Stock Markets
ABIONYX Pharma has completed a successful pre-IND meeting with the FDA for CER-001 Phase 2b/3 Clinical Trial for Patients with Sepsis
- Based on encouraging Phase 2a data and a productive pre-IND Type B meeting with U.S. Food and Drug Administration (FDA), ABIONYX Pharma intends to file an Investigational New Drug application (IND) in the coming months which will include a Phase 2b/3 clinical trial for CER-001 in Sepsis
TOULOUSE, France & LAKELAND, Mich.–(BUSINESS WIRE)–Regulatory News:
ABIONYX Pharma, (FR0012616852 – ABNX – eligible for PEA PME), a new generation biotech company dedicated to the discovery and development of innovative therapies based on the world’s only natural recombinant apoA-I, today announced that the company has completed a pre-IND (Investigational New Drug Application, IND) meeting with the US Food and Drug Administration and has received feedback to support an IND filing for its candidate drug. This is an important validation of the quality of the project and a significant step towards an application to include American study centers in future clinical trials. ABIONYX Pharma intends to file an IND application to the US authority in the coming months.
Our latest phase 2a clinical study with CER-001, was published by BMC Medicine, in a translational research paper that included important in-vitro data, proof of concept in a pig model of sepsis and a four-arm controlled study in patients with sepsis. All sets of data showed statistically significant effects on parameters such as endotoxin levels, key inflammatory cytokines such as IL-6 and TNF-α and endothelial markers of inflammation such as sVCAM-1, sICAM-1 and MCP-1.
The positive pre-IND meeting with the FDA reflects the quality and strength of the combined preclinical and clinical generated so far during the development of CER-001. We appreciate the FDA’s guidance as we prepare to advance our novel therapy into phase 2b/3″, said Dr. Rob Scott, Head of R&D and CMO at ABIONYX Pharma. “The successful completion of this pre-IND engagement is an important milestone that provides much regulatory clarity for the future path forward for CER-001. Based on the wealth of scientific evidence for the role of apoA-I in sepsis produced by us and others, including compelling genetic validation, we believe our recombinant apoA-I has potential to change the outcomes for patients with sepsis. We are now eager to move ahead in the future clinical development phases.
About Sepsis
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis affects an estimated 49 million people worldwide each year, including more than 20 million children under age 5, and 1.7 million people in the U.S alone. It is a leading cause of mortality worldwide and causes more than 350,000 deaths per year in the U.S., which makes it the third leading cause of overall mortality and the leading cause of in-hospital death. Sepsis causes more deaths than chronic lower respiratory diseases, stroke, Alzheimer’s disease, diabetes, or accidental death. Sepsis is also the most expensive in-hospital condition in the U.S., costing an estimated $62 billion each year, counting just acute in-hospital care and skilled nursing costs. There are no approved treatments that specifically target sepsis and current management relies on anti-microbial therapy and supportive care. Without any approved therapies for sepsis, the global sepsis market size is still estimated to reach $7 billion in 2030 and grow at a compound annual growth rate of 5.6% between 2024 to 2030.
About CER-001
CER-001 is an engineered pre-β HDL particle which contains recombinant human apolipoprotein A-I (apoA-I), complexed with phospholipids. Pre-β HDL particles have been shown to be highly effective scavengers of bacterial endotoxins, thereby inactivating lipopolysaccharide (LPS) for removal by the liver.
About ABIONYX Pharma
ABIONYX Pharma is a next-generation biotech company focused on developing innovative medicines for diseases where there is no effective or existing treatment, even the rarest ones. The company expedites the development of novel therapeutics through an extensive expertise in lipid science and a differentiated apoA-I-based technology platform. ABIONYX Pharma is committed to radically improving treatment outcomes in Sepsis and critical care.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240613991966/en/
NewCap
Investor relations
Nicolas Fossiez
Louis-Victor Delouvrier
abionyx@newcap.eu
+33 (0)1 44 71 98 53
NewCap
Media relations
Arthur Rouillé
abionyx@newcap.eu
+33 (0)1 44 71 00 15
Source: ABIONYX Pharma
Stock Markets
SCWO Stock Hits 52-Week Low at $0.71 Amid Market Challenges
In a challenging market environment, shares of 374Water (SCWO) have touched a 52-week low, dipping to $0.71. The company, with a market capitalization of $104 million, maintains a strong liquidity position with a current ratio of 3.81 and more cash than debt on its balance sheet, according to InvestingPro data. The company, which specializes in water treatment solutions, has seen its stock price struggle significantly over the past year, reflecting a broader trend in the sector. Investors have been cautious, as evidenced by the stock’s 1-year change, which shows a substantial decline of 52.96%. InvestingPro analysis indicates the stock is currently in oversold territory, with 18 additional investment insights available to subscribers. This downturn highlights the volatility faced by environmental technology companies and raises concerns about future performance amidst uncertain market conditions. With a beta of -0.51, the stock typically moves opposite to market direction, potentially offering diversification benefits.
