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AMLX Rises as Avexitide Nears 2026-End Filing With Phase III Study Win
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Key Takeaways
AMLX's avexitide cut Level 2 and 3 hypoglycemic events by 55% versus placebo through week 16.
Avexitide was generally well tolerated, with no serious treatment-related adverse effects reported.
AMLX plans an FDA filing by 2026-end for avexitide in PBH, with Breakthrough Therapy tag already granted.
Shares of Amylyx Pharmaceuticals (AMLX - Free Report) surged 63.8% yesterday after it announced positive top-line data from the phase III LUCIDITY study. This study evaluated its lead candidate, avexitide, a GLP-1 receptor antagonist, in participants with post-bariatric hypoglycemia (“PBH”), following Roux-en-Y gastric bypass surgery.
Year to date, shares of Amylyx have rallied 190.7% against the industry’s decline of 0.8%.
Image Source: Zacks Investment Research
More on AMLX’s Latest LUCIDITY Study Data
The double-blind, placebo-controlled phase III LUCIDITY study met its FDA-agreed primary endpoint, with avexitide reducing the composite rate of Level 2 and Level 3 hypoglycemic events by 55% compared with placebo through week 16.
The LUCIDITY study also met all secondary endpoints, showing statistically significant reductions in Level 2 events measured by self-monitoring of blood glucose and continuous glucose monitoring, as well as independently adjudicated Level 3 events.
Treatment with avexitide was generally well tolerated, with most adverse effects being mild to moderate and no serious adverse effects related to treatment reported.
The LUCIDITY study enrolled 78 adults with PBH following Roux-en-Y gastric bypass surgery. Participants were randomized 3:2 to receive either avexitide (90 mg) subcutaneously once daily or placebo.
AMLX Eyes 2026-End Regulatory Filing for Avexitide
Management noted that the latest results from the LUCIDITY study, together with data from five earlier clinical studies, support avexitide’s potential as the first approved treatment for PBH.
Per the company, PBH is a chronic metabolic condition that can cause recurrent episodes of dangerously low blood sugar levels. The condition currently has no FDA-approved treatment, creating a significant unmet medical need.
Amylyx plans to submit a new drug application (“NDA”) for avexitide to treat PBH to the FDA by the end of 2026.
The FDA has already granted a Breakthrough Therapy designation to avexitide for treating PBH.
If approved, Amylyx aims to launch avexitide commercially in 2027. This would give the company its first marketed drug and a potential recurring source of product revenues.
Amylyx is also exploring avexitide in congenital hyperinsulinism.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 1.4% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 earnings per share have risen from 41 cents to $1.05, while estimates for 2027 have increased from 46 cents to 95 cents during the same time. ANIK’s shares have surged 124.5% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.
Over the past 60 days, estimates for Amneal’s 2026 earnings per share have risen from $1.00 to $1.02, while estimates for 2027 have increased from $1.12 to $1.21 during the same time. AMRX’s shares have rallied 44.4% year to date.
Amneal’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 32.82%.
View the Zacks #1 Rank List
Image: Bigstock
AMLX Rises as Avexitide Nears 2026-End Filing With Phase III Study Win
Key Takeaways
Shares of Amylyx Pharmaceuticals (AMLX - Free Report) surged 63.8% yesterday after it announced positive top-line data from the phase III LUCIDITY study. This study evaluated its lead candidate, avexitide, a GLP-1 receptor antagonist, in participants with post-bariatric hypoglycemia (“PBH”), following Roux-en-Y gastric bypass surgery.
Year to date, shares of Amylyx have rallied 190.7% against the industry’s decline of 0.8%.
Image Source: Zacks Investment Research
More on AMLX’s Latest LUCIDITY Study Data
The double-blind, placebo-controlled phase III LUCIDITY study met its FDA-agreed primary endpoint, with avexitide reducing the composite rate of Level 2 and Level 3 hypoglycemic events by 55% compared with placebo through week 16.
The LUCIDITY study also met all secondary endpoints, showing statistically significant reductions in Level 2 events measured by self-monitoring of blood glucose and continuous glucose monitoring, as well as independently adjudicated Level 3 events.
Treatment with avexitide was generally well tolerated, with most adverse effects being mild to moderate and no serious adverse effects related to treatment reported.
The LUCIDITY study enrolled 78 adults with PBH following Roux-en-Y gastric bypass surgery. Participants were randomized 3:2 to receive either avexitide (90 mg) subcutaneously once daily or placebo.
AMLX Eyes 2026-End Regulatory Filing for Avexitide
Management noted that the latest results from the LUCIDITY study, together with data from five earlier clinical studies, support avexitide’s potential as the first approved treatment for PBH.
Per the company, PBH is a chronic metabolic condition that can cause recurrent episodes of dangerously low blood sugar levels. The condition currently has no FDA-approved treatment, creating a significant unmet medical need.
Amylyx plans to submit a new drug application (“NDA”) for avexitide to treat PBH to the FDA by the end of 2026.
The FDA has already granted a Breakthrough Therapy designation to avexitide for treating PBH.
If approved, Amylyx aims to launch avexitide commercially in 2027. This would give the company its first marketed drug and a potential recurring source of product revenues.
Amylyx is also exploring avexitide in congenital hyperinsulinism.
Amylyx Pharmaceuticals, Inc. Price
Amylyx Pharmaceuticals, Inc. price | Amylyx Pharmaceuticals, Inc. Quote
AMLX’s Zacks Rank & Stocks to Consider
Amylyx currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the drug/biotech sector are Repligen (RGEN - Free Report) , Anika Therapeutics (ANIK - Free Report) and Amneal Pharmaceuticals (AMRX - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 1.4% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 earnings per share have risen from 41 cents to $1.05, while estimates for 2027 have increased from 46 cents to 95 cents during the same time. ANIK’s shares have surged 124.5% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.
Over the past 60 days, estimates for Amneal’s 2026 earnings per share have risen from $1.00 to $1.02, while estimates for 2027 have increased from $1.12 to $1.21 during the same time. AMRX’s shares have rallied 44.4% year to date.
Amneal’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 32.82%.