Unicycive Therapeutics Provides Update from FDA Type A Meeting and Expects to Resubmit OLC NDA Before Year-End
Unicycive Therapeutics (Nasdaq: UNCY) reported outcomes from an FDA Type A meeting and said it plans to resubmit the NDA for Oxylanthanum Carbonate (OLC) by year-end 2025 after receiving a Complete Response Letter (CRL) on June 30, 2025.
The CRL cited a single deficiency tied to the compliance status of a third-party manufacturing vendor; no preclinical, clinical, or safety concerns were identified. The company said FDA meeting minutes were constructive and it is engaging the vendor to resolve the issue, potentially yielding a PDUFA date in H1 2026.
Unicycive reported $42 million cash as of September 30, 2025, which it says provides a cash runway into 2027 to support the resubmission, potential approval, and commercialization preparations for OLC.
Unicycive Therapeutics (Nasdaq: UNCY) ha riportato i risultati di un incontro di tipo A della FDA e ha detto che intende presentare nuovamente l'NDA per Oxylanthanum Carbonato (OLC) entro la fine del 2025 dopo aver ricevuto una Lettera di Risposta Completa (CRL) il 30 giugno 2025.
La CRL ha citato una singola deficienza legata allo stato di conformità di un fornitore di produzione terzo; non sono stati identificati problemi preclinici, clinici o di sicurezza. L'azienda ha dichiarato che i verbali dell'incontro FDA sono stati costruttivi e sta collaborando con il fornitore per risolvere la questione, il che potrebbe portare a una data PDUFA entro la prima metà del 2026.
Unicycive ha comunicato $42 milioni di liquidità al 30 settembre 2025, che secondo l'azienda fornisce una linea di credito fino al 2027 per supportare la ripresentazione, l'eventuale approvazione e i preparativi di commercializzazione per OLC.
Unicycive Therapeutics (Nasdaq: UNCY) informó resultados de una reunión de la FDA de tipo A y dijo que planea volver a presentar la NDA para Oxylanthanum Carbonate (OLC) para fines de 2025 tras recibir una Carta de Respuesta Completa (CRL) el 30 de junio de 2025.
La CRL citó una única deficiencia relacionada con el estado de cumplimiento de un proveedor de fabricación externo; no se identificaron preocupaciones preclínicas, clínicas o de seguridad. La compañía dijo que las actas de la reunión de la FDA fueron constructivas y que está trabajando con el proveedor para resolver el problema, lo que podría dar lugar a una fecha PDUFA en la primera mitad de 2026.
Unicycive reportó $42 millones en efectivo al 30 de septiembre de 2025, lo que, según la empresa, proporciona una trayectoria de caja hasta 2027 para apoyar la re-presentación, la posible aprobación y los preparativos de comercialización de OLC.
Unicycive Therapeutics (Nasdaq: UNCY)는 FDA Type A 회의의 결과를 보고했고 2025년 말까지 Oxylanthanum Carbonate(OLC)의 NDA를 재제출할 계획이라고 밝혔습니다. 이는 2025년 6월 30일에 완전한 반응 서한(CRL)을 받은 후의 소식입니다.
CRL은 제3자 제조 공급자의 준수 상태와 관련된 단일 결함을 지적했으며, 선행임상, 임상 또는 안전성 문제는 확인되지 않았습니다. 회사는 FDA 회의록이 건설적이었다고 밝히고 문제를 해결하기 위해 공급자와 협력 중이며, 2026년 상반기 PDUFA 날짜가 나올 수 있다고 말했습니다.
Unicycive는 2025년 9월 30일 기준 $42백만의 현금을 보유하고 있으며, 이는 OLC의 재제출, 잠재적 승인 및 상용화 준비를 지원하기 위해 2027년까지 현금 흐름을 확보하는 데 도움이 된다고 밝혔습니다.
Unicycive Therapeutics (Nasdaq: UNCY) a publié les résultats d'une réunion de type A avec la FDA et a déclaré qu'elle prévoyait de soumettre à nouveau le NDA pour Oxylanthanum Carbonate (OLC) d'ici la fin de 2025 après avoir reçu une Lettre de réponse complète (CRL) le 30 juin 2025.
La CRL a cité une défaut unique lié à l'état de conformité d'un fournisseur de fabrication tiers; aucune préoccupation préclinique, clinique ou de sécurité n'a été identifiée. La société a déclaré que les procès-verbaux de la réunion FDA étaient constructifs et qu'elle travaille avec le fournisseur pour résoudre le problème, ce qui pourrait aboutir à une date PDUFA au cours du premier semestre 2026.
Unicycive a indiqué 42 millions de dollars en liquidités au 30 septembre 2025, ce qui, selon elle, prévoit une marge de trésorerie jusqu'en 2027 pour soutenir la nouvelle soumission, l'éventuelle approbation et les préparatifs de commercialisation pour l'OLC.
Unicycive Therapeutics (Nasdaq: UNCY) berichtete Ergebnisse eines FDA Type-A-Meetings und sagte, dass geplant ist, den NDA für Oxylanthanumcarbonat (OLC) bis Ende 2025 erneut einzureichen, nachdem am 30. Juni 2025 ein CRL (Complete Response Letter) eingegangen war.
Die CRL nannte eine einzige Defizienz im Zusammenhang mit dem Compliance-Status eines Drittanbieter-Herstellers; es wurden keine präklinischen, klinischen oder sicherheitsrelevanten Bedenken identifiziert. Das Unternehmen sagte, die FDA-Meeting-Minuten seien konstruktiv gewesen und es arbeitet mit dem Anbieter zusammen, um das Problem zu lösen, was möglicherweise zu einem PDUFA-Termin in H1 2026 führt.
