Latest news with #AmylyxPharmaceuticals
Yahoo
20 hours ago
- Business
- 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
a day ago
- Business
- 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
Business Wire
3 days ago
- Health
- Business Wire
Amylyx Pharmaceuticals Presents New Exploratory Analyses from Phase 2 and Phase 2b Clinical Trials of Avexitide in Post-Bariatric Hypoglycemia at ENDO 2025
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) ('Amylyx' or the 'Company') today announced the presentation of new exploratory analyses from the Phase 2 PREVENT and Phase 2b clinical trials of avexitide, an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist for the treatment of post-bariatric hypoglycemia (PBH) at the Endocrine Society's annual meeting (ENDO 2025). In the Phase 2b trial, avexitide 90 mg once daily, the dose being evaluated in the pivotal Phase 3 LUCIDITY trial, led to a 64% least-squares (LS) mean reduction (p=0.0031) vs. baseline in the composite rate of Level 2 and Level 3 hypoglycemic events in PBH, with more than half of the participants experiencing no events during the treatment period. LUCIDITY is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of avexitide in approximately 75 participants with PBH following Roux-en-Y gastric bypass surgery. The FDA-agreed-upon primary endpoint of LUCIDITY is reduction in the composite of Level 2 and Level 3 hypoglycemic events. Consistent reductions in composite rate of Level 2 and Level 3 hypoglycemic events also were seen with avexitide 45 mg twice daily studied in the Phase 2b trial and avexitide 30 mg twice daily and 60 mg once daily studied in the Phase 2 PREVENT trial. New pharmacokinetic (PK) and pharmacodynamic (PD) data were also presented demonstrating continuous pharmacologic activity of the 90 mg once daily dose regimen for a 24-hour period. 'Post-bariatric hypoglycemia can profoundly disrupt daily life, requiring individuals to carefully manage meals, social interactions, and routines, often while living in fear of their next hypoglycemic event. The new analysis presented at ENDO 2025 continues to support that avexitide may significantly reduce the frequency of these events,' said Marilyn Tan, MD, FACE, Principal Investigator of the LUCIDITY trial and Clinical Associate Professor at Stanford University. Camille L. Bedrosian, MD, Chief Medical Officer of Amylyx, added, 'Post-bariatric hypoglycemia is a serious and underrecognized condition with no FDA-approved treatments. The data presented show that, in an exploratory analysis from the Phase 2 PREVENT and Phase 2b clinical trials, avexitide significantly reduced the composite rate of Level 2 and 3 hypoglycemic events, including at the 90 mg once daily dose that is being studied in our pivotal Phase 3 LUCIDITY trial. We are particularly encouraged that over half of participants did not experience Level 2 or Level 3 hypoglycemic events during the treatment period. In addition, the pharmacokinetic and pharmacodynamic data demonstrated continuous pharmacologic activity of avexitide 90 mg once daily dose over 24 hours. We continue to be encouraged by avexitide's potential to deliver consistent, meaningful benefit to people living with PBH.' The population PK and PD analyses presented at ENDO 2025 demonstrated that avexitide 90 mg once daily maintained consistent GLP-1 receptor inhibition from morning to midnight and between doses. In vitro potency studies showed an IC₅₀ of approximately 20-30 nM (70-100 ng/mL), indicating robust target inhibition even in the presence of significant levels of GLP-1. PK modeling demonstrated that avexitide plasma levels exceeded IC₅₀ for a full 24-hour period. LUCIDITY was informed by data from five PBH clinical trials of avexitide showing consistent, dose-dependent effects, including statistically significant and clinically meaningful reductions in hypoglycemic events. Avexitide was generally well-tolerated, with a favorable safety profile replicated across clinical trials. Completion of recruitment for LUCIDITY is expected in 2025, with a data readout anticipated in the first half of 2026 and, if approved, commercial launch anticipated in 2027. The presentation and posters are available on the ' Presentations ' tab of the Amylyx website. Webcast Information Amylyx will host an investor event today, July 13, 2025, at 6:00 p.m. PT / 9:00 p.m. ET in San Francisco to discuss post-bariatric hypoglycemia and avexitide. A live webcast of the presentation and Q&A portion of the event can be accessed under 'Events and Presentations' in the Investor section of the Company's website, The webcast will be archived and available for replay for 90 days following the event. About Avexitide Avexitide is an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist that has been evaluated in five Phase 1 and Phase 2 clinical trials for post-bariatric hypoglycemia (PBH) and has also been studied in congenital hyperinsulinism (HI). The U.S. Food and Drug Administration (FDA) has granted avexitide Breakthrough Therapy Designation for both indications, Rare Pediatric Disease Designation in congenital HI, and Orphan Drug Designation for the treatment of hyperinsulinemic hypoglycemia (which includes PBH and congenital HI). Avexitide is designed to bind to the GLP-1 receptor on pancreatic islet beta cells and inhibit the effect of GLP-1 to mitigate hypoglycemia by decreasing insulin secretion and stabilizing blood glucose levels. In PBH, excessive GLP-1 can lead to the hypersecretion of insulin and subsequent debilitating hypoglycemic events. In two Phase 2 PBH clinical trials, avexitide demonstrated highly statistically significant reductions in hypoglycemic events. These events can lead to autonomic and neuroglycopenic symptoms that can have a devastating impact on daily living. About Post-Bariatric Hypoglycemia (PBH) Post-bariatric hypoglycemia (PBH) is a condition that is estimated to affect approximately 8% of people in the U.S. who have undergone the two most common types of bariatric surgery, sleeve gastrectomy and Roux-en-Y gastric bypass (approximately 160,000 people in the U.S.). PBH is thought to be caused by an excessive glucagon-like peptide-1 (GLP-1) response leading to hypoglycemia and impaired quality of life. PBH can cause debilitating hypoglycemic events associated with inadequate supply of glucose to the brain, known as neuroglycopenia. Clinical manifestations can include impaired