FDA accepts Rani Therapeutics' RaniPill platform into emerging tech program

Rani Therapeutics Holdings (Nasdaq: RANI) announced that its RaniPill Capsule platform technology has been accepted into the U.S. Food and Drug Administration's Emerging Technology Program (ETP), according to a company press release.

The ETP, administered by the FDA's Center for Drug Evaluation and Research, is designed to support the development of innovative approaches to pharmaceutical product design and manufacturing. Technologies accepted into the program must demonstrate potential to improve pharmaceutical product quality and incorporate novel elements for which the FDA has limited review or inspection experience.

Participation gives Rani Therapeutics early, direct engagement with the FDA's Emerging Technology Team through pre-submission meetings and potential site visits. The company said these interactions can address the broader applicability of the underlying technology rather than being limited to individual drug products.

Chief Executive Officer Talat Imran said the program would be "especially valuable" as the company works to automate its vertically integrated manufacturing process in anticipation of broader clinical use. Rani Therapeutics has existing partnerships with Chugai, ProGen, and PegBio focused on rare disease, immunology, and obesity applications.

The RaniPill Capsule is a proprietary platform technology intended to replace subcutaneous injection or intravenous infusion of biologics with oral dosing. Rani Therapeutics describes itself as a clinical-stage biotherapeutics company.

You May Also Be Interested In

• Bank of America adds two former CEOs to its board
• Needham reiterates Buy rating on Nvidia with $300 target
• N-able and SentinelOne expand cybersecurity partnership