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 (NASDAQ: AMLX) announced that the FDA has lifted the clinical hold on its Phase 1 clinical trial of AMX0114, an antisense oligonucleotide targeting calpain-2 for ALS treatment. The company will proceed with opening U.S. sites for screening, enrollment, and dosing.
The Phase 1 LUMINA clinical trial is expected to begin in Canada in early 2025. This multicenter, randomized, placebo-controlled trial will evaluate AMX0114's safety and biological activity, involving approximately 48 ALS patients randomized 3:1 to receive either AMX0114 or placebo via intrathecal administration once every four weeks for up to 4 doses. The trial will assess ALS biomarkers, including changes in neurofilament light levels.
The company expects to obtain early cohort data from LUMINA in 2025.
Amylyx Pharmaceuticals (Nasdaq: AMLX) has announced the pricing of a public offering of 17,142,857 shares of common stock at $3.50 per share. The company expects to raise approximately $60.0 million in gross proceeds, before deducting underwriting costs and expenses.
The company has also granted the underwriter a 30-day option to purchase up to an additional 2,571,428 shares at the same price. The offering is expected to close around January 13, 2025. Leerink Partners is acting as the sole bookrunning manager.
Amylyx plans to use the net proceeds, combined with existing cash and marketable securities, to advance commercialization preparations, pipeline programs, working capital, and general corporate purposes.
Amylyx Pharmaceuticals (NASDAQ: AMLX) has announced the launch of an underwritten public offering of its common stock shares. The company plans to grant underwriters a 30-day option to purchase additional shares up to 15% of the offered shares at the public offering price, less underwriting discounts and commissions.
The net proceeds will be used alongside existing cash, cash equivalents, and marketable securities to advance commercialization preparations and pipeline programs, working capital, and general corporate purposes. Leerink Partners is serving as the sole book-running manager for the offering.
The offering is being made pursuant to an automatically effective shelf registration statement on Form S-3 filed with the SEC on March 13, 2023. The completion, size, and terms of the offering are subject to market conditions.
Amylyx Pharmaceuticals (NASDAQ: AMLX) has appointed Dan Monahan as Chief Commercial Officer, joining the company's Leadership Team in January 2024. Monahan brings over 20 years of commercial leadership experience from positions at Otsuka, Novartis, and Sanofi.
The appointment comes as Amylyx prepares for the Phase 3 LUCIDITY clinical trial of avexitide, a first-in-class GLP-1 receptor antagonist for post-bariatric hypoglycemia (PBH). The trial is planned to begin in Q1 2025, with data expected in 2026. Avexitide aims to be the first approved therapy for PBH.
In his previous role at Otsuka Pharmaceuticals, Monahan led U.S. commercialization efforts for the CNS franchise. At Novartis, he managed the commercial execution of COSENTYX®, and at Sanofi, he held various leadership positions across sales, marketing, and market access.
Amylyx Pharmaceuticals (AMLX) has announced the design of its pivotal Phase 3 LUCIDITY trial for avexitide, a first-in-class GLP-1 receptor antagonist for treating post-bariatric hypoglycemia (PBH). The trial will evaluate the reduction in hypoglycemia events as the primary outcome, with the first participant expected to be dosed in Q1 2025 and topline results in 2026.
The trial will involve approximately 75 participants across 20 U.S. sites, randomized 3:2 to receive either 90 mg avexitide or placebo. The study includes a three-week run-in period and a 16-week treatment period, followed by a 32-week open-label extension. Previous Phase 2 trials showed significant reductions in hypoglycemia events, with the Phase 2b trial demonstrating a 53% reduction in Level 2 and 66% reduction in Level 3 hypoglycemia events.
Amylyx Pharmaceuticals (Nasdaq: AMLX) has announced its participation in the 7th Annual Evercore ISI HealthCONx Conference. The company's management will engage in a fireside chat on Wednesday, December 4, 2024, at 11:15 a.m. ET in Coral Gables, Florida.
The event will be accessible via live webcast in the Investor section of Amylyx's website under 'Events and Presentations.' The recording will remain available for replay for 90 days after the event.
Amylyx Pharmaceuticals reported its Q3 2024 financial results, highlighting key developments and financial metrics. The company announced positive topline data from its Phase 2 HELIOS trial of AMX0035 in Wolfram syndrome, showing improvements in pancreatic function and other disease measures. Amylyx plans to initiate a Phase 3 program for avexitide in post-bariatric hypoglycemia by Q1 2025. The company holds $234.4 million in cash and securities, sufficient to fund operations into 2026. Financial results showed a net product revenue of $0.4 million, a net loss of $72.7 million, and significant decreases in R&D and SG&A expenses compared to Q3 2023. The company is also progressing with other clinical programs, including the Phase 1 LUMINA trial for AMX0114 in ALS, expected to start in late 2024 or early 2025.
Amylyx Pharmaceuticals (Nasdaq: AMLX) has scheduled its third quarter 2024 financial results announcement for Thursday, November 7, 2024. The company will host a conference call and audio webcast at 8:00 a.m. ET, where senior management will discuss financial results and company updates. Participants can join via phone or watch the webcast through the company's investor relations website, where it will remain available for replay for 90 days.
Amylyx Pharmaceuticals (NASDAQ: AMLX) announced positive topline results from its Phase 2 HELIOS clinical trial of AMX0035 in adults with Wolfram syndrome. The trial showed improvement in pancreatic function after 24 weeks of treatment, contrary to expected disease progression. Improvements or stabilization were observed across all secondary endpoints, including glycemic control, vision, and patient- and clinician-reported impressions of disease burden.
Key findings include:
- Sustained improvement over time in longer-term data for participants completing Week 36 and Week 48 assessments
- AMX0035 was generally well-tolerated
- Amylyx plans to meet with the FDA to inform a Phase 3 program, with an update expected in 2025
The results suggest AMX0035 has the potential to favorably change the trajectory of Wolfram syndrome, a rare, progressive disease with no approved treatment options.
Amylyx Pharmaceuticals (Nasdaq: AMLX) has announced a virtual webcast on October 17, 2024 at 1:30 p.m. ET to discuss topline results from the HELIOS Phase 2 trial of AMX0035 for the investigational treatment of Wolfram syndrome. The webcast will feature management and Dr. Fumihiko Urano, the principal investigator of the HELIOS trial and a professor at Washington University School of Medicine in St. Louis.
The presentation follows the release of data at the International Society for Pediatric and Adolescent Diabetes 50th Annual Congress in Lisbon, Portugal. The live webcast will be accessible on the company's website and available for replay for 90 days. Dr. Urano, a leading expert in Wolfram syndrome, directs the Wolfram Syndrome Clinic and International Registry & Clinical Study at Washington University.
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