Biophytis（ALBPS）株式概要臨床段階のバイオテクノロジー企業であるBiophytis S.A.は、老化関連疾患に苦しむ患者の退行プロセスを遅らせ、機能的転帰を改善する治療薬の開発に注力している。 詳細ALBPS ファンダメンタル分析スノーフレーク・スコア評価0/6将来の成長0/6過去の実績0/6財務の健全性0/6配当金0/6報酬過去5年間の収益は年間17.9%増加しました。 リスク分析過去1年間で株主の希薄化は大幅に進んだ マイナスの株主資本 意味のある時価総額がありません ( €1M )収益が 100 万ドル未満 ( €0 )+2 さらなるリスクすべてのリスクチェックを見るALBPS Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair Value€Current Price€0.015該当なし内在価値ディスカウントEst. Revenue$PastFuture-30m12016201920222025202620282031Revenue €1.0Earnings €0.2AdvancedSet Fair ValueView all narrativesBiophytis S.A. 競合他社NeovacsSymbol: ENXTPA:ALNEVMarket cap: €318.1kOncodesign Precision Medicine Société anonymeSymbol: ENXTPA:ALOPMMarket cap: €6.7mPlant Advanced TechnologiesSymbol: ENXTPA:ALPATMarket cap: €7.6mAtonSymbol: ENXTPA:ALTAOMarket cap: €10.3m価格と性能株価の高値、安値、推移の概要Biophytis過去の株価現在の株価€0.01552週高値€0.2252週安値€0.015ベータ0.891ヶ月の変化-26.44%3ヶ月変化-49.00%1年変化-88.32%3年間の変化-99.82%5年間の変化-99.90%IPOからの変化-99.90%最新ニュースお知らせ • Apr 30Biophytis S.A. announced delayed 20-F filingOn 04/29/2025, Biophytis S.A. announced that they will be unable to file their next 20-F by the deadline required by the SEC.お知らせ • Apr 10Biophytis S.A. Confirms the Launch of the Phase 2 Oba Clinical Trial in ObesityBiophytis SA confirmed the launch of the Phase 2 OBA clinical study in obesity, expected to begin as early as possible in 2025. Following the recent 2.6 million capital increase announced on March 26, 2025, and promising preclinical results presented at the 15th International Conference on Frailty and Sarcopenia in Toulouse, Biophytis will continue the clinical development of BIO101 in obesity. The goal is to evaluate the efficacy and safety of BIO101 in reducing muscle strength loss caused by GLP-1 agonists in patients with obesity. As a reminder, Biophytis received Investigational New Drug (IND) clearance from the FDA in July 2024, marking a major milestone for the OBA program, which benefits from the expertise of Professor Marc-Andr Cornier, a world-renowned expert in the field of obesity.お知らせ • Jul 11Biophytis SA Obtains IND Approval from the FDA to Start Its Phase 2 Oba Study in ObesityBiophytis SA announced that it has received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) for its phase 2 OBA clinical study in obesity with BIO101 (20-hydroxyecdysone). The primary objective of the study is to measure the improvement in muscle strength in the lower limbs, as assessed by knee extension test. Secondary endpoints will include analysis of mobility (via the 6-minute walk test) and body composition (assessment of fat and lean mass). A world-renowned medical expert in the field of obesity and President-elect of the American Obesity Society, Marc-Andre Cornier, Professor of Medicine and Director of the Endocrinology, Diabetes and Metabolic Diseases Unit at the Medical University of South Carolina, will be the principal investigator of the phase 2 OBA study. The multicenter study is due to start mid-2024 in the USA and could be extended to Europe. Preliminary results on the efficacy of BIO101 (20- hydroxyecdysone) are expected in 2025. Biophytis is seeking funding and partnerships to complete this study.お知らせ • May 17Biophytis S.A., Annual General Meeting, Jun 24, 2024Biophytis S.A., Annual General Meeting, Jun 24, 2024. Location: sorbonne universite, 4 place jussieu, paris Franceお知らせ • May 15Biophytis SA Announces the Design of its Phase 2 OBA Clinical Study in ObesityBiophytis SA announced the design of its phase 2 OBA clinical study in obesity with BIO101 (20-hydroxyecdysone). BIO101 (20- hydroxyecdysone) will be evaluated in obese patients treated with GLP-1 RAs, together with hypocaloric dieting. The OBA phase 2 study will test the efficacy and safety of BIO101 (20- Hydroxyecdysone) in patients with obesity and overweight with secondary comorbidities, who are starting treatment with GLP-1 R As for weight loss. The OBA Phase 2 study is a double-blind, randomized, placebo-controlled clinical study in which 164 patients are planned to be enrolled with obesity (BMI 30) or overweight (BMI 27 with one or more sequalae e.g. diabetes, hypertension) at the start of treatment with GLP-1RAs in combination with hypocaloric diet. Double-blind treatment with 350 mg BID of BIO101 (20 -hydroxyecdysone) will been given for 21 weeks. The primary efficacy endpoint is muscle strength as measured by knee extension, and important secondary outcomes include 6 Minute Walking Distance and other performance tests, muscle strength normalized to lean body mass, abdominal lean mass and fat mass, biomarkers and various Patient-Reported Outcomes (PROs). Biophytis is preparing for filing an Investigational New Drug (IND) to start the OBA Phase 2 study in the USA in the coming weeks. The OBA Phase 2 clinical study is expected to start mid 2024, upon regulatory approvals, with first patients expected to be treated in the second half of 2024. First results of the safety and efficacy of BIO101 (20 thehydroxyecdysone) drug candidate are expected to be available in 2025.お知らせ • Apr 27Biophytis S.A.(OTCPK:BPTS.Y) dropped from NASDAQ Composite IndexBiophytis SA has been dropped from NASDAQ Composite Index最新情報をもっと見るRecent updatesお知らせ • Apr 30Biophytis S.A. announced delayed 20-F filingOn 04/29/2025, Biophytis S.A. announced that they will be unable to file their next 20-F by the deadline required by the SEC.お知らせ • Apr 10Biophytis S.A. Confirms the Launch of the Phase 2 Oba Clinical Trial in ObesityBiophytis SA confirmed the launch of the Phase 2 OBA clinical study in obesity, expected to begin as early as possible in 2025. Following the recent 2.6 million capital increase announced on March 26, 2025, and promising preclinical results presented at the 15th International Conference on Frailty and Sarcopenia in Toulouse, Biophytis will continue the clinical development of BIO101 in obesity. The goal is to evaluate the efficacy and safety of BIO101 in reducing muscle strength loss caused by GLP-1 agonists in patients with obesity. As a reminder, Biophytis received Investigational New Drug (IND) clearance from the FDA in July 2024, marking a major milestone for the OBA program, which benefits from the expertise of Professor Marc-Andr Cornier, a world-renowned expert in the field of obesity.お知らせ • Jul 11Biophytis SA Obtains IND Approval from the FDA to Start Its Phase 2 Oba Study in ObesityBiophytis SA announced that it has received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) for its phase 2 OBA clinical study in obesity with BIO101 (20-hydroxyecdysone). The primary objective of the study is to measure the improvement in muscle strength in the lower limbs, as assessed by knee extension test. Secondary endpoints will include analysis of mobility (via the 6-minute walk test) and body composition (assessment of fat and lean mass). A world-renowned medical expert in the field of obesity and President-elect of the American Obesity Society, Marc-Andre Cornier, Professor of Medicine and Director of the Endocrinology, Diabetes and Metabolic Diseases Unit at the Medical University of South Carolina, will be the principal investigator of the phase 2 OBA study. The multicenter study is due to start mid-2024 in the USA and could be extended to Europe. Preliminary results on the efficacy of BIO101 (20- hydroxyecdysone) are expected in 2025. Biophytis is seeking funding and partnerships to complete this study.お知らせ • May 17Biophytis S.A., Annual General Meeting, Jun 24, 2024Biophytis S.A., Annual General Meeting, Jun 24, 2024. Location: sorbonne universite, 4 place jussieu, paris Franceお知らせ • May 15Biophytis SA Announces the Design of its Phase 2 OBA Clinical Study in ObesityBiophytis SA announced the design of its phase 2 OBA clinical study in obesity with BIO101 (20-hydroxyecdysone). BIO101 (20- hydroxyecdysone) will be evaluated in obese patients treated with GLP-1 RAs, together with hypocaloric dieting. The OBA phase 2 study will test the efficacy and safety of BIO101 (20- Hydroxyecdysone) in patients with obesity and overweight with secondary comorbidities, who are starting treatment with GLP-1 R As for weight loss. The OBA Phase 2 study is a double-blind, randomized, placebo-controlled clinical study in which 164 patients are planned to be enrolled with obesity (BMI 30) or overweight (BMI 27 with one or more sequalae e.g. diabetes, hypertension) at the start of treatment with GLP-1RAs in combination with hypocaloric diet. Double-blind treatment with 350 mg BID of BIO101 (20 -hydroxyecdysone) will been given for 21 weeks. The primary efficacy endpoint is muscle strength as measured by knee extension, and important secondary outcomes include 6 Minute Walking Distance and other performance tests, muscle strength normalized to lean body mass, abdominal lean mass and fat mass, biomarkers and various Patient-Reported Outcomes (PROs). Biophytis is preparing for filing an Investigational New Drug (IND) to start the OBA Phase 2 study in the USA in the coming weeks. The OBA Phase 2 clinical study is expected to start mid 2024, upon regulatory approvals, with first patients expected to be treated in the second half of 2024. First results of the safety and efficacy of BIO101 (20 thehydroxyecdysone) drug candidate are expected to be available in 2025.お知らせ • Apr 27Biophytis S.A.(OTCPK:BPTS.Y) dropped from NASDAQ Composite IndexBiophytis SA has been dropped from NASDAQ Composite Indexお知らせ • Apr 19Biophytis SA Announces Formation of New Scientific Advisory Board for Its Phase 2 OBA Clinical Study in ObesityBiophytis SA announced the formation of a new Scientific Advisory Board to support the advancement of its phase 2 OBA clinical study in obesity. This Scientific Advisory Board will be composed of a few worldwide medical experts in the field of obesity, including Professor Dennis Villareal from the USA and Professor Francisco Guarner from Spain. The OBA SAB will guide the company to develop BIO101 (20-hydroxyecdysone) in obesity, in combination with GLP1-RA, and will actively work towards the finalization of the OBA Phase 2 clinical study design. Biophytis plans to file for an Investigational New Drug (IND) application to start the OBA Phase 2 clinical study in the USA with FDA in the coming weeks. The first two members of Biophytis' new Scientific Advisory Board for the OBA clinical study are: Prof. Dennis T. Villareal, MD, PhD, a Professor of Medicine-Endocrinology, Diabetes and Metabolism at Baylor College of Medicine, Houston, Texas, United States.He is a physician-scientist with specialty training in geriatrics and endocrinology. He has extensive clinical and research experience in examining the impact of lifestyle interventions in reversing frailty in older adults with obesity. His clinical and translational laboratories involve hormonal, nutritional, and behavioral/lifestyle interventions to retard or reverse the metabolic and physical complications of aging, including sarcopenia and type 2 diabetes. He is dedicated to research designed to inform practice guidelines with respect to optimal treatment strategies for older adults with obesity. Prof. Francisco Guarner, MD, PhD, a Professor of Internal Medicine, Gastroenterology and Hepatology at the Hospital Clinic in Barcelona and at the University Clinic of Navarra. He is well known for his research studies on liver cell cytoprotection with prostaglandins. He has been Visiting Scientist and Research Fellow at the Upjohn Company in Kalamazoo (Michigan), the Royal Free Hospital (London), the King's College Hospital (London), and the Wellcome Research Laboratories (Beckenham). He is currently Consultant of Gastroenterology at the Digestive System Research Unit and Head of the Experimental Laboratory in University Hospital Vall d'Hebron (Barcelona). He is a member of the Scientific Committee of the Research Institution of University Hospital Vall d'Hebron (Barcelona).お知らせ • Apr 09Biophytis SA Launches OBA Phase 2 Clinical Study in Obesity with BIO101 (20-Hydroxyecdysone)Biophytis SA announced that it is launching a new clinical development program named OBA, with BIO101 (20-hydroxyecdysone) as a potential treatment for obesity in combination with GLP-1 receptor agonists. Obesity treatment can lead to loss of muscle mass and function, notably as a consequence of dieting when combined with the recently introduced GLP-1 receptor agonists. Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs are very effective drugs that lead to significant weight loss. Up to 40% of the total weight loss comes from muscle, which is a problem as muscle tissue's role is central in controlling metabolism, on top of its motor function. Promising results already obtained in obesity: BIO101 (20-hydroxyecdysone) is the first oral daily MAS receptor activator and has demonstrated metabolic effects on muscle and fat tissues in preclinical studies in obesity. These benefical effects of BIO101 (20-hydroxyecdysone) may translate into improved mobility and muscle strength in obese sarcopenic patients, as suggested in the SARA-INT phase 2 study. Furthermore, the 20-hydroxyecdysone molecule was already tested in obese patients during hypocaloric dieting in the Quinolia study, showing promising effects on muscle strength and fat mass loss. BIO101's (20-hydroxyecdysone) potential in the treatment of obesity in combination with GLP-1RAs to counteract the undesirable effects on muscle wasting associated with drastic weight-loss was highlighted in Nature Biotechnology ("After obesity drugs' success, companies rush to preserve skeletal muscle") on March 05, 2024. An accelerated clinical development with results expected in 2025: The OBA Phase 2 clinical study is expected to start mid 2024, upon regulatory approvals, with first patients expected to be treated in the second half of 2024. BIO101 (20-hydroxyecdysone) will be evaluated in obese patients treated with GLP-1 RAs, and following hypocaloric dieting. The Company expects the first results of the efficacy of drug candidate to be available in 2025. Further information on the OBA program and the clinical study is expected to be provided through the coming weeks.お知らせ • Feb 15Biophytis S.A., Annual General Meeting, Mar 18, 2024Biophytis S.A., Annual General Meeting, Mar 18, 2024.お知らせ • Jan 06Biophytis S.A. Announces the Publication of the Results of its COVA Phase 2-3 Study in eClinicalMedicine, Part of The LancetBiophytis S.A. announced the publication of an article on the results of its COVA phase 2-3 clinical trial in the treatment of respiratory symptoms in severe forms of COVID-19 in eClinicalMedicine, a medical journal part of the prestigious scientific review The Lancet. This publication is an endorsement of the strength of Biophytis' clinical research and the value of its drug candidate Sarconeos (BIO101) in the treatement of severe forms of COVID-19. Therapeutic advances are still needed in this pathology, as more than 230,000 patients will still have died of the virus worldwide in 2023, out of a total of nearly 7 million since the start of the pandemic. As a reminder, the objective of the COVA Phase 2-3 study (ClinicalTrials.gov, NCT04472728) was to investigate the efficacy and safety of Sarconeos (BIO101), 350 mg BID in hospitalized COVID-19 patients with hypoxemia, at risk of respiratory failure and death. The proportion and time of onset of these adverse events were studied for 28 days, with mortality and safety monitored for more than 90 days. The main result was that in the study population (233 patients; 126 Sarconeos (BIO101) and 107 placebo), respiratory failure or early death by day 28, the primary end-point, was 11.4% lower in the Sarconeos (BIO101) (13.5%) than in the placebo (24.3%) group, (p = 0.0426). Sarconeos (BIO101) significantly reduced the risk of death or respiratory failure by 44%, supporting its use in adults hospitalized with severe respiratory symptoms due to COVID-19. To follow this publication, Biophytis will host two press conferences in France and the United States on 17 January 2024, alongside experts from the scientific and medical communities, to reiterate the potential and clinical benefits of Sarconeos (BIO101) in severe forms of COVID-19, and provide further details on the Group's strategic choice to explore the compound's potential in the treatment of other respiratory viral infections such as influenza.お知らせ • Dec 07Biophytis S.A. and the University of Li Ge Explore the Potential of Sarconeos (BIO101) in the Treatment of Viral Respiratory DiseasesBiophytis SA announced the signing of a new partnership with the University of Li ge to carry out a range of preclinical research projects, particularly in the treatment of respiratory failure caused by the flu virus Influenza. Under this partnership, the University's animal pathology research laboratory, headed by Professor Daniel Desmecht, will conduct a series of experiments aimed at establishing the therapeutic potential of Sarconeos (BIO101) in an experimental murine model of infection by an Influenza A virus, which could cause respiratory failure and death in the elderlies. This research is a continuation of the collaboration begun in 2020, which established proof of efficacy on respiratory function and the original mode of action of Sarconeos (BIO101) in an animal model of COVID-19, now confirmed by the clinical data from the Phase 2-3 COVA study.お知らせ • Nov 29Biophytis S.A. Appoints Yann Meunier and Bernard L vy to its Scientific Advisory BoardBiophytis SA announced the appointment of Dr. Yann Meunier and Professor Bernard L vy to its Scientific Advisory Board. Yann Meunier is a US-based healthcare professional, currently Professor and Director of the International Institute of Medicine and Science Inc. (IIMS), where he leads the development and implementation of innovative educational programmes and research projects in global health and related fields. He is also a consultant and health expert with HealthConnect International LLC. Over the course of his career, he has worked with leading organizations such as Stanford Hospital & Clinics, Stanford University School of Medicine, George Washington University and Universit Paris VI. He has published widely in the international medical literature and, as an investigator, has led and participated in clinical trials for new treatments for HIV/AIDS, tropical andinfectious diseases, and cardiovascular and respiratory diseases. Bernard L vy is Professor Emeritus of Physiology and a senior member of PARCC (Inserm U970). He headed the physiology and functional investigations department and the Inserm cardiovascular research centre at Lariboisi re Hospital in Paris. After studying medicine, he focused on physiology, fluid mechanics, cardiology and vascular medicine. His work focuses on vascular biology in ageing, hypertension, diabetes and Alzheimer's disease, and he has particularly studied the functions of the renin-angiotensin system in these different diseases.お知らせ • Oct 28Biophytis Receives Notice of Delisting from Nasdaq and Announces It Will Request A Hearing Before the Nasdaq Hearings PanelBiophytis S.A. announced that it has received a notice of delisting from Nasdaq. The staff of the Listing Qualifications Department has determined that the Company's securities have not regained compliance with the minimum $2,500,000 stockholders' equity requirement for continued listing on The Nasdaq Capital Market, as set in Listing Rule 5550(b). The Notice further states that unless the Company timely requests a hearing before a Nasdaq Hearings Panel, the Company's securities would be subject to delisting. Accordingly, the Company intends to timely request a hearing before the Panel. The hearing request will automatically stay any suspension or delisting action pending the hearing. Pursuant to the Nasdaq Listing Rules, the Panel has the discretion to grant the Company an additional extension not to exceed April 23, 2024. At the hearing, the Company will present its plan for regaining and sustaining compliance with the Equity Requirement for continued listing.お知らせ • Sep 29Biophytis S.A. Provides an Update on the Progress of its R&D Projects over the 1St Half of the Year and the Last Few MonthsOBiophytis S.A. provided an update on the progress of its R&D projects over the 1st half of the year and the last few months. During the first half of 2023, the company achieved key milestones in the development of main drug candidate, Sarconeos (BIO101), with a view to partnerships and market access in 2024, despite a particularly challenging financial environment. Pursuant to an accelerated development over the last two years, the company obtained positive results from phase 2-3 COVA. Biophytis is one of the few European companies to have obtained proof of efficacy in patients with severe forms of COVID-19. The company is pursuing the pharmaceutical and regulatory development of Sarconeos (BIO101), and are currently in discussions with European and American regulatory agencies to define the conditions for market access. In addition, due to the encouraging results obtained with the SARA-INT phase 2b study, Biophytis has received authorizations from the US and Belgian agencies to start the clinical SARA-31 study, which will be the first phase 3 study ever launched in sarcopenia. Finally, the Company has strengthened its management team over the last few months, notably in pharmaceutical operations, finance and business development, in order to forge strategic partnerships for the development of Sarconeos (BIO101).With the progress made in its pipeline, Biophytis is confirming its pioneering position in the development of treatments for age-related diseases, generating a strong medical need that is set to grow very rapidly in the years ahead. Second half of 2023: discussions with the European Agency for the Evaluation of Medicinal Products (EMA) and the US Food and Drug Administration (FDA) in the context of scientific advice to clarify the additional information to be submitted as part of marketing authorization applications, in particular the protocol for a confirmatory phase 3 clinical study. Biophytis will also present to the agencies the possibility of extending the scope of its indication to respiratory viral diseases other than COVID-19, in particular influenza. Second half of 2023: request for reactivation of the authorization for the early access program in Brazil, granted in early 2022. First half of 2024: resubmission to the HAS of an application for authorization of an early access program in France. SARA program: Following the authorizations received from the Belgian and US agencies to conduct a phase 3 trial, the Company will actively pursue its search for partners with a view to initiating the trial in 2024, in collaboration with global or regional pharmaceutical companies under a licensing agreement. MYODA program: first half of 2024: start of a phase 1-2 trial. MACA program: Continuing pre-clinical development work on Macuneos (BIO201) and its back-up BIO203 and preparing for clinical development in dry AMD.お知らせ • Sep 21Biophytis SA Provides Update on its Early Access Programs for Sarconeos (BIO101) in Treatment of Severe Forms of COVID-19Biophytis SA announced that it has received a response from the French National Authority for Health (HAS) to its request for Early Access Authorization in France for patients suffering from severe forms of COVID-19 and provides an update on its strategy in other countries. After examining the Early Access Authorization request file submitted at the end of May 2023, HAS considered that the Company had not provided sufficient data allowing it to evaluate precisely the benefit vs. risk ratio and to authorize the treatment of patients with severe forms of COVID-19, despite the statistically significant results of the phase 2-3 COVA study. The Company must therefore complete the file by providing in particular certain results of pharmaceutical studies, in progress with its industrial partner Sequens, as well as certain additional data and scientific arguments relating to its phase 2-3 COVA study. On the basis of these various elements, it is planned to resubmit the application to the HAS in the first quarter of 2024, with pharmaceutical partner Intsel Chimos, depending on the progress made in the development plan. At the same time, Biophytis is taking steps in Brazil to confirm the early access authorization obtained in early 2022 that was interrupted pending publication of the full results of the COVA study. This new authorization is expected by the end of the year. Finally, the Company is exploring the possibilities of launching early access programs in other key countries in Europe, in order to best respond to the medical need in a pathology that has become endemic.