Datum | Källa | Rubrik | Typ | Alternativ |
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2023-11-29 | Alzinova | Alzinova meddelar positiva fas 1b-resultat med vaccinkandidaten ALZ-101 mot Alzheimers sjukdom | Pressreleaser | Ladda ner | Visa Stäng |
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2023-11-29 | Alzinova | Alzinova announces positive phase 1b results with the vaccine candidate ALZ-101 against Alzheimer's disease | Pressreleaser | Ladda ner | Visa Stäng |
Pressreleaser |
Alzinova announces positive phase 1b results with the vaccine candidate ALZ-101 against Alzheimer’s disease
Alzinova AB (publ) (ticker: ALZ) announces positive top-line results from its phase 1b clinical trial of the vaccine candidate ALZ-101 in Alzheimer’s disease. A first analysis of the study data shows that ALZ-101 has continued good tolerability, an acceptable safety profile and a high immune responder rate. Furthermore, the results show that patients treated with ALZ-101 responded with antibody levels that increased with the number of doses given. A full analysis of the study data is expected to be completed in the first quarter of 2024. The positive results support continued clinical development of ALZ-101, and preparations for a planned phase 2 study are ongoing. The primary endpoint of the study is to evaluate the safety and tolerability of repeated doses of the vaccine candidate ALZ-101 in patients with early Alzheimer’s disease. The study also includes secondary and exploratory endpoints related to immune response and biomarkers. Exploratory efficacy data of the treatment’s effect on biomarkers and cognition will be included in the full analysis of the study results, which is expected to be completed in the first quarter of 2024. “The positive top-line results further strengthen our confidence in that ALZ-101 can become a unique therapeutic vaccine and thus help patients suffering from Alzheimer’s disease and their families to a better life. Alzinova has the potential to revolutionise the treatment of Alzheimer’s, and we look forward to the final analysis, where we will see outcomes on several different endpoints. This result also strengthens our position in discussions with potential partners”, says Alzinova’s CEO Kristina Torfgård. The double-blind randomised phase 1b study included 26 patients with early Alzheimer’s disease. The study, which is divided into two parts, is examining two different dose levels of ALZ-101, 125 and 250 μg, as well as placebo. In part A of the study, 20 patients were treated with ALZ-101 vaccine and six patients with placebo. The top-line results are based on analysis after the first part of treatment when all patients received four doses over 20 weeks of treatment. Results from part A show good tolerability, an acceptable safety profile and a high immune responder rate. All 26 patients completed part A of the study. Antibody levels show that the patients administered with ALZ-101 responded favourably to treatment with antibody levels increasing with the number of doses given. One patient who entered the study with a history of ARIA-H (microbleeding) had a symptom-free increase in size. No patients developed ARIA-E (localised brain swelling). ”Alzinova has the potential to transform the treatment of Alzheimer’s, which has now been confirmed by the strong results from the first part of the study, and we look forward to seeing the results from part B of the study. Our vaccine candidate has great potential to make a difference in reducing the burden for both patients and the healthcare system.”, says Alzinova’s CMO Kirsten Harting. All patients underwent magnetic resonance imaging to detect ARIA-E and ARIA-H. These types of side effects can occur with antibody treatment against the peptide Aβ. ARIA-H may occur spontaneously in individuals with mild cognitive impairment or Alzheimer’s disease. Clinical studies on Aβ antibodies have previously shown an increased risk of both ARIA-E and ARIA-H as a result of the treatments. Alzinova is proceeding with the extension part (part B) of the study, where all patients are offered active treatment with ALZ-101 for a 20-week period. Patients are then followed during 48 weeks. Part B of the study will provide information on long-term safety and tolerability, the long-term immune response, as well as information on the effect on biomarkers and cognitive functions. About ALZ-101 and Alzheimer’s disease |
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2023-11-21 | Penser Future | Penser Future: Terapeutiskt vaccin mot Alzheimers sjukdom i fokus - Alzinova AB | Pressreleaser | Visa Stäng |
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2023-11-20 | Alzinova | Alzinova presents at Erik Penser Bank's Investor Day on November 23rd | Pressreleaser | Ladda ner | Visa Stäng |
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2023-11-20 | Alzinova | Alzinova presenterar på Erik Penser Banks Bolagsdag den 23 november | Pressreleaser | Ladda ner | Visa Stäng |
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2023-11-06 | Alzinova | BioStock: Alzinova om förväntningarna inför BIO-Europe | Pressreleaser | Visa Stäng |
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2023-11-02 | Redeye | Redeye: Alzinova Q3 - All eyes on the readout | Pressreleaser | Ladda ner | Visa Stäng |
