Amylyx Pharmaceuticals, Inc., a biopharmaceutical company, develops therapeutics for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases in the United States and Canada. The company's product candidature includes AMX0035, a dual UPR-Bax apoptosis inhibitor composed of sodium phenylbutyrate and tauroursodeoxycholic acid for the treatment of ALS and other neurodegenerative diseases. It is also developing products for Wolfram syndrome and Alzheimer's diseases. Amylyx Pharmaceuticals, Inc. was founded in 2013 and is headquartered in Cambridge, Massachusetts.
IPO Year: 2022
Exchange: NASDAQ
Website: https://amylyx.com
Date | Price Target | Rating | Analyst |
---|---|---|---|
3/18/2024 | $32.00 → $4.00 | Buy → Neutral | Mizuho |
3/11/2024 | $27.00 → $4.00 | Outperform → Market Perform | Leerink Partners |
3/11/2024 | $37.00 → $4.00 | Outperform → Neutral | Robert W. Baird |
3/8/2024 | Buy → Neutral | Goldman | |
3/8/2024 | Outperform → In-line | Evercore ISI | |
1/3/2024 | $37.00 | Outperform | Robert W. Baird |
12/12/2023 | $36.00 | Buy | Deutsche Bank |
7/24/2023 | $45.00 → $49.00 | Neutral → Buy | Goldman |
3/31/2023 | $52.00 | Buy | Mizuho |
1/5/2023 | $50.00 | Buy | BofA Securities |
- 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
Company plans to engage with FDA based on interim data from the Phase 2 HELIOS clinical trial demonstrating improvements in pancreatic function, glycemic control, and vision in participants with Wolfram syndrome treated with AMX0035; topline data from all 12 participants at Week 24 anticipated in fall of 2024 Interim analysis from the ORION study of AMX0035 in progressive supranuclear palsy continues to be expected in mid-2025 Amylyx expects to initiate clinical trial of AMX0114 in ALS in the second half of 2024 Cash, cash equivalents and short-term investments of $373.3 million at March 31, 2024 provides expected cash runway into 2026 Management to host conference call and web
Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced that Joshua Cohen and Justin Klee, Co-CEOs of Amylyx, and Camille L. Bedrosian, MD, Chief Medical Officer of Amylyx, will participate in the 2024 Bank of America Health Care Conference. The conference is being conducted in-person in Las Vegas, Nevada, and the fireside chat will take place on Wednesday, May 15, 2024, at 8:40 a.m. PT/11:40 a.m. ET. 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. (NASDAQ:AMLX) ("Amylyx" or the "Company") will report its first quarter 2024 financial results on Thursday, May 9, 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 (877)-346-6112 (U.S. & Canada) or +1 (848)-280-6350 (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/ev
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)
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)
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
- 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
- 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
Company plans to engage with FDA based on interim data from the Phase 2 HELIOS clinical trial demonstrating improvements in pancreatic function, glycemic control, and vision in participants with Wolfram syndrome treated with AMX0035; topline data from all 12 participants at Week 24 anticipated in fall of 2024 Interim analysis from the ORION study of AMX0035 in progressive supranuclear palsy continues to be expected in mid-2025 Amylyx expects to initiate clinical trial of AMX0114 in ALS in the second half of 2024 Cash, cash equivalents and short-term investments of $373.3 million at March 31, 2024 provides expected cash runway into 2026 Management to host conference call and web
Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") will report its first quarter 2024 financial results on Thursday, May 9, 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 (877)-346-6112 (U.S. & Canada) or +1 (848)-280-6350 (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/ev
- Dr. Zeiher brings more than 20 years of drug development experience in areas with serious unmet treatment needs at companies including Astellas Pharma, Pfizer, Eli Lilly and Company, and Merck Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced the addition of Bernhardt G. Zeiher, MD, FCCP, FACP, to its Board of Directors ("Board"). Dr. Zeiher brings more than 20 years of drug development experience where, in his various roles, he oversaw the approval of 15 new treatments that addressed people's unmet needs in serious diseases with few to no treatment options. Most recently, he served as Chief Medical Officer ("CMO") of Astellas Pharma, where he led ea
- PHOENIX Study Did Not Meet Prespecified Primary or Secondary Endpoints - Data From 664-Participant Study Reinforce That AMX0035 is Generally Safe and Well-Tolerated - Within the Next Eight Weeks, Amylyx Will Continue to Engage With Regulatory Authorities and the ALS Community to Share Topline Data; Amylyx Will Share Plans for RELYVRIO/ALBRIOZA in ALS Which May Include Voluntarily Withdrawing RELYVRIO/ALBRIOZA From the Market - At This Time, RELYVRIO/ALBRIOZA Will Continue to be Available for People Living With ALS; Amylyx Has Voluntarily Decided to Pause Promotion; Related Patient Support Services Will Remain in Place - Studies With AMX0035 in Wolfram Syndrome (WS) and Progressive
Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") will report its fourth quarter and full year 2023 financial results on Thursday, February 22, 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.amyl
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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.
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
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
Goldman downgraded Amylyx Pharmaceuticals from Buy to Neutral
Evercore ISI downgraded Amylyx Pharmaceuticals from Outperform to In-line
Robert W. Baird initiated coverage of Amylyx Pharmaceuticals with a rating of Outperform and set a new price target of $37.00
Deutsche Bank initiated coverage of Amylyx Pharmaceuticals with a rating of Buy and set a new price target of $36.00
Goldman upgraded Amylyx Pharmaceuticals from Neutral to Buy and set a new price target of $49.00 from $45.00 previously
Mizuho initiated coverage of Amylyx Pharmaceuticals with a rating of Buy and set a new price target of $52.00
BofA Securities initiated coverage of Amylyx Pharmaceuticals with a rating of Buy and set a new price target of $50.00