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<title>Unicycive Therapeutics Inc — News on 6ix</title>
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<title>Unicycive Therapeutics Inc</title>
<link>https://6ix.com/company/unicycive-therapeutics-inc</link>
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<title>Unicycive Therapeutics to Present at the 25th Annual Needham Virtual Healthcare Conference</title>
<link>https://6ix.com/company/unicycive-therapeutics-inc/news/unicycive-therapeutics-to-present-at-the-25th-annual-needham-virtual-healthcare-conference</link>
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<pubDate>Thu, 09 Apr 2026 04:00:00 GMT</pubDate>
<description>LOS ALTOS, Calif., April 09, 2026 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies</description>
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<title>Unicycive Therapeutics Announces Full Year 2025 Financial Results and Provides Business Update</title>
<link>https://6ix.com/company/unicycive-therapeutics-inc/news/unicycive-therapeutics-announces-full-year-2025-financial-results-and-provides-business-update</link>
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<pubDate>Mon, 30 Mar 2026 04:00:00 GMT</pubDate>
<description>Oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission under review by U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee</description>
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<title>Unicycive Therapeutics to Participate in a Fireside Chat at Guggenheim’s Emerging Outlook: Biotech Summit</title>
<link>https://6ix.com/company/unicycive-therapeutics-inc/news/unicycive-therapeutics-participate-fireside-chat-120500288</link>
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<pubDate>Wed, 04 Feb 2026 12:05:00 GMT</pubDate>
<description>LOS ALTOS, Calif., Feb. 04, 2026 (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 that Shalabh Gupta, M.D., Chief Executive Officer, will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit on Wednesday, February 11, 2026, at 1:30 p.m. ET. A link to the live and archived webcast may be accessed on the Unicycive</description>
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<title>UPDATE - Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) Resubmission</title>
<link>https://6ix.com/company/unicycive-therapeutics-inc/news/unicycive-therapeutics-announces-fda-acceptance-141500278</link>
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<pubDate>Thu, 29 Jan 2026 14:15:00 GMT</pubDate>
<description>FDA assigns Prescription Drug User Fee Act (PDUFA) target date of June 29, 2026Ended 2025 with unaudited cash position of $41.3M with expected runway into 2027 LOS ALTOS, Calif., Jan. 29, 2026 (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 accepted the resubmission of its New Drug Applic</description>
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<title>Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) Resubmission</title>
<link>https://6ix.com/company/unicycive-therapeutics-inc/news/unicycive-therapeutics-announces-fda-acceptance-120500984</link>
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<pubDate>Thu, 29 Jan 2026 12:05:00 GMT</pubDate>
<description>DA assigns Prescription Drug User Fee Act (PDUFA) target date of June 27, 2026Ended 2025 with unaudited cash position of $41.3M with expected runway into 2027 LOS ALTOS, Calif., Jan. 29, 2026 (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 accepted the resubmission of its New Drug Applica</description>
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<title>Unicycive Therapeutics Announces Resubmission of New Drug Application (NDA) for Oxylanthanum Carbonate (OLC)</title>
<link>https://6ix.com/company/unicycive-therapeutics-inc/news/unicycive-therapeutics-announces-resubmission-drug-120500200</link>
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<pubDate>Mon, 29 Dec 2025 12:05:00 GMT</pubDate>
<description>New PDUFA date expected in 1H 2026 within 30 days of NDA resubmissionLOS ALTOS, Calif., Dec. 29, 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 it has resubmitted its 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for oxylanthanum carbonate (OLC), the Company’s investigational oral phosphate b</description>
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<title>Unicycive Therapeutics to Participate in Upcoming Investor Events in December</title>
<link>https://6ix.com/company/unicycive-therapeutics-inc/news/unicycive-therapeutics-participate-upcoming-investor-120500454</link>
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<pubDate>Tue, 25 Nov 2025 12:05:00 GMT</pubDate>
<description>LOS ALTOS, Calif., Nov. 25, 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 that Shalabh Gupta, M.D., Chief Executive Officer, will participate in two investor events in December. Event: Piper Sandler 37th Annual Healthcare ConferenceType: Fireside chatDate/Time: Wednesday, December 3, 2025, at 10:00 a.m. ET Event: Noble Capital Market</description>