Unicycive meldete zum 30.09.2025 $42 Millionen Bargeld, was nach eigenen Angaben eine Cash-Runway bis 2027 ermöglicht, um die erneute Einreichung, eine potenzielle Zulassung und die Vermarktungsvorbereitungen für OLC zu unterstützen.
Unicycive Therapeutics (ناسداك: UNCY) أصدرت نتائج اجتماع من النوع A مع إدارة الغذاء والدواء وقالت إنها تعتزم إعادة تقديم NDA لـ Oxylanthanum Carbonate (OLC) بحلول نهاية عام 2025 بعد تلقيها رسالة استجابة كاملة (CRL) في 30 يونيو 2025.
أشارت CRL إلى عيب واحد مرتبط بحالة الامتثال لدى مورد تصنيع خارجي؛ لم يتم تحديد مخاوف تتعلق بالخلفية قبل السريرية أو السريرية أو السلامة. قالت الشركة إن محاضر اجتماع FDA كانت بناءة وهي تتعاون مع المورد لحل المشكلة، مما قد يؤدي إلى تاريخ PDUFA في النصف الأول من 2026.
ذكرت Unicycive أن لديها $42 مليون نقدًا حتى 30 سبتمبر 2025، وهو ما يوفر وفقًا لها مسارًا نقديًا حتى 2027 لدعم إعادة التقديم والموافقة المحتملة والتحضيرات التسويقية لـ OLC.
Unicycive Therapeutics（纳斯达克：UNCY） 公布了FDA Type A 会议的结果，并表示计划在2025年底前重新提交 Oxylanthanum Carbonate（OLC）的 NDA，此前于 2025 年 6 月 30 日收到一封完整回应信（CRL）。
CRL 指出与第三方制造商合规状态相关的单一缺陷；未发现任何前临床、临床或安全性问题。公司表示 FDA 会议纪要具有建设性，正在与供应商合作解决该问题，可能带来一个 2026 年上半年的 PDUFA 日期。
据宣布，Unicycive 截至 2025 年 9 月 30 日 拥有 $42 百万美元现金，据称这将为到 2027 年的现金流提供路径，以支持重新提交、潜在批准以及 OL C 的商业化准备工作。
- Planned NDA resubmission by year-end 2025
- Potential PDUFA date in H1 2026
- No clinical or safety concerns identified in FDA review
- $42 million cash as of September 30, 2025 supports runway into 2027
- Received a CRL on June 30, 2025
- Outstanding issue tied to third-party manufacturing vendor compliance
- Regulatory approval depends on vendor remediation timing
Insights
Resubmission planned by
Unicycive plans a targeted NDA resubmission for OLC to resolve a single manufacturing-compliance deficiency cited in the CRL. The FDA identified only that vendor compliance issue and recorded no concerns about pre-clinical, clinical, or safety data, which narrows the regulatory path to a discrete compliance remediation rather than new trials.
The main dependency remains timely remediation with the third-party manufacturer and formal FDA acceptance of the corrective documentation. Execution risk centers on the vendor’s corrective actions and the FDA’s review of those measures; any additional findings could extend review timelines. The company reports
Watch for three concrete near-term milestones: the formal NDA resubmission by
Cash runway into 2027, which is expected to support application resubmission, potential FDA approval, and launch of OLC
LOS ALTOS, Calif., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the Company or Unicycive), today announced an update from its meeting with the U.S. Food and Drug Administration (FDA) and timing of the resubmission of its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) following receipt of a Complete Response Letter (CRL) on June 30, 2025. The Type A FDA meeting was held to discuss the resolution of the single deficiency identified in the CRL related to the compliance status of a third-party manufacturing vendor. No other concerns have been identified to the Company, including pre-clinical, clinical, or safety data submitted as part of the NDA. Following receipt of the official meeting minutes from the Type A meeting and engaging in discussions with its third-party manufacturing vendor, the Company plans to resubmit the NDA for OLC by year-end.
"We are grateful for the highly constructive feedback and detailed meeting minutes we received from the FDA and look forward to resubmitting the NDA as we advance OLC toward potential approval," said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. "Following our interactions with the FDA, we are very encouraged about the potential for a swift resolution of the issue raised in our CRL and we believe we are now on track to resubmit our NDA before the end of the year, which could lead to a PDUFA date in the first half of 2026. With over
About Oxylanthanum Carbonate (OLC)
OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden. Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.
About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.1 Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
1Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145. Epub 2023 Jun 29. PMID: 37229723; PMCID: PMC10371371.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers.
Preliminary Financial Information
The preliminary financial information included in this press release is unaudited and is subject to completion of the Company’s quarter-end closing procedures and further financial review. Actual results may differ from these estimates as a result of the completion of quarter-end closing procedures, review adjustments and other developments that may arise between now and the time such financial information for the period is finalized. As a result, these estimates are preliminary, may change and constitute forward-looking information and, as a result, are subject to risks and uncertainties. These preliminary estimates should not be viewed as a substitute for full financial statements prepared in accordance with United States generally accepted accounting principles, and they should not be viewed as indicative of our results for any future period. The Company’s independent registered public accountants have not audited, reviewed, compiled, or performed any procedures with respect to these estimated financial results and, accordingly, do not express an opinion or any other form of assurance with respect to these preliminary estimates.
Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to our ability to file an NDA before the end of 2025, risk that we do not get a PDUFA date in the first half of 2026; the accuracy of our cash on hand at September 30, 2025 and risk that our cash runway does not extend into 2027. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor Contacts:
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
Media Contact:
Layne Litsinger
Real Chemistry
llitsinger@realchemistry.com
SOURCE: Unicycive Therapeutics, Inc.
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