SEPTEMBER 25, 2023

Biophytis and Skyepharma sign a Partnership Agreement for the Production of Sarconeos (BIO101) Biophytis and Skyepharma, a French pharmaceutical company specializing in the formulation, development and production of pharmaceutical products, announce the signature of a partnership agreement for the production of regulatory batches of Sarconeos (BIO101) for severe forms of Covid-19, with a view to the submission of marketing authorization applications. Based on the active ingredient produced by SEQENS, Skyepharma will develop finished product batches meeting the GMP (Good Manufacturing Practice) standards required for market access filings. The key stages in the production of Sarconeos (BIO101) will be entrusted to

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SEPTEMBER 19, 2023

Biophytis provides an update on its early access programs for Sarconeos (BIO101) in the treatment of severe forms of COVID-19 Biophytis 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

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SEPTEMBER 14, 2023

Biophytis Strengthens its Management Team with the Appointment of its Chief Business Officer Biophytis announced the strengthening of its management team with the appointment of Edouard Bieth as Chief Business Officer and member of the Executive Committee. Stanislas Veillet, Chief Executive Officer of Biophytis, stated: “Over the past two years, Biophytis has made significant progress in the development of its key asset Sarconeos (BIO101). Our COVA programme in severe forms of COVID-19 has demonstrated its efficacy in a phase 2/3 study and we are currently discussing the next steps with the regulatory authorities, in particular the implementation of early access

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SEPTEMBER 12, 2023

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

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SEPTEMBER 11, 2023

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

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AUGUST 16, 2023

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

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AUGUST 8, 2023

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

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JULY 20, 2023

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

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JULY 18, 2023

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

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