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2023-11-02 | Alzinova | Alzinova AB interim report January – September 2023 | Rapporter | Ladda ner | Visa Stäng |
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2023-11-02 | Alzinova | Alzinova AB delårsrapport för januari - september 2023 | Rapporter | Ladda ner | Visa Stäng |
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2023-10-24 | Alzinova | Alzinova anlitar Erik Penser Bank som likviditetsgarant | Pressreleaser | Ladda ner | Visa Stäng |
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2023-10-24 | Alzinova | Alzinova engages Erik Penser Bank as liquidity provider | Pressreleaser | Ladda ner | Visa Stäng |
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2023-10-05 | Alzinova | Alzinova will attend Europe's largest Life Science conference and investor meetings this fall | Pressreleaser | Ladda ner | Visa Stäng |
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2023-10-05 | Alzinova | Alzinova deltar under hösten vid Europas största Life science-konferens och investerarträffar | Pressreleaser | Ladda ner | Visa Stäng |
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2023-09-28 | Alzinova | BioStock: Alzinova säkrar regulatoriskt stöd från EMA | Pressreleaser | Visa Stäng |
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2023-09-26 | Alzinova | Alzinova erhåller positivt svar från European Medicines Agency EMA | Pressreleaser | Ladda ner | Visa Stäng |
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2023-09-26 | Alzinova | Alzinova receives positive response from the European Medicines Agency EMA | Pressreleaser | Ladda ner | Visa Stäng |
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2023-09-21 | Alzinova | Alzinova interviewed by Redeye in connection with World Alzheimer's Day | Pressreleaser | Ladda ner | Visa Stäng |
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2023-09-21 | Alzinova | Alzinova intervjuas hos Redeye i samband med World Alzheimer’s Day | Pressreleaser | Ladda ner | Visa Stäng |
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2023-09-11 | Alzinova | BioStock: Alzinovas vd sammanfattar 2023 och blickar framåt | Pressreleaser | Visa Stäng |
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2023-08-25 | Alzinova | Alzinova inleder samarbete med PolyPeptide | Pressreleaser | Ladda ner | Visa Stäng |
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2023-08-25 | Alzinova | Alzinova initiates collaboration with PolyPeptide | Pressreleaser | Ladda ner | Visa Stäng |
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2023-08-17 | Redeye | Redeye: Alzinova Q2 2023 - Proactive preparations | Pressreleaser | Ladda ner | Visa Stäng |
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2023-08-17 | Alzinova | Alzinova AB interim report January – June 2023 | Rapporter | Ladda ner | Visa Stäng |
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2023-08-17 | Alzinova | Alzinova AB delårsrapport för januari - juni 2023 | Rapporter | Ladda ner | Visa Stäng |
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2023-08-10 | Alzinova | BioStock: Alzinova meddelar positiva samtal med FDA | Pressreleaser | Visa Stäng |
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2023-08-09 | Alzinova | Alzinova avancerar efter positivt Pre-IND-möte med FDA | Pressreleaser | Ladda ner | Visa Stäng |
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2023-08-09 | Alzinova | Alzinova progresses following positive Pre-IND meeting with FDA | Pressreleaser | Ladda ner | Visa Stäng |
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2023-08-03 | Alzinova | Alzinova rekryterar Kirsten Harting som ny Chief Medical Officer | Pressreleaser | Ladda ner | Visa Stäng |
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2023-08-03 | Alzinova | Alzinova recruits Kirsten Harting as new Chief Medical Officer | Pressreleaser | Ladda ner | Visa Stäng |
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2023-06-16 | Alzinova | BioStock: Alzinovas vd om kontakterna med FDA och EMA - BioStock | Pressreleaser | Visa Stäng |
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2023-06-13 | Alzinova | Alzinova ansöker om Pre-IND möte med FDA och EMA Scientific Advice | Pressreleaser | Ladda ner | Visa Stäng |
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2023-06-13 | Alzinova | Alzinova submits request for Pre-IND meeting with FDA and applies for EMA Scientific Advice | Pressreleaser | Ladda ner | Visa Stäng |
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2023-05-30 | Alzinova | Bulletin from the annual general meeting of Alzinova AB (publ) | Pressreleaser | Ladda ner | Visa Stäng |
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2023-05-30 | Alzinova | Kommuniké från årsstämma i Alzinova AB (publ) | Pressreleaser | Ladda ner | Visa Stäng |
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2023-05-29 | Alzinova | First patient dosed in the extension part of the phase 1b study with ALZ-101 | Pressreleaser | Ladda ner | Visa Stäng |
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2023-05-29 | Alzinova | Första patienten doserad i förlängningsdelen av fas 1b studien med ALZ-101 | Pressreleaser | Ladda ner | Visa Stäng |
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2023-05-17 | Redeye | Redeye: Alzinova Q1 2023 - Promising clinical progress | Pressreleaser | Ladda ner | Visa Stäng |
