Unicycive Therapeutics Announces Receipt of Complete Response Letter for Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis
Unicycive Therapeutics (Nasdaq: UNCY) announced receiving a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC), intended to treat hyperphosphatemia in chronic kidney disease patients on dialysis.
The CRL cited deficiencies at a third-party manufacturing vendor unrelated to OLC itself. The FDA did not raise concerns about pre-clinical, clinical, or safety data. The company has identified a second manufacturing vendor that has already produced OLC drug product and could help resolve the Clinical Manufacturing and Controls (CMC) issues.
Unicycive plans to request a Type A meeting with the FDA to discuss next steps. The company reports an unaudited cash balance of approximately $20.7 million, with runway expected into the second half of 2026.
Unicycive Therapeutics (Nasdaq: UNCY) ha annunciato di aver ricevuto una Lettera di Risposta Completa (CRL) dalla FDA riguardo alla sua Domanda di Nuovo Farmaco (NDA) per l'Oxylanthanum Carbonate (OLC), destinato al trattamento dell'iperfosfatemia nei pazienti con malattia renale cronica in dialisi.
La CRL ha evidenziato carenze presso un fornitore di produzione terzo non correlate all'OLC stesso. La FDA non ha sollevato preoccupazioni riguardo ai dati preclinici, clinici o di sicurezza. L'azienda ha identificato un secondo fornitore di produzione che ha già prodotto il farmaco OLC e potrebbe contribuire a risolvere le problematiche relative alla Produzione Clinica e ai Controlli (CMC).
Unicycive prevede di richiedere un incontro di tipo A con la FDA per discutere i prossimi passi. L'azienda segnala un saldo di cassa non revisionato di circa 20,7 milioni di dollari, con una disponibilità finanziaria prevista fino alla seconda metà del 2026.
Unicycive Therapeutics (Nasdaq: UNCY) anunció que recibió una Carta de Respuesta Completa (CRL) de la FDA respecto a su Solicitud de Nuevo Medicamento (NDA) para Carbonato de Oxilantano (OLC), destinado a tratar la hiperfosfatemia en pacientes con enfermedad renal crónica en diálisis.
La CRL señaló deficiencias en un proveedor de fabricación externo no relacionadas con el OLC en sí. La FDA no expresó preocupaciones sobre los datos preclínicos, clínicos o de seguridad. La compañía ha identificado un segundo proveedor de fabricación que ya ha producido el producto farmacéutico OLC y podría ayudar a resolver los problemas de Manufactura Clínica y Controles (CMC).
Unicycive planea solicitar una reunión Tipo A con la FDA para discutir los próximos pasos. La compañía reporta un saldo de efectivo no auditado de aproximadamente 20,7 millones de dólares, con fondos disponibles hasta la segunda mitad de 2026.
유니사이시브 테라퓨틱스(Nasdaq: UNCY)는 만성 신장 질환 투석 환자의 고인산혈증 치료를 위한 옥실란탄 카보네이트(OLC) 신약 신청서(NDA)에 대해 FDA로부터 완전 반응 서한(CRL)을 받았다고 발표했습니다.
CRL에서는 OLC 자체와 무관한 제3자 제조업체의 결함이 지적되었습니다. FDA는 전임상, 임상 또는 안전성 데이터에 대해 우려를 표하지 않았습니다. 회사는 이미 OLC 약물을 생산한 두 번째 제조업체를 확인했으며, 임상 제조 및 관리(CMC) 문제 해결에 도움이 될 수 있습니다.
유니사이시브는 FDA와의 A형 회의를 요청하여 다음 단계를 논의할 계획입니다. 회사는 약 2,070만 달러의 감사되지 않은 현금 잔액을 보고했으며, 자금은 2026년 하반기까지 지속될 것으로 예상됩니다.
Unicycive Therapeutics (Nasdaq : UNCY) a annoncé avoir reçu une lettre de réponse complète (CRL) de la FDA concernant sa demande d'autorisation de mise sur le marché (NDA) pour le carbonate d'oxylanthane (OLC), destiné au traitement de l'hyperphosphatémie chez les patients atteints de maladie rénale chronique sous dialyse.
La CRL a mentionné des insuffisances chez un fabricant tiers sans lien avec l'OLC lui-même. La FDA n'a soulevé aucune inquiétude concernant les données précliniques, cliniques ou de sécurité. L'entreprise a identifié un second fabricant qui a déjà produit le médicament OLC et pourrait contribuer à résoudre les problèmes liés à la fabrication clinique et aux contrôles (CMC).
Unicycive prévoit de demander une réunion de type A avec la FDA pour discuter des prochaines étapes. L'entreprise rapporte un solde de trésorerie non audité d'environ 20,7 millions de dollars, avec une autonomie financière prévue jusqu'à la seconde moitié de 2026.
