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  • Medivir
    Medivir AB, Box 1086, SE-141 22 Huddinge, Sweden Visit: Lunastigen 5
    +46 8 5468 3100
    http://www.medivir.com
  • Jens Lindberg

    CEO


    +46 8 5468 3100
    http://www.medivir.com
  • Magnus Christensen

    CFO


    +46-73 125-0620
    http://www.medivir.com
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    Medivir's CEO to BioStock: "Fostrox is unique in its kind"

    Medivir's phase I study, which established clinical proof-of-concept for fostrox as monotherapy in patients with liver cancer, has been published in the Journal of Hepatocellular Carcinoma. The study shows that fostrox is safe and well-tolerated with preliminary anti-tumour activity, confirming that the drug specifically targets cancer cells in the liver while sparing healthy cells. BioStock reached out to CEO Jens Lindberg for a comment.Read the article at biostock.se: https://www.biostock.se/en/2024/10/medivirs-ceo-fostrox-is-unique-in-its-kind/ This is a press release from BioStock

    Medivir to present at the Pareto Securities Healthcare Conference

    Stockholm, Sweden, September 16, 2024 — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, today announces that the company will present at the Pareto Securities Healthcare Conference tomorrow, September 19. CEO Jens Lindberg will provide an update on the mature and detailed data from the phase 1b/2a study with fostrox-+ Lenvima® in advanced hepatocellular carcinoma (HCC) recently presented at the ESMO conference. The presentation will be available on Medivir’s website after the

    BioStock: Medivir – live from ESMO in Barcelona

    At the ESMO conference in Barcelona, Medivir presented mature results from its ongoing Phase Ib/IIa trial of fostrox in combination with Lenvima, confirming the potential for improved outcomes in advanced liver cancer. BioStock contacted Dr. Pia Baumann, Medivir’s Chief Medical Officer, who joined us live from Barcelona.See the video interview with Dr. Pia Baumann at biostock.se: https://www.biostock.se/en/2024/09/medivir-live-from-esmo-in-barcelona/ This is a press release from BioStock - Connecting Innovation & Capital. https://www.biostock.se/

    Medivir’s fostrox + Lenvima confirm promise of improved outcomes in advanced liver cancer, detailed and mature data presented at ESMO

    · Mature results from Medivir’s phase 1b / 2a open label trial of fostrox + Lenvima® confirm improved outcomes in second-line advanced liver cancer with a median time to progression (TTP) of 10.9 months[1] (4.1 – 18.1). · The results showed an objective response (ORR) of 24%, and a median duration of response of 7.0 months. · Detailed safety update reinforces the ability to combine fostrox and Lenvima long-term, only 1 patient discontinuing fostrox due to adverse events. · Medivir’s fostrox (fostroxacitabine bralpamide) is the only orally-administered, liver-targeted inhibitor

    Medivir to present mature clinical data for fostrox + Lenvima at ESMO Conference and to host a webcast on September 16

    Stockholm — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, has previously announced that detailed and mature data from the phase 1b/2a study of fostrox (fostroxacitabine) in combination with Lenvima® (lenvatinib) for the treatment of advanced hepatocellular carcinoma (HCC) will be presented at the European Society for Medical Oncology (ESMO) Congress in Barcelona, September 16, 2024.   The abstract, titled “Fostrox (fostroxacitabine bralpamide) plus lenvatinib in patients with

    BioStock: Q2 marked continued progress for Medivir in advanced liver cancer

    At the ESMO GI congress in June, Medivir presented greatly improved results for patients with advanced liver cancer in the ongoing phase Ib/IIa study with fostrox in combination with Lenvima. The company is increasingly optimistic about the possibility of launching the first approved drug treatment after first-line treatment of the disease. This is evident from Medivir’s interim report.– We are now looking forward to presenting detailed and mature clinical data from the study with fostrox at the ESMO Cancer Congress in Barcelona in September, says CEO Jens Lindberg.Read the full article

    MEDIVIR AB – INTERIM REPORT JANUARY – JUNE 2024

    “Our study shows a superior profile with the combination of fostrox and Lenvima in advanced liver cancer”     April – June Financial summary for the quarter · Net turnover amounted to SEK 1.1 (2.0) million. · The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -36.7 (-26.3) million. Basic and diluted earnings per share amounted to SEK -0.32 (-0.47). · Cash flow from operating activities amounted to SEK -26.3 (-17.9) million. · Cash and cash equivalents at the end of the period amounted to SEK 126.7 (82.8) million.

