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Amylyx Pharmaceuticals Inc (AMLX)
NASDAQ:AMLX
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Amylyx Pharmaceuticals Inc
(NASDAQ:AMLX)
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Rating:55Neutral
Price Target:
$15.50
▲(3.82% Upside)
Action:ReiteratedDate:03/03/26
The score is held down primarily by deteriorated financial performance (revenue dropping to zero and continued losses/cash burn), partially offset by strong technical momentum and a constructive earnings call centered on clear Phase III timelines and an expected cash runway into 2028.
Positive Factors
Phase III Enrollment & Timeline
Enrollment completion materially de‑risks near‑term execution by removing major recruitment uncertainty and enabling a defined regulatory timetable. A clear Q3 2026 top‑line target allows focused NDA preparation and commercial planning, shortening time to value realization if results are positive.
Cash Runway into 2028
A multi‑year cash runway supports completion of pivotal readout, NDA preparation and initial commercial investments without immediate financing. That funding buffer allows management to execute regulatory and IND activities, hire key commercial personnel, and fund AMX318 IND‑enabling work while reducing near‑term financing pressure.
Pipeline Expansion & Regulatory Support
Nomination of AMX318 and ongoing IND work broaden the product pipeline beyond avexitide, improving long‑term franchise potential. Coupled with Fast Track designation for AMX114, this diversification strengthens growth optionality and reduces single‑asset dependency if clinical development proceeds as planned.
Negative Factors
Revenue Collapse & Volatile Profitability
The abrupt fall to zero revenue and large losses indicate the business is no longer supported by recurring product sales, leaving future revenue contingent on clinical success and commercialization. This unstable earnings profile weakens operating leverage and makes long‑term profitability dependent on binary regulatory outcomes.
Persistent Cash Burn
Sustained negative operating and free cash flow necessitates ongoing external financing or milestone receipts to sustain R&D and commercial preparation. Even with improved burn, the company remains capital‑intensive, increasing dilution or covenant risk and constraining discretionary investment into market access and scale‑up if trials delay or fail.
Concentrated Regulatory/Clinical Binary Risk
Value creation is highly concentrated around a single pivotal trial and subsequent regulatory pathway. A failed or ambiguous Phase III readout would significantly impair revenue prospects, pipeline prioritization, and ability to finance development, making long‑term company trajectory highly sensitive to one binary outcome.
Amylyx Pharmaceuticals Inc (AMLX) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$1.59B
Dividend YieldN/A
Average Volume (3M)1.00M
Price to Earnings (P/E)―
Beta (1Y)1.45
Revenue Growth-100.34%
EPS Growth52.85%
CountryUS
Employees123
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.30
Shares Outstanding110,536,940
10 Day Avg. Volume1,211,172
30 Day Avg. Volume1,003,971
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 Cap0.61
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-48.48
Enterprise Value/Ebitda-6.76
Forecast
1Y Price Target
$23.14Price Target Upside54.99% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering8
EPS Forecast (FY)-1.38
Revenue Forecast (FY)N/A
Amylyx Pharmaceuticals Inc Business Overview & Revenue Model
Company DescriptionAmylyx 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 dual UPR-Bax apoptosis inhibitor composed of sodium phenylbutyrate and taurursodiol for the treatment of amyotrophic lateral sclerosis. It is also developing AMX0035 for other neurodegenerative diseases. The company was founded in 2013 and is headquartered in Cambridge, Massachusetts.
How the Company Makes MoneyAmylyx Pharmaceuticals generates revenue primarily through the commercialization of its therapeutic products, particularly AMX0035, which has received regulatory approval for use in ALS patients. The company may also explore partnerships with larger pharmaceutical firms for co-development or licensing agreements to expand its product offerings and market reach. Additionally, revenue can be supplemented through grants and funding from governmental and non-governmental organizations aimed at fostering innovation in the biotech sector. As Amylyx progresses through clinical trials and achieves regulatory milestones, it may also benefit from milestone payments from partners, further contributing to its earnings.
