Highest-materiality recent filing
Amylyx prices $471.7M equity offering to fund avexitide launch
14,090,000 shares at $35.50/share; 30-day option for 2,113,500 more.
Positive topline results announced Aug 18, 2026 from LUCIDITY Phase 3 trial of avexitide in post-bariatric hypoglycemia (PBH).
Amylyx reports positive Phase 3 LUCIDITY results for avexitide in post-bariatric hypoglycemia
LUCIDITY met primary endpoint: 55% reduction in composite Level 2/3 hypoglycemic events vs placebo (p=0.000003).
Amylyx Q2 net loss $43.4M; Phase 3 PBH topline data expected late Aug/early Sep 2026
Net loss of $43.4M ($0.39 per share) vs $41.4M ($0.46 per share) in Q2 2025.
Amylyx stockholders elect directors, ratify auditor, approve say-on-pay at annual meeting
Elected George Mclean Milne Jr., Ph.D. (76.9M for, 14.1M withheld) and Paul Fonteyne (86.3M for, 4.8M withheld) as Class II directors.
Amylyx Q1 net loss $41.3M; Phase 3 avexitide topline data in Q3 2026
Net loss of $41.3M ($0.37 per share) vs $35.9M ($0.42) in Q1 2025; cash used in operations.
Completed enrollment in Phase 3 LUCIDITY trial.
Net loss for FY2025: $144.7M ($1.53/share) vs $301.7M ($4.43/share) in FY2024.
Amylyx selects GLP-1 antagonist AMX0318 as development candidate for post-bariatric hypoglycemia
AMX0318 is a long-acting GLP-1 receptor antagonist for post-bariatric hypoglycemia and other rare diseases.
Amylyx Q3 net loss narrows to $34.4M; cash $344M after $191M offering
Net loss $34.4M ($0.37/sh) vs $72.7M ($1.07/sh) in Q3 2024; R&D $19.9M, SG&A $16.2M.
Amylyx launches $164M common stock offering at $10.00 per share to fund avexitide launch
Offering of 17.5M shares (2.625M option) at $10.00/share; net proceeds ~$164M, up to ~$188.7M.
Amylyx discontinues AMX0035 program for PSP after Phase 2b miss
AMX0035 failed to show differences vs placebo on primary or secondary outcomes at Week 24.
Amylyx Q2 net loss narrows to $41.4M; cash $180.8M; pipeline milestones on track
Net loss of $41.4M ($0.46 per share) vs $72.7M ($1.07) in Q2 2024; lower SG&A and R&D spend in ALS.
Amylyx shareholders elect three Class I directors; ratify Deloitte; approve say-on-pay proposal
Karen Firestone, Justin Klee, and Bernhardt Zeiher elected as Class I directors for term ending 2028. Firestone and Zeiher each had ~21.3M votes withheld; Klee had 1.5M.
Amylyx Q1 net loss $35.9M, cash $204.1M; avexitide Phase 3 underway
Q1 net loss $35.9M ($0.42/share), down from $118.8M ($1.75/share) YoY on lower R&D and SG&A costs.
Amylyx reports Q4 net loss of $37.5M, cash runway extended through 2026 after $65.5M raise
Net loss for Q4 2024 was $37.5M ($0.55 per share); FY2024 net loss of $301.7M ($4.43 per share).
Amylyx prices 17.1M-share public offering at $3.50/sh for ~$56.9M net proceeds
Offering of 17,142,857 common shares at $3.50 per share, with 30-day option for up to 2,571,428 additional shares.
Amylyx and Gubra collaborate on GLP-1 antagonist; milestones up to >$50M
Collaboration with Gubra to develop a novel long-acting GLP-1 receptor antagonist; Amylyx to make small upfront and research payments (not material).
Amylyx reports Q3 net loss of $72.7M; cash $234.4M; pipeline updates on AMX0035, avexitide, AMX0114
Net loss of $72.7M ($1.07 loss per share) vs net income of $20.9M in Q3 2023; acquired IPR&D expense of $36.2M for avexitide.
HELIOS Phase 2: AMX0035 improves C-peptide AUC by +3.8 min*ng/mL at Week 24 in Wolfram syndrome
Primary endpoint: C-peptide AUC improved at Week 24 (ITT +3.8 min*ng/mL; Per Protocol +20.2) and sustained through Week 48 (+36.7).
Amylyx Q2 net loss $72.7M; revenue negative after RELYVRIO withdrawal; avexitide acquisition
Q2 net loss $72.7M ($1.07/share) vs net income $22.1M ($0.31) a year ago; revenue negative $(1.0)M after RELYVRIO/ALBRIOZA withdrawal.
Amylyx completes acquisition of Avexitide from Eiger for $35.1M
Acquired Avexitide from Eiger BioPharmaceuticals for $35.1 million plus cure costs and assumed liabilities.
Amylyx acquires Avexitide from bankrupt Eiger BioPharma for $35.1M
Acquires substantially all assets for Avexitide, a GLP-1 receptor antagonist, from Eiger BioPharmaceuticals.
Amylyx shareholders elect Cohen, Quimi as directors; ratify Deloitte
Joshua Cohen and Daphne Quimi elected as Class III directors with ~32.6M and ~32.5M votes for, respectively.
Amylyx Q1 net loss $118.8M; discontinues RELYVRIO/ALBRIOZA; inventory write-down $110.5M
Net loss of $118.8M ($1.75 diluted per share) vs. net income of $1.6M in Q1 2023.
Interim Phase 2 data for AMX0035 shows clinically meaningful effects in Wolfram syndrome (n=8)
C-peptide AUC increased +15.6 ng*min/mL at Week 24; 7 of 8 participants had shorter time to peak C-peptide.
