ISIN:US09076G1040

Biophytis and Skyepharma sign a Partnership Agreement for the Production of Sarconeos (BIO101)

Retrieved on: 
Lundi, septembre 25, 2023
GMP, Good, Partnership, Euronext Growth, CET, Therapy, ANVISA, Marketing, Ageing, Good manufacturing practice, EMA, COVID-19, Patient, FDA, Notifiable disease, Pharmaceutical industry, Fine chemical

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.

Key Points: 
  • 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 leading, innovative French partners meeting the highest standards of pharmaceutical quality.
  • Pharmaceutical development work at the industrial stage will complete the information required for early access authorizations, particularly in France and Brazil.
  • David Lescuyer, CEO of Skyepharma, added: "We are delighted to be working alongside Biophytis to develop the regulatory batches for Sarconeos (BIO101).

Biophytis Strengthens its Management Team with the Appointment of its Chief Business Officer

Retrieved on: 
Samedi, septembre 16, 2023
HEC Paris, Euronext Growth, SARA, CET, Therapy, Marketing, Benelux, London Business School, COVID-19, Ageing, AstraZeneca, Sarcopenia, Mene Pangalos, Medical director, Patient, Executive Committee, Master, Biology, Knowledge, Executive Committee of the Space Research Council, Notifiable disease, Pharmacology, Respiratory failure, Pharmaceutical industry

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).

Key Points: 
  • 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).
  • Meanwhile, our SARA programme in sarcopenia has obtained authorization to start a phase 3 trial in the United States and Belgium.
  • In this context, the arrival of Edouard Bieth as Chief Business Officer is a key element in accelerating the availability of our drug candidates.
  • He will be a member of the Executive Committee and will report directly to Stanislas Veillet, Chairman and CEO of Biophytis.

Biophytis obtains FDA Authorization to initiate the SARA-31 phase 3 study in sarcopenia

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Samedi, septembre 16, 2023
Partnership, Euronext Growth, CET, Therapy, COVID-19, Ageing, Food and Drug Administration, Sarcopenia, Trial of the century, Relief Therapeutics, Patient, Ethics, FDA, Notifiable disease, Food, Respiratory failure, Pharmaceutical industry

This authorization complements the positive opinion obtained this summer from the Belgian authorities to conduct the SARA-31 phase 3 study.

Key Points: 
  • 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.
  • Stanislas Veillet, Chief Executive Officer of Biophytis, commented: "FDA approval suggests authorities may be increasingly aware of the growing need for effective therapeutics against a major disease in an aging society.

Biophytis to Participate at the H.C. Wainwright 25th Global Investment Conference in New York

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Lundi, septembre 4, 2023
Euronext Growth, CET, Therapy, COVID-19, Ageing, Patient, Notifiable disease, Conference, Respiratory failure, Pharmaceutical industry

Biophytis to Participate at the H.C. Wainwright 25th Global Investment Conference in New York

Key Points: 
  • Biophytis to Participate at the H.C. Wainwright 25th Global Investment Conference in New York
    Biophytis to Participate at the H.C. Wainwright
    Paris (France) and Cambridge (Massachusetts, USA), September 4, 2023 – 11:00 pm CET – Biophytis SA (Nasdaq CM : BPTS, Euronext Growth Paris : ALBPS), ("Biophytis" or the "Company"), a clinical-stage biotechnology company specialized in 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, including severe respiratory failure in patients suffering from COVID-19, announces that its CEO, Stanislas Veillet, will participate and hold a presentation at the “H.C.
  • Wainwright 25th Annual Global Investment Conference”, which takes place from September 11 to 13, 2023 in New York.
  • The presentation will be available post-meeting on the conference website.
  • Stanislas Veillet will also meet with institutional investors in one-to-one meetings on September 11-13, 2023.

Biophytis announces next regulatory steps in Europe and the United States for its COVA project

Retrieved on: 
Mardi, août 22, 2023
Euronext Growth, CET, Therapy, Marketing, European Medicines Agency, Ageing, Trial of the century, History of COVID-19 vaccine development, EMA, Food and Drug Administration, COVID-19, Patient, FDA, Notifiable disease, Food, Vaccine

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.

Key Points: 
  • 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.
  • 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).