cognition, loss of consciousness, and seizures. PBH is also associated with a high degree of disability that can result in major disruptions to independent living. There are no approved therapies for PBH. About the LUCIDITY Trial LUCIDITY (NCT06747468) is an approximately 75-participant, multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of avexitide in participants with PBH following Roux-en-Y gastric bypass (RYGB) surgery. The Phase 3 trial will be conducted at approximately 20 sites in the U.S. Participants will be randomized 3:2 to receive either 90 mg of avexitide subcutaneously once daily or placebo. The trial includes an up to six-week screening period, including a three-week run-in period, and a 16-week double-blind treatment period. Participants who complete the double-blind period will be eligible to enter an open-label extension (OLE) period with a duration of 32 weeks. The primary efficacy objective of LUCIDITY will evaluate the FDA-agreed upon primary outcome of reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16. Safety and tolerability will also be evaluated. About Amylyx Pharmaceuticals At Amylyx, our mission is to usher in a new era of treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are currently focused on three investigational therapies across several neurodegenerative and endocrine diseases in which we believe they can make the greatest impact. For more information, visit and follow us on LinkedIn and X. For investors, please visit Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, Amylyx' expectations regarding: the potential of avexitide as a treatment for PBH; expectations regarding the timing for recruitment completion and topline data readout of the Phase 3 LUCIDITY trial of avexitide in PBH; and expectations regarding timing for potential commercialization of avexitide. Any forward-looking statements in this press release and related comments in the Company's earnings conference call are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Amylyx' program development activities; Amylyx' ability to execute on its regulatory development plans and expectations regarding the timing of results from its planned data announcements and initiation of clinical studies; the risk that early-stage results may not reflect later-stage results; Amylyx' ability to fund operations, and the impact that global macroeconomic uncertainty, geopolitical instability, and public health events will have on Amylyx' operations, as well as the risks and uncertainties set forth in Amylyx' United States Securities and Exchange Commission (SEC) filings, including Amylyx' Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent filings with the SEC. All forward-looking statements contained in this press release and related comments in our earnings conference call speak only as of the date on which they were made. Amylyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Yahoo
24-06-2025
- Business
- Yahoo
Amylyx Pharmaceuticals Gains FDA Fast Track for ALS Drug AMX0114
Amylyx Pharmaceuticals Inc. (NASDAQ:AMLX) is one of the best biotech stocks to invest in now. On June 3, Amylyx Pharmaceuticals announced that the US FDA granted Fast Track designation to AMX0114. AMX0114 is an investigational antisense oligonucleotide/ASO that is specifically designed to target calpain-2. This protein is believed to be a significant contributor to axonal degeneration, which is a key driver in the progression of amyotrophic lateral sclerosis/ALS. ALS is a rapidly progressive and fatal neurodegenerative disorder with limited therapeutic options. The Fast Track designation is a crucial step for Amylyx in its mission to develop treatments for ALS. The FDA's decision acknowledges both the severity of ALS and the encouraging preclinical data supporting AMX0114's potential. A medical scientist in a lab coat gazing at a microscopic view of a drug in development. Calpain-2 is a calcium-activated protease. Research has indicated that overactive calpain-2 activity might accelerate disease progression in ALS and other neurodegenerative conditions by causing the degeneration of axons, which are vital for transmitting signals between neurons and muscles. Preclinical studies of AMX0114 have demonstrated improved neuronal survival and reduced levels of extracellular neurofilament light (NfL), which is a biomarker for neuronal damage across various disease models. AMX0114 was also well-tolerated in preclinical safety studies. Amylyx Pharmaceuticals Inc. (NASDAQ:AMLX) is a clinical-stage pharmaceutical company that discovers and develops treatments 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.
Globe and Mail
07-05-2025
- Business
- Globe and Mail
This Biotech Found Mid-Week Success Following Analyst Upgrade
A biotech company based out of Massachusetts found a tremendous amount of success on Wednesday after Leerink Partners upgraded the stock from market perform to outperform, raising their price target for the stock from $4 to $10. Traders wasted no time buying up shares of Amylyx Pharmaceuticals Inc. (Nasdaq:AMLX), pushing the small cap to close up at $4.87/share (+4.73%) on the day. This doesn't come at too much of a surprise given the bullish price target versus yesterday's close at just $4.65. This move was a strong continuation of the success this stock has had over the last month. Amylyx Pharmaceuticals Inc is a clinical-stage pharmaceutical company working on developing a novel therapeutic for amyotrophic lateral sclerosis and other neurodegenerative diseases. Copyright © 2025 All rights reserved. Republication or redistribution of content is expressly prohibited without the prior written consent of shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. View more of this article on About Media, Inc.: Founded in 1999, is one of North America's leading platforms for micro-cap insights. Catering to both Canadian and U.S. markets, we provide a wealth of resources and expert content designed for everyone—from beginner investors to seasoned traders. is rapidly gaining recognition as a leading authority in the micro-cap space, with our insightful content prominently featured across numerous top-tier financial platforms, reaching a broad audience of investors and industry professionals. Want to showcase your company's story to a powerful network of investors? We can help you elevate your message and make a lasting impact. Contact us today. Contact: Media, Inc.
