Glycomimetics - GLYC STOCK NEWS

GlycoMimetics (NASDAQ: GLYC) announced that multiple clinical trial data studying uproleselan in acute myeloid leukemia (AML) patients will be presented at the 66th ASH Annual Meeting in San Diego, December 7-10, 2024. The presentations include: an international Phase 3 trial comparing uproleselan plus chemotherapy versus chemotherapy alone in relapsed/refractory AML; updated results from a Phase I study combining uproleselan with azacitidine and venetoclax in older/unfit treatment-naive AML patients; and final results of a Phase II study of uproleselan combined with cladribine and low-dose cytarabine for treated secondary AML.

GlycoMimetics (NASDAQ: GLYC) has announced an acquisition agreement with Crescent Biopharma, a private biotech company focused on solid tumor treatments. The combined company will operate as Crescent Biopharma, backed by a $200 million financing from a syndicate of investors. The transaction is expected to close in Q2 2025, with funding projected through 2027. The company will advance Crescent's portfolio, including CR-001, a tetravalent PD-1 x VEGF bispecific antibody with preliminary proof of concept data expected in 2H26, and two antibody-drug conjugates (CR-002 and CR-003) with topoisomerase inhibitor payloads.

GlycoMimetics announced that the Phase 2 analysis of its uproleselan study, conducted by the National Cancer Institute and the Alliance for Clinical Trials in Oncology, did not achieve its primary endpoint. The trial evaluated the drug in combination with 7+3 chemotherapy versus chemotherapy alone in newly diagnosed acute myeloid leukemia (AML) patients aged 60 or older. The study failed to demonstrate statistically significant improvement in event-free survival. The company is now working with the Alliance to analyze the full trial data to identify potential efficacy signals in specific patient subgroups for future clinical trials.

GlycoMimetics (Nasdaq: GLYC) has announced a strategic review and corporate restructuring plan following FDA feedback on uproleselan for relapsed/refractory Acute Myeloid Leukemia (AML). Key points include:

1. An additional clinical trial is required for uproleselan in R/R AML.
2. The company will explore strategic alternatives to maximize shareholder value.
3. Discussions continue with NCI and Alliance for Clinical Trials in Oncology for the ongoing Phase 2/3 study of uproleselan in newly diagnosed AML.
4. Workforce reduction of approximately 80%.
5. Cash runway extended into Q2 2025.

GlycoMimetics aims to find partners to advance uproleselan and GMI-1687, believing both have potential to address unmet needs in their respective areas. The company had $31.3 million in cash as of March 31, 2024.

GlycoMimetics announced results from its Phase 3 study of uproleselan for relapsed/refractory acute myeloid leukemia (AML). The study showed that uproleselan significantly improved median overall survival (mOS) to 31.2 months in primary refractory AML patients, compared to 10.1 months for the placebo group. However, for the intent-to-treat population, the mOS was 13.0 months for uproleselan and 12.3 months for placebo, which is not statistically significant. Severe oral mucositis incidence and serious treatment-emergent adverse events were comparable between groups. The company is in discussions with the National Cancer Institute for further studies.

GlycoMimetics (Nasdaq: GLYC) announced a key opinion leader event on June 4, 2024, to discuss comprehensive results from their pivotal Phase 3 study of uproleselan in relapsed/refractory acute myeloid leukemia (AML). The event will feature Dr. Daniel DeAngelo of Harvard Medical School, who will present the findings and discuss the current AML treatment landscape and unmet needs. The event will start at 8:30am ET and will be accessible via phone and live webcast.

GlycoMimetics, a biotech company, announced results from a Phase 3 study of uproleselan in AML patients, showing no improvement in overall survival when combined with chemotherapy. The company is analyzing the data and plans to present it at a medical meeting. The Phase 3 study evaluated uproleselan in R/R AML patients and did not meet the primary endpoint. The company also reported first-quarter 2024 financial results, including a decreased cash position and increased R&D expenses.