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BridgeBio Pharma Presents Cardiac Magnetic Resonance (CMR) Imaging Evidence Consistent with Clinical Improvement Observed in the ATTRibute-CM Phase 3 Study in Patients with Transthyretin Amyloid Cardi
– In this exploratory substudy, treatment with acoramidis was associated with possible cardiac structural and functional improvement compared with placebo, with potential cardiac amyloid regression
– The data demonstrate that targeting near-complete transthyretin (TTR) stabilization with acoramidis may enable cardiac remodeling and functional recovery in patients with ATTR-CM
– These results are the first prospective, longitudinal evaluation of cardiac structure and function by CMR imaging in a double-blind, placebo-controlled, interventional study in ATTR-CM
– The findings from this study build upon positive results from BridgeBio’s global ATTRibute-CM Phase 3 trial, wherein the primary endpoint was met (Win Ratio of 1.8) with a high statistical significance (p
– Acoramidis was well-tolerated, with no safety signals of potential clinical concern observed
– BridgeBio’s New Drug Application (NDA) has been accepted by the U.S. Food and Drug Administration (FDA) with a PDUFA action date of November 29, 2024; a Marketing Authorization Application (MAA) for acoramidis has been accepted by the European Medicines Agency (EMA), with an expected decision in 2025
PALO ALTO, Calif., April 07, 2024 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: NASDAQ:) (BridgeBio or the Company), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today presented results from the exploratory CMR imaging substudy of ATTRibute-CM, its Phase 3 trial of acoramidis in ATTR-CM. These data were presented at the American College of Cardiology (ACC) Annual Scientific Sessions & Expo in a moderated poster session by Yousef Razvi, M.D. of University College London. ATTRibute-CM was designed to study the efficacy and safety of acoramidis, an investigational, next-generation, orally-administered, highly potent, small molecule stabilizer of TTR. Based on the positive results from ATTRibute-CM, BridgeBio submitted an NDA to the U.S. FDA, which has been accepted with a PDUFA action date of November 29, 2024, and an MAA to the European Medicines Agency, with a decision expected in 2025.
CMR is the reference non-invasive imaging method to evaluate cardiac structure, function, and amyloid burden in patients with ATTR-CM. The results shown in the imaging substudy are indicative of potential improvement of cardiac structure and function in patients with ATTR-CM, consistent with the clinical outcomes with acoramidis treatment observed in the ATTRibute-CM Phase 3 clinical trial. The impact on cardiac amyloid load highlights the potential that acoramidis could lead to cardiac amyloid regression in a proportion of patients with ATTR-CM, which we have not observed in such a controlled clinical trial to date, said Marianna Fontana, M.D., Ph.D., Professor of Cardiology and Honorary Consultant Cardiologist at the National Amyloidosis Centre, Division of Medicine, University College London, and Principal Investigator of the Substudy.
CMR imaging was performed at baseline before the first dose in 35 participants or within three months after the first dose in 17 participants (range, 14-105 days); subsequent CMR imaging was performed at months 12, 24, and 30 in those individuals who were available to undergo imaging, which was influenced by survival. Images were read centrally at the National Amyloidosis Centre in a fashion blinded to other clinical data. Findings included:
- Key CMR imaging parameters measuring cardiac structure, including mean indexed left ventricular mass, were found to be stable or have a trend towards improvement on acoramidis vs. deteriorated on placebo over 30 months
- Treatment with acoramidis preserved or was associated with a trend towards improvement in measures of cardiac function including left ventricular ejection fraction and stroke volume compared to initial measures, and relative to placebo
In July 2023, BridgeBio announced positive results from ATTRibute-CM, reporting a highly statistically significant result, demonstrated by a Win Ratio of 1.8 (pEuropean Society of Cardiology Congress 2023 and at the American Heart Association Scientific Sessions 2023. In February 2024, BridgeBio shared positive results of a single-arm Phase 3 study of acoramidis in Japanese patients with ATTR-CM, including no mortality observed in the trial at 30 months.
About BridgeBio Pharma, Inc.
BridgeBio Pharma Inc . (BridgeBio) is a commercial-stage biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers, and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn and Twitter.
BridgeBio Pharma, Inc. Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as anticipates, believes, estimates, expects, intends, may, plans, projects, seeks, should, continue, will, and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including statements relating to the clinical and therapeutic potential of our programs and product candidates, including our clinical development program for acoramidis for patients with transthyretin amyloid cardiomyopathy, the timing and success of our clinical development programs, the progress of our ongoing and planned clinical trials of acoramidis for patients with transthyretin amyloid cardiomyopathy, including the expectations of receiving a PDUFA action from the FDA on November 29, 2024 and receiving a decision from the EMA on the MAA for acoramidis in 2025, the expected intellectual property protection of acoramidis, our planned interactions with regulatory authorities, the statements regarding the potential clinical benefits or of potential benefits for ATTR-CM patients in the quotes of Dr. Fontana, and the timing of these events, reflect our current views about our plans, intentions, expectations and strategies, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations, or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from our clinical trials not being indicative of final data, the design and success of ongoing and planned clinical trials, difficulties with enrollment in our clinical trials, adverse events that may be encountered in our clinical trials, the FDA or other regulatory agencies not agreeing with our regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy, the impacts of current macroeconomic and geopolitical events, including changing conditions from the COVID-19 pandemic, hostilities in the Middle East and Ukraine, increasing rates of inflation and rising interest rates, on our overall business operations and expectations, as well as those risks set forth in the Risk Factors section of our Annual Report on Form 10-K for the year ended December 31, 2023 and our other filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
BridgeBio Media Contact:
Vikram Bali
contact@bridgebio.com
(650)-789-8220
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.
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]
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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