お知らせ • Sep 20Biophytis SA Receives Response from the French National Authority for Health to Request for Early Access Authorization in France for Patients Suffering from Severe Forms of COVID-19Biophytis SA announced that it has received a response from the French National Authority for Health (HAS) to its request for Early Access Authorization in France for patients suffering from severe forms of COVID-19 and provides an update on its strategy in other countries. After examining the Early Access Authorization request file submitted at the end of May 2023, has considered that the Company had not provided sufficient data allowing it to evaluate precisely the benefit vs. risk ratio and to authorize the treatment of patients with severe forms of COVID- 19, despite the statistically significant results of the phase 2-3 COVA study. The Company must therefore complete the file by providing in particular certain results of pharmaceutical studies, in progress with its industrial partner Sequens, as well as certain additional data and scientific arguments relating to its phase 2-3 COVA Study. On the basis of these various elements, it is planned to resubmit the application to the HAS in the first quarter of 2024, with pharmaceutical partner Intsel Chimos, depending on the progress made in the development plan. At the same time, Biophytis is taking steps in Brazil to confirm the early access authorization obtained in early 2022 that was interrupted pending publication of the full results of the COVA study. This new authorization is expected by the end of the year. Finally, the Company is exploring the possibilities of launching early access programs in other key countries in Europe, in order to best respond to the medical need in a pathology that has become endemic.お知らせ • Sep 14Biophytis S.A. Announces Executive ChangesBiophytis S.A. announced the strengthening of its management team with the appointment of Edouard Bieth as Chief Business Officer and member of the Executive Committee. A recognized industry leader with over 18 years' experience in the pharmaceutical industry, Edouard Bieth has held a number of senior management positions and has developed strong expertise in market access and sales and marketing strategy, both globally and locally. He will be a member of the Executive Committee and will report directly to Stanislas Veillet, Chairman and CEO of Biophytis. Most recently Edouard spent 6 years as General Manager France & BeNeLux of Tillotts Pharma's commercial subsidiary. During his career, Edouard has also worked for various industry players, including AstraZeneca, Servier and Menarini. He has a Master's degree in biology and pharmacology of ageing and trained in sales and marketing strategy at HEC Paris and in finance at the London Business School. Biophytis has also appointed Claudia Ferreira as Medical Director, reporting to Rob Van Manen, Chief Medical Officer, to strengthen links with the medical community and unite experts around development programmes, which address major unmet medical needs in severe age-related diseases.お知らせ • Sep 12Biophytis Obtains Fda Authorization to Initiate the Sara-31 Phase 3 Study in SarcopeniaBiophytis SA aimed at slowing the degenerative processes associated with aging improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19, announced that it has received FDA (Food and Drug Administration) authorization to launch its SARA-31 study in the US, the first ever phase 3 study in sarcopenia. This authorization complements the positive opinion obtained this summer from the Belgian authorities to conduct the SARA-31 phase 3 study. The company still needs to obtain authorizations from ethics committees in the countries before launching this study. The effective start of the study is scheduled for 2024, and will depend on the conclusion of partnership agreements and the Company's financial resources. The aim of phase 3 is to evaluate the efficacy and safety of Sarconeos (BIO101) in the treatment of sarcopenic patients at risk of motor disability. Around 900 patients aged over 65 will be included with sarcopenia (Short Physical Performance Battery (SPPB) score between 3 and 7), with low walking speed (4-meter walking speed ? 0.8 m/s) and low hand grip strength (HGS < 20kg for women and < 35.5 kg for men). They will be treated for a minimum of 12 months and a maximum of 36 months, receiving either placebo or 350 mg of Sarconeos (BIO101) twice daily. The primary efficacy parameter will be the time to onset of Major Mobility Disability (MMD), measured by the inability to walk 400m in less than 15 minutes without sitting, help from another person or use of a walker. This main measure will be supplemented by the following secondary effectiveness measures: walking speed (4-m walking speed from the SPPB test), hand grip strength and patient-reported quality of life (Patient Reported Outcome SarQol, a questionnaire specifically developed for sarcopenia). Roger A. Fielding, PhD, sarcopenia expert and laboratory director at Tufts University, Boston, will be the principal investigator of the SARA-31 study. He is continuing his contribution to the Sarconeos (BIO101) clinical development program in this indication.お知らせ • Aug 17Biophytis SA Announces Next Regulatory Steps in Europe and the United States for its COVA ProjectBiophytis SA announced that it has received feedback from the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) enabling it to plan the next regulatory steps for its COVA project dedicated to the development of Sarconeos (BIO101) for severe forms of Covid-19. After filing requests for pre-submission meetings with both agencies in recent weeks, the company will now request a scientific advice meeting in Europe and a Type B meeting in the United States. The purpose of these meetings will be to gather recommendations from the EMA and the FDA to fine-tune COVA's development plan prior to marketing approval. These discussions will enable Biophytis to present the available data (preclinical, clinical, product and industrialization) and specify the additional information to be provided in the context of marketing authorization applications, in particularly the design of a confirmatory phase 3 clinical study. Biophytis will also present the agencies with the possibility of extending the scope of its indication to viral respiratory pathologies other than Covid-19, notably influenza, based on its non-specific mechanism of action. This extension would significantly increase the number of patients eligible for treatment and optimize the commercial potential of Sarconeos (BIO101).お知らせ • Aug 09Biophytis SA Receives Positive Opinion for its SARA-31 Phase 3 Study in Sarcopenia in EuropeBiophytis SA announced that it has received a positive opinion from Belgian authorities to conduct its SARA-31 program, which will be the first phase 3 study ever launched in sarcopenia. The launch of the Phase 3 program follows the promising results obtained in the SARA-INT Phase 2b study, and the scientific advice given in 2022 by the EMA (European Medicine Agency), which helped define the conditions for starting such a study in Europe, specifying the Phase 3 protocol. Final authorization depends on a positive opinion from the Ethics Committee in Belgium. A similar application has been filed with the FDA (Food and Drug Administration) to start this study in the United States, with a response expected in the coming weeks. Further authorizations may be requested in other countries, depending on the needs of the study. About SARA-31 The aim of phase 3 is to evaluate the efficiency and safety of Sarconeos (BIO101) in the treatment of sarcopenic patients at risk of motor disability. Around 900 patients aged over 65 with severe sarcopenia (3 SPPB 7) with low walking speed (4-meter walking speed 0.8 m/s) and low grip strength (HGS < 20kg for women and < 35.5kg for men) will be included. They will be treated for a minimum of 12 months and a maximum of 36 months, receiving either placebo or 350mg of Sarconeos ("BIO101") twice daily. The main criterion will be an assessment of the risk of Major Mobility Disability (MMD), measured by the ability to walk 400m in less than 15 minutes. This main criterion will be supplemented by the following secondary criteria: walking speed (4-m walking speed from the SPPB - Short Physical Performance Battery - test), grip strength (HGS) and patient-reported quality of life (Patient Reported Outcome SarQol, a questionnaire specifically developed for sarcopenia). Roger A. Fielding, PhD, sarcopenia expert and laboratory director at Tufts University, Boston, will be the principal investigator of the SARA-31 study. He is continuing his contribution to the SARA-31 clinical development program in this indication.お知らせ • Jul 23Biophytis S.A. Files for a Pre-Submission Meeting with the FDA for an Emergency Use Authorization of Sarconeos (BIO101) for the Treatment of COVID-19Biophytis SA announced that it has filed for a pre-submission meeting request with the Food and Drug Administration (FDA) to discuss filing for Emergency Use Authorization (EUA) in the United States for Sarconeos (BIO101) in the treatment of severe forms of COVID-19. This is a further key step in defining the conditions for rapid market access in the United States for SARConeos(BIO101) in thetreatment of severe forms of COVID -19, following the similar process initiated with the European Medicine Agency (EMA) in May, in a context where COVID-19 is still associated with a public health problem in the United States and in Europe. Like influenza, this pathology has become an endemic respiratory infectious disease that can lead to Acute Respiratory Distress Syndrome (ARDS) in elderly, immunocompromised or co-morbid patients. According to the WHO, the medical need remains high, with several thousand deaths per week in the United States and Europe. In this context, the positive clinical results of the phase 2-3 COVA study, with a 44% reduction in the risk of respiratory failure or early death, suggests that Sarconeos (BIo101) could become an important new therapeutic option alongside antiviral or anti-inflammatory treatments.お知らせ • Jul 21Biophytis and Seqens Sign A Partnership to Produce Sarconeos (Bio101) Active CompoundBiophytis SA announced the conclusion of a master agreement for the production of the active compound in Sarconeos (BIO101), Biophytis' main drug candidate developed for three indications: severe forms of Covid-19, sarcopenia and Duchenne muscular dystrophy. SEQENS will produce the active ingredient in Sarconeos (BIO101) in France at its Villeneuve La Garenne plant, near Paris. This historic site was modernized and expanded in 2020 with the opening of a unit to produce high-pot potential active pharmaceutical ingredients (APIs). This partnership is part of a political context in which the relocation of the production of certain active compounds is recognized as essential to national and European health sovereignty.お知らせ • Jul 11Biophytis SA Filed with the FDA for Authorization to Initiate SARA-31 Phase 3 Study in SarcopeniaBiophytis SA announced that it has filed for approval on the Food and Drug Administration (FDA) portal to launch its SARA-31 program in the U.S., the first ever Phase 3 study in sarcopenia. The launch of the Phase 3 program follows promising results from the SARA-INT Phase 2b study and discussions with health authorities in 2022. Based on the results of the previous study and feedback from the U.S. government agency, Biophytis is starting its Phase 3 program by filing the first ever Phase 3 application (SARA-31) in sarcopenia with the FDA. This follows the recent submission to the European Medicines Agency. The objective of the SARA-31 phase 3 study in sarcopenia is to evaluate the efficacy and safety of Sarconeos (BIO101) in the treatment of sarcopenic patients at risk of mobility disability. Approximately 900 patients over 65 years of age with severe sarcopenia (3 = SPPB = 7) with low walking speed (4-m Gait speed = 0.8 m/s) and low grip strength (HGS < 20kg for women and < 35.5 kg for men) will be included. They will be treated for a minimum of 12 months and a maximum of 36 months, receiving either placebo or 350mg of Sarconeos (BIO101) twice daily. The primary endpoint will be the assessment of the risk of Major Mobility Disability (MMD), measured by the ability to walk 400m in less than 15 minutes over time. In addition to this primary endpoint, the following secondary endpoints will be assessed: walking speed (4-m walking speed from the Short Physical Performance Battery (SPPB) test), handgrip strength (HGS) and patient-reported quality of life (Patient Reported Outcome SarQol, a questionnaire developed specifically for sarcopenia). Biophytis expects a response from the regulatory authorities during the third quarter of 2023, which would enable Biophytis to initiate the study in the United States. The principal investigator will be Roger A. Fielding, PhD, who heads the Nutrition, Physiology, Exercise and Sarcopenia (NEPS) Laboratory at Tufts University in Boston.