Rezolute
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2010-01-01
- Employees
- 51
- Market Cap
- $265.1M
- Website
- http://www.rezolutebio.com
- Introduction
Rezolute, Inc. operates as a biopharmaceutical company, which engages in the development of drug therapies for patients with metabolic and orphan diseases. Its clinical assets include Ersodetug, a potential treatment for hypoglycemia caused by multiple forms of hyperinsulinism, and RZ402, an oral plasma kallikrein inhibitor and potential therapy for the chronic treatment of diabetic macular edema. The company was founded by Nevan Charles Elam, Ho Young Huh, and Sankaram Mantripragada on July 26, 2010 and is headquartered in Redwood City, CA.
Rezolute's congenital hyperinsulinism treatment receives FDA breakthrough therapy designation
Rezolute's RZ358 for CHI received FDA breakthrough therapy designation after positive phase 2b trials. Phase 3 trials for CHI and THI are advancing, with results expected in late 2025. Handok and Genexine are major shareholders, supporting development and commercialization efforts.
Rezolute Receives Breakthrough Therapy Designation for Hypoglycemia Treatment in Congenital Hyperinsulinism
Rezolute's ersodetug (RZ358) received FDA Breakthrough Therapy Designation for treating hypoglycemia in congenital hyperinsulinism (HI), based on Phase 2b (RIZE) study results showing significant improvements. Topline sunRIZE data expected in 2025. Ersodetug also advances for tumor HI treatment, with Phase 3 study starting in 2025.
Rezolute Receives Breakthrough Therapy Designation from FDA for Ersodetug in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism
Rezolute's ersodetug (RZ358) received FDA Breakthrough Therapy Designation for treating hypoglycemia in congenital hyperinsulinism (HI), based on Phase 2b study results showing significant hypoglycemia improvement. Topline sunRIZE data expected in 2025, with Phase 3 study for tumor HI starting in 2025. Ersodetug targets all HI forms, showing promise in clinical trials.
FDA Grants Breakthrough Therapy Status to Rezolute's Rezodetug for Hypoglycemia Treatment
Rezolute's ersodetug received FDA Breakthrough Therapy Designation for treating hypoglycemia due to congenital hyperinsulinism, based on Phase 2b study results showing significant improvement. The drug is advancing in clinical development, with topline results from the sunRIZE study expected in 2025. Rezolute also strengthened its financial position with a $73 million raise.
Rezolute Receives Breakthrough Therapy Designation from FDA for Hypoglycemia Treatment in Congenital Hyperinsulinism
Rezolute received FDA Breakthrough Therapy Designation for ersodetug (RZ358) to treat hypoglycemia in congenital hyperinsulinism (HI), based on Phase 2b study results showing significant improvements. Ersodetug advances in clinical development, with topline sunRIZE data expected in 2025. The company also progresses in tumor HI treatment, with Phase 3 study start anticipated in 2025.
Novartis taps immuno-oncology partner BeiGene for TIGIT drug
Novartis partners with BeiGene, paying $300M upfront for an option on ociperlimab, a TIGIT antibody in phase 3 for NSCLC, potentially adding $700M. This move aims to enhance cancer immunotherapy efficacy by combining TIGIT and PD-1/PD-L1 inhibitors, following Novartis' previous $650M deal for tislelizumab. The deal includes rights in multiple regions, with BeiGene retaining exclusivity in China and other Asian markets. TIGIT-targeting drugs are highly sought after, with various pharma companies investing heavily in their development.
Rezolute Receives Breakthrough Therapy Designation for Ersodetug (RZ358) in Hypoglycemia Treatment
Rezolute, Inc. received FDA Breakthrough Therapy Designation for ersodetug (RZ358) to treat hypoglycemia in congenital hyperinsulinism (HI), based on Phase 2b RIZE study results showing significant improvement. Topline sunRIZE data expected in 2025. Ersodetug also shows promise for tumor HI, with Phase 3 study planned. The company raised $73M to support clinical programs.
Rezolute Receives Breakthrough Therapy Designation for Ersodetug (RZ358) to Treat Hypoglycemia in Congenital Hyperinsulinism
Rezolute, Inc. received FDA Breakthrough Therapy Designation for ersodetug (RZ358) to treat hypoglycemia in congenital hyperinsulinism (HI), based on Phase 2b (RIZE) study results showing significant hypoglycemia improvement. Topline sunRIZE data expected in 2025. Ersodetug also shows promise for tumor HI treatment, with Phase 3 study start anticipated in 2025.
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