Rani Therapeutics Receives FDA Feedback For Its Osteoporosis Candidate

Rani Therapeutics Holdings Inc RANI completed a pre-Investigational New Drug (IND) meeting with the FDA regarding RT-102, the RaniPill GO containing a proprietary formulation of human parathyroid hormone (1-34) analog (PTH) for the potential treatment of osteoporosis.
Following feedback, Rani believes that a 505(b)(2) pathway is suitable for developing RT-102 in the U.S.
In addition, Rani obtained guidance from the FDA on its preclinical and clinical development plans for RT-102, including the Phase 2 clinical trial, which is expected to initiate in 2H of 2023.
Related: Rani Therapeutics Lead Program Achieves Endpoints In Repeat-Dose Part Of Osteoporosis Study.
Rani held approximately $99 million in cash and equivalents as of December 31, 2022.
Price Action: RANI shares closed 8.12% higher at $6.66 on Thursday.