Earnings summaries and quarterly performance for Amylyx Pharmaceuticals.
Executive leadership at Amylyx Pharmaceuticals.
Board of directors at Amylyx Pharmaceuticals.
Research analysts who have asked questions during Amylyx Pharmaceuticals earnings calls.
Michael DiFiore
Evercore ISI
4 questions for AMLX
Also covers: AMGN, BIIB, ELAN +8 more
Ananda Ghosh
H.C. Wainwright & Co.
3 questions for AMLX
Also covers: ABOS, ALEC, PEPG +1 more
Basma Radwan Ibrahim
Leerink Partners
2 questions for AMLX
Also covers: ACAD, BLTE, RLMD +2 more
Joel Beatty
Baird
2 questions for AMLX
Also covers: ACAD, ALKS, ARGX +11 more
Marc Goodman
Leerink Partners
2 questions for AMLX
Also covers: ACAD, ALDX, ALKS +14 more
Chen Yang
Bank of America
1 question for AMLX
Also covers: CVAC, NMRA
Corinne Johnson
Goldman Sachs
1 question for AMLX
Also covers: ALT, GERN, HALO +5 more
Dan Akshit
Pareto Securities
1 question for AMLX
Graig Suvannavejh
Mizuho Securities
1 question for AMLX
Also covers: ADAP, ADVM, ALEC +11 more
Jarwei Fang
Citi
1 question for AMLX
Joel Beatty
Robert W. Baird & Co.
1 question for AMLX
Also covers: IDYA
Joseph Thome
TD Cowen
1 question for AMLX
Also covers: ALKS, ARDX, ARWR +12 more
Samuel Lee
Mizuho Financial Group, Inc.
1 question for AMLX
Seamus Fernandez
Guggenheim Partners
1 question for AMLX
Also covers: ARCT, ARQT, AZN +9 more
Susan
Bank of America Securities
1 question for AMLX
Susan Chor
Bank of America
1 question for AMLX
Tim Anderson
Bank of America
1 question for AMLX
Also covers: ABBV, BIIB, BMY +4 more
Recent press releases and 8-K filings for AMLX.
Amylyx Pharmaceuticals Provides Update on Avexitide and Pipeline Progress
AMLX
New Projects/Investments
Product Launch
Guidance Update
- Amylyx Pharmaceuticals (AMLX) is focused on its lead asset, Avexitide, for post-bariatric hypoglycemia (PBH), a condition affecting an estimated 160,000 people in the U.S.. The pivotal study is anticipated to complete enrollment in Q1 2026 and report top-line results in Q3 2026, with potential commercialization in 2027.
- Avexitide has FDA Breakthrough Therapy Designation and demonstrated a 64% reduction in hypoglycemic events in Phase 2 trials. The Phase 3 trial is powered to detect a 35% treatment effect.
- The company is also developing a potential long-acting daily subcutaneous treatment for Avexitide, with a decision on a candidate for IND-enabling studies expected in the next few months.
- In its pipeline, AMLX is advancing AMX0114 for ALS, with Phase 1 safety and tolerability data presented this week and biomarker results expected in H1 2026.
- For AMX0035 in Wolfram syndrome, strong data from an open-label study was presented this year, and a Phase 3 trial is targeted for initiation in H2 2026, pending FDA alignment.
Dec 3, 2025, 9:00 PM
Amylyx Pharmaceuticals Provides Updates on Avexitide, AMX0035, and AMX0114 Development Timelines
AMLX
New Projects/Investments
Product Launch
Guidance Update
- Amylyx Pharmaceuticals anticipates completing enrollment for its pivotal study of Avexitide for post-bariatric hypoglycemia (PBH) in Q1 2026, with top-line results expected in Q3 2026 and potential commercialization in 2027.
- Avexitide addresses a significant unmet medical need in PBH, affecting approximately 160,000 people in the U.S. with no approved treatments.
- The company is also advancing other pipeline assets, including a long-acting Avexitide candidate (decision point for IND-enabling studies in the next few months), AMX0035 for Wolfram syndrome (Phase 3 initiation in H2 2026), and AMX0114 for ALS (Phase 1 biomarker data in H1 2026).
