banks could unify the
technical specifications of their reporting for all their European entities.
2
The scope of the IReF
The IReF seeks to integrate existing ESCB statistical data requirements for banks as
far as possible into a single, standardised reporting framework applicable across the
euro area.
The feasibility of aligning the IReF
more closely with the Financial Reporting (FINREP) requirements applicable at solo
level11 is also being assessed.
Some NCBs have
developed an integrated reporting framework for investment funds (covering both
MMFs and non-MMFs).
The Eurosystem reviewed the results of the CBA to identify optimal features for
banks, the Eurosystem and its users.
This time frame will give reporting agents and the Eurosystem enough lead time to
prepare the legal and technical framework without unduly delaying the expected
reduction in the reporting burden.
16
See ?On a Feasibility Study of an Integrated Reporting System under Article 430c CRR?, EBA, 2021;
and ?The EBA?s feasibility study on integrated reporting system provides a long-term vision for
increasing efficiencies and reducing reporting costs?, EBA, December 2021.
The Eurosystem is already cooperating closely with the banking industry to optimise
reporting and reduce the overall reporting burden via the Banks? Integrated Reporting
Dictionary (BIRD).19 BIRD offers a redundancy-free source (i.e.
The IReF describes statistical requirements in a redundancy-free layer
and will represent future statistical reporting obligations issued by the ECB and
applicable to Eurosystem banks.
Data quality should increase and costs decrease, as the BIRD input layer would
provide a comprehensive and flexible tool to support data reporting.

The EBA consults on draft technical standards on off-balance sheet items under the standardised approach of credit risk

Retrieved on:

Tuesday, April 2, 2024

RTS, EBA, CRR, Calibration, Level 1, Comment, Capital Requirements Regulation 2013, Risk management

The EBA consults on draft technical standards on off-balance sheet items under the standardised approach of credit risk

Key Points:

The EBA consults on draft technical standards on off-balance sheet items under the standardised approach of credit risk
- The EBA plays an important role in the implementation of the Basel III framework through the Banking Package in the EU.
- These draft technical standards are part of the first phase of the EBA roadmap on the implementation of the EU Banking Package.
- These draft technical standards will contribute to a more a robust regulatory framework, efficient supervision, and enhanced risk control by credit institutions.
The European Banking Authority (EBA) today launched a public consultation on its draft Regulatory Technical Standards (RTS) under the Capital Requirements Regulation (CRR3) regarding off-balance sheet items under the standardised approach of credit risk.