Amylyx Pharmaceuticals, Inc. (AMLX)
NASDAQ:AMLX
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Amylyx Pharmaceuticals Inc
(NASDAQ:AMLX)
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Rating:52Neutral
Price Target:
$14.50
▼(-21.02% Downside)
Action:Reiterated
Date:06/05/26
Overall score reflects a high-risk setup: sharply deteriorated revenue and sustained large losses with significant cash burn are the primary drags, partially offset by low leverage and positive equity. Near-term technicals are mixed (negative momentum, but RSI near oversold), while the earnings call provides a meaningful positive catalyst path via the fully enrolled Phase III program and runway into 2028—though execution and trial outcomes remain the key swing factors.
Positive Factors
Pivotal Phase III Enrollment Complete
Completion of the LUCIDITY pivotal trial materially reduces enrollment and execution risk and creates a defined near-term regulatory milestone. A powered (≈90%) Phase III readout provides a clear binary outcome that can unlock NDA submission and commercialization planning, changing the company’s cash needs and strategic optionality.
Negative Factors
Revenue Collapse & Large Losses
A severe deterioration in commercial revenue and a swing to sustained multi‑period losses indicate structural challenges in monetization and operating leverage. This long-term erosion reduces internal funding capacity, pressures margins, and increases reliance on successful clinical outcomes or external financing to restore growth and profitability.
Read all positive and negative factors
Positive Factors
Negative Factors
Pivotal Phase III Enrollment Complete
Completion of the LUCIDITY pivotal trial materially reduces enrollment and execution risk and creates a defined near-term regulatory milestone. A powered (≈90%) Phase III readout provides a clear binary outcome that can unlock NDA submission and commercialization planning, changing the company’s cash needs and strategic optionality.
Read all positive factors
Amylyx Pharmaceuticals Inc (AMLX) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$1.48B
Dividend YieldN/A
Average Volume (3M)1.08M
Price to Earnings (P/E)―
Beta (1Y)1.52
Revenue GrowthN/A
EPS Growth51.42%
CountryUS
Employees123
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-1.48
Shares Outstanding111,186,320
10 Day Avg. Volume1,018,938
30 Day Avg. Volume1,081,395
Financial Highlights & Ratios
PEG Ratio0.12
Price to Book (P/B)3.74
Price to Sales (P/S)0.00
P/FCF Ratio-9.25
Enterprise Value/Market Cap0.65
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-47.98
Enterprise Value/Ebitda-6.45
Forecast
1Y Price Target
$25.17Price Target Upside37.07% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering7
EPS Forecast (FY)-1.41
Revenue Forecast (FY)N/A
Amylyx Pharmaceuticals Inc Business Overview & Revenue Model
Company Description
Amylyx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, engages in developing various therapeutics for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases. The company's product pipeline includes AMX0035, a d...
How the Company Makes Money
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Amylyx Pharmaceuticals Inc Earnings Call Summary
Earnings Call Date:May 07, 2026
(Q1-2026)
| % Change Since: |
Next Earnings Date:Aug 06, 2026
Earnings Call Sentiment Positive
The call emphasized strong operational execution: pivotal Phase III LUCIDITY enrollment completed and on track for a Q3 2026 top-line readout, active NDA preparation, clear commercial planning (including an EAP for up to 250 patients), and multiple pipeline programs advancing (AMX0318 IND-enabling work, AMX0035 longer-term data, AMX0114 cohort progress). Financially, while the company has a cash position of $279.8M with runway into 2028, cash declined ~11.7% year-over-year and operating expenses increased (total operating expenses +16% YoY; R&D +24.9% YoY), driven by development and milestone payments—risks remain tied to the upcoming LUCIDITY result and the need to convert clinical success into regulatory approval and commercial uptake.Positive Updates
Pivotal Phase III LUCIDITY Enrollment Complete and On Track
Randomized and dosed the last participant in late March; clear line of sight to complete the 16-week trial with top-line readout expected in Q3 2026. Study is powered at 90% and was designed to replicate prior positive trials (prior trials showed ~55% and 64% reductions in hypoglycemic events).
Negative Updates
Decrease in Cash Position Year-over-Year
Cash and marketable securities declined from $317.0M (prior comparable period) to $279.8M, a decrease of approximately $37.2M or ~11.7%, increasing reliance on execution of planned milestones to preserve runway.
Read all updates
Q1-2026 Updates
Positive
Negative
Pivotal Phase III LUCIDITY Enrollment Complete and On Track
Randomized and dosed the last participant in late March; clear line of sight to complete the 16-week trial with top-line readout expected in Q3 2026. Study is powered at 90% and was designed to replicate prior positive trials (prior trials showed ~55% and 64% reductions in hypoglycemic events).