- The vast majority of capital is currently directed towards Avexitide's pre-commercialization efforts.
Dec 3, 2025, 9:00 PM
Amylyx Provides Clinical Pipeline and Avexetide Trial Updates
AMLX
New Projects/Investments
Guidance Update
- Amylyx's lead asset, Avexetide, a GLP-1 receptor inhibitor, is in a Phase 3 pivotal study for post-bariatric hypoglycemia (PBH), with enrollment completion anticipated in Q1 2026 and top-line results in Q3 2026.
- The company estimates 160,000 people in the U.S. have PBH, a market that is growing and not currently impacted by GLP-1 weight loss drugs.
- AMX0035 for Wolfram syndrome had positive Phase 2A results, and a Phase 3 trial is expected to start in H2 2026, pending FDA alignment, targeting an estimated 3,000 people in the U.S..
- An antisense oligonucleotide targeting Calpain-2 for ALS is in a Phase 1 study, with safety and tolerability data expected later this year (2025) and biomarker data in H1 2026.
- Amylyx recently completed financing, extending its cash runway into 2028.
Dec 2, 2025, 1:20 PM
Amylyx Provides Clinical Pipeline and Market Updates
AMLX
New Projects/Investments
Guidance Update
- Amylyx's lead asset, Avexetide, is in a Phase 3 pivotal study for post-bariatric hypoglycemia (PBH), with enrollment expected to complete in Q1 2026 and top-line results anticipated in Q3 2026.
- The company estimates 160,000 people with PBH in the U.S., a market that is growing, and Avexetide has previously received FDA Breakthrough Therapy designation.
- Amylyx also has AMX0035 for Wolfram syndrome, with Phase 3 trial design underway and expected to start in H2 2026, and an antisense oligonucleotide for ALS in a Phase 1 study, with safety data expected later in 2025 and biomarker data in H1 2026.
- The company recently completed a financing round, providing a cash runway into 2028.
Dec 2, 2025, 1:20 PM
Amylyx Provides Clinical Pipeline and Market Updates
AMLX
New Projects/Investments
Guidance Update
- Amylyx's lead asset, Avexitide, a GLP-1 receptor inhibitor for post-bariatric hypoglycemia (PBH), is in a Phase 3 pivotal study with enrollment completion anticipated in Q1 2026 and top-line results in Q3 2026. The U.S. PBH market is estimated at 160,000 people.
- The company's pipeline also includes AMX0035 for Wolfram syndrome, which had positive Phase II-A results and is targeting a Phase III trial start in H2 2026.
- An antisense oligonucleotide targeting Calpain-2 for ALS is in a Phase I study, with safety and tolerability data expected in late 2025 and biomarker data in H1 2026.
- Amylyx recently completed a financing that extends its cash runway into 2028.
Dec 2, 2025, 1:20 PM
Amylyx Provides Update on Evexetide Phase 3 Study and Pipeline Progress
AMLX
Guidance Update
New Projects/Investments
- Amylyx's lead candidate, Evexetide, is in a pivotal Phase 3 study for post-bariatric hypoglycemia (PBH), with enrollment expected to complete in Q1 2026 and top-line results anticipated in Q3 2026.
- PBH represents a substantial unmet need, affecting an estimated 160,000 people in the US with no FDA-approved treatments, and Evexetide has received FDA Breakthrough Therapy Designation.
- The company reported $344 million in cash on hand as of its third-quarter results, providing a cash runway into 2028.
- Amylyx is also advancing other programs, including a small molecule for Wolfram syndrome with Phase 3 planning for H2 2026, and Amylyx 114 for ALS with early cohort data expected later in 2025.
- The Evexetide Phase 3 study is designed to replicate strong Phase 2B results, which showed a 64% reduction in the composite of level two and level three hypoglycemia, and is 90% powered to detect a 35% therapeutic effect.
Nov 10, 2025, 9:30 PM
Amylyx Pharmaceuticals Reports Q3 2025 Financial Results and Updates Pipeline Timelines
AMLX
Earnings
Guidance Update
New Projects/Investments
- Amylyx Pharmaceuticals ended Q3 2025 with a strong cash position of $344 million, up from $181 million at the end of Q2 2025, following $191 million in net proceeds from a public offering, which is expected to provide a cash runway into 2028.
