European Journal

SeaStar Medical Reports 2023 Financial Results and Provides a Business Update

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星期三, 四月 17, 2024

DENVER, April 17, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the 12 months ended December 31, 2023 and provides a business update.

Key Points:

DENVER, April 17, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the 12 months ended December 31, 2023 and provides a business update.
“Lastly, I’m pleased that we have filed our Form 10-K for 2023, which includes restated 2022 financial statements,” said Mr. Schlorff.
Mr. Green brings to SeaStar Medical extensive financial experience at public medical device and therapeutics companies.
The Company reported cash of $176,000 as of December 31, 2023, compared with $47,000 as of December 31, 2022.

CVRx announces availability of additional data supporting long-term benefits of Barostim

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星期一, 四月 15, 2024

MINNEAPOLIS, Minn., April 15, 2024 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company, announced today the availability of additional data, including the publication of results of the post-market phase of the BeAT-HF trial in the European Journal of Heart Failure. These data highlight long-term sustained benefits of Barostim in heart failure patients with reduced ejection fraction.

Key Points:

(NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company, announced today the availability of additional data, including the publication of results of the post-market phase of the BeAT-HF trial in the European Journal of Heart Failure.
These data highlight long-term sustained benefits of Barostim in heart failure patients with reduced ejection fraction.
CVRx previously announced some of these data as part of expanded labeling granted by FDA on December 23, 2023.
We look forward to the generation of additional evidence about Barostim from the BeAT-HF trial, as well as from real-world experience through our REBALANCE post-market registry and investigator-initiated research,” said Hykes.

Global $4.93 Bn Neonatal Intensive Care Market Trends, Competitive Analysis and Forecasts, 2018-2023 & 2024-2030 - ResearchAndMarkets.com

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星期一, 四月 29, 2024

North America dominated the global neonatal intensive care market in 2023, followed by Europe.

Key Points:

North America dominated the global neonatal intensive care market in 2023, followed by Europe.
Neonatal monitoring devices such as cardiac monitors are used in neonatal intensive care units for continuous monitoring of neonates.
The neonatal & pediatric hospital facilities dominate the global neonatal intensive care market because of their specialized information, dedicated infrastructure, and comprehensive services.
The increasing number of maternity hospitals offering neonatal intensive care services worldwide increases the popularity of this segment.

Adial Pharmaceuticals Announces Peer-Reviewed Publication Highlighting Promising Safety Data and High Patient Compliance in a Clinical Trial of AD04 as a Potential Treatment for Alcohol Use Disorder

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星期三, 四月 10, 2024

Liver injury, Safety, GLEN, Epistasis, ALT, Patient, European Journal, Liver, ALD, GGT, Annals of Internal Medicine, Aes, Manuscript, Internal medicine, Liver transplantation, Open access

According to the publication, low-dose AD04 did not significantly change biochemical markers of liver injury, such as ALT, AST, and Serum Bilirubin.

Key Points:

According to the publication, low-dose AD04 did not significantly change biochemical markers of liver injury, such as ALT, AST, and Serum Bilirubin.
Additionally, while patients with AUD displayed elevated GGT levels, typically associated with increased alcohol consumption, this parameter remained unaffected by low-dose AD04.
This peer-reviewed publication emphasizes the safety and potential of AD04 in addressing the critical needs of individuals suffering from AUD and ALD.
Most importantly, the publication highlighted the potential of AD04 for the treatment for AUD among patients with a specified genetic background.

