{"success":true,"data":{"pressRelease":{"id":"155100","rtpr_id":"nGNX2LQpgd-20260929","ticker":"UNCY","exchange":"NASDAQ","all_tickers":["UNCY"],"title":"Unicycive Therapeutics Announces Resubmission of New Drug Application for Oxylanthanum Carbonate","author":"Globe Newswire","published_at":"2026-09-29T11:05:00.169Z","article_body":"* Resubmission of NDA includes Chemistry, Manufacturing, and Controls (CMC)\ndata from a new drug product manufacturing vendor \n* The resubmission package includes 12 months of OLC drug product stability\ndata from the new manufacturing vendor \n* Company anticipates FDA acceptance of the NDA within 30 days of\nresubmission; new assigned PDUFA date expected to be 6 months from\nresubmission\n* Current cash position allows runway into 2H 2027\nMOUNTAIN VIEW, Calif., Sept. 29, 2026 (GLOBE NEWSWIRE) -- Unicycive\nTherapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a\nclinical-stage biotechnology company developing therapies for patients with\nkidney disease, today announced the resubmission of its New Drug Application\n(NDA) for oxylanthanum carbonate (OLC), the Company’s investigational oral\nphosphate binder for the treatment of hyperphosphatemia in patients with\nchronic kidney disease (CKD) on dialysis. The Company anticipates United\nStates Food and Drug Administration (FDA) acceptance of the NDA within 30 days\nand a new assigned PDUFA date to be six months from the date of resubmission.\n\nThe NDA resubmission includes CMC data from a new third-party drug product\nmanufacturing vendor. The new vendor’s facility was last inspected by the\nFDA in March 2024 and received “No Action Indicated” status, the highest\nFDA inspection classification indicating that a facility is in an acceptable\nstate of current Good Manufacturing Practices (cGMP) compliance. The new\nvendor's CMC data package includes technical specifications similar to the\noriginal third-party manufacturing vendor, and the new vendor has already\nproduced OLC drug product and completed 12-month stability studies. In\naddition, the Company has provided additional in-vitro bridging data between\nthe two vendors as recommended by the FDA in previous discussions.\n\nIn June 2026, the Company received a Complete Response Letter (CRL) from the\nFDA regarding the first OLC NDA resubmission. The 2026 CRL cited the same\nthird-party manufacturing deficiencies identified in a previous CRL issued in\nJune 2025 to the initial NDA submission, as a result of the FDA not having\nconducted the reinspection of the original third-party manufacturing vendor.\nThe FDA did not raise concerns regarding clinical efficacy or safety data and\ndid not request additional data from the Company. The Company’s original\nthird-party manufacturing vendor has received written notification from the\nFDA that its facility inspection has been assigned, but the inspection has not\nyet occurred as of September 29, 2026. If the original third-party\nmanufacturing vendor is inspected in the near term and deemed cGMP-compliant,\nthe Company plans to seek FDA alignment on a shorter approval timeline for the\nOLC NDA resubmission. Unicycive intends to keep both drug product vendors to\nmaintain supply chain redundancy.\n\n“We believe this resubmission reflects an efficient path to potential\napproval and, if approved, a potentially faster path to bringing OLC to\npatients who need additional treatment options,” said Shalabh Gupta, M.D.,\nChief Executive Officer of Unicycive. “By adding an alternative primary\nmanufacturing vendor, we are positioning the NDA for expedient review and\npotential approval. If the FDA’s assigned inspection of the original vendor\nis completed favorably in the interim, that outcome could provide a potential\ntiming benefit. We continue to advance commercial readiness activities in\nanticipation of a potential launch, with the goal of helping patients with CKD\non dialysis who continue to struggle with hyperphosphatemia.”\n\nThe NDA is supported by data from three clinical studies: a Phase 1 study in\nhealthy volunteers, a bioequivalence study in healthy volunteers, and a\ntolerability study of OLC in CKD patients on dialysis, along with multiple\npreclinical studies and CMC data.