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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.

Rhea-AI Summary

Medivir AB announced that an abstract for the combination of fostrox + Lenvima in hepatocellular carcinoma (HCC) has been accepted for presentation at the European Society for Medical Oncology Gastrointestinal Cancers Congress. The abstract titled 'Liver pharmacodynamics in an open-label phase Ib/IIa study of fostrox in combination with lenvatinib in hepatocellular carcinoma' will be presented at the conference. The presentation will include pharmacodynamic data from patients in the ongoing clinical study, evaluating the impact on normal liver function and DNA damage in tumor cells vs healthy cells. It will also provide an update on efficacy endpoints as the study continues to mature. The poster will be available on Medivir's website after the presentation.

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Medivir AB's MIV-711 receives Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA for the treatment of Legg-Calvé-Perthes Disease, providing potential fast track review and market exclusivity benefits.
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Medivir AB (NASDAQ: MVIR) provided an update from a Type C meeting with the FDA regarding their plans for a global phase 2b study and opening of an IND for fostrox in the US. The key outcomes include adjustments to the study design, focusing on the improved capsule formulation of fostrox and changing the primary endpoint to Objective Response Rate (ORR). The preparations for the study are progressing, with the aim to start in early 2025.
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Medivir's partner Vetbiolix reports positive results from a Proof-of-Concept study with VBX-1000 (MIV-701), a cathepsin-K inhibitor for periodontal disease in dogs. The drug met primary efficacy endpoint, showing a significant reduction in bone degradation biomarker. Medivir stands to benefit from milestone and royalty payments.
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Medivir AB (MVIR) to present at Investing in Oncology Forum on April 10, 2024, focusing on fostrox's development program for cancer treatment.
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Medivir AB (MVIR) announces the availability of the Annual Report for 2023, highlighting positive clinical data from the ongoing study with fostrox in combination with Lenvima® for liver cancer treatment. The company aims to accelerate fostrox's clinical development to potentially become the first approved therapy for HCC, a $2.5 billion market. The Annual Report details Medivir's focus on innovative cancer drugs, fostrox's development, and upcoming clinical projects.
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Medivir AB (MVIR) to present at Swiss Nordic Bio conference, focusing on fostrox clinical study data for cancer treatment acceleration.
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Medivir AB (MVIR) to present at Life Science Day in Gothenburg on March 6, 2024, focusing on fostrox's Phase 1b/2a clinical trial data for liver cancer treatment.
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Medivir AB announces changes in the nomination committee before the annual general meeting in May 2024. Anders Hallberg and HealthInvest Partners are no longer part of the committee. Stefan Bengtsson from CA Fastigheter AB joins the committee. The 2024 Annual General Meeting will be held on May 7, 2024.
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Medivir AB announces positive clinical pharmacokinetic data on fostrox at EASL Liver Cancer Summit, showing dose linearity and encouraging safety profile.
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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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