C-peptide

Diamyd Medical received final minutes from a positive FDA Type C meeting, confirming alignment on Diamyd®'s development for Stage 3 Type 1 Diabetes. The FDA supported the Accelerated Approval Pathway, safety dataset, co-primary endpoints, and statistical analysis plan. Diamyd® has Orphan Drug Designation, highlighting its potential for unmet needs in Type 1 Diabetes treatment.

Diamyd Medical updated on a positive FDA meeting regarding Diamyd (rhGAD65/alum) for Stage 3 Type 1 Diabetes, aligning on development milestones, statistical plan, and Accelerated Approval Pathway. The DIAGNODE-3 trial's interim efficacy data and safety dataset support potential accelerated approval, with co-primary endpoints of C-peptide levels and HbA1c. FDA reaffirmed Orphan Drug Designation for Diamyd.

Diamyd Medical updated on a positive FDA meeting, aligning on Diamyd's development for Type 1 Diabetes treatment. Key agreements include Accelerated Approval Pathway, safety dataset suitability, DIAGNODE-3 as pivotal trial, co-primary endpoints, and statistical analysis plan. FDA reaffirmed Orphan Drug Designation for Diamyd.

Diamyd Medical updates on FDA Type C meeting outcomes, confirming alignment on Diamyd®'s development for Stage 3 Type 1 Diabetes treatment. Key agreements include Accelerated Approval Pathway, safety dataset suitability, co-primary endpoints, and statistical analysis plan. FDA reaffirms Orphan Drug Designation for Diamyd®.

Diamyd Medical updates on FDA meeting outcomes for Diamyd®'s Accelerated Approval, focusing on DIAGNODE-3 trial alignment, safety data, co-primary endpoints, and statistical analysis plan. FDA feedback supports expedited review pathway, leveraging interim efficacy data and confirmatory evidence for Stage 3 Type 1 Diabetes treatment.

Diamyd Medical progresses toward Accelerated Approval for Diamyd® after a positive FDA Type C meeting, focusing on Stage 3 Type 1 Diabetes. Key milestones include alignment on study protocols and statistical plans. The company also highlights advancements in precision medicine, with significant recruitment in the DIAGNODE-3 trial and partnerships to enhance Type 1 Diabetes research and treatment awareness.

Diamyd Medical updates on FDA Type C meeting, confirming alignment for Accelerated Approval of Diamyd® for Stage 3 Type 1 Diabetes. Agreement on DIAGNODE-3 trial's role, safety dataset, co-primary endpoints, and statistical analysis plan. FDA reaffirms Orphan Drug Designation for Diamyd®, highlighting its potential for unmet needs in Type 1 Diabetes treatment.

Diamyd Medical updates on FDA Type C meeting, confirming alignment on Diamyd®'s Accelerated Approval pathway for Stage 3 Type 1 Diabetes, focusing on DIAGNODE-3 trial's interim efficacy data, safety dataset, and co-primary endpoints. FDA reaffirms Orphan Drug Designation for Diamyd®.

Sana Biotechnology's first-in-human study with a type 1 diabetes patient showed positive results using HIP-engineered allogeneic pancreatic islet cells without immunosuppression. Four weeks post-transplant, detectable C-peptide levels and MRI-confirmed graft survival indicated insulin production and cell functionality, marking a potential paradigm shift towards a functional cure for type 1 diabetes.

Morgan Stanley's Vikram Purohit maintains a Buy rating on Sana Biotechnology (SANA) with a $9.00 target, citing promising UP421 therapy results in Type 1 Diabetes showing no adverse effects and immune evasion. Positive trial outcomes support transformative therapy potential, with future updates on SC451 and pipeline advancements expected to enhance value.