\n\nAs of June 30, 2026, unaudited cash, cash equivalents and marketable\nsecurities totaled $61.4 million, supporting continued OLC commercial launch\npreparation and an expected cash runway into the second half of 2027.\n\nAbout Oxylanthanum Carbonate\nOLC is an investigational oral phosphate binder that leverages proprietary\nnanoparticle technology to deliver high phosphate binding potency, reducing\nthe number and size of pills that patients must take to treat\nhyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.\nIts potential best-in-class profile may have meaningful patient adherence\nbenefits over currently available treatment options as it requires a lower\npill burden. Unicycive is seeking FDA approval of OLC via the 505(b)(2)\nregulatory pathway. OLC is protected by a strong global patent portfolio\nincluding issued patents on composition of matter with exclusivity until 2031,\nand with the potential for patent term extension until 2035.\n\nAbout Hyperphosphatemia\nHyperphosphatemia is a serious medical condition that occurs in nearly all\npatients with End Stage Renal Disease (ESRD). Annually there are over 450,000\nindividuals in the U.S. that require medication to control their phosphate\nlevels.(1) Uncontrolled hyperphosphatemia is strongly associated with\nincreased death and hospitalization for CKD patients on dialysis. Treatment of\nhyperphosphatemia is aimed at lowering serum phosphate levels via two means:\n(1) restricting dietary phosphorus intake; and (2) using, on a daily basis,\nand with each meal, oral phosphate binding drugs that facilitate fecal\nelimination of dietary phosphate rather than its absorption from the\ngastrointestinal tract into the bloodstream.\n\n(1)Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives\nSeries. Kidney360. 2023 May 1;4(5):567-568. doi:\n10.34067/KID.0000000000000145.\n\nAbout Unicycive Therapeutics\n\nUnicycive Therapeutics is a biotechnology company developing novel treatments\nfor kidney diseases. Unicycive’s lead investigational treatment is\noxylanthanum carbonate, a novel phosphate binding agent for the treatment of\nhyperphosphatemia in patients with chronic kidney disease who are on dialysis.\nUnicycive’s second investigational treatment UNI-494 is intended for the\ntreatment of conditions related to acute kidney injury. It has been granted\norphan drug designation (ODD) by the FDA for the prevention of Delayed Graft\nFunction (DGF) in kidney transplant patients and has completed a Phase 1\ndose-ranging safety study in healthy volunteers. For more information, please\nvisit Unicycive.com\n(https://www.globenewswire.com/Tracker?data=kC1nLZKVqHJ71HTfZkYtnX7MOt1x-ZgjBAOLHIoHqDyHQWS_NCbTJ53EXOvoKYLy5IDot2qA1dnGOnAoKEV_xSfdnZa64xgXAk7Pf5rg1qJAxaB3hW8bH1fi6nCs5VWMCBVRxE-ga_oJIzOZrSRhTqjg1tN6EiVLVYlw-FhTm8qlmhYAwnr5s1ptg2Sscv0t86GcWVDfTafAC9Z5pvH4Ic6uNz9pHbGHtUCS-znfwTA=) and\nfollow us on LinkedIn\n(https://www.globenewswire.com/Tracker?data=klZUxGx-SqapEThAGqwbRRVHOCfDOg-KOV_hnE-Q004f4ukHxMHpsBWnvjI2Q6VCePeA5H_CzbYfF8LQaeumRmPML3kmGv1upUW8RsD7Kq5HVz_W84DGFtDptLGvy44dEQjTvX_Jf5kTeChC0W1wCtrvM35dF7kGZ27DgGtqzmwKMZMS92lAwEK-0EimzKojdqHS-t6Y42Y_OCwzxzNlYXwiFePmZKQ53uIqugpKtm42pCMHBC-wkJj7jyxjA-Hp) and X\n(https://www.globenewswire.com/Tracker?data=2Shzvw2EgAB85vDTeUxs3DUheW88trDpNVPAxH1fj-YIqt8aIlZvJ175_JmUgdf90I-VkG9REb3yXTpbyJw9s1DaMzbT2JSQvdu7nlmlQAaQH7kwKbQnmmmtSH1r3eFM0Bl81yAAhillcYboHjdJKxFm7WfRejFVLRMUUzrcTgh5T9109v3XrvsIeTUo2uXTDpNEgXecKDQfTO-GUkOKeg==).\n\nForward-looking statements\n\nCertain statements in this press release are forward-looking within the\nmeaning of the Private Securities Litigation Reform Act of 1995. These\nstatements may be identified using words such as \"anticipate,\" \"believe,\"\n\"forecast,\" \"estimated\" and \"intend\" or other similar terms or expressions\nthat concern Unicycive's expectations, strategy, plans or intentions. These\nforward-looking statements are based on Unicycive's current expectations and\nactual results could differ materially. There are several factors that could\ncause actual events to differ materially from those indicated by such\nforward-looking statements. These factors include, but are not limited to,\nclinical trials involve a lengthy and expensive process with an uncertain\noutcome, and results of earlier studies and trials may not be predictive of\nfuture trial results; our clinical trials may be suspended or discontinued due\nto unexpected