Core Insights - A Co-CEO of Amylyx Pharmaceuticals executed significant insider selling, but the sale was primarily to cover option costs and tax obligations, not discretionary [6][7] - The company has shown strong stock performance, with a 313% increase over the past year, recovering from previous losses [4][7] Transaction Summary - Joshua B Cohen sold 138,167 shares for approximately $1.9 million, following the exercise of 200,000 stock options [1][2] - Post-transaction, Cohen holds 3,379,465 shares, representing a 4.07% insider ownership [2][7] Company Overview - Amylyx Pharmaceuticals focuses on developing therapeutics for neurodegenerative diseases, particularly amyotrophic lateral sclerosis (ALS) [5] - The company is advancing its flagship therapy, AMX0035 (RELYVRIO), which has shown effectiveness in slowing ALS progression [8] Financial Performance - The company's market capitalization is $1.57 billion, with a net income of -$149.28 million [4] - The stock price as of January 31, 2026, was $14.29, reflecting a significant recovery and growth [4] Investigations - Amylyx is currently under investigation for alleged breaches of fiduciary duties by its directors and officers, which may be a concern for investors [9]

Amylyx Pharmaceuticals Inc. (NASDAQ:AMLX) is one of the overlooked growth stocks to buy. On January 8, Amylyx Pharmaceuticals (NASDAQ:AMLX) announced the nomination of AMX0318 as its newest development candidate. Identified through a strategic collaboration with Gubra A/S, AMX0318 is a novel, long-acting glucagon-like peptide-1/GLP-1 receptor antagonist designed to treat post-bariatric hypoglycemia/PBH and other rare diseases. The development of AMX0318 utilized Gubra’s proprietary streaMLine platform, w ...

Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) is one of the best performing pharma stocks in 2025. Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) announced on January 8 the selection of AMX0318 as a development candidate for post-bariatric hypoglycemia (PBH) and other rare diseases. AMX0318 is a long-acting glucagon-like peptide-1 (GLP-1) receptor antagonist and was identified through a research collaboration with Gubra A/S. Gubra A/S is involved in peptide-based drug discovery and preclinical contract research s ...

Company Overview - Amylyx Pharmaceuticals is a clinical-stage biotechnology company focused on developing treatments for amyotrophic lateral sclerosis (ALS) and related neurodegenerative diseases [5][8] - As of the latest market close, the share price is $13.67, with a market capitalization of $1.5 billion and a net income of -$149.3 million over the trailing twelve months (TTM) [4][5] Investment Activity - Saturn V Capital Management increased its stake in Amylyx Pharmaceuticals by 1.3 million shares during the third quarter, raising the position's value to $62.6 million as of September 30 [2][10] - Amylyx now constitutes approximately 13.7% of Saturn V's reportable assets under management (AUM), making it the second-largest holding in the fund's portfolio [3][10] Performance Metrics - Amylyx's stock has surged 166% over the past year, significantly outperforming the S&P 500, which has risen 12% in the same timeframe [3] - The company completed a $191 million equity raise in September, which supports its ongoing clinical programs [9] Development Pipeline - Amylyx is advancing several clinical programs, including the pivotal Phase 3 LUCIDITY trial of avexitide, with recruitment expected to finish in the first quarter and topline results anticipated in the third quarter [9] - Early Phase 1 LUMINA data for AMX0114 in ALS indicated that the therapy was generally well tolerated, allowing for dose escalation without serious adverse events [9]

Company Overview - Amylyx is presenting at the Citi Global Healthcare Conference, highlighting its lead asset, Avexitide, which is in a pivotal study for post-bariatric hypoglycemia (PBH) [3][4] - The company anticipates completion of enrollment for the study in the first quarter and expects top-line results in the third quarter of the year [4] Market Opportunity - PBH affects approximately 160,000 individuals in the U.S., with no approved treatments currently available, indicating a significant unmet medical need [4] - The company is planning for commercialization of Avexitide in 2027 following the study results [4] Future Developments - Amylyx is also exploring a potential long-acting formulation of Avexitide, which would be a daily subcutaneous treatment [4]

