Latest news with #hyperphosphatemia
Associated Press
01-07-2025
- Business
- Associated Press
Kaplan Fox & Kilsheimer LLP is Investigating Unicycive Therapeutics, Inc. (UNCY) for Potential Securities Law Violations
NEW YORK, NY - June 30, 2025 ( NEWMEDIAWIRE ) - Kaplan Fox & Kilsheimer LLP is investigating potential securities violations against Unicycive Therapeutics, Inc. ('Unicycive' or the 'Company') (NASDAQ: UNCY). CLICK HERE TO RECEIVE MORE INFORMATION ABOUT THIS INVESTIGATION If you are an Unicycive investor and have suffered losses, you may CLICK HERE to contact us. You may also contact Kaplan Fox by emailing [email protected] or by calling (212) 329-8571. On June 10, 2025, before the market opened, Unicycive issued a press release announcing an 'update on its New Drug Application (NDA) for oxlanthanum carbonate (OLC) to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.' Hyperphosphatemia is a medical condition that effects over 450,000 individuals annually and 'occurs in nearly all patients with End Stage Renal Disease', 'requir[ing] medication to control their phosphate levels.' The Company revealed that the Federal Drug Administration ('FDA') 'identified deficiencies in cGMP compliance at a third-party manufacturing vendor following an FDA inspection.' Following this news, the price of Unicycive stock fell $3.68 per share, over 40%, to close at $5.32 per share on June 10, 2024 on heavy trading volume. Then, on June 30, 2025, Unicycive announced receipt of a Complete Response Letter for OLC for the treatment of hyperphosphatemia in patients with CKD on dialysis (the 'CRL'), thereby indicating that the agency denied approval of the Company's NDA in its current form. The Company stated that the CRL 'cited deficiencies previously identified at a third-party manufacturing vendor. . . ' and that it has requested a meeting with the FDA. Following this news, the price of Unicycive stock fell over 25% during intraday trading on June 30, 2025 on heavy trading volume. WHY CONTACT KAPLAN FOX - Kaplan Fox is a leading national law firm focusing on complex litigation with offices in New York, Oakland, Los Angeles, Chicago and New Jersey. With over 50 years of experience in securities litigation, Kaplan Fox offers the professional experience and track record that clients demand. Through prosecuting cases on the federal and state levels, Kaplan Fox has successfully shaped the law through winning many important decisions on behalf of our clients. For more information about Kaplan Fox & Kilsheimer LLP, you may visit our website at This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules. If you have any questions about this investigation, please contact: CONTACT: Jeffrey P. Campisi KAPLAN FOX & KILSHEIMER LLP 800 Third Avenue, 38th Floor New York, New York 10022 (212) 329-8571 [email protected] Laurence D. King KAPLAN FOX & KILSHEIMER LLP 1999 Harrison Street, Suite 1501 Oakland, California 94612 (415) 772-4704 [email protected] Contacting or submitting information to Kaplan Fox & Kilsheimer LLP does not create an attorney-client relationship, nor an obligation on the part of Kaplan Fox to retain you as a client.
Associated Press
30-06-2025
- Business
- Associated Press
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 request a Type A meeting with the FDA to align on next steps --Unicycive currently has an unaudited cash balance of approximately $20.7 million, with cash runway currently expected into the second half of 2026 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 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. Investor Contact: Kevin Gardner LifeSci Advisors [email protected] Media Contact: Rachel Visi Real Chemistry [email protected]
Globe and Mail
14-05-2025
- Business
- Globe and Mail
Unicycive Therapeutics Announces First Quarter 2025 Financial Results and Provides Business Update
- Oxylanthanum carbonate (OLC) New Drug Application (NDA) for hyperphosphatemia in chronic kidney disease patients on dialysis under review by FDA with PDUFA target action date of June 28, 2025; ongoing commercial planning in preparation for anticipated commercial launch in late 2025 - New data from patient surveys and patient-reported outcomes studies highlight adherence challenges for patients with hyperphosphatemia on dialysis and emphasize the market potential of OLC LOS ALTOS, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended March 31, 2025, and provided a business update. 'We are making incredible strides as we prepare for the potential FDA approval of oxylanthanum carbonate (OLC) so we can bring this treatment to people with chronic kidney disease (CKD) on dialysis as efficiently as possible,' said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. 'The need for our differentiated treatment, which offers high potency and a significantly reduced pill burden for people struggling to control hyperphosphatemia, has been further validated by new patient survey findings and patient-reported outcomes data. We remain dedicated to bolstering our commercial infrastructure as we strive to deliver a much-needed solution to patients and healthcare providers.' Key Highlights & Upcoming Milestones The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025, for OLC. Unicycive continues to prepare for the potential launch of OLC by building key functions, engaging directly with prescribers and other stakeholders, and supporting market access. Expanded awareness of OLC and its potential to address significant needs for CKD patients by publishing data and presentations at medical meetings. Recently, findings were presented at the National Kidney Foundation (NKF) Spring Clinical Meetings and the 2025 American Nephrology Nurses