Biophytis S.A

Biophytis SA operates as a clinical-stage biotechnology company. It specializes in the development of therapeutics that are aimed at slowing the degenerative processes associated with aging, including severe respiratory failure in patients suffering from COVID-19. Its products include Sarconeos (BIO101), which is used to treat sarcopenic obesity and Macuneos (BIO201), which is used to treat dry age-related macular degeneration (AMD). The company was founded by Stanislas Veillet and René Lafont on September 15, 2006 and is headquartered in Paris, France.

Biophytis SA operates as a clinical-stage biotechnology company. It specializes in the development of therapeutics that are aimed at slowing the degenerative processes associated with aging, including severe respiratory failure in patients suffering from COVID-19. Its products include Sarconeos (BIO101), which is used to treat sarcopenic obesity and Macuneos (BIO201), which is used to treat dry age-related macular degeneration (AMD). The company was founded by Stanislas Veillet and René Lafont on September 27, 2006 and is headquartered in Paris, France.

Biophytis (NASDAQ: BPTS ) stock is rising higher on Monday after the company announced a Sarconeos production agreement. According to a press release from Biophytis, the company reached an agreement with Skyepharma for the manufacturing of Sarconeos.

Why Is Biophytis (BPTS) Stock Up 49% Today?

PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / September 25, 2023 / Biophytis SA (Nasdaq CM:BPTS, Euronext Growth Paris:ALBPS), (Biophytis), 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, 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.

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

PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / September 19, 2023 / Biophytis SA (Nasdaq CM:BPTS, Euronext Growth Paris:ALBPS), (Biophytis), 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, today 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.

Biophytis Provides an Update on its Early Access Programs for Sarconeos (BIO101) in the Treatment of Severe Forms of COVID-19

PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / September 14, 2023 / Biophytis SA (Nasdaq CM:BPTS, Euronext Growth Paris:ALBPS), (Biophytis), 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, today 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).

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

PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / September 11,2023 / Biophytis SA (Nasdaq CM:BPTS)(Euronext Growth Paris:ALBPS), («Biophytis»), 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, today 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.

Biophytis Obtains FDA Authorization to Initiate the SARA-31 Phase 3 Study in Sarcopenia

PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / September 4, 2023 / 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.

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

PARIS FRANCE and CAMBRIDGE, MA / ACCESSWIRE / August 16, 2023 / Biophytis SA (Nasdaq CM:BPTS, Euronext Growth Paris:ALBPS), ("Biophytis"), 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, announced today 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.

Biophytis Announces Next Regulatory Steps in Europe and the United States for its COVA Project

Biophytis (NASDAQ: BPTS ) stock is soaring higher on Tuesday as investors react to a positive opinion for its upcoming Phase 3 clinical trial. The big news here is Belgium authorities giving a positive opinion of the company conducting its SARA-31 program.

Why Is Biophytis (BPTS) Stock Up 18% Today?

PARIS, FRANCE / CAMBRIDGE, MA / ACCESSWIRE / August 8, 2023 / Biophytis SA (Nasdaq CM:BPTS, Euronext Growth Paris:ALBPS), ("Biophytis"), 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, today 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.

Biophytis Receives a Positive Opinion for its SARA-31 Phase 3 Study in Sarcopenia in Europe

PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / July 20, 2023 / Biophytis SA (Nasdaq CM:BPTS)(Euronext Growth Paris:ALBPS), ("Biophytis"), 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, today 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 European Medicine Agency (EMA) in May, in a context where COVID-19 is still associated with a public health problem in the United States and in Europe.

Biophytis has Requested a Pre-Submission Meeting with the FDA for an Emergency Use Authorization of Sarconeos (BIO101) for the Treatment of COVID-19

PARIS, FRANCE / CAMBRIDGE, MA / ACCESSWIRE / July 19, 2023 / Biophytis SA (Nasdaq CM:BPTS, Euronext Growth Paris:ALBPS), ("Biophytis" or the "Company"), 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, today announced that it has entered into definitive agreements for the purchase and sale of 1,333,334 units, each consisting of one (1) American Depositary Share ("ADS") or one (1) prefunded warrant giving right to one (1) ADS (the "prefunded warrants")) and one (1) warrant (the "ordinary warrant") to purchase one (1) ADS, at a purchase price of $2.85 per unit comprising an ADS and $2.84 per unit comprising a prefunded warrant. Each ADS represents the right to receive one hundred new ordinary shares,nominal value €0.01 per share, of the Company.

