Diamyd Medical

Diamyd Medical receives U.S. FDA Fast Track designation for Diamyd®

Retrieved on: 
Thursday, February 15, 2024

STOCKHOLM, Feb. 15, 2024 /PRNewswire/ -- Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Diamyd® (rhGAD65/alum) that is being investigated to improve glycemic control in recently diagnosed stage 3 Type 1 Diabetes patients with the genotype HLA DR3-DQ2.

Key Points: 
  • STOCKHOLM, Feb. 15, 2024 /PRNewswire/ -- Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Diamyd® (rhGAD65/alum) that is being investigated to improve glycemic control in recently diagnosed stage 3 Type 1 Diabetes patients with the genotype HLA DR3-DQ2.
  • The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need.
  • Fast Track designation is intended to bring promising medicines to patients sooner.
  • "We are very pleased with the FDA's decision to grant Fast Track designation for Diamyd and the potential this provides to accelerate Diamyd's path to entering the US market", says Ulf Hannelius, CEO of Diamyd Medical.

Diamyd Medical receives U.S. FDA Fast Track designation for Diamyd®

Retrieved on: 
Thursday, February 15, 2024

STOCKHOLM, Feb. 15, 2024 /PRNewswire/ -- Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Diamyd® (rhGAD65/alum) that is being investigated to improve glycemic control in recently diagnosed stage 3 Type 1 Diabetes patients with the genotype HLA DR3-DQ2.

Key Points: 
  • STOCKHOLM, Feb. 15, 2024 /PRNewswire/ -- Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Diamyd® (rhGAD65/alum) that is being investigated to improve glycemic control in recently diagnosed stage 3 Type 1 Diabetes patients with the genotype HLA DR3-DQ2.
  • The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need.
  • Fast Track designation is intended to bring promising medicines to patients sooner.
  • "We are very pleased with the FDA's decision to grant Fast Track designation for Diamyd and the potential this provides to accelerate Diamyd's path to entering the US market", says Ulf Hannelius, CEO of Diamyd Medical.

Diamyd Medical gains market research findings to guide U.S. commercial strategy

Retrieved on: 
Monday, January 8, 2024

"These results both confirm and exceed our previous insights regarding pricing and the market potential of Diamyd in the US", says Ulf Hannelius, CEO of Diamyd Medical.

Key Points: 
  • "These results both confirm and exceed our previous insights regarding pricing and the market potential of Diamyd in the US", says Ulf Hannelius, CEO of Diamyd Medical.
  • Educational Needs and Market Preparation: The research highlighted some gaps in awareness regarding type 1 diabetes staging and the diversity in first-line therapy approaches.
  • These findings underscore the importance of continuous educational efforts in tandem with the introduction of new treatments like Diamyd®.
  • The research pointed to Integrated Delivery Networks (IDNs) as a natural and effective delivery channel for Diamyd® outpatient treatment.

Diamyd Medical gains market research findings to guide U.S. commercial strategy

Retrieved on: 
Monday, January 8, 2024

"These results both confirm and exceed our previous insights regarding pricing and the market potential of Diamyd in the US", says Ulf Hannelius, CEO of Diamyd Medical.

Key Points: 
  • "These results both confirm and exceed our previous insights regarding pricing and the market potential of Diamyd in the US", says Ulf Hannelius, CEO of Diamyd Medical.
  • Educational Needs and Market Preparation: The research highlighted some gaps in awareness regarding type 1 diabetes staging and the diversity in first-line therapy approaches.
  • These findings underscore the importance of continuous educational efforts in tandem with the introduction of new treatments like Diamyd®.
  • The research pointed to Integrated Delivery Networks (IDNs) as a natural and effective delivery channel for Diamyd® outpatient treatment.

Registrational Phase III trial in Type 1 Diabetes with Diamyd® expands to the US

Retrieved on: 
Tuesday, September 5, 2023

STOCKHOLM, Sept. 5, 2023 /PRNewswire/ -- Final preparations are in place to initiate the first clinical site for DIAGNODE-3 in the United States, and additional sites are expected to be initiated over the coming months. Approximately 10-12 clinical sites across the US are planned to be initiated, expanding the DIAGNODE-3 trial in the US and eight European countries to approximately 60 clincal sites in total. An Investigators' Meeting for the US clinical sites will be held on September 15th in Washington DC with several US key opinion leaders in attendance.

Key Points: 
  • The first clinical site in the United States is pending imminent initiation in the precision medicine Phase III trial DIAGNODE-3, which is ongoing in eight European countries.
  • The goal is to have the trial fully enrolled in the second half of 2024.
  • "This shows the operational and clinical feasibility of our precision medicine approach to Type 1 Diabetes and we look forward to expanding the trial to the United States".
  • The partnership with JDRF, the largest Type 1 Diabetes patient advocacy organisation in the US, forms the backbone of Diamyd Medical's focus on completing enrolment of the registrational trial within the expected timeframe.

Registrational Phase III trial in Type 1 Diabetes with Diamyd® expands to the US

Retrieved on: 
Tuesday, September 5, 2023

STOCKHOLM, Sept. 5, 2023 /PRNewswire/ -- Final preparations are in place to initiate the first clinical site for DIAGNODE-3 in the United States, and additional sites are expected to be initiated over the coming months. Approximately 10-12 clinical sites across the US are planned to be initiated, expanding the DIAGNODE-3 trial in the US and eight European countries to approximately 60 clincal sites in total. An Investigators' Meeting for the US clinical sites will be held on September 15th in Washington DC with several US key opinion leaders in attendance.

