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.
Amylyx Pharmaceuticals announced data from the CENTAUR and PEGASUS clinical trials, confirming that AMX0035 is safe and well tolerated in patients with amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease (AD). The majority of treatment-emergent adverse events (TEAEs) were gastrointestinal, with no new safety signals identified. These findings clarify the safety profile of AMX0035. Participants from both trials reported similar incidences of TEAEs, attributed largely to disease progression in ALS. The data will be presented at the AAN conference on April 4, 2022.
Amylyx Pharmaceuticals, Inc. (AMLX) reported a transformative year in 2021, focusing on the progress of AMX0035 for ALS treatment. The FDA set a PDUFA action date of June 29, 2022. The company successfully submitted regulatory applications in the U.S., Europe, and Canada. Financially, R&D expenses rose to $44 million, while general and administrative expenses reached $38.9 million, resulting in a net loss of $87.9 million for 2021. Despite this, cash reserves significantly improved to $96.1 million, bolstered by a successful IPO that raised $196.9 million in net proceeds.
Amylyx Pharmaceuticals (NASDAQ: AMLX) announced the outcome of the FDA's PCNSDAC meeting regarding its NDA for AMX0035, intended for ALS treatment. The advisory committee voted 4 (yes) to 6 (no) on whether the data supports AMX0035's effectiveness. Nonetheless, Amylyx remains confident in the drug's potential and continues to seek FDA approval, which is expected by June 29, 2022. AMX0035 is designed to target pathways involved in neuronal degeneration. The CENTAUR trial met its primary efficacy endpoint, demonstrating a reduction in functional decline.
Amylyx Pharmaceuticals (AMLX) announced that Nasdaq has halted trading of its common stock.
The FDA's Peripheral and Central Nervous System Drugs Advisory Committee is meeting to review the New Drug Application (NDA) for AMX0035, a treatment for ALS, scheduled for discussion at 10:00 a.m. ET. The target action date set by the Prescription Drug User Fee Act for the NDA is June 29, 2022.
The company continues to develop novel therapies for neurodegenerative diseases.
Amylyx Pharmaceuticals announced the FDA briefing documents for the PMDA meeting regarding their New Drug Application (NDA) for AMX0035, aimed at treating amyotrophic lateral sclerosis (ALS). The meeting is scheduled for March 30, 2022, at 10 a.m. ET, with the PDUFA target action date set for June 29, 2022. AMX0035 combines sodium phenylbutyrate (PB) and taurursodiol (TURSO) to reduce neuronal death in ALS. The success of this application could significantly impact Amylyx's future as a clinical-stage biopharmaceutical company.
Amylyx Pharmaceuticals has launched an Expanded Access Program (EAP) for its drug AMX0035, targeting individuals with amyotrophic lateral sclerosis (ALS) in the U.S. The program, designed in collaboration with the ALS community, aims to provide access to potential therapies prior to FDA approval. Eligible participants cannot overlap with those in the ongoing Phase 3 PHOENIX trial. AMX0035 is a combination of sodium phenylbutyrate and taurursodiol, targeting neuronal degeneration in ALS and other neurodegenerative diseases.
Amylyx Pharmaceuticals (AMLX) has announced that its Marketing Authorisation Application for AMX0035, a treatment for amyotrophic lateral sclerosis (ALS), has been validated by the European Medicines Agency (EMA) and is now under review. The application is supported by positive data from the CENTAUR trial, which indicated that AMX0035 reduced clinical decline and improved survival rates compared to placebo. The company is preparing its European team for a potential launch pending a favorable review outcome.
Amylyx Pharmaceuticals has appointed Gina M. Mazzariello as its new Chief Legal Officer and General Counsel. Ms. Mazzariello brings over 20 years of experience in healthcare law, including extensive knowledge in drug commercialization and regulatory matters. Prior to joining Amylyx, she served at Boehringer Ingelheim USA, where she led legal operations for the human pharmaceuticals division. Her expertise is expected to facilitate Amylyx's global expansion and regulatory approvals, reinforcing their commitment to the neurodegenerative community.
Amylyx Pharmaceuticals announced a virtual FDA advisory committee meeting on March 30, 2022, to review the New Drug Application (NDA) for AMX0035, an investigational therapy for amyotrophic lateral sclerosis (ALS). The FDA has prioritized this review with a Prescription Drug User Fee Act date set for June 29, 2022. AMX0035 is a combination of sodium phenylbutyrate and taurursodiol, aimed at reducing neuronal death in ALS. The company anticipates a thorough scientific discussion on the clinical data backing their application.
Amylyx Pharmaceuticals will present at the 11th Annual SVB Leerink Global Healthcare Conference on February 17, 2022, at 4:20 PM ET. Co-CEOs Joshua Cohen and Justin Klee will host the virtual presentation. Interested parties can access a live webcast through the Company’s investor section on their website, with a replay available for 90 days post-event.
Amylyx is focused on developing therapies for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases.
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