Melphalan flufenamide

Monica Shaw appointed CEO of Oncopeptides - Jakob Lindberg assumes position as Chief Scientific Officer

Retrieved on: 
Wednesday, January 4, 2023

(Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the Board of Directors has appointed Dr Monica Shaw as Chief Executive Officer, CEO, of Oncopeptides.

Key Points: 
  • (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the Board of Directors has appointed Dr Monica Shaw as Chief Executive Officer, CEO, of Oncopeptides.
  • She replaces Jakob Lindberg, who has been the CEO since November 15, 2021.
  • Lindberg assumes his previous position as Chief Scientific Officer.
  • "I am also very grateful that Jakob Lindberg will continue his dedicated scientific engagement in Oncopeptides, in his capacity as Chief Scientific Officer."

Monica Shaw appointed CEO of Oncopeptides - Jakob Lindberg assumes position as Chief Scientific Officer

Retrieved on: 
Wednesday, January 4, 2023

(Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the Board of Directors has appointed Dr Monica Shaw as Chief Executive Officer, CEO, of Oncopeptides.

Key Points: 
  • (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the Board of Directors has appointed Dr Monica Shaw as Chief Executive Officer, CEO, of Oncopeptides.
  • She replaces Jakob Lindberg, who has been the CEO since November 15, 2021.
  • Lindberg assumes his previous position as Chief Scientific Officer.
  • "I am also very grateful that Jakob Lindberg will continue his dedicated scientific engagement in Oncopeptides, in his capacity as Chief Scientific Officer."

Oncopeptides has announced the Nomination Committee

Retrieved on: 
Thursday, December 22, 2022

According to the principles for the appointment of the Nomination Committee in Oncopeptides AB (publ), the Nomination Committee for the annual general meeting 2023 shall be composed of members appointed by the three largest shareholders in terms of voting rights as of September 30 who are willing to participate in the Nomination Committee, along with the Chairman of the Board of Directors.

Key Points: 
  • According to the principles for the appointment of the Nomination Committee in Oncopeptides AB (publ), the Nomination Committee for the annual general meeting 2023 shall be composed of members appointed by the three largest shareholders in terms of voting rights as of September 30 who are willing to participate in the Nomination Committee, along with the Chairman of the Board of Directors.
  • The composition of the Nomination Committee has now been established, and Oncopeptides today announced that the Nomination Committee in respect of the annual general meeting 2023 consists of the following persons who together represent approximately 29 percent of the number of shares and votes in the company based on the shareholder information at end of September.
  • The Nomination Committee's proposals will be presented in the Notice to the annual general meeting 2023 and on Oncopeptides' website, www.oncopeptides.com .
  • Shareholders who wish to submit proposals to the Nomination Committee can do so by sending an e-mail to [email protected] (subject "Nomination Committee") or by letter posted to Oncopeptides AB (publ), Attn: Oncopeptides Nomination Committee, Luntmakargatan 46, SE-111 37 Stockholm, Sweden.

Oncopeptides has announced the Nomination Committee

Retrieved on: 
Thursday, December 22, 2022

According to the principles for the appointment of the Nomination Committee in Oncopeptides AB (publ), the Nomination Committee for the annual general meeting 2023 shall be composed of members appointed by the three largest shareholders in terms of voting rights as of September 30 who are willing to participate in the Nomination Committee, along with the Chairman of the Board of Directors.

Key Points: 
  • According to the principles for the appointment of the Nomination Committee in Oncopeptides AB (publ), the Nomination Committee for the annual general meeting 2023 shall be composed of members appointed by the three largest shareholders in terms of voting rights as of September 30 who are willing to participate in the Nomination Committee, along with the Chairman of the Board of Directors.
  • The composition of the Nomination Committee has now been established, and Oncopeptides today announced that the Nomination Committee in respect of the annual general meeting 2023 consists of the following persons who together represent approximately 29 percent of the number of shares and votes in the company based on the shareholder information at end of September.
  • The Nomination Committee's proposals will be presented in the Notice to the annual general meeting 2023 and on Oncopeptides' website, www.oncopeptides.com .
  • Shareholders who wish to submit proposals to the Nomination Committee can do so by sending an e-mail to [email protected] (subject "Nomination Committee") or by letter posted to Oncopeptides AB (publ), Attn: Oncopeptides Nomination Committee, Luntmakargatan 46, SE-111 37 Stockholm, Sweden.

Oncopeptides presents new scientific data at the Annual American Society of Hematology Meeting ASH

Retrieved on: 
Monday, December 12, 2022

Pepaxti(melphalan flufenamide, also called melflufen) has been granted Marketing Authorization, in the European Union, the EEA-countries Iceland, Lichtenstein and Norway, as well as the UK.