Association (ANNA) National Symposium from a patient survey conducted in partnership with the NKF. The survey included a total of 200 dialysis patients who identified excessive pill numbers, large pill sizes, and forgetfulness as the primary barriers to phosphate binder adherence. Patients also expressed a strong preference for medication regimens with fewer and smaller pills. New patient-reported outcomes data from the pivotal Phase 2 study of OLC were presented at the 2025 American Dialysis Conference (ADC) and the NKF Spring Clinical Meeting, which demonstrated that patients preferred OLC in comparison to their pre-trial phosphate binder medications and significantly enhanced patient satisfaction. Financial Results for the Quarter Ended March 31, 2025 Research and Development (R&D) expenses were $2.2 million for the three months ended March 31, 2025, compared to $6.8 million for the three months ended March 31, 2024. The decrease in research and development expenses was primarily due to decreased drug development costs. General and Administrative (G&A) expenses were $5.8 million for the three months ended March 31, 2025, compared to $2.4 million for the three months ended March 31, 2024. The increase was primarily due to increased consulting and professional services related to our commercial launch preparation. In addition to the above launch expenses, we continue to focus on the manufacturing of commercial supplies, as reflected in prepaid expenses and other current assets on our balance sheet which increased from $4.8 million as of December 31, 2024 to $7.6 million as of March 31, 2025. Other income was $8.6 million for the three months ended March 31, 2025, compared to an expense of $11.8 million for the three months ended March 31, 2024, primarily due to a decrease in the fair value of our warrant liability. Net income attributable to common stockholders for the three months ended March 31, 2025, was $0.5 million, compared to a net loss attributable to common stockholders of $21.2 million for the three months ended March 31, 2024. The net income for the three-month period ended March 31, 2025, was primarily due to a decrease in the fair value of our warrant liability. As of March 31, 2025, cash and cash equivalents totaled $19.8 million. 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 about Unicycive, visit 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; our need to raise substantial additional capital in the future to fund our continuing operations and the development and commercialization of our current product candidates and future product candidates; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; risks related to delays in obtaining or failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; and our failure, or the failure of our third-party manufacturers, or their subcontractors, to comply with cGMPs or other applicable regulations, which could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations. 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@ Media Contact: Rachel Visi Real Chemistry redery@ SOURCE: Unicycive Therapeutics, Inc. Unicycive Therapeutics, Inc. Balance Sheets (in thousands, except for share and per share amounts) As of As of December 31, March 31, 2024 2025 (Unaudited) Assets Current assets: Cash $ 26,142 $ 19,769 Prepaid expenses and other current assets 4,806 7,577 Total current assets 30,948 27,346 Right of use asset, net 645 518 Property, plant and equipment, net 75 83 Total assets $ 31,668 $ 27,947 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 1,058 $ 1,397 Accrued liabilities 3,562 4,143 Warrant liability 18,936 10,588 Operating lease liability - current 564 548 Total current liabilities 24,120 16,676 Operating lease liability - long term 117 - Total liabilities 24,237 16,676 Commitments and contingencies Stockholders' equity: Series A-2 Prime preferred stock, $0.001 par value per share - 21,338.01 Series A-2 Prime shares authorized at December 31, 2024 and March 31, 2025; 6,150.21 and 5,464.21 Series A-2 Prime shares issued and outstanding at December 31, 2024 and March 31, 2025, respectively - - Series B-2 preferred stock, $0.001 par value per share - 7,882 Series B-2 shares authorized at December 31, 2024 and March 31, 2025; 3,000 Series B-2 shares issued and outstanding at December 31, 2024 and March 31, 2025 - - Preferred stock: $0.001 par value per share - 9,846,891 shares authorized at December 31, 2024 and March 31, 2025; zero shares issued and outstanding at December 31, 2024 and March 31, 2025 - - Common stock, $0.001 par value per share - 400,000,000 shares authorized at December 31, 2024 and March 31, 2025; 113,842,364 and 119,749,743 shares issued and outstanding at December 31, 2024 and March 31, 2025, respectively 114 120 Additional paid-in capital 108,587 111,851 Accumulated deficit (101,270 ) (100,700 ) Unicycive Therapeutics, Inc. Statements of Operations (in thousands, except for share and per share amounts) (Unaudited) Three Months Ended March 31, 2024 2025 Operating expenses: Research and development $ 6,813 $ 2,171 General and administrative 2,391 5,818 Total operating expenses 9,204 7,989 Loss from operations (9,204) (7,989) Other income (expenses): Interest income 69 226 Interest expense (20) (15) Change in fair value of warrant liability (11,808) 8,348 Total other income (expenses) (11,759) 8,559 Net (loss) income (20,963) 570 Net (loss) income attributable to common stockholders, basic (21,171) 510 Net loss attributable to common stockholders, diluted (21,171) (6,214) Net (loss) income per share: Basic $ (0.61) $ - Diluted $ (0.61) $ (0.05) Weighted-average shares outstanding: Basic 34,912,692 116,818,811 Diluted 34,912,692 123,834,773
