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Yahoo
3 minutes ago
- Yahoo
Amylyx Pharmaceuticals Shares Promising Avexitide Data for Post-Bariatric Hypoglycemia at ENDO 2025, Phase 3 Enrollment Nears Completion
Amylyx Pharmaceuticals Inc. (NASDAQ:AMLX) is one of the best low priced pharma stocks to buy now. On July 13, Amylyx Pharmaceuticals announced new exploratory analyses from its Phase 2 PREVENT and Phase 2b clinical trials of avexitide for post-bariatric hypoglycemia/PBH at the Endocrine Society's annual meeting (ENDO 2025). Avexitide is an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist and has received FDA Breakthrough Therapy designation for PBH. PBH is a complication that can arise after bariatric surgery, such as Roux-en-Y gastric bypass. A medical scientist in a lab coat gazing at a microscopic view of a drug in development. There are currently no FDA-approved treatments for PBH. Avexitide works by binding to the GLP-1 receptor on pancreatic islet beta cells, blocking the effect of excessive GLP-1 and thus mitigating hypoglycemia by decreasing insulin secretion and stabilizing glucose levels. Avexitide has generally been well-tolerated with a favorable safety profile across all trials. Amylyx expects to complete recruitment for the LUCIDITY trial this year, with topline data anticipated in H1 2026. Amylyx Pharmaceuticals Inc. (NASDAQ:AMLX) is a clinical-stage pharmaceutical company that discovers and develops treatment options for neurodegenerative diseases and endocrine conditions in the US. While we acknowledge the potential of AMLX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
4 minutes ago
- Yahoo
Klotho Neurosciences, Inc. Granted FDA Orphan Drug Designation for KLTO-202 for Treatment of Amyotrophic Lateral Sclerosis ("ALS" or "Lou Gehrig's Disease")
NEW YORK, July 10, 2025 /PRNewswire/ -- Klotho Neurosciences, Inc. (Nasdaq: KLTO), a gene and cell therapy company focused on the treatment of neurodegenerative and other aging-related diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company's novel secreted-Klotho (s-KL) promoter, gene and delivery system (KLTO-202, or for the treatment of ALS. The FDA grants Orphan Drug Designation to drugs and biologics that are intended for safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. The Orphan Drug Designation provides certain incentives, such as tax credits, toward the cost of human clinical trials and a waiver for the payment of the GDUFA User Fee for market applications. Additionally, Orphan Drug Designation of the product provides the developers seven years of US market exclusivity and independent from the Company's intellectual property protection. "Receiving the Orphan Drug Designation for for the early treatment of ALS underscores the importance of bringing new treatment options to patients suffering from this rare, universally fatal disease" said Dr. Joseph Sinkule, Klotho's Chief Executive Officer. "My cousin Karen died from this horrific disease. We aim to deliver the first gene replacement therapy addressing the neurologic insult resulting in motor neuron damage and the potential neurologic protection induced by providing therapeutic blood, brain, and muscle concentrations of the s-KL protein. After the FDA's review of the data leading to the Orphan Drug Designation, we believe this ODD designation provides strong validation of our science and our approach to treat this disease" concludes Dr. Sinkule. ALS is sometimes referred to as Lou Gehrig's disease. Lou Gehrig, who played for the New York Yankees for 17 years in the 1920s and 1930s, stunned players and fans by retiring from baseball at the age of 36 after being diagnosed with ALS. Prior to this diagnosis, Gehrig played in a record-breaking 2,130 consecutive games, was referred to as the "Iron Horse," and was considered one of the greatest baseball players of all time. Less than two years later, at the age of 37, Gehrig died of complications from ALS. ALS is also referred to as Motor Neuron Disease in the UK and elsewhere. ALS is considered a rare disease and affects fewer than 200,000 people in the US, with around 5,000 new cases diagnosed each year. Klotho Neurosciences will have completed "proof of concept" studies in two animal models of human ALS and the Company is currently initiating manufacturing of the ALS-targeted product candidate, followed by meetings with the U.S. FDA and EMA in Europe to concur with the development path going forward. KLTO-202, the company's lead product candidate targeting motor neuron diseases and muscular dystrophies, is composed of a muscle-specific promoter called "desmin," driving the expression of the s-KL gene transcript and s-KL protein, with targeted delivery of the gene therapy to the neuromuscular junction - the interface between the spinal cord and the muscles. At this time, KLTO-202 is not approved for human use by any regulatory authority. About Klotho Neurosciences, Neurosciences, Inc. (NASDAQ: KLTO), is a biogenetics company focused on the development of innovative, disease-modifying cell and gene therapies using a protein derived from a patented form of the "anti-aging" human Klotho gene (s-KL), and its novel delivery systems to transform and improve the treatment of neurodegenerative and age-related disorders such as ALS, Alzheimer's, and Parkinson's disease. The Company's current portfolio consists of its proprietary cell and gene therapy programs using DNA and RNA as therapeutics and genomics-based diagnostic assays. The Company is managed by a team of individuals and advisors who are highly experienced in biopharmaceutical product development and commercialization. For more information, please visit the company's website at Investor Contact and Corporate Communications: - Jeffrey LeBlanc, CFOir@ Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements generally are identified by the words "believe," "project," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Without limiting the generality of the foregoing, the forward-looking statements in this press release include descriptions of the Company's future commercial operations. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, such as the Company's inability to implement its business plans, identify and realize additional opportunities, or meet or exceed its financial projections and changes in the regulatory or competitive environment in which the Company operates. You should carefully consider the foregoing factors and the other risks and uncertainties described in the documents filed or to be filed by the Company with the U.S. Securities and Exchange Commission (the "SEC") from time to time, which could cause actual events and results to differ materially from those contained in the forward-looking statements. Copies of these documents are available on the SEC's website, All information provided herein is as of the date of this press release, and the Company undertakes no obligation to update any forward-looking statement, except as required under applicable law. View original content to download multimedia: SOURCE Klotho Neurosciences, Inc.
