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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.

News

Amylyx Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(C)(4)

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Amylyx Pharmaceuticals, Inc. granted stock options and restricted stock units to Chief Human Resources Officer Linda Arsenault. The options allow purchasing up to 101,400 shares at $14.91 per share, with a ten-year term and four-year vesting period. RSUs will vest in four installments over four years. The grant was made under the 2023 Inducement Plan to induce Ms. Arsenault's employment.
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Amylyx Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

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Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) reported $380.8 million in net product revenue for full year 2023, with $108.4 million in the fourth quarter. The company achieved $49.3 million in net income for the full year, including $4.7 million in Q4. Amylyx aims to expand its presence globally with its ALS therapy, RELYVRIO, and anticipates sharing Phase 3 trial data in Q2 2024. Financially, the company ended 2023 with $371.4 million in cash, cash equivalents, and short-term investments.
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Amylyx Pharmaceuticals to Report Fourth Quarter and Full Year 2023 Financial Results on February 22, 2024

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Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) will announce its Q4 and full-year 2023 financial results on February 22, 2024. The senior management team will hold a conference call to discuss the results and company updates.
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Amylyx Pharmaceuticals to Present Updates on its AMX0114 and RELYVRIO® Programs in ALS at the 2024 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference

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Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) announced the presentation of abstracts on the development of AMX0114 for ALS treatment and findings from a study of AMX0035 at the MDA Conference. AMX0035, marketed as RELYVRIO®, is approved for ALS treatment in the U.S. and Canada. The abstracts detail the progress of AMX0114 and study results of AMX0035 in participants with ALS.
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Amylyx Pharmaceuticals Announces Completion of Enrollment in HELIOS, a Phase 2 Study of AMX0035 for the Treatment of Wolfram Syndrome

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Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) has completed enrollment of its Phase 2 HELIOS trial of AMX0035 for the treatment of Wolfram syndrome, a rare genetic disease with no known cure. Preliminary results are anticipated in the second half of 2024. The trial has enrolled 12 adult participants, and the FDA has granted orphan drug designation to AMX0035 for the treatment of WS, providing potential benefits for the company.
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Amylyx Pharmaceuticals Announces First Participant Dosed in the Global Phase 3 ORION Study of AMX0035 in Progressive Supranuclear Palsy (PSP)

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Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) announced the initiation of the ORION Phase 3 clinical trial of AMX0035 for the treatment of progressive supranuclear palsy (PSP). The trial will enroll approximately 600 participants in the largest PSP clinical trial to date, spanning across the U.S., Canada, Europe, and Japan. The primary efficacy endpoint will evaluate change in disease progression from baseline to Week 52, with topline results anticipated in 2-3 years.
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Amylyx Pharmaceuticals Announces Publication of Data Showing the Effect of AMX0035 on Plasma Neuroinflammatory Biomarkers in ALS

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Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) announced the publication of analyses performed on neuroinflammatory biomarkers from the Phase 2 CENTAUR trial. The post hoc analyses demonstrated a significant reduction in plasma concentrations of YKL-40 and CRP, but not CHIT1, over 24 weeks, with reductions observed as early as Week 12 in participants from the CENTAUR trial. The results suggest that YKL-40 could be a treatment-sensitive biomarker, and further analyses are planned in the ongoing Phase 3 PHOENIX trial to confirm these results.
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Amylyx Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) granted stock options and restricted stock units to its new Chief Medical Officer, Dr. Camille L. Bedrosian. The Compensation Committee approved the grant effective November 27, 2023, consisting of non-qualified stock option awards to purchase up to 162,500 shares of the company's common stock and 58,333 RSUs under the 2023 Inducement Plan. The options have an exercise price of $12.93 per share, with a ten-year term and vesting over four years. The RSUs will vest in four installments on the first four anniversaries of the applicable vesting commencement date, subject to Dr. Bedrosian’s continued employment with Amylyx. The awards were granted as an inducement material to Dr. Bedrosian entering into employment with Amylyx in accordance with Nasdaq Listing Rule 5635(c)(4).
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Amylyx Pharmaceuticals Appoints Camille L. Bedrosian, MD, as Chief Medical Officer

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Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) announced the appointment of Dr. Camille L. Bedrosian as Chief Medical Officer. Dr. Bedrosian brings nearly 30 years of leadership in clinical research and development, with experience at Ultragenyx, Alexion, and ARIAD Pharmaceuticals. She will lead global medical functions at Amylyx, focusing on addressing unmet medical needs for people with rare and serious diseases.
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RELYVRIO® and AMX0114 Data to be Presented at 34th International Symposium on ALS/MND

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Amylyx Pharmaceuticals, Inc. (AMLYX) announced the presentation of new data on AMX0035 and AMX0114 for the potential treatment of ALS and other neurodegenerative diseases at the 34th International Symposium on ALS/MND. The abstracts detail studies on mortality-adjusted progression, ongoing and planned studies for AMX0035, development of a diagnostic biomarker for ALS, and strategies to enhance the palatability of the treatment. The Company aims to use the MAP model for the primary efficacy analysis in the Phase 3 PHOENIX trial with results expected in Q2 2024.
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FAQ

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

The current stock price of Amylyx Pharmaceuticals (AMLX) is $5.19 as of November 21, 2024.

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

The market cap of Amylyx Pharmaceuticals (AMLX) is approximately 351.0M.

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.

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Amylyx Pharmaceuticals, Inc.

Nasdaq:AMLX

AMLX Rankings

#3399 Ranked by Market Cap
N/A Ranked by Dividends

AMLX Stock Data

350.97M
54.18M
14.32%
82.47%
1.88%
Biotechnology
Pharmaceutical Preparations
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United States of America
CAMBRIDGE