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2023-08-14 | Biosergen | Biosergen AB: Biosergen publishes interim report for first quarter 2023 | Pressreleaser | Ladda ner | Visa Stäng |
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2023-08-11 | Biosergen | Biosergen AB: The subscription price for warrants series TO2 in Biosergen has been determined to SEK 0.66 and the exercise period starts on August 14, 2023 | Pressreleaser | Ladda ner | Visa Stäng |
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2023-08-11 | Biosergen | Biosergen AB: Biosergen publish financial report for second quarter ahead of schedule. | Pressreleaser | Ladda ner | Visa Stäng |
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2023-08-07 | Biosergen | Biosergen AB: Biosergen Announces Abstract Accepted for Presentation at the 11th Congress on Trends in Medical Mycology (TIMM-11) | Pressreleaser | Ladda ner | Visa Stäng |
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2023-06-12 | Biosergen | Biosergen AB: Biosergen will present at Aktiespararnas Småbolagsdagarna June 13, 2023 | Pressreleaser | Visa Stäng |
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2023-05-31 | Biosergen | Biosergen AB: Biosergen publishes interim report for first quarter 2023 | Rapporter | Ladda ner | Visa Stäng |
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2023-05-31 | Biosergen | Bulletin from the annual general meeting on 31 May 2023 in Biosergen AB | Pressreleaser | Ladda ner | Visa Stäng |
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2023-05-10 | Biosergen | Biosergen AB: Biosergen publishes 2022 annual report | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-28 | Biosergen | Notice of annual general meeting in Biosergen AB | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-05 | Biosergen | Biosergen AB: Biosergen - Reduced risk after positive phase 1-studies - Mangold Insight Analys | Pressreleaser | Ladda ner | Visa Stäng |
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2023-04-05 | Biosergen | Biosergen AB: Biosergen - Minskad risk efter positiva fas 1-studier - Mangold Insight Analys | Pressreleaser | Ladda ner | Visa Stäng |
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2023-03-31 | Biosergen | Biosergen AB: Biosergen publishes interim report for fourth quarter 2022 | Rapporter | Ladda ner | Visa Stäng |
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2023-03-29 | Carlsquare | Carlsquare: Mrkt BUZZ, Biosergen: Plans for speedy development of lead candidate | Pressreleaser | Ladda ner | Visa Stäng |
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2023-03-29 | Biosergen | Biosergen AB: Biosergen provides Phase 2 clinical development strategy update | Pressreleaser | Ladda ner | Visa Stäng |
Pressreleaser |
Biosergen AB: Biosergen provides Phase 2 clinical development strategy updateBiosergen is pleased to announce its plans to initiate its first Phase 2 clinical trial towards the end of Q2 2023. The multi-indication, open-label, single-center trial will be conducted at a site in India and enrol 15 patients suffering from invasive fungal infections, expected to include the infectious diseases the Company has previously highlighted as the main candidates for its Phase 2 programs; mucormycosis (”Black Fungus”), aspergillosis, and later febrile, neutropenic patients with symptoms of invasive fungal disease. The key enrolment criteria for the first phase 2 trial is, that the patients are, or have been, undergoing treatment with an Amphotericin B antifungal product but, due to intolerability or toxicity of Amphotericin B, have been taken off this last resort treatment, and are left without any effective treatment options. A top-line data readout is expected approximately six months after the dosing of the first patient, expected in early Q3 2023. Study rationale The primary endpoint of the trial has been designed to show that BSG005 has the potential to challenge Amphotericin B’s role as a last resort treatment in difficult-to-treat invasive fungal infections. The choice to focus on this endpoint was prompted by the recent positive outcome of the Company’s Phase I trial, as announced on March 13 ( https://mb.cision.com/Main/20568/3732376/1907335.pdf ), where no serious adverse events were observed. Importantly, there were no signs in all laboratory assessments of any influence from BSG005 on kidney and liver function. This is significant because currently, 20 – 40% of patients receiving an Amphotericin B product have to be taken off the treatment due to organ intolerance or toxicity, mainly kidney damage. For the vast majority of such seriously ill patients, where Amphotericin B is not a viable treatment option, there are no real effective alternative treatments, and the invasive fungal infection may, for example in the case of mucormycosis, severely injure patients’ organs, and develop into a life-threatening condition or major disability. Since Biosergen became a listed company in June 2021, the general market conditions for biotech companies’ access to capital have deteriorated due to macroeconomic changes. Therefore, it is currently highly important to de-risk clinical development and plan as thoroughly as possible for maximal clinical impact for patients in the first single-indication registration trial. With the data from the multi-indication Phase 2 trial announced today, Biosergen will be able to identify any significant indicative differences in the potency of BSG005 for the treatment of various invasive fungal infectious diseases. In addition, the Company will gain important data on needed dosing size, treatment cycle time, and