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.

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Amylyx Pharmaceuticals shares fell Friday after its ALS (amyotrophic lateral sclerosis) drug was denied marketing authorization by European Union regulators for the second time.  The repeat rebuff comes after Amylyx asked in June for a formal re-examination of the original denial adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

Amylyx Pharmaceuticals's ALS dug rejected again by EU regulators

Amylyx Pharmaceuticals Inc. AMLX, -4.60% shares fell 7.5% premarket on Friday after the company said the European Medicines Agency had confirmed its negative opinion on Albrioza, a treatment for amyotrophic lateral sclerosis. The decision comes after a re-examination of the initial negative opinion issued in June.

Amylyx Pharmaceuticals shares fall after ALS treatment is rejected by European regulator

Amylyx Pharmaceuticals said on Friday the European Union medicines regulator for the second time declined to recommend a marketing authorisation for the company's drug to treat amyotrophic lateral sclerosis (ALS).

EU regulator declines to recommend Amylyx' ALS drug

CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $AMLX--Amylyx Pharmaceuticals Receives Negative CHMP Opinion on its MAA for AMX0035 for the Treatment of ALS in the European Union Following Re-Examination.

Amylyx Pharmaceuticals Receives Negative CHMP Opinion on its Marketing Authorisation Application for AMX0035 for the Treatment of ALS in the European Union Following Re-Examination Process

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CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $AMLX--Amylyx Pharmaceuticals announced the publication of a post hoc analysis of survival data from the CENTAUR study.

Amylyx Pharmaceuticals Announces Publication of Survival Analysis Comparing CENTAUR to Historical Clinical Trial Control

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals Provides Update on Accès Compassionnel for AMX0035 in France.

Amylyx Pharmaceuticals Provides Update on Accès Compassionnel for AMX0035 in France

CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $AMLX--Amylyx Pharmaceuticals, Inc. announced the acceptance of several abstracts for presentation at the 2023 Northeast ALS Consortium Annual Meeting.

RELYVRIO® and AMX0114 Data to be Presented at 22nd Annual Northeast ALS Consortium (NEALS) Meeting

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Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX ) Q2 2023 Earnings Conference Call August 10, 2023 4:30 PM ET Company Participants Lindsey Allen - Head of Investor Relations & Communications Justin Klee - Co-Chief Executive Officer Margaret Olinger - Chief Commercial Officer Jim Frates - Chief Financial Officer Josh Cohen - Co-Chief Executive Officer Conference Call Participants Corinne Jenkins - Goldman Sachs Geoff Meacham - Bank of America Michael DiFiore - Evercore Marc Goodman - Leerink Partners Graig Suvannavejh - Mizuho Ananda Ghosh - H.C. Wainwright Operator Good afternoon.

Amylyx Pharmaceuticals, Inc. (AMLX) Q2 2023 Earnings Call Transcript

Amylyx Pharmaceuticals, Inc. (AMLX) came out with quarterly earnings of $0.31 per share, beating the Zacks Consensus Estimate of $0.01 per share. This compares to loss of $0.93 per share a year ago.

Amylyx Pharmaceuticals, Inc. (AMLX) Surpasses Q2 Earnings and Revenue Estimates

CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $AMLX--Amylyx Pharmaceuticals Reports Second Quarter 2023 Financial Results.

Amylyx Pharmaceuticals Reports Second Quarter 2023 Financial Results

CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $AMLX--Amylyx Pharmaceuticals announces it will report its second quarter 2023 financial results on Thursday, August 10, 2023.

Amylyx Pharmaceuticals to Report Second Quarter 2023 Financial Results on August 10, 2023

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Amylyx focuses on neurodegenerative diseases. After launching its first product in September, the company turned its first profitable quarter.

Why Shares of Amylyx Pharmaceuticals Were Up Monday

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CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $AMLX--Amylyx Pharmaceuticals Announces Webcast to Discuss the PSP Treatment Landscape and the Company's Clinical Development Plans on July 26, at 1:30pm ET.

Amylyx Pharmaceuticals to Host Virtual Webcast on AMX0035 Progressive Supranuclear Palsy (PSP) Program

Amylyx's (AMLX) shares plunge on getting a negative opinion from the Committee for Medicinal Products for Human Use for the marketing authorization of AMX0035, used to treat amyotrophic lateral sclerosis.

Amylyx (AMLX) Down on Negative CHMP Opinion for ALS candidate

CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $AMLX--Amylyx Pharmaceuticals Receives CHMP Negative Opinion on its Conditional Marketing Authorisation Application for AMX0035 - Will Seek Re-Examination.

Amylyx Pharmaceuticals Receives CHMP Negative Opinion on its Conditional Marketing Authorisation Application for AMX0035 for the Treatment of ALS in the European Union

CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $AMLX--Amylyx signs LOI with the pCPA for ALBRIOZA™ and will now work with drug plans to ensure public coverage to eligible Canadians with ALS.

Amylyx Pharmaceuticals Completes Negotiation Process and Signs Letter of Intent with the pCPA for ALBRIOZA™ for the Treatment of ALS

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Amylyx Pharmaceuticals and Viking Therapeutics have been on fire over the past year. Even so, both companies still look incredibly undervalued relative to their long-term growth potential.

Better Growth Stock: Amylyx Pharmaceuticals or Viking Therapeutics?

CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $AMLX--Joshua Cohen and Justin Klee, Co-CEOs of Amylyx, will participate in the Goldman Sachs 44th Annual Global Healthcare Conference on June 13, 2023.

Amylyx Pharmaceuticals to Present at the Goldman Sachs 44th Annual Global Healthcare Conference

Shares have lost a third of their value year to date. Relyvrio launch in ALS has produced promising metrics out of the gate and the company will be generating positive cash flow going forward. The confirmatory readout from PHOENIX trial in 2024 is a key concern, as in the worst-case scenario Relyvrio could be pulled off the market if no benefit is observed.

Amylyx Pharmaceuticals: Post Q1 Selloff Appears Overdone

Amylyx Pharmaceuticals Inc said on Tuesday the European drug regulator was likely to reject its amyotrophic lateral sclerosis (ALS) drug, sending its shares down 8.5% in premarket trading.

News for Amylyx Pharmaceuticals Stock (AMLX)