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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 announces acceptance of abstracts for presentation at the NEALS Annual Meeting, highlighting progress on AMX0035 and AMX0114 for ALS treatment. Updates include the development of a diagnostic biomarker test, targeting axonal degeneration, and evaluating neuroprotective strategies. Real-world experiences and safety data are also shared.
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Amylyx Pharmaceuticals to participate in upcoming investor conferences in September
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Amylyx Pharmaceuticals reported strong financial results for the second quarter of 2023, with product revenue of $98.2 million and net income of $22.1 million. The company's commercial launches of RELYVRIO in the U.S. and ALBRIOZA in Canada continued to progress, and five Canadian provinces announced public reimbursement for ALBRIOZA. Amylyx also plans to initiate a global Phase 3 trial of AMX0035 for the treatment of progressive supranuclear palsy later this year. Additionally, the Marketing Authorisation Application for AMX0035 for the treatment of ALS is under review with the European Medicines Agency's Committee for Medicinal Products for Human Use.
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Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) will report its second quarter 2023 financial results on August 10, 2023, followed by a conference call and webcast to discuss the results and company updates. Investors can access the call and webcast through the company's website or by dialing the provided numbers.
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Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) announced a virtual webcast with Prof. Dr. Günter Höglinger to discuss the treatment landscape for progressive supranuclear palsy (PSP) and the Company’s clinical development plans for AMX0035 in PSP on July 26, 2023 at 1:30pm ET. Prof. Dr. Höglinger is an expert in neurodegenerative Parkinson syndromes and has been involved in international clinical trials in PSP.
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Amylyx Pharmaceuticals provides an update on the review of its Marketing Authorisation Application for AMX0035 for the treatment of ALS by the CHMP of the EMA. The CHMP is trending toward a negative opinion, but Amylyx plans to request a formal re-examination if a negative opinion is issued. The MAA is based on data from the CENTAUR clinical trial, which showed significant benefits in function and survival. The CHMP is expected to adopt a formal opinion in June.
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Amylyx Pharmaceuticals reports Q1 2023 product revenue of $71.4 million and progress in commercial launches of RELYVRIO and ALBRIOZA for ALS treatment. Regulatory review ongoing in the EU. Expansion of pipeline with Phase 2 HELIOS study and planned Phase 3 study in progressive supranuclear palsy.
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FAQ

What is the current stock price of Amylyx Pharmaceuticals (AMLX)?

The current stock price of Amylyx Pharmaceuticals (AMLX) is $3.84 as of January 7, 2025.

What is the market cap of Amylyx Pharmaceuticals (AMLX)?

The market cap of Amylyx Pharmaceuticals (AMLX) is approximately 263.2M.

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

AMLX Rankings

AMLX Stock Data

263.22M
54.19M
14.3%
82.32%
2.28%
Biotechnology
Pharmaceutical Preparations
Link
United States of America
CAMBRIDGE