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Medivir AB (Nasdaq Stockholm: MVIR) is a pharmaceutical company dedicated to developing innovative treatments for cancer, especially in areas with high unmet medical needs. Medivir's core focus is on creating drugs that address severe medical conditions where existing options are limited or ineffective. Their flagship product is fostroxacitabine bralpamide (fostrox), a smart chemotherapy targeting liver cancer with minimal side effects.

In recent developments, Medivir announced a directed issue of 7,547,170 new ordinary shares to Hallberg Management AB, raising approximately SEK 20 million. This move is aimed at advancing the fostrox development and providing increased financial flexibility. The board expects this strategic partnership to add significant value to the company and its shareholders.

The company's most recent phase 1b/2a study in advanced hepatocellular carcinoma (HCC) showcased promising data at the ASCO GI Symposium. The combination of fostrox and Lenvima was well-tolerated, with continued clinical benefits. This study aligns with Medivir’s strategy to enhance patient outcomes in liver cancer treatment.

Medivir also reported on the clinical pharmacokinetic data of fostrox, highlighting dose linearity and systemic exposure. These findings were shared at the EASL Liver Cancer Summit, underscoring the company’s commitment to scientific rigor and transparency.

Additionally, Medivir's partner Vetbiolix announced positive results from a Proof-of-Concept study in dogs with periodontal disease using VBX-1000 (previously MIV-701). This highlights Medivir’s strategy of leveraging partnerships to expand the clinical utility of its compounds beyond human medicine.

In regulatory achievements, Medivir received Rare Pediatric Disease and Orphan Drug Designations for its cathepsin K inhibitor, MIV-711, aimed at treating Legg-Calvé-Perthes Disease. This designation could significantly accelerate the drug’s development timeline.

The company maintains a robust financial and strategic posture, with a focus on collaborative partnerships to advance its drug candidates. Their lead program, fostrox, is gearing up for a pivotal phase 2b study, with the potential to become the first approved treatment for HCC patients who have progressed on current first-line therapies.

For more information, visit the Medivir website.

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Medivir AB (MVIR) to present at Carlsquare Equity Research Investor Day, focusing on the latest developments and future plans, including a rights issue and the development program for fostrox with the aim of starting a pivotal phase 2b study in 2024.
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Medivir AB (MVIR) has developed an updated commercial formulation of fostrox, a potential treatment for hepatocellular carcinoma (HCC), a life-threatening form of liver cancer. The formulation was developed in collaboration with Quotient Sciences, the company's partner for formulation development and drug manufacture. Fostrox is currently being evaluated in a phase 1b/2a study in combination with Lenvima®, showing promising interim data for HCC patients who have progressed on current first-line standard of care. The company plans to initiate a phase 2b study with accelerated approval intent based on the positive results.
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Medivir AB (MVIR) to Participate at Redeye Life Science Day; CEO to Discuss Latest Developments and Future Plans
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Medivir AB (MVIR) to Present at Erik Penser Bank Company Event on November 23
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Medivir AB (Nasdaq Stockholm: MVIR) announces the presentation of clinical data from the phase 1b/2a study of fostrox in combination with Lenvima at the ASCO Gastrointestinal Cancers Symposium. The FDA interactions for fostrox's clinical development plan have intensified, with a positive response for the planned phase 2b study design.
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Medivir AB plans to report new and updated data from its ongoing phase 2a study with the candidate drug fostrox in combination with Lenvima® in advanced hepatocellular carcinoma (HCC). The data will focus on the 18 out of 21 total patients that have had a minimum follow-up of 12 weeks. The data update will be part of Medivir's interim report for the third quarter on Friday, October 27, 2023, followed by a comprehensive update in a webcasted presentation at 14.00 CET the same day.
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Medivir AB announces appointment of nomination committee for Annual General Meeting in 2024
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Medivir AB board member Anette Lindqvist resigns due to personal reasons
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Medivir AB announces promising clinical benefit in ongoing phase 2a study for advanced hepatocellular carcinoma
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Medivir to present at the Pareto Securities Healthcare Conference
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FAQ

What is Medivir's primary focus?

Medivir focuses on developing innovative treatments for cancer, particularly in areas with high unmet medical needs.

What is fostrox?

Fostroxacitabine bralpamide (fostrox) is a smart chemotherapy designed to selectively treat liver cancer cells with minimal side effects.

What recent financial actions has Medivir taken?

Medivir recently completed a directed issue of 7,547,170 new shares, raising approximately SEK 20 million to advance its drug development programs.

What are Medivir's recent clinical study results?

Recent studies show that the combination of fostrox and Lenvima is well-tolerated and offers continued clinical benefits for advanced hepatocellular carcinoma (HCC).

Who are Medivir's strategic partners?

Medivir collaborates with various partners, including Hallberg Management AB, Vetbiolix, and Tango Therapeutics, to advance its drug development programs.

What regulatory achievements has Medivir recently obtained?

Medivir received Rare Pediatric Disease and Orphan Drug Designations for MIV-711, aimed at treating Legg-Calvé-Perthes Disease.

What is the significance of the directed issue to Hallberg Management AB?

The directed issue provides Medivir with additional capital and strategic partnership, allowing for accelerated development of fostrox and enhanced financial flexibility.

What is the status of Medivir's phase 2b study for fostrox?

Medivir is preparing for a global phase 2b study for fostrox, including a dose run-in period and focusing on Objective Response Rate (ORR) as the primary endpoint.

What other therapeutic areas is Medivir involved in?

Beyond cancer, Medivir collaborates on treatments for veterinary diseases, such as periodontal disease in dogs, through partnerships like the one with Vetbiolix.

Where can I get more information about Medivir's developments?

For more detailed information, visit Medivir's official website at www.medivir.com.

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