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 has announced an upsized public offering of 6,693,750 shares of common stock, priced at $32.00 per share, expected to generate gross proceeds of $214.2 million. The offering is set to close around October 11, 2022, pending customary conditions. The company has granted underwriters a 30-day option for an additional 1,004,062 shares. Goldman Sachs, BofA Securities, SVB Securities, and Evercore ISI are the joint book-running managers of the offering. Registration statements became effective on October 6, 2022.
Amylyx Pharmaceuticals has announced a public offering of 6,000,000 shares of common stock under an S-1 registration statement filed with the SEC. The company plans to offer all shares and may grant underwriters a 30-day option to purchase an additional 900,000 shares. The offering is subject to market conditions and may not be completed as anticipated. Goldman Sachs, BofA Securities, SVB Securities, and Evercore ISI are acting as joint book-running managers.
Amylyx Pharmaceuticals announced that the FDA has approved RELYVRIO (sodium phenylbutyrate and taurursodiol) for treating adults with amyotrophic lateral sclerosis (ALS).
RELYVRIO significantly slowed physical function loss in clinical trials, offering hope for approximately 29,000 ALS patients in the U.S. with median survival from diagnosis of 2-3 years. The drug is expected to be accessible through specialty pharmacies within 4-6 weeks. Amylyx plans to support ALS patients with a dedicated care team.
Amylyx Pharmaceuticals announced that clinical data from the placebo group of the CENTAUR trial for AMX0035 are now accessible in the PRO-ACT database. This initiative supports the ALS research community by enabling collaborative efforts to uncover new treatment pathways. The PRO-ACT platform, awarded for its innovation, contains data from over 11,600 ALS participants and has been essential for numerous publications. AMX0035, under evaluation for ALS, aims to reduce neuronal cell death.
Amylyx Pharmaceuticals (NASDAQ: AMLX) announced significant preclinical data demonstrating that AMX0035, a combination of sodium phenylbutyrate and taurursodiol, has a pronounced effect on ALS-relevant molecular pathways compared to individual components. The published study in Annals of Clinical and Translational Neurology showed AMX0035 altered more genes and metabolites in fibroblasts from ALS patients than either compound alone. This underscores its potential benefits in treating ALS, a disease affecting over 90% of ALS patients.
Amylyx Pharmaceuticals has received a positive vote from the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, with a 7:2 vote supporting the approval of AMX0035 for treating ALS. If approved, it will be the first treatment to show significant slowing of disease progression and functional decline in ALS. The final decision from the FDA is expected by September 29, 2022. The clinical trial data for AMX0035 indicated potential benefits in overall survival and was well tolerated, with the CENTAUR trial meeting its primary efficacy endpoint.
Amylyx Pharmaceuticals announced that Nasdaq has halted trading of its common stock in conjunction with the second FDA Advisory Committee meeting regarding the NDA for AMX0035, aimed at treating ALS. This meeting is crucial for reviewing AMX0035, previously discussed on March 30, 2022. The FDA's target action date for this application is set for September 29, 2022. The company emphasizes its commitment to the neurodegenerative community through innovative treatments.
Amylyx Pharmaceuticals announced the reconvened meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) by the FDA to review the New Drug Application (NDA) for AMX0035, a treatment for amyotrophic lateral sclerosis (ALS). Scheduled for September 7, 2022, this follows a previous meeting on March 30, 2022. The NDA's target action date is September 29, 2022, which was extended for further analysis of clinical data. AMX0035 is under regulatory review in the U.S. and EU, and is already approved in Canada as ALBRIOZA™.
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.
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