Rani Therapeutics gets FDA Emerging Technology Program acceptance, updates RT-114 enrollment

Rani Therapeutics Holdings, Inc. announced on November 9, 2026 that in October 2026, the RaniPill Capsule platform technology was accepted into the U.S. Food and Drug Administration's Emerging Technology Program, administered within the agency's Center for Drug Evaluation and Research to support development and implementation of innovative approaches to pharmaceutical product design and manufacturing.¹ The program requires that accepted technologies show potential to improve pharmaceutical product quality and include novel elements for which the FDA has limited review or inspection experience.¹ The company said this engagement will cover technical and regulatory topics related to the platform, including meetings ahead of formal submissions and possible site visits, though it noted that program participation does not represent FDA approval or change the standard approval pathway.

Enrollment is ongoing in the Phase 1a expansion cohort for RT-114, an orally administered RaniPill Capsule delivering PG-102, a GLP-1/GLP-2 dual agonist being developed by ProGen Co., Ltd.¹ The expansion is designed to add fifteen healthy volunteers to the study, with the goal of better defining how oral dosing compares pharmacokinetically to subcutaneous dosing for the RaniPill HC, with completion targeted by the end of 2026.

On the balance sheet, cash, cash equivalents and marketable securities totaled $45.3 million as of September 30, 2026, down from $53.4 million as of June 30, 2026.¹ Based on its current operating plan, the company said it expects this cash position to fund operations at least through the end of 2027.¹ Contract revenue for the third quarter was $1.7 million, versus no contract revenue in the same period of 2025, an increase the company attributed primarily to its collaboration and license agreement with Chugai.¹ Net loss for the quarter was $8.8 million, compared with $7.9 million in the same period last year.¹