Amylyx Pharmaceuticals Inc Earnings Call Summary
Earnings Call Date:Mar 03, 2026
(Q4-2025)
| % Change Since: |
Next Earnings Date:May 07, 2026
Earnings Call Sentiment Positive
The call conveyed predominantly positive progress: pivotal trial enrollment complete, clear timelines (top-line Q3 2026), expanded pipeline (AMX318 nomination), AMX114 Fast Track and favorable safety, and a cash runway into 2028. Near-term cautions include a reduced cash balance versus the prior quarter, a $4M milestone payment, modeled placebo/powering conservatism, and the binary risk around the Phase III readout and subsequent regulatory/ commercialization steps. Overall, the positives — clinical progress, pipeline expansion, cost discipline, and adequate cash runway — outweigh the near-term operational and clinical uncertainties.Q4-2025 Updates
Positive Updates
Phase III LUCIDITY Initiation and Enrollment Complete
Completed recruitment for the pivotal Phase III LUCIDITY trial of Avexatide (90 mg daily) in post-bariatric hypoglycemia (PBH); expect to randomize and dose remaining eligible participants this month and deliver top-line data in Q3 2026.
Strong Clinical Efficacy Signal from Prior Trials
Five prior Avexatide trials informed LUCIDITY; Phase 2 data showed a 64% least squares mean reduction versus baseline in composite level 2 and 3 hypoglycemic events (p=0.0031). Phase 2b 90 mg showed ~64–66% effect with median patient event rate of zero.
Regulatory and Commercial Preparations Underway
NDA drafting and regulatory preparations underway to enable rapid submission following positive top-line data; commercial buildout includes medical affairs hires, market research, disease education, and market access planning targeting a potential 2027 launch if approved.
Pipeline Expansion and New Development Candidate
Announced nomination of AMX318 (long-acting GLP-1 receptor antagonist) as a development candidate in January; IND-enabling studies underway with IND targeted for 2027 — supports lifecycle and broader GLP-1 antagonist strategy.
AMX114 Progress in ALS
AMX114 received Fast Track designation for ALS; cohort 1 of Phase 1 LUMINA showed favorable safety/tolerability with no treatment-related serious adverse events, enabling progression to cohort 2 and expected completion of cohort 2 enrollment this month. Biomarker data from cohort 1 planned in H1 2026.
Improved Financial Position and Cash Runway Extended
Ended Q4 with $317 million in cash and marketable securities (down from $344 million at end of Q3), with management stating an anticipated cash runway into 2028 to fund key milestones including LUCIDITY top-line readout and potential NDA/commercial activities.
Quarterly Expense Reductions
Total operating expenses for Q4 were $36.6 million, down 8% year-over-year. R&D was $21.2 million (down from $22.9 million in Q4 2024, ≈7.4% decrease) and SG&A was $15.4 million (down from $17.1 million in Q4 2024, ≈10% decrease). Non-cash stock-based compensation was $6.4 million vs $6.8 million prior quarter (≈5.9% decrease).
Market Opportunity Quantified
Internal analysis and literature triangulation estimate ≈160,000 people living with PBH in the U.S., reinforcing a sizable orphan-market opportunity and informing go-to-market planning.
Negative Updates
Near-Term Cash Movement and Upcoming Milestone Spend
Cash balance decreased from $344M to $317M quarter-over-quarter (≈7.8% decline). Management disclosed a $4.0 million milestone payment to Gubra recognized in Q1 2026 R&D, which will increase near-term spend.
Ongoing Regulatory and Clinical Execution Risks
Top-line readout, NDA filing, approval, and commercialization timelines are conditional on positive LUCIDITY results and regulatory review — key milestones concentrated in 2026–2027 create binary outcomes and execution risk.
Placebo and Powering Uncertainty Modeled Conservatively
Although prior trials showed minimal placebo response, LUCIDITY powering modeled a potential placebo effect up to 50% and a 35% effect size versus placebo for conservatism — this uncertainty could affect statistical outcomes and perceived effect size.