side effects or other safety risks that could preclude approval\nof our product candidates; our dependence on third parties for manufacturing;\nthe possibility that FDA may require inspection of any vendor prior to\napproval, which could delay or prevent approval of our NDA; the risk that the\noriginal third-party manufacturing vendor’s reinspection may not occur\nwithin a timeframe that benefits our regulatory timeline, or may result in\nadverse findings; risks related to business interruptions, which could\nseriously harm our financial condition and increase our costs and expenses;\ndependence on key personnel; substantial competition; uncertainties of patent\nprotection and litigation; dependence upon third parties; market acceptance of\nour products; and risks related to failure to obtain FDA clearances or\napprovals and noncompliance with FDA regulations. Actual results may differ\nmaterially from those indicated by such forward-looking statements as a result\nof various important factors, including: the uncertainties related to market\nconditions and other factors described more fully in the section entitled\n‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year\nended December 31, 2025, and other periodic reports filed with the Securities\nand Exchange Commission. Any forward-looking statements contained in this\npress release speak only as of the date hereof, and Unicycive specifically\ndisclaims any obligation to update any forward-looking statement, whether as a\nresult of new information, future events or otherwise.\n\nInvestor Contacts:\nKevin Gardner\nLifeSci Advisors\nkgardner@lifesciadvisors.com\n\nMedia Contact:\nUnicycive Therapeutics\nmedia@unicycive.com \n\nSOURCE: Unicycive Therapeutics, Inc.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/a3961581-fb46-43bc-8ee2-1097bc7051c3)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX2LQpgd-20260929","title":"Unicycive Therapeutics Announces Resubmission of New Drug Application for Oxylanthanum Carbonate","author":"Globe Newswire","ticker":"UNCY","created":"2026-09-29T11:05:00.169Z","tickers":["UNCY"],"exchange":"NASDAQ","article_body":"* Resubmission of NDA includes Chemistry, Manufacturing, and Controls (CMC)\ndata from a new drug product manufacturing vendor \n* The resubmission package includes 12 months of OLC drug product stability\ndata from the new manufacturing vendor \n* Company anticipates FDA acceptance of the NDA within 30 days of\nresubmission; new assigned PDUFA date expected to be 6 months from\nresubmission\n* Current cash position allows runway into 2H 2027\nMOUNTAIN VIEW, Calif., Sept. 29, 2026 (GLOBE NEWSWIRE) -- Unicycive\nTherapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a\nclinical-stage biotechnology company developing therapies for patients with\nkidney disease, today announced the resubmission of its New Drug Application\n(NDA) for oxylanthanum carbonate (OLC), the Company’s investigational oral\nphosphate binder for the treatment of hyperphosphatemia in patients with\nchronic kidney disease (CKD) on dialysis. The Company anticipates United\nStates Food and Drug Administration (FDA) acceptance of the NDA within 30 days\nand a new assigned PDUFA date to be six months from the date of resubmission.\n\nThe NDA resubmission includes CMC data from a new third-party drug product\nmanufacturing vendor. The new vendor’s facility was last inspected by the\nFDA in March 2024 and received “No Action Indicated” status, the highest\nFDA inspection classification indicating that a facility is in an acceptable\nstate of current Good Manufacturing Practices (cGMP) compliance. The new\nvendor's CMC data package includes technical specifications similar to the\noriginal third-party manufacturing vendor, and the new vendor has already\nproduced OLC drug product and completed 12-month stability studies. In\naddition, the Company has provided additional in-vitro bridging data between\nthe two vendors as recommended by the FDA in previous discussions.\n\nIn June 2026, the Company received a Complete Response Letter (CRL) from the\nFDA regarding the first OLC NDA resubmission. The 2026 CRL cited the same\nthird-party manufacturing deficiencies identified in a previous CRL issued in\nJune 2025 to the initial NDA submission, as a result of the FDA not having\nconducted the reinspection of the original third-party manufacturing vendor.