Amylyx gets FDA fast track status for ALS treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 03 2025
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Source: SeekingAlpha
FDA Fast Track Designation: Amylyx Pharmaceuticals has received fast track status from the U.S. FDA for its antisense RNA drug AMX0114, aimed at treating amyotrophic lateral sclerosis (ALS), which facilitates quicker development and review processes for serious conditions with unmet needs.
Ongoing Clinical Trials: An early-stage trial for AMX0114 is currently in progress, with initial data expected later this year, and the company's stock has seen a premarket increase of 5.7%.
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Analyst Views on AMLX
Wall Street analysts forecast AMLX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for AMLX is 20.14 USD with a low forecast of 15.00 USD and a high forecast of 25.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
8 Analyst Rating
8 Buy
0 Hold
0 Sell
Strong Buy
Current: 14.850
Low
15.00
Averages
20.14
High
25.00
Current: 14.850
Low
15.00
Averages
20.14
High
25.00
About AMLX
Amylyx Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company. The Company is focused on three investigational therapies across several neurodegenerative and endocrine diseases. Its lead investigational asset is avexitide, an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist. Avexitide has been evaluated as a treatment for Post-Bariatric Hypoglycemia (PBH) and congenital HI, two indications characterized by hyperinsulinemic hypoglycemia. In addition to avexitide, it is advancing AMX0035, an oral, fixed-dose combination of sodium phenylbutyrate and taurursodiol in Wolfram syndrome and progressive supranuclear palsy (PSP), and AMX0114 in amyotrophic lateral sclerosis (ALS). AMX0035 is designed to mitigate neurodegeneration by targeting endoplasmic reticulum stress and mitochondrial dysfunction, two cellular processes central to neuronal cell death and neurodegeneration. AMX0114 is an investigational antisense oligonucleotide.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Investigation into Amylyx Pharmaceuticals' Corporate Governance Breaches
- Shareholder Action: Halper Sadeh LLC is investigating whether certain officers and directors of Amylyx Pharmaceuticals breached their fiduciary duties, potentially leading to shareholder losses.
- Legal Relief Options: Long-term shareholders of Amylyx may seek corporate governance reforms, fund recovery, or court-approved financial awards, enhancing shareholder rights and protections.
- Importance of Participation: Shareholder involvement can improve company policies and oversight mechanisms, thereby increasing transparency and accountability, which ultimately helps enhance shareholder value.
- Law Firm Background: Halper Sadeh LLC represents global investors focusing on securities fraud and corporate misconduct, having successfully implemented corporate reforms and recovered millions for defrauded investors in the past.
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AMLX Options Contract Analysis and Investment Opportunities
- Put Option Appeal: The current bid for the $15.00 put option is $3.20, and if an investor sells this contract, they commit to buying the stock at $15.00, resulting in an effective cost basis of $11.80, which offers an attractive 4% discount compared to the current price of $15.55, appealing to those interested in AMLX shares.
- Yield Potential Analysis: Should the put option expire worthless, it would yield a 21.33% return on the cash commitment, or an annualized return of 33.28%, showcasing the YieldBoost potential of this strategy, which is likely to attract yield-seeking investors.
- Call Option Opportunity: The $16.00 call option has a current bid of $3.60, and if an investor buys AMLX shares at $15.55 and sells this call, they could achieve a total return of 26.05% if the stock is called away at expiration, highlighting the attractiveness of this strategy.
- Risk and Return Assessment: The $16.00 call option has a 32% chance of expiring worthless, in which case the investor retains both the shares and the premium collected, providing an additional 23.15% return, or an annualized yield of 36.12%, further enhancing investor return expectations.
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