- Pivotal Phase 3 LUCIDITY trial of avexitide, a potential first-in-class GLP-1 receptor antagonist with FDA Breakthrough Therapy designation, underway in post-bariatric hypoglycemia; completion of recruitment expected in 2025, with topline data anticipated in first half of 2026 - In the Phase 2b trial, avexitide 90 mg once daily led to a 64% least-squares mean reduction in the composite rate of Level 2 and Level 3 hypoglycemic events in post-bariatric hypoglycemia, the FDA-agreed upon primary outcome that LUCIDITY is evaluating - Population pharmacokinetic and pharmacodynamic data demonstrated avexitide 90 mg once daily has sustained therapeutic exposure for 24 hours - Amylyx to host

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced that it will host an investor event at the Endocrine Society's annual meeting (ENDO 2025) on Sunday, July 13, 2025, at 6:00 p.m. PT, both in-person in San Francisco, California and virtually. Speakers will discuss the current burden of post-bariatric hypoglycemia (PBH) and background on avexitide, a potential first-in-class GLP-1 receptor antagonist with FDA breakthrough therapy designation. Speakers will also review new exploratory analyses from the Phase 2 PREVENT and Phase 2b clinical trials of avexitide in post-bariatric hypoglycemia, which will be presented during ENDO 2025. These data include compos

- AMX0114 is an Amylyx-developed antisense oligonucleotide designed to target calpain-2, a key contributor to the axonal degeneration pathway in ALS - Phase 1 LUMINA trial of AMX0114 underway; early cohort data expected in 2025 Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AMX0114, an investigational antisense oligonucleotide (ASO) targeting calpain-2 for the treatment of people living with amyotrophic lateral sclerosis (ALS). "Obtaining FDA Fast Track designation for AMX0114 is an important step forward in our mission to develop potential treatments for peop

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced that management will participate in the following upcoming investor conferences, which are being conducted in-person and virtually. Jefferies Global Healthcare Conference: Fireside chat on Thursday, June 5, 2025, at 1:25 p.m. ET in New York City Goldman Sachs 46th Annual Global Healthcare Conference: Fireside chat on Tuesday, June 10, 2025, at 3:20 p.m. ET in Miami, Florida Virtual H.C. Wainwright @ Home Fireside Chat Series: Fireside chat on Thursday, June 26, 2025, at 11:00 a.m. ET A live webcast of all presentations can be accessed under "Events and Presentations" in the Investor section of the

Data at Week 48 demonstrated that treatment with AMX0035 led to sustained stabilization or improvement in multiple outcomes related to disease progression, including pancreatic function, glycemic control, vision, and overall symptom burden AMX0035 continued to be generally well-tolerated in all participants Week 48 data and discussions with FDA will inform the design of a Phase 3 trial of AMX0035 in Wolfram syndrome Amylyx continues to expect cash runway through the end of 2026 Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced positive Week 48 data from the Phase 2 open-label HELIOS clinical trial of AMX0035 (sodium phenylbutyrate [PB] and t

Pivotal Phase 3 LUCIDITY trial of avexitide, a potential first-in-class GLP-1 receptor antagonist with FDA breakthrough therapy designation, underway in post-bariatric hypoglycemia (PBH); completion of recruitment expected in 2025, with topline data anticipated in first half of 2026 Data through Week 48 from the ongoing Phase 2 HELIOS trial of AMX0035 in Wolfram syndrome to be presented at the Joint Congress of the European Society for Pediatric Endocrinology (ESPE) and the European Society of Endocrinology (ESE) taking place from May 10-13 Phase 1 LUMINA trial of AMX0114, an investigational, potent antisense oligonucleotide targeting knockdown of calpain-2, underway in people livi

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced that management will participate in the following upcoming investor conferences, which are being conducted in-person. Bank of America 2025 Health Care Conference: Fireside chat on Tuesday, May 13, 2025, at 1:55 p.m. PT in Las Vegas, Nevada H.C. Wainwright 3rd Annual BioConnect Investor Conference: Corporate Presentation and Q&A on Tuesday, May 20, 2025, at 5:00 p.m. ET in New York City A live webcast of both presentations can be accessed under "Events and Presentations" in the Investor section of the Company's website, https://investors.amylyx.com/events-presentations, and will be available for repl