    Medivir to present updated clinical data for fostrox + Lenvima in HCC at ESMO Conference in September

    Stockholm — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, is pleased to announce that updated data from the phase 1b/2a study of fostrox (fostroxacitabine) in combination with Lenvima® (lenvatinib) for the treatment of advanced hepatocellular carcinoma (HCC) has been accepted for presentation at the European Society for Medical Oncology (ESMO) Congress in Barcelona, September 13-17, 2024.   The abstract, titled “Fostrox (fostroxacitabine bralpamide) plus lenvatinib in patients

    Number of shares and votes in Medivir AB on 28 June 2024

    Stockholm — Medivir AB (Nasdaq Stockholm: MVIR) today announces that the number of shares and votes in Medivir has changed during June 2024 as a result of the issue of 1,700,000 shares of series C and the reclassification of 114 587 shares of series C to ordinary shares which was carried out as a part of the implementation of the incentive program resolved by the general meeting on 7 May 2024. Both the issue and the reclassification have been previously announced through a separate press release.   Today, the last trading day of the month, there are in total 114,617,968 shares in

    BioStock: Medivir presents promising results in difficult-to-treat patient population

    Medivir today presents new clinical data from its phase Ib/IIa study at ESMO GI in Munich. The company's candidate fostrox shows strongly improved results in combination with Lenvima for patients with advanced primary liver cancer, a difficult-to-treat patient group that currently lacks approved treatment options in the second line.– We are particularly encouraged by the durable benefit, with patients remaining on treatment for much longer than expected. More than 10 months median time to progression is significantly longer than previously achieved with second-line treatment with Lenvima

    Fostrox + Lenvima® holds promise of greatly improved outcomes for advanced liver cancer patients, reveals new data from Medivir at ESMO GI

    · New results from Medivir’s Phase 1b / 2a open label trial of fostrox + Lenvima® show great promise treating second-line hepatocellular carcinoma (HCC) patients, an extremely hard to treat population · Fostrox + Lenvima® achieved a 24% overall response rate (ORR) and estimated median time to progression (TTP) of 10.8 months1 (4.1 – NE) – with one patient still on treatment after 22 months · Results come despite very poor prognosis for most second-line HCC patients today, with just 5 – 10% responding to current standard of care treatment, and a typical TTP of only 3 - 4 months ·

    Medivir selects global CRO partner for upcoming phase 2b study in HCC with fostrox + Lenvima and initiates study feasibility

    Stockholm — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that it has selected a global CRO partner for the planned phase 2b study evaluating fostroxacitabine bralpamide (fostrox) + Lenvima® vs Lenvima alone in second line HCC.   In the next phase of development, Medivir is planning for a global, randomized phase 2b study aligned with its recent supportive Type C interaction with the FDA. The objective is to evaluate the combination of fostrox + Lenvima in second

    Issue, repurchase and reclassification of shares of series C and transfer of ordinary shares under LTIP 2024

    In light of the incentive program adopted by the annual general meeting of Medivir AB (publ) (“Medivir”) on 7 May 2024 (“LTIP 2024”), it is today announced that the board of directors of Medivir has resolved on (i) a share issue of 1,700,000 shares of series C, (ii) repurchase of the 1,700,000 shares of series C, (iii) reclassification of 114,587 shares of series C into ordinary shares and (iv) partial execution of the annual general meeting’s resolution on transfer of own ordinary shares by transferring 126,000 own ordinary shares to participants in LTIP 2024.Aktieinvest FK AB will

    Medivir to present at Redeye Growth Day

    Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announces that the company will participate at Redeye Growth Day, today May 30, 2024.   CEO Jens Lindberg will present updated data from the ongoing phase 1b/2a clinical study with fostroxacitabine bralpamide (fostrox) and the development plans moving forward at 09.40 CET. The presentation is live broadcasted and can be followed at the event page, where the replay and the presentations will be available

    Medivir´s licensee, Tango Therapeutics, has discontinued development of its TNG348 clinical program

    Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that Medivir’s licensee, Tango Therapeutics (NASDAQ: TNGX; Tango), has announced that the phase 1/2 clinical trial of TNG348, a novel USP1 inhibitor, is being terminated due to toxicity observed in the initial study cohorts.   TNG348 is a novel USP1 (ubiquitin-specific protease 1) inhibitor, for the treatment of BRCA1/2-mutant and other homologous recombination deficiency (HRD)+ cancers, and has