more. Such data will be valuable in qualifying the decision on what disease to initiate the Company’s first subsequent registration-oriented single-indication Phase 2 trial and ensure an optimized trial design. Additionally, having data from a human clinical trial verifying that BSG005 shows potency as a valuable treatment for specific patient populations, which globally currently does not have any real treatment options, will increase Biosergen’s chances of securing non-dilutive soft-money funding of the further development of BSG005, as the Company has successfully done in the past. The Company’s two main targets for registration-oriented Phase 2 trials remain to be mucormycosis and, of course, the Aspergillosis indication for which Biosergen has Orphan Drug Designation in the US. Biosergen does not anticipate that this trial will prompt a need for additional equity financing. Biosergen’s CEO Peder M. Andersen comments: |
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2023-03-28 | Biosergen | Biosergen AB: Biosergen will be participating in Investerarträff arranged by Financial Stockholm, March 29 | Pressreleaser | Visa Stäng |
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2023-03-21 | Biosergen | Biosergen AB: Biosergen will be participating at Mangold Insight Investor Day, March 22 | Pressreleaser | Visa Stäng |
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2023-03-21 | Biosergen | Biosergen AB: Carlsquare has initiated its coverage of Biosergen | Pressreleaser | Visa Stäng |
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2023-03-20 | Carlsquare | Carlsquare: Initiation of coverage, Biosergen: Make antifungals great again | Pressreleaser | Ladda ner | Visa Stäng |
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2023-03-13 | Biosergen | Biosergen AB: Positive topline data from phase 1 study of BSG005 shows it is safe and well tolerated. It gives hope for a change in the treatment paradigm of patients with invasive fungal infections. | Pressreleaser | Ladda ner | Visa Stäng |
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2023-01-24 | Biosergen | Biosergen AB: Biosergen - Fungicide with potential - Mangold Insight Analys | Pressreleaser | Ladda ner | Visa Stäng |
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2023-01-24 | Biosergen | Biosergen AB: Biosergen - Svampdödare med potential - Mangold Insight Analys | Pressreleaser | Ladda ner | Visa Stäng |
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2023-01-16 | Biosergen | Biosergen AB: Biosergen completes the first Multiple Ascending Dose (MAD) cohort of BSG005 phase I trial | Pressreleaser | Ladda ner | Visa Stäng |
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2022-12-12 | Biosergen | Biosergen AB: The first volunteer has been dosed in the MAD part of the Phase I trial of BSG005 | Pressreleaser | Ladda ner | Visa Stäng |
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2022-11-30 | Biosergen | Biosergen AB: Biosergen publishes interim report for third quarter 2022 | Rapporter | Ladda ner | Visa Stäng |
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2022-10-20 | Biosergen | Biosergen AB: Biosergen's warrants of series TO2 are admitted to trading | Pressreleaser | Ladda ner | Visa Stäng |
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2022-10-19 | Biosergen | Biosergen AB: Biosergen allocates shares to an underwriter in connection with the completed rights issue | Pressreleaser | Ladda ner | Visa Stäng |
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2022-10-05 | Biosergen | Biosergen AB: Biosergen appoints Mangold Fondkommission to act as a liquidity provider | Pressreleaser | Ladda ner | Visa Stäng |
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2022-10-04 | Biosergen | Biosergen AB: Biosergen announces the outcome in the rights issue | Pressreleaser | Ladda ner | Visa Stäng |
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2022-09-26 | Biosergen | Biosergen AB: Mangold Insight publishes interview with Biosergen's CEO | Pressreleaser | Ladda ner | Visa Stäng |
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2022-09-22 | Biosergen | Biosergen AB: Members of the board of directors and executive management subscribe in ongoing rights issue | Pressreleaser | Ladda ner | Visa Stäng |
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2022-09-15 | Biosergen | Biosergen AB: The subscription period in Biosergen's rights issue starts today | Pressreleaser | Visa Stäng |
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2022-09-08 | Biosergen | Biosergen AB: Biosergen moves into the MAD (Multiple Ascending Dose) part of its phase I study after 4 cohorts tested in the SAD (Single Ascending Dose) part of the study. | Pressreleaser | Ladda ner | Visa Stäng |
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2022-09-02 | Biosergen | Biosergen AB: Biosergen's Board of Directors decides on a rights issue of units of approximately SEK 60.2 million | Pressreleaser | Ladda ner | Visa Stäng |
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2022-08-31 | Biosergen | Biosergen AB: Biosergen publishes interim report for second quarter 2022 | Pressreleaser | Ladda ner | Visa Stäng |
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2022-08-31 | Biosergen | Biosergen AB: Biosergen receives a loan of SEK 7 million to finance continued development | Pressreleaser | Ladda ner | Visa Stäng |
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2022-08-26 | Biosergen | Biosergen AB: Biosergen completes the third cohort of BSG005 phase I trial | Pressreleaser | Ladda ner | Visa Stäng |
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