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Amylyx Pharmaceuticals, Inc. - AMLX STOCK NEWS

Welcome to our dedicated page for Amylyx Pharmaceuticals news (Ticker: AMLX), a resource for investors and traders seeking the latest updates and insights on Amylyx Pharmaceuticals stock.

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) is a pioneering biopharmaceutical company headquartered in Cambridge, Massachusetts. Focused on the development of novel therapeutics for neurodegenerative diseases, Amylyx has garnered attention primarily for AMX0035, an experimental therapy designed to treat amyotrophic lateral sclerosis (ALS) and other neurodegenerative disorders. The company operates in a single segment dedicated to the research and development of these groundbreaking treatments.

The company’s flagship product, AMX0035, has made significant strides in the treatment of ALS. It was previously marketed under the names RELYVRIO and ALBRIOZA in the U.S. and Canada, respectively. However, based on recent data from the Phase 3 PHOENIX trial, Amylyx has voluntarily discontinued the marketing authorizations for these products. Despite this setback, the company remains committed to its mission, with ongoing studies and upcoming trials aimed at exploring AMX0035's efficacy in other conditions such as Wolfram syndrome and Progressive Supranuclear Palsy (PSP).

Recently, Amylyx has reported promising interim data from the Phase 2 HELIOS clinical trial of AMX0035 in adults with Wolfram syndrome. These preliminary results demonstrated improvements in pancreatic function, glycemic control, and vision, indicating significant promise for this therapy. Additionally, the Phase 3 ORION trial is currently evaluating AMX0035 for PSP, with an interim analysis expected in mid-2025.

Amylyx is also advancing AMX0114, an antisense oligonucleotide targeting calpain-2 for the treatment of ALS. The company is preparing to initiate a clinical trial for AMX0114 in the second half of 2024. With a strategic focus and substantial pipeline, Amylyx is dedicated to bringing innovative treatments to the neurodegenerative disease community.

Financially, Amylyx reported $88.6 million in net product revenue for Q1 2024, and maintains a strong cash position with $373.3 million in cash, cash equivalents, and short-term investments as of March 31, 2024. This robust financial standing provides the company with a runway into 2026, supporting its unwavering commitment to its pipeline and upcoming clinical milestones.

For more information, visit amylyx.com and follow the company on LinkedIn and X, formerly known as Twitter. Investors can access further details at investors.amylyx.com.

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Amylyx Pharmaceuticals has acquired avexitide, a first-in-class GLP-1 receptor antagonist, from Eiger BioPharmaceuticals for $35.1 million. Avexitide is designed to treat hyperinsulinemic hypoglycemia and has received FDA Breakthrough Therapy Designation for post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism (HI). The Phase 3 trial for PBH is set to begin in Q1 2025, with results expected in 2026. Two Phase 2 trials demonstrated significant reductions in hypoglycemic events, and avexitide showed a favorable safety profile. Amylyx will incorporate avexitide into its existing pipeline, bolstering its focus on treating endocrine and neuroscience disorders.

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Amylyx Pharmaceuticals (NASDAQ: AMLX) announced that it will host a conference call and webcast on Wednesday, July 10, 2024, at 8:00 a.m. ET to discuss its acquisition of avexitide from Eiger BioPharmaceuticals.

The conference call can be accessed by dialing +1 (800) 836-8184 in the U.S. and Canada or +1 (646) 357-8785 internationally, 10 minutes before the start time, and by asking to join the Amylyx Pharmaceuticals call.

A live audio webcast will be available in the Investor section of the Amylyx website and can be replayed for 90 days post-event.

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Amylyx Pharmaceuticals (Nasdaq: AMLX) will participate in the Goldman Sachs 45th Annual Global Healthcare Conference. The event is in-person in Miami, Florida. Amylyx's management will present a fireside chat on June 11, 2024, at 8:00 AM EDT. Investors can access a live webcast of the presentation on the company's website, and it will be available for replay for 90 days.

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Amylyx Pharmaceuticals reported financial results for the first quarter of 2024, highlighting progress in clinical trials for AMX0035 in Wolfram syndrome and PSP, along with plans to initiate a clinical trial of AMX0114 in ALS. The company announced intention to remove RELYVRIO/ALBRIOZA from the market based on Phase 3 trial results. Interim data from the HELIOS trial showed promising results in participants with Wolfram syndrome, and ORION study data is expected in mid-2025.

