Rani Therapeutics reports ~$99M cash; FDA feedback supports 505(b)(2) pathway for RT-102; Phase 2 in H2 2023

Rani Therapeutics Holdings, Inc.

Preliminary cash, cash equivalents, restricted cash equivalents and marketable securities of ~$99M as of Dec 31, 2022, subject to audit.
FDA pre-IND feedback indicates 505(b)(2) pathway suitable for RT-102 (oral PTH analog for osteoporosis); Phase 2 trial expected H2 2023.
Positive topline Phase 1 repeat-dose results for RT-102 announced in Dec 2022, meeting all endpoints.
Plans to initiate three additional Phase 1 studies in 2023: RT-105 (adalimumab biosimilar), RT-110 (PTH for hypoparathyroidism), RT-111 (ustekinumab biosimilar).

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