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Biophytis SA (Symbol: BPTS) is a clinical-stage biotechnology company dedicated to developing drug candidates for age-related diseases. Founded in 2006 as a spin-off from Université Pierre et Marie Curie (Paris), Biophytis focuses on addressing conditions that become increasingly prevalent with aging, such as sarcopenia, dry age-related macular degeneration, and COVID-19-related respiratory issues.
The company's leading drug candidate, Ruvembri™ (20-hydroxyecdysone), has shown promising results in clinical trials. It is currently being evaluated in several rigorous studies, including the phase 3 SARA-31 study for sarcopenia and a phase 2-3 study for severe COVID-19. The SARA-INT phase 2 study demonstrated notable improvements in physical performance, evidenced by the 400 Meter Walking Test results.
Biophytis has also recently initiated the OBA clinical program, which aims to explore the efficacy of BIO101 (20-hydroxyecdysone) in treating obesity, especially in patients who are also being treated with GLP-1 receptor agonists. This program addresses the often-overlooked issue of muscle loss during obesity treatment, aiming to preserve muscle function while facilitating weight loss.
The company operates out of Paris, France, and Cambridge, Massachusetts, and is actively seeking partnerships to further develop and market its drug candidates. Biophytis' American Depositary Shares (ADS) are traded on the Nasdaq Capital Market under the ticker BPTS, while its ordinary shares are listed on Euronext Growth Paris under the ticker ALBPS.
In terms of financial health, Biophytis has successfully secured financing to sustain its activities until early 2025, despite a challenging financial environment for the biotech sector. This stable financial footing allows the company to continue its innovative work and expand its clinical programs.
Stay updated with the latest from Biophytis, including their groundbreaking research and strategic developments, by visiting their official website.
BIOPHYTIS has successfully recruited the 155th participant for Part 2 of its COVA Phase 2-3 study of Sarconeos (BIO101) in COVID-19 patients. This milestone allows the independent Data Monitoring Committee (DMC) to perform its second interim analysis based on safety and efficacy data. The DMC's recommendations will be reported by the end of Q2 2021, depending on COVID-19-related factors. The COVA study aims to enroll 310 participants across multiple countries, with final results expected in Q3 2021.
BIOPHYTIS announces the successful adoption of all resolutions during its Combined General Meeting held on May 11, 2021. Over 80% approval was achieved for 31 resolutions, including the ratification of 2020 financial accounts and the allocation of profit and loss. A total of 2,077 shareholders participated, representing 22.37% of shares and 22.82% of voting rights. The meeting was conducted behind closed doors due to COVID-19. Stanislas Veillet, CEO, expressed gratitude to shareholders for their commitment and support.
Biophytis announces its second Annual General Meeting (AGM) on May 10, 2021, at Sorbonne University, Paris, at 5 PM CET. Due to COVID-19 restrictions, the meeting will be held behind closed doors. Shareholders are encouraged to vote by mail or via the secure VOTACCESS platform. Voting deadlines are set for May 6, 7, and 9 for postal and online votes. All AGM documents can be accessed on the Biophytis website. The company's lead drug candidate, Sarconeos (BIO101), is currently in Phase 2 trials targeting age-related diseases and respiratory failure from COVID-19.
Biophytis SA has secured a non-dilutive funding of €980,000 from BPI France's DeepTech program for its MACA program aimed at treating dry Age-Related Macular Degeneration (AMD). This funding includes a conditional advance of €600,000 and a grant of €380,000. The company plans to start a Phase 1 clinical trial for Macuneos (BIO201) in healthy volunteers in the second half of 2021, pending regulatory approvals. AMD affects around 8.5% of the global population aged 45-85, highlighting the significance of developing treatments for this condition.
Biophytis SA (BPTS) announced that its combined Annual General Meeting (AGM) on April 26, 2021, did not reach the required quorum for deliberation. Only 19.11% of the share capital and 19.46% of voting rights participated. The necessary 20% quorum for ordinary matters and 25% for extraordinary matters were not met, resulting in the adjournment of the AGM. A new meeting will be scheduled for a second call, allowing shareholders to vote through VOTACCESS or by mail. All AGM documents are available on Biophytis’ website.
Biophytis SA provides an update on its programs for Sarconeos (BIO101), targeted at age-related diseases, including severe respiratory failure from COVID-19. The Phase 2-3 COVA study expects potential authorization in Q3 2021, with market preparation beginning by late 2021. The SARA-INT Phase 2 trial in sarcopenia may lead to a Phase 3 study in early 2022, depending on results. Furthermore, the MYODA trial for Duchenne Muscular Dystrophy is set to resume, aiming for a mid-2021 launch. The company emphasizes the potential impacts of COVID-19 on trials and regulatory processes.
BIOPHYTIS SA (NasdaqCM: BPTS) addressed a false report regarding its COVA study for Sarconeos (BIO101) in COVID-19, which was disseminated without its consent. The misleading information was circulated by unknown sources, prompting the company to notify relevant authorities. As per the latest updates, an independent Data Monitoring Committee (DMC) provided a favorable opinion on the safety of Sarconeos following an interim analysis of 50 participants in the study. BIOPHYTIS focuses on therapeutics for age-related diseases, with Sarconeos being developed for conditions like sarcopenia and severe respiratory symptoms of COVID-19.
BIOPHYTIS has received a favorable opinion from the Data Monitoring Committee (DMC) regarding the safety of its drug candidate Sarconeos (BIO101) in the COVA study, following an interim analysis. With 97 out of 155 planned patients enrolled, 28 clinical centers across the US, Brazil, France, and Belgium are now active in recruitment. The DMC will reassess trial parameters during the second interim analysis, which will inform the continuation of the study involving up to 310 patients. Results for both phases are anticipated in Q2 2021, subject to delays from the pandemic.
Biophytis SA (BPTS) announced a court ruling on March 16, 2021, which ordered the company to pay Negma Group Ltd a total of €1.01 million, including contractual penalties and legal fees. Biophytis must also deliver 7 million shares, facing daily penalties for delays. The company plans to appeal this judgement, which it deems unjustified. Biophytis focuses on developing therapeutics for age-related diseases, including treatments for COVID-19 related severe respiratory failure.
Biophytis will hold its Annual General Meeting (AGM) on April 26, 2021, at 5.00 p.m. CET in Paris. Due to COVID-19 restrictions, the meeting will be closed to shareholders. Voting documents are available on the company’s website, and shareholders are urged to vote in advance via mail, proxy, or the VOTACCESS platform. Key deadlines include submitting votes by April 23 for mail or proxy and by April 25 for VOTACCESS. BPTS is listed on the Nasdaq Capital Market, with ongoing clinical trials focused on age-related diseases and COVID-19.
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