Clinical Variability Observed in Prior Data
Phase 2b reported large standard deviations for hypoglycemia rates (noted by analysts), suggesting inter-patient variability and potential sub- or non-responders, which could influence Phase III outcome distribution despite strong median responses.
Increased Near-Term R&D Spend for New Programs
Selection and handover of AMX318 and IND-enabling activities (plus the Gubra milestone) will drive additional R&D investment in 2026–2027, increasing the company's near-term cash burn profile relative to current quarter reductions.
Uncertainties Around Reimbursement & Market Dynamics
Although ICD-10 code consideration and physician interest are positive, reimbursement pathways and payer uptake remain contingent on clinical benefit magnitude, labeling, and real-world adoption; pharmacy benefit dynamics were noted but remain to be realized if approved.
Company Guidance
Amylyx reiterated a clear, metric-driven plan: deliver top‑line LUCIDITY Phase III data in Q3 2026 (trial enrollment is complete and final randomizations/dosing expected this month), testing Avexatide 90 mg once daily on the FDA‑agreed Week‑16 composite of level‑2 and level‑3 hypoglycemic events (program informed by five prior trials—Phase 2 showed a 64% least‑squares mean reduction vs baseline, p=0.0031—and the Phase III was conservatively powered assuming up to a 50% placebo effect and a 35% effect size vs placebo); prepare NDA sections and regulatory readiness to move rapidly after readout with the goal of a potential 2027 commercial launch if approved; and continue portfolio development (AMX318 nominated in January with an IND target of 2027; AMX114 Fast Track with cohort‑two enrollment completing this month and biomarker data expected H1). Financially, the company ended Q4 with $317M in cash and marketable securities (down from $344M in Q3), providing an anticipated cash runway into 2028 to fund milestones, while Q4 operating expenses were $36.6M (−8% YoY) with R&D $21.2M, SG&A $15.4M, stock‑based compensation $6.4M, and a noted $4M milestone payment to Gubra to be reflected in Q1 2026 R&D.Amylyx Pharmaceuticals Inc Financial Statement Overview
Summary
Financial profile is pressured: revenue fell from $380.8M (2023) to $87.4M (2024) and then to $0 (2025) with large net losses in 2024–2025. The balance sheet benefits from low leverage, but persistent, sizable free-cash-flow burn (e.g., -$167.8M in 2024 and -$123.5M in 2025) indicates ongoing funding dependence despite some improvement in burn.Income Statement
Profitability and growth deteriorated sharply: revenue fell from $380.8M (2023) to $87.4M (2024) and then to $0 (2025), with net income swinging from a $49.3M profit (2023) to a -$301.7M loss (2024) and -$144.7M loss (2025). While 2023 showed strong gross profit and positive operating profit, the subsequent collapse in revenue and return to large losses indicates a highly unstable earnings profile and weak operating leverage.22
Negative
Balance Sheet
Leverage is low (debt remains minimal versus equity in the years provided), which reduces solvency risk. However, equity has been volatile—rising strongly in 2022–2023, then declining to $164.8M in 2024 before rebounding to $305.3M in 2025—consistent with significant losses and likely financing activity. Overall, the balance sheet is not debt-stressed, but shareholder value is exposed to dilution/volatility tied to ongoing losses.58
Neutral
Cash Flow
Cash burn is persistent and significant: operating cash flow and free cash flow are deeply negative in most years (e.g., free cash flow of -$167.8M in 2024 and -$123.5M in 2025), with only a modest positive year in 2023. The improvement in burn from 2024 to 2025 is a positive, but the business is still consuming substantial cash, which can increase reliance on external funding.26
