Rani Therapeutics Receives FDA Feedback For Osteoporosis Candidate

 

• Rani Therapeutics Holdings Inc 
  RANI-2.40%+ Free Alerts
   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.
• Rani held approximately $99 million in cash and equivalents as of December 31, 2022.

https://www.benzinga.com/general/biotech/23/01/30309407/rani-therapeutics-receives-fda-feedback-for-its-osteoporosis-candidate