
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.

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
an hour ago
- Yahoo
SINTX Technologies Announces Strategic Vision Focused on Expansion Across Key Sectors
New leadership and recapitalization to accelerate commercialization of proprietary silicon nitride technologies in medical and high-growth markets SALT LAKE CITY, Utah, June 12, 2025 (GLOBE NEWSWIRE) -- SINTX Technologies, Inc. (NASDAQ: SINT) ('SINTX' or the 'Company'), the only FDA-registered producer of implantable silicon nitride and a global leader in advanced ceramics, today announced a renewed corporate vision and strategic plan to accelerate commercialization and unlock the full value of its intellectual property portfolio. This follows the company's successful recapitalization in February 2025 and the restructure of its leadership team and Board of Directors. A Legacy of Innovation in Silicon Nitride In 2008 SINTX Technologies made history with the first FDA-cleared implant material that is neither metal nor plastic—but medical-grade silicon nitride. The initial clearance covered a family of interbody devices and marked a pivotal moment in spinal surgery. These implants offered a unique trifecta of benefits: antimicrobial activity, osteogenic potential, and radiographic translucency. With over 50,000 spinal implants successfully placed worldwide, SINTX has demonstrated the clinical viability and long-term advantages of this revolutionary biomaterial. Today, SINTX remains the industry leader in silicon nitride technology, with 18 issued U.S. patents and 84 pending applications. Known for its strength, biocompatibility, and infection-resistant properties, the company's proprietary ceramic platform has applications across multiple markets—including the $62 billion global orthopedic implant sector, as well as emerging fields like agribiotech and performance textiles. Renewed Vision and Mission SINTX is now taking this one step further by developing next-generation hybrid biomaterials that combine the biological performance of silicon nitride and merging the flexibility, and manufacturability of polymers like PEEK and PEKK. These new composites are being optimized for applications in spine, oral/maxillofacial (OMF), cranio-maxillofacial (CMF), and oncologic reconstruction. 'Our mission is clear: to drive sustainable growth and value creation by collaborating with market leaders who recognize the transformative potential of silicon nitride,' said Mr. Eric Olson, CEO of SINTX Technologies. 'With a strengthened balance sheet and a robust intellectual property portfolio, we are uniquely positioned to accelerate commercialization and deliver superior outcomes for patients, customers, and shareholders alike.' Strategic Initiatives and Market Expansion SINTX is actively pursuing strategic partnerships and licensing opportunities to expand the reach of its technology. The company's near-term focus includes: Joint Ventures: Collaborating with established manufacturers in orthopedics, wound care, agribiotech, and other potential sectors to integrate silicon nitride into next-generation products. IP Monetization: Unlocking value from its extensive patent portfolio through licensing agreements and technology transfer initiatives. Operational Excellence: Enhancing AI supported 3D manufacturing capabilities at its FDA cleared and ISO certified headquarters to support anticipated growth and ensure the highest quality standards. Commitment to Stakeholders As SINTX enters this new era, the Company reaffirms its commitment to transparency, disciplined execution, and long-term value creation for all stakeholders. 'We are grateful for the continued support of our shareholders and partners,' said Mr. Olson. 'Together, we will realize the full potential of silicon nitride and secure SINTX's position as a leader in advanced ceramics. For more information, please visit About SINTX Technologies, Inc. Located in Salt Lake City, Utah, SINTX Technologies is an advanced ceramics company that develops and commercializes materials, components, and technologies for medical and agribiotech applications. SINTX is a global leader in the research, development, and manufacturing of silicon nitride, and its products have been implanted in humans since 2008. Over the past several years, SINTX has utilized strategic acquisitions and alliances to enter new markets. For more information on SINTX Technologies or its materials platform, visit Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 ('PSLRA') that are subject to a number of risks and uncertainties. Forward-looking statements can be identified by words such as: "anticipate," "believe," "project," "estimate," "expect," "strategy,' "future," "likely," "may," "should," "will" and similar references to future periods. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. Forward looking statements include our efforts to develop next-generation hybrid biomaterials, our expectation that will drive sustainable growth and value creation, and that we will expand the reach of our technology pursuing strategic partnerships and licensing opportunities. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, difficulty in developing and commercializing medical device technologies. A discussion of other risks and uncertainties that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements can be found in SINTX's Risk Factors disclosure in its Annual Report on Form 10-K, filed with the SEC on March 19, 2025, and in SINTX's other filings with the SEC. SINTX undertakes no obligation to publicly revise or update the forward-looking statements to reflect events or circumstances that arise after the date of this report, except as required by law. Business and Media Inquiries for SINTX:SINTX Technologies, Inc. 801.839.3502IR@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
an hour ago
- Yahoo
ReShape Lifesciences® Signs Exclusive Distribution Agreement with Recon Supply to Access the VA and DoD Markets
Recon Supply Named Exclusive U.S. Distributor of ReShape's STIMEL-03, Lap-Band® 2.0 FLEX, and Full Product Portfolio to Reach U.S. Veterans and Active-Duty Service Members IRVINE, Calif., June 12, 2025 (GLOBE NEWSWIRE) -- ReShape Lifesciences® (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced the signing of an exclusive U.S. distribution agreement with Recon Supply. Through this new strategic partnership, Recon Supply will distribute ReShape's cutting-edge portfolio, including the STIMEL-03 neuromuscular rehabilitation device, the next-generation Lap-Band® 2.0 FLEX, and the full range of ReShape products, across the Veterans Administration (VA) and Department of Defense (DoD) healthcare systems. This collaboration will expand access to proven, life-changing treatments for more than 18 million U.S. veterans and active military personnel. 'This agreement with Recon Supply marks a pivotal step forward in ReShape's mission to expand access to innovative medical technologies that improve lives,' stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences. 'Through Recon's extensive footprint across the VA and DoD healthcare systems, we look forward to bringing our FDA-cleared STIMEL-03 system, a cutting-edge neurorehabilitation platform that is transforming clinical care with real-time EMG biofeedback and personalized electrical stimulation, to veterans and military personnel recovering from stroke, injury, or surgery. Additionally, the Lap-Band® 2.0 FLEX, our next-generation, minimally invasive weight loss solution, offers a safe, adjustable option for individuals struggling with obesity. Together, these technologies reflect our commitment to delivering high-impact, clinically proven solutions to patients in need, including those who have served our country.' 'Partnering with ReShape Lifesciences aligns perfectly with our mission to deliver innovative, life-changing medical solutions to those who have served our country,' added Steve Clark, Chief Executive Officer of Recon Supply and a U.S. Marine Corps veteran. 'With established access to VA and DoD facilities through our Distribution and Pricing Agreement (DAPA), Federal Supply Schedule (FSS), and Electronic Catalog (ECAT) contracts, this agreement allows us to expand the reach of ReShape's most impactful technologies—including the STIMEL-03 rehabilitation system and the Lap-Band® 2.0 FLEX. These solutions are well-suited to the complex needs of the veteran and active-duty populations we serve. Since relaunching in 2022, Recon Supply has grown over 113% year-over-year and now distributes to 102 VA Medical Centers nationwide, with a team made up almost entirely of veterans and veteran spouses. We are proud to partner with ReShape to bring these vital solutions to the men and women who have sacrificed for our country.' About Recon SupplyRecon Supply is a trusted distributor of medical products and technologies, specializing in providing high-quality solutions to federal agencies and healthcare systems. As a Service-Disabled Veteran-Owned Small Business (SDVOSB), Recon Supply is dedicated to delivering the most innovative medical technologies while actively supporting the veteran community through hiring initiatives. With a focus on excellence and reliability, Recon Supply is committed to enhancing patient care through innovative partnerships. For more information on Recon Supply, visit About ReShape Lifesciences® ReShape Lifesciences® is America's premier weight loss and metabolic health-solutions company, offering an integrated portfolio of proven products and services that manage and treat obesity and metabolic disease. The FDA-approved Lap-Band® System