H.C. Wainwright maintains Anavex Buy rating, $42 target

On Monday, H.C. Wainwright analyst Raghuram Selvaraju maintained a Buy rating and a $42.00 price target on Anavex Life Sciences (NASDAQ:AVXL), suggesting significant upside from the current price of $8.72. According to InvestingPro data, analysts maintain a strong buy consensus with price targets ranging from $15 to $46, despite the stock’s recent 9.26% decline over the past week. This reiteration follows recent regulatory developments concerning treatments for Alzheimer’s disease (AD).

European regulators have recently rejected Eli Lilly (NYSE:LLY) & Co.’s anti-amyloid monoclonal antibody Kisunla (donanemab) for early symptomatic AD. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) advised against the drug’s marketing authorization, citing concerns that its benefits did not outweigh the risks of serious side effects, including potentially fatal brain swelling and bleeding known as amyloid-related imaging abnormalities (ARIA).

Despite the setback, Eli Lilly plans to seek a re-examination of the decision. The EMA’s stance reflects a broader caution in Europe regarding the safety profiles of anti-amyloid AD drugs. Another drug in this class, Leqembi (lecanemab), received CHMP endorsement in February for a restricted patient population after an initial denial due to safety concerns.

In the United Kingdom (TADAWUL:4280), the National Institute for Health and Care Excellence (NICE) has declined to recommend Kisunla and Leqembi for National Health Service (NHS) coverage, even though both drugs have been approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) with warnings for ARIA risk. In the United States, both drugs are FDA-approved but come with a black boxed warning label for the same risk.

Selvaraju’s affirmation of the Buy rating and price target for Anavex Life Sciences comes amid these regulatory challenges for competing AD treatments. The analyst’s statement underscores the ongoing scrutiny and regulatory hurdles faced by AD drugs in the market.

In other recent news, Anavex Life Sciences disclosed its fiscal first-quarter 2025 financial results, reporting a net loss of $12.1 million or $0.14 per share. This result was slightly better than H.C. Wainwright analysts’ estimate of a $0.17 per share loss, leading the firm to maintain its Buy rating and a $42.00 price target for the company. Anavex’s financial position remains robust, with $120.8 million in cash and no debt, providing a cash runway of approximately four years. Additionally, Anavex highlighted significant progress in its Alzheimer’s treatment trials, with its lead drug candidate, blarcamesine, showing a 36.3% slowdown in disease progression during a Phase 2b/3 trial.

The company also announced the issuance of a new U.S. patent for Anavex 273, expected to remain in force until at least July 2039, covering crystalline forms and transdermal patches for treating neurodegenerative disorders. CEO Christopher Missling emphasized growing support from stakeholders for Anavex’s potential novel treatment for early Alzheimer’s disease. While the company faces regulatory hurdles and competition from established treatments, its financial stability and research advancements are seen as strengths. Anavex is planning further updates on its Parkinson’s disease program and other initiatives, with ongoing discussions regarding potential partnerships to maximize shareholder value.

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