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UNCY (Unicycive Therapeutics, Inc.) News

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• Unicycive Therapeutics Provides Update from FDA Type A Meeting and Expects to Resubmit OLC NDA Before Year-End
  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
  Oct 28, 2025 - $UNCY
• When Will Unicycive Therapeutics, Inc. (NASDAQ:UNCY) Turn A Profit?
  We feel now is a pretty good time to analyse Unicycive Therapeutics, Inc.'s ( NASDAQ:UNCY ) business as it appears the...
  Oct 14, 2025 - $UNCY
• Unicycive Therapeutics to Participate in Upcoming Investor Events in September
  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
  Aug 26, 2025 - $UNCY
• Unicycive Therapeutics Granted New U.S. Patent for UNI-494 to Treat Chronic Kidney Disease
  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
  Aug 18, 2025 - $UNCY
• Unicycive Therapeutics Announces Second Quarter 2025 Financial Results and Provides Business Update
  - 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,
  Aug 14, 2025 - $UNCY
• Unicycive Therapeutics Announces the Publication of Oxylanthanum Carbonate Pivotal Trial Data in Clinical Journal of the American Society of Nephrology
  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
  Jul 24, 2025 - $UNCY
• Is Unicycive Therapeutics (NASDAQ:UNCY) In A Good Position To Invest In Growth?
  Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...
  Jul 22, 2025 - $UNCY
• Unicycive Therapeutics Regains Compliance with Nasdaq Minimum Bid Price Requirement
  --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
  Jul 8, 2025 - $UNCY
• Unicycive Therapeutics to Present at the H.C. Wainwright 4th Annual Kidney Virtual Conference
  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
  Jul 7, 2025 - $UNCY
• Unicycive Therapeutics Announces Receipt of Complete Response Letter for Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis
  --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
  Jun 30, 2025 - $UNCY