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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 (AMLX) announced the launch of ALBRIOZA™ (AMX0035) in Canada, marking its first commercial product. The FDA has scheduled an advisory meeting on September 7, 2022, regarding the NDA for AMX0035 for ALS, with a PDUFA action date set for September 29, 2022. Financial results for Q2 2022 show a net loss of $54.1 million, up from $21.9 million year-over-year, primarily due to increased R&D and administrative costs. Cash reserves stood at $206.7 million as of June 30, 2022, indicating ongoing funding for development and launch activities.
Amylyx Pharmaceuticals (NASDAQ: AMLX) announced the U.S. FDA's Peripheral and Central Nervous System Drugs Advisory Committee will reconvene on September 7, 2022, to review the New Drug Application (NDA) for AMX0035, a treatment for amyotrophic lateral sclerosis (ALS). The review follows a previous meeting on March 30, 2022, and the FDA's extension of the PDUFA target action date from June 29 to September 29, 2022. The company emphasizes the urgent need for effective ALS treatments and is confident in the clinical data supporting AMX0035's benefits.
Amylyx Pharmaceuticals announced the commercial availability of ALBRIOZA™ (sodium phenylbutyrate and ursodoxicoltaurine) in Canada for ALS patients. This oral therapy may reduce neuronal cell death and was shown to significantly slow disease progression in clinical trials. Amylyx is actively pursuing reimbursement options with various Canadian health organizations to ensure patient access. CEO Tammy Moore emphasized the importance of equitable access to ALBRIOZA for Canadians living with ALS. The drug is also under review for marketing in the US and EU.
Amylyx Pharmaceuticals (NASDAQ: AMLX) announced a two-year research agreement with Sunnybrook Research Institute to discover Bax and Bak inhibitor candidates for treating ALS and other neurodegenerative diseases. The collaboration aims to expedite the identification of therapeutic candidates through biochemical and in vivo studies. Promising preclinical results suggest that targeted inhibition of these proteins may preserve motor neurons and improve survival rates in ALS models. Amylyx will have rights to license successful drug candidates post-research.
Amylyx Pharmaceuticals has announced a poster presentation on its Phase 3 PHOENIX trial for AMX0035, a treatment for amyotrophic lateral sclerosis (ALS). Scheduled for July 9, 2022, at the International Congress on Neuromuscular Diseases in Brussels, the poster will detail the trial's design and methodology and discuss plans for an open-label extension phase. The ongoing trial aims to enroll a broader ALS population compared to the previous CENTAUR trial, providing additional data on AMX0035's effects.
Amylyx Pharmaceuticals has announced that the FDA is planning to reconvene the Peripheral and Central Nervous System Drugs Advisory Committee to discuss the NDA for AMX0035, a treatment for ALS, on September 7, 2022. This follows the FDA's extension of the PDUFA target action date to September 29, 2022. The meeting will focus on additional analyses from clinical studies, which aim to support the reported benefits of AMX0035. The drug is currently approved for ALS in Canada under the brand name ALBRIOZA.
Amylyx Pharmaceuticals has received its first global regulatory approval from Health Canada for ALBRIOZA™ (AMX0035), a new therapy for amyotrophic lateral sclerosis (ALS) that may reduce neuronal cell death. The approval is based on positive results from the CENTAUR clinical trial, showing significant functional benefits compared to placebo. ALBRIOZA is expected to be commercially available in Canada within six weeks, pending negotiations with local authorities. Further results from the ongoing Phase 3 PHOENIX trial are anticipated in 2024.
Amylyx Pharmaceuticals (NASDAQ: AMLX) announced that the FDA has extended the PDUFA goal date for its New Drug Application (NDA) for AMX0035, a treatment for amyotrophic lateral sclerosis (ALS), to September 29, 2022. This extension allows additional time for the FDA to review new data analyses from the company's clinical studies, which was classified as a major amendment to the NDA. The CENTAUR trial, involving 137 participants, demonstrated efficacy in reducing functional decline in ALS patients.
Amylyx Pharmaceuticals announced a new post hoc analysis demonstrating significant individual responses to its drug AMX0035 in ALS patients. The findings will be presented at the ENCALS 2022 Meeting on June 2 in Edinburgh, Scotland. The study revealed a higher proportion of patients in the AMX0035 group exhibiting substantial responses compared to placebo. AMX0035 combines sodium phenylbutyrate and taurursodiol to combat neuronal death in ALS. The CENTAUR trial backing this data confirmed its efficacy and safety.
Amylyx Pharmaceuticals (NASDAQ: AMLX) announced new findings from the Phase 2 CENTAUR trial, highlighting significant benefits of AMX0035 in patients with amyotrophic lateral sclerosis (ALS). The treatment reduces the risk of death or tracheostomy/permanent assisted ventilation by 49% and lowers the rate of first hospitalization by 44%. Additionally, participants showed a median key event-free survival duration of 4.8 months longer with AMX0035. These results underscore AMX0035's potential impact on delaying severe medical interventions for ALS patients.
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