OCTOBER 30, 2023

Biophytis and Innovation Solutions Pharma sign a partnership agreement to accelerate market access for Sarconeos (BIO101) in Brazil Biophytis announces the signature of a partnership with Innovation Solutions Pharma, a company specializing in support for clinical development and drug registration operations in South America, with a view to accelerate market access for Sarconeos (BIO101) in Brazil. As part of this partnership, Innovative Solutions Pharma will represent Biophytis in front of the Brazilian agency ANVISA to lift the suspension of the Early Access Program (EAP) authorized at the beginning of 2022. This program will enable a maximum of 80 patients suffering

Read the press release »

OCTOBER 27, 2023

Biophytis receives notice of delisting from Nasdaq and announces it will request a hearing before the Nasdaq Hearings Panel Biophytis announces 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 forth 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

Read the press release »

OCTOBER 23, 2023

Biophytis announces the launch of a rights issue with maintenance of shareholders’ preferential subscription rights to continue the execution of its strategic roadmap Public offering of ABSARs: new shares with redeemable share subscription warrants (BSARs) Subscription price: €0.0093 per new share each with a subscription warrant Subscription ratio: 3 ABSARs for 8 existing shares Trading period for the preferential subscription rights: from October 26, 2023 to November 9, 2023 inclusive Subscription period: from October 30, 2023 to November 13, 2023 inclusive Subscription commitments: €1,960,000 or 75% of the issue   Biophytis is announcing the terms of a rights issue set

Read the press release »

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

Read the press release »

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

Read the press release »

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

Read the press release »

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

Read the press release »

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

Read the press release »

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

Read the press release »

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

Read the press release »