Welcome to our dedicated page for Amylyx Pharmaceuticals news (Ticker: AMLX), a resource for investors and traders seeking the latest updates and insights on Amylyx Pharmaceuticals stock.
Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) is a biopharmaceutical company focused on investigational therapies for neurodegenerative and endocrine diseases, and its news flow reflects the progress and setbacks typical of clinical-stage drug development. Company updates frequently highlight milestones in its pipeline, including avexitide for post-bariatric hypoglycemia (PBH), AMX0035 for Wolfram syndrome, AMX0114 for amyotrophic lateral sclerosis (ALS), and AMX0318 as a long-acting GLP-1 receptor antagonist candidate.
Investors following AMLX news can expect regular announcements on clinical trial progress, such as enrollment status, early safety and tolerability data, and biomarker analyses from studies like the Phase 3 LUCIDITY trial in PBH and the Phase 1 LUMINA trial in ALS. Amylyx also issues press releases when it reports financial results, providing context on research and development spending, cash runway, and the anticipated timing of key clinical and regulatory milestones.
Another recurring news theme is regulatory and program updates, including FDA designations, decisions to advance or discontinue specific programs, and detailed descriptions of conditions such as PBH, ALS, PSP, and Wolfram syndrome. The company has, for example, communicated its decision to discontinue the ORION program of AMX0035 in progressive supranuclear palsy after Phase 2b results, while continuing development of AMX0035 in Wolfram syndrome.
Amylyx also announces capital markets events and investor outreach, such as underwritten public offerings of common stock and participation in healthcare and biopharma conferences. For readers tracking AMLX, this news page offers a consolidated view of clinical, financial, and strategic disclosures that shape the company’s development trajectory. Bookmarking this feed can help investors and observers monitor how Amylyx’ investigational therapies advance through trials and how management communicates key developments.
Amylyx Pharmaceuticals (NASDAQ: AMLX) has initiated the LUMINA Phase 1 trial for AMX0114, dosing its first participant. This multinational, randomized, double-blind, placebo-controlled study will evaluate AMX0114, an antisense oligonucleotide targeting calpain-2, in people with Amyotrophic Lateral Sclerosis (ALS).
The trial will enroll approximately 48 participants across North America, randomized 3:1 to receive AMX0114 or placebo via intrathecal administration once every four weeks for up to 4 doses. The study aims to assess safety, tolerability, pharmacokinetics, and pharmacodynamics, including changes in neurofilament light chain (NfL) levels.
Early cohort data from LUMINA is expected in 2025. Preclinical studies have shown improved neuronal survival and reduced extracellular NfL levels across multiple disease models. The drug targets calpain-2, a calcium-activated protease believed to be a key contributor to axonal degeneration in ALS.
Amylyx Pharmaceuticals (Nasdaq: AMLX) has announced its upcoming participation in the 24th Annual Needham Virtual Healthcare Conference. The company's management will deliver a corporate presentation on Wednesday, April 9, 2025, at 8:00 a.m. ET.
Interested parties can access a live webcast of the presentation through the 'Events and Presentations' section of the company's investor relations website at investors.amylyx.com. The presentation recording will remain available for replay on the website for 90 days after the event.
Amylyx Pharmaceuticals (NASDAQ: AMLX) reported its Q4 and full year 2024 financial results, highlighting significant pipeline progress and financial updates. The company's pivotal Phase 3 LUCIDITY trial of avexitide for post-bariatric hypoglycemia is underway, with topline data expected in H1 2026.
Key financial metrics include:
- Q4 2024 net loss of $37.5 million ($0.55 per share)
- Full year 2024 net loss of $301.7 million ($4.43 per share)
- Cash position of $176.5 million as of December 31, 2024
- Additional $65.5 million raised through public offering in January 2025
R&D expenses decreased to $22.9 million in Q4 2024 (vs $44.9 million in Q4 2023), while SG&A expenses reduced to $17.1 million (vs $52.2 million in Q4 2023). The company expects its current cash runway to extend through the end of 2026.
Amylyx Pharmaceuticals (Nasdaq: AMLX) has announced its participation in two major investor conferences in March 2025. The company will deliver a corporate presentation and Q&A session at the TD Cowen 45th Annual Health Care Conference on March 4 at 10:30 a.m. ET in Boston. Additionally, Amylyx will participate in a fireside chat at the Leerink Global Healthcare Conference on March 10 at 2:20 p.m. ET in Miami.
