Latest news with #OLC
Business Wire
3 days ago
- Business
- Business Wire
UNCY Investors Have Opportunity to Join Unicycive Therapeutics, Inc. Fraud Investigation With the Schall Law Firm
LOS ANGELES--(BUSINESS WIRE)-- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Unicycive Therapeutics, Inc. ('Unicycive' or 'the Company') (NASDAQ: UNCY) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Unicycive announced on June 30, 2025, that the FDA 'has issued a CRL [Complete Response Letter] for its New Drug Application (NDA) for OLC to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis." The Company added that "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." Based on this news, shares of Unicycive fell by 29.85% on the same day. If you are a shareholder who suffered a loss, click here to participate. We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at or by email at bschall@ The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.
Yahoo
10-06-2025
- Business
- Yahoo
Unicycive Provides Update on New Drug Application for Oxylanthanum Carbonate to Treat Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis
- 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 patients with chronic kidney disease (CKD) on dialysis. The 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. 'We are discussing with our partners to help resolve FDA's concerns and remain confident in the promise of OLC based on the extensive clinical and preclinical data we've generated,' said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. 'We believe OLC is a promising new treatment option and we are eager to bring it as quickly as we can to patients with CKD on dialysis who are living with hyperphosphatemia.' 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 HyperphosphatemiaHyperphosphatemia 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.2 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 TherapeuticsUnicycive 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.1 Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18. doi: 10.1097/ PMID: 15284307.2 Flythe 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 GardnerLifeSci Advisorskgardner@ Contact:Rachel Visi Real Chemistryredery@ 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
06-06-2025
- Politics
- Yahoo
There's nothing but cruel cynicism backing the Biden autopen investigation
For President Donald Trump, there tends to be a fine line between the dangerous and the absurd. His latest broadside against his predecessor Joe Biden hopscotches between the two effortlessly. In a memo issued Wednesday, the president ordered the White House counsel and Attorney General Pam Bondi to investigate whether Biden's aides used 'autopen' signatures to hide an alleged cognitive decline. Trump's obsession with the use of an autopen in Biden's White House stretches back months. He claimed in March that pardons Biden signed were supposedly void because of an autopen's use. Last month, he foreshadowed to reporters that his administration would 'start looking into this whole thing with who signed this legislation. Who signed legislation opening our border? I don't think he knew.' It's a bonkers line of inquiry, not least because autopens aren't exactly a new thing for a chief executive to use. Presidents going back to Harry Truman have had them around to sign their name to personal documents and correspondence. It became a talking point for Republicans in 2011, though, when President Barack Obama became the first to use the machine to affix his signature to a law while he was overseas. He used the autopen again while in Hawaii in 2013 to sign legislation to prevent a government shutdown. Even then, though, it was a bit of a tempest in a teapot, legally speaking at least. Before Obama even became president, the Justice Department's Office of Legal Counsel had determined under President George W. Bush that it was constitutionally kosher to use an autopen to sign legislation. 'We emphasize that we are not suggesting that the President may delegate the decision to approve and sign a bill,' wrote Deputy Attorney General Howard Nielson for the OLC, 'only that, having made this decision, he may direct a subordinate to affix the President's signature to the bill.' Not everyone has agreed with that assessment, but there were no legal challenges to its usage during the Obama era. But now, this supposed secret autopen plot has gone from Truth Social posts to Justice Department investigations. Whatever probe Bondi conducts would theoretically hinge not on whether the White House autopen was used to sign official documents but on somehow proving that it was used without Biden's express authorization. Is there any evidence backing up Trump's allegation? Of course not, and Trump himself said as much in the Oval Office on Thursday. But just because the investigation will likely go nowhere doesn't mean that there isn't ample reason for Republicans to lean into this fiction. The rush from Trump's allies to capitalize on the conspiracy theory was telling, as my colleague Steve Benen noted Thursday: 'With this in mind, the endgame is coming into focus: Trump and his party want to invalidate parts of Biden's presidency, clearing the way for, among other things, new partisan investigations into those whom Biden protected, further empowering the incumbent in the process.' I'll add to that assessment that the focus on Biden's supposed actions — rather than on Biden himself — is cynically clever. It darkly mirrors the internal debate Democrats are still having over whether Biden's diminished capacity to run for re-election was at all purposefully hidden until it was too late. In going one step further, Trump's investigation adds an evidence-free motive to explain why Americans would be kept out of the loop. There's a thread to pull at there that might lure in some of the more disillusioned on the left who are eager to see shadowy puppet masters pulling the party's strings. Again, none of this will amount to anything legally without concrete evidence that a law or other official document was falsely signed without Biden's consent. In both reality and the conspiracy theory being spun here, the autopen is merely a tool to be used. And in Trump's hands, it's gone from being a useful time-saver to a handy excuse to further politically persecute his predecessor's allies. This article was originally published on
Business Upturn
28-05