お知らせ • Jun 20Biophytis SA Reports Clinical Results for Sarconeos (BIO101) in Sarcopenia Treatment at the 16th SCWD International CongressBiophytis SA announced that it is taking part in the 16th SCWD (Society on Sarcopenia, Cachexia & Wasting disorders) international congress, a event bringing together experts from all over the world to share thoughts, research and innovations on sarcopenia, Cachexia and wasting disorders. Biophytis has given an oral presentation entitled "BIOPHYTIS BIO101 - a candidate treatment for muscle diseases" on the development of Sarconeos (BIO101) for the treatment of sarcopenia. It was made by Cendrine Tourette, PhD in Neuroscience and Director of translational and clinical research projects on neuromuscular diseases at Biophytis. Ms. Tourette also took part in a round table discussion with top-notch experts on new trials and recent results in the treatment of sarcopenia and cachexia. Building on the promising results of Phase 2 of SARA-INT, Biophytis is currently in advanced discussions with the European (EMA) and American (FDA) regulatory authorities. EEMA and FDA approvals for the start of Phase 3 of the SARA program are expected in the second half of 2023. Sarconeos (BIo101) would therefore be the first and only drug candidate to enter Phase 3 for the treatment of sarcopenia.お知らせ • May 19Biophytis S.A., Annual General Meeting, Jun 16, 2023Biophytis S.A., Annual General Meeting, Jun 16, 2023.お知らせ • May 12Biophytis S.A. has completed a Follow-on Equity Offering in the amount of €2.302535 million.Biophytis S.A. has completed a Follow-on Equity Offering in the amount of €2.302535 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 18,562,859 Price\Range: €0.0222 Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 85,154,952 Price\Range: €0.0222お知らせ • May 10Biophytis SA Files for Pre-Submission Meeting Request with the European Medicine Agency (EMA) to Discuss Filing for Conditional Marketing Authorisation (CMA) in EuropeBiophytis SA announced that it has filed for a pre-submission meeting request with the European Medicine Agency (EMA) to discuss filing for conditional Marketing Authorisation (cMA) in Europe for Sarconeos (BIO101) in the treatment of severe form of COVID-19. This is the first step in the regulatory process that the company is undertaking to define the eligibility and conditions for conditional Marketing Authorisation application in Europe for SarconeOS (BIO101) in The treatment of severe form of COVID-19. A request for a pre-submission meeting with the Food and Drug Administration (FDA) for an Emergency Use Authorisation (EUA) application in the US is expected to be filed later this quarter.お知らせ • Feb 02Biophytis Announces Positive Final Results of the Phase 2-3 COVA Study with Sarconeos (BIO101) in Severe COVID-19Biophytis SA released the final results from its phase 2-3 COVA clinical study evaluating Sarconeos (BIO101) in the treatment of COVID-19-related respiratory failure. Biophytis announced final results following the reintegration of data from 54 patients, among 233 patients treated, that were missing in the Top Line analysis released on September 7, 2022. The final analysis demonstrates that COVA study met the primary endpoint, with a 44% statistically significant reduction (p = 0.043) in the risk of respiratory failure or early death in hospitalized patients with severe COVID-19, in line with positive Post-Hoc analysis released on November 3, 2022. Biophytis is nowinitiating key regulatory activities to give access to Sarconeos (BIO101) to hospitalized patients with severe COVID-19 at risk of respiratory failure and death in 2023. The strategy to give access to Sarconeos (BIO101) as quickly as possible is to file for Early Access Programs (EAP) in France and Brazil, while filing for conditional Marketing Authorisation (CMA) in Europe and Emergency Use Authorization (EUA) in the USA. An EAP has already been approved in 2022 in Brazil to treat COVID-19 patients at critical stage in Intensice Care Units (ICU) and the request to lift the hold given completion of the study and positive results is pending. The filing of the request for starting the EAP program in France is being prepared and will be made in First Quarter 2023 with the objective to be granted approval in Second Quarter 2023. Requests for pre-submission meetings regarding conditional Marketing Authorisation in Europe and Emergency Use Authorization in the USA are under preparation and will be sent in First Quarter 2023, targeting an approval later in 2023, depending on feedback from authorities. Biophytis will present the results in detail at the American Thoracic Society conference in Washington, DC, USA in May 2023 and at the European Respiratory Society Lung Science meeting in Estoril, Portugal, in March 2023. The objective of the study was to investigate the efficacy and safety of Sarconeos (BIO101), 350 mg BID in hospitalized COVID-19 patients with hypoxemia, at risk of respiratory failure requiring high flow oxygen or mechanical ventilation, and death. The proportion of patients and time to respiratory failure or early death were studied at 28 days in the primary analysis, corresponding to the maximum treatment period, with follow-up of mortality and safety for at least 90 days. The 233 treated patients (Intent To Treat, ITT population) were 63 years old on average, 64% of the patients were male, recruited in 37 centers in Europe, the US and Brazil between Third Quarter 2020 and First Quarter 2022, infected with the main SARS-Cov-2 variants. The trial ended early before reaching the 310 patients originally planned, due to stalled recruitment. The sub-population of patients without major protocol deviations (Per Protocol, PP sub-population) included 180 patients with similar baseline demographics and disease characteristics as the ITT population. The study met its pre-defined primary endpoint demonstrating a statistically significant difference between Sarconeos (BIO101) and placebo in the proportion of patients with respiratory failure or early death at day 28, representing a relative reduction of risk of 44% (p=0.043, Cochran-Mantel-Haenszel test). Moreover, the analysis of time to respiratory failure or early death had shown significant differences over 28 days in the Kaplan Meier curves for Sarconeos (BIO101) versus placebo (p=0.022). The pre-specified analysis of time to death over the complete follow-up period over 90 days showed that mortality rate with Sarconeos (BIO101) was reduced compared to placebo in the ITT population (p=0.083) and in the PP population (p=0.038). Post hoc Kaplan-Meier analysis released on November 3, 2022 confirmed the effect of Sarconeos (BIO101) on the primary endpoint and on mortality at day 90.お知らせ • Jan 20Biophytis S.A. Judgment of the Paris Court of Appeal of 17 January 2023 in the Case Between Biophytis and Negma Group LtdBiophytis S.A. announces that on the 17th of January 2023 the Paris Court of Appeal rendered a decision in the case between Biophytis and Negma Group Ltd. on the subject of the ORNANEBSA agreement concluded on 21st August 2019. The Paris Court of Appeal has: confirmed the judgment of the Paris Commercial Court of March 16, 2021; ordered Biophytis to pay Negma EUR 75,000 pursuant to Article 700 of the French Code of Civil Procedure as well as costs. Biophytis specifies that it has already performed, in 2021, the entirety of the Judgment. The judgment of the Paris Court of Appeal of January 17, 2023 has not yet been served. Biophytis reserves the right to appeal against it before the French Supreme Court (Cour de Cassation).お知らせ • Jan 13Biophytis to Take Appropriate Measures After Receiving Nasdaq Deficiency NoticeBiophytis S.A. received a deficiency notice from The Nasdaq Stock Market Inc. ("Nasdaq") stating that the Company has not filed its financial information for the six-month period ended June 30, 2022 on a Form 6-K (the "Filing") and as a result the Company no longer complies with Nasdaq's listing rules for continued listing set forth in the Listing Rule 5250(c)(2). Nasdaq has informed the Company that it has 60 calendar days or until March 6, 2023 to submit a plan (the "Plan") as definitive as possible to regain compliance with the Nasdaq's continued listing requirements. If Nasdaq accepts the Company's Plan to regain compliance in that respect, Nasdaq can grant an exception of up to 180 calendar days from the prescribed Filing due date or until June 28, 2023 to regain compliance. In determining whether to accept the Company's Plan, Nasdaq will consider such things as the likelihood that the Filing and any subsequent periodic filings can be made within the 180-day period, the Company's past compliance history, the reasons for the late filing, other corporate events that may occur within the Nasdaq review period, the Company's overall financial condition and its public disclosures. The Company is currently working on the Plan to regain compliance with respect to the Listing Rule 5250(c)(2) to meet the requirements for continued listing on the Nasdaq Capital Market. It intends to submit such Plan to Nasdaq as soon as practicable prior to March 6, 2023.分析記事 • Nov 18Biophytis (EPA:ALBPS) Has Debt But No Earnings; Should You Worry?Howard Marks put it nicely when he said that, rather than worrying about share price volatility, 'The possibility of...Executive Departure • Jul 15Independent Director Jean Franchi has left the companyOn the 7th of July, Jean Franchi's tenure as Independent Director ended after 4.1 years in the role. We don't have any record of a personal shareholding under Jean's name. Jean is the only executive to leave the company over the last 12 months. The current median tenure of the management team is 1.75 years, which is considered inexperienced in the Simply Wall St Risk Model.Is New 90 Day High Low • Feb 09New 90-day high: €1.69The company is up 217% from its price of €0.53 on 10 November 2020. The French market is up 7.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 53% over the same period.Is New 90 Day High Low • Jan 18New 90-day high: €1.32The company is up 150% from its price of €0.53 on 20 October 2020. The French market is up 13% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 38% over the same period.Is New 90 Day High Low • Dec 09New 90-day high: €0.74The company is up 42% from its price of €0.52 on 10 September 2020. The French market is up 11% over the last 90 days, indicating the company outperformed over that time. However, its price trend is similar to the Biotechs industry, which is also up 42% over the same period.Is New 90 Day High Low • Nov 03New 90-day high: €0.71The company is up 6.0% from its price of €0.67 on 04 August 2020. The French market is down 3.0% over the last 90 days, indicating the company outperformed over that time. However, it underperformed the Biotechs industry, which is up 7.0% over the same period.Is New 90 Day High Low • Oct 15New 90-day low: €0.39The company is down 45% from its price of €0.71 on 17 July 2020. The French market is down 1.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 11% over the same period.Is New 90 Day High Low • Sep 19New 90-day low: €0.51The company is down 38% from its price of €0.81 on 19 June 2020. The French market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 6.0% over the same period.株主還元ALBPSFR BiotechsFR 市場7D-19.5%-1.9%2.7%1Y-88.3%241.4%6.3%株主還元を見る業界別リターン: ALBPS過去 1 年間で241.4 % の収益を上げたFrench Biotechs業界を下回りました。リターン対市場: ALBPSは、過去 1 年間で6.3 % のリターンを上げたFrench市場を下回りました。価格変動Is ALBPS's price volatile compared to industry and market?ALBPS volatilityALBPS Average Weekly Movement19.5%Biotechs Industry Average Movement9.6%Market Average Movement5.2%10% most volatile stocks in FR Market11.2%10% least volatile stocks in FR Market2.7%安定した株価: ALBPSの株価は、 French市場と比較して過去 3 か月間で変動しています。時間の経過による変動: ALBPSの 週次ボラティリティ は、過去 1 年間で14%から19%に増加しました。会社概要設立従業員CEO（最高経営責任者ウェブサイト200619Stanislas Veilletwww.biophytis.com臨床段階のバイオテクノロジー企業であるBiophytis S.A.は、老化関連疾患に苦しむ患者の退行プロセスを遅らせ、機能的転帰を改善する治療薬の開発に注力している。同社の治療薬は、加齢関連疾患につながる炎症性、酸化性、代謝性、ウイルス性ストレスを含む複数の生物学的・環境的ストレスの影響から保護し、その影響を打ち消すことができる主要な生物学的回復経路を標的とし、活性化する。BIO101は経口投与可能な低分子化合物で、サルコペニア、デュシェンヌ型筋ジストロフィー（DMD）、肥満症などの神経筋疾患の治療薬として、またCOVID-19患者の重症呼吸不全の治療薬として開発中である。また、乾性加齢黄斑変性症やスターガルト病などの網膜症治療用の経口投与低分子化合物BIO201も開発している。Biophytis SA社は、DMD治療薬BIO101の開発に関してAFM-Telethon社と共同研究契約を結んでいる。同社は2006年に設立され、フランスのパリに本社を置いている。もっと見るBiophytis S.A. 基礎のまとめBiophytis の収益と売上を時価総額と比較するとどうか。ALBPS 基礎統計学時価総額€1.40m収益（TTM）-€8.03m売上高(TTM)n/a0.0xP/Sレシオ-0.2xPER（株価収益率ALBPS は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計ALBPS 損益計算書（TTM）収益€0売上原価€0売上総利益€0その他の費用€8.03m収益-€8.03m直近の収益報告Jun 30, 2025次回決算日該当なし一株当たり利益（EPS）-0.088グロス・マージン0.00%純利益率0.00%有利子負債／自己資本比率-98.7%ALBPS の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/06/16 10:16終値2026/06/16 00:00収益2025/06/30年間収益2024/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Biophytis S.A. 0 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。2 アナリスト機関Raghuram SelvarajuH.C. Wainwright & Co.Joseph PantginisH.C. Wainwright & Co.