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") will report its first quarter 2025 financial results on Thursday, May 8, 2025. Amylyx' senior management team will host a conference call and audio webcast at 8:00 a.m. ET to discuss the financial results and other company updates. To access the conference call, please dial +1 (800) 836-8184 (U.S. & Canada) or +1 (646) 357-8785 (international) at least 10 minutes prior to the start time and ask to be joined into the Amylyx Pharmaceuticals call. A live audio webcast of the call will be available under "Events and Presentations" in the Investor section of the Company's website, https://investors.amylyx.com/events-presenta

Amylyx expects completion of recruitment for the LUCIDITY trial in 2025, with topline data in first half of 2026 Pivotal Phase 3 LUCIDITY trial evaluating avexitide, a GLP-1 receptor antagonist with FDA Breakthrough Therapy Designation and Orphan Drug Designation; FDA-agreed-upon primary outcome of reduction in hypoglycemic events Avexitide has been previously evaluated in five post-bariatric hypoglycemia (PBH) clinical trials of avexitide showing consistent, dose-dependent effects, including statistically significant reductions in hypoglycemic events The Company continues to expect cash runway through the end of 2026 Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "

- Amylyx expects early cohort data from LUMINA this year - AMX0114 is an Amylyx-developed antisense oligonucleotide designed to target calpain-2, a key contributor to the axonal degeneration pathway in ALS Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced that the first participant has been dosed in LUMINA, the Company's Phase 1, multinational, randomized, double-blind, placebo-controlled, multiple ascending dose clinical trial of AMX0114, an investigational, potent antisense oligonucleotide (ASO) targeting calpain-2, in people living with amyotrophic lateral sclerosis (ALS). The Company continues to expect early cohort data from LUMINA in 2025. The L

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Goldman resumed coverage of Amylyx Pharmaceuticals with a rating of Buy and set a new price target of $10.00

Guggenheim initiated coverage of Amylyx Pharmaceuticals with a rating of Buy and set a new price target of $17.00

Citigroup initiated coverage of Amylyx Pharmaceuticals with a rating of Buy and set a new price target of $12.00

TD Cowen initiated coverage of Amylyx Pharmaceuticals with a rating of Buy

Mizuho upgraded Amylyx Pharmaceuticals from Neutral to Outperform and set a new price target of $7.00

Robert W. Baird upgraded Amylyx Pharmaceuticals from Neutral to Outperform and set a new price target of $11.00 from $3.00 previously

BofA Securities upgraded Amylyx Pharmaceuticals from Neutral to Buy and set a new price target of $10.00 from $4.20 previously

Mizuho downgraded Amylyx Pharmaceuticals from Buy to Neutral and set a new price target of $4.00 from $32.00 previously

Leerink Partners downgraded Amylyx Pharmaceuticals from Outperform to Market Perform and set a new price target of $4.00 from $27.00 previously

Robert W. Baird downgraded Amylyx Pharmaceuticals from Outperform to Neutral and set a new price target of $4.00 from $37.00 previously

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Investors can contact the law firm at no cost to learn more about recovering their losses LOS ANGELES, April 08, 2024 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) investors that a lawsuit was filed on behalf of investors that purchased Amylyx securities between November 11, 2022 and November 8, 2023, inclusive (the "Class Period"). Investors are encouraged to contact attorney Lesley F. Portnoy, by phone 310-692-8883 or email: [email protected], to discuss their legal rights, or click here to join the case via www.portnoylaw.com. The Portnoy Law Firm can provide a complimentary case evaluation and discuss investors' options for pursui