In other recent news, 374Water Inc. has secured approximately $12.2 million through a registered direct offering, involving the sale of common stock and warrants. The cleantech company expects the gross proceeds before fees and expenses to be around the $12.2 million mark, with D. Boral (OTC:) Capital LLC serving as the exclusive placement agent for the offering. The capital infusion is scheduled to be finalized by November 18, 2024, pending customary closing conditions.
In further developments, 374Water has initiated operations of its AirSCWO technology at the Iron Bridge Regional Water Reclamation Facility in Orlando. This marks a significant step in commercial biosolids processing, with the technology designed to efficiently process biosolids and PFAS contaminated wastes. The successful integration of the AirSCWO system into the Iron Bridge facility demonstrates the company’s capacity to destroy persistent organic pollutants, including PFAS.
The Florida Department of Environmental Protection supported the installation with a grant under the Bilateral Infrastructure Law emerging contaminant funding. Notably, CEO Chris Gannon highlighted the operational success in Orlando as crucial for showcasing the technology’s capacity to manage municipal, federal, and industrial organic waste streams at scale. The company anticipates additional commitments across the United States, including a deployment to Orange County Sanitation (CA) in 2025.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
Stock Markets
Global shares and dollar firm in muted pre-Christmas trade
By Alden Bentley, Samuel Indyk and Rae Wee
NEW YORK/LONDON (Reuters) -Wall Street topped off a global share rally in thin trade on Thursday as markets prepared for early Christmas Eve closes, while the dollar was buoyed by firmer Treasury yields and speculation that the Federal Reserve would slow its easing in 2025.
The was 0.47% higher in late morning trade, the rose 0.73% and the rose 0.99%.
U.S. stock trading wraps up at 1:00 p.m. EDT/1800 GMT, and the bond market closes at 2:00 p.m. Most financial centers around the world are closed on Wednesday for Christmas. The U.S. reopens on Thursday, while many financial centers have a second day off.
“Meagre news and data flow should keep the focus on a more hawkish Fed,” said Ipek Ozkardeskaya, senior analyst at Swissquote Bank.
MSCI’s gauge of stocks across the globe went up more than half a percent. The pan-European index rose 0.18%. 100 rose 0.19% and 40 rose 0.14%. German stocks were closed for the Christmas holiday.
In Asia, Chinese stocks rose after sources told Reuters that Beijing planned to issue a record amount of special treasury bonds next year as it ramps up fiscal stimulus to revive a faltering economy.
The blue-chip index and both ended 1.3% higher. Hong Kong’s advanced 1.1%.
The news came shortly after China’s finance ministry said authorities would ramp up fiscal support for consumption next year by raising pensions and medical insurance subsidies for residents, as well as expanding consumer goods trade-ins.
Still, investors remain cautious on the outlook for the world’s second-largest economy, particularly as it faces the threat of hefty tariffs from U.S. President-elect Donald Trump.
Elsewhere, MSCI’s broadest index of Asia-Pacific shares outside Japan rose 0.37%.
FED FOCUS
Investors are taking direction from last week’s 25 basis point Fed interest rate cut, its signals on the strength of the economy and its slow progress bringing inflation down to its 2% target. Markets are now pricing in about 35 basis points of easing for 2025, implying one quarter-point rate cut and around a 40% chance of a second.
U.S. Treasury yields pared gains after the Treasury saw solid demand for a $70 billion sale of five-year notes, but remained higher on the day. The two-year Treasury yield, which is sensitive to changes in Fed rate expectations, was up 0.9 bp at 4.359%, while the benchmark 10-year yield rose 2.6 bp to 4.625%, reaching a seven-month high at 4.629%. [US/]
“Like markets, the Fed will need to consider U.S. policies on tariffs and immigration in its inflation and growth outlook. We believe the subtle slowing in the U.S. labor market will still be the Fed’s paramount concern,” said analysts at Citi Wealth.
