Datum | Källa | Rubrik | Typ | Alternativ |
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2024-04-23 | Vivesto | Vivesto publicerar årsredovisning för 2023 | Rapporter | Ladda ner | Visa Stäng |
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2024-04-23 | Vivesto | Notice of Annual General Meeting in Vivesto AB | Pressreleaser | Ladda ner | Visa Stäng |
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2024-04-23 | Vivesto | Kallelse till årsstämma i Vivesto AB | Pressreleaser | Ladda ner | Visa Stäng |
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2024-03-19 | Vivesto | Vivesto bjuder in till livesänd R&D Update med fokus på Paccal Vet den 26 mars | Pressreleaser | Ladda ner | Visa Stäng |
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2024-03-19 | Vivesto | Vivesto to hold live-streamed Paccal Vet R&D Update on March 26 | Pressreleaser | Ladda ner | Visa Stäng |
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2024-03-07 | Vivesto | Första patienten doserad i Vivestos kliniska studie med Paccal Vet | Pressreleaser | Ladda ner | Visa Stäng |
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2024-03-07 | Vivesto | Vivesto doses first patient in its clinical Paccal Vet trial | Pressreleaser | Ladda ner | Visa Stäng |
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2024-02-26 | Penser Access by Carnegie | Penser Access by Carnegie: Intervju med Vivesto - Carnegie Investment Bank - 26 feb 2024 | Pressreleaser | Visa Stäng |
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2024-02-22 | Vivesto | Bokslutskommuniké för räkenskapsåret 1 januari – 31 december 2023 | Rapporter | Ladda ner | Visa Stäng |
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2024-01-30 | Vivesto | Vivestos internationella patentansökan för XR-18 får positivt besked | Pressreleaser | Ladda ner | Visa Stäng |
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2024-01-30 | Vivesto | Vivesto's international patent application for XR-18 receives positive decision | Pressreleaser | Ladda ner | Visa Stäng |
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2023-12-28 | Vivesto | Vivestos amerikanska kliniska studie med Paccal Vet får godkänt att starta patientrekrytering | Pressreleaser | Ladda ner | Visa Stäng |
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2023-12-28 | Vivesto | Vivesto’s US clinical Paccal Vet trial receives approval to start patient recruitment | Pressreleaser | Ladda ner | Visa Stäng |
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2023-12-22 | Vivesto | Vivesto’s Paccal Vet granted FDA MUMS designation | Pressreleaser | Ladda ner | Visa Stäng |
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2023-12-22 | Vivesto | Vivestos Paccal Vet beviljas MUMS-klassificering av FDA | Pressreleaser | Ladda ner | Visa Stäng |
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2023-12-22 | Vivesto | Vivesto gör nedskrivning av tillgångar efter tillbakadragande av de europeiska marknadsföringstillstånden för Apealea | Pressreleaser | Ladda ner | Visa Stäng |
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2023-12-22 | Vivesto | Vivesto makes impairment charge following withdrawal of European market authorizations for Apealea | Pressreleaser | Ladda ner | Visa Stäng |
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2023-12-19 | Vivesto | Vivesto reports positive preclinical data supporting continued development of Cantrixil | Pressreleaser | Ladda ner | Visa Stäng |
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2023-12-19 | Vivesto | Vivesto rapporterar positiva prekliniska data som stödjer fortsatt utveckling av Cantrixil | Pressreleaser | Ladda ner | Visa Stäng |
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2023-11-23 | Vivesto | Nomination Committee appointed for the 2024 Annual General Meeting in Vivesto | Pressreleaser | Ladda ner | Visa Stäng |
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2023-11-23 | Vivesto | Valberedning utsedd inför Vivestos årsstämma 2024 | Pressreleaser | Ladda ner | Visa Stäng |
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2023-11-23 | Vivesto | Vivesto och Elevar tecknar avtal för att avsluta partnerskap rörande Apealea® | Pressreleaser | Ladda ner | Visa Stäng |
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2023-11-23 | Vivesto | Vivesto and Elevar sign agreement ending Apealea® partnership | Pressreleaser | Ladda ner | Visa Stäng |
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2023-11-17 | Penser Access | Penser Access: Intervju med Vivesto - Erik Penser Bank - 17 november 2023 | Pressreleaser | Visa Stäng |
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2023-11-16 | Vivesto | Delårsrapport för perioden 1 januari – 30 september 2023 | Rapporter | Ladda ner | Visa Stäng |
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2023-11-16 | Vivesto | Interim report for the period January 1, 2023 – September 30, 2023 | Rapporter | Ladda ner | Visa Stäng |
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2023-10-26 | Penser Access | Penser Access: Intervju med Vivesto - Erik Penser Bank - 26 oktober 2023 | Pressreleaser | Visa Stäng |