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<title>Unicycive Therapeutics Announces Third Quarter 2025 Financial Results and Provides Business Update</title>
<link>https://6ix.com/company/unicycive-therapeutics-inc/news/unicycive-therapeutics-announces-third-quarter-120500116</link>
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<pubDate>Wed, 12 Nov 2025 12:05:00 GMT</pubDate>
<description>- Remain on track to resubmit the New Drug Application (NDA) for oxylanthanum carbonate (OLC) by year end - Presented new analysis of OLC data at American Society of Nephrology (ASN) which demonstrates that OLC significantly reduced pill burden in terms of both pill volume (7x) and pill count (2x) compared to currently available phosphate binders - Ended Q3 with $42.7 million of cash with expected runway into 2027 LOS ALTOS, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.</description>
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<title>Unicycive Therapeutics to Participate in a Fireside Chat at the Guggenheim 2nd Annual Healthcare Innovation Conference</title>
<link>https://6ix.com/company/unicycive-therapeutics-inc/news/unicycive-therapeutics-participate-fireside-chat-120500917</link>
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<pubDate>Mon, 03 Nov 2025 12:05:00 GMT</pubDate>
<description>LOS ALTOS, Calif., Nov. 03, 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 that Shalabh Gupta, M.D., Chief Executive Officer, will participate in a fireside chat at the Guggenheim 2nd Annual Healthcare Innovation Conference on Monday, November 10, 2025, at 3:30 p.m. ET. A link to the live and archived webcast may be accessed on the Un</description>
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<title>Unicycive Therapeutics Announces Upcoming Presentation of New Data Reinforcing the Potential of Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia at the American Society of Nephrology Kidney Week 2025 Conference</title>
<link>https://6ix.com/company/unicycive-therapeutics-inc/news/unicycive-therapeutics-announces-upcoming-presentation-110500433</link>
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<pubDate>Thu, 30 Oct 2025 11:05:00 GMT</pubDate>
<description>Analysis of the data from the open-label pivotal trial of oxylanthanum carbonate (OLC) highlights that pill burden was significantly reduced in terms of both pill volume (7x) and pill count (2x) from pre-trial phosphate binder therapyLOS ALTOS, Calif., Oct. 30, 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 that it will present new ox</description>
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<title>Unicycive Therapeutics Provides Update from FDA Type A Meeting and Expects to Resubmit OLC NDA Before Year-End</title>
<link>https://6ix.com/company/unicycive-therapeutics-inc/news/unicycive-therapeutics-provides-fda-type-110500461</link>
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<pubDate>Tue, 28 Oct 2025 11:05:00 GMT</pubDate>
<description>Cash runway into 2027, which is expected to support application resubmission, potential FDA approval, and launch of OLCLOS 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 O</description>
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<title>Unicycive Therapeutics to Participate in Upcoming Investor Events in September</title>
<link>https://6ix.com/company/unicycive-therapeutics-inc/news/unicycive-therapeutics-participate-upcoming-investor-110000528</link>
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<pubDate>Tue, 26 Aug 2025 11:00:00 GMT</pubDate>
<description>LOS ALTOS, Calif., Aug. 26, 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 that Shalabh Gupta, M.D., Chief Executive Officer will participate in two investor events in September. Event: H.C. Wainwright 27th Annual Global Investment Conference Type: Fireside chatDate/Time: Wednesday, September 10, 2025, at 8:30 a.m. ET Event: Truist Se</description>
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<title>Unicycive Therapeutics Granted New U.S. Patent for UNI-494 to Treat Chronic Kidney Disease</title>
<link>https://6ix.com/company/unicycive-therapeutics-inc/news/unicycive-therapeutics-granted-u-patent-110500549</link>
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<pubDate>Mon, 18 Aug 2025 11:05:00 GMT</pubDate>
<description>Ensures Intellectual Property Protection Until 2040LOS ALTOS, Calif., Aug. 18, 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 the issuance of U.S. Patent 12,377,082 by the U.S. Patent and Trademark Office for UNI-494 to treat Chronic Kidney Disease (CKD). This patent follows the issuance of an earlier method of use patent for the trea</description>
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<title>Unicycive Therapeutics Announces Second Quarter 2025 Financial Results and Provides Business Update</title>
<link>https://6ix.com/company/unicycive-therapeutics-inc/news/unicycive-therapeutics-announces-second-quarter-110000771</link>
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<pubDate>Thu, 14 Aug 2025 11:00:00 GMT</pubDate>
