Latest news with #UnicyciveTherapeutics
Associated Press
2 days ago
- Business
- Associated Press
Kaplan Fox is Investigating Unicycive Therapeutics, Inc. (UNCY) for Potential Securities Law Violations
NEW YORK, NY - June 11, 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 a 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.' The press release stated that the U.S. Federal Drug Administration ('FDA') 'communicated to the Company that it had identified deficiencies in cGMP compliance at a third-party manufacturing vendor (one of its CDMO's third-party subcontractors and not its Drug Substance vendor) following an FDA inspection. The FDA indicated that, given the identified deficiencies, any label discussions between the FDA and the Company are precluded. The Company has responded to all FDA information requests and expects a final decision from the FDA by the PDUFA action date of June 28, 2025.' Following this news, the price of Unicycive stock fell as much as $0.43 per share, over 47%, during intraday trading on June 10, 2025 on unusually heavy 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 1560 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.
Business Insider
2 days ago
- Business
- Business Insider
Why Is Unicycive Therapeutics Stock (UNCY) Down 35% Today?
Unicycive Therapeutics (UNCY) stock suffered a major setback on Tuesday due to an update from the Food and Drug Administration (FDA). The agency found deficiencies at one of the clinical-stage biopharmaceutical company's third-party manufacturing vendors. Confident Investing Starts Here: Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Due to these deficiencies, the FDA has precluded any label discussions surrounding a New Drug Application for oxylanthanum carbonate. This is the company's treatment for hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive Therapeutics expects a final decision from the FDA by June 28, 2025. UNCY stock dropped 35.56% alongside today's news and is down 31.65% year-to-date. Despite this, the shares are still up 37.4% over the past 12 months. Is Unicycive Therapeutics Stock a Buy, Sell, or Hold? Turning to Wall Street, the analysts' consensus rating for Unicycive Therapeutics is Strong Buy, based on six Buy ratings over the last three months. With that comes an average UNCY stock price target of $6.67, representing a potential 1,012.04% upside for the shares.
Yahoo
14-05-2025
- Business
- Yahoo
Analysts Expect Breakeven For Unicycive Therapeutics, Inc. (NASDAQ:UNCY) Before Long
We feel now is a pretty good time to analyse Unicycive Therapeutics, Inc.'s () business as it appears the company may be on the cusp of a considerable accomplishment. Unicycive Therapeutics, Inc., a clinical-stage biotechnology company, identifies, develops, and commercializes therapies to address unmet medical needs in the United States. The US$78m market-cap company announced a latest loss of US$38m on 31 December 2024 for its most recent financial year result. Many investors are wondering about the rate at which Unicycive Therapeutics will turn a profit, with the big question being 'when will the company breakeven?' In this article, we will touch on the expectations for the company's growth and when analysts expect it to become profitable. AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. Unicycive Therapeutics is bordering on breakeven, according to the 7 American Biotechs analysts. They expect the company to post a final loss in 2025, before turning a profit of US$206m in 2026. So, the company is predicted to breakeven just over a year from now. What rate will the company have to grow year-on-year in order to breakeven on this date? Using a line of best fit, we calculated an average annual growth rate of 40%, which is rather optimistic! Should the business grow at a slower rate, it will become profitable at a later date than expected. Underlying developments driving Unicycive Therapeutics' growth isn't the focus of this broad overview, but, bear in mind that typically biotechs, depending on the stage of product development, have irregular periods of cash flow. This means that a high growth rate is not unusual, especially if the company is currently in an investment period. View our latest analysis for Unicycive Therapeutics Before we wrap up, there's one aspect worth mentioning. Unicycive Therapeutics currently has no debt on its balance sheet, which is rare for a loss-making biotech, which usually has a high level of debt relative to its equity. This means that the company has been operating purely on its equity investment and has no debt burden. This aspect reduces the risk around investing in the loss-making company. There are too many aspects of Unicycive Therapeutics to cover in one brief article, but the key fundamentals for the company can all be found in one place – Unicycive Therapeutics' company page on Simply Wall St. We've also put together a list of key aspects you should further research: Valuation: What is Unicycive Therapeutics worth today? Has the future growth potential already been factored into the price? The intrinsic value infographic in our free research report helps visualize whether Unicycive Therapeutics is currently mispriced by the market. Management Team: An experienced management team on the helm increases our confidence in the business – take a look at who sits on Unicycive Therapeutics's board and the CEO's background. Other High-Performing Stocks: Are there other stocks that provide better prospects with proven track records? Explore our free list of these great stocks here. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Sign in to access your portfolio
