During the 25th annual H.C. Wainwright Global Investment Conference, Biophytis’ CEO Stanislas Veillet presented the company, its ambitions and the latest progress it made on its various projets. A replay will be available for 90 days at the following link: https://journey.ct.events/view/1037e68b-3f79-4b25-9a15-27affba4d7c4 Watch here
Biophytis obtains FDA Authorization to initiate the SARA-31 phase 3 study in sarcopenia Biophytis 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
Biophytis announces next regulatory steps in Europe and the United States for its COVA project Biophytis 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
Biophytis receives a positive opinion for its SARA-31 phase 3 study in sarcopenia in Europe Biophytis 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
Biophytis has requested a pre-submission meeting with the FDA for an Emergency Use Authorization of Sarconeos (BIO101) for the treatment of COVID-19 Biophytis 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 the treatment of severe forms of COVID-19, following the similar process initiated with the
Biophytis Announces $3.8 Million Registered Direct Offering Fullscreen Mode
Biophytis and SEQENS sign a partnership to produce Sarconeos Biophytis, a clinical-stage biotechnology company focused on the development of therapeutics that are aimed at slowing the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases and SEQENS, integrated global player in solutions and ingredients for the pharmaceutical and specialty markets, offering a broad portfolio of active ingredients, pharmaceutical intermediates and specialty products, 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
HALF-YEAR REPORT ON THE BIOPHYTIS LIQUIDITY CONTRACT Fullscreen Mode
Biophytis has filed with the FDA for authorization to initiate SARA-31 phase 3 study in sarcopenia Biophytis 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
Biophytis reports clinical results for Sarconeos (BIO101) in sarcopenia treatment at the 16th SCWD International Congress Biophytis announces that it is taking part in the 16th SCWD (Society on Sarcopenia, Cachexia & Wasting disorders) international congress, a flagship 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