Decomposing systemic risk: the roles of contagion and common exposures

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星期二, 四月 23, 2024

Tao, CIBC, Tax, RWA, Risk, European Systemic Risk Board, Research Papers in Economics, Contagion, RT, The Big Six, NBC, International, Shock, Observation, Bank of Canada, HTC, European Economic Association, The Washington Post, Great, JPMorgan Chase, Paper, GM, Environment, Political economy, Journal of Financial Economics, COVID-19, Perception, BNS, Website, Silicon, IAT, Cifuentes, Probability, Balance sheet, RAN, Medical classification, Algorithm, Information technology, Quarterly Journal of Economics, LN, Nature, European Journal, Royal Bank of Canada, Technical report, Journal of Political Economy, Equitable Bank, Bankruptcy, RAI, PDF, Private, ECB, Policy, CHS, Supercapacitor, Social science, Journal of Financial Stability, Intelligence (journal), Elsevier, Home, Cambridge University Press, Journal, Springer Science+Business Media, Research, Classification, Regulation, News, EQB, Credit, Literature, AIK, European Central Bank, COVID, SVAR, Section 5, Management science, DRA, M4, VL, National bank, Government, ISSN, BMO, Panel, International Financial Reporting Standards, BIS, FIS, Basel III, Commerce, Scotiabank, C32, Econometric Society, Interbank, Fraud, Section 4, Bank, Schedule, VAR, Section 3, The Journal of Finance, RBC, Volcanic explosivity index, Fire, Wassily Leontief, Financial economics, Metric, Section 2, L14, Central bank, Superintendent, Bank of Montreal, Kronecker, BOC, Lithium, BCBS, Sale, Macroeconomic Dynamics, Christophe, CWB, LBC, NHA, Imperial Bank, Private equity, Quarterly Journal, National Bank of Canada, C51, Canadian Western Bank, Currency crisis, JEL classification codes, Victor Drai, L.1, MFC, Silicon Valley Bank, EB, Laurentian Bank of Canada, Federal, RA1, Series, W0, FEVD, Journal of Econometrics, Aggregate, University, FRB, MB, Financial institution, Element, Health, Book, Angels & Airwaves, Common, OSFI, GFC, Reproduction, K L, Systematic, Housing, G21, Home Capital Group, Communications satellite

Abstract

Key Points:

Abstract
We evaluate the effects of contagion and common exposure on banks? capital through
a regression design inspired by the structural VAR literature and derived from the balance
sheet identity.
Contagion can occur through direct exposures, fire sales, and market-based
sentiment, while common exposures result from portfolio overlaps.
First, we document that contagion varies in time, with the highest levels
around the Great Financial Crisis and lowest levels during the pandemic.
Our new framework complements
traditional stress-tests focused on single institutions by providing a holistic view of systemic risk.
While existing literature presents various contagion narratives, empirical findings on
distress propagation - a precursor to defaults - remain scarce.
We decompose systemic risk into three elements: contagion, common exposures, and idiosyncratic risk, all derived from banks? balance sheet identities.
The contagion factor encompasses both sentiment- and contractual-based elements, common exposures consider systemic
aspects, while idiosyncratic risk encapsulates unique bank-specific risk sources.
Our empirical analysis of the Canadian banking system reveals the dynamic nature of contagion, with elevated levels observed during the Global Financial Crisis.
In conclusion, our model offers a comprehensive lens for policy intervention analysis and
scenario evaluations on contagion and systemic risk in banking.
This
notion of systemic risk implies two key components: first, systematic risks (e.g., risks related
to common exposures) and second, contagion (i.e., an initially idiosyncratic problem becoming
more widespread throughout the financial system) (see Caruana, 2010).
In this paper, we decompose systemic risk into three components: contagion, common exposures, and idiosyncratic risk.
First, we include contagion in three forms: sentiment-based contagion, contractual-based
contagion, and price-mediated contagion.
In this context,
portfolio overlaps create common exposures, implying that bigger overlaps make systematic
shocks more systemic.
With the COVID-19 pandemic starting
in 2020, contagion drops to all time lows, potentially related to strong fiscal and monetary
supports.
That is, our
structural model provides a framework for analyzing the impact of policy interventions and
scenarios on different levels of contagion and systemic risk in the banking system.
This provides a complementary approach to
seminal papers that took a structural approach to contagion, such as DebtRank Battiston et al.
More generally, the literature on networks and systemic risk started with Allen and Gale
(2001) and Eisenberg and Noe (2001).
The matrix is structured as follows:
1
In our model, we do not distinguish between interbank liabilities and other types of liabilities.
In other words, we can and aim to estimate different degrees
of contagion per asset class, i.e., potentially distinct parameters ?Ga .
For that, we build three major
metrics to check: average contagion, average common exposure, and average idiosyncratic risk.
N i j
et ,
Further, we define the (N ?K) common exposure matrix as Commt = [A