Read all positive updates
Company Guidance
Management reiterated that avexitide’s pivotal Phase III LUCIDITY trial (90 mg once daily, 16‑week study; FDA‑agreed primary endpoint = composite of Level 2 [<54 mg/dL] and Level 3 hypoglycemic events) is fully enrolled, remains on track for a top‑line readout in Q3 2026, and that NDA preparations are underway with potential FDA approval and a commercial launch targeted in 2027; they also launched a U.S. expanded access program for up to 250 adults, estimate ~160,000 U.S. PBH patients after sleeve or Roux‑en‑Y surgery, and are building commercial and medical teams. Financials/guidance included $279.8M in cash and marketable securities (vs. $317M a year earlier) supporting a cash runway into 2028, Q1 operating expenses of $43.8M (up 16% year‑over‑year) with R&D $27.6M (vs. $22.1M) and SG&A $16.2M (vs. $15.7M), $6.1M non‑cash stock‑based comp (vs. $6.8M), and a $4M milestone paid to Gubra; other pipeline timelines noted: AMX0318 IND‑enabling work targeting a 2027 IND, AMX0035 week‑96 data planned for an upcoming meeting, and AMX0114 Cohort 2 fully enrolled with Cohort 1 biomarker data to be presented at ENCALS in June (LUCIDITY was powered ~90% and prior avexitide studies showed ~55% [PREVENT] and ~64% (90 mg) reductions, p=0.0031).Amylyx Pharmaceuticals Inc Financial Statement Overview
Summary
Income Statement
18
Very Negative
Balance Sheet
62
Positive
Cash Flow
24
Negative
| Breakdown | TTM | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 87.37M | 380.79M | 22.23M | 0.00 |
| Gross Profit | -20.20M | -525.00K | 45.22M | 355.35M | 19.24M | 0.00 |
| EBITDA | -150.30M | -144.16M | -290.98M | 39.89M | -200.85M | -82.64M |
| Net Income | -150.11M | -144.74M | -301.74M | 49.27M | -198.38M | -87.93M |
Balance Sheet | ||||||
| Total Assets | 293.60M | 332.64M | 193.63M | 517.45M | 391.45M | 105.61M |
| Cash, Cash Equivalents and Short-Term Investments | 279.77M | 316.98M | 176.50M | 371.36M | 346.94M | 96.12M |
| Total Debt | 5.63M | 5.96M | 1.98M | 4.24M | 6.28M | 0.00 |
| Total Liabilities | 20.44M | 27.39M | 28.87M | 84.02M | 50.85M | 256.78M |
| Stockholders Equity | 273.16M | 305.26M | 164.76M | 433.43M | 340.61M | -151.17M |
Cash Flow | ||||||
| Free Cash Flow | -120.53M | -123.48M | -167.80M | 10.68M | -182.40M | -75.15M |
| Operating Cash Flow | -120.40M | -123.34M | -167.65M | 11.92M | -179.87M | -74.80M |
| Investing Cash Flow | 93.96M | 14.04M | 75.65M | 92.05M | -238.99M | -46.41M |
| Financing Cash Flow | 194.58M | 257.03M | 348.00K | 3.54M | 431.79M | 158.51M |
Amylyx Pharmaceuticals Inc Technical Analysis
Negative
18.36
Price Trends
15.23
Negative
14.83
Negative
13.82
Negative
Market Momentum
-0.46
Negative
41.62
Neutral
50.23
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AMLX, the sentiment is Negative. The current price of 18.36 is above the 20-day moving average (MA) of 13.85, above the 50-day MA of 15.23, and above the 200-day MA of 13.82, indicating a bearish trend. The MACD of -0.46 indicates Negative momentum. The RSI at 41.62 is Neutral, neither overbought nor oversold. The STOCH value of 50.23 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for AMLX.
Amylyx Pharmaceuticals Inc Risk Analysis
Amylyx Pharmaceuticals Inc disclosed 89 risk factors in its most recent earnings report. Amylyx Pharmaceuticals Inc reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Amylyx Pharmaceuticals Inc Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
78 Outperform | $1.86B | 12.79 | 17.19% | ― | 20.71% | -5.53% | |
61 Neutral | $2.14B | -4.45 | 123.57% | ― | 75.92% | -569.22% | |
61 Neutral | $4.40B | -341.53 | -1.78% | ― | -79.52% | -43.40% | |
52 Neutral | $1.48B | -9.81 | -55.68% | ― | ― | 51.42% | |
52 Neutral | $2.15B | -10.41 | -67.40% | ― | ― | -5.22% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
45 Neutral | $1.63B | -2.46 | -866.46% | ― | ― | 39.46% |
* Healthcare Sector Average
AMLX
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Amylyx Pharmaceuticals Inc Corporate Events
Executive/Board ChangesShareholder Meetings
Amylyx Shareholders Approve Directors, Auditor and Executive Pay
Positive
Jun 4, 2026
On June 4, 2026, Amylyx Pharmaceuticals, Inc. held its Annual Meeting of Stockholders, where investors elected George Mclean Milne Jr., Ph.D., and Paul Fonteyne as Class II directors for three-year terms ending at the 2029 annual meeting, reinforc...
Business Operations and StrategyProduct-Related Announcements
Amylyx Highlights Pipeline Progress in Updated Corporate Presentation
Positive
Mar 24, 2026
On March 24, 2026, Amylyx Pharmaceuticals updated its corporate presentation to reflect several clinical development milestones across its rare disease pipeline. The company reported completion of enrollment in the Phase 3 LUCIDITY trial of avexit...
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.