\nThe FDA did not raise concerns regarding clinical efficacy or safety data and\ndid not request additional data from the Company. The Company’s original\nthird-party manufacturing vendor has received written notification from the\nFDA that its facility inspection has been assigned, but the inspection has not\nyet occurred as of September 29, 2026. If the original third-party\nmanufacturing vendor is inspected in the near term and deemed cGMP-compliant,\nthe Company plans to seek FDA alignment on a shorter approval timeline for the\nOLC NDA resubmission. Unicycive intends to keep both drug product vendors to\nmaintain supply chain redundancy.\n\n“We believe this resubmission reflects an efficient path to potential\napproval and, if approved, a potentially faster path to bringing OLC to\npatients who need additional treatment options,” said Shalabh Gupta, M.D.,\nChief Executive Officer of Unicycive. “By adding an alternative primary\nmanufacturing vendor, we are positioning the NDA for expedient review and\npotential approval. If the FDA’s assigned inspection of the original vendor\nis completed favorably in the interim, that outcome could provide a potential\ntiming benefit. We continue to advance commercial readiness activities in\nanticipation of a potential launch, with the goal of helping patients with CKD\non dialysis who continue to struggle with hyperphosphatemia.”\n\nThe NDA is supported by data from three clinical studies: a Phase 1 study in\nhealthy volunteers, a bioequivalence study in healthy volunteers, and a\ntolerability study of OLC in CKD patients on dialysis, along with multiple\npreclinical studies and CMC data.\n\nAs of June 30, 2026, unaudited cash, cash equivalents and marketable\nsecurities totaled $61.4 million, supporting continued OLC commercial launch\npreparation and an expected cash runway into the second half of 2027.\n\nAbout Oxylanthanum Carbonate\nOLC is an investigational oral phosphate binder that leverages proprietary\nnanoparticle technology to deliver high phosphate binding potency, reducing\nthe number and size of pills that patients must take to treat\nhyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.\nIts potential best-in-class profile may have meaningful patient adherence\nbenefits over currently available treatment options as it requires a lower\npill burden. Unicycive is seeking FDA approval of OLC via the 505(b)(2)\nregulatory pathway. OLC is protected by a strong global patent portfolio\nincluding issued patents on composition of matter with exclusivity until 2031,\nand with the potential for patent term extension until 2035.\n\nAbout Hyperphosphatemia\nHyperphosphatemia is a serious medical condition that occurs in nearly all\npatients with End Stage Renal Disease (ESRD). Annually there are over 450,000\nindividuals in the U.S. that require medication to control their phosphate\nlevels.(1) Uncontrolled hyperphosphatemia is strongly associated with\nincreased death and hospitalization for CKD patients on dialysis. Treatment of\nhyperphosphatemia is aimed at lowering serum phosphate levels via two means:\n(1) restricting dietary phosphorus intake; and (2) using, on a daily basis,\nand with each meal, oral phosphate binding drugs that facilitate fecal\nelimination of dietary phosphate rather than its absorption from the\ngastrointestinal tract into the bloodstream.\n\n(1)Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives\nSeries. Kidney360. 2023 May 1;4(5):567-568. doi:\n10.34067/KID.0000000000000145.\n\nAbout Unicycive Therapeutics\n\nUnicycive Therapeutics is a biotechnology company developing novel treatments\nfor kidney diseases. Unicycive’s lead investigational treatment is\noxylanthanum carbonate, a novel phosphate binding agent for the treatment of\nhyperphosphatemia in patients with chronic kidney disease who are on dialysis.