TD Cowen reiterates Buy rating on Amylyx stock, cites avexitide potential

Investing.com - TD Cowen has reiterated a Buy rating on Amylyx Pharmaceuticals Inc. (NASDAQ:AMLX), highlighting the potential of the company’s drug avexitide for post-bariatric hypoglycemia (PBH). The stock, which has surged over 145% in the past six months, currently trades at $8.41. According to InvestingPro data, analysts maintain a Strong Buy consensus with a high target of $17.

The firm’s analysis follows Amylyx’s key opinion leader (KOL) event discussing new analyses from avexitide’s Phase II program presented at the ENDO conference. Previous Phase IIb data showed avexitide generated 53% and 66% reductions in level 2 and level 3 hypoglycemia events at the 90 mg once daily dose. The company, with a market capitalization of $684.6 million, maintains a strong financial position with an "GOOD" Financial Health Score according to InvestingPro’s comprehensive analysis.

A new pharmacokinetic model presented at ENDO suggested that a single administration of the 90 mg dose maintains plasma concentrations above avexitide’s IC50 for the GLP-1 receptor for more than 24 hours. Additional data showed the 90 mg once-daily dose resulted in a 64% reduction in the composite number of level 2 and level 3 events in the prior Phase IIb study.

TD Cowen expressed optimism for avexitide’s success in the Phase III LUCIDITY study, which will use the same 90 mg once-daily dose and composite event endpoint as its primary outcome measure. The firm believes Amylyx is undervalued considering avexitide’s potential alone, with topline data from LUCIDITY expected in the first half of 2026. This view aligns with InvestingPro’s Fair Value assessment, which suggests the stock is currently undervalued. Discover more insights and 12+ additional ProTips for AMLX with an InvestingPro subscription, including detailed analysis of the company’s growth prospects and financial metrics.

KOLs at the event emphasized the high unmet need for PBH patients, noting that no FDA-approved treatment options exist, forcing physicians to rely on dietary therapy and off-label medications. The restrictive nature of dietary approaches leads many patients to either fail or not adhere to this treatment option.

In other recent news, Amylyx Pharmaceuticals has been in the spotlight following several key developments. The company announced that the FDA has granted Fast Track designation to its investigational ALS drug candidate, AMX0114, which aims to inhibit calpain-2, a key enzyme in ALS progression. This regulatory milestone is intended to expedite the drug’s development and review process. Additionally, Citi has reiterated a Buy rating on Amylyx with a $12.00 price target, citing promising data from avexitide’s phase 2 studies for post-bariatric hypoglycemia and the potential success of its phase 3 LUCIDITY trial.

Goldman Sachs also resumed coverage of Amylyx with a Buy rating and a $10.00 price target, highlighting avexitide’s potential to generate significant sales in the U.S. market. Furthermore, H.C. Wainwright reaffirmed its Buy rating with a $16.00 price target, focusing on the anticipated data from the LUCIDITY trial and the significance of neurofilament light chain as a biomarker in ALS research. Citi initiated coverage on Amylyx, emphasizing its diverse pipeline and strong intellectual property protection. These recent developments reflect a positive outlook from multiple analysts on Amylyx’s potential in addressing unmet medical needs across various indications.

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