Unicycive Therapeutics (Nasdaq: UNCY) gab bekannt, dass es von der FDA einen Complete Response Letter (CRL) bezüglich seines New Drug Application (NDA) für Oxylanthanum Carbonate (OLC) erhalten hat, das zur Behandlung von Hyperphosphatämie bei Patienten mit chronischer Nierenerkrankung unter Dialyse vorgesehen ist.
Im CRL wurden Mängel bei einem Drittanbieter-Hersteller genannt, die nicht mit OLC selbst zusammenhängen. Die FDA äußerte keine Bedenken hinsichtlich der präklinischen, klinischen oder Sicherheitsdaten. Das Unternehmen hat einen zweiten Hersteller identifiziert, der bereits OLC produziert hat und helfen könnte, die Probleme in der klinischen Herstellung und Kontrolle (CMC) zu lösen.
Unicycive plant, ein Type-A-Meeting mit der FDA anzufordern, um die nächsten Schritte zu besprechen. Das Unternehmen berichtet über einen unauditierten Kassenbestand von etwa 20,7 Millionen US-Dollar, mit einer erwarteten finanziellen Reichweite bis in die zweite Hälfte des Jahres 2026.
- No concerns raised by FDA regarding pre-clinical, clinical, or safety data of OLC
- Second manufacturing vendor already identified and has produced OLC drug product
- Strong cash position of $20.7 million with runway into second half of 2026
- Manufacturing vendor issues unrelated to OLC product itself
- FDA issued Complete Response Letter (CRL) rejecting the NDA application
- Manufacturing deficiencies at third-party vendor delay potential drug approval
- Additional regulatory steps required before potential approval, extending timeline
Insights
FDA rejected Unicycive's kidney disease drug due to third-party manufacturing issues, not drug-related problems; company has backup manufacturer and sufficient cash runway.
Unicycive Therapeutics has received a Complete Response Letter (CRL) from the FDA for Oxylanthanum Carbonate (OLC), their hyperphosphatemia treatment for dialysis patients. The rejection stems from deficiencies at a third-party manufacturing vendor unrelated to OLC itself, with no concerns about pre-clinical, clinical, or safety data.
This represents a manufacturing-related setback rather than an issue with the drug's efficacy or safety profile. The company has proactively identified a second manufacturing vendor that has already produced OLC drug product, potentially providing a pathway to resolve the Clinical Manufacturing and Controls (CMC) issues identified in the CRL.
The company's plan to request an immediate Type A meeting with the FDA is the appropriate regulatory response. Type A meetings are specifically designated for stalled product development programs, allowing for expedited discussions (typically within 30 days) to resolve critical issues. This suggests Unicycive is pursuing the fastest possible resolution timeline.
Importantly, Unicycive reports an unaudited cash balance of approximately
--Complete Response Letter (CRL) cited deficiencies previously identified at a third-party manufacturing vendor unrelated to Oxylanthanum Carbonate (OLC)
--No other concerns stated, including pre-clinical, clinical, or safety data
--The Company identified a second manufacturing vendor that has already produced OLC drug product, which could also be used to support the resolution of the Clinical Manufacturing and Controls (CMC) issues identified in the CRL
--The Company plans to immediately request a Type A meeting with the FDA to align on next steps
--Unicycive currently has an unaudited cash balance of approximately
LOS ALTOS, Calif., June 30, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has issued a CRL for its New Drug Application (NDA) for OLC to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
“We plan to immediately seek a Type A meeting with the Agency to gain alignment on the best strategy to ensure rapid resolution of the CRL,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “With a second manufacturing vendor identified that has produced OLC drug product, we remain optimistic about our ability to bring this promising new treatment option to patients with CKD on dialysis who are managing hyperphosphatemia, and we plan to provide an update as soon as we have additional clarity on next steps from the FDA.”
After submitting the NDA, and as a part of the application review and routine information requests, the FDA notified Unicycive that a third-party manufacturing vendor of its main contract development and manufacturing organization (CDMO) was cited for deficiencies following a cGMP inspection. This citation is unrelated to OLC. Unicycive also notes that as part of the NDA review, the Agency has not highlighted any other technical concerns related to the submitted CMC documentation or testing of OLC itself.
As part of its overall manufacturing strategy, the Company had previously identified a back-up third-party manufacturing vendor to build redundancy into its supply chain. The second vendor has a long history of successful FDA and international regulatory inspections and has already produced OLC drug product, which could also be used to support the resolution of the CMC issues identified in the CRL.
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.
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 currently under review by the U.S. Food and Drug Administration (FDA) 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. For more information, please visit Unicycive.com and follow us on LinkedIn and X.
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; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. 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.
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.
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FAQ
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