provides minimally invasive, long-term treatment of obesity and is an alternative to more invasive surgical stapling procedures such as the gastric bypass or sleeve gastrectomy. The investigational vagal neuromodulation system utilizes a proprietary vagus nerve block and stimulation technology platform for the treatment of type 2 diabetes and metabolic disorders. The Obalon® balloon technology is a non-surgical, swallowable, gas-filled intra-gastric balloon that is designed to provide long-lasting weight loss. For more information, please visit Forward-Looking Safe Harbor Statement This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results could differ materially from those discussed due to known and unknown risks, uncertainties, and other factors. These forward-looking statements generally can be identified by the use of words such as "expect," "plan," "anticipate," "could," "may," "intend," "will," "continue," "future," other words of similar meaning and the use of future dates. Forward-looking statements in this press release include statements about the expectations regarding the distribution arrangement of Recon Supply. These and additional risks and uncertainties are described more fully in the company's filings with the Securities and Exchange Commission, including those factors identified as "risk factors" in our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise, except as required by law. CONTACTSReShape Lifesciences Investor Contact:Paul F. HickeyPresident and Chief Executive Officer949-276-7223ir@ Investor Relations Contact:Rx Communications GroupMichael Miller(917)-633-6086mmiller@ Errore nel recupero dei dati Effettua l'accesso per consultare il tuo portafoglio Errore nel recupero dei dati Errore nel recupero dei dati Errore nel recupero dei dati Errore nel recupero dei dati
Yahoo
an hour ago
- Yahoo
Pluristyx Launches PluriForm™ Organoid Kit, Slashing Weeks Off Organoid Development Timelines
SEATTLE, June 12, 2025--(BUSINESS WIRE)--Pluristyx, a leading provider of tools and services for cell product development, today announced the launch of their first-of-its-kind PluriForm™ Organoid Kit, a turnkey solution to eliminate critical bottlenecks in organoid research and allow scientists to rapidly and reliably make pluripotent aggregates using quality-assured, induced pluripotent stem cells (iPSCs). The kit saves weeks of cell culture work and eliminates variability in organoid manufacturing, allowing reproducible and iterative development and application of organoids. Organoids are three-dimensional cellular models that recapitulate key aspects of organ function. They are used in safety and toxicology screening, drug discovery, disease modeling, and personalized medicine and could replace many instances where animal testing is required. However, organoid use has been hindered by lengthy and highly variable processes to make iPSC aggregates. The PluriForm Organoid Kit solves this challenge by providing a ready-to-use system that includes cryopreserved, Ready-to-Differentiate® (RTD®), suspension-adapted iPSCs and optimized media with a simple protocol. Each kit contains a vial of 25 million cells and all necessary reagents. Within minutes, the end-user can combine the components and generate thousands of uniform aggregates in just one day. These pluripotent aggregates display consistent morphology and size distribution, critical parameters for reproducible differentiation to a wide range of organoids, including neuronal, liver, intestinal, pancreatic, kidney, and cardiac models. "Our goal is to accelerate the pace of discovery in the pharmaceutical and biotech industries," said Dr. Benjamin Fryer, Co-founder and CEO of Pluristyx. "With PluriForm, we have addressed consistent feedback that the initial step of creating reproducible cell aggregates is a major source of delay and inconsistency in organoid workflows." The FDA's Roadmap to Reduced Animal Testing in Preclinical Safety Studies, released in April 2025, explicitly advocates use of organoids to replace animal models. The PluriForm™ Organoid Kit is essential to enabling and accelerating the transition away from use of animals and other less-than-optimal cell assays and is now available for purchase through Pluristyx direct sales channels. About Pluristyx Pluristyx enables the development of next-generation therapies and technologies through a portfolio of cutting-edge products and services for the regenerative medicine industry. With a focus on quality, consistency, and scalability, Pluristyx empowers scientists to bring their most innovative concepts from the lab to the clinic. Pluristyx: Tomorrow's Cell Therapies, Today®. View source version on Contacts Media Contact Dr. Priya BaraniakChief Commercial and Development Officerpriya@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data