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 |
|---|---|---|---|
| 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 |
| 12/12/2023 | $36.00 | Buy | Deutsche Bank |
| 7/24/2023 | $45.00 → $49.00 | Neutral → Buy | Goldman |
SC 13G/A - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)
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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)
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8-K - Amylyx Pharmaceuticals, Inc. (0001658551) (Filer)
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424B5 - Amylyx Pharmaceuticals, Inc. (0001658551) (Filer)
8-K - Amylyx Pharmaceuticals, Inc. (0001658551) (Filer)
10-Q - Amylyx Pharmaceuticals, Inc. (0001658551) (Filer)
8-K - Amylyx Pharmaceuticals, Inc. (0001658551) (Filer)
8-K - Amylyx Pharmaceuticals, Inc. (0001658551) (Filer)
10-Q - 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
Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced that Amylyx management will present at the virtual Oppenheimer 35th Annual Healthcare Life Sciences Conference. The presentation will take place on Wednesday, February 12, 2025, at 2:00 p.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 opp
• 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
Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced the pricing of an underwritten public offering of 17,142,857 shares of its common stock at a public offering price of $3.50 per share. All of the shares are being offered by Amylyx. In addition, Amylyx has granted the underwriter a 30-day option to purchase up to an additional 2,571,428 shares of its common stock at the public offering price per share, less underwriting discounts and commissions. The gross proceeds to Amylyx from this offering are expected to be approximately $60.0 million, before deducting underwriting discounts and commissions and offering expenses and excluding any exercise of the unde
Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced that it has commenced an underwritten public offering of shares of its common stock. All of the shares are being offered by Amylyx. In addition, Amylyx intends to grant the underwriter a 30-day option to purchase additional shares of its common stock in an amount up to 15% of the shares offered in the public offering at the public offering price per share, less underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Amylyx intends t
- 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
Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced that management will participate in the 7th Annual Evercore ISI HealthCONx Conference. The conference is being conducted in-person in Coral Gables, Florida, and the fireside chat will take place on Wednesday, December 4, 2024, at 11:15 a.m. ET. A live webcast of the fireside chat can be accessed under "Events and Presentations" 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 is committed to the discovery and development of new treatment options for
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
- 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
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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)
• 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
- 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
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
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
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