Key Points: 
  • The first clinical site in the United States is pending imminent initiation in the precision medicine Phase III trial DIAGNODE-3, which is ongoing in eight European countries.
  • The goal is to have the trial fully enrolled in the second half of 2024.
  • "This shows the operational and clinical feasibility of our precision medicine approach to Type 1 Diabetes and we look forward to expanding the trial to the United States".
  • The partnership with JDRF, the largest Type 1 Diabetes patient advocacy organisation in the US, forms the backbone of Diamyd Medical's focus on completing enrolment of the registrational trial within the expected timeframe.

Diamyd Medical partners with JDRF to advance the DIAGNODE-3 Phase 3 trial in Type 1 Diabetes

Retrieved on: 
Tuesday, April 4, 2023

STOCKHOLM, April 4, 2023 /PRNewswire/ -- Diamyd Medical and JDRF, the leading global type 1 diabetes research and advocacy organization, have entered into a four-year research and development collaboration including a non-dilutive $5 million award to Diamyd Medical to support its ongoing Phase 3 trial with the precision medicine antigen-specific immunotherapy Diamyd®.

Key Points: 
  • STOCKHOLM, April 4, 2023 /PRNewswire/ -- Diamyd Medical and JDRF, the leading global type 1 diabetes research and advocacy organization, have entered into a four-year research and development collaboration including a non-dilutive $5 million award to Diamyd Medical to support its ongoing Phase 3 trial with the precision medicine antigen-specific immunotherapy Diamyd®.
  • "JDRF is committed to supporting and advancing disease modifying therapies to delay and reverse type 1 diabetes," said Sanjoy Dutta, Ph.D., chief scientific officer at JDRF.
  • "We are excited about Diamyd Medical's groundbreaking Phase 3 trial and its potential advancements in the preservation of insulin production for people recently diagnosed with type 1 diabetes."
  • "JDRF's commitment to this Phase 3 program is a validation of the scientific and clinical value of the antigen-specific immunotherapy Diamyd.

Diamyd Medical partners with JDRF to advance the DIAGNODE-3 Phase 3 trial in Type 1 Diabetes

Retrieved on: 
Tuesday, April 4, 2023

STOCKHOLM, April 4, 2023 /PRNewswire/ -- Diamyd Medical and JDRF, the leading global type 1 diabetes research and advocacy organization, have entered into a four-year research and development collaboration including a non-dilutive $5 million award to Diamyd Medical to support its ongoing Phase 3 trial with the precision medicine antigen-specific immunotherapy Diamyd®.

Key Points: 
  • STOCKHOLM, April 4, 2023 /PRNewswire/ -- Diamyd Medical and JDRF, the leading global type 1 diabetes research and advocacy organization, have entered into a four-year research and development collaboration including a non-dilutive $5 million award to Diamyd Medical to support its ongoing Phase 3 trial with the precision medicine antigen-specific immunotherapy Diamyd®.
  • "JDRF is committed to supporting and advancing disease modifying therapies to delay and reverse type 1 diabetes," said Sanjoy Dutta, Ph.D., chief scientific officer at JDRF.
  • "We are excited about Diamyd Medical's groundbreaking Phase 3 trial and its potential advancements in the preservation of insulin production for people recently diagnosed with type 1 diabetes."
  • "JDRF's commitment to this Phase 3 program is a validation of the scientific and clinical value of the antigen-specific immunotherapy Diamyd.

Diamyd Medical brings Karin Rosén, M.D, PhD, to its Board of Directors

Retrieved on: 
Friday, March 10, 2023

STOCKHOLM, March 10, 2023 /PRNewswire/ -- Diamyd Medical today announced that Karin Rosén, M.D, Ph.D, San Francisco, will join the Board of Directors as an adjunct member, and be proposed for election to the Board at its next General Meeting of Shareholders.

Key Points: 
  • STOCKHOLM, March 10, 2023 /PRNewswire/ -- Diamyd Medical today announced that Karin Rosén, M.D, Ph.D, San Francisco, will join the Board of Directors as an adjunct member, and be proposed for election to the Board at its next General Meeting of Shareholders.
  • "We are thrilled to welcome Dr. Rosén to Diamyd Medical at this transformative period of the Company", says Ulf Hannelius, CEO of Diamyd Medical.
  • "Karin Rosén's extensive drug development and commercial launch experience spanning a wide variety of indications including immunology, oncology, respiratory and infectious diseases will be invaluable for Diamyd Medical."
  • "The antigen-specific immunotherapy Diamyd constitutes a potential scientific and therapeutic paradigm shift for the field of type 1 diabetes," says Karin Rosén.

Diamyd Medical brings Karin Rosén, M.D, PhD, to its Board of Directors

Retrieved on: 
Friday, March 10, 2023

STOCKHOLM, March 10, 2023 /PRNewswire/ -- Diamyd Medical today announced that Karin Rosén, M.D, Ph.D, San Francisco, will join the Board of Directors as an adjunct member, and be proposed for election to the Board at its next General Meeting of Shareholders.

Key Points: 
  • STOCKHOLM, March 10, 2023 /PRNewswire/ -- Diamyd Medical today announced that Karin Rosén, M.D, Ph.D, San Francisco, will join the Board of Directors as an adjunct member, and be proposed for election to the Board at its next General Meeting of Shareholders.
  • "We are thrilled to welcome Dr. Rosén to Diamyd Medical at this transformative period of the Company", says Ulf Hannelius, CEO of Diamyd Medical.
  • "Karin Rosén's extensive drug development and commercial launch experience spanning a wide variety of indications including immunology, oncology, respiratory and infectious diseases will be invaluable for Diamyd Medical."
  • "The antigen-specific immunotherapy Diamyd constitutes a potential scientific and therapeutic paradigm shift for the field of type 1 diabetes," says Karin Rosén.