- Dr. Bedrosian brings to Amylyx nearly 30 years of leadership in clinical research, development, and advancing pipeline programs into commercialized global products including as CMO at Ultragenyx, Alexion, and ARIAD Pharmaceuticals Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced the appointment of Camille L. Bedrosian, MD, as Chief Medical Officer ("CMO"). In this role, Dr. Bedrosian will lead global functions in medical affairs, regulatory, safety and pharmacovigilance, biometrics, clinical development, and clinical operations. Dr. Bedrosian brings nearly 30 years of experience addressing unmet medical needs for people with rare and serious disease

Amylyx will seek re-examination of its Conditional Marketing Authorisation Application Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the application for conditional marketing authorisation of AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine [also known as taurursodiol]), under the trade name ALBRIOZA®, for the treatment of adults with amyotrophic lateral sclerosis (ALS) in the European Union (EU). Today's update follows the Company's May 2023 announcement that the CHMP was trending toward a negative opinion.

Ms. Nakamura brings over 30 years of leadership in commercializing therapies internationally, including most recently as SVP, Head of Asia at Alnylam Pharmaceuticals Joins Amylyx as a key leader with the goal of bringing AMX0035 to as many people who may benefit around the world as possible Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced the appointment of Masako Nakamura to General Manager and Head of International Markets - Asia Pacific and Latin America. Ms. Nakamura brings 30 years of commercial, general management, and operational leadership experience in the biopharmaceutical industry with a strong focus on introducing rare disease therapi

Amylyx Pharmaceuticals, Inc., (NASDAQ:AMLX) ("Amylyx" or the "Company"), today announced the appointment of Gina M. Mazzariello as Amylyx' Chief Legal Officer (CLO) and General Counsel, where she will oversee all legal and compliance matters for the Company. Ms. Mazzariello brings more than 20 years of corporate and commercial legal experience in the healthcare industry and will bring to Amylyx a deep knowledge of industry standards related to the investigation, approval, sales and marketing of pharmaceutical products. "With Gina's established track record in drug commercialization, coupled with her experience across global markets, her counsel will be invaluable as we navigate our global

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- Pivotal Phase 3 LUCIDITY trial of avexitide, a potential first-in-class GLP-1 receptor antagonist with FDA Breakthrough Therapy designation, underway in post-bariatric hypoglycemia; completion of recruitment expected in 2025, with topline data anticipated in first half of 2026 - In the Phase 2b trial, avexitide 90 mg once daily led to a 64% least-squares mean reduction in the composite rate of Level 2 and Level 3 hypoglycemic events in post-bariatric hypoglycemia, the FDA-agreed upon primary outcome that LUCIDITY is evaluating - Population pharmacokinetic and pharmacodynamic data demonstrated avexitide 90 mg once daily has sustained therapeutic exposure for 24 hours - Amylyx to host

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced that it will host an investor event at the Endocrine Society's annual meeting (ENDO 2025) on Sunday, July 13, 2025, at 6:00 p.m. PT, both in-person in San Francisco, California and virtually. Speakers will discuss the current burden of post-bariatric hypoglycemia (PBH) and background on avexitide, a potential first-in-class GLP-1 receptor antagonist with FDA breakthrough therapy designation. Speakers will also review new exploratory analyses from the Phase 2 PREVENT and Phase 2b clinical trials of avexitide in post-bariatric hypoglycemia, which will be presented during ENDO 2025. These data include compos

- AMX0114 is an Amylyx-developed antisense oligonucleotide designed to target calpain-2, a key contributor to the axonal degeneration pathway in ALS - Phase 1 LUMINA trial of AMX0114 underway; early cohort data expected in 2025 Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AMX0114, an investigational antisense oligonucleotide (ASO) targeting calpain-2 for the treatment of people living with amyotrophic lateral sclerosis (ALS). "Obtaining FDA Fast Track designation for AMX0114 is an important step forward in our mission to develop potential treatments for peop

Data at Week 48 demonstrated that treatment with AMX0035 led to sustained stabilization or improvement in multiple outcomes related to disease progression, including pancreatic function, glycemic control, vision, and overall symptom burden AMX0035 continued to be generally well-tolerated in all participants Week 48 data and discussions with FDA will inform the design of a Phase 3 trial of AMX0035 in Wolfram syndrome Amylyx continues to expect cash runway through the end of 2026 Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced positive Week 48 data from the Phase 2 open-label HELIOS clinical trial of AMX0035 (sodium phenylbutyrate [PB] and t

