Rznomics Inc. | MedPath

Eli Lilly Partners with Rznomics in $1.3B Deal to Develop RNA Editing Therapy for Hereditary Hearing Loss

8 days ago

• Rznomics Inc. has secured a potential $1.35 billion global license option agreement with Eli Lilly to codevelop an RNA editing-based gene therapy targeting hereditary hearing loss. • Under the partnership structure, Rznomics will lead initial R&D efforts to discover and develop the therapy, while Lilly will handle subsequent development and commercialization phases. • The deal represents a significant expansion of Lilly's gene therapy pipeline for hearing disorders, though specific details regarding up-front payments and option terms remain undisclosed.

FDA Grants Second Fast Track Designation to Alginomics' RZ-001 for Hepatocellular Carcinoma Treatment

3 months ago

• Alginomics' anticancer drug RZ-001 receives FDA Fast Track designation for hepatocellular carcinoma treatment, marking its second such designation following glioblastoma in November 2023. • The Fast Track status enables expedited review processes, enhanced FDA communication, and rolling reviews of data submissions, potentially accelerating the drug's development timeline. • This regulatory milestone reinforces RZ-001's potential as an innovative treatment option for patients with life-threatening cancers, according to Alginomics CEO Lee Seong-wook.

Ziftomenib Shows Promise in AML: Kura Oncology and Kyowa Kirin Advance to Phase 3 Trials

6 months ago

• Kura Oncology and Kyowa Kirin's ziftomenib demonstrates statistically significant efficacy in Phase 2 trial for relapsed/refractory NPM1-mutant acute myeloid leukemia (AML). • The companies plan to submit a New Drug Application (NDA) to the FDA in the second quarter of 2025, seeking approval for ziftomenib in R/R NPM1-m AML. • Phase 3 trials are set to begin in the second half of 2025, evaluating ziftomenib in combination with intensive and non-intensive chemotherapy regimens for newly diagnosed AML. • FDA feedback supports potential accelerated approval pathways in both intensive and non-intensive treatment settings, based on MRD negative CR and CR endpoints.