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2023-10-25 | Vivesto | Vivesto focuses its project portfolio and introduces cost-saving measures | Pressreleaser | Ladda ner | Visa Stäng |
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2023-10-25 | Vivesto | Vivesto fokuserar projektportföljen och inför kostnadsbesparande åtgärder | Pressreleaser | Ladda ner | Visa Stäng |
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2023-09-15 | Vivesto | Delisting of Vivesto’s shares from Frankfurt Stock Exchange effective as of 15 September 2023 | Pressreleaser | Ladda ner | Visa Stäng |
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2023-09-15 | Vivesto | Avnotering av Vivestos aktier från Frankfurt Stock Exchange per den 15 september 2023 | Pressreleaser | Ladda ner | Visa Stäng |
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2023-08-24 | Vivesto | Delårsrapport för perioden 1 januari – 30 juni 2023 | Rapporter | Ladda ner | Visa Stäng |
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2023-08-24 | Vivesto | Interim report for the period January 1, 2023 – June 30, 2023 | Rapporter | Ladda ner | Visa Stäng |
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2023-08-04 | Vivesto | Vivesto announces early termination of patient enrollment in the investigator-initiated Phase 1b Docetaxel micellar study | Pressreleaser | Ladda ner | Visa Stäng |
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2023-08-04 | Vivesto | Vivesto meddelar att rekryteringen av patienter i den prövarinitierade fas 1b-studien med Docetaxel micellar avslutas i förtid | Pressreleaser | Ladda ner | Visa Stäng |
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2023-06-16 | Vivesto | Vivesto announces positive Paccal Vet FDA pre-submission meeting | Pressreleaser | Ladda ner | Visa Stäng |
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2023-06-16 | Vivesto | Vivesto har haft positivt pre-submission möte med FDA om Paccal Vet | Pressreleaser | Ladda ner | Visa Stäng |
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2023-05-25 | Vivesto | Report from Annual General Meeting in Vivesto AB | Pressreleaser | Ladda ner | Visa Stäng |
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2023-05-25 | Vivesto | Kommuniké från årsstämma i Vivesto AB | Pressreleaser | Ladda ner | Visa Stäng |
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2023-05-25 | Vivesto | Delårsrapport för perioden januari – mars 2023 | Rapporter | Ladda ner | Visa Stäng |
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2023-05-25 | Vivesto | Interim report for the period January 2023 – March 2023 | Rapporter | Ladda ner | Visa Stäng |
Rapporter |
Interim report for the period January 2023 – March 2023SIGNIFICANT EVENTS DURING THE FIRST QUARTER
FIRST QUARTER: JANUARY 1, 2023 – MARCH 31, 2023
CEO REVIEW As a result of our review, we decided to intensify our investment in veterinary oncology. There is a great unmet medical need for better treatments and more effective veterinary oncology drugs. This is especially true in the treatment of cancer in dogs, where drugs developed for humans through so-called off-label use are widely used. Since today’s human medicines are not designed for use in pets, they are often associated with side effects and lack of efficacy. It is clearly demonstrated in current paclitaxel formulations which, due to the fact that they contain the solvent cremophor or human albumin, are not tolerated by dogs and therefore are excluded as a treatment option despite paclitaxel being a well-documented and effective cytostatic drug. The market for veterinary medicines in general is growing as the number of pets grows, and especially the number of dogs. At the same time, we are becoming increasingly aware of the importance of caring for our pets and more willing to pay for adequate medical care and medicines. Based on the great medical need and the commercial potential we see in the field, we have decided to initiate clinical development of the veterinary oncology drug candidate Paccal Vet. In a first step, we plan to start a clinical efficacy study with Paccal Vet in dogs in the cancer indications hemangiosarcoma and malignant melanoma during the second half of the year. Both are indications where there are currently no approved chemotherapy treatments available. Positive safety and efficacy data are already available for the use of Paccal Vet in dogs. A pre-submission meeting with the FDA is planned to discuss the continued clinical development path for Paccal Vet and we await feedback from that meeting in early summer. In March, American pharmaceutical company Elevar Therapeutics announced its intention to transfer the rights and obligations of the cancer drug Apealea to a third party. Vivesto has had a global strategic partnership with Elevar since 2020 and so far Apealea has been market-launched in Germany by Elevar’s partner Inceptua. Although there are ongoing pre-launch activities in other markets, such as the UK, our view