お知らせ • Apr 30Biophytis S.A. announced delayed 20-F filingOn 04/29/2025, Biophytis S.A. announced that they will be unable to file their next 20-F by the deadline required by the SEC.
お知らせ • Apr 10Biophytis S.A. Confirms the Launch of the Phase 2 Oba Clinical Trial in ObesityBiophytis SA confirmed the launch of the Phase 2 OBA clinical study in obesity, expected to begin as early as possible in 2025. Following the recent 2.6 million capital increase announced on March 26, 2025, and promising preclinical results presented at the 15th International Conference on Frailty and Sarcopenia in Toulouse, Biophytis will continue the clinical development of BIO101 in obesity. The goal is to evaluate the efficacy and safety of BIO101 in reducing muscle strength loss caused by GLP-1 agonists in patients with obesity. As a reminder, Biophytis received Investigational New Drug (IND) clearance from the FDA in July 2024, marking a major milestone for the OBA program, which benefits from the expertise of Professor Marc-Andr Cornier, a world-renowned expert in the field of obesity.
お知らせ • Jul 11Biophytis SA Obtains IND Approval from the FDA to Start Its Phase 2 Oba Study in ObesityBiophytis SA announced that it has received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) for its phase 2 OBA clinical study in obesity with BIO101 (20-hydroxyecdysone). The primary objective of the study is to measure the improvement in muscle strength in the lower limbs, as assessed by knee extension test. Secondary endpoints will include analysis of mobility (via the 6-minute walk test) and body composition (assessment of fat and lean mass). A world-renowned medical expert in the field of obesity and President-elect of the American Obesity Society, Marc-Andre Cornier, Professor of Medicine and Director of the Endocrinology, Diabetes and Metabolic Diseases Unit at the Medical University of South Carolina, will be the principal investigator of the phase 2 OBA study. The multicenter study is due to start mid-2024 in the USA and could be extended to Europe. Preliminary results on the efficacy of BIO101 (20- hydroxyecdysone) are expected in 2025. Biophytis is seeking funding and partnerships to complete this study.
お知らせ • May 17Biophytis S.A., Annual General Meeting, Jun 24, 2024Biophytis S.A., Annual General Meeting, Jun 24, 2024. Location: sorbonne universite, 4 place jussieu, paris France
お知らせ • May 15Biophytis SA Announces the Design of its Phase 2 OBA Clinical Study in ObesityBiophytis SA announced the design of its phase 2 OBA clinical study in obesity with BIO101 (20-hydroxyecdysone). BIO101 (20- hydroxyecdysone) will be evaluated in obese patients treated with GLP-1 RAs, together with hypocaloric dieting. The OBA phase 2 study will test the efficacy and safety of BIO101 (20- Hydroxyecdysone) in patients with obesity and overweight with secondary comorbidities, who are starting treatment with GLP-1 R As for weight loss. The OBA Phase 2 study is a double-blind, randomized, placebo-controlled clinical study in which 164 patients are planned to be enrolled with obesity (BMI 30) or overweight (BMI 27 with one or more sequalae e.g. diabetes, hypertension) at the start of treatment with GLP-1RAs in combination with hypocaloric diet. Double-blind treatment with 350 mg BID of BIO101 (20 -hydroxyecdysone) will been given for 21 weeks. The primary efficacy endpoint is muscle strength as measured by knee extension, and important secondary outcomes include 6 Minute Walking Distance and other performance tests, muscle strength normalized to lean body mass, abdominal lean mass and fat mass, biomarkers and various Patient-Reported Outcomes (PROs). Biophytis is preparing for filing an Investigational New Drug (IND) to start the OBA Phase 2 study in the USA in the coming weeks. The OBA Phase 2 clinical study is expected to start mid 2024, upon regulatory approvals, with first patients expected to be treated in the second half of 2024. First results of the safety and efficacy of BIO101 (20 thehydroxyecdysone) drug candidate are expected to be available in 2025.
お知らせ • Apr 27Biophytis S.A.(OTCPK:BPTS.Y) dropped from NASDAQ Composite IndexBiophytis SA has been dropped from NASDAQ Composite Index
お知らせ • Apr 30Biophytis S.A. announced delayed 20-F filingOn 04/29/2025, Biophytis S.A. announced that they will be unable to file their next 20-F by the deadline required by the SEC.
お知らせ • Apr 10Biophytis S.A. Confirms the Launch of the Phase 2 Oba Clinical Trial in ObesityBiophytis SA confirmed the launch of the Phase 2 OBA clinical study in obesity, expected to begin as early as possible in 2025. Following the recent 2.6 million capital increase announced on March 26, 2025, and promising preclinical results presented at the 15th International Conference on Frailty and Sarcopenia in Toulouse, Biophytis will continue the clinical development of BIO101 in obesity. The goal is to evaluate the efficacy and safety of BIO101 in reducing muscle strength loss caused by GLP-1 agonists in patients with obesity. As a reminder, Biophytis received Investigational New Drug (IND) clearance from the FDA in July 2024, marking a major milestone for the OBA program, which benefits from the expertise of Professor Marc-Andr Cornier, a world-renowned expert in the field of obesity.
お知らせ • Jul 11Biophytis SA Obtains IND Approval from the FDA to Start Its Phase 2 Oba Study in ObesityBiophytis SA announced that it has received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) for its phase 2 OBA clinical study in obesity with BIO101 (20-hydroxyecdysone). The primary objective of the study is to measure the improvement in muscle strength in the lower limbs, as assessed by knee extension test. Secondary endpoints will include analysis of mobility (via the 6-minute walk test) and body composition (assessment of fat and lean mass). A world-renowned medical expert in the field of obesity and President-elect of the American Obesity Society, Marc-Andre Cornier, Professor of Medicine and Director of the Endocrinology, Diabetes and Metabolic Diseases Unit at the Medical University of South Carolina, will be the principal investigator of the phase 2 OBA study. The multicenter study is due to start mid-2024 in the USA and could be extended to Europe. Preliminary results on the efficacy of BIO101 (20- hydroxyecdysone) are expected in 2025. Biophytis is seeking funding and partnerships to complete this study.
お知らせ • May 17Biophytis S.A., Annual General Meeting, Jun 24, 2024Biophytis S.A., Annual General Meeting, Jun 24, 2024. Location: sorbonne universite, 4 place jussieu, paris France
お知らせ • May 15Biophytis SA Announces the Design of its Phase 2 OBA Clinical Study in ObesityBiophytis SA announced the design of its phase 2 OBA clinical study in obesity with BIO101 (20-hydroxyecdysone). BIO101 (20- hydroxyecdysone) will be evaluated in obese patients treated with GLP-1 RAs, together with hypocaloric dieting. The OBA phase 2 study will test the efficacy and safety of BIO101 (20- Hydroxyecdysone) in patients with obesity and overweight with secondary comorbidities, who are starting treatment with GLP-1 R As for weight loss. The OBA Phase 2 study is a double-blind, randomized, placebo-controlled clinical study in which 164 patients are planned to be enrolled with obesity (BMI 30) or overweight (BMI 27 with one or more sequalae e.g. diabetes, hypertension) at the start of treatment with GLP-1RAs in combination with hypocaloric diet. Double-blind treatment with 350 mg BID of BIO101 (20 -hydroxyecdysone) will been given for 21 weeks. The primary efficacy endpoint is muscle strength as measured by knee extension, and important secondary outcomes include 6 Minute Walking Distance and other performance tests, muscle strength normalized to lean body mass, abdominal lean mass and fat mass, biomarkers and various Patient-Reported Outcomes (PROs). Biophytis is preparing for filing an Investigational New Drug (IND) to start the OBA Phase 2 study in the USA in the coming weeks. The OBA Phase 2 clinical study is expected to start mid 2024, upon regulatory approvals, with first patients expected to be treated in the second half of 2024. First results of the safety and efficacy of BIO101 (20 thehydroxyecdysone) drug candidate are expected to be available in 2025.
