SC 13G - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)

SC 13G - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)

SC 13G/A - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)

SC 13G - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)

SC 13G/A - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)

SC 13G/A - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)

SC 13G/A - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)

SC 13G/A - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)

SC 13G - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)

SC 13G - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)

Analysts' ratings for Amylyx Pharma (NASDAQ:AMLX) over the last quarter vary from bullish to bearish, as provided by 5 analysts. The following table summarizes their recent ratings, shedding light on the changing sentiments within the past 30 days and comparing them to the preceding months. Bullish Somewhat Bullish Indifferent Somewhat Bearish Bearish Total Ratings 3 0 2 0 0 Last 30D 0 0 1 0 0 1M Ago 2 0 0 0 0 2M Ago 0 0 1 0 0 3M Ago 1 0 0 0 0 Analysts provide deeper insights through their assessments of 12-month price targets, revealing an average target of $6.2, a high estimate of $8.00, and a low estimate of $3.00. No alteration is observed as the current average remai

Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades and downgrades, please see our analyst ratings page. Piper Sandler cut the price target for Adobe Inc. (NASDAQ:ADBE) from $700 to $635. Piper Sandler analyst Brent Bracelin maintained an Overweight rating. Adobe shares fell 1.2% to close at $557.63 on Thursday. See how other analysts view this stock. Needham slashed the price target for KalVista Pharmaceuticals, Inc. (NASDAQ:KALV) from $35 to $32. Needham analyst Serge Belanger maintained a Buy rating. KalVista Pharmaceuticals shares fell 0.6% to close at $12.50 on Thursday. See how other analysts vi

Goldman Sachs analyst Chris Shibutani maintains Amylyx Pharma (NASDAQ:AMLX) with a Neutral and raises the price target from $3 to $4.

Amylyx Pharmaceuticals Inc (NASDAQ:AMLX) acquired avexitide from Eiger BioPharmaceuticals Inc (OTC:EIGRQ) for $35.1 million. Avexitide is an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist that has been evaluated in five clinical trials for post-bariatric hypoglycemia (PBH) and has also been studied in congenital hyperinsulinism (HI), two indications characterized by hyperinsulinemic hypoglycemia. The FDA has granted avexitide Breakthrough Therapy Designation for both indications, Rare Pediatric Disease Designation in congenital HI, and Orphan Drug Designation for hyperinsulinemic hypoglycemia (which includes PBH and congenital HI). Also Read: Amy

HC Wainwright & Co. analyst Andrew Fein reiterates Amylyx Pharma (NASDAQ:AMLX) with a Buy and maintains $8 price target.

As part of the transaction, Amylyx assumed certain contractual obligations from Eiger, including a 3% royalty on future sales of avexitide in PBH, if approved, to certain academic institutions.

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced that Amylyx' management team will host a conference call and webcast tomorrow, Wednesday, July 10, 2024, at 8:00 a.m. ET to discuss the acquisition of avexitide from Eiger BioPharmaceuticals.

Across the recent three months, 6 analysts have shared their insights on Amylyx Pharma (NASDAQ:AMLX), expressing a variety of opinions spanning from bullish to bearish. The table below provides a snapshot of their recent ratings, showcasing how sentiments have evolved over the past 30 days and comparing them to the preceding months. Bullish Somewhat Bullish Indifferent Somewhat Bearish Bearish Total Ratings 4 0 2 0 0 Last 30D 1 0 0 0 0 1M Ago 0 0 0 0 0 2M Ago 1 0 1 0 0 3M Ago 2 0 1 0 0 The 12-month price targets assessed by analysts reveal further insights, featuring an average target of $6.33, a high estimate of $8.00, and a low estimate of $3.00. A decline of 1.09% from

HC Wainwright & Co. analyst Andrew Fein reiterates Amylyx Pharma (NASDAQ:AMLX) with a Buy and maintains $8 price target.

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

- Improvement observed in pancreatic function, as measured by C-peptide response, following 24 weeks of treatment with AMX0035; worsening is typically expected with disease progression based on natural history studies of Wolfram syndrome - Longer-term data for all participants who have completed Week 36 and Week 48 assessments showed sustained improvement over time - Improvements or stabilization observed across all secondary endpoints, including measures of glycemic control, vision, and patient- and clinician-reported impressions of overall disease burden - AMX0035 was generally well-tolerated in all participants - Amylyx plans to meet with the FDA and other stakeholders to inform a Ph

