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 |
|---|---|---|---|
| 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 |
| 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 |
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)
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
Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced that management will present at the 24th Annual Needham Virtual Healthcare Conference. The corporate presentation will take place on Wednesday, April 9, 2025, at 8:00 a.m. ET. A live webcast of the presentation 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 replay for 90 days following the event. About Amylyx Pharmaceuticals At Amylyx, our mission is to usher in a new era of treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pur
Pivotal Phase 3 LUCIDITY trial of avexitide, a potential first-in-class GLP-1 receptor antagonist, in post-bariatric hypoglycemia underway; completion of recruitment expected in 2025, with topline data anticipated in first half of 2026 Completed a public offering of common stock with net proceeds of approximately $65.5 million, extending the company's cash runway through the end of 2026 Management to host conference call and webcast today at 8:00 a.m. Eastern Time Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today reported financial results for the fourth quarter and full year ended December 31, 2024. "We made significant progress in 2024 across our pipel
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. TD Cowen 45th Annual Health Care Conference: Corporate Presentation and Q&A on Tuesday, March 4, 2025, at 10:30 a.m. ET in Boston, Massachusetts Leerink Global Healthcare Conference: Fireside chat on Monday, March 10, 2025, at 2:20 p.m. ET in Miami, Florida 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 replay for 90
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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
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)
4 - Amylyx Pharmaceuticals, Inc. (0001658551) (Issuer)
4 - Amylyx Pharmaceuticals, Inc. (0001658551) (Issuer)
4 - Amylyx Pharmaceuticals, Inc. (0001658551) (Issuer)
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
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
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
- Pivotal Phase 3 LUCIDITY trial will evaluate FDA-agreed upon primary outcome of reduction in hypoglycemia events and designed to align as closely as possible with previous Phase 2 trial designs - Amylyx expects first study participant dosed in LUCIDITY in Q1 2025 and topline results in 2026 - Avexitide has FDA Breakthrough Therapy Designation for the treatment of post-bariatric hypoglycemia and Orphan Drug Designation - Amylyx to present the Phase 3 LUCIDITY trial design at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on December 12-14 Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced the design of its pivotal Pha
On track to initiate a Phase 3 program for Company's lead asset avexitide, a GLP-1 receptor antagonist with FDA Breakthrough Therapy and Orphan Drug Designations, in post-bariatric hypoglycemia (PBH) in the first quarter of 2025 Reported positive topline data from Phase 2 HELIOS clinical trial of AMX0035 in Wolfram syndrome demonstrating improvement or stabilization across all disease measures at Week 24 and sustained improvement at Weeks 36 and 48 Cash, cash equivalents and marketable securities of $234.4 million as of September 30, 2024; cash runway expected into 2026 Management to host conference call and webcast today at 8:00 a.m. Eastern Time Amylyx Pharmaceuticals, Inc. (N
Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") will report its third quarter 2024 financial results on Thursday, November 7, 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-ev