Annamycin

Moleculin Biotech reports Q3 2024 financial results, focusing on the advancement of Annamycin in the MIRACLE trial for R/R AML, with a median durability of CRc exceeding 8 months. The company plans to start dosing in the pivotal Phase 3 trial in Q1 2025 and expects key milestones through 2028, including potential NDA submission for accelerated approval.

Moleculin Biotech reports financial results for Q3 2024, focusing on upcoming MIRACLE trial for Annamycin in R/R AML, with CRc durability now over 8 months. The company plans to start dosing in Q1 2025 and hosts a conference call on Nov 11, 2024.

Moleculin Biotech advances Annamycin for R/R AML treatment, with Phase 3 MIRACLE trial dosing expected in Q1 2025. Median CRc durability in MB-106 trial exceeds 8 months. Recent AML KOL event highlighted Annamycin's potential. Financial results for Q3 2024 show increased R&D expenses. Conference call scheduled for November 11, 2024.

Moleculin Biotech appoints Dr. Daniel D. Von Hoff to its Annamycin Scientific Advisory Board, recognizing his expertise in pancreatic cancer and his enthusiasm for Annamycin's potential in treating various cancers.

Annamycin shows over double the complete remission rate for relapsed/refractory AML compared to existing treatments, addressing a significant unmet need. The MIRACLE trial enrollment starts Q1 2025, with interim data by mid-2026, aiming for NDA by 2028. Its market potential is in the billions, targeting three times more patients than current therapies.

Moleculin Biotech advances Annamycin for R/R AML treatment, following positive FDA feedback. Plans pivotal Phase 3 MIRACLE trial with adaptive design. Reports financials, expecting sufficient funding into 2025. Annamycin holds Fast Track and Orphan Drug Designations.

In July 2024, the FDA made significant strides in cancer treatment approvals and designations, including the approval of FoundationOne Liquid CDx for BRCA-mutated mCRPC and Guardant Shield for colorectal cancer detection. Fast track designations were granted to therapies like OBX-115 for melanoma and AIC100 for thyroid cancer. The FDA also accepted BLAs for treatments targeting SR-aGVHD and EBV+ PTLD, and mandated phase assessments for NSCLC perioperative regimens, aiming to improve patient outcomes.

Moleculin Biotech concluded an FDA end-of-phase 2 meeting for annamycin (MB-106) combined with cytarabine in treating AML, discussing phase 1b/2 trial results. The trial showed a 45% CRc rate in efficacy-evaluable patients, with a median response duration of ~7 months. The treatment was well-tolerated, with myelosuppression and infections as common adverse effects. Annamycin has received FDA fast track and orphan drug designations for AML and soft tissue sarcoma.

Moleculin Biotech reports a 62% CRc rate for Annamycin combined with Cytarabine in AML treatment, with 20 subjects enrolled in the MB-106 study. The company plans a pivotal trial following positive interim data, supported by FDA discussions. Financial results show decreased R&D expenses, with sufficient cash into Q4 2024.