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced the Company will host a virtual webcast on October 17, 2024 at 1:30 p.m. ET with management and Fumihiko Urano, MD, PhD, principal investigator of the HELIOS clinical trial and the Samuel E. Schechter Professor of Medicine in the Division of Endocrinology, Metabolism & Lipid Research at Washington University School of Medicine in St. Louis (WashU Medicine), to discuss topline results from HELIOS, a Phase 2 trial of AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO, also known as ursodoxicoltaurine]) for the investigational treatment of Wolfram syndrome. The live webcast follows the presentation

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 in New York City: Morgan Stanley 22nd Annual Global Healthcare Conference: Fireside chat on Thursday, September 5, 2024, at 1:50pm ET Baird 2024 Global Healthcare Conference: Fireside chat on Tuesday, September 10, 2024, at 3:45pm ET H.C. Wainwright 26th Annual Global Investment Conference: Corporate presentation on Wednesday, September 11, 2024, at 8:30am ET A live webcast of each conference event can be accessed under "Events and Presentations" in the Investor section of the C

- Findings from exploratory analysis of the PEGASUS trial provide preliminary evidence that AMX0035 engages multiple pathological pathways related to neurodegeneration, including tau Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced the publication of exploratory analyses on cerebrospinal fluid (CSF) biomarkers from participants with Alzheimer's disease (AD) from the Phase 2 PEGASUS trial. Data analyses suggest that treatment with AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO]) resulted in consistent changes in AD and neurodegeneration CSF biomarkers in participants with a broad range of disease severity. The results were published in the

Expanded pipeline with avexitide, a Phase 3-ready GLP-1 receptor antagonist with FDA Breakthrough Therapy and Orphan Drug Designations; Phase 3 program initiation in post-bariatric hypoglycemia (PBH) on track for Q1 2025 Company expects to present updated data from its Phase 2 HELIOS trial of AMX0035 in Wolfram syndrome at ISPAD 2024, including data from all 12 participants at Week 24 and any participant who completed their Week 36 or 48 assessment prior to the data cutoff Multiple ascending dose clinical trial of AMX0114 in people living with ALS planned to initiate in the second half of 2024 Cash, cash equivalents and short-term investments of $309.8 million at June 30, 2024;

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") will report its second quarter 2024 financial results on Thursday, August 8, 2024. 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/news-event

- New designation follows the U.S. Food and Drug Administration (FDA) Orphan Drug Designation for AMX0035 in Wolfram syndrome granted in 2020 - Topline data for all 12 participants from Phase 2 HELIOS trial studying impact of AMX0035 on endocrine, metabolic, and neurodegenerative aspects of Wolfram syndrome anticipated fall 2024 Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced the European Commission (EC), based on a positive opinion issued by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA), has granted Orphan Drug Designation for AMX0035, Amylyx' proprietary, fixed-dose combination of sodium phenylbutyrate

- Avexitide is a novel, first-in-class GLP-1 receptor antagonist with the potential to treat hyperinsulinemic hypoglycemia - FDA Breakthrough Therapy Designation granted for avexitide for post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism - Acquisition builds on Amylyx' endocrine and neuroscience expertise and aligns with pipeline focus of delivering important potential treatment options to communities with high unmet needs - Phase 3 program for avexitide in PBH expected to begin in Q1 2025, with data readout anticipated in 2026; FDA has agreed to the primary endpoint expected to be utilized in Phase 3 - Data from two Phase 2 studies of avexitide in people with PBH dem

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced that Amylyx' management team will host a conference call and webcast tomorrow, Wednesday, July 10, 2024, at 8:00 a.m. ET to discuss the acquisition of avexitide from Eiger BioPharmaceuticals. To access the conference call, please dial +1 (800) 836-8184 (U.S. and 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/news-events/events, and will be avai

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced that management will participate in a fireside chat presentation at the Goldman Sachs 45th Annual Global Healthcare Conference. The conference is being conducted in-person in Miami, Florida, and the fireside chat will take place on Tuesday, June 11, 2024, at 8:00 AM EDT. A live webcast of the presentation can be accessed under "Events" in the Investor section of the Company's website, https://investors.amylyx.com/news-events/events, and will be available for replay for 90 days following the event. About Amylyx Pharmaceuticals Amylyx Pharmaceuticals, Inc. is committed to supporting and creating more

4 - Amylyx Pharmaceuticals, Inc. (0001658551) (Issuer)

4 - Amylyx Pharmaceuticals, Inc. (0001658551) (Issuer)

4 - Amylyx Pharmaceuticals, Inc. (0001658551) (Issuer)

4 - Amylyx Pharmaceuticals, Inc. (0001658551) (Issuer)

4 - Amylyx Pharmaceuticals, Inc. (0001658551) (Issuer)

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