CAMBRIDGE, Mass. - Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX), a biopharmaceutical company focused on developing treatments for serious diseases, announced the acquisition of a novel treatment, avexitide, from Eiger BioPharmaceuticals for the potential management of hyperinsulinemic hypoglycemia conditions, including post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism (HI).
This acquisition, completed for $35.1 million plus additional costs and liabilities, aligns with Amylyx's strategic focus on addressing diseases with high unmet medical needs.
Avexitide, a glucagon-like peptide-1 (GLP-1) receptor antagonist, has demonstrated significant potential in clinical trials to reduce hypoglycemic events in patients suffering from PBH. The U.S. Food and Drug Administration (FDA) has granted avexitide Breakthrough Therapy Designation for both PBH and congenital HI, recognizing its potential to provide substantial improvement over existing therapies.
Clinical trials have shown avexitide to be generally well tolerated, with most common adverse events being mild to moderate and including injection site bruising, headache, and nausea. Results from two Phase 2 studies in PBH patients indicated statistically significant reductions in severe hypoglycemic events, supporting the FDA's endorsement of the primary endpoint for the upcoming Phase 3 program.
Amylyx plans to initiate the Phase 3 trial for avexitide in PBH in the first quarter of 2025, with anticipation of data readout in 2026. Additionally, the company is actively engaging with experts to explore development paths for avexitide in congenital HI, based on promising results from earlier studies.
The company's portfolio also includes other significant programs such as AMX0035 for Wolfram syndrome, AMX0035 for progressive supranuclear palsy, and AMX0114 targeting calpain-2 for the treatment of amyotrophic lateral sclerosis (ALS).
Today, Amylyx's management will host a conference call and webcast to discuss the acquisition details and the future of avexitide.
The company's commitment to research and development is underscored by its efforts to bring innovative treatments to market, guided by scientific rigor and a focus on diseases that currently lack effective therapies.
In other recent news, Amylyx Pharmaceuticals Inc. reported a net loss of $118.8 million and net product revenues of $88.6 million for the first quarter of 2024. The company has initiated a restructuring plan, including workforce reduction, to extend its cash runway until 2026 and refocus on research and development.
Mizuho Securities recently adjusted its outlook on Amylyx, lowering the 12-month price target to $3 from $4 while maintaining a neutral rating. This revision follows Amylyx's decision to withdraw their drug Relyvrio/AMX0035 from the market after negative outcomes from the Phase 3 PHOENIX study.
Despite this setback, Amylyx shared promising results from a study in Wolfram syndrome and plans to engage with the FDA based on positive interim data. The company's focus now turns to the upcoming final data from the Phase 2 HELIOS study, evaluating AMX0035 for Wolfram syndrome. Mizuho's current stance is one of caution, opting to observe from the sidelines until there is more confidence in the potential success of Amylyx's pipeline.
InvestingPro Insights
In light of Amylyx Pharmaceuticals' recent acquisition and their strategic focus on innovative treatments, a glance at the company's financial health through InvestingPro data provides a window into their market standing. With a modest market capitalization of $112.21 million, Amylyx is a smaller player in the biopharmaceutical industry, reflecting its specialized focus on serious diseases with high unmet medical needs.
Despite the challenges often faced by companies in the drug development phase, Amylyx has shown impressive revenue growth over the last twelve months as of Q1 2024, with a staggering increase of 324.95%. This surge is indicative of the company's potential to capitalize on its unique offerings in the market. Moreover, the revenue for the same period stands at $398.0 million, which is a testament to the company's ability to generate significant sales from its products.
An InvestingPro Tip highlights the company's fair value as estimated by analysts at $3.25 and InvestingPro's own fair value calculation at $2.51, suggesting that the current share price of $1.65 may offer room for growth. Investors and analysts will be keeping a close eye on the upcoming Phase 3 trial for avexitide, as positive outcomes could further drive investor confidence and valuation.
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