<description>- Type A Meeting requested with U.S. Food and Drug Administration (FDA) for resolution of the Complete Response Letter (CRL) for oxylanthanum carbonate (OLC) - OLC pivotal study data, published in the Clinical Journal of the American Society of Nephrology (CJASN), demonstrated OLC was well tolerated and enabled serum phosphate control in over 90% of patients with a low pill burden - Ended Q2 with $22.3 million of cash with expected runway into the second half of 2026 LOS ALTOS, Calif., Aug. 14,</description>
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<title>Unicycive Therapeutics Announces the Publication of Oxylanthanum Carbonate Pivotal Trial Data in Clinical Journal of the American Society of Nephrology</title>
<link>https://6ix.com/company/unicycive-therapeutics-inc/news/unicycive-therapeutics-announces-publication-oxylanthanum-120000871</link>
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<pubDate>Thu, 24 Jul 2025 12:00:00 GMT</pubDate>
<description>OLC was well-tolerated and enabled serum phosphate control in over 90% of patients with a low pill burdenLOS ALTOS, Calif., July 24, 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 the publication of pivotal trial data describing the safety and tolerability of oxylanthanum carbonate (OLC) in chronic kidney disease (CKD) patients on dia</description>
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<title>Unicycive Therapeutics Regains Compliance with Nasdaq Minimum Bid Price Requirement</title>
<link>https://6ix.com/company/unicycive-therapeutics-inc/news/unicycive-therapeutics-regains-compliance-nasdaq-123000576</link>
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<pubDate>Tue, 08 Jul 2025 12:30:00 GMT</pubDate>
<description>--Nasdaq compliance follows reverse stock split previously announced on June 17, 2025LOS ALTOS, Calif., July 08, 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 it has regained compliance with the Nasdaq Stock Market (“Nasdaq”) continued listing standard for minimum share price under Rule 5550(a)(2) of the Nasdaq Listing Qualifications</description>
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<title>Unicycive Therapeutics to Present at the H.C. Wainwright 4th Annual Kidney Virtual Conference</title>
<link>https://6ix.com/company/unicycive-therapeutics-inc/news/unicycive-therapeutics-present-h-c-110000340</link>
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<pubDate>Mon, 07 Jul 2025 11:00:00 GMT</pubDate>
<description>LOS ALTOS, Calif., July 07, 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 Shalabh Gupta, M.D., Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 4th Annual Kidney Virtual Conference on Monday, July 14, 2025 at 11 a.m. ET. A link to the webcast may be accessed on the Unicycive website under the I</description>
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<title>Unicycive Therapeutics Announces Receipt of Complete Response Letter for Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis</title>
<link>https://6ix.com/company/unicycive-therapeutics-inc/news/unicycive-therapeutics-announces-receipt-complete-110500372</link>
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<pubDate>Mon, 30 Jun 2025 11:05:00 GMT</pubDate>
<description>--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 reques</description>
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<title>Unicycive Therapeutics, Inc. Announces Reverse Stock Split</title>
<link>https://6ix.com/company/unicycive-therapeutics-inc/news/unicycive-therapeutics-inc-announces-reverse-110000949</link>
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<pubDate>Tue, 17 Jun 2025 11:00:00 GMT</pubDate>
<description>Shares Expected to Begin Trading on Split-Adjusted Basis on June 20, 2025LOS ALTOS, Calif., June 17, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (NASDAQ: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that it will implement a 1-for-10 reverse split of the issued shares of its common stock, effective at 4:01 p.m. Eastern Time on June 18, 2025. The Company's common stock is expected to begin trading on a split-adjusted</description>
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<title>Unicycive Provides Update on New Drug Application for Oxylanthanum Carbonate to Treat Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis</title>
<link>https://6ix.com/company/unicycive-therapeutics-inc/news/unicycive-provides-drug-application-oxylanthanum-100000136</link>
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<pubDate>Tue, 10 Jun 2025 10:00:00 GMT</pubDate>
<description>- The U.S. Food and Drug Administration (FDA) identified deficiencies at a third-party manufacturing vendor - FDA to provide final decision by PDUFA action date of June 28, 2025 LOS ALTOS, Calif., June 10, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY or the “Company”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced an update on its New Drug Application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosph</description>
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