Amylyx Pharmaceuticals Stock Price, News & Analysis

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.

Amylyx Pharmaceuticals (AMLX) has announced the design of its pivotal Phase 3 LUCIDITY trial for avexitide, a first-in-class GLP-1 receptor antagonist for treating post-bariatric hypoglycemia (PBH). The trial will evaluate the reduction in hypoglycemia events as the primary outcome, with the first participant expected to be dosed in Q1 2025 and topline results in 2026.

The trial will involve approximately 75 participants across 20 U.S. sites, randomized 3:2 to receive either 90 mg avexitide or placebo. The study includes a three-week run-in period and a 16-week treatment period, followed by a 32-week open-label extension. Previous Phase 2 trials showed significant reductions in hypoglycemia events, with the Phase 2b trial demonstrating a 53% reduction in Level 2 and 66% reduction in Level 3 hypoglycemia events.

Amylyx Pharmaceuticals (Nasdaq: AMLX) has announced its participation in the 7th Annual Evercore ISI HealthCONx Conference. The company's management will engage in a fireside chat on Wednesday, December 4, 2024, at 11:15 a.m. ET in Coral Gables, Florida.

The event will be accessible via live webcast in the Investor section of Amylyx's website under 'Events and Presentations.' The recording will remain available for replay for 90 days after the event.

Amylyx Pharmaceuticals reported its Q3 2024 financial results, highlighting key developments and financial metrics. The company announced positive topline data from its Phase 2 HELIOS trial of AMX0035 in Wolfram syndrome, showing improvements in pancreatic function and other disease measures. Amylyx plans to initiate a Phase 3 program for avexitide in post-bariatric hypoglycemia by Q1 2025. The company holds $234.4 million in cash and securities, sufficient to fund operations into 2026. Financial results showed a net product revenue of $0.4 million, a net loss of $72.7 million, and significant decreases in R&D and SG&A expenses compared to Q3 2023. The company is also progressing with other clinical programs, including the Phase 1 LUMINA trial for AMX0114 in ALS, expected to start in late 2024 or early 2025.