SAN FRANCISCO – Vir Biotechnology, Inc. (NASDAQ: VIR), currently with a stock price of $7.43 and a solid liquidity position with a cash ratio of 8.94, has announced that its investigational drugs Tobevibart and Elebsiran are approved by the U.S The US Food and Drug Administration (FDA) gave it Breakthrough Therapy status and the European Medicines Agency (EMA) gave it PRIME designation for the treatment of chronic hepatitis Delta (CHD). According to InvestingPro analysis, the company has more cash than debt on its balance sheet, which positions it well for its drug development initiatives. These approvals, based on results from the Phase 2 SOLSTICE trial, aim to accelerate the development and testing of therapies for serious diseases with unmet medical needs.
CHD, caused by hepatitis delta virus, is the most severe form of chronic viral hepatitis and significantly increases the risk of liver cancer, cirrhosis, and liver failure. There are currently no approved treatments for CHD in the United States, and options in the European Union and worldwide are limited.
Data from the phase 2 SOLSTICE trial show that tobevibart and elebsiran can suppress hepatitis delta virus to undetectable levels. “The FDA Breakthrough Therapy and European PRIME designations recognize the potential of this combination to transform the lives of people with CHD,” said Mark Eisner, MD, MPH, executive vice president and chief medical officer at Vir Biotechnology. The company plans to launch the Phase 3 ECLIPSE registration program in the first half of 2025. Although the stock has seen a 25% decline over the past six months, InvestingPro data shows that 4 analysts have upgraded their profit forecasts for the coming period, indicating potential confidence in the company's pipeline.
The FDA Breakthrough Therapy designation facilitates accelerated development and testing of drugs that show significant potential in preliminary clinical evidence and may offer advantages over existing therapies. Similarly, EMA's PRIME designation is awarded to medicines that could significantly benefit patients with unmet medical needs and ensures future collaboration with EMA to support robust data collection and faster assessments.
Tobevibart is a broadly neutralizing monoclonal antibody that targets the hepatitis B surface antigen and is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and reduce the amount of circulating viral particles. Elebsiran, a small interfering ribonucleic acid (siRNA), is reported to degrade hepatitis B virus RNA transcripts and potentially exhibit direct antiviral activity against both hepatitis B and hepatitis delta viruses.
This news is based on a press release from Vir Biotechnology, Inc. The Company's focus is on the discovery and development of treatments for serious infectious diseases and cancer, with a clinical portfolio including the Chronic Hepatitis Delta and Chronic Hepatitis B programs includes. InvestingPro analysis suggests the company is currently undervalued, with analysts setting price targets between $10 and $110.
In other recent news, Vir Biotechnology has made significant progress in its clinical programs. The company's hepatitis treatments Tobevibart and Elebsiran have received a positive opinion for orphan designation from the European Medicines Agency (EMA). This status could provide Vir Biotechnology with scientific advice, fee reductions and 10 years of market exclusivity following approval. The treatments are currently in clinical development for chronic hepatitis B and hepatitis delta.
At the same time, Vir Biotechnology presented promising results from a phase 2 study for the treatment of chronic hepatitis B. The study evaluated the effectiveness of Tobevibart and elebsiran and found significant rates of hepatitis B surface antigen (HBsAg) loss in participants with low baseline HBsAg levels. The safety profile of the treatments remained consistent with previous studies and did not reveal any new safety concerns.
Additionally, the company reported significant developments during its third quarter 2024 earnings report, including a licensing agreement with Sanofi for three T cell engager programs and progress in hepatitis studies. Vir's R&D expenses increased to $195 million as a result of this transaction, while selling and administrative expenses decreased to $25.7 million. The company ended the quarter with $1.19 billion in cash and equivalents.
Additionally, TD Cowen maintained its Buy rating on shares of Vir Biotechnology, highlighting the potential of the company's pipeline programs. The company's confidence is supported by the promising data presented for Vir's treatments against hepatitis B virus (HBV) and hepatitis D virus (HDV). These recent developments underscore Vir Biotechnology's commitment to advancing its clinical program, particularly in the areas of oncology and hepatitis.
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