SEC Form 10-Q filed by Amylyx Pharmaceuticals Inc.
$AMLX
Biotechnology: Pharmaceutical Preparations
Health Care
Unavailable
Unavailable
Save time and jump to the most important pieces.
| 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 |
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
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.
4 - Amylyx Pharmaceuticals, Inc. (0001658551) (Issuer)
4 - Amylyx Pharmaceuticals, Inc. (0001658551) (Issuer)
4 - Amylyx Pharmaceuticals, Inc. (0001658551) (Issuer)
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
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.
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
4 - Amylyx Pharmaceuticals, Inc. (0001658551) (Issuer)
4 - Amylyx Pharmaceuticals, Inc. (0001658551) (Issuer)
4 - Amylyx Pharmaceuticals, Inc. (0001658551) (Issuer)
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
10-Q - Amylyx Pharmaceuticals, Inc. (0001658551) (Filer)
8-K - Amylyx Pharmaceuticals, Inc. (0001658551) (Filer)
8-K - Amylyx Pharmaceuticals, Inc. (0001658551) (Filer)
SC 13G/A - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)
SC 13G - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)
SC 13G - Amylyx Pharmaceuticals, Inc. (0001658551) (Subject)