EMA Verleiht Orphan-Drug-Status en Vir Biotechs Hepatitis-Trehandlungen Von Investing.com

SAN FRANCISCO – Vir Biotechnology, Inc. (NASDAQ: VIR) has been engaged in the treatment of chronic Hepatitis Delta, Tobevibart and Elebsiran, a positive stellungnahme for the Ausweisung als Orphan-Arzneimittel vom Ausschuss für Orphan-Arzneimittel (COMP) of Europe Arzneimittel-Agentur (EMA) has a solution found. The research continues at the Liver Meeting, established by the American Association for the Study of Liver Diseases (AASLD) in San Diego, California, dating back to the Phase-2 Study SOLSTICE presentation.

The Ausweisung als Orphan-Arzneimittel in the European Union (EU) is potential policy for seltene, living or chronically ill health, for which there are currently no health problems. Dieser Status könnte Vir Biotechnology Anreize wie witschaftliche Beratung und Gebührenermäßigungen anyway a zehnjährige Marktexklusivität after the Zulassung bieten.

The positive outcome of the COMP is based on previous data from the Phase 2 Study SOLSTICE, which examined the Safety, Vertraglichkeit and Wirksamkeit of Tobevibart and Elebsiran, all interwoven in or in combination, in Patients with chronic Hepatitis Delta concentrate. This disease caused by hepatitis delta virus (HDV) is the aggressive form of chronic viral hepatitis and often persists for years after the infection by the disease and the disease.

Dr. Mark Eisner, Executive Vice President and Chief Medical Officer at Vir Biotechnology, considered the urgent consideration of new therapy options for chronic Hepatitis Delta and the consideration of the clinical clinical data that will enable significant treatment of the underlying patients.

The external investors’ conference call for investors is for tomorrow, when further details of the study and business plans for these transactions will be carried out.

The US Food and Drug Administration (FDA) in June 2024 adopted orphan status in the EU through the combination of Tobevibart and Elebsiran with the Fast-Track-Status, an investigation and drug investigation for carrying out uncovered medical treatments Bedarf zu to protect.

It is a monoclonal antibody, one of the most common diseases, one of the end rings of Hepatitis B and Hepatitis Delta Viren in Zellen in Hemmen, while Elebsiran is a small interfering ribonucle disease (siRNA), which is on the Hepatitis B -Virus RNA dies as a result. Both treatments find their place in the clinical treatment of chronic hepatitis B and Hepatitis Delta.

This analysis takes place at a press conference of Vir Biotechnology, Inc.

In other cases, Vir Biotechnology may have conducted a Phase 2 study in the chronic treatment of Hepatitis B, which has produced a significant assessment of disease B disease antibodies in the pathogen. The study consists of the Wirksamkeit of Tobevibart and Elebsiran, with or without other interferon alpha. The study’s Security Profile stimulated the investigation and said there was no new security thinking.

In financial advice, Vir Biotechnology reports in due course until written in Quartal 2024 about economic growth. A woman’s life with Sanofi for the T-Zell-Engager Program and Hepatitis Recovery Study has begun. The research and processing costs cost the Sanofi transaction to 195 million US dollars, while the processing and processing costs decreased to 25.7 million US dollars. This quarter, US$1.19 billion in Barmitteln and equivalents was spent.

It is a strong program for starting the Hepatitis-Delta-Virus (HDV) program in 2025. More than 50% of patients in the SOLSTICE study are no longer available by the 24th week of the virus. There are more and more developments for Vir Biotechnology.

InvestingPro Insights

Während Vir Biotechnology (NASDAQ: VIR) has been researching the chronic hepatitis delta, yielding a number of financial insights and insights from InvestingPro.

Laut InvestingPro-Daten involved the market capitalization of 969.55 million US dollars and was the active Bewertung of the possibilities of the Unternehmen during the broader market mirror. This relatively modest market capitalization is a result of the market potential of the market’s orphan drug candidates, nor is there complete control.

An InvestingPro-Tipp had so much more money than debt in Bilanz, was for a Biotech entrepreneur, who has new, separate transactions. This strong liquidity position can increase financial flexibility, which is clinical studies and potential market developments for tobevibart and electronic inheritance order light.

Another relevant InvestingPro tip has taught us that four analysts have calculated their earnings forecasts for the coming period after they have been corrected. This positive immunity is caused by the young disease in viral hepatitis delta infections and can cause disease in the pipeline of the latter world.

It’s erwähnenswert, that’s it InvestPro 11 other tips for the viral biotechnology offer a new analysis for the love of investors, which can grow a little in the world’s financial prosperity and market position.

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