• Designation will ac­cel­er­ate oNKord®'s mar­ket access for MM
• Together with Clinical Trial Approval for a pivotal phase I-IIa trial in AML, this is another im­por­tant step for­ward in making Glyco­stem's allo­geneic Natural Killer cell-based treat­ment accessible for can­cer patients

Oss, The Netherlands (Press Release) – Glyco­stem Thera­peutics, a lead­ing clin­i­cal-stage com­pany focused on the de­vel­op­ment of thera­peutic off-the-shelf Natural Killer (NK) cells, an­nounces it has re­ceived the FDA's Orphan Drug Desig­na­tion (ODD) for treat­ment of mul­ti­ple myeloma (MM) patients with its inves­ti­ga­tional prod­uct oNKord®. The desig­na­tion will pro­vide Glyco­stem with cer­tain incentives, like eligibility for 7 years of mar­ket exclusivity and clear FDA guidance on spe­cif­ic as­pects of de­vel­op­ment for rare dis­eases. These pave an ac­cel­er­ated path to­wards mar­ket access and treat­ment of patients …