お知らせ • Apr 27Biophytis S.A.(OTCPK:BPTS.Y) dropped from NASDAQ Composite IndexBiophytis SA has been dropped from NASDAQ Composite Index
お知らせ • Apr 19Biophytis SA Announces Formation of New Scientific Advisory Board for Its Phase 2 OBA Clinical Study in ObesityBiophytis SA announced the formation of a new Scientific Advisory Board to support the advancement of its phase 2 OBA clinical study in obesity. This Scientific Advisory Board will be composed of a few worldwide medical experts in the field of obesity, including Professor Dennis Villareal from the USA and Professor Francisco Guarner from Spain. The OBA SAB will guide the company to develop BIO101 (20-hydroxyecdysone) in obesity, in combination with GLP1-RA, and will actively work towards the finalization of the OBA Phase 2 clinical study design. Biophytis plans to file for an Investigational New Drug (IND) application to start the OBA Phase 2 clinical study in the USA with FDA in the coming weeks. The first two members of Biophytis' new Scientific Advisory Board for the OBA clinical study are: Prof. Dennis T. Villareal, MD, PhD, a Professor of Medicine-Endocrinology, Diabetes and Metabolism at Baylor College of Medicine, Houston, Texas, United States.He is a physician-scientist with specialty training in geriatrics and endocrinology. He has extensive clinical and research experience in examining the impact of lifestyle interventions in reversing frailty in older adults with obesity. His clinical and translational laboratories involve hormonal, nutritional, and behavioral/lifestyle interventions to retard or reverse the metabolic and physical complications of aging, including sarcopenia and type 2 diabetes. He is dedicated to research designed to inform practice guidelines with respect to optimal treatment strategies for older adults with obesity. Prof. Francisco Guarner, MD, PhD, a Professor of Internal Medicine, Gastroenterology and Hepatology at the Hospital Clinic in Barcelona and at the University Clinic of Navarra. He is well known for his research studies on liver cell cytoprotection with prostaglandins. He has been Visiting Scientist and Research Fellow at the Upjohn Company in Kalamazoo (Michigan), the Royal Free Hospital (London), the King's College Hospital (London), and the Wellcome Research Laboratories (Beckenham). He is currently Consultant of Gastroenterology at the Digestive System Research Unit and Head of the Experimental Laboratory in University Hospital Vall d'Hebron (Barcelona). He is a member of the Scientific Committee of the Research Institution of University Hospital Vall d'Hebron (Barcelona).
お知らせ • Apr 09Biophytis SA Launches OBA Phase 2 Clinical Study in Obesity with BIO101 (20-Hydroxyecdysone)Biophytis SA announced that it is launching a new clinical development program named OBA, with BIO101 (20-hydroxyecdysone) as a potential treatment for obesity in combination with GLP-1 receptor agonists. Obesity treatment can lead to loss of muscle mass and function, notably as a consequence of dieting when combined with the recently introduced GLP-1 receptor agonists. Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs are very effective drugs that lead to significant weight loss. Up to 40% of the total weight loss comes from muscle, which is a problem as muscle tissue's role is central in controlling metabolism, on top of its motor function. Promising results already obtained in obesity: BIO101 (20-hydroxyecdysone) is the first oral daily MAS receptor activator and has demonstrated metabolic effects on muscle and fat tissues in preclinical studies in obesity. These benefical effects of BIO101 (20-hydroxyecdysone) may translate into improved mobility and muscle strength in obese sarcopenic patients, as suggested in the SARA-INT phase 2 study. Furthermore, the 20-hydroxyecdysone molecule was already tested in obese patients during hypocaloric dieting in the Quinolia study, showing promising effects on muscle strength and fat mass loss. BIO101's (20-hydroxyecdysone) potential in the treatment of obesity in combination with GLP-1RAs to counteract the undesirable effects on muscle wasting associated with drastic weight-loss was highlighted in Nature Biotechnology ("After obesity drugs' success, companies rush to preserve skeletal muscle") on March 05, 2024. An accelerated clinical development with results expected in 2025: The OBA Phase 2 clinical study is expected to start mid 2024, upon regulatory approvals, with first patients expected to be treated in the second half of 2024. BIO101 (20-hydroxyecdysone) will be evaluated in obese patients treated with GLP-1 RAs, and following hypocaloric dieting. The Company expects the first results of the efficacy of drug candidate to be available in 2025. Further information on the OBA program and the clinical study is expected to be provided through the coming weeks.
お知らせ • Feb 15Biophytis S.A., Annual General Meeting, Mar 18, 2024Biophytis S.A., Annual General Meeting, Mar 18, 2024.
お知らせ • Jan 06Biophytis S.A. Announces the Publication of the Results of its COVA Phase 2-3 Study in eClinicalMedicine, Part of The LancetBiophytis S.A. announced the publication of an article on the results of its COVA phase 2-3 clinical trial in the treatment of respiratory symptoms in severe forms of COVID-19 in eClinicalMedicine, a medical journal part of the prestigious scientific review The Lancet. This publication is an endorsement of the strength of Biophytis' clinical research and the value of its drug candidate Sarconeos (BIO101) in the treatement of severe forms of COVID-19. Therapeutic advances are still needed in this pathology, as more than 230,000 patients will still have died of the virus worldwide in 2023, out of a total of nearly 7 million since the start of the pandemic. As a reminder, the objective of the COVA Phase 2-3 study (ClinicalTrials.gov, NCT04472728) was to investigate the efficacy and safety of Sarconeos (BIO101), 350 mg BID in hospitalized COVID-19 patients with hypoxemia, at risk of respiratory failure and death. The proportion and time of onset of these adverse events were studied for 28 days, with mortality and safety monitored for more than 90 days. The main result was that in the study population (233 patients; 126 Sarconeos (BIO101) and 107 placebo), respiratory failure or early death by day 28, the primary end-point, was 11.4% lower in the Sarconeos (BIO101) (13.5%) than in the placebo (24.3%) group, (p = 0.0426). Sarconeos (BIO101) significantly reduced the risk of death or respiratory failure by 44%, supporting its use in adults hospitalized with severe respiratory symptoms due to COVID-19. To follow this publication, Biophytis will host two press conferences in France and the United States on 17 January 2024, alongside experts from the scientific and medical communities, to reiterate the potential and clinical benefits of Sarconeos (BIO101) in severe forms of COVID-19, and provide further details on the Group's strategic choice to explore the compound's potential in the treatment of other respiratory viral infections such as influenza.
お知らせ • Dec 07Biophytis S.A. and the University of Li Ge Explore the Potential of Sarconeos (BIO101) in the Treatment of Viral Respiratory DiseasesBiophytis SA announced the signing of a new partnership with the University of Li ge to carry out a range of preclinical research projects, particularly in the treatment of respiratory failure caused by the flu virus Influenza. Under this partnership, the University's animal pathology research laboratory, headed by Professor Daniel Desmecht, will conduct a series of experiments aimed at establishing the therapeutic potential of Sarconeos (BIO101) in an experimental murine model of infection by an Influenza A virus, which could cause respiratory failure and death in the elderlies. This research is a continuation of the collaboration begun in 2020, which established proof of efficacy on respiratory function and the original mode of action of Sarconeos (BIO101) in an animal model of COVID-19, now confirmed by the clinical data from the Phase 2-3 COVA study.
お知らせ • Nov 29Biophytis S.A. Appoints Yann Meunier and Bernard L vy to its Scientific Advisory BoardBiophytis SA announced the appointment of Dr. Yann Meunier and Professor Bernard L vy to its Scientific Advisory Board. Yann Meunier is a US-based healthcare professional, currently Professor and Director of the International Institute of Medicine and Science Inc. (IIMS), where he leads the development and implementation of innovative educational programmes and research projects in global health and related fields. He is also a consultant and health expert with HealthConnect International LLC. Over the course of his career, he has worked with leading organizations such as Stanford Hospital & Clinics, Stanford University School of Medicine, George Washington University and Universit Paris VI. He has published widely in the international medical literature and, as an investigator, has led and participated in clinical trials for new treatments for HIV/AIDS, tropical andinfectious diseases, and cardiovascular and respiratory diseases. Bernard L vy is Professor Emeritus of Physiology and a senior member of PARCC (Inserm U970). He headed the physiology and functional investigations department and the Inserm cardiovascular research centre at Lariboisi re Hospital in Paris. After studying medicine, he focused on physiology, fluid mechanics, cardiology and vascular medicine. His work focuses on vascular biology in ageing, hypertension, diabetes and Alzheimer's disease, and he has particularly studied the functions of the renin-angiotensin system in these different diseases.
お知らせ • Oct 28Biophytis Receives Notice of Delisting from Nasdaq and Announces It Will Request A Hearing Before the Nasdaq Hearings PanelBiophytis S.A. announced that it has received a notice of delisting from Nasdaq. The staff of the Listing Qualifications Department has determined that the Company's securities have not regained compliance with the minimum $2,500,000 stockholders' equity requirement for continued listing on The Nasdaq Capital Market, as set in Listing Rule 5550(b). The Notice further states that unless the Company timely requests a hearing before a Nasdaq Hearings Panel, the Company's securities would be subject to delisting. Accordingly, the Company intends to timely request a hearing before the Panel. The hearing request will automatically stay any suspension or delisting action pending the hearing. Pursuant to the Nasdaq Listing Rules, the Panel has the discretion to grant the Company an additional extension not to exceed April 23, 2024. At the hearing, the Company will present its plan for regaining and sustaining compliance with the Equity Requirement for continued listing.
お知らせ • Sep 29Biophytis S.A. Provides an Update on the Progress of its R&D Projects over the 1St Half of the Year and the Last Few MonthsOBiophytis S.A. provided an update on the progress of its R&D projects over the 1st half of the year and the last few months. During the first half of 2023, the company achieved key milestones in the development of main drug candidate, Sarconeos (BIO101), with a view to partnerships and market access in 2024, despite a particularly challenging financial environment. Pursuant to an accelerated development over the last two years, the company obtained positive results from phase 2-3 COVA. Biophytis is one of the few European companies to have obtained proof of efficacy in patients with severe forms of COVID-19. The company is pursuing the pharmaceutical and regulatory development of Sarconeos (BIO101), and are currently in discussions with European and American regulatory agencies to define the conditions for market access. In addition, due to the encouraging results obtained with the SARA-INT phase 2b study, Biophytis has received authorizations from the US and Belgian agencies to start the clinical SARA-31 study, which will be the first phase 3 study ever launched in sarcopenia. Finally, the Company has strengthened its management team over the last few months, notably in pharmaceutical operations, finance and business development, in order to forge strategic partnerships for the development of Sarconeos (BIO101).With the progress made in its pipeline, Biophytis is confirming its pioneering position in the development of treatments for age-related diseases, generating a strong medical need that is set to grow very rapidly in the years ahead. Second half of 2023: discussions with the European Agency for the Evaluation of Medicinal Products (EMA) and the US Food and Drug Administration (FDA) in the context of scientific advice to clarify the additional information to be submitted as part of marketing authorization applications, in particular the protocol for a confirmatory phase 3 clinical study. Biophytis will also present to the agencies the possibility of extending the scope of its indication to respiratory viral diseases other than COVID-19, in particular influenza. Second half of 2023: request for reactivation of the authorization for the early access program in Brazil, granted in early 2022. First half of 2024: resubmission to the HAS of an application for authorization of an early access program in France. SARA program: Following the authorizations received from the Belgian and US agencies to conduct a phase 3 trial, the Company will actively pursue its search for partners with a view to initiating the trial in 2024, in collaboration with global or regional pharmaceutical companies under a licensing agreement. MYODA program: first half of 2024: start of a phase 1-2 trial. MACA program: Continuing pre-clinical development work on Macuneos (BIO201) and its back-up BIO203 and preparing for clinical development in dry AMD.
