Amylyx Pharmaceuticals

Amylyx Pharmaceuticals, Inc. operates as a biopharmaceutical company, which provides disease-modifying solutions for neurodegenerative diseases. The firm focuses on streamlined clinical development and drug discovery. It specializes in developing a proprietary therapeutic for Amyotrophic Lateral Sclerosis (ALS) and other neurodegenerative diseases that target the neuroinflammation and nerve cell death that characterize these disorders. The company was founded by Joshua Cohen and Justin Klee in 2013 and is headquartered in Cambridge, MA.

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Amylyx Pharmaceuticals excels in Q4 with RELYVRIO launch success

Amylyx Pharmaceuticals demonstrated strong financial performance in Q4 2022, driven by the successful commercial launch of RELYVRIO for ALS treatment.
The company's focus on key priorities for the U.S. launch and commitment to serving ALS patients position it well for future growth and impact.
While facing challenges in meeting analyst expectations and study success criteria, Amylyx Pharmaceuticals remains optimistic about the opportunities ahead in advancing ALS treatment.

Amylyx Pharmaceuticals achieves profitability in Q1, plans global PSP study

Amylyx Pharmaceuticals delivered strong financial performance in Q1, driven by the success of RELYVRIO and plans for AMX0035 in PSP. While facing challenges in profitability expectations and pipeline expansion, the company is well-positioned to capitalize on opportunities for growth and impact.

Amylyx Pharmaceuticals reports robust Q2 performance and strategic growth focus

Amylyx Pharmaceuticals' Q2 2023 Earnings Call highlighted strong financials, patient-centric initiatives, and advancements in R&D programs for neurodegenerative diseases.
Analysts' inquiries underscored the need for clarity on compliance rates, expansion strategies, and study design considerations to address potential challenges.
The company's emphasis on trial design strength, patient support, and market positioning opportunities signals a strategic focus on growth and innovation.

Amylyx Pharmaceuticals reports strong Q3 earnings, eyes growth opportunities

Amylyx Pharmaceuticals had a strong Q3 performance with significant net product revenues and a focus on expanding patient reach. While facing challenges in discontinuations and revenue impact, the company is optimistic about growth opportunities through education and trial results.

Amylyx Pharmaceuticals reports robust earnings, poised for market expansion

Amylyx Pharmaceuticals had a successful year financially, with strong revenue growth and a solid financial position.
The company's focus on expanding market reach, developing innovative biomarkers, and enhancing disease diagnosis underscores their commitment to advancing ALS treatment.
While facing uncertainties with upcoming trial data and regulatory challenges, Amylyx remains optimistic about growth opportunities and R&D advancements.

Amylyx Pharmaceuticals adapts strategy post-PHOENIX trial, eyes regulatory milestones

Amylyx Pharmaceuticals navigated a challenging quarter with a focus on pipeline diversification and strategic planning for multiple neurodegenerative diseases. Despite setbacks in the PHOENIX trial, the company remains resilient and proactive in addressing challenges while seizing opportunities for growth and regulatory progress.

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Amylyx Pharmaceuticals, Inc. is a commercial-stage biotechnology company, which engages in the provision of therapies for neurodegenerative diseases and amyotrophic lateral sclerosis (ALS). Its commercial product is Relyvrio, also known as Albrioza in Canada. The company was founded by Joshua Cohen and Justin Klee in 2013 and is headquartered in Cambridge, MA.

Amylyx Pharmaceuticals has just one drug in its pipeline -- but it's for ALS, and the available treatments for that disease leave much to be desired.

This Stock Has Delivered a Gain of 100% Over the Past 3 Months. Can You Still Buy?

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Amylyx Pharmaceuticals today announced the publication of preclinical data.

Amylyx Pharmaceuticals Announces Publication of Preclinical Data Showing Potential Synergistic Effect of AMX0035 Compared to Individual Compounds

The FDA will most likely approve this company's first drug, but what comes next is more difficult to predict.

Does a Revolutionary New ALS Drug Make This Biotech Stock a Buy Now?

The FDA's PCNSDAC recommends granting marketing approval to Amylyx's (AMLX) oral drug, which slows the progression of ALS.

Amylyx (AMLX) Up 51% After FDA Committee Endorses ALS Drug

The drugmaker's ALS drug got a thumbs-up from a panel of experts yesterday.

Why Amylyx Pharmaceuticals Stock Is on Fire Today

Source: JHVEPhoto / Shutterstock.com Amylyx Pharmaceuticals (NASDAQ: AMLX ) stock is rocketing higher on Thursday following an update from the FDA on its ALS treatment. A letter from the FDA reveals that it now supports AMX0035 for the treatment of ALS.

