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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Earnings data Q2 2024

Earnings data Q3 2024

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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.

CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $AMLX--Amylyx Pharmaceuticals Provides Update on Ongoing Regulatory Review of AMX0035 for the Treatment of ALS in the European Union.

Amylyx Pharmaceuticals Provides Update on Ongoing Regulatory Review of AMX0035 for the Treatment of ALS in the European Union

The biotech sector is notoriously volatile, populated with plenty of unprofitable companies that soar on optimism about clinical trials. Those same stocks can later plummet on poor trial results, or a delay when it comes to regulatory approval.

Amylyx Pharmaceuticals Turns Profitable On Successful Drug Launch

Amylyx Pharmaceuticals, a biotech firm focusing on neurodegenerative disorders, has seen impressive Q1 2023 financial performance despite clinical uncertainties around its flagship product, Relyvrio. Relyvrio, an ALS treatment drug, generated $71.4 million in revenue, bolstering predictions of annual revenues surpassing $1 billion.

Amylyx: A Biotech Underdog's Resilient Performance And Promising Market Potential

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Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX ) Q1 2023 Earnings Conference Call May 11, 2023 6:00 PM ET Company Participants Lindsey Allen - Head of Investor Relations and Communications Justin Klee - Co-Chief Executive Officer and Co-Founder Margaret Olinger - Global Head of Commercial and CCO James Frates - Chief Financial Officer Josh Cohen - Co-Chief Executive Officer and Co-Founder Conference Call Participants Corinne Jenkins - Goldman Sachs Marc Goodman - SVB Securities Ananda Ghosh - H.C. Wainwright Neena Bitritto-Garg - Citi Lindsey Allen Good afternoon and thank you for joining today to discuss our First Quarter 2023 Earnings.

Amylyx Pharmaceuticals, Inc. (AMLX) Q1 2023 Earnings Call Transcript

Amylyx Pharmaceuticals, Inc. (AMLX) came out with quarterly earnings of $0.02 per share, beating the Zacks Consensus Estimate of a loss of $0.27 per share. This compares to loss of $0.93 per share a year ago.

Amylyx Pharmaceuticals, Inc. (AMLX) Q1 Earnings and Revenues Surpass Estimates

Amylyx Pharmaceuticals reported an unexpected first-quarter gain and sales blew past forecasts. In response, AMLX stock rocketed.

Amylyx Blows Past Sales Expectations, Reports Unexpected Profit — Shares Rocket

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

Amylyx Pharmaceuticals Reports First Quarter 2023 Financial Results

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals to Report First Quarter 2023 Financial Results on May 11, 2023.

Amylyx Pharmaceuticals to Report First Quarter 2023 Financial Results on May 11, 2023

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CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $AMLX #APAC--Ms. Masako Nakamura joins Amylyx as a key leader with the goal of bringing AMX0035 to as many people who may benefit around the world as possible.

Amylyx Pharmaceuticals Appoints Masako Nakamura to General Manager and Head of International Markets - Asia Pacific and Latin America

Amylyx (AMLX) progresses with the phase II study of pipeline candidate AMX0035 for the treatment of Wolfram syndrome as it doses the first patient.

Amylyx (AMLX) Doses First Patient in Wolfram Syndrome Study

CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $AMLX #NeurodegenerativeDiseases--Amylyx announces first participant dosed in exploratory open-label proof of biology study of AMX0035 in Wolfram syndrome (WS).

Amylyx Pharmaceuticals Announces First Participant Dosed in Phase 2 Study of AMX0035 for the Treatment of Wolfram Syndrome

CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $AMLX--Joshua Cohen and Justin Klee, Co-CEOs of Amylyx, will participate in the 22nd Annual Needham Virtual Healthcare Conference on Tuesday, April 18, 2023.

Amylyx Pharmaceuticals to Present at the 22nd Annual Needham Virtual Healthcare Conference

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Amylyx Pharmaceuticals scored a major regulatory approval with its amyotrophic lateral sclerosis (ALS) drug last year. The drug's sales far surpassed expectations in its first quarter on the market inside the United States.

Why Amylyx Pharmaceuticals Stock Is Bolting Higher Today

Amylyx's new ALS treatment crushed Wall Street's fourth-quarter expectations, pushing AMLX stock above its 50-day line Tuesday. The post Amylyx, A Top 5% Biotech Stock, Just Scored A Huge Win In ALS Treatment appeared first on Investor's Business Daily.

Amylyx, A Top 5% Biotech Stock, Just Scored A Huge Win In ALS Treatment

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX ) Q4 2022 Earnings Conference Call March 13, 2023 4:30 PM ET Company Participants Lindsey Allen - Head of Investor Relations and Communications Justin Klee - Co-Chief Executive Officer and Co-Founder Margaret Olinger - Global Head of Commercial and CCO James Frates - Chief Financial Officer Josh Cohen - Co-Chief Executive Officer and Co-Founder Conference Call Participants Geoff Meacham - Bank of America Umer Raffat - Evercore ISI Neena Bitritto-Garg - Citi Corinne Jenkins - Goldman Sachs Marc Goodman - SVB Securities Ananda Ghosh - H.C. Wainwright Operator Good afternoon.

Amylyx Pharmaceuticals, Inc. (AMLX) Q4 2022 Earnings Call Transcript

Amylyx Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) will report its fourth quarter and full year 2022 financial results on Monday, March 13, 2023, following the close of the U.S. financial markets. Amylyx' senior management team will host a conference call and audio webcast at 4:30 p.m. ET to discuss the financial results and other company updates.

Amylyx Pharmaceuticals to Report Fourth Quarter and Full Year 2022 Financial Results on March 13, 2023

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AMLX got relyvrio approved through an interesting set of events. There are questions surrounding high price, low benefit, trial design, and so on.

Amylyx: Patient Advocacy, If Not Drug Merit, Will See It Through

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX), today announced that Joshua Cohen and Justin Klee, Co-CEOs of Amylyx, will participate in the SVB Securities Global Biopharma Conference. The conference is being conducted in a virtual format, and the fireside chat will take place on Tuesday, February 14, 2023, at 10:00am ET.

Amylyx Pharmaceuticals to Participate in the SVB Securities Global Biopharma Conference

CAMBRIDGE, Mass.--( BUSINESS WIRE )--Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced the completion of enrollment in PHOENIX, a global, 48-week, randomized, placebo-controlled Phase 3 clinical trial of AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) in people living with amyotrophic lateral sclerosis (ALS). Amylyx anticipates topline results in 2024. The study enrolled 664 participants living with ALS.

Amylyx Pharmaceuticals Announces Completion of Enrollment in Global Phase 3 PHOENIX Trial of AMX0035 in ALS

CAMBRIDGE, Mass.--( BUSINESS WIRE )--Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced it has entered into an exclusive license and distribution agreement with Neopharm in which Neopharm will commercialize, subject to regulatory review and approval, AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine) for the treatment of amyotrophic lateral sclerosis (ALS) in Israel, Gaza, West Bank, and the Palestinian Authority.

News for Amylyx Pharmaceuticals Stock (AMLX)