The Hill
19 minutes ago
- The Hill
Most US stocks fall, but Nvidia keeps Wall Street near records
NEW YORK (AP) — Most U.S. stocks are falling on Tuesday after an update on inflation hurt Wall Street's hopes for lower interest rates. But indexes are staying close to their records thanks to Nvidia, the market's most influential stock. The S&P 500 was down 0.1% in midday trading and just a bit below its all-time high, which was set on Thursday. The Dow Jones Industrial Average was down 294 points, or 0.7%, as of 11 a.m. Eastern time, and the Nasdaq composite was 0.4% higher and on track to set another record. Stocks were feeling pressure from a report showing inflation accelerated to 2.7% last month in the United States from 2.4% in May. Economists pointed to increases in prices for clothes, toys and other things that tend to get imported from other countries. Their prices could be rising because of tariffs that President Donald Trump has imposed on countries worldwide in hopes of getting them to open their markets further to U.S. products. 'Inflation has begun to show the first signs of tariff pass-through,' according to Ellen Zentner, chief economic strategist for Morgan Stanley Wealth Management. To be sure, the inflation rate for June reported on Tuesday morning wasn't far from what economists expected. And an underlying measure of inflation that economists think is a better predictor of future trends accelerated by less than feared. Altogether, the data caused Treasury yields to yo-yo a few times in the bond market before they began rising. The yield on the 10-year Treasury climbed to 4.47% from 4.43% late Monday. The yield on the two-year Treasury, which more closely tracks expectations for what the Federal Reserve will do with short-term interest rates, rose to 3.94% from 3.90%. A further acceleration in inflation could tie the hands of the Fed, which has kept interest rates on hold so far this year, because lower rates can give inflation more fuel. Wall Street loves lower interest rates because they goose prices higher for stocks and other investments, and Trump himself has been clamoring for the Fed to cut more quickly. Fed Chair Jerome Powell, though, has been adamant that he wants to wait for more data about how tariffs affect the economy and inflation before moving. Following Tuesday's inflation data, traders are still overwhelmingly betting that the Fed will cut its main interest rate at least once by the end of the year. But they pulled back their bets on the number of potential cuts, compared with a day before, according to data from CME Group. On Wall Street, tech stocks were the outliers and rose after Nvidia said the U.S. government assured it that licenses will be granted for its H20 chip again and that deliveries will hopefully begin soon. Nvidia's 4.3% gain was by far the strongest force pushing upward on the S&P 500. Earlier this year, Nvidia said that U.S. restrictions on the chips used in artificial-intelligence development chiseled billions of dollars off its results for the first quarter of the year. Nvidia's announcement could also be an encouraging signal for trade talks between the United States and China, the world's two largest economies. Stocks of big U.S. banks, meanwhile, were mixed following their latest profit reports. JPMorgan Chase fell 0.9% despite reporting a stronger profit than analysts expected, as CEO Jamie Dimon warned of risks to the economy because of tariffs and other concerns. Citigroup rose 1.6%, and Wells Fargo fell 5.3% following their profit reports, which also topped analysts' expectations. In stock markets abroad, indexes slipped in Europe after a mixed session in Asia. Indexes rose 1.6% in Hong Kong but fell 0.4% in Shanghai after a report said China's economic growth slowed only slightly last quarter despite pressure from Trump's tariffs.