Amylyx pulls RELYVRIO from market after Phase 3 miss, cuts 70% of staff
Voluntarily discontinues RELYVRIO/ALBRIOZA in U.S. and Canada; no new patients after today.
Amylyx appoints Dr. Bernhardt Zeiher to board, fills Class I director vacancy
Appointed March 14, 2024 as Class I director; term expires at 2025 annual meeting.
Amylyx Phase 3 ALS trial misses primary endpoint; may withdraw RELYVRIO
PHOENIX trial: no significant difference on ALSFRS-R at Week 48 (p=0.667); secondary endpoints also missed.
Amylyx reports FY 2023 net income $49.3M vs loss; product revenue $380.8M
Full-year 2023 net product revenue $380.8M; Q4 revenue $108.4M vs $102.7M in Q3 2023.
Amylyx CCO Margaret Olinger to depart Dec 31, 2023; search underway
Margaret Olinger, Chief Commercial Officer, will leave Amylyx effective end of day Dec 31, 2023.
Amylyx reports Q3 product revenue $102.7M, net income $20.9M, PHOENIX topline Q2 2024
Net product revenue $102.7M (Q3) vs $98.2M (Q2 2023) and $0.3M (Q3 2022).
CHMP confirms negative opinion on Amylyx's AMX0035 for ALS in EU
CHMP confirmed its initial negative opinion on Marketing Authorisation Application for AMX0035 (ALBRIOZA) for ALS.
Amylyx Q2 product revenue $98.2M, net income $22.1M; CHMP re-examining MAA
Net product revenue $98.2M in Q2 2023 (up from $71.4M in Q1); net income $22.1M ($0.31 diluted EPS).
Amylyx announces conference call on AMX0035 Phase 3 PSP trial; no new data
Hosted investor call on July 26, 2023 to discuss PSP and Orion Phase 3 trial of AMX0035.
Amylyx receives CHMP negative opinion for AMX0035 ALS approval in EU; will seek re-examination
CHMP adopted negative opinion on conditional marketing authorisation for AMX0035 (ALBRIOZA) for ALS in EU.
Amylyx shareholders elect two Class II directors and ratify Deloitte as auditor
George Mclean Milne Jr. and Paul Fonteyne elected as Class II directors; term until 2026.
Amylyx Q1 net product revenue $71.4M; net income $1.6M vs $47.8M loss YoY
Net product revenue $71.4M from RELYVRIO/ALBRIOZA ALS sales; cost of sales $5.3M.
Amylyx appoints Karen Firestone to board of directors, effective March 16, 2023
Karen Firestone appointed as Class I director effective March 16, 2023.
Amylyx reports $22.2M full-year product revenue; net loss $198.4M
Q4 net product revenue $21.9M; full-year 2022 net product revenue $22.2M from RELYVRIO/ALBRIOZA sales.
Amylyx expects Q4 and FY 2022 revenue to meaningfully exceed consensus on higher RELYVRIO demand
Insurers covering ~25% of U.S. covered lives have published policies; nearly all provide broad access to RELYVRIO.
Amylyx CMO Patrick Yeramian moves to part-time, salary reduced to $214K; successor search ongoing
CMO Patrick Yeramian's working hours reduced to 20 per week as of Dec 1, 2022.
Amylyx reports Q3 net loss of $53.8M; FDA-approved RELYVRIO now commercially available in U.S.
FDA approval of RELYVRIO for ALS on Sep 29; shipments began Oct 24.
Director Isaac Cheng resigns from Amylyx board effective Nov 1, 2022
Isaac Cheng, MD, resigned from the board of directors on November 1, 2022.
FDA approves Amylyx's RELYVRIO for ALS; Phase 2 trial showed slowed physical decline
FDA approved RELYVRIO (AMX0035) for adults with ALS based on Phase 2 CENTAUR trial in 137 participants that met primary efficacy endpoint.
Amylyx reports Q2 net loss $54.1M; ALBRIOZA launched in Canada; FDA PDUFA Sept 29
Net loss of $54.1M ($0.93/sh) vs $21.9M ($3.41/sh) in Q2 2021; cash $206.7M at quarter end.
Amylyx Q2 net loss $54.1M ($0.93/shr); ALBRIOZA launched in Canada; FDA PDUFA Sept 29
Net loss $54.1M vs $21.9M in Q2 2021; R&D $24.3M, G&A $30.0M; no product revenue.
FDA plans to reconvene advisory committee for Amylyx's ALS drug AMX0035 on Sept 7
FDA to reconvene PCNSDAC on September 7, 2022 to discuss AMX0035 NDA for ALS.
Amylyx receives first global approval: Health Canada approves ALBRIOZA for ALS
Health Canada approved ALBRIOZA (AMX0035) with conditions for ALS; first marketing approval worldwide.
Amylyx shareholders elect Class I directors and ratify Deloitte as auditor at 2022 annual meeting
Justin Klee elected Class I director with 42,100,898 votes for, 1,607,476 withheld.
On March 14, 2024 (the “Effective Date”), the Board of Directors (the “Board”) of Amylyx Pharmaceuticals, Inc. (the “Company”) appointed Bernhardt Zeiher, MD, FCCP, FACP to fill a vacancy on the Board as a Class I director
appointed Karen Firestone to fill the vacancy on the Board as a Class I director, effective as of March 16, 2023
On November 1, 2022, Isaac Cheng, MD, a member of the board of directors of Amylyx Pharmaceuticals, Inc. (the “Company”), submitted his resignation from the board of directors, effective as of close of business on November 1, 2022.
Max materiality 1.00 · Median 0.70 · Most common event earnings