Associated tags: Medication, Health, Pharmaceutical, Amylyx Pharmaceuticals, Biotechnology, Neurology, Pharmaceutical industry, AMX0035, ALS, Clinical Trials, Research, General Health
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Pharmaceutical industry Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the first quarter ended March 31, 2024.
Key Points:
- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the first quarter ended March 31, 2024.
- This decision was informed by topline PHOENIX trial results, engagement with regulatory authorities, and discussions with the ALS community.
- Amylyx anticipates reporting topline data from all 12 participants at Week 24 in the fall of 2024.
- Amylyx’ management team will host a conference call and webcast today, May 9, 2024, at 8:00 a.m.
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Amylyx Pharmaceuticals 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.
Key Points:
- 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.
Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) will report its first quarter 2024 financial results on Thursday, May 9, 2024.
Key Points:
- 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.
- 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 .
Retrieved on:
Wednesday, April 10, 2024
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Pharmaceutical industry “I have been studying Wolfram syndrome and caring for people with the disease for more than 20 years.
Key Points:
- “I have been studying Wolfram syndrome and caring for people with the disease for more than 20 years.
- Outcomes for people with Wolfram syndrome consistently worsen over time, so disease stabilization alone is clinically meaningful for both patients and their doctors.
- Because of the clear link between WFS1 mutations and ER stress, Wolfram syndrome is considered a prototypical ER stress disorder.
- Amylyx announced that the FDA granted orphan drug designation to AMX0035 for the treatment of Wolfram syndrome in November 2020.
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Pharmaceutical industry 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/news-events/events , and will be available for replay for 90 days following the event.
Key Points:
- 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/news-events/events , and will be available for replay for 90 days following the event.
- Dr. Fumihiko Urano is a physician and medical researcher specializing in Wolfram syndrome.
- Dr. Urano is a driving force in the study of Wolfram syndrome and related disorders, including WFS1-related disorders/Wolfram-like disorders.
- As director of the Wolfram Syndrome Clinic and the Wolfram Syndrome International Registry & Clinical Study at Washington University, Dr. Urano treats patients with Wolfram syndrome and related disorders, and leads basic science, clinical, translational, and interventional studies of Wolfram syndrome and related disorders.
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Pharmaceutical industry Amylyx will continue to evaluate and share learnings from PHOENIX to help inform future ALS research.
Key Points:
- Amylyx will continue to evaluate and share learnings from PHOENIX to help inform future ALS research.
- At this time, Amylyx intends to continue to collect available data on survival at the encouragement of ALS specialists.
- “Our pipeline is supported by compelling clinical and preclinical science demonstrating the potential of AMX0035 and AMX0114 in neurodegenerative diseases.
- “We are so thankful and grateful to our Amylyx team for their contributions and steadfast dedication,” said Cohen and Klee.
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Pharmaceutical industry 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”).
Key Points:
- 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”).
- Most recently, he served as Chief Medical Officer (“CMO”) of Astellas Pharma, where he led early- and late-stage drug development, medical and regulatory affairs, pharmacovigilance, and quality assurance.
- “Dr.
- Zeiher brings to the Board his distinguished drug development background in overseeing the approval of 15 medicines, and his first-hand experience as a physician.
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Pharmaceutical industry Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced topline results from PHOENIX, a global, 48-week, randomized, placebo-controlled Phase 3 clinical trial of AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]; RELYVRIO® in the U.S., ALBRIOZA™ in Canada) in people living with amyotrophic lateral sclerosis (ALS).
Key Points:
- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced topline results from PHOENIX, a global, 48-week, randomized, placebo-controlled Phase 3 clinical trial of AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]; RELYVRIO® in the U.S., ALBRIOZA™ in Canada) in people living with amyotrophic lateral sclerosis (ALS).
- Amylyx intends to share plans for RELYVRIO/ALBRIOZA in ALS, which may include voluntarily withdrawing RELYVRIO/ALBRIOZA from the market.
- “We are surprised and deeply disappointed by the PHOENIX results following the positive data from the CENTAUR trial.
- Update on Ongoing AMX0035 Studies:
The global, randomized, double-blind, placebo-controlled Phase 3 ORION clinical study of AMX0035 in PSP remains ongoing.
Retrieved on:
Friday, February 23, 2024
Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that it has granted stock options and restricted stock units (“RSUs”) to Linda Arsenault, the Company’s newly appointed Chief Human Resources Officer.
Key Points:
- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that it has granted stock options and restricted stock units (“RSUs”) to Linda Arsenault, the Company’s newly appointed Chief Human Resources Officer.
- The Compensation Committee of Amylyx’ Board of Directors approved the grant, effective February 20, 2024, to Ms. Arsenault of non-qualified stock option awards to purchase up to 101,400 shares of the Company’s common stock and 67,600 RSUs under the Amylyx Pharmaceuticals, Inc. 2023 Inducement Plan (“2023 Inducement Plan”).
- The awards were granted as an inducement material to Ms. Arsenault entering into employment with Amylyx in accordance with Nasdaq Listing Rule 5635(c)(4).
- The awards are subject to the terms and conditions of the 2023 Inducement Plan.
Retrieved on:
Thursday, February 22, 2024
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Pharmaceutical industry Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the fourth quarter and full year ended December 31, 2023.
Key Points:
- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the fourth quarter and full year ended December 31, 2023.
- Net product revenue for the three months ended December 31, 2023 was $108.4 million, compared to net product revenue of $102.7 million for the three months ended September 30, 2023.
- Amylyx announced the first patient dosed in the Global Phase 3 ORION Study of AMX0035 in Progressive Supranuclear Palsy (PSP).
- The first participant was dosed in December 2023, and topline results are anticipated in 2025 or 2026.
