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 receives BTD from FDA for ersodetug in treatment of hypoglycemia
Rezolute's RZ358, ersodetug, received FDA Breakthrough Therapy Designation for treating hypoglycemia in congenital HI, based on Phase 2b study data and unmet medical needs. It's advancing as a potential treatment for all hyperinsulinism-related hypoglycemia, with sunRIZE data expected in H2 this year.
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 improvements. Topline sunRIZE data expected in 2025. Ersodetug also shows potential for tumor HI treatment, with Phase 3 study start anticipated in 2025. The company raised $73M to support clinical programs.
Rezolute, Inc. (RZLT) Closes Public Offering Raising ~$60M
Rezolute, Inc. closed a public offering, raising ~$60M by selling 11.25M shares at $4.00 each and offering pre-funded warrants for 3.75M shares to certain investors.
FDA grants Breakthrough Therapy Designation to ersodetug
FDA granted Breakthrough Therapy Designation to Rezolute's RZ358 for congenital hyperinsulinism treatment, following positive Phase 2b results. Rezolute plans Phase 3 trials, bolstered by a $73M fundraising. RZ358, a monoclonal antibody, shows promise in treating hyperinsulinism, with financial health and market interest growing.
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2024 mixed for biotech; sector down 14% due to Q3 results, guidance cuts, pipeline setbacks, and vaccine skeptic nominee. Despite challenges, biotech remains attractive for innovation and M&A activity. Recommended stocks: Allogene Therapeutics (ALLO), Rezolute (RZLT), Vanda Pharmaceuticals (VNDA), all under $10 with strong Zacks Rank and ABR.
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Rezolute's SWOT analysis: biotech stock's pipeline progress and market potential
Rezolute, Inc. focuses on metabolic diseases and ophthalmologic conditions, with lead candidates ersodetug for hyperinsulinism and RZ402 for diabetic macular edema showing promise. Ersodetug is in Phase 3 trials, with U.S. enrollment starting in 2025. RZ402 demonstrated significant efficacy in Phase 2. Rezolute has a strong cash position, with $118 million reported, supporting its clinical programs. The company faces competition but has potential for growth through partnerships and expanding its pipeline.
FDA Grants Orphan Drug Designation to Rezolute's Ersodetug (RZ358) for the ...
Rezolute, Inc. receives FDA Orphan Drug Designation for ersodetug to treat hypoglycemia due to tumor hyperinsulinism (HI), with Phase 3 trial expected in 2025. Ersodetug, a monoclonal antibody, aims to counteract insulin receptor over-activation, potentially offering universal treatment for HI-induced hypoglycemia.
FDA Grants Orphan Drug Designation to Rezolute’s Ersodetug (RZ358) for Hypoglycemia in Tumor Hyperinsulinism
Rezolute, Inc. received FDA Orphan Drug Designation for ersodetug, targeting hypoglycemia in tumor hyperinsulinism (HI), highlighting its potential as a universal treatment. This designation supports development for rare diseases, offering market exclusivity and expedited approval pathways. Ersodetug counters insulin receptor over-activation, promising broad HI treatment efficacy.
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