“While always uncertain, our base case expectation for a 3.75% policy rate is unchanged. It’s a far cry from the 1.7% U.S. policy rate average of the past 20 years.”
The Fed’s cut was the third one this cycle, taking the Fed funds rate to 4.25%-4.5%.
Ahead of Trump’s return to the White House in January, global central banks have urged caution over their rate paths due to uncertainty on how his planned tariffs, lower taxes and immigration curbs might affect policy.
Data on Monday showed U.S. consumer confidence unexpectedly weakened in December as the post-election euphoria fizzled and concerns about future business conditions emerged.
In currencies, the rose 0.14% hovering near a two-year high hit Monday, having climbed more than 2% in December so far.
The euro eased 0.15% to $1.0389, while the yen languished near last week’s five-month low, trading at 157.35 per dollar.
Japan’s Finance Minister Katsunobu Kato on Tuesday reiterated Tokyo’s discomfort with excessive foreign exchange moves and put speculators on notice that authorities are ready to act to stabilise a faltering yen.
rose 0.13% to $2,616.26 an ounce, having risen about 27% this year, heading for its biggest yearly gain since 2010.
rose 1.56% to $70.32 a barrel and rose to $73.73 per barrel, up 1.51% on the day. [O/R]
Stock Markets
Wall Street advances in short Christmas Eve session on megacap gains
By David French
(Reuters) -Wall Street’s main indexes all ended higher on Tuesday, with gains in megacap and growth stocks bolstering benchmarks in a truncated Christmas Eve session.
Both the and the scored four straight sessions of gains. For the Dow, the run follows its 10-session skid earlier this month, its longest losing streak since 1974.
The benchmarks closed higher on the first day of a historically strong period called the “Santa Claus rally.” The on average has gained 1.3% in the last five days of December and first two days of January, according to data from the Stock Trader’s Almanac going back to 1969.
With megacap stocks having outsized influence on markets, their performance is often a key driver of indexes. When coupled with reduced trading volumes and few other catalysts, as many investors take time off for the holidays, this is even more pronounced.
All the so-called Magnificent Seven megacap technology stocks climbed on Tuesday, led by Tesla (NASDAQ:).
The automaker’s rise helped push consumer discretionary shares higher, making them the top gaining sector in the S&P.
Elsewhere, chip manufacturers were also buoyant. Broadcom (NASDAQ:) and Nvidia (NASDAQ:) were up, while Arm Holdings (NASDAQ:) climbed a day after losses from losing a court case.
Growth names rose despite U.S. Treasury interest rates remaining elevated – the benchmark 10-year note yielded around 4.61% on Tuesday. Traditionally, higher debt costs crimp growth stocks.
However, the long-term themes around technology development, including advancements in artificial intelligence, overshadow any near-term moves in Treasuries, said Charlie Ripley, senior investment strategist for Allianz (ETR:) Investment Management.
“This reinforces that view that the sector is going to remain strong, and should be well into the new year,” he said.
According to preliminary data, the S&P 500 gained 64.93 points, or 1.09%, to end at 6,039.00 points, while the Nasdaq Composite gained 264.31 points, or 1.34%, to 20,029.19. The Dow Jones Industrial Average rose 366.75 points, or 0.85%, to 43,273.70.
Stock markets shut at 1:00 p.m. ET on Tuesday and will be closed for Christmas on Wednesday.
After a stellar run to record highs following the November election, which sparked hopes of pro-business policies under U.S. President-elect Donald Trump, Wall Street’s rally hit a bump this month as investors grappled with the prospect of higher interest rates in 2025.
The U.S. Federal Reserve eased borrowing costs for the third time this year last Wednesday, but signaled only two more 25-basis-point reductions next year, down from its September projection of four cuts, as policymakers weigh the possibility of Trump’s policies stoking inflation.
Allianz’s Ripley said the themes which had driven the market higher in the past two months remained intact, and actions by the Fed had not killed the rally.
“Heading into 2025, things are set up with good positioning,” he said, noting factors including economic outlook, consumption in the U.S. and the labor market.
Crypto-related stocks traded higher on Tuesday, including Microstrategy (NASDAQ:), Riot Platforms (NASDAQ:), and MARA Holdings, as the price of bitcoin advanced.
NeueHealth soared after the healthcare provider said New Enterprise Associates, its largest shareholder, and a group of existing investors will take the company private in a $1.3 billion deal.
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