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 |
|---|---|---|---|
| 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 |
| 3/11/2024 | $27.00 → $4.00 | Outperform → Market Perform | Leerink Partners |
| 3/11/2024 | $37.00 → $4.00 | Outperform → Neutral | Robert W. Baird |
8-K - Amylyx Pharmaceuticals, Inc. (0001658551) (Filer)
424B5 - Amylyx Pharmaceuticals, Inc. (0001658551) (Filer)
424B5 - Amylyx Pharmaceuticals, Inc. (0001658551) (Filer)
8-K - Amylyx Pharmaceuticals, Inc. (0001658551) (Filer)
144 - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)
SCHEDULE 13G/A - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)
10-Q - Amylyx Pharmaceuticals, Inc. (0001658551) (Filer)
8-K - Amylyx Pharmaceuticals, Inc. (0001658551) (Filer)
SCHEDULE 13G - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)
SCHEDULE 13G - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)
Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.
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
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
Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.
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)
Insider purchases reveal critical bullish sentiment about the company from key stakeholders. See them live in this feed.
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)
Live FDA approvals issued by the Food and Drug Administration and FDA breaking news
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
Live Leadership Updates
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
This live feed shows all institutional transactions in real time.
SC 13G/A - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)
SC 13G - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)
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)
Live finance-specific insights
Completion of recruitment for pivotal Phase 3 LUCIDITY trial of avexitide in PBH expected in 2025, with topline data anticipated in first half of 2026 Cash, cash equivalents, and marketable securities of $180.8 million as of June 30, 2025; cash runway expected 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 and business results for the second quarter ended June 30, 2025. "As we look ahead to the second half of the year and into 2026, we remain encouraged by the strength of our pipeline and the continued momentum towards our cl
Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") will report its second quarter 2025 financial results on Thursday, August 7, 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-pre
- 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
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
Fastest customizable press release news feed in the world
Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced the pricing of an underwritten public offering of 17,500,000 shares of its common stock at a public offering price of $10.00 per share. All of the shares of common stock are being offered by Amylyx. In addition, Amylyx has granted the underwriters a 30-day option to purchase up to an additional 2,625,000 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 $175.0 million, before deducting underwriting discounts and commissions and offering expenses and excluding any exercise of the
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 of common stock are being offered by Amylyx. In addition, Amylyx intends to grant the underwriters 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.
- AMX0035 did not show differences compared to placebo on primary or secondary outcomes at Week 24 - AMX0035 continued to be generally well-tolerated Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") today announced the decision to discontinue the ORION program of AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO, also known as ursodoxicoltaurine]) in adults living with progressive supranuclear palsy (PSP). AMX0035 did not show differences compared to placebo on primary or secondary outcomes at Week 24. Based on these results, the Company will discontinue the Phase 2b trial and open-label extension and will not initiate the Phase 3 portion of the program
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 Boston and New York City. Citi's 2025 Biopharma Back to School Conference: Fireside chat on Tuesday, September 2, 2025, at 1:00pm ET Cantor Global Healthcare Conference 2025: Fireside chat on Wednesday, September 3, 2025, at 8:00am ET Morgan Stanley 23rd Annual Global Healthcare Conference: Fireside chat on Monday, September 8, 2025, at 4:50pm ET Baird 2025 Global Healthcare Conference: Fireside chat on Tuesday, September 9, 2025, at 3:10pm ET H.C. Wainwright 27th Annual G
Completion of recruitment for pivotal Phase 3 LUCIDITY trial of avexitide in PBH expected in 2025, with topline data anticipated in first half of 2026 Cash, cash equivalents, and marketable securities of $180.8 million as of June 30, 2025; cash runway expected 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 and business results for the second quarter ended June 30, 2025. "As we look ahead to the second half of the year and into 2026, we remain encouraged by the strength of our pipeline and the continued momentum towards our cl
Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) ("Amylyx" or the "Company") will report its second quarter 2025 financial results on Thursday, August 7, 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-pre
- 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
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