(20)

et ]diag (?C
?L

such that average common exposure reads,
average common exposure =

1 XX
Commik,t .
N i j
(22)

20

? c ),

The three metrics?average contagion, average common exposure, and average idiosyncratic risk?provide a comprehensive framework for understanding banking dynamics.
Figure 4 depicts the average level of risks per systemic risk channel: contagion risk, common exposure, and idiosyncratic risk.
Figure 4: Average levels of contagion (Equation (20)), common exposure (Equation (21)), and idiosyncratic risk
(Equation (22)).
The market-based contagion is the contagion due to
investors? sentiment, and the network is an estimate FEVD on volatility data.
For most of
the sample, we find that contagion had a bigger impact on the variance than common exposures.

Strong data from DSR® proof-of-concept studies in heart failure published in European Journal of Heart Failure

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星期三, 四月 3, 2024

Cardiorenal syndrome, Congestion, DSR, Brussels Stock Exchange, Liver disease, Associate, RED, Patient, NYHA, Mortality, Cancer, Fluid, Heart failure, European Journal, Diuretic, Overload, Syndrome, Yale University, Pharmaceutical industry

The publication can be accessed here .

Key Points:

The publication can be accessed here .
Dr. Jeffrey Testani, Associate professor at Yale University and senior author of the publication commented: “Cardiorenal syndrome is a major clinical challenge in heart failure with a clear unmet need for therapies to effectively and durably address congestion and cardio-renal dysfunction.
Currently the mainstay of therapy for sodium avidity and congestion are the loop diuretics, which actually worsen sodium avidity and cardiorenal syndrome.
Diuretic-resistant heart failure and cardiorneal syndrome are large and growing markets both in the US and rest of world, with the clear need for novel treatments that can improve clinical outcomes beyond loop diuretics.

Perspective Therapeutics Provides Recent Business Highlights and Reports Fiscal Year 2023 Financial Results

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星期四, 三月 28, 2024

SEATTLE, March 28, 2024 (GLOBE NEWSWIRE) -- Perspective, Therapeutics, Inc. (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body, today provided a business update and announced fiscal year 2023 financial results for the period ended December 31, 2023.

Key Points:

SEATTLE, March 28, 2024 (GLOBE NEWSWIRE) -- Perspective, Therapeutics, Inc. (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body, today provided a business update and announced fiscal year 2023 financial results for the period ended December 31, 2023.
“We made tremendous progress during 2023 in building a fully integrated radiopharmaceuticals company dedicated to advancing potentially best- or first-in-class alpha-particle therapies,” said Thijs Spoor, Perspective Therapeutics' CEO.
Preliminary results from Cohorts 1 and 2 of the Phase 1/2a trial are expected in the third quarter 2024.
In January 2024, Perspective Therapeutics entered into strategic agreements with Lantheus Holdings, Inc. and its affiliates (“Lantheus”) (NASDAQ: LNTH).

Transgene anticipates significant progress from immunotherapy pipeline in 2024 and extends financial visibility until Q4 2025

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星期三, 三月 27, 2024

Extended financial visibility secured until Q4 2025 through a revised credit facility provided by the major shareholder Institut Mérieux.

Key Points:

Extended financial visibility secured until Q4 2025 through a revised credit facility provided by the major shareholder Institut Mérieux.
“During 2023 Transgene continued to make significant progress, delivering compelling data that confirm the value of our approach to treating cancer using our novel immunotherapies” commented Dr. Alessandro Riva, MD, Chairman and CEO of Transgene.
As announced on May 5, 2023, AstraZeneca terminated its oncolytic virus research and development collaboration with Transgene following a strategic review of its pipeline.
In 2024, Transgene expects to communicate progress and significant results and readout on all of its clinical stage assets.

