Welcome to our dedicated page for Vivani Medical news (Ticker: VANI), a resource for investors and traders seeking the latest updates and insights on Vivani Medical stock.
Vivani Medical, Inc. reports developments from a clinical-stage biopharmaceutical business focused on miniature, ultra long-acting subdermal drug implant candidates using its proprietary NanoPortal™ technology. News commonly centers on financial results, business updates, manufacturing and clinical-development spending, and progress for semaglutide-based implant candidates such as NPM-139 for chronic weight management and NPM-133 for type 2 diabetes.
The company’s updates also cover Cortigent, its wholly owned subsidiary developing brain implant devices based on precision neurostimulation technology. Cortigent disclosures include the Orion® Visual Cortical Prosthesis System, a cortical stimulation system under development to provide visual perception for blind persons, as well as equity financings, registered direct offerings, private placements, shareholder matters and governance updates.
Vivani Medical has announced plans to begin the first clinical study for its NPM-115 program, focused on a 6-month GLP-1 (exenatide) implant for chronic weight management in obese or overweight patients, in Q4 2024 in Australia, pending regulatory approval. The study, named LIBERATE-1, will test the safety, tolerability, and pharmacokinetic profile of the implant. Patients will receive weekly semaglutide injections for 8 weeks before randomization into three treatment groups. Results are expected in 2025. The company has prioritized obesity treatment due to significant medical need and market demand. Positive preclinical data and FDA clearance for a related program (NPM-119) support the initiative.
Vivani Medical has received FDA clearance for its Investigational New Drug Application (IND) and the lifting of a clinical hold on NPM-119, enabling the initiation of the LIBERATE-1 Phase 1 clinical trial. This trial will assess the safety, tolerability, and pharmacokinetics of NPM-119, a miniature six-month GLP-1 implant for type 2 diabetes. The LIBERATE-1 trial will be the first clinical application of Vivani's NanoPortal™ implant technology in humans. NPM-119 aims to address medication non-adherence and improve tolerability issues associated with oral and injectable type 2 diabetes medications. Vivani is also developing NPM-115 and NPM-139 for chronic weight management. The company anticipates starting the LIBERATE-1 trial in the second half of the year.
Vivani Medical (Nasdaq: VANI) announced positive data on its OKV-119 exenatide implant for feline weight loss, published in BMC Veterinary Research. The study highlights that a single OKV-119 implant delivers exenatide over 3 months, leading to significant weight loss in cats. This reinforces the potential of Vivani's NanoPortal™ technology for addressing obesity in both humans and animals. Vivani's development partner, Okava Pharmaceuticals, is exploring the use of OKV-119 for pre-diabetes, diabetes, and obesity in companion felines. The promising results support further clinical evaluations of the implant for chronic weight management in humans.
Vivani Medical (Nasdaq: VANI) has provided a business update and first quarter 2024 financial results. The company is advancing the development of GLP-1 implants for chronic weight management and type 2 diabetes. Key highlights include the initiation of preclinical activities for NPM-115 and the expected IND submission by year-end. A $15-million stock offering in March will fund operations until the second half of 2025. Vivani reported a cash balance of $31.0 million as of March 31, 2024, a net loss of $6.0 million, and a slight reduction in R&D and administrative expenses compared to the previous year.
Vivani Medical, Inc. (Nasdaq: VANI) will present at the TIDES Conference 2024 in Boston to discuss its lead asset NPM-115 for chronic weight management and NPM-119 for type 2 diabetes. The presentation will cover the Company's NanoPortal™ platform and updates on its programs.
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