Biophytis Announces $3.8 Million Registered Direct Offering

Biophytis (NASDAQ: BPTS ) stock is rocketing higher on Tuesday following after announcing a production partnership with SEQENS. According to a press release, Biophytis will work with SEQENS for the production of the active ingredient in Sarconeos.

Why Is Biophytis (BPTS) Stock Up 66% Today?

PARIS, FRANCE / ACCESSWIRE / July 18, 2023 / Biophytis SA (Nasdaq CM:BPTS, Euronext Growth Paris:ALBPS), ("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 muscular dystrophy. SEQENS will produce the active ingredient in Sarconeos (BIO101) in France at its Villeneuve La Garenne plant, near Paris.

Biophytis and SEQENS Sign a Partnership to Produce Sarconeos (BIO101) Active Compound

PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / July 10, 2023 / Biophytis SA (Nasdaq CM:BPTS)(Euronext Growth Paris:ALBPS) (the "Company" or "Biophytis"), a clinical-stage biotechnology company specializing in the development of therapies aimed at slowing the degenerative processes associated with aging and improving functional outcomes in patients suffering from age-related diseases, including respiratory failure in patients affected by COVID-19, today 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.

Biophytis Has Filed with The FDA For Authorization to Initiate SARA-31 Phase 3 Study in Sarcopenia

PARIS, FRANCE / CAMBRIDGE, MA / ACCESSWIRE / June 19, 2023 / Biophytis SA (Nasdaq CM: BPTS, Euronext Growth Paris: ALBPS), («Biophytis» or the «company»), 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, 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.

Biophytis Reports Clinical Results for Sarconeos (BIO101) in Sarcopenia Treatment at the 16th SCWD International Congress

RESULTS OF THE ANNUAL GENERAL MEETING ON JUNE 16, 2023 ALL RESOLUTIONS PRESENTED BY THE COMPANY HAVE BEEN ADOPTED PARIS FRANCE and CAMBRIDGE, MA / ACCESSWIRE / June 16, 2023 / Biophytis SA (NASDAQ:BPTS)(Euronext Growth Paris:ALBPS), («Biophytis» or the «company»), 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, today announces the approval by a very large majority of all resolutions presented by the company and falling within the remit of the Annual General Meeting. Thanks to the mobilization of shareholders, the AGM could be held with a quorum of more than 26% of the shareholders present or represented.

Biophytis: Results of the Annual General Meeting on June 16, 2023 All Resolutions Presented by the Company Have Been Adopted

PARIS, FRANCE / CAMBRIDGE, MA / ACCESSWIRE / June 5, 2023 / Biophytis SA (NasdaqCM:BPTS)(Euronext Growth Paris:ALBPS), ("Biophytis" or the "Company"), a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging, including severe respiratory failure in patients suffering from COVID-19, today announces it will participate at the Biotechnology Innovation Organization (BIO) International Convention to be held in Boston from the 5th to the 8th of June 2023, alongside thousands of world leaders in biotechnology and the pharmaceutical industry. Biophytis' participation in BIO is aligned with the Company's strategy to partner with global or regional players for its main drug candidates developed in age-related diseases, in particular sarcopenia, and in rare neuromuscular diseases, in particular Duchenne muscular dystrophy.

Biophytis to Participate at the BIO International Convention in Boston from the 5th to the 8th of June

PARIS, FRANCE / CAMBRIDGE, MA / ACCESSWIRE / May 26, 2023 / Biophytis SA (NasdaqCM:BPTS)(Euronext Growth Paris:ALBPS) (the "Company" or "Biophytis"), a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging, including severe respiratory failure in patients suffering from COVID-19, today 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 for Health (HAS) for the use of Sarconeos (BIO101)[1] in the treatment of adult patients with a severe form of COVID-19, who are at risk of developing a critical form of the disease and for whom therapeutic alternatives are not appropriate. Following the positive results of the COVA phase 2-3 study, Biophytis met with the HAS on March 9, 2023 for a pre-submission meeting to review the eligibility requirements of the application.