Financially, net product revenue increased, but the company incurred significant costs associated with discontinuing RELYVRIO/ALBRIOZA. Research and development expenses and SG&A expenses also increased, resulting in a net loss for the quarter. Despite this, the company maintains a strong cash position, providing expected cash runway into 2026.

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Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) will be participating in the 2024 Bank of America Health Care Conference with its Co-CEOs and Chief Medical Officer. The conference will feature a fireside chat on May 15, 2024, in Las Vegas. The presentation will be available via live webcast on the company's investor section for 90 days post-event.

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Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) will report its first quarter 2024 financial results on May 9, 2024. The senior management team will host a conference call and webcast to discuss the financial results and company updates. Investors can access the call by dialing the provided numbers or through the company's website.

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Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) announced positive interim data from the Phase 2 HELIOS clinical trial of AMX0035 in adults with Wolfram syndrome. The data showed improvements in pancreatic function, glycemic control, and vision, with all participants meeting responder criteria. AMX0035 was well-tolerated and demonstrated promising results, defying the typical disease progression. The trial aims to slow diabetic and visual decline in Wolfram syndrome patients.
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Amylyx Pharmaceuticals, Inc. announces a virtual webcast to discuss interim data from the Phase 2 trial of AMX0035 for Wolfram syndrome treatment. Dr. Fumihiko Urano to present findings on April 10, 2024.
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Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) has initiated the process to discontinue the marketing authorizations for RELYVRIO/ALBRIOZA based on Phase 3 PHOENIX trial results. Patients can transition to a free drug program. The company is focusing on AMX0035 in Wolfram syndrome and PSP, and AMX0114 in ALS. A restructuring plan reduces the workforce by 70% to extend cash runway into 2026.
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Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) appoints Dr. Bernhardt G. Zeiher, a seasoned industry expert with over 20 years of drug development experience, to its Board of Directors. Dr. Zeiher's background includes overseeing the approval of 15 new treatments for serious diseases with unmet needs. His addition is expected to enhance Amylyx's pipeline development for neurodegenerative diseases, reinforcing the company's commitment to addressing these devastating conditions.
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FAQ

What is Amylyx Pharmaceuticals best known for?

Amylyx Pharmaceuticals is best known for developing AMX0035, an experimental therapy for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases.

What recent achievement has Amylyx Pharmaceuticals reported?

Amylyx recently reported promising interim data from the Phase 2 HELIOS clinical trial of AMX0035 in Wolfram syndrome, showing improvements in pancreatic function, glycemic control, and vision.

What is the current focus of Amylyx Pharmaceuticals?

Amylyx is currently focused on advancing AMX0035 in Wolfram syndrome and progressive supranuclear palsy (PSP), as well as developing AMX0114 for ALS.

What financial condition is Amylyx Pharmaceuticals in as of Q1 2024?

Amylyx reported $88.6 million in net product revenue for Q1 2024 and maintains a strong cash position with $373.3 million in cash, cash equivalents, and short-term investments.

Will RELYVRIO/ALBRIOZA continue to be available?

No, Amylyx has started a process to voluntarily discontinue the marketing authorizations for RELYVRIO/ALBRIOZA based on recent PHOENIX trial results. However, patients currently on therapy who wish to continue can be transitioned to a free drug program.

What makes AMX0035 unique?

AMX0035 is unique due to its ability to target both endoplasmic reticulum stress and mitochondrial dysfunction, which are central pathways leading to cell death and neurodegeneration.

What are the upcoming milestones for Amylyx Pharmaceuticals?

Upcoming milestones include topline data from the HELIOS trial of AMX0035 in Wolfram syndrome in fall 2024, an interim analysis from the ORION study in mid-2025, and the initiation of a clinical trial for AMX0114 in ALS in the second half of 2024.

Where is Amylyx Pharmaceuticals headquartered?

Amylyx Pharmaceuticals is headquartered in Cambridge, Massachusetts.

How can investors get more information about Amylyx Pharmaceuticals?

Investors can get more information by visiting the investor relations section on Amylyx's website at https://investors.amylyx.com.

Amylyx Pharmaceuticals, Inc.

Nasdaq:AMLX

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68.01M
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10.61%
Medicinal and Botanical Manufacturing
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United States of America
CAMBRIDGE