{"success":true,"data":{"pressRelease":{"id":"160416","rtpr_id":"nGNX4rhJkT-20261005","ticker":"RANI","exchange":"NASDAQ","all_tickers":["RANI"],"title":"Rani Therapeutics Announces Acceptance into U.S. FDA's Emerging Technology Program (ETP)","author":"Globe Newswire","published_at":"2026-10-05T12:00:01.543Z","article_body":"SAN JOSE, Calif., Oct. 05, 2026 (GLOBE NEWSWIRE) -- Rani Therapeutics\nHoldings, Inc. (Nasdaq: RANI), a clinical-stage biotherapeutics company\nfocused on oral delivery of biologics, today announced that the RaniPill(®)\nCapsule™ platform technology has been accepted into the U.S. Food and Drug\nAdministration (FDA) Emerging Technology Program (ETP).\n\nThe FDA’s Emerging Technology Program, administered within the Agency’s\nCenter for Drug Evaluation and Research (CDER), is designed to support the\ndevelopment and implementation of innovative approaches to pharmaceutical\nproduct design and manufacturing. Technologies accepted into the program must\ndemonstrate the potential to improve pharmaceutical product quality and\nincorporate novel elements for which the FDA has limited review or inspection\nexperience. Participation provides Rani with early, direct engagement with the\nFDA’s Emerging Technology Team to address technical and regulatory\nconsiderations related to the RaniPill platform, including through\npre-submission meetings and potential site visits. Importantly, these\ninteractions can address the broader applicability of the underlying\ntechnology rather than being limited to individual drug products.\n\n“Our acceptance into the FDA's Emerging Technology Program reflects the\nAgency's recognition of the RaniPill(®) platform as a novel and innovative\napproach to the oral delivery of biologics,” said Talat Imran, Chief\nExecutive Officer of Rani Therapeutics. “This program enables direct,\ncollaborative access to the FDA on a technology as novel as Rani’s, and we\nexpect that engagement to be especially valuable as we work to automate our\nvertically integrated manufacturing process in anticipation of broader\nclinical use. Combined with our rare disease, immunology, and obesity focused\npartnerships with Chugai, ProGen and PegBio, this milestone reflects our\ncontinued confidence in the RaniPill platform's potential as an alternative to\ninjectable biologics. We look forward to working closely with the FDA as we\ncontinue to advance the platform.”\n\nAbout Rani Therapeutics\nRani Therapeutics is a clinical-stage biotherapeutics company focused on\nadvancing technologies to enable the development of orally administered\nbiologics and drugs. Rani has developed the RaniPill(®) Capsule™, a novel,\nproprietary and patented platform technology, intended to replace subcutaneous\ninjection or intravenous infusion of biologics and drugs with oral dosing.\nRani has successfully conducted several preclinical and clinical studies to\nevaluate safety, tolerability and bioavailability using RaniPill(®) Capsule\ntechnology.\n\nForward-Looking Statements\nStatements contained in this press release regarding matters that are not\nhistorical facts are “forward-looking statements” within the meaning of\nthe Private Securities Litigation Reform Act of 1995. Forward-looking\nstatements include, without limitation, statements regarding the potential of\nRani’s RaniPill(®) platform to convert injectable biologics into oral\ntherapies, and to address unmet needs in the treatment of patients requiring\ninjectable biologics, the anticipated value of Rani’s engagement with the\nFDA under the Emerging Technology Program, Rani’s plans to automate its\nvertically integrated manufacturing process in anticipation of broader\nclinical use, Rani’s expectations regarding its partnerships with Chugai,\nProGen and PegBio and the continued development of the RaniPill platform.\nBecause such statements are subject to risks and uncertainties, actual results\nmay differ materially from those expressed or implied by such forward-looking\nstatements. Words such as “continue,” “intend,” “look forward to,”\n“potential,” “expect,” “will,” and similar expressions are\nintended to identify forward-looking statements. These forward-looking\nstatements are based upon Rani’s current expectations and involve\nassumptions that may never materialize or may prove to be incorrect. Actual\nresults could differ materially from those anticipated in such forward-looking\nstatements as a result of various risks and uncertainties, which include,\nwithout limitation, risks and uncertainties associated with Rani’s business\nin general and the other risks described in Rani’s filings with the\nSecurities and Exchange Commission, including Rani’s annual report on Form\n10-K for the year ended December 31, 2025, and subsequent filings and reports\nby Rani. All forward-looking statements contained in this press release speak\nonly as of the date on which they were made and are based on management’s\nassumptions and estimates as of such date. Rani undertakes no obligation to\nupdate such statements to reflect events that occur or circumstances that\nexist after the date on which they were made, except as required by law.