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

PARIS, FRANCE / CAMBRIDGE, MA / ACCESSWIRE / May 25, 2023 / Biophytis SA (NasdaqCM:BPTS)(Euronext Growth Paris:ALBPS) (the "Company" or "Biophytis"), a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging, including severe respiratory failure in patients suffering from COVID-19, today announces that it presented the positive results of the phase 2-3 COVA study with Sarconeos (BIO101) in severe COVID-19 at the American Thoracic Society International Conference (ATS 2023) that was held in Washington DC between the 19th and 24th of May 2023. DR Girish Nair, MD - William Beaumont Hospital, Royal Oak, MI 48073, USAand principal investigator of the COVA study in the USA held an oral presentation of the results titled"COVA clinical study: Results from a double-blind, placebo-controlled phase 2-3 study to assess efficacy and safety of BIO101 in hospitalized severe COVID-19 patients.

Biophytis Presented Positive Results of Phase 2-3 COVA Study At The American Thoracic Society International Conference

PARIS, FRANCE / CAMBRIDGE, MA / ACCESSWIRE / May 15, 2023 / Biophytis SA (NasdaqCM:BPTS)(Euronext Growth Paris:ALBPS) (the "Company" or "Biophytis"), a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging, including severe respiratory failure in patients suffering from COVID-19, today 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 program follows encouraging results from the SARA-INT Phase 2b study and interactions with health authorities in 2022.

Biophytis has Filed with the EMA for Authorization to Initiate SARA-31 Phase 3 Study in Sarcopenia

Success of the placement with professional investors, historical supporters of the Company, for an amount of €1.9M. Strong participation of retail investors via the PrimaryBid platform with an offer allocated to €0.4M[1].

Successful Capital Increase for Biophytis with €2.3 million Raised

Capital increases as part of a global offering comprising an offer reserved for professional investors and a public offering for retail investors through the PrimaryBid platform. The PrimaryBid offering will close on May 10 2023 at 10pm Paris time and the offering reserved for professional investors will close on May 11, 2023 before start of trading (subject to early closure).

Biophytis Launches a Round of Fundraising for Approximately 2 Million Euros

PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / May 9, 2023 / Biophytis SA (NasdaqCM:BPTS)(Euronext Growth Paris:ALBPS) (the "Company" or "Biophytis"), a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging, including severe respiratory failure in patients suffering from COVID-19, today 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 severe form of COVID-19. This is the first step in the regulatory process that the company is undertaking to define the eligibility and conditions for conditional Marketing Authorisation application in Europe for Sarconeos (BIO101) in the treatment of severe forms of COVID-19.

Biophytis has Requested a Pre-Submission Meeting with the EMA for the Marketing Authorisation of Sarconeos (BIO101) for the Treatment of COVID-19

Appointment of Chiara Baccelli as Director of Pharmaceutical Operations and Quality Assurance Appointment of Nicolas Fellmann as Chief Financial Officer PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWORE / May 2, 2023 / Biophytis SA (NasdaqCM: BPTS, Euronext Growth Paris: ALBPS) (the "Company" or "Biophytis"), a clinical-stage biotechnology company specialized in the development of therapeutics that slow the degenerative processes associated with aging, including severe respiratory failure in patients suffering from COVID-19, announces today the strengthening of its management team with the appointment of Chiara Baccelli to the newly created position of Director of Pharmaceutical Operations and Quality Assurance and the upcoming arrival of Nicolas Fellmann as Chief Financial Officer as of 22 May 2022. He will replace Philippe Rousseau who is leaving the company to pursue other projects.

Biophytis Strengthens its Management Team

PARIS, FRANCE and CAMBRIDGE, MA / ACCESSWIRE / April 19, 2023 / Biophytis SA (NASDAQ:BPTS)(Euronext Growth Paris:ALBPS) (the "Company" or "Biophytis"), a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging, including severe respiratory failure in patients suffering from COVID-19, today announced that it has received written notification (the "Notification Letter") from the Nasdaq Stock Market LLC ("NASDAQ") dated April 14, 2022, indicating that Biophytis has regained compliance with he Nasdaq Global Select Market minimum bid price requirement. On October 20, 2022, the Nasdaq had notified Biophytis that based upon a closing bid price of less than $1.00 per share for the Company's American Depositary Shares ("ADSs") for the prior 30 consecutive business deay period, the Company no longer satisfied Nasdaq Listing Rule 5550(a)(2).

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