Why Is Amylyx Pharmaceuticals (AMLX) Stock Up 70% Today?

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals Announces FDA Advisory Committee Supports Approval of AMX0035 for the Treatment of ALS

Amylyx Pharmaceuticals Announces FDA Advisory Committee Supports Approval of AMX0035 for the Treatment of ALS

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals today announced that Nasdaq has halted trading of the company's common stock.

Amylyx Pharmaceuticals Stock Trading Halted Today

The FDA offered mixed messages Friday for Amylyx Pharmaceuticals' experimental neurological disease treatment, and AMLX stock crashed. The post The FDA's Mixed Messages Sent Amylyx Pharmaceuticals Stock Off A Cliff appeared first on Investor's Business Daily.

The FDA's Mixed Messages Sent Amylyx Pharmaceuticals Stock Off A Cliff

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals today announced that the U.S. FDA posted briefing documents for the September 7, 2022, Advisory Committee meeting.

Amylyx Pharmaceuticals Announces Posting of Briefing Documents for Second FDA Advisory Committee Meeting on AMX0035

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals Reports Second Quarter 2022 Financial Results

Amylyx Pharmaceuticals Reports Second Quarter 2022 Financial Results

Amylyx Pharmaceuticals (AMLX) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.

Is a Surprise Coming for Amylyx Pharmaceuticals (AMLX) This Earnings Season?

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals today announced that the second meeting of the PCNSDAC to discuss the AMX0035 NDA is scheduled for September 7, 2022.

Amylyx Pharmaceuticals Announces FDA Advisory Committee Will Reconvene to Review New Drug Application for AMX0035 for the Treatment of ALS on September 7, 2022

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals today announced that ALBRIOZA™ is now commercially available in Canada for people living with ALS.

Amylyx Pharmaceuticals Announces ALBRIOZA™ is Now Available in Canada for the Treatment of ALS

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CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Amylyx Pharmaceuticals today announced a two-year sponsored research agreement with Sunnybrook Research Institute (SRI).

Amylyx Pharmaceuticals Announces Partnership Agreement with Sunnybrook Research Institute to Identify Novel Drug Candidates for Neurodegenerative Diseases

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx today announced a poster on the international Phase 3 PHOENIX trial of AMX0035 in people living with ALS will be presented at the ICNMD.

Amylyx Pharmaceuticals to Announce Plans for an Open Label Extension (OLE) Phase for Global PHOENIX Trial of AMX0035 in ALS at the 17th International Congress on Neuromuscular Diseases

A new wrinkle in the story of Amylyx Pharmaceuticals' ongoing battle against ALS bodes well for patients, and for AMLX stock holders. The post Amylyx (AMLX) Stock Spikes 13% as FDA Resumes Discussion of ALS Drug appeared first on InvestorPlace.

Amylyx (AMLX) Stock Spikes 13% as FDA Resumes Discussion of ALS Drug

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals Announces FDA Plan to Reconvene Advisory Committee to Review AMX0035 NDA for the Treatment of ALS on September 7, 2022

Amylyx Pharmaceuticals Announces FDA Plan to Reconvene Advisory Committee to Review AMX0035 NDA for the Treatment of ALS on September 7, 2022

The Canadian approval has significantly increased the probability of a positive PDUFA despite negative AdCom. Phase 2 CENTAUR trial showed a slowing of functional decline and improved survival in ALS, a debilitating neurological disease.

Amylyx: Thoughts Ahead Of September 29 PDUFA In Amyotrophic Lateral Sclerosis

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Citi Research has raised the price target on Amylyx Pharmaceuticals Inc's (NASDAQ: AMLX) to $33 from $32, with a Buy rating. It says the small market opportunity for the newly approved amyotrophic lateral sclerosis (ALS) drug in Canada (~$100 million peak).

Here's How Citi Views Amylyx Pharma

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals today announced that Health Canada has approved ALBRIOZA™, with conditions, for the treatment of ALS.

Amylyx Pharmaceuticals Announces Health Canada Approval of ALBRIOZA™ for the Treatment of ALS

Amylyx Pharmaceuticals (AMLX) stock is rising higher on Friday following an update from the U.S. Food and Drug Administration (FDA). The post Why Is Amylyx Pharmaceuticals (AMLX) Stock Up 23% Today?

Why Is Amylyx Pharmaceuticals (AMLX) Stock Up 23% Today?

Amylyx Pharmaceuticals Inc (NASDAQ: AMLX) shares are trading higher by 37.67% at $13.45 after the company announced the FDA extended the review timeline of the New Drug Application for AMX0035. Amylyx says the FDA extended the PDUFA date to allow more time to review additional analyses of data from.

News for Amylyx Pharmaceuticals Stock (AMLX)