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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's partner Tango Therapeutics receives FDA clearance for TNG348, a USP1 inhibitor for the treatment of HRD+ cancers. Phase 1/2 study to be initiated in 2024. Medivir entitled to milestone payments and royalties.
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Medivir AB announces data on fostroxacitabine bralpamide's potential effect on hepatocellular carcinoma (HCC) to be presented at ILCA Annual Meeting. Preclinical results show fostrox's potential to enhance anti-tumor activity with kinase inhibitors such as Lenvima or sorafenib. Encouraging clinical results seen in ongoing phase 1b/2a study with fostrox + Lenvima. Expert Perspectives Webcast on HCC treatment challenges to be hosted on September 8th.
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Medivir AB announces promising interim safety and efficacy data from its phase 1b/2a study of fostrox in combination with Lenvima® for advanced hepatocellular carcinoma (HCC) patients.
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Medivir AB to host key opinion leader webcast on HCC treatment landscape
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Medivir to present at the Erik Penser Bank Company Event on August 24, 2023
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Medivir AB (MVIR) Announces Positive Preliminary Results from Phase 2a Study of Fostrox + Lenvima® in Advanced Hepatocellular Carcinoma Patients
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Medivir AB announces establishment of safe dose for fostroxacitabine bralpamide in combination with Keytruda® in hepatocellular carcinoma study
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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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