Both presentations will be accessible via live webcast through the company's investor relations website under the 'Events and Presentations' section. The webcasts will remain available for replay for 90 days after the events.
Amylyx Pharmaceuticals (Nasdaq: AMLX) has announced it will release its fourth quarter and full year 2024 financial results on Tuesday, March 4, 2025. The company's senior management will host a conference call and audio webcast at 8:00 a.m. ET to discuss financial results and company updates.
Investors can access the conference call by dialing +1 (800) 836-8184 (U.S. & Canada) or +1 (646) 357-8785 (international). A live audio webcast will be available on the company's investor website and archived for 90 days after the event.
Amylyx Pharmaceuticals (Nasdaq: AMLX) has announced its participation in the upcoming Oppenheimer 35th Annual Healthcare Life Sciences Conference. The company's management will deliver a presentation at this virtual event on Wednesday, February 12, 2025, at 2:00 p.m. ET.
Interested parties can access a live webcast of the presentation through the 'Events and Presentations' section of Amylyx's investor relations website at investors.amylyx.com/events-presentations. The presentation recording will remain available for replay on the company's website for 90 days after the event.
Amylyx Pharmaceuticals (NASDAQ: AMLX) announced that the FDA has lifted the clinical hold on its Phase 1 clinical trial of AMX0114, an antisense oligonucleotide targeting calpain-2 for ALS treatment. The company will proceed with opening U.S. sites for screening, enrollment, and dosing.
The Phase 1 LUMINA clinical trial is expected to begin in Canada in early 2025. This multicenter, randomized, placebo-controlled trial will evaluate AMX0114's safety and biological activity, involving approximately 48 ALS patients randomized 3:1 to receive either AMX0114 or placebo via intrathecal administration once every four weeks for up to 4 doses. The trial will assess ALS biomarkers, including changes in neurofilament light levels.
The company expects to obtain early cohort data from LUMINA in 2025.
Amylyx Pharmaceuticals (Nasdaq: AMLX) has announced the pricing of a public offering of 17,142,857 shares of common stock at $3.50 per share. The company expects to raise approximately $60.0 million in gross proceeds, before deducting underwriting costs and expenses.
The company has also granted the underwriter a 30-day option to purchase up to an additional 2,571,428 shares at the same price. The offering is expected to close around January 13, 2025. Leerink Partners is acting as the sole bookrunning manager.
Amylyx plans to use the net proceeds, combined with existing cash and marketable securities, to advance commercialization preparations, pipeline programs, working capital, and general corporate purposes.
Amylyx Pharmaceuticals (NASDAQ: AMLX) has announced the launch of an underwritten public offering of its common stock shares. The company plans to grant underwriters a 30-day option to purchase additional shares up to 15% of the offered shares at the public offering price, less underwriting discounts and commissions.
The net proceeds will be used alongside existing cash, cash equivalents, and marketable securities to advance commercialization preparations and pipeline programs, working capital, and general corporate purposes. Leerink Partners is serving as the sole book-running manager for the offering.
The offering is being made pursuant to an automatically effective shelf registration statement on Form S-3 filed with the SEC on March 13, 2023. The completion, size, and terms of the offering are subject to market conditions.
Amylyx Pharmaceuticals (NASDAQ: AMLX) has appointed Dan Monahan as Chief Commercial Officer, joining the company's Leadership Team in January 2024. Monahan brings over 20 years of commercial leadership experience from positions at Otsuka, Novartis, and Sanofi.
The appointment comes as Amylyx prepares for the Phase 3 LUCIDITY clinical trial of avexitide, a first-in-class GLP-1 receptor antagonist for post-bariatric hypoglycemia (PBH). The trial is planned to begin in Q1 2025, with data expected in 2026. Avexitide aims to be the first approved therapy for PBH.
In his previous role at Otsuka Pharmaceuticals, Monahan led U.S. commercialization efforts for the CNS franchise. At Novartis, he managed the commercial execution of COSENTYX®, and at Sanofi, he held various leadership positions across sales, marketing, and market access.
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