oxylanthanum carbonate

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Unicycive Therapeutics Regains Compliance with Nasdaq Minimum Bid Price Requirement
Globenewswire· 2025-07-08 12:30
--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. This updat ...
Unicycive Therapeutics to Present at the H.C. Wainwright 4th Annual Kidney Virtual Conference
Globenewswire· 2025-07-07 11:00
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 Investors sec ...
Unicycive Therapeutics Announces Receipt of Complete Response Letter for Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis
Globenewswire· 2025-06-30 11:05
--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 ...
Unicycive Therapeutics, Inc. Announces Reverse Stock Split
Globenewswire· 2025-06-17 11:00
Core Viewpoint - Unicycive Therapeutics, Inc. is implementing a 1-for-10 reverse stock split to comply with Nasdaq's minimum bid price requirement, effective June 18, 2025, with trading on a split-adjusted basis starting June 20, 2025 [1][2]. Group 1: Reverse Stock Split Details - The reverse stock split will combine every ten shares into one, reducing the number of issued shares from approximately 126,409,281 to about 12,640,929 [4]. - Stockholders will not receive fractional shares; instead, fractional interests will be rounded up to the next whole share [3]. - The reverse stock split will not affect stockholders' percentage ownership or voting power, except for minor changes due to fractional shares [3]. Group 2: Compliance and Adjustments - The reverse stock split aims to increase the bid price of the common stock to meet the $1.00 minimum bid price requirement for continued listing on Nasdaq [2]. - Proportionate adjustments will be made to the exercise prices and number of shares underlying stock options, warrants, and preferred stock as a result of the reverse stock split [5]. Group 3: Company Overview - Unicycive Therapeutics is focused on developing therapies for kidney diseases, with its lead investigational treatment, oxylanthanum carbonate, under FDA review for treating hyperphosphatemia in chronic kidney disease patients on dialysis [8]. - The second investigational treatment, UNI-494, is aimed at conditions related to acute kidney injury and has received orphan drug designation from the FDA [9].
Unicycive Provides Update on New Drug Application for Oxylanthanum Carbonate to Treat Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis
Globenewswire· 2025-06-10 10:00
- 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 hyperphosphatemia in pa ...
Unicycive Therapeutics to Present at Upcoming Investor Conferences
Globenewswire· 2025-05-22 11:00
LOS ALTOS, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (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 present at two upcoming virtual investment conferences. Event: Lytham Partners Spring 2025 Investor Conference Type: Fireside ChatDate/Time: Thursday, May 29, 2025, at 12:30 p.m. ET Event: Noble Capital Markets 2025 Emerging Growth Virtual Equity Con ...
Unicycive Therapeutics Announces Time Change for 2025 Annual Meeting of Stockholders
Globenewswire· 2025-05-21 11:00
Investor Contacts: LOS ALTOS, Calif., May 21, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (NASDAQ: UNCY) ("Unicycive" or the "Company"), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced a change in the time of the 2025 Annual Meeting of Stockholders (the "Annual Meeting"). The previously announced date of the meeting (June 9, 2025) and location of the meeting (4300 El Camino Real, Suite 210, Los Altos, CA 94022) will not change, but the ...