Rani Therapeutics Holdings, Inc. Stock Price, News & Analysis

Rani Therapeutics, a clinical-stage biotherapeutics company, announced that CEO Talat Imran will present at the 22^nd Annual Needham Virtual Healthcare Conference on April 18, 2023, at 12:45 p.m. PT / 3:45 p.m. ET. The presentation will focus on Rani's innovative RaniPill capsule technology, designed to facilitate the oral delivery of biologics and drugs, potentially replacing subcutaneous and intravenous methods. Interested individuals can access the live webcast via Rani's Investor Relations page, with replays available for approximately 90 days post-event. Rani Therapeutics is committed to advancing oral drug delivery technologies and has successfully completed multiple studies to assess the safety and efficacy of its RaniPill platform.

Rani Therapeutics Holdings (RANI) announced significant advancements in its pipeline, including the anticipated initiation of its first Phase 2 study for RT-102 targeting osteoporosis in 2H 2023. The company reported positive topline results from a Phase 1 repeat-dose study of RT-102, achieving all endpoints. Moreover, initial feedback from the FDA suggests a suitable 505(b)(2) pathway for RT-102's development. A partnership with Celltrion has been established to advance the RT-111 program, an oral ustekinumab biosimilar. Financially, Rani reported a net loss of $63.3 million for 2022, an increase from $53.1 million in 2021, with cash reserves of $98.5 million expected to support operations through mid-2024.

Rani Therapeutics Holdings, Inc. (Nasdaq: RANI) will release its fourth quarter and full year financial results for 2022 on March 22, 2023, after the market closes. Following the announcement, management will host a conference call at 4:30 p.m. ET to discuss the results and take questions. Rani Therapeutics focuses on oral delivery technologies for biologics and has developed the RaniPill™ capsules aimed at replacing injections with oral dosing. The company has conducted various studies to assess the safety and bioavailability of its products, emphasizing its innovative approach to drug administration.

Rani Therapeutics has partnered with Celltrion to develop RT-111, an oral biosimilar of ustekinumab (CT-P43). As per the agreement, Celltrion will be the exclusive supplier of CT-P43 for Rani's RT-111 program. Rani holds exclusive rights to use CT-P43 in its development efforts. The RaniPill™ technology aims to facilitate oral administration of biologics, enhancing patient comfort. Rani’s CEO highlighted the validation of RaniPill's effectiveness in previous trials. The partnership positions Rani for potential commercial success following clinical trials.

Rani Therapeutics announced preliminary FDA feedback on RT-102, suggesting a 505(b)(2) development pathway could be suitable. The company presented updates on its clinical trials, including positive topline results from the Phase 1 study, achieving all endpoints and demonstrating good tolerability. The anticipated key milestones for 2023 include the initiation of the Phase 2 trial for RT-102 in osteoporosis and three additional Phase 1 studies. Rani's preliminary cash position stands at approximately $99 million as of December 31, 2022.

Rani Therapeutics announced positive topline results from Part 2 of its Phase 1 study for RT-102, an oral drug for osteoporosis. The study met all endpoints, with a 91% success rate in drug delivery via the RaniPill™ GO capsule, which was well tolerated by the participants, showing no serious adverse events. The data supports moving to a Phase 2 trial anticipated in H2 2023. Approximately 185 capsules have been administered in clinical studies, reinforcing the viability of the RaniPill™ platform for oral biologic delivery.

Rani Therapeutics reported its Q3 2022 financial results and key corporate updates on Nov. 10, 2022. The highlights include positive topline results from the Phase 1 study of RT-102, a proprietary PTH formulation, and the initiation of preclinical development for RT-111, a biosimilar targeting autoimmune conditions. Financially, Rani ended Q3 with cash reserves of $98.7 million. Although R&D expenses decreased to $9.1 million, the net loss reduced to $16.2 million from $28.7 million year-over-year. Upcoming milestones involve additional data from RT-102 and new Phase 1 studies in 2023.

Rani Therapeutics, a clinical stage biotherapeutics company, will present at the Stifel Healthcare Conference on November 15-16, 2022. CEO Talat Imran is scheduled to speak on November 16 at 9:45 AM EST. The company focuses on oral delivery of biologics through its innovative RaniPill capsule technology, aimed at replacing injections with oral dosing. Interested parties can access live webcasts from the Investor Relations section of their website, with replays available for 90 days post-presentation.

Rani Therapeutics announced the preclinical development of RT-111, an oral ustekinumab biosimilar targeting psoriatic arthritis, ulcerative colitis, Crohn's disease, and psoriasis. The product aims to simplify patient treatment by replacing injections with oral delivery.

Additionally, topline data for RT-102 is expected in Q4 2022, alongside the start of in vivo studies for the RaniPill HC. The company also plans to ramp up its pipeline with three new Phase 1 studies in 2023.