Amendment: SEC Form SC 13G/A filed by Amylyx Pharmaceuticals Inc.
$AMLX
Biotechnology: Pharmaceutical Preparations
Health Care
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| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 7/10/2025 | $10.00 | Buy | Goldman |
| 6/24/2025 | $17.00 | Buy | Guggenheim |
| 6/17/2025 | $12.00 | Buy | Citigroup |
| 5/30/2025 | Buy | TD Cowen | |
| 4/7/2025 | $7.00 | Neutral → Outperform | Mizuho |
| 11/18/2024 | $3.00 → $11.00 | Neutral → Outperform | Robert W. Baird |
| 10/23/2024 | $4.20 → $10.00 | Neutral → Buy | BofA Securities |
| 3/18/2024 | $32.00 → $4.00 | Buy → Neutral | Mizuho |
- 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
4 - Amylyx Pharmaceuticals, Inc. (0001658551) (Issuer)
4 - Amylyx Pharmaceuticals, Inc. (0001658551) (Issuer)
4 - Amylyx Pharmaceuticals, Inc. (0001658551) (Issuer)
SCHEDULE 13G - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)
SCHEDULE 13G - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)
8-K - Amylyx Pharmaceuticals, Inc. (0001658551) (Filer)
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
4 - Amylyx Pharmaceuticals, Inc. (0001658551) (Issuer)
4 - Amylyx Pharmaceuticals, Inc. (0001658551) (Issuer)
4 - Amylyx Pharmaceuticals, Inc. (0001658551) (Issuer)
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
SC 13G/A - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)
SC 13G - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)
SC 13G - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)
- 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
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.