\nUnicycive’s second investigational treatment UNI-494 is intended for the\ntreatment of conditions related to acute kidney injury. It has been granted\norphan drug designation (ODD) by the FDA for the prevention of Delayed Graft\nFunction (DGF) in kidney transplant patients and has completed a Phase 1\ndose-ranging safety study in healthy volunteers. For more information, please\nvisit Unicycive.com\n(https://www.globenewswire.com/Tracker?data=kC1nLZKVqHJ71HTfZkYtnX7MOt1x-ZgjBAOLHIoHqDyHQWS_NCbTJ53EXOvoKYLy5IDot2qA1dnGOnAoKEV_xSfdnZa64xgXAk7Pf5rg1qJAxaB3hW8bH1fi6nCs5VWMCBVRxE-ga_oJIzOZrSRhTqjg1tN6EiVLVYlw-FhTm8qlmhYAwnr5s1ptg2Sscv0t86GcWVDfTafAC9Z5pvH4Ic6uNz9pHbGHtUCS-znfwTA=) and\nfollow us on LinkedIn\n(https://www.globenewswire.com/Tracker?data=klZUxGx-SqapEThAGqwbRRVHOCfDOg-KOV_hnE-Q004f4ukHxMHpsBWnvjI2Q6VCePeA5H_CzbYfF8LQaeumRmPML3kmGv1upUW8RsD7Kq5HVz_W84DGFtDptLGvy44dEQjTvX_Jf5kTeChC0W1wCtrvM35dF7kGZ27DgGtqzmwKMZMS92lAwEK-0EimzKojdqHS-t6Y42Y_OCwzxzNlYXwiFePmZKQ53uIqugpKtm42pCMHBC-wkJj7jyxjA-Hp) and X\n(https://www.globenewswire.com/Tracker?data=2Shzvw2EgAB85vDTeUxs3DUheW88trDpNVPAxH1fj-YIqt8aIlZvJ175_JmUgdf90I-VkG9REb3yXTpbyJw9s1DaMzbT2JSQvdu7nlmlQAaQH7kwKbQnmmmtSH1r3eFM0Bl81yAAhillcYboHjdJKxFm7WfRejFVLRMUUzrcTgh5T9109v3XrvsIeTUo2uXTDpNEgXecKDQfTO-GUkOKeg==).\n\nForward-looking statements\n\nCertain statements in this press release are forward-looking within the\nmeaning of the Private Securities Litigation Reform Act of 1995. These\nstatements may be identified using words such as \"anticipate,\" \"believe,\"\n\"forecast,\" \"estimated\" and \"intend\" or other similar terms or expressions\nthat concern Unicycive's expectations, strategy, plans or intentions. These\nforward-looking statements are based on Unicycive's current expectations and\nactual results could differ materially. There are several factors that could\ncause actual events to differ materially from those indicated by such\nforward-looking statements. These factors include, but are not limited to,\nclinical trials involve a lengthy and expensive process with an uncertain\noutcome, and results of earlier studies and trials may not be predictive of\nfuture trial results; our clinical trials may be suspended or discontinued due\nto unexpected side effects or other safety risks that could preclude approval\nof our product candidates; our dependence on third parties for manufacturing;\nthe possibility that FDA may require inspection of any vendor prior to\napproval, which could delay or prevent approval of our NDA; the risk that the\noriginal third-party manufacturing vendor’s reinspection may not occur\nwithin a timeframe that benefits our regulatory timeline, or may result in\nadverse findings; risks related to business interruptions, which could\nseriously harm our financial condition and increase our costs and expenses;\ndependence on key personnel; substantial competition; uncertainties of patent\nprotection and litigation; dependence upon third parties; market acceptance of\nour products; and risks related to failure to obtain FDA clearances or\napprovals and noncompliance with FDA regulations. Actual results may differ\nmaterially from those indicated by such forward-looking statements as a result\nof various important factors, including: the uncertainties related to market\nconditions and other factors described more fully in the section entitled\n‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year\nended December 31, 2025, and other periodic reports filed with the Securities\nand Exchange Commission. Any forward-looking statements contained in this\npress release speak only as of the date hereof, and Unicycive specifically\ndisclaims any obligation to update any forward-looking statement, whether as a\nresult of new information, future events or otherwise.\n\nInvestor Contacts:\nKevin Gardner\nLifeSci Advisors\nkgardner@lifesciadvisors.com\n\nMedia Contact:\nUnicycive Therapeutics\nmedia@unicycive.com \n\nSOURCE: Unicycive Therapeutics, Inc.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/a3961581-fb46-43bc-8ee2-1097bc7051c3)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-09-29T11:05:00.228470837Z","server_sent_at_ms":1790679900228},"received_at":"2026-09-29T11:05:00.330Z","source_url":null},"analysis":{"id":"143844","press_release_id":"155100","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["two prior CRLs (2025 and 2026) both cited third-party manufacturing deficiencies","approval timeline depends on FDA reinspection of original vendor, which has not yet occurred","clinical-stage company with $61.4M cash and runway only into 2H 2027"],"eventType":"regulatory","narrative":"Unicycive Therapeutics resubmitted its NDA for oxylanthanum carbonate (OLC), an investigational oral phosphate binder for hyperphosphatemia in dialysis patients, with CMC data from a new manufacturing vendor.