    Resolutions at the Annual General Meeting in Medivir on 7 May 2024

    Medivir Aktiebolag (publ) held its annual general meeting today on 7 May 2024. The annual general meeting was held by physical presence of shareholders and with the option for shareholders to exercise their voting rights by advance voting (postal voting). The annual general meeting in Medivir Aktiebolag (publ) resolved the following:   Approval of profit and loss accounts and balance sheets, and discharge from liability of the board members and the managing director The annual general meeting resolved to approve the profit and loss accounts and balance sheets for the financial year

    BioStock: Double thumbs up for Medivir from the FDA

    Medivir’s drug candidate MIV-711 has received both Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of the rare childhood disease Legg-Calvé-Perthes disease.– LCPD is a disease with a high risk of future complications such as osteoarthritis. MIV-711 has the potential to be the first drug to have a positive impact on disease progression, says Jens Lindberg, CEO of Medivir.Read the full interview with Jens Lindberg at biostock.se: https://www.biostock.se/en/2024/05/double-thumbs-up-for-medivir-from-the-fda/ This is a press release from BioStock -

    MEDIVIR AB – INTERIM REPORT JANUARY – MARCH 2024

    ”Preparations for the planned phase 2b study continue according to plan after the completed Type C meeting with the FDA, strengthened by the fact that the median time to progression with fostrox + Lenvima increased to 7 months”   January – MarchFinancial summary for the quarter · Net turnover amounted to SEK 0.5 (0.4) million. · The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -26.7 (-18.9) million. Basic and diluted earnings per share amounted to SEK -0.23 (-0.34) and SEK -0.23 (-0.34) respectively. · Cash flow from operating

    Medivir brings the Q1 webcast forward to 10 a.m. on April 30

    Stockholm — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that the company will host the Q1 Quarterly Results webcast tomorrow, April 30, at 10 a.m. CET. The webcast is brought forward as Nasdaq Stockholm closes earlier.       For additional information, please contactMagnus Christensen, CFO, Medivir ABTelephone: +46 8 5468 3100E-mail: magnus.christensen@medivir.com         About Medivir Medivir develops innovative drugs with a focus

    Medivir to present data for the combination of fostrox + Lenvima in HCC at ESMO GI

    Stockholm — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that an abstract for the combination of fostroxacitabine bralpamide (fostrox) + Lenvima® in hepatocellular carcinoma (HCC) has been accepted for presentation at the European Society for Medical Oncology (ESMO) Gastrointestinal (GI) Cancers Congress in June 26-29, 2024 in Munich.   The abstract, titled “Liver pharmacodynamics in an open-label phase Ib/IIa study of fostroxacitabine bralpamide (fostrox, MIV-

    BioStock: Medivir optimizes study design after meeting FDA

    Medivir has held another meeting with the FDA concerning the upcoming global phase IIb study, in which the company’s drug candidate, fostrox, will be evaluated in combination with Lenvima in liver cancer patients. The aim is to initiate the study in the US by early 2025.– We have great momentum in the development program with fostrox right now, says Medivir’s CEO Jens Lindberg.Read the full interview with Jens Lindberg at biostock.se: https://www.biostock.se/en/2024/04/medivir-optimizes-study-design-after-meeting-fda/ This is a press release from BioStock - Connecting Innovation &

    FDA grants Medivir´s MIV-711 Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Legg-Calvé-Perthes Disease

    Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that its selective cathepsin K inhibitor, MIV-711, has been granted Rare Pediatric Disease Designation (RPDD) as well as Orphan Drug Designation (ODD) for the treatment of Legg-Calvé-Perthes Disease (LCPD).   The FDA defines a rare pediatric disease as a serious or life-threatening disease in which the disease manifestations primarily affect individuals aged from birth to 18 years of age. Pediatric

    Medivir provides update from supportive Type C meeting with the FDA; preparations for enhanced phase 2b in HCC with fostrox + Lenvima continue

    Stockholm — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today an update from a Type C meeting with the FDA, regarding the company’s plans for a global phase 2b study and opening of an IND for fostroxacitabine bralpamide (fostrox) in the US.   The key outcome of the Type C meeting was that Medivir’s preparations for the randomized phase 2b study, comparing fostrox + Lenvima® with Lenvima alone, continues with two key adjustments to the study design.   Firstly,

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