- Total operating expenses for Q3 2025 were $36 million, representing a 53% decrease from Q3 2024, mainly due to one-time acquisition expenses incurred in the prior year.
- The company updated its timeline for the pivotal phase 3 Lucidity Trial for Avexitide in post-bariatric hypoglycemia (PBH), now projecting recruitment completion in Q1 2026 and top-line data in Q3 2026, a slight delay from previous guidance, though the potential launch timing in 2027 remains unchanged.
- In its pipeline, Amylyx fully enrolled cohort one of the Phase 1 Lumina trial for AMX0114 in ALS in September, with early safety data anticipated later this year and biomarker data in the first half of 2026. Additionally, a focused pivotal phase three trial for AMX0035 in Wolfram syndrome is planned for initiation in the second half of 2026, pending FDA alignment.
Nov 6, 2025, 1:00 PM
Amelix Pharmaceuticals Updates Avextide Trial Timeline and Reports Strong Cash Position in Q3 2025
AMLX
Guidance Update
New Projects/Investments
Earnings
- Amelix Pharmaceuticals reported a strong cash position of $344 million at the end of Q3 2025, supported by $191 million in net proceeds from a recent public offering, providing an anticipated cash runway into 2028.
- The company updated the timeline for its pivotal Phase III Lucidity trial for Avextide in post-bariatric hypoglycemia (PBH), now expecting to complete recruitment in Q1 2026 with top-line data anticipated in Q3 2026, a delay from previous guidance.
- Despite the Lucidity trial timeline adjustment, the potential launch of Avextide in PBH remains projected for 2027, pending FDA approval, targeting an estimated 160,000 people in the US.
- In its broader pipeline, Amelix plans to initiate a pivotal Phase III trial for AMX-thirty five in Wolfram syndrome in 2026 and fully enrolled Cohort one of the Phase one LUMINA trial for AMX-one hundred fourteen in ALS, with safety data expected in December 2025 and biomarker data in 2026.
Nov 6, 2025, 1:00 PM
Amylyx Pharmaceuticals Reports Q3 2025 Financial Results and Clinical Trial Updates
AMLX
Earnings
Guidance Update
New Projects/Investments
- Amylyx Pharmaceuticals reported a net loss of $34.4 million, or $0.37 per share, for the third quarter ended September 30, 2025.
- The company's cash, cash equivalents, and marketable securities totaled $344.0 million as of September 30, 2025, an increase from $180.8 million at June 30, 2025, primarily due to net proceeds of approximately $191 million from a public offering in September 2025.
- Amylyx expects its cash runway to extend into 2028, which funds the company through important milestones, including the potential commercial launch of avexitide in 2027, if approved.
- Recruitment for the pivotal Phase 3 LUCIDITY trial of avexitide is expected to be completed in Q1 2026, with topline data anticipated in Q3 2026.
Nov 6, 2025, 12:03 PM
Amylyx Pharmaceuticals Reports Q3 2025 Financial Results
AMLX
Earnings
Guidance Update
New Projects/Investments
- Amylyx Pharmaceuticals reported a net loss of $34.4 million, or $0.37 per share, for the third quarter ended September 30, 2025.
- The company's cash, cash equivalents, and marketable securities totaled $344.0 million at September 30, 2025, which includes approximately $191 million in net proceeds from a public offering in September 2025.
- Amylyx expects its cash runway to extend into 2028, funding operations through the potential approval and commercial launch of avexitide.
- Recruitment for the pivotal Phase 3 LUCIDITY trial of avexitide is anticipated to complete in Q1 2026, with topline data expected in Q3 2026 and a potential commercial launch in 2027.
- The company plans to initiate a pivotal Phase 3 clinical trial for AMX0035 in Wolfram syndrome in the second half of 2026, pending FDA alignment, and will present early Phase 1 LUMINA trial data for AMX0114 in ALS in December.
Nov 6, 2025, 12:00 PM
Quarterly earnings call transcripts for Amylyx Pharmaceuticals.
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