お知らせ • Sep 21Biophytis SA Provides Update on its Early Access Programs for Sarconeos (BIO101) in Treatment of Severe Forms of COVID-19Biophytis SA announced that it has received a response from the French National Authority for Health (HAS) to its request for Early Access Authorization in France for patients suffering from severe forms of COVID-19 and provides an update on its strategy in other countries. After examining the Early Access Authorization request file submitted at the end of May 2023, HAS considered that the Company had not provided sufficient data allowing it to evaluate precisely the benefit vs. risk ratio and to authorize the treatment of patients with severe forms of COVID-19, despite the statistically significant results of the phase 2-3 COVA study. The Company must therefore complete the file by providing in particular certain results of pharmaceutical studies, in progress with its industrial partner Sequens, as well as certain additional data and scientific arguments relating to its phase 2-3 COVA study. On the basis of these various elements, it is planned to resubmit the application to the HAS in the first quarter of 2024, with pharmaceutical partner Intsel Chimos, depending on the progress made in the development plan. At the same time, Biophytis is taking steps in Brazil to confirm the early access authorization obtained in early 2022 that was interrupted pending publication of the full results of the COVA study. This new authorization is expected by the end of the year. Finally, the Company is exploring the possibilities of launching early access programs in other key countries in Europe, in order to best respond to the medical need in a pathology that has become endemic.
お知らせ • Sep 20Biophytis SA Receives Response from the French National Authority for Health to Request for Early Access Authorization in France for Patients Suffering from Severe Forms of COVID-19Biophytis SA announced that it has received a response from the French National Authority for Health (HAS) to its request for Early Access Authorization in France for patients suffering from severe forms of COVID-19 and provides an update on its strategy in other countries. After examining the Early Access Authorization request file submitted at the end of May 2023, has considered that the Company had not provided sufficient data allowing it to evaluate precisely the benefit vs. risk ratio and to authorize the treatment of patients with severe forms of COVID- 19, despite the statistically significant results of the phase 2-3 COVA study. The Company must therefore complete the file by providing in particular certain results of pharmaceutical studies, in progress with its industrial partner Sequens, as well as certain additional data and scientific arguments relating to its phase 2-3 COVA Study. On the basis of these various elements, it is planned to resubmit the application to the HAS in the first quarter of 2024, with pharmaceutical partner Intsel Chimos, depending on the progress made in the development plan. At the same time, Biophytis is taking steps in Brazil to confirm the early access authorization obtained in early 2022 that was interrupted pending publication of the full results of the COVA study. This new authorization is expected by the end of the year. Finally, the Company is exploring the possibilities of launching early access programs in other key countries in Europe, in order to best respond to the medical need in a pathology that has become endemic.
お知らせ • Sep 14Biophytis S.A. Announces Executive ChangesBiophytis S.A. announced the strengthening of its management team with the appointment of Edouard Bieth as Chief Business Officer and member of the Executive Committee. A recognized industry leader with over 18 years' experience in the pharmaceutical industry, Edouard Bieth has held a number of senior management positions and has developed strong expertise in market access and sales and marketing strategy, both globally and locally. He will be a member of the Executive Committee and will report directly to Stanislas Veillet, Chairman and CEO of Biophytis. Most recently Edouard spent 6 years as General Manager France & BeNeLux of Tillotts Pharma's commercial subsidiary. During his career, Edouard has also worked for various industry players, including AstraZeneca, Servier and Menarini. He has a Master's degree in biology and pharmacology of ageing and trained in sales and marketing strategy at HEC Paris and in finance at the London Business School. Biophytis has also appointed Claudia Ferreira as Medical Director, reporting to Rob Van Manen, Chief Medical Officer, to strengthen links with the medical community and unite experts around development programmes, which address major unmet medical needs in severe age-related diseases.
お知らせ • Sep 12Biophytis Obtains Fda Authorization to Initiate the Sara-31 Phase 3 Study in SarcopeniaBiophytis SA aimed at slowing the degenerative processes associated with aging improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19, announced that it has received FDA (Food and Drug Administration) authorization to launch its SARA-31 study in the US, the first ever phase 3 study in sarcopenia. This authorization complements the positive opinion obtained this summer from the Belgian authorities to conduct the SARA-31 phase 3 study. The company still needs to obtain authorizations from ethics committees in the countries before launching this study. The effective start of the study is scheduled for 2024, and will depend on the conclusion of partnership agreements and the Company's financial resources. The aim of phase 3 is to evaluate the efficacy and safety of Sarconeos (BIO101) in the treatment of sarcopenic patients at risk of motor disability. Around 900 patients aged over 65 will be included with sarcopenia (Short Physical Performance Battery (SPPB) score between 3 and 7), with low walking speed (4-meter walking speed ? 0.8 m/s) and low hand grip strength (HGS < 20kg for women and < 35.5 kg for men). They will be treated for a minimum of 12 months and a maximum of 36 months, receiving either placebo or 350 mg of Sarconeos (BIO101) twice daily. The primary efficacy parameter will be the time to onset of Major Mobility Disability (MMD), measured by the inability to walk 400m in less than 15 minutes without sitting, help from another person or use of a walker. This main measure will be supplemented by the following secondary effectiveness measures: walking speed (4-m walking speed from the SPPB test), hand grip strength and patient-reported quality of life (Patient Reported Outcome SarQol, a questionnaire specifically developed for sarcopenia). Roger A. Fielding, PhD, sarcopenia expert and laboratory director at Tufts University, Boston, will be the principal investigator of the SARA-31 study. He is continuing his contribution to the Sarconeos (BIO101) clinical development program in this indication.
お知らせ • Aug 17Biophytis SA Announces Next Regulatory Steps in Europe and the United States for its COVA ProjectBiophytis SA announced that it has received feedback from the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) enabling it to plan the next regulatory steps for its COVA project dedicated to the development of Sarconeos (BIO101) for severe forms of Covid-19. After filing requests for pre-submission meetings with both agencies in recent weeks, the company will now request a scientific advice meeting in Europe and a Type B meeting in the United States. The purpose of these meetings will be to gather recommendations from the EMA and the FDA to fine-tune COVA's development plan prior to marketing approval. These discussions will enable Biophytis to present the available data (preclinical, clinical, product and industrialization) and specify the additional information to be provided in the context of marketing authorization applications, in particularly the design of a confirmatory phase 3 clinical study. Biophytis will also present the agencies with the possibility of extending the scope of its indication to viral respiratory pathologies other than Covid-19, notably influenza, based on its non-specific mechanism of action. This extension would significantly increase the number of patients eligible for treatment and optimize the commercial potential of Sarconeos (BIO101).
お知らせ • Aug 09Biophytis SA Receives Positive Opinion for its SARA-31 Phase 3 Study in Sarcopenia in EuropeBiophytis SA announced that it has received a positive opinion from Belgian authorities to conduct its SARA-31 program, which will be the first phase 3 study ever launched in sarcopenia. The launch of the Phase 3 program follows the promising results obtained in the SARA-INT Phase 2b study, and the scientific advice given in 2022 by the EMA (European Medicine Agency), which helped define the conditions for starting such a study in Europe, specifying the Phase 3 protocol. Final authorization depends on a positive opinion from the Ethics Committee in Belgium. A similar application has been filed with the FDA (Food and Drug Administration) to start this study in the United States, with a response expected in the coming weeks. Further authorizations may be requested in other countries, depending on the needs of the study. About SARA-31 The aim of phase 3 is to evaluate the efficiency and safety of Sarconeos (BIO101) in the treatment of sarcopenic patients at risk of motor disability. Around 900 patients aged over 65 with severe sarcopenia (3 SPPB 7) with low walking speed (4-meter walking speed 0.8 m/s) and low grip strength (HGS < 20kg for women and < 35.5kg for men) will be included. They will be treated for a minimum of 12 months and a maximum of 36 months, receiving either placebo or 350mg of Sarconeos ("BIO101") twice daily. The main criterion will be an assessment of the risk of Major Mobility Disability (MMD), measured by the ability to walk 400m in less than 15 minutes. This main criterion will be supplemented by the following secondary criteria: walking speed (4-m walking speed from the SPPB - Short Physical Performance Battery - test), grip strength (HGS) and patient-reported quality of life (Patient Reported Outcome SarQol, a questionnaire specifically developed for sarcopenia). Roger A. Fielding, PhD, sarcopenia expert and laboratory director at Tufts University, Boston, will be the principal investigator of the SARA-31 study. He is continuing his contribution to the SARA-31 clinical development program in this indication.
お知らせ • Jul 23Biophytis S.A. Files for a Pre-Submission Meeting with the FDA for an Emergency Use Authorization of Sarconeos (BIO101) for the Treatment of COVID-19Biophytis SA announced that it has filed for a pre-submission meeting request with the Food and Drug Administration (FDA) to discuss filing for Emergency Use Authorization (EUA) in the United States for Sarconeos (BIO101) in the treatment of severe forms of COVID-19. This is a further key step in defining the conditions for rapid market access in the United States for SARConeos(BIO101) in thetreatment of severe forms of COVID -19, following the similar process initiated with the European Medicine Agency (EMA) in May, in a context where COVID-19 is still associated with a public health problem in the United States and in Europe. Like influenza, this pathology has become an endemic respiratory infectious disease that can lead to Acute Respiratory Distress Syndrome (ARDS) in elderly, immunocompromised or co-morbid patients. According to the WHO, the medical need remains high, with several thousand deaths per week in the United States and Europe. In this context, the positive clinical results of the phase 2-3 COVA study, with a 44% reduction in the risk of respiratory failure or early death, suggests that Sarconeos (BIo101) could become an important new therapeutic option alongside antiviral or anti-inflammatory treatments.
お知らせ • Jul 21Biophytis and Seqens Sign A Partnership to Produce Sarconeos (Bio101) Active CompoundBiophytis SA announced the conclusion of a master agreement for the production of the active compound in Sarconeos (BIO101), Biophytis' main drug candidate developed for three indications: severe forms of Covid-19, sarcopenia and Duchenne muscular dystrophy. SEQENS will produce the active ingredient in Sarconeos (BIO101) in France at its Villeneuve La Garenne plant, near Paris. This historic site was modernized and expanded in 2020 with the opening of a unit to produce high-pot potential active pharmaceutical ingredients (APIs). This partnership is part of a political context in which the relocation of the production of certain active compounds is recognized as essential to national and European health sovereignty.