The impact of regulatory changes on rating behaviour

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星期二, 四月 2, 2024

Długosz, Disagreement, Pi bond, Direct lending, Key, Research Papers in Economics, Finance Secretary (India), University of Oxford, STS, Journal of Economic Perspectives, International, American Economic Review, Life, Columbia Business School, British Academy of Management, Risk assessment, ABS, Rating, EBA, Development, Reputational damage, OBS, CRA, Bond credit rating, Cras, Journal of Monetary Economics, CDO, Becker, Paper, 2007–2008 financial crisis, Raja, University, Environment, Journal of Financial Economics, Perception, H3, Website, Securitization, Working paper, Market, Collection, Total, European Banking Authority, Quarterly Journal of Economics, BBB, Whetten, Column, ESMA, European Journal, Issuer, Asset quality, Information revolution, Federal Reserve Bank, OLS, Statistics, PDF, Private, ECB, Surety, Weighted-average life, CCC, European Commission, Social science, Journal of Financial Stability, JEL, Real, Bias, Journal, Research, Classification, Certification, Commission, Credit, The Journal of Finance, Literature, Karel Škréta, European Central Bank, AA, Finance Research Letters, Origination (telephony), Monetary economics, Section 5, Xia, Kraft Foods, Government, AAA, Mukherjee, Finance, Deku, DOI, White, Risk, IOSCO, MBS, OECD, Wang, Section 4, University Challenge 2013–14, Section 3, Ashcraft, Financial management, Accounting, Financial economics, Fannie Mae, Conference, Pressure, Central bank, Griffin, University of Michigan, Systematic review, EPRS, Freddie Mac, Loan, BCBS, Palgrave Macmillan, R2, Microeconomics, Quarterly Journal, Financial statement analysis, The Japanese Economic Review, Christian Social Union (UK), Green, University of Huddersfield, PSM, Management, Security (finance), Security, Civil service commission, Private placement, American Economic Journal, GFC, Reproduction, IMF, Small business, Trustee, Data

Abstract

Key Points:

Abstract
We examine rating behaviour after the introduction of new regulations regarding Credit Rating
Agencies (CRAs) in the European securitisation market.
There is empirical evidence of rating catering in the securitisation market in the pre-GFC period (He et al.,
2012; Efing and Hau, 2015).
Competition among
CRAs could diminish ratings quality (Golan, Parlour, and Rajan, 2011) and promotes rating shopping by
issuers resulting in rating inflation (Bolton et al., 2012).
This paper investigates the impact of the post-GFC regulatory changes in the European
securitisation market.
In 2011, in addition to the creation of
European Securities and Markets Authority (ESMA), a regulatory and supervisory body for CRAs was
introduced.
We examine how rating behaviours have changed in the European securitisation market after the
introduction of these new regulations.
We utilise the existence of multiple ratings and rating agreements between
CRAs to identify the existence of rating shopping and rating catering, respectively (Griffin et al., 2013; He
et al., 2012; 2016).
We find that the regulatory changes have been effective in tackling conflicts of interest between issuers
and CRAs in the structured finance market.
Rating catering, which is a direct consequence of issuer and
CRA collusion, seems to have disappeared after the introduction of these regulations.
There is empirical evidence of rating catering in the securitisation market in
the pre-GFC period (He et al., 2012; Efing and Hau, 2015).
Competition among CRAs could diminish ratings quality (Golan, Parlour,
and Rajan, 2011) and promotes rating shopping by issuers resulting in rating inflation (Bolton et
al., 2012).
This paper investigates the impact of the post-GFC regulatory changes in the European
securitisation market.
In 2011, in addition
to the creation of European Securities and Markets Authority (ESMA), a regulatory and
supervisory body for CRAs was introduced.
We find that the regulatory changes have been effective in tackling conflicts of interest
between issuers and CRAs in the structured finance market.
Rating catering, which is a direct
consequence of issuer and CRA collusion, seems to have disappeared after the introduction of
these regulations.
Investors who previously demanded higher spreads for rating agreements for a
multiple rated tranche, did not consider the effect of rating harmony as a risk in the post-GFC
period.
Regarding rating shopping, we find that the effectiveness of the changes has been limited,
potentially for two reasons.
Additionally, we also find that rating over-reliance might still be an issue, especially
Rating catering is a broad term and it can involve rating shopping.
They re-examine the rating shopping and rating
catering phenomena in the US market by looking at the post-crisis period between 2009 and 2013.
Using 622 CDO tranches, they also observe the existence of rating shopping and the diminishing
of the rating catering.
Firstly, our main focus is the EU?s CRA Regulation and its effectiveness in reducing
rating inflation and rating over-reliance.
To the best of our knowledge, this paper is the first to
examine the effectiveness of the EU?s CRA regulatory changes on the investors? perception of
rating inflation in the European ABS market.
Hence, the coverage and quality of our dataset constitutes significant addition
to the literature and allows us to test the rating shopping and rating catering more authoritatively.
The following section reviews the literature
on securitisation concerning CRAs and conflicts of interest, and outlines the regulatory changes
introduced in the post-GFC period.
Firstly, ratings became ever more important as the Securities and
Exchange Commission (SEC) 5 began heavily relying on CRA assessments for regulatory purposes
(i.e.
the investment mandates that highlight rating agencies as the main benchmark for investment
eligibility) (SEC, 2008; Kisgen and Strahan, 2010; Bolton et al., 2012).
issuers) as one of the main explanations for the rating inflation (He et al., 2011; 2012; Bolton
et al., 2012; Efing and Hau, 2015).
Bolton et al., (2012) demonstrate that competition
promotes rating shopping by issuers, leading to rating inflation.
The last phase, CRA III, was implemented in mid-2013 and involves an additional
set of measures on reducing transparency and rating over-reliance.
As mentioned above, rating inflation can be caused by rating shopping
In order to be eligible to use the STS classification, main parties (i.e.
The higher the difference in the number of ratings for a
given ABS tranche, the greater the risk of rating shopping.
Alternatively, the impact of the new
regulations could be limited when it comes to reducing rating shopping.
This is because, firstly,
the conflict of interest between securitisation parties is not necessarily the sole cause for the
occurrence of rating shopping.
L is a set of variables (Multiple ratings, CRA reported, Rating agreement) that
we utilise interchangeably to capture the rating shopping and rating catering behaviour.
Hence, issuers are incentivised to report the highest possible rating and
ensure each additional rating matches the desired level.
All in all, our results suggest that
the new stricter regulatory measures have been effective in tackling conflicts of interest and
reducing rating inflation caused by rating catering.
Self-selection might be a concern in analysing the impact of the
new measures and investors? response with regard to the rating inflation.
This
result is in line with the earlier findings suggesting that regulatory changes have reduced investors?
suspicion of rating inflation and increased trust of CRAs.
Conclusion
Several regulatory changes were introduced in Europe following the GFC aimed at tackling
conflicts of interest between issuers and CRAs in the ABS market.
Utilising a sample of 12,469
ABS issued between 1998 and 2018 in the European market, this paper examined whether these
changes have had any impact on rating inflations caused by rating shopping and rating catering
phenomena.
We find that the
effectiveness of the changes has been more limited on rating shopping potentially for two reasons.
Tranche Credit Rating is the rating reported for a tranche at launch.

