Biophytis obtains EMA authorization to launch its Phase 2 clinical trial in obesity Biophytis announces that the European Medicines Agency (EMA) has issued a favorable outcome on Part I of its Clinical Trial Application (CTA) for the initiation of a Phase 2 clinical trial of BIO101 (20-hydroxyecdysone) in patients suffering from muscle wasting associated with…
Biophytis Receives EMA and Belgian Regulatory Approval to Initiate Phase 3 Sarcopenia Clinical Trial Biophytis announced that both Part I (European Medicines Agency scientific review) and Part II (Belgian national ethical assessment) of its Clinical Trial Application (CTA) for a Phase 3 study in sarcopenia have been successfully reviewed and accepted. With these approvals, Biophytis…
Biophytis announces filing of an IND application with the US FDA for its phase 2 study in obesity Biophytis announces that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) regarding its phase 2 OBA clinical study in obesity with BIO101 (20-hydroxyecdysone). Fullscreen Mode
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…
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…
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)…
Biophytis has filed with the French National Authority for Health (HAS) an application for Early Access Authorisation (EAA) for Sarconeos (BIO101) in the treatment of severe forms of COVID-19 Biophytis announced that it has filed, through its pharmaceutical partner Intsel Chimos, an application for Early Access Authorisation (EAA) in France with the French National Authority…
Biophytis has filed with the EMA for authorization to initiate SARA-31 phase 3 study in sarcopenia Biophytis announced that it has submitted the application for Clinical Trial Authorization (CTA) to initiate SARA-31, the first phase 3 study in sarcopenia, on the European portal of the EMA (European Medicines Agency). The launch of the Phase 3…
Biophytis has requested a pre-submission meeting with the EMA for the Marketing Authorisation of Sarconeos (BIO101) for the treatment of COVID-19 Biophytis 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…
Biophytis initiates the regulatory process for an early access authorization in France from the French National Authority for Health (HAS) for the treatment with Sarconeos (BIO101) of severe forms of COVID-19 Biophytis announced that it has begun the process of early access application in France from the French National Authority for Health (HAS) for the…
Biophytis received approval from ANVISA (Brazil) to give access to Sarconeos (BIO101) to hospitalized COVID-19 patients through an Expanded Access Program ANVISA (Brazilian Health Authority) approved Biophytis’ Expanded Access Program (EAP) for hospitalized patients with severe COVID-19 and mechanically ventilated in Intensive Care Unit Sarconeos (BIO101) treatment will be given to a maximum of 80…
Biophytis Announces Expansion of Patient Recruitment for Part 2 of the Phase 2-3 COVA Trial (“COVA Study”) following Regulatory Authorities approvals in France and Belgium
Biophytis Announces the Start of Patient Recruitment in Brazil and the USA for Part 2 of the Phase 2-3 COVA Trial (“COVA Study”)
Biophytis Announces Public Filing of a Registration Statement for Proposed Initial Public Offering in the United-States
Biophytis receives DMC recommendation for starting recruitment for Part 2 of its Phase 2-3 COVA study in COVID-19
Biophytis Receives Approval from Brazilian Health Regulatory Agency to Start COVA, a Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID19 Related Respiratory Failure. Read the Press Release
Biophytis Receives Approval from the French Health Authority (ANSM) to Initiate COVA, a Clinical Trial with Sarconeos (BIO101) for the Treatment of COVID-19 Related Respiratory Failure. Read the Press Release
Biophytis Receives FDA IND Clearance for COVA, a Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure. Read the Press Release
Biophytis Receives MHRA Approval to Initiate the COVA Clinical Trial in the UK with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure. Read the Press Release
Biophytis Receives Approval from the Belgian Regulatory Agency (FAMHP) to Initiate COVA, a Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID19 Related Respiratory Failure. Read the Press Release
Biophytis Receives Approval from the Belgian Regulatory Agency to Proceed with the MYODA Program for Clinical Development of Sarconeos (BIO101) in Patients with DMD. Read the Press Release
