COPENHAGEN - Zealand Pharma A/S (NASDAQ:ZEAL), a biotechnology company specializing in peptide-based medicines, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its dasiglucagon solution. This recommendation is for the use of dasiglucagon in treating severe hypoglycemia in diabetes patients aged six years and above.
The CHMP's favorable opinion is a precursor to potential marketing authorization by the European Commission for the European Union market, which is expected to be decided upon within the next three months. Dasiglucagon, marketed as Zegalogue® in the United States, has been available since its FDA approval on March 22, 2021.
Adam Steensberg, CEO of Zealand Pharma, expressed satisfaction with the CHMP's recommendation, highlighting the company's goal to extend the reach of dasiglucagon globally through its partnership with Novo Nordisk (NYSE:NVO), a renowned diabetes care company.
Clinical trials have demonstrated dasiglucagon's efficacy, with a median recovery time from severe hypoglycemia of 10 minutes post-injection. The trials also noted the most common adverse events, including nausea, vomiting, headache, diarrhea, and injection site pain in adults, as well as nausea, vomiting, headache, and injection site pain in pediatric patients.
Under a licensing agreement with Novo Nordisk, Zealand Pharma is eligible for milestone payments up to DKK 265 million, along with sales royalties. The collaboration also designates Zealand Pharma responsible for certain regulatory and manufacturing activities outside the U.S., including the Marketing Authorization Application (MAA) to the EMA.
Zealand Pharma, founded in 1998 and headquartered in Copenhagen, has a robust pipeline of drug candidates, with two products already on the market and three in late-stage development. This latest development represents a significant step in the company's expansion and its commitment to address the needs of diabetes patients worldwide.
The information in this article is based on a press release statement from Zealand Pharma.
InvestingPro Insights
Zealand Pharma's recent positive opinion from the CHMP could signal a turning point for the company as it expands its presence in the European market. The InvestingPro data provides a snapshot of the company's financial health and market performance, which is crucial for investors following this development. As of the last twelve months as of Q1 2024, Zealand Pharma boasts a market capitalization of $5.71 billion, underscoring its substantial size within the biotech industry. Despite a negative P/E ratio of -62.19, indicating the company is not currently profitable, the impressive revenue growth of 222.76% over the same period suggests that Zealand Pharma is rapidly expanding its sales.
Moreover, the company's shares have experienced significant volatility, with a 1-year price total return of 131.62%, reflecting the high-risk, high-reward nature of biotech investments. The InvestingPro Fair Value estimate currently stands at $61.27, which is significantly lower than the analyst target of $118.55, indicating a divergence in valuation perspectives.
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