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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, Inc. (AMLX) announced participation in the 22nd Annual Needham Virtual Healthcare Conference. Co-CEOs Joshua Cohen and Justin Klee will present on April 18, 2023, at 12:45 PM ET. Investors can access a live webcast of the event through the company’s investor relations page, with a replay available for 90 days post-event.

Amylyx focuses on innovative treatments for neurodegenerative diseases, headquartered in Cambridge, Massachusetts, with operations in Canada and EMEA. For more details, visit the company's website.

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Amylyx Pharmaceuticals reported full-year 2022 product revenue of $22.2 million, primarily from the launches of RELYVRIO® in the U.S. and ALBRIOZA™ in Canada. In Q4 2022, net product revenue was $21.9 million, while the net loss for the quarter increased to $42.7 million or $0.65 per share. The company announced the appointment of Karen Firestone to its Board of Directors and emphasized upcoming regulatory reviews in the EU. Despite strong launch engagement and ongoing Phase 3 trials, the company is aware of the challenges that lie ahead in expanding access for ALS patients.

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Amylyx Pharmaceuticals (NASDAQ: AMLX) announced participation in two upcoming virtual investor conferences. Co-CEOs Joshua Cohen and Justin Klee will engage in a fireside chat at the Oppenheimer 33rd Annual Healthcare Conference on March 14, 2023, at 8:40 am ET, followed by a presentation at the Stifel 2023 CNS Days on March 28, 2023, at 11:00 am ET. Both events will be accessible via live webcast on the company's investor relations page.

Amylyx focuses on developing innovative treatments for neurodegenerative diseases and is headquartered in Cambridge, Massachusetts, with operations in Canada and EMEA.

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Amylyx Pharmaceuticals will release its fourth quarter and full year 2022 financial results on March 13, 2023, after U.S. market close. Senior management will host a conference call at 4:30 p.m. ET to discuss these results along with other company updates. Investors can access the call by dialing (833) 816-1395 in the U.S. or +1 (412) 317-0488 internationally, and a live audio webcast will be available in the Investor section of the company's website. The event will also be archived for 90 days.

Amylyx is focused on developing innovative treatments for the neurodegenerative disease community.

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Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) announced that Co-CEOs Joshua Cohen and Justin Klee will participate in the SVB Securities Global Biopharma Conference on February 14, 2023, at 10:00am ET. The conference will be held virtually, and a live webcast of their presentation will be available in the 'Events' section of the company's website. A replay will be accessible for 90 days post-event. Amylyx is focused on developing innovative treatments for neurodegenerative diseases, with operations based in Cambridge, Massachusetts, and across Canada and EMEA.

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Amylyx Pharmaceuticals has completed enrollment for the Phase 3 clinical trial, PHOENIX, evaluating AMX0035 for treating amyotrophic lateral sclerosis (ALS). This global, placebo-controlled study enrolled 664 participants and aims to assess the treatment's safety and efficacy over 48 weeks. Topline results are expected in 2024. The trial builds on positive outcomes from the prior Phase 2 CENTAUR trial, which demonstrated significant functional benefits and potential survival advantages. The European Medicines Agency is currently reviewing the marketing application for AMX0035, with a decision anticipated in early 2023.

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Amylyx Pharmaceuticals (NASDAQ: AMLX) will have Co-CEOs Joshua Cohen and Justin Klee participate in the Evercore ISI 5th Annual HealthCONx Conference on November 29, 2022, at 3:05 p.m. ET. The conference will take place virtually, and a live webcast can be accessed on the company's investor relations website. A replay will be available for 90 days post-event. Amylyx Pharmaceuticals is dedicated to innovating treatments for the neurodegenerative community and is headquartered in Cambridge, Massachusetts.

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Amylyx Pharmaceuticals (AMLX) announced significant updates, including the FDA approval and commercial launch of RELYVRIO™ for ALS treatment in the U.S. and the ongoing launch of ALBRIOZA™ in Canada. For Q3 2022, net product revenue reached $0.3 million, primarily from ALBRIOZA sales. Research and development expenses surged to $24.9 million, and general expenses rose to $29.9 million. The net loss was $53.8 million, or $0.92 per share. Cash reserves stood at $162.6 million after an upsized public offering raised $230.8 million.

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Amylyx Pharmaceuticals will announce its third quarter 2022 financial results on November 10, 2022, after U.S. market close. The management team will hold a conference call at 4:30 p.m. ET to discuss the results and company updates. Investors can access the call by dialing either (877) 870-4263 for local or (412) 317-0790 for international attendees. A live audio webcast will also be available on the company's investor website, with an archive accessible for 90 days.

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Amylyx Pharmaceuticals announced the successful completion of its upsized public offering, raising $246.3 million through the sale of 7,697,812 shares at $32.00 each. The offering included the full exercise of an option for an additional 1,004,062 shares. The funds generated will support the company's efforts in developing innovative treatments for the neurodegenerative community. The offering was managed by a consortium of financial firms, including Goldman Sachs and BofA Securities.

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FAQ

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

The current stock price of Amylyx Pharmaceuticals (AMLX) is $5.27 as of November 22, 2024.

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

The market cap of Amylyx Pharmaceuticals (AMLX) is approximately 364.3M.

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

364.33M
54.18M
14.32%
82.47%
1.88%
Biotechnology
Pharmaceutical Preparations
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United States of America
CAMBRIDGE