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") will report its first quarter 2025 financial results on Thursday, May 8, 2025. Amylyx' senior management team will host a conference call and audio webcast at 8:00 a.m. ET to discuss the financial results and other company updates. To access the conference call, please dial +1 (800) 836-8184 (U.S. & Canada) or +1 (646) 357-8785 (international) at least 10 minutes prior to the start time and ask to be joined into the Amylyx Pharmaceuticals call. A live audio webcast of the call will be available under "Events and Presentations" in the Investor section of the Company's website, https://investors.amylyx.com/events-presenta

Amylyx expects completion of recruitment for the LUCIDITY trial in 2025, with topline data in first half of 2026 Pivotal Phase 3 LUCIDITY trial evaluating avexitide, a GLP-1 receptor antagonist with FDA Breakthrough Therapy Designation and Orphan Drug Designation; FDA-agreed-upon primary outcome of reduction in hypoglycemic events Avexitide has been previously evaluated in five post-bariatric hypoglycemia (PBH) clinical trials of avexitide showing consistent, dose-dependent effects, including statistically significant reductions in hypoglycemic events The Company continues to expect cash runway through the end of 2026 Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "

- Amylyx expects early cohort data from LUMINA this year - AMX0114 is an Amylyx-developed antisense oligonucleotide designed to target calpain-2, a key contributor to the axonal degeneration pathway in ALS Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced that the first participant has been dosed in LUMINA, the Company's Phase 1, multinational, randomized, double-blind, placebo-controlled, multiple ascending dose clinical trial of AMX0114, an investigational, potent antisense oligonucleotide (ASO) targeting calpain-2, in people living with amyotrophic lateral sclerosis (ALS). The Company continues to expect early cohort data from LUMINA in 2025. The L

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") will report its fourth quarter and full year 2024 financial results on Tuesday, March 4, 2025. Amylyx' senior management team will host a conference call and audio webcast at 8:00 a.m. ET to discuss the financial results and other company updates. To access the conference call, please dial +1 (800) 836-8184 (U.S. & Canada) or +1 (646) 357-8785 (international) at least 10 minutes prior to the start time and ask to be joined into the Amylyx Pharmaceuticals call. A live audio webcast of the call will be available under "Events and Presentations" in the Investor section of the Company's website, https://investors.amylyx.com

• Company will move forward with trial sites across North America Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on the Phase 1 clinical trial of AMX0114, an investigational antisense oligonucleotide (ASO) targeting calpain-2 for people living with amyotrophic lateral sclerosis (ALS). With the clinical hold lifted, Amylyx is now working to open U.S. sites for screening, enrollment, and dosing. The announcement comes as Amylyx expects to initiate the Phase 1 LUMINA clinical trial in Canada in the beginning of 2025. LUMINA is a multicenter, randomized, placebo-contr

- Dan Monahan will lead the commercialization strategy across Amylyx' product portfolio, beginning with avexitide, an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist for the treatment of post-bariatric hypoglycemia (PBH) - Mr. Monahan has more than 20 years of commercial leadership experience, including launching industry-leading franchises at Otsuka, Novartis, and Sanofi - Strong commercial and medical team in place for potential first-to-market launch in PBH and advancement of late-stage pipeline with the goal to bring new potential treatment options to communities with high unmet need Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "C

For Immediate Release: September 29, 2022 The U.S. Food and Drug Administration today approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease.  “This approval provides another important treatment option for ALS, a life-threatening disease that currently has no cure,” said Billy Dunn, M.D., director of the Off

For Immediate Release: September 02, 2022 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:   On Thursday, the FDA published the FDA Voices: “Using A Whole-Of-Governments Approach to Combating Illicit Health Products,” by Cathy Hermsen, Assistant Commissioner for Criminal Investigations and Ritu Nalubola, Director of the FDA’s Europe Office. Crimi