Financial Data and Key Metrics Changes - The company is excited about the upcoming pivotal study for Avexitide, targeting post-bariatric hypoglycemia (PBH), with an estimated 160,000 patients in the U.S. and no approved treatments, indicating a significant unmet need [4][9] - Enrollment for the pivotal study is expected to complete in Q1 2026, with top-line results anticipated in Q3 2026, leading to potential commercialization in 2027 [4][12] Business Line Data and Key Metrics Changes - Avexitide is the lead asset, with a focus on treating PBH, and the company is also developing a long-acting formulation and two other candidates, AMX0035 for Wolfram syndrome and AMX0114 for ALS [5][20] - The phase 2B trial of Avexitide showed a 64% reduction in severe hypoglycemic events, which supported the FDA Breakthrough Therapy Designation [16] Market Data and Key Metrics Changes - There is a growing awareness of PBH among endocrinologists, with initiatives for coverage and coding, including a petition to CMS for continuous glucose monitoring (CGM) coverage and a presentation to the CDC for an ICD-10 code [12][38] - The company estimates that the number of patients with PBH will increase, highlighting the urgency for treatment options [9] Company Strategy and Development Direction - The company aims to leverage its experience in rare diseases to establish a robust go-to-market strategy for Avexitide, focusing on understanding the patient journey and ensuring continuity of care [32][50] - There is a strategic emphasis on expanding the indications for Avexitide beyond Roux-en-Y gastric bypass to include other bariatric surgeries and conditions associated with hyperinsulinemic hypoglycemia [21][23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential impact of Avexitide on patients' lives, emphasizing the low bar for clinical meaningfulness due to the high unmet need in PBH [15][14] - The company is preparing for commercialization while ensuring that the pivotal trial is executed effectively, indicating strong potential for Avexitide in the market [50] Other Important Information - The company is also advancing AMX0114 for ALS, focusing on targeting Calpain-2, a key player in axon degeneration, with ongoing studies to assess safety and tolerability [56][58] - The company is working on AMX0035 for Wolfram syndrome, with plans to initiate a phase three trial in the second half of next year [66] Q&A Session Summary Question: Can you provide context on Avexitide as an opportunity? - The company has been actively seeking to in-license assets in rare diseases and found Avexitide to be a unique opportunity due to its strong pharmacology and significant unmet need in PBH [6][9] Question: What does success look like for the pivotal study? - Any reduction in hypoglycemic events would be considered meaningful, as these events are debilitating for patients [14][15] Question: How does the company plan to address the continuity of care? - The company is mapping out the patient journey and focusing on adult endocrinologists as primary call points for treatment [32][34] Question: What is the significance of the ICD-10 code for PBH? - While an ICD-10 code would be beneficial for claims databases and awareness, it is not essential for diagnosis, as endocrinologists are already trained to recognize PBH [47][48] Question: How does the company view the treatment landscape for ALS? - The company believes that combination therapy will be key in treating ALS, with AMX0114 targeting axon degeneration as a critical component [64]

Financial Data and Key Metrics Changes - The company is excited about the upcoming pivotal study for Avexitide, targeting post-bariatric hypoglycemia (PBH), with an estimated 160,000 patients in the U.S. and no approved treatments [2][6][12] - Enrollment for the pivotal study is expected to complete in Q1 2026, with top-line results anticipated in Q3 2026, leading to potential commercialization in 2027 [2][3] Business Line Data and Key Metrics Changes - Avexitide is positioned as a competitive inhibitor of the GLP-1 receptor, with significant unmet needs in PBH and strong prior trial data supporting its efficacy [5][6] - The company is also developing a long-acting formulation of Avexitide, which is expected to enhance market appeal [3][21] Market Data and Key Metrics Changes - There is a growing awareness of PBH among endocrinologists, with initiatives for coverage and coding underway, including a petition for an ICD-10 code [9][36] - The company has identified a clear patient journey for PBH, which aids in diagnosis and treatment planning [34][41] Company Strategy and Development Direction - The company aims to leverage its experience in rare diseases to establish a robust commercialization strategy for Avexitide, focusing on patient connectivity and care pathways [30][32] - Future plans include exploring additional indications for Avexitide beyond Roux-en-Y gastric bypass patients, potentially expanding to sleeve gastrectomy and other surgeries [18][19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming pivotal trial results and the potential impact of Avexitide on patient quality of life [12][14] - The company is preparing for a chronic treatment model, anticipating ongoing patient management needs [31][32] Other Important Information - The company is also advancing its ALS candidate AMX0114, with ongoing studies to assess its safety and efficacy [53][56] - AMX0035 for Wolfram syndrome is in the pipeline, with plans for a phase three trial pending FDA alignment [65][66] Q&A Session Summary Question: What is the expected timeline for Avexitide's pivotal study results? - The company anticipates completion of enrollment in Q1 2026 and top-line results in Q3 2026, with commercialization targeted for 2027 [2][3] Question: How does the company plan to raise awareness about PBH? - The company is working with the American Society of Metabolic and Bariatric Surgery to develop educational materials and increase awareness among healthcare providers [40][41] Question: What is the significance of the potential ICD-10 code for PBH? - While the ICD-10 code is seen as beneficial for claims databases and awareness, it is not deemed essential for diagnosis, as endocrinologists are already trained to recognize PBH [46][47]