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2023-05-17 | Alzinova | Alzinova AB delårsrapport för januari - mars 2023 | Rapporter | Ladda ner | Visa Stäng |
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2023-05-17 | Alzinova | Alzinova AB interim report January – March 2023 | Rapporter | Ladda ner | Visa Stäng |
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2023-05-10 | Alzinova | BioStock: Fortsatt robusta interimdata i Alzinovas Alzheimerstudie | Pressreleaser | Visa Stäng |
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2023-05-04 | Alzinova | Alzinova: Nya positiva interimdata från pågående fas 1b-studie med vaccinkandidaten ALZ-101 – Inleder förlängning av studien | Pressreleaser | Ladda ner | Visa Stäng |
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2023-05-04 | Alzinova | Alzinova: New positive interim data from ongoing phase 1b study with vaccine candidate ALZ-101 – Initiates extension of the study | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-28 | Alzinova | Alzinova publicerar årsredovisningen för 2022 | Rapporter | Ladda ner | Visa Stäng |
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2023-04-28 | Alzinova | Alzinova publishes the Annual Report for 2022 | Rapporter | Ladda ner | Visa Stäng |
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2023-04-27 | Alzinova | Alzinova: Förändring i ledningsgruppen | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-27 | Alzinova | Alzinova: Change in the management team | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-27 | Alzinova | Warrants of series TO3 were subscribed to approximately 93.4 percent and Alzinova receives approximately SEK 26.3 million | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-27 | Alzinova | Teckningsoptioner av serie TO3 nyttjades till cirka 93,4 procent och Alzinova tillförs cirka 26,3 MSEK | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-25 | Alzinova | Notice of annual general meeting in Alzinova AB (publ) | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-25 | Alzinova | Kallelse till årsstämma i Alzinova AB (publ) | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-24 | Alzinova | Alzinova terminates agreement with liquidity provider | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-24 | Alzinova | Alzinova avslutar avtal med likviditetsgarant | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-21 | Alzinova | BioStock: Inlösen av Alzinovas TO3 kan tillföra 28 Mkr | Pressreleaser | Visa Stäng |
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2023-04-21 | Alzinova | Sista dag för handel med teckningsoptionerna av serie TO3 i Alzinova AB är idag, den 21 april 2023 | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-21 | Alzinova | The last day of trading with the warrants of series TO3 in Alzinova AB is today, April 21, 2023 | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-18 | Alzinova | BioStock: Alzinova når milstolpe i Alzheimerstudie | Pressreleaser | Visa Stäng |
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2023-04-18 | Alzinova | Alzinova erhåller myndighetsgodkännande inför förlängningsdel av fas 1b-studie | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-18 | Alzinova | Alzinova receives regulatory approval for extension part of phase 1b study | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-13 | Alzinova | Alzinova AB meddelar om ingångna teckningsförbindelser motsvarande 26,6 procent av utestående teckningsoptioner av serie TO3 | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-13 | Alzinova | Alzinova AB announces subscription commitments corresponding to 26.6 percent of outstanding warrants of series TO3 | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-12 | Alzinova | Alzinova: Samtliga patienter i fas 1b-studien har fått fjärde och sista dosen | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-12 | Alzinova | Alzinova: All patients in the phase 1b study have received the fourth and final dose | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-11 | Alzinova | Teckning av aktier med stöd av teckningsoptioner av serie TO3 inleds idag | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-11 | Alzinova | Subscription of shares supported by warrants of series TO3 begins today | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-05 | Alzinova | Teckningskursen för nyttjande av teckningsoptioner av serie TO3 i Alzinova har fastställts till 2,17 SEK per aktie | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-05 | Alzinova | The subscription price for exercise of warrants of series TO3 in Alzinova has been set at SEK 2.17 per share | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-05 | Alzinova | Intresse från potentiella partners och positivt mottagande av ALZ-101 på AD/PD™ konferensen | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-05 | Alzinova | Interest from potential partners and positive response to ALZ-101 at the AD/PD™ conference | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-03 | Alzinova | BioStock: Alzinova presenterade lovande data vid internationell konferens | Pressreleaser | Visa Stäng |
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2023-03-29 | Alzinova | Alzinova presents promising data for the ALZ-101 vaccine at the international Alzheimer conference AD/PD™ | Pressreleaser | Ladda ner | Visa Stäng |