Manuscript Discussing the Benefit of SeaStar Medical’s Selective Cytopheretic Device in Patients with Heart Failure and Hyperinflammation Published in European Journal of Heart Failure

Retrieved on:

星期二, 二月 27, 2024

DENVER, Feb. 27, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces publication of a manuscript discussing the role of chronic dysregulated systemic inflammation in heart failure and the potential application of the adult Selective Cytopheretic Device, part of the Quelimmune™ product family, in enabling previously ineligible patients with severe disease to receive a left ventricular assist device (LVAD) or heart transplant in the peer-reviewed European Journal of Heart Failure February 2024, Pitt, B., Iyer, S.P.N. and Humes, H.D. (2024), Eur J Heart Fail. https://doi.org/10.1002/ejhf.3177.

Key Points:

The manuscript, titled “New Opportunity for Targeting Systemic Inflammation in Patients with Heart Failure through Leukocyte Immunomodulation” cites increasing evidence of the role of chronic systemic inflammation in patients with heart failure and discusses the Adult SCD’s potential to improve hypertensive heart failure and mortality following hospitalization for acute or worsening heart failure.
Following treatment with the Adult SCD, this patient was effectively bridged to LVAD three days after discontinuing treatment and was subsequently discharged without further complications.
“Prior attempts targeting singular proinflammatory factors as well as systemic immunosuppression with glucocorticoids in patients with acute heart failure have yielded unclear results, raising the need to identify new strategies.
“While our manuscript discusses a positive outcome in one patient following treatment for six hours daily over six consecutive days, the results suggest that more study with Adult SCD is warranted for patients with heart failure and hyperinflammation.”