Relyvrio
Search documents
Amylyx Pharmaceuticals (AMLX) Announces the Selection of AMX0318 as Development Candidate for PBH and Other Rare Diseases
Yahoo Finance· 2026-01-10 19:57
Core Insights - Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) is recognized as one of the best-performing pharmaceutical stocks in 2025, with a focus on developing AMX0318 for post-bariatric hypoglycemia and other rare diseases [1] - The company has demonstrated strong confidence in the therapeutic potential of AMX0318, a long-acting GLP-1 receptor antagonist, which has shown robust preclinical and chemical properties [2] - Amylyx anticipates advancing AMX0318 into investigational new drug (IND)-enabling studies later this year, with an IND targeted for 2027 [3] Group 1 - AMX0318 was selected as a development candidate through a collaboration with Gubra A/S, which specializes in peptide-based drug discovery [1] - The management of Amylyx Pharmaceuticals is optimistic about the long-acting administration potential of AMX0318, supported by significant data from their first-in-class GLP-1 receptor antagonist, avexitide [2] - The pivotal Phase 3 LUCIDITY trial for avexitide is expected to complete recruitment by Q1 2026, with topline data anticipated in Q3 2026 [2] Group 2 - The company provides therapies for neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), with its commercial product being Relyvrio, also known as Albrioza in Canada [3] - AMX0318 has completed extensive preclinical evaluation, positioning the company for future advancements in its drug development pipeline [3]
AMYLYX INVESTIGATION: Bragar Eagel & Squire, P.C. Urges Amylyx Investors to Contact the Firm Regarding Ongoing Investigation into Amylyx Pharmaceuticals, Inc. on Behalf of Long-Term Stockholders
Globenewswire· 2025-10-16 20:40
Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Amylyx Pharmaceuticals, Inc. due to allegations of misleading statements regarding the commercial launch of their drug Relyvrio, which may have breached fiduciary duties to shareholders [2][3]. Group 1: Investigation Details - A class action complaint was filed against Amylyx on July 1, 2025, covering a class period from November 11, 2022, to November 8, 2023 [2]. - The complaint alleges that the board of directors made false and misleading statements about the success of the Relyvrio launch, including claims of "significant demand" that were not substantiated [3]. - Specific allegations include that the initial surge in demand for Relyvrio was temporary and that there was no meaningful growth potential among newly diagnosed ALS patients [3]. Group 2: Implications of Allegations - The complaint states that high discontinuation rates of Relyvrio were not disclosed, which undermined the drug's commercial viability and inflated the perceived potential for acquiring new patients [3]. - As a result of these misleading statements, the company's public disclosures were deemed materially false and lacked a reasonable basis [3]. Group 3: Next Steps for Shareholders - Long-term stockholders of Amylyx are encouraged to contact Bragar Eagel & Squire for more information regarding their rights and potential claims [4].
AMYLYX ALERT: Bragar Eagel & Squire, P.C. is Investigating Amylyx Pharmaceuticals, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm
GlobeNewswire News Room· 2025-07-08 01:00
Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Amylyx Pharmaceuticals, Inc. due to a class action complaint alleging breaches of fiduciary duties by the company's board of directors during the specified class period [1][2]. Summary by Relevant Sections Allegations of Misconduct - The complaint asserts that the Individual Defendants made false and misleading statements regarding the Relyvrio commercial launch, claiming significant demand that was not sustainable [2]. - It is alleged that the initial surge in demand for Relyvrio was temporary and had already subsided within months of its launch, undermining growth potential among newly diagnosed ALS patients [2]. - The complaint highlights that there were high, undisclosed discontinuation rates for Relyvrio, which negatively impacted the drug's commercial viability and inflated the perceived potential for acquiring new patients [2]. Legal Representation - Bragar Eagel & Squire, P.C. is representing long-term stockholders of Amylyx and is open to inquiries regarding the claims and rights of investors [3]. Firm Background - Bragar Eagel & Squire, P.C. is a recognized law firm specializing in representing individual and institutional investors in various complex litigations across state and federal courts [4].