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2023-03-29 | Alzinova | Alzinova presenterar lovande data på vaccinet ALZ-101 vid den internationella Alzheimerkonferensen AD/PD™ | Pressreleaser | Ladda ner | Visa Stäng |
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2023-03-23 | Alzinova | BioStock: Alzinovas patentansökan stärker portföljen | Pressreleaser | Visa Stäng |
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2023-03-22 | Alzinova | Alzinova - Ny Alzheimerkandidat stormar fram - Mangold Insight Analys | Pressreleaser | Ladda ner | Visa Stäng |
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2023-03-21 | Alzinova | Alzinova ansöker om patent för antikroppen ALZ-201 | Pressreleaser | Ladda ner | Visa Stäng |
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2023-03-21 | Alzinova | Alzinova files patent application for the ALZ-201 antibody | Pressreleaser | Ladda ner | Visa Stäng |
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2023-03-16 | Alzinova | Alzinova: Ny positiv säkerhetsgranskning av fas 1b-studien för vaccinet ALZ-101 | Pressreleaser | Ladda ner | Visa Stäng |
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2023-03-16 | Alzinova | Alzinova: New positive safety review of the Phase 1b study for the ALZ-101 vaccine | Pressreleaser | Ladda ner | Visa Stäng |
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2023-03-08 | Alzinova | Alzinova presents at several conferences and investor meetings in the spring of 2023 | Pressreleaser | Ladda ner | Visa Stäng |
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2023-03-08 | Alzinova | Alzinova presenterar på flera konferenser och investerarträffar under våren 2023 | Pressreleaser | Ladda ner | Visa Stäng |
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2023-03-03 | Alzinova | BioStock: Alzinovas vd ser fler potentiella framsteg under 2023 | Pressreleaser | Visa Stäng |
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2023-02-23 | Redeye | Redeye: Alzinova Q4 report - Right on track | Pressreleaser | Ladda ner | Visa Stäng |
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2023-02-23 | Alzinova | Alzinova AB Year-end report 2022 | Rapporter | Ladda ner | Visa Stäng |
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2023-02-23 | Alzinova | Alzinova AB Bokslutskommuniké för 2022 | Rapporter | Ladda ner | Visa Stäng |
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2023-02-09 | Alzinova | BioStock: Han ska leda Alzinovas affärsutveckling framåt | Pressreleaser | Visa Stäng |
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2023-01-24 | Alzinova | Alzinova rekryterar Business Development Director | Analyser | Ladda ner | Visa Stäng |
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2023-01-24 | Alzinova | Alzinova recruits Business Development Director | Analyser | Ladda ner | Visa Stäng |
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2023-01-11 | Alzinova | BioStock: Alzinova om FDA-godkännandet av lecanemab | Pressreleaser | Visa Stäng |
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2023-01-05 | Alzinova | BioStock: Alzinovas CSO om de nya vetenskapliga rönen kring ALZ-201 | Pressreleaser | Visa Stäng |
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2023-01-03 | Alzinova | Published research demonstrates high specificity of Alzinova's ALZ-201 antibody which may contribute to good efficacy and favourable side-effect profile | Analyser | Ladda ner | Visa Stäng |
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2023-01-03 | Alzinova | Publicerade forskningsresultat påvisar hög specificitet hos Alzinovas antikropp ALZ-201 vilket kan bidra till god effekt och fördelaktig biverkningsprofil | Analyser | Ladda ner | Visa Stäng |
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2022-12-21 | Alzinova | BioStock: Alzinova om interimsresultaten och den nu fullrekryterade fas Ib-studien | Pressreleaser | Visa Stäng |
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2022-12-19 | Alzinova | Alzinova reaches important milestone - phase 1b study fully recruited | Analyser | Ladda ner | Visa Stäng |
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2022-12-19 | Alzinova | Alzinova når viktig milstolpe - fas 1b-studie fullrekryterad | Analyser | Ladda ner | Visa Stäng |
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2022-12-15 | Alzinova | Alzinova presents at Redeye Investor AW - Gothenburg | Analyser | Ladda ner | Visa Stäng |
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2022-12-15 | Alzinova | Alzinova presenterar på Redeye Investor AW - Göteborg | Analyser | Ladda ner | Visa Stäng |
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2022-12-12 | Alzinova | Alzinova meddelar ny positiv säkerhetsgranskning och interimsdata från pågående fas 1b-studie med vaccinkandidaten ALZ-101 | Analyser | Ladda ner | Visa Stäng |
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2022-12-12 | Alzinova | Alzinova announces new positive safety review and interim data from ongoing phase 1b study with vaccine candidate ALZ-101 | Analyser | Ladda ner | Visa Stäng |
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2022-12-01 | Alzinova | BioStock: Alzinovas CSO om presentationen av ALZ-201 på CTAD | Pressreleaser | Visa Stäng |
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