\n\nThe FDA did not raise clinical efficacy or safety concerns in prior CRLs; the resubmission includes 12 months of stability data and in-vitro bridging data, and the new vendor's facility received a 'No Action Indicated' FDA inspection in March 2024. Acceptance is anticipated within 30 days with a new PDUFA date roughly six months from resubmission.\n\nThe company held $61.4 million in cash and securities as of June 30, 2026, supporting a runway into 2H 2027, but approval still hinges on FDA inspection outcomes and prior CRL history shows manufacturing-site risk has delayed the program twice.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"OLC NDA resubmission via alternate cGMP-compliant vendor sets up a ~6-month PDUFA catalyst for UNCY."},"keyFigures":{"drugName":"oxylanthanum carbonate (OLC)","customDimensions":{"cash_runway":"into 2H 2027","cash_position":"$61.4 million","pdufa_timeline":"expected 6 months from resubmission","patent_exclusivity":"until 2031, potential extension to 2035","stability_data_months":12,"nda_acceptance_expected":"within 30 days"}},"quotedText":"We believe this resubmission reflects an efficient path to potential approval and, if approved, a potentially faster path to bringing OLC to patients who need additional treatment options","namedEntities":{"people":[{"name":"Shalabh Gupta, M.D.","role":"CEO"}],"products":["oxylanthanum carbonate (OLC)","UNI-494"],"companies":[{"name":"Unicycive Therapeutics, Inc.","ticker":"UNCY","relationship":"filer"},{"name":"LifeSci Advisors","relationship":"investor relations"}],"dollarAmounts":[{"amount":"$61.4 million","context":"cash, cash equivalents and marketable securities as of June 30, 2026"}]},"materialImpact":{"score":3,"reasoning":"NDA resubmission for lead asset OLC with a new CMC vendor addresses prior CRL deficiencies; FDA acceptance expected within 30 days and PDUFA ~6 months out. Approval path is de-risked versus prior CRLs but still pending FDA inspection risk."},"tickerRelevance":{"others":[],"primary":"UNCY"},"globalImportance":32,"audienceRelevance":25,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"micro-cap clinical-stage biotech","eventGravity":"NDA resubmission after two CRLs — binary catalyst ~6 months out","issuerAuthored":true}},"event_type":"regulatory","event_type_secondary":null,"sentiment":"bullish","material_impact_score":3,"narrative":"Unicycive Therapeutics resubmitted its NDA for oxylanthanum carbonate (OLC), an investigational oral phosphate binder for hyperphosphatemia in dialysis patients, with CMC data from a new manufacturing vendor.\n\nThe FDA did not raise clinical efficacy or safety concerns in prior CRLs; the resubmission includes 12 months of stability data and in-vitro bridging data, and the new vendor's facility received a 'No Action Indicated' FDA inspection in March 2024. Acceptance is anticipated within 30 days with a new PDUFA date roughly six months from resubmission.\n\nThe company held $61.4 million in cash and securities as of June 30, 2026, supporting a runway into 2H 2027, but approval still hinges on FDA inspection outcomes and prior CRL history shows manufacturing-site risk has delayed the program twice.","key_figures":{"drugName":"oxylanthanum carbonate (OLC)","customDimensions":{"cash_runway":"into 2H 2027","cash_position":"$61.4 million","pdufa_timeline":"expected 6 months from resubmission","patent_exclusivity":"until 2031, potential extension to 2035","stability_data_months":12,"nda_acceptance_expected":"within 30 days"}},"named_entities":{"people":[{"name":"Shalabh Gupta, M.D.","role":"CEO"}],"products":["oxylanthanum carbonate (OLC)","UNI-494"],"companies":[{"name":"Unicycive Therapeutics, Inc.","ticker":"UNCY","relationship":"filer"},{"name":"LifeSci Advisors","relationship":"investor relations"}],"dollarAmounts":[{"amount":"$61.4 million","context":"cash, cash equivalents and marketable securities as of June 30, 2026"}]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-29T11:05:07.194Z","global_importance":32,"audience_relevance":25,"importance_components":{"tickerTier":"micro-cap clinical-stage biotech","eventGravity":"NDA resubmission after two CRLs — binary catalyst ~6 months out","issuerAuthored":true}},"durationMs":6804,"modelName":"glm-5.3-flashx"}}