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.

Shares of Amylyx Pharmaceuticals Inc. Inc. AMLX, +14.27% soared 21.6% in premarket trading on Friday after the company said U.S. regulators extended the review time for its experimental amyotrophic lateral sclerosis treatment. The new Prescription Drug User Fee Act date is Sept.

Amylyx says FDA decision date for ALS therapy is now in September; shares jump

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals Receives Notification of PDUFA Date Extension for AMX0035 for the Treatment of ALS

Amylyx Pharmaceuticals Receives Notification of PDUFA Date Extension for AMX0035 for the Treatment of ALS

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx announces poster presentation at the European Network to Cure ALS (ENCALS) 2022 Meeting on June 2, 2022 in Edinburgh, Scotland.

Amylyx Pharmaceuticals Announces Presentation of New Analysis of CENTAUR Trial Results at the European Network to Cure ALS 2022 Meeting

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx announced the publication of long-term prespecified analyses in the Journal of Neurology, Neurosurgery and Psychiatry (JNNP).

Amylyx Pharmaceuticals Announces Publication of Data Showing Randomization to AMX0035 Prolonged Tracheostomy/Ventilation-free Survival and Reduced Occurrence of First Hospitalization

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

Amylyx Pharmaceuticals Reports First Quarter 2022 Financial Results

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx announced the publication of long-term survival analyses of the Phase 2 CENTAUR trial adjusting for treatment crossover of the placebo group.

Amylyx Pharmaceuticals Announces Publication of New CENTAUR Trial Analyses Further Demonstrating Significant Survival Benefit with AMX0035 in People with ALS

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If readouts on clinical trials can impact the stocks of pharma companies, the Food and Drug Administration (FDA) decisions on whether or not specific drugs are approved can affect not only the stock price but also a company's future.

5 Key FDA Decisions Could Affect Drug Stocks

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals today announced the presentation of safety and tolerability data on AMX0035 as assessed in the CENTAUR and PEGASUS trials.

Amylyx Pharmaceuticals Announces Oral Presentation of Safety and Tolerability Data on AMX0035 from Clinical Trials at 2022 American Academy of Neurology Annual Meeting

On March 30, FDA's advisory committee voted 6 No to 4 Yes, to the question if AMLX's single phase 2 trial data established its effectiveness in treating ALS.

Amylyx's ALS Drug Application Hangs In The Balance

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals today reported financial results for the full year ended December 31, 2021

Amylyx Pharmaceuticals Reports Full Year 2021 Financial Results

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals announced the outcome of the U.S. FDA's Advisory Committee meeting to review the NDA for AMX0035 for the treatment of ALS

Amylyx Pharmaceuticals Announces Outcome of FDA Advisory Committee Meeting on AMX0035 for the Treatment of ALS

The FDA's currently looking at an application for the company's lead candidate.

Could Amylyx Pharmaceuticals Have a Blockbuster ALS Treatment?

The FDA released its briefing documents for the advisory committee to discuss Amylyx Pharmaceuticals Inc's (NASDAQ: AMLX) sodium phenylbutyrate/taurursodiol (AMX0035) powder for amyotrophic lateral sclerosis (ALS). Agency statisticians called into question the Company's.

Amylyx Shares Plummet On Skeptical FDA Adcomm Docs On ALS Drug

It seems the FDA isn't going to approve the company's ALS drug before an ongoing phase 3 trial produces evidence of efficacy.

Here's Why Amylyx Pharmaceuticals Stock Is Getting Hammered on Monday

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals today announced that the U.S. FDA posted briefing documents for its March 30, 2022 Advisory Committee meeting

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

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx launches an Expanded Access Program (EAP) for AMX0035 in the U.S. for people living with ALS that meet program eligibility criteria.

Amylyx Pharmaceuticals Announces Launch of U.S. Expanded Access Program for AMX0035

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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx' MAA to the European Medicines Agency's (EMA) CHMP for AMX0035 for the treatment of ALS has been validated and is now under CHMP review.

Amylyx Pharmaceuticals Announces EMA Validation of Marketing Authorisation Application (MAA) for AMX0035 for the Treatment of ALS

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals today announced the appointment of Gina M. Mazzariello to Chief Legal Officer (CLO) and General Counsel.

Amylyx Pharmaceuticals Expands Executive Team with Appointment of Gina M. Mazzariello as Chief Legal Officer and General Counsel

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx today announced that a meeting of the U.S. FDA Advisory Committee to review the NDA for AMX0035 has been scheduled for March 30, 2022.

Amylyx Pharmaceuticals Announces FDA Advisory Committee Meeting to Review New Drug Application for AMX0035 for the Treatment of ALS Scheduled for March 30, 2022

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals to Present at the 11th Annual SVB Leerink Global Healthcare Conference on Thursday, February 17, 2022 at 4:20pm ET.

Amylyx Pharmaceuticals to Present at the 11th Annual SVB Leerink Global Healthcare Conference

CALGARY, Alberta & TORONTO--(BUSINESS WIRE)--CNDR and Amylyx Pharmaceuticals are partnering on a real‐world evidence generation initiative for Amylyx' novel investigational therapy AMX0035.

The Canadian Neuromuscular Disease Registry and Amylyx Pharmaceuticals Partner on Real-World Evidence Generation for a Novel Investigational Therapy in ALS with the Goal of Advancing Health Outcomes for Canadians Living with ALS

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Andreas Halvorsen (Trades, Portfolio), chief investment officer of Viking Global Investors, disclosed a stake in Amylyx Pharmaceuticals Inc. ( AMLX , Financial) late last week.

News for Amylyx Pharmaceuticals Stock (AMLX)