\n\nInvestor Contact:\ninvestors@ranitherapeutics.com\n\nMedia Contact:\nmedia@ranitherapeutics.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/8ce7774c-3696-4aa1-8bcd-413805f0a642)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX4rhJkT-20261005","title":"Rani Therapeutics Announces Acceptance into U.S. FDA's Emerging Technology Program (ETP)","author":"Globe Newswire","ticker":"RANI","created":"2026-10-05T12:00:01.543Z","tickers":["RANI"],"exchange":"NASDAQ","article_body":"SAN JOSE, Calif., Oct. 05, 2026 (GLOBE NEWSWIRE) -- Rani Therapeutics\nHoldings, Inc. (Nasdaq: RANI), a clinical-stage biotherapeutics company\nfocused on oral delivery of biologics, today announced that the RaniPill(®)\nCapsule™ platform technology has been accepted into the U.S. Food and Drug\nAdministration (FDA) Emerging Technology Program (ETP).\n\nThe FDA’s Emerging Technology Program, administered within the Agency’s\nCenter for Drug Evaluation and Research (CDER), is designed to support the\ndevelopment and implementation of innovative approaches to pharmaceutical\nproduct design and manufacturing. Technologies accepted into the program must\ndemonstrate the potential to improve pharmaceutical product quality and\nincorporate novel elements for which the FDA has limited review or inspection\nexperience. Participation provides Rani with early, direct engagement with the\nFDA’s Emerging Technology Team to address technical and regulatory\nconsiderations related to the RaniPill platform, including through\npre-submission meetings and potential site visits. Importantly, these\ninteractions can address the broader applicability of the underlying\ntechnology rather than being limited to individual drug products.\n\n“Our acceptance into the FDA's Emerging Technology Program reflects the\nAgency's recognition of the RaniPill(®) platform as a novel and innovative\napproach to the oral delivery of biologics,” said Talat Imran, Chief\nExecutive Officer of Rani Therapeutics. “This program enables direct,\ncollaborative access to the FDA on a technology as novel as Rani’s, and we\nexpect that engagement to be especially valuable as we work to automate our\nvertically integrated manufacturing process in anticipation of broader\nclinical use. Combined with our rare disease, immunology, and obesity focused\npartnerships with Chugai, ProGen and PegBio, this milestone reflects our\ncontinued confidence in the RaniPill platform's potential as an alternative to\ninjectable biologics. We look forward to working closely with the FDA as we\ncontinue to advance the platform.”\n\nAbout Rani Therapeutics\nRani Therapeutics is a clinical-stage biotherapeutics company focused on\nadvancing technologies to enable the development of orally administered\nbiologics and drugs. Rani has developed the RaniPill(®) Capsule™, a novel,\nproprietary and patented platform technology, intended to replace subcutaneous\ninjection or intravenous infusion of biologics and drugs with oral dosing.\nRani has successfully conducted several preclinical and clinical studies to\nevaluate safety, tolerability and bioavailability using RaniPill(®) Capsule\ntechnology.\n\nForward-Looking Statements\nStatements contained in this press release regarding matters that are not\nhistorical facts are “forward-looking statements” within the meaning of\nthe Private Securities Litigation Reform Act of 1995. Forward-looking\nstatements include, without limitation, statements regarding the potential of\nRani’s RaniPill(®) platform to convert injectable biologics into oral\ntherapies, and to address unmet needs in the treatment of patients requiring\ninjectable biologics, the anticipated value of Rani’s engagement with the\nFDA under the Emerging Technology Program, Rani’s plans to automate its\nvertically integrated manufacturing process in anticipation of broader\nclinical use, Rani’s expectations regarding its partnerships with Chugai,\nProGen and PegBio and the continued development of the RaniPill platform.