SAN FRANCISCO - The European Medicines Agency (EMA) has granted Priority Medicines (PRIME) status to 89bio, Inc.'s (NASDAQ:ETNB) pegozafermin for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), a serious liver condition. This designation, announced today, is based on positive results from the Phase 2b ENLIVEN trial, which studied pegozafermin in patients with non-cirrhotic MASH with fibrosis and MASH with compensated cirrhosis.
PRIME status is awarded to drugs that show the potential to offer significant benefits over existing therapies or address unmet medical needs based on initial clinical data. It provides advantages such as enhanced support from the EMA, guidance on development plans, and the possibility of expedited assessment during the marketing authorization application.
The ENLIVEN trial's findings contributed to the PRIME designation, with pegozafermin demonstrating promising anti-fibrotic and metabolic effects. "This status recognizes the urgent need for effective treatment options for MASH patients with advanced fibrosis," stated Rohan Palekar, CEO of 89bio.
MASH, formerly known as nonalcoholic steatohepatitis (NASH), is a progressive disease characterized by fat accumulation and scarring in the liver, which can lead to cirrhosis, liver failure, and increased cardiovascular disease risk.
89bio is currently enrolling for the Phase 3 ENLIGHTEN-Fibrosis trial, targeting non-cirrhotic MASH patients, and plans to initiate the ENLIGHTEN-Cirrhosis trial for patients with compensated cirrhosis in the second quarter of 2024.
Pegozafermin is an engineered analog of the hormone FGF21, which regulates metabolism and has shown potential in reducing liver fibrosis and inflammation, as well as improving lipid and glucose metabolism. The U.S. Food and Drug Administration (FDA) previously granted pegozafermin Breakthrough Therapy designation for MASH with fibrosis.
The company is also conducting the ENTRUST Phase 3 trial for severe hypertriglyceridemia (SHTG), another cardiometabolic disease.
This news is based on a press release statement from 89bio, Inc.
InvestingPro Insights
As 89bio, Inc. (NASDAQ:ETNB) garners significant attention with the PRIME status granted by the European Medicines Agency for pegozafermin, investors and stakeholders are closely monitoring the company's financial health and market performance. The latest data from InvestingPro shows a market capitalization of approximately 1050 million USD, indicating the size of the company in the biotechnology industry.
Despite the promising clinical advancements, InvestingPro Tips highlight that analysts are not expecting profitability in the immediate future, a common scenario for biotech firms focused on research and development. Additionally, while the company holds more cash than debt—a positive sign of liquidity—89bio is noted for having weak gross profit margins, which could be a concern for cost management and long-term financial stability.
InvestingPro Data further reveals a negative P/E ratio of -7.1 for the last twelve months as of Q4 2023, reflecting the company's current earnings deficit. However, with liquid assets surpassing short-term obligations, 89bio appears to be in a stable position to meet its immediate financial commitments.
For those interested in a deeper dive into 89bio's financials and future prospects, additional InvestingPro Tips are available, offering a comprehensive analysis to support informed investment decisions. By using the coupon code PRONEWS24, readers can get an extra 10% off a yearly or biyearly Pro and Pro+ subscription to access these insights.
With the next earnings date slated for May 8, 2024, and the fair value estimated by analysts at 31 USD compared to InvestingPro's fair value of 12.33 USD, the upcoming period will be crucial for 89bio as it continues to advance its clinical programs and strives for market success.
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