Negative
| Breakdown | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 0.00 | 87.37M | 380.79M | 22.23M | 0.00 |
| Gross Profit | -525.00K | 45.22M | 355.35M | 19.24M | 0.00 |
| EBITDA | -144.16M | -290.98M | 39.89M | -200.85M | -82.64M |
| Net Income | -144.74M | -301.74M | 49.27M | -198.38M | -87.93M |
Balance Sheet | |||||
| Total Assets | 332.64M | 193.63M | 517.45M | 391.45M | 105.61M |
| Cash, Cash Equivalents and Short-Term Investments | 316.98M | 176.50M | 371.36M | 346.94M | 96.12M |
| Total Debt | 5.96M | 1.98M | 4.24M | 6.28M | 0.00 |
| Total Liabilities | 27.39M | 28.87M | 84.02M | 50.85M | 256.78M |
| Stockholders Equity | 305.26M | 164.76M | 433.43M | 340.61M | -151.17M |
Cash Flow | |||||
| Free Cash Flow | -123.48M | -167.80M | 10.68M | -182.40M | -75.15M |
| Operating Cash Flow | -123.34M | -167.65M | 11.92M | -179.87M | -74.80M |
| Investing Cash Flow | 14.04M | 75.65M | 92.05M | -238.99M | -46.41M |
| Financing Cash Flow | 257.03M | 348.00K | 3.54M | 431.79M | 158.51M |
Amylyx Pharmaceuticals Inc Technical Analysis
Positive
14.93
Price Trends
14.02
Positive
13.81
Positive
11.36
Positive
Market Momentum
0.14
Negative
54.18
Neutral
55.81
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AMLX, the sentiment is Positive. The current price of 14.93 is above the 20-day moving average (MA) of 14.44, above the 50-day MA of 14.02, and above the 200-day MA of 11.36, indicating a bullish trend. The MACD of 0.14 indicates Negative momentum. The RSI at 54.18 is Neutral, neither overbought nor oversold. The STOCH value of 55.81 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive 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 |
|---|---|---|---|---|---|---|---|
70 Outperform | $2.10B | 6.20 | -76.45% | ― | 45.38% | 92.85% | |
69 Neutral | $1.61B | 13.56 | 19.84% | ― | 21.13% | 50.86% | |
56 Neutral | $1.69B | -8.91 | -67.11% | ― | ― | -20.08% | |
55 Neutral | $1.59B | -7.89 | -57.52% | ― | -100.34% | 52.85% | |
53 Neutral | $3.57B | -9.59 | -28.57% | ― | -42.64% | -39.78% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
45 Neutral | $1.49B | -1.64 | -688.89% | ― | ― | 18.76% |
* Healthcare Sector Average
AMLX
Amylyx Pharmaceuticals Inc
14.38
10.71
291.83%
BCRX
BioCryst
8.38
0.84
11.14%
DNTH
Dianthus Therapeutics
80.32
59.04
277.44%
HRMY
Harmony Biosciences Holdings
27.79
-4.93
-15.07%
PHVS
Pharvaris
26.38
9.47
56.00%
BHVN
Biohaven Ltd.
9.91
-18.31
-64.88%
Amylyx Pharmaceuticals Inc Corporate Events
Business Operations and StrategyProduct-Related Announcements
Amylyx Advances AMX0318 as New Rare-Disease Candidate
Positive
Jan 8, 2026
On January 8, 2026, Amylyx Pharmaceuticals selected AMX0318, a long-acting GLP-1 receptor antagonist discovered under its collaboration with peptide drug specialist Gubra A/S, as a development candidate for post-bariatric hypoglycemia and other rare diseases, triggering a $4 million milestone payment and positioning Gubra to earn more than $50 million in additional development and commercialization milestones plus mid-single-digit royalties on worldwide sales. The company also updated its corporate presentation in January 2026 to highlight a growing rare-disease pipeline led by avexitide, which is in a Phase 3 LUCIDITY trial for PBH with topline data expected in the third quarter of 2026 and a potential 2027 launch, while earlier clinical data have shown avexitide can sharply reduce hypoglycemic events in PBH patients, underscoring Amylyx’s strategic push to build a leading franchise in GLP-1 pathway modulation for underserved endocrine and neurodegenerative indications.
The most recent analyst rating on (AMLX) stock is a Buy with a $20.00 price target. To see the full list of analyst forecasts on Amylyx Pharmaceuticals Inc stock, see the AMLX Stock Forecast page.
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.