\nBecause such statements are subject to risks and uncertainties, actual results\nmay differ materially from those expressed or implied by such forward-looking\nstatements. Words such as “continue,” “intend,” “look forward to,”\n“potential,” “expect,” “will,” and similar expressions are\nintended to identify forward-looking statements. These forward-looking\nstatements are based upon Rani’s current expectations and involve\nassumptions that may never materialize or may prove to be incorrect. Actual\nresults could differ materially from those anticipated in such forward-looking\nstatements as a result of various risks and uncertainties, which include,\nwithout limitation, risks and uncertainties associated with Rani’s business\nin general and the other risks described in Rani’s filings with the\nSecurities and Exchange Commission, including Rani’s annual report on Form\n10-K for the year ended December 31, 2025, and subsequent filings and reports\nby Rani. All forward-looking statements contained in this press release speak\nonly as of the date on which they were made and are based on management’s\nassumptions and estimates as of such date. Rani undertakes no obligation to\nupdate such statements to reflect events that occur or circumstances that\nexist after the date on which they were made, except as required by law.\n\nInvestor Contact:\ninvestors@ranitherapeutics.com\n\nMedia Contact:\nmedia@ranitherapeutics.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/8ce7774c-3696-4aa1-8bcd-413805f0a642)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-05T12:00:01.626971407Z","server_sent_at_ms":1791201601626},"received_at":"2026-10-05T12:00:01.676Z","source_url":null},"analysis":{"id":"148984","press_release_id":"160416","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":[],"eventType":"regulatory","narrative":"Rani Therapeutics' RaniPill Capsule platform has been accepted into the FDA's Emerging Technology Program, run within CDER to support novel pharmaceutical design and manufacturing approaches.\n\nParticipation gives Rani early, direct FDA engagement via pre-submission meetings and potential site visits, covering the platform broadly rather than individual drug products.\n\nManagement framed the acceptance as validation of the oral-biologics platform alongside partnerships with Chugai, ProGen, and PegBio, though the milestone carries no immediate financial impact.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"FDA ETP acceptance validates RaniPill platform and unlocks early regulatory engagement, but is a modest de-risking signal rather than a near-term catalyst."},"keyFigures":{"drugName":"RaniPill Capsule platform"},"quotedText":"Our acceptance into the FDA's Emerging Technology Program reflects the Agency's recognition of the RaniPill(®) platform as a novel and innovative approach to the oral delivery of biologics","namedEntities":{"people":[{"name":"Talat Imran","role":"Chief Executive Officer"}],"products":["RaniPill Capsule"],"companies":[{"name":"Rani Therapeutics Holdings, Inc.","ticker":"RANI","relationship":"filer"},{"name":"Chugai","relationship":"partner"},{"name":"ProGen","relationship":"partner"},{"name":"PegBio","relationship":"partner"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Acceptance into the FDA Emerging Technology Program is a modest positive regulatory validation enabling early FDA engagement, but it is not an approval, trial result, or financing event and carries no immediate revenue impact."},"tickerRelevance":{"others":[],"primary":"RANI"},"globalImportance":20,"audienceRelevance":25,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"micro-cap clinical-stage biotech","eventGravity":"regulatory program acceptance, no approval or trial data","issuerAuthored":true}},"event_type":"regulatory","event_type_secondary":null,"sentiment":"bullish","material_impact_score":2,"narrative":"Rani Therapeutics' RaniPill Capsule platform has been accepted into the FDA's Emerging Technology Program, run within CDER to support novel pharmaceutical design and manufacturing approaches.\n\nParticipation gives Rani early, direct FDA engagement via pre-submission meetings and potential site visits, covering the platform broadly rather than individual drug products.\n\nManagement framed the acceptance as validation of the oral-biologics platform alongside partnerships with Chugai, ProGen, and PegBio, though the milestone carries no immediate financial impact.","key_figures":{"drugName":"RaniPill Capsule platform"},"named_entities":{"people":[{"name":"Talat Imran","role":"Chief Executive Officer"}],"products":["RaniPill Capsule"],"companies":[{"name":"Rani Therapeutics Holdings, Inc.","ticker":"RANI","relationship":"filer"},{"name":"Chugai","relationship":"partner"},{"name":"ProGen","relationship":"partner"},{"name":"PegBio","relationship":"partner"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-05T12:00:24.144Z","global_importance":20,"audience_relevance":25,"importance_components":{"tickerTier":"micro-cap clinical-stage biotech","eventGravity":"regulatory program acceptance, no approval or trial data","issuerAuthored":true}},"durationMs":4800,"modelName":"glm-5.3-flashx"}}