お知らせ • Jul 11Biophytis SA Filed with the FDA for Authorization to Initiate SARA-31 Phase 3 Study in SarcopeniaBiophytis SA announced that it has filed for approval on the Food and Drug Administration (FDA) portal to launch its SARA-31 program in the U.S., the first ever Phase 3 study in sarcopenia. The launch of the Phase 3 program follows promising results from the SARA-INT Phase 2b study and discussions with health authorities in 2022. Based on the results of the previous study and feedback from the U.S. government agency, Biophytis is starting its Phase 3 program by filing the first ever Phase 3 application (SARA-31) in sarcopenia with the FDA. This follows the recent submission to the European Medicines Agency. The objective of the SARA-31 phase 3 study in sarcopenia is to evaluate the efficacy and safety of Sarconeos (BIO101) in the treatment of sarcopenic patients at risk of mobility disability. Approximately 900 patients over 65 years of age with severe sarcopenia (3 = SPPB = 7) with low walking speed (4-m Gait speed = 0.8 m/s) and low grip strength (HGS < 20kg for women and < 35.5 kg for men) will be included. They will be treated for a minimum of 12 months and a maximum of 36 months, receiving either placebo or 350mg of Sarconeos (BIO101) twice daily. The primary endpoint will be the assessment of the risk of Major Mobility Disability (MMD), measured by the ability to walk 400m in less than 15 minutes over time. In addition to this primary endpoint, the following secondary endpoints will be assessed: walking speed (4-m walking speed from the Short Physical Performance Battery (SPPB) test), handgrip strength (HGS) and patient-reported quality of life (Patient Reported Outcome SarQol, a questionnaire developed specifically for sarcopenia). Biophytis expects a response from the regulatory authorities during the third quarter of 2023, which would enable Biophytis to initiate the study in the United States. The principal investigator will be Roger A. Fielding, PhD, who heads the Nutrition, Physiology, Exercise and Sarcopenia (NEPS) Laboratory at Tufts University in Boston.
お知らせ • Jun 20Biophytis SA Reports Clinical Results for Sarconeos (BIO101) in Sarcopenia Treatment at the 16th SCWD International CongressBiophytis SA announced that it is taking part in the 16th SCWD (Society on Sarcopenia, Cachexia & Wasting disorders) international congress, a event bringing together experts from all over the world to share thoughts, research and innovations on sarcopenia, Cachexia and wasting disorders. Biophytis has given an oral presentation entitled "BIOPHYTIS BIO101 - a candidate treatment for muscle diseases" on the development of Sarconeos (BIO101) for the treatment of sarcopenia. It was made by Cendrine Tourette, PhD in Neuroscience and Director of translational and clinical research projects on neuromuscular diseases at Biophytis. Ms. Tourette also took part in a round table discussion with top-notch experts on new trials and recent results in the treatment of sarcopenia and cachexia. Building on the promising results of Phase 2 of SARA-INT, Biophytis is currently in advanced discussions with the European (EMA) and American (FDA) regulatory authorities. EEMA and FDA approvals for the start of Phase 3 of the SARA program are expected in the second half of 2023. Sarconeos (BIo101) would therefore be the first and only drug candidate to enter Phase 3 for the treatment of sarcopenia.
お知らせ • May 19Biophytis S.A., Annual General Meeting, Jun 16, 2023Biophytis S.A., Annual General Meeting, Jun 16, 2023.
お知らせ • May 12Biophytis S.A. has completed a Follow-on Equity Offering in the amount of €2.302535 million.Biophytis S.A. has completed a Follow-on Equity Offering in the amount of €2.302535 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 18,562,859 Price\Range: €0.0222 Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 85,154,952 Price\Range: €0.0222
お知らせ • May 10Biophytis SA Files for Pre-Submission Meeting Request with the European Medicine Agency (EMA) to Discuss Filing for Conditional Marketing Authorisation (CMA) in EuropeBiophytis SA announced that it has filed for a pre-submission meeting request with the European Medicine Agency (EMA) to discuss filing for conditional Marketing Authorisation (cMA) in Europe for Sarconeos (BIO101) in the treatment of severe form of COVID-19. This is the first step in the regulatory process that the company is undertaking to define the eligibility and conditions for conditional Marketing Authorisation application in Europe for SarconeOS (BIO101) in The treatment of severe form of COVID-19. A request for a pre-submission meeting with the Food and Drug Administration (FDA) for an Emergency Use Authorisation (EUA) application in the US is expected to be filed later this quarter.
お知らせ • Feb 02Biophytis Announces Positive Final Results of the Phase 2-3 COVA Study with Sarconeos (BIO101) in Severe COVID-19Biophytis SA released the final results from its phase 2-3 COVA clinical study evaluating Sarconeos (BIO101) in the treatment of COVID-19-related respiratory failure. Biophytis announced final results following the reintegration of data from 54 patients, among 233 patients treated, that were missing in the Top Line analysis released on September 7, 2022. The final analysis demonstrates that COVA study met the primary endpoint, with a 44% statistically significant reduction (p = 0.043) in the risk of respiratory failure or early death in hospitalized patients with severe COVID-19, in line with positive Post-Hoc analysis released on November 3, 2022. Biophytis is nowinitiating key regulatory activities to give access to Sarconeos (BIO101) to hospitalized patients with severe COVID-19 at risk of respiratory failure and death in 2023. The strategy to give access to Sarconeos (BIO101) as quickly as possible is to file for Early Access Programs (EAP) in France and Brazil, while filing for conditional Marketing Authorisation (CMA) in Europe and Emergency Use Authorization (EUA) in the USA. An EAP has already been approved in 2022 in Brazil to treat COVID-19 patients at critical stage in Intensice Care Units (ICU) and the request to lift the hold given completion of the study and positive results is pending. The filing of the request for starting the EAP program in France is being prepared and will be made in First Quarter 2023 with the objective to be granted approval in Second Quarter 2023. Requests for pre-submission meetings regarding conditional Marketing Authorisation in Europe and Emergency Use Authorization in the USA are under preparation and will be sent in First Quarter 2023, targeting an approval later in 2023, depending on feedback from authorities. Biophytis will present the results in detail at the American Thoracic Society conference in Washington, DC, USA in May 2023 and at the European Respiratory Society Lung Science meeting in Estoril, Portugal, in March 2023. The objective of the study was to investigate the efficacy and safety of Sarconeos (BIO101), 350 mg BID in hospitalized COVID-19 patients with hypoxemia, at risk of respiratory failure requiring high flow oxygen or mechanical ventilation, and death. The proportion of patients and time to respiratory failure or early death were studied at 28 days in the primary analysis, corresponding to the maximum treatment period, with follow-up of mortality and safety for at least 90 days. The 233 treated patients (Intent To Treat, ITT population) were 63 years old on average, 64% of the patients were male, recruited in 37 centers in Europe, the US and Brazil between Third Quarter 2020 and First Quarter 2022, infected with the main SARS-Cov-2 variants. The trial ended early before reaching the 310 patients originally planned, due to stalled recruitment. The sub-population of patients without major protocol deviations (Per Protocol, PP sub-population) included 180 patients with similar baseline demographics and disease characteristics as the ITT population. The study met its pre-defined primary endpoint demonstrating a statistically significant difference between Sarconeos (BIO101) and placebo in the proportion of patients with respiratory failure or early death at day 28, representing a relative reduction of risk of 44% (p=0.043, Cochran-Mantel-Haenszel test). Moreover, the analysis of time to respiratory failure or early death had shown significant differences over 28 days in the Kaplan Meier curves for Sarconeos (BIO101) versus placebo (p=0.022). The pre-specified analysis of time to death over the complete follow-up period over 90 days showed that mortality rate with Sarconeos (BIO101) was reduced compared to placebo in the ITT population (p=0.083) and in the PP population (p=0.038). Post hoc Kaplan-Meier analysis released on November 3, 2022 confirmed the effect of Sarconeos (BIO101) on the primary endpoint and on mortality at day 90.
お知らせ • Jan 20Biophytis S.A. Judgment of the Paris Court of Appeal of 17 January 2023 in the Case Between Biophytis and Negma Group LtdBiophytis S.A. announces that on the 17th of January 2023 the Paris Court of Appeal rendered a decision in the case between Biophytis and Negma Group Ltd. on the subject of the ORNANEBSA agreement concluded on 21st August 2019. The Paris Court of Appeal has: confirmed the judgment of the Paris Commercial Court of March 16, 2021; ordered Biophytis to pay Negma EUR 75,000 pursuant to Article 700 of the French Code of Civil Procedure as well as costs. Biophytis specifies that it has already performed, in 2021, the entirety of the Judgment. The judgment of the Paris Court of Appeal of January 17, 2023 has not yet been served. Biophytis reserves the right to appeal against it before the French Supreme Court (Cour de Cassation).
お知らせ • Jan 13Biophytis to Take Appropriate Measures After Receiving Nasdaq Deficiency NoticeBiophytis S.A. received a deficiency notice from The Nasdaq Stock Market Inc. ("Nasdaq") stating that the Company has not filed its financial information for the six-month period ended June 30, 2022 on a Form 6-K (the "Filing") and as a result the Company no longer complies with Nasdaq's listing rules for continued listing set forth in the Listing Rule 5250(c)(2). Nasdaq has informed the Company that it has 60 calendar days or until March 6, 2023 to submit a plan (the "Plan") as definitive as possible to regain compliance with the Nasdaq's continued listing requirements. If Nasdaq accepts the Company's Plan to regain compliance in that respect, Nasdaq can grant an exception of up to 180 calendar days from the prescribed Filing due date or until June 28, 2023 to regain compliance. In determining whether to accept the Company's Plan, Nasdaq will consider such things as the likelihood that the Filing and any subsequent periodic filings can be made within the 180-day period, the Company's past compliance history, the reasons for the late filing, other corporate events that may occur within the Nasdaq review period, the Company's overall financial condition and its public disclosures. The Company is currently working on the Plan to regain compliance with respect to the Listing Rule 5250(c)(2) to meet the requirements for continued listing on the Nasdaq Capital Market. It intends to submit such Plan to Nasdaq as soon as practicable prior to March 6, 2023.
分析記事 • Nov 18Biophytis (EPA:ALBPS) Has Debt But No Earnings; Should You Worry?Howard Marks put it nicely when he said that, rather than worrying about share price volatility, 'The possibility of...
Executive Departure • Jul 15Independent Director Jean Franchi has left the companyOn the 7th of July, Jean Franchi's tenure as Independent Director ended after 4.1 years in the role. We don't have any record of a personal shareholding under Jean's name. Jean is the only executive to leave the company over the last 12 months. The current median tenure of the management team is 1.75 years, which is considered inexperienced in the Simply Wall St Risk Model.
Is New 90 Day High Low • Feb 09New 90-day high: €1.69The company is up 217% from its price of €0.53 on 10 November 2020. The French market is up 7.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 53% over the same period.
Is New 90 Day High Low • Jan 18New 90-day high: €1.32The company is up 150% from its price of €0.53 on 20 October 2020. The French market is up 13% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 38% over the same period.
Is New 90 Day High Low • Dec 09New 90-day high: €0.74The company is up 42% from its price of €0.52 on 10 September 2020. The French market is up 11% over the last 90 days, indicating the company outperformed over that time. However, its price trend is similar to the Biotechs industry, which is also up 42% over the same period.
Is New 90 Day High Low • Nov 03New 90-day high: €0.71The company is up 6.0% from its price of €0.67 on 04 August 2020. The French market is down 3.0% over the last 90 days, indicating the company outperformed over that time. However, it underperformed the Biotechs industry, which is up 7.0% over the same period.
Is New 90 Day High Low • Oct 15New 90-day low: €0.39The company is down 45% from its price of €0.71 on 17 July 2020. The French market is down 1.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 11% over the same period.
Is New 90 Day High Low • Sep 19New 90-day low: €0.51The company is down 38% from its price of €0.81 on 19 June 2020. The French market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 6.0% over the same period.