Key Points: 
  • Pepaxti(melphalan flufenamide, also called melflufen) has been granted Marketing Authorization, in the European Union, the EEA-countries Iceland, Lichtenstein and Norway, as well as the UK.
  • For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.
  • On December 7, 2022, the FDA recommended that the Company voluntarily withdraw the US marketing authorization for Pepaxto.
  • Melflufen (melphalan flufenamide) is a lipophilic peptide conjugated alkylating drug that rapidly and selectively delivers cytotoxic agents into tumor cells.

Oncopeptides presents new scientific data at the Annual American Society of Hematology Meeting ASH

Retrieved on: 
Monday, December 12, 2022

Pepaxti(melphalan flufenamide, also called melflufen) has been granted Marketing Authorization, in the European Union, the EEA-countries Iceland, Lichtenstein and Norway, as well as the UK.

Key Points: 
  • Pepaxti(melphalan flufenamide, also called melflufen) has been granted Marketing Authorization, in the European Union, the EEA-countries Iceland, Lichtenstein and Norway, as well as the UK.
  • For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.
  • On December 7, 2022, the FDA recommended that the Company voluntarily withdraw the US marketing authorization for Pepaxto.
  • Melflufen (melphalan flufenamide) is a lipophilic peptide conjugated alkylating drug that rapidly and selectively delivers cytotoxic agents into tumor cells.

Oncopeptides provides an update from the meeting with FDAs advisory committee ODAC

Retrieved on: 
Friday, September 23, 2022

A majority of the panel considered that OCEAN did not confirm a favorable benefit-risk profile in the current indicated patient population.

Key Points: 
  • A majority of the panel considered that OCEAN did not confirm a favorable benefit-risk profile in the current indicated patient population.
  • In a 14 to 2 vote, the ODAC answered no to the question.
  • The FDA will not issue a final determination on the issues discussed until input from the advisory committee process has been considered and all reviews have been finalized.
  • Rolf Gulliksen, Global Head of Corporate Communications, Oncopeptides AB (publ)
    The information in the press release is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation.

Oncopeptides provides an update from the meeting with FDAs advisory committee ODAC

Retrieved on: 
Friday, September 23, 2022

A majority of the panel considered that OCEAN did not confirm a favorable benefit-risk profile in the current indicated patient population.

Key Points: 
  • A majority of the panel considered that OCEAN did not confirm a favorable benefit-risk profile in the current indicated patient population.
  • In a 14 to 2 vote, the ODAC answered no to the question.
  • The FDA will not issue a final determination on the issues discussed until input from the advisory committee process has been considered and all reviews have been finalized.
  • Rolf Gulliksen, Global Head of Corporate Communications, Oncopeptides AB (publ)
    The information in the press release is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation.

Briefing Book for ODAC meeting on benefit/risk profile of Pepaxto now published

Retrieved on: 
Tuesday, September 20, 2022

The purpose of the meeting is to obtain the advisory committee's input regarding the benefit/risk of Pepaxto(melphalan flufenamide, also called melflufen) for the currently indicated patient population.

Key Points: 
  • The purpose of the meeting is to obtain the advisory committee's input regarding the benefit/risk of Pepaxto(melphalan flufenamide, also called melflufen) for the currently indicated patient population.
  • "Oncopeptides is committed to enhancing treatment success in patients with RRMM treated with Pepaxto," says Klaas Bakker, MD, PhD, Executive Vice President and Chief Medical Officer.
  • The briefing book contains background information prepared by the FDA and Oncopeptides for the panel members of the ODAC.
  • This may be affected by issues not discussed at the ODAC meeting.

Briefing Book for ODAC meeting on benefit/risk profile of Pepaxto now published

Retrieved on: 
Tuesday, September 20, 2022

The purpose of the meeting is to obtain the advisory committee's input regarding the benefit/risk of Pepaxto(melphalan flufenamide, also called melflufen) for the currently indicated patient population.

Key Points: 
  • The purpose of the meeting is to obtain the advisory committee's input regarding the benefit/risk of Pepaxto(melphalan flufenamide, also called melflufen) for the currently indicated patient population.
  • "Oncopeptides is committed to enhancing treatment success in patients with RRMM treated with Pepaxto," says Klaas Bakker, MD, PhD, Executive Vice President and Chief Medical Officer.
  • The briefing book contains background information prepared by the FDA and Oncopeptides for the panel members of the ODAC.
  • This may be affected by issues not discussed at the ODAC meeting.