One investor is making a bold bet on Amylyx just as its 2026 catalyst calendar starts to take shape.On November 14, New York City-based Commodore Capital disclosed a new position in Amylyx Pharmaceuticals (AMLX +2.76%), acquiring nearly 4.1 million shares valued at approximately $55 million, according to a recent SEC filing.What HappenedAccording to a filing with the U.S. Securities and Exchange Commission dated November 14, Commodore Capital LP disclosed a new stake in Amylyx Pharmaceuticals (AMLX +2.76%). ...

Summary of Amylyx Pharmaceuticals FY Conference Call Company Overview - **Company**: Amylyx Pharmaceuticals (NasdaqGS:AMLX) - **Focus**: Development of innovative therapies, particularly in the area of post-bariatric hypoglycemia (PBH) and other rare diseases Key Points on Avexetide and PBH - **Avexetide**: A competitive inhibitor of the GLP-1 receptor currently in a phase three pivotal study for PBH, following five successful prior studies that supported FDA Breakthrough Therapy designation [1][2] - **Market Size**: Approximately 160,000 people in the U.S. are estimated to have PBH, a number expected to grow due to the increasing prevalence of bariatric surgeries [3][4] - **Bariatric Surgery**: About 270,000 bariatric surgeries are performed annually in the U.S., with a significant portion of patients potentially developing PBH [7][10] - **Awareness and Diagnosis**: PBH has historically been under-recognized, but awareness is increasing, with presentations at medical conferences and discussions about creating an ICD-10 code for PBH [5][16] Clinical Development and Pipeline - **AMX0035**: In clinical development for Wolfram syndrome, with positive phase two results and phase three design pending FDA alignment [2][25] - **Calpain-2 Antisense Oligonucleotide**: Currently in phase one study for ALS, with safety and tolerability data expected later this year [2][25] Market Dynamics and Adoption Drivers - **Patient Journey**: Diagnosis of PBH can take one to three years post-bariatric surgery, with a significant number of patients actively managed at specialized centers [12][13] - **Educational Efforts**: There is a need for increased education among general endocrinologists and surgeons to recognize PBH symptoms and refer patients appropriately [13][15] - **Launch Expectations**: Anticipation of a bolus effect of initial patients seeking treatment upon approval, followed by a typical S-shaped launch curve [14][15] Phase Three Study Design - **Study Duration**: The phase three study has a treatment period of 16 weeks, increased from 4 weeks in phase two, with no evidence of tachyphylaxis expected [18][19] - **Outcome Measurement**: Primary outcomes will measure hypoglycemic events using the same methods as in phase two, ensuring consistency [19][20] Future Opportunities - **Potential for Other Indications**: The mechanism of Avexetide may have applications in other conditions related to persistent hypoglycemia, such as congenital hyperinsulinism and complications from upper GI surgeries [23][24] - **Market Size for Wolfram Syndrome**: Estimated at about 3,000 people in the U.S., with a larger population outside the U.S. [25] Conclusion - **Financial Position**: Recent financing provides a cash runway into 2028, supporting ongoing clinical programs and market entry strategies [2] - **Outlook**: The company is optimistic about its pipeline and the potential for Avexetide to address an unmet medical need in the PBH market [2][26]

Core Points - Halper Sadeh LLC is investigating potential breaches of fiduciary duties by certain officers and directors of Amylyx Pharmaceuticals, Inc. [1] - Long-term shareholders of Amylyx may seek corporate governance reforms, financial incentives, or other benefits through legal action [2] - Shareholder involvement is emphasized as a means to improve company policies and enhance shareholder value [3] - Halper Sadeh LLC has a history of representing investors affected by securities fraud and corporate misconduct, recovering millions for defrauded investors [4]