is that the launch and sales in Europe have developed significantly slower than expected. We therefore see Elevar’s announcement as a potential opportunity where we could find a more suitable partner to drive sales and the continued development of Apealea. We are now working intensively with Elevar to explore all the possibilities that this new situation may present. In parallel, we are also working to find a partner for Apealea in China, which we see as an important and prioritized market. An important part of the review has been to evaluate the company’s existing development projects to find out if it is possible to increase the chances of success, shorten the time to market approval or increase the future market potential. As a result of this work, we intend to expand the indication area for the Cantrixil cancer program to also include bladder cancer and blood cancer, both indications with high unmet medical needs and significant commercial potential. I look forward to coming back with more information when we have a more detailed development plan in place. Patient recruitment in the investigator-initiated Phase 1b study evaluating Docetaxel micellar in patients with metastatic prostate cancer continues and more than half of the planned patients have been included. However, recruitment is somewhat slower than expected and we are therefore evaluating together with the study’s sponsor, the Swiss Group for Clinical Cancer Research (SAKK), various opportunities for continued recruitment in the study. In doing so, we hope to be able to keep to the schedule and complete the study before the end of the year and be able to present results in 2024 according to plan. In addition to our clinical projects, we are actively working to develop the next generation drug delivery technology XR-18, a technology that may play an important role for many molecules that today cannot be used because they are too large or do not dissolve properly. XR-18 works in the same way as Vivesto’s existing technology XR-17, which is used with the drug Apealea, among other things. It makes poorly soluble substances soluble in order to improve uptake in potential patients. In addition, XR-18 has some improved and novel properties that are currently being evaluated in ongoing in vitro studies. In parallel with the development of XR-18, early evaluation of trials with poorly soluble drug substances is also underway. What we have observed so far looks promising, although the project is at an early stage. To streamline the organization and reduce our running costs, we are now reorganizing Vivesto to strengthen our focus on research and development. This means that we reduce the company’s internal expertise in quality control and analysis in the production of pharmaceuticals, as well as general administrative resources to partially replace them with external consulting services. It is estimated that the number of permanent employees can thus be reduced by five people. At the same time, the Chief Medical Officer has announced that he wishes to seek a new assignment outside the company and we are now reviewing the possibilities of replacing the need for medical expertise with flexible external resources to further streamline operations. Overall, after my first months as CEO, I see significant potential in Vivesto. This applies both to our existing assets, as well as the opportunity to develop the company by using the expertise and experience we have internally in taking a drug from early development, through the clinical and regulatory development stages. An expansion of the portfolio with projects in preclinical or early clinical development phases will be evaluated. Drug development in the early phase involves less extensive studies and requires significantly less resources in the form of capital and personnel, while the increase in value in a project can be significant in the event of successful development. The possibilities are many but given the current company-specific conditions and the overall market situation, the company still intends to have a strict cost focus. Our work continues with a clear ambition – to develop Vivesto into a leading research and development company focusing on the development of new treatment options for patients with high unmet medical needs. Thank you for your continued support. The report is available on the company’s website: https://www.vivesto.com/en/financial-reports-and-presentations/ For more information: |
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2023-04-25 | Vivesto | Kallelse till årsstämma i Vivesto AB | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-25 | Vivesto | Notice of Annual General Meeting in Vivesto AB | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-25 | Vivesto | Vivesto publicerar årsredovisning för 2022 | Rapporter | Ladda ner | Visa Stäng |
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2023-04-25 | Vivesto | Vivesto publishes Annual Report for 2022 | Rapporter | Ladda ner | Visa Stäng |
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