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Amylyx Pharmaceuticals Inc
(NASDAQ:AMLX)
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Rating:61Neutral
Price Target:
$29.00
▼(-22.58% Downside)
Action:Reiterated
Date:09/09/26
AMLX scores as a moderate-risk, catalyst-driven biotech: weak financial performance (minimal revenue and significant ongoing cash burn despite low leverage) is the biggest drag, partly offset by strong technical momentum and a generally positive earnings narrative centered on near-term clinical/regulatory milestones and multi-year cash runway. Valuation is difficult to anchor due to current losses and no dividend support.
Positive Factors
Phase 3 efficacy milestone
The positive Phase 3 result materially strengthens Amylyx’s lead-program prospects by demonstrating clinically meaningful efficacy in an underserved condition. If confirmed through regulatory review, the outcome could support differentiated positioning, approval, and a recurring commercial revenue base.
Negative Factors
Revenue engine remains underdeveloped
The sharp revenue deterioration shows that Amylyx currently lacks a stable operating revenue base following RELYVRIO’s withdrawal. Continued losses leave future financial performance highly dependent on avexitide approval, launch execution and successful development of additional candidates.
Read all positive and negative factors
Positive Factors
Negative Factors
Phase 3 efficacy milestone
The positive Phase 3 result materially strengthens Amylyx’s lead-program prospects by demonstrating clinically meaningful efficacy in an underserved condition. If confirmed through regulatory review, the outcome could support differentiated positioning, approval, and a recurring commercial revenue base.
Read all positive factors
Amylyx Pharmaceuticals Inc (AMLX) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$3.49B
Dividend Yield5.64%
Average Volume (3M)1.61M
Price to Earnings (P/E)―
Beta (1Y)1.23
Revenue GrowthN/A
EPS Growth42.67%
CountryUS
Employees136
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-1.41
Shares Outstanding125,513,050
10 Day Avg. Volume1,270,104
30 Day Avg. Volume1,608,393
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 Cap0.50
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-87.31
Enterprise Value/Ebitda-11.69
Forecast
1Y Price Target
$45.75Price Target Upside22.13% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering9
EPS Forecast (FY)-1.51
Revenue Forecast (FY)N/A
Amylyx Pharmaceuticals Inc Business Overview & Revenue Model
Company Description
Amylyx Pharmaceuticals, Inc. operates as a clinical-stage biopharmaceutical firm, primarily focused on creating therapies for amyotrophic lateral sclerosis (ALS) and various other neurodegenerative conditions. A key asset in its developmental pipe...
How the Company Makes Money
As of the latest available public information, Amylyx’s revenue model is primarily tied to the commercialization of its lead product and, secondarily, to potential collaboration-related income. Product revenue: Amylyx previously generated sales fr...
Amylyx Pharmaceuticals Inc Earnings Call Summary
Earnings Call Date:Aug 06, 2026
(Q2-2026)
| % Change Since: |
Next Earnings Date:Nov 05, 2026
Earnings Call Sentiment Positive
The call conveyed clear momentum: a pivotal Phase III (LUCIDITY) nearing top-line readout, active NDA and launch preparations, formal disease recognition via ICD-10 coding, a defined prevalent patient population (~160,000 U.S. patients with ~75% RYGB), and continued pipeline progress (AMX0035, AMX0114, AMX0318). Financially, the company has a solid cash balance with runway into 2028 but experienced a quarter-over-quarter cash decline (~10.4%), rising operating/SG&A costs (SG&A +40.4% YoY), and an unspecified one-time legal charge. Key risks remain: the outcome of the blinded Phase III readout and potential label limitations, early-stage EAP activation constraints, and possible additional manufacturing obligations. Overall the positives (imminent pivotal readout, launch preparedness, market opportunity, and pipeline advancement) outweigh the operational and financial headwinds discussed.Positive Updates
Phase III LUCIDITY Nearing Top-Line Readout
Last participant completed last visit; database cleaning and lock pending; top-line data expected late August or early September 2026. Trial is powered conservatively (90% power to detect a 35% treatment effect even with up to a 50% placebo rate).
Negative Updates
Cash Balance Decline Quarter-to-Quarter
Cash and marketable securities decreased from $279.8M at the end of Q1 to $250.8M at the end of Q2 — a decline of $29.0M, or approximately a 10.4% decrease quarter-over-quarter.
Read all updates
Q2-2026 Updates
Positive
Negative
Phase III LUCIDITY Nearing Top-Line Readout
Last participant completed last visit; database cleaning and lock pending; top-line data expected late August or early September 2026. Trial is powered conservatively (90% power to detect a 35% treatment effect even with up to a 50% placebo rate).
Read all positive updates
Company Guidance
The company reiterated that LUCIDITY’s pivotal Phase III database is not yet locked but that last patient visits occurred in mid–late July with a top-line readout expected in late August or early September; the trial’s FDA‑agreed primary endpoint is reduction in the composite of Level 2 and Level 3 hypoglycemic events through week 16 and the study was conservatively powered (≥90% to detect a 35% treatment effect assuming up to a 50% placebo rate). Financially, Amylyx finished Q2 with $250.8 million in cash and marketable securities (down from $279.8M at Q1 end) and expects runway into 2028 to fund milestones including the LUCIDITY readout, potential FDA approval and a possible commercial launch in 2027; Q2 operating expenses were $45.7M (up 7% YoY) comprising R&D of $23.8M (vs $27.2M in Q2 2025), SG&A of $21.9M (vs $15.6M), and non‑cash stock‑based comp of $8.3M (vs $7.4M). Other program and operational metrics noted: prevalent U.S. PBH population ~160,000 (≈120,000 RYGB), CMO payment commitments of ~$35M through 2028, AMX0318 IND‑enabling work targeting a 2027 IND, an Early Access Program open to LUCIDITY completers and prior trial participants, an ICD‑10 code for PBH effective October 1, 2026, and that the company will enter a quiet period following database lock.Amylyx Pharmaceuticals Inc Financial Statement Overview
Summary
Income Statement
24
Negative
Balance Sheet
62
Positive
Cash Flow
28
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 | -20.06M | -525.00K | 45.22M | 355.35M | 19.24M | 0.00 |
| EBITDA | -149.78M | -144.16M | -290.98M | 55.38M | -197.11M | -87.88M |
| Net Income | -152.09M | -144.74M | -301.74M | 49.27M | -198.38M | -87.93M |
Balance Sheet | ||||||
| Total Assets | 264.56M | 332.64M | 193.63M | 517.45M | 391.45M | 105.61M |
| Cash, Cash Equivalents and Short-Term Investments | 250.76M | 316.98M | 176.50M | 371.36M | 346.94M | 96.12M |
| Total Debt | 5.25M | 5.96M | 1.98M | 4.24M | 6.28M | 0.00 |
| Total Liabilities | 25.40M | 27.39M | 28.87M | 84.02M | 50.85M | 256.78M |
| Stockholders Equity | 239.17M | 305.26M | 164.76M | 433.43M | 340.61M | -151.17M |
Cash Flow | ||||||
| Free Cash Flow | -126.72M | -123.48M | -167.80M | 10.68M | -182.40M | -75.15M |
| Operating Cash Flow | -126.58M | -123.34M | -167.65M | 11.92M | -179.87M | -74.80M |
| Investing Cash Flow | -78.83M | 14.04M | 75.65M | 92.05M | -238.99M | -46.41M |
| Financing Cash Flow | 196.09M | 257.03M | 348.00K | 3.54M | 431.79M | 158.51M |
Amylyx Pharmaceuticals Inc Technical Analysis
Neutral
37.46
Price Trends
29.33
Negative
22.51
Positive
18.52
Positive
Market Momentum
-0.58
Positive
37.07
Neutral
7.30
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AMLX, the sentiment is Neutral. The current price of 37.46 is above the 20-day moving average (MA) of 31.48, above the 50-day MA of 29.33, and above the 200-day MA of 18.52, indicating a neutral trend. The MACD of -0.58 indicates Positive momentum. The RSI at 37.07 is Neutral, neither overbought nor oversold. The STOCH value of 7.30 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for AMLX.
Amylyx Pharmaceuticals Inc Risk Analysis
Amylyx Pharmaceuticals Inc disclosed 90 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 |
|---|---|---|---|---|---|---|---|
81 Outperform | $2.31B | 12.66 | 20.06% | ― | 24.25% | -0.83% | |
61 Neutral | $3.49B | -19.71 | -52.92% | 5.64% | ― | 42.67% | |
58 Neutral | $2.09B | -5.68 | 101.55% | ― | 68.72% | -737.08% | |
58 Neutral | $4.93B | -678.54 | -3.51% | ― | -60.77% | -27.57% | |
58 Neutral | $2.18B | -10.26 | -61.24% | ― | ― | 9.42% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
45 Neutral | $1.94B | -2.77 | -1328.94% | ― | ― | 39.33% |
* Healthcare Sector Average
AMLX
Amylyx Pharmaceuticals Inc
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Amylyx Pharmaceuticals Inc Corporate Events
Business Operations and Strategy
Amylyx inks long-term manufacturing deal for avexitide
Positive
Sep 8, 2026
On September 8, 2026, Amylyx Pharmaceuticals entered into a long‑term manufacturing and supply agreement with Bachem Americas, and on September 1, 2026, it signed a term sheet with Polypeptide Group AG to secure commercial‑scale produc...
Business Operations and StrategyPrivate Placements and Financing
Amylyx Pharmaceuticals Announces Equity Offering to Fund Avexitide
Positive
Aug 20, 2026
On August 19, 2026, Amylyx Pharmaceuticals Inc. entered into an underwriting agreement with a syndicate of banks to issue and sell 14,090,000 shares of common stock at $35.50 per share, with an additional 2,113,500 shares available under a 30-day ...
Business Operations and StrategyProduct-Related Announcements
Amylyx Highlights Positive Phase 3 Avexitide LUCIDITY Results
Positive
Aug 18, 2026
On August 18, 2026, Amylyx Pharmaceuticals hosted a conference call with investors and analysts to present positive topline data from its Phase 3 LUCIDITY trial of avexitide in post-bariatric hypoglycemia after Roux-en-Y gastric bypass surgery. Th...
Business Operations and StrategyProduct-Related Announcements
Amylyx announces positive Phase 3 LUCIDITY avexitide results
Positive
Aug 18, 2026
On August 18, 2026, Amylyx reported positive topline Phase 3 results from its LUCIDITY trial of avexitide in post-bariatric hypoglycemia after Roux-en-Y gastric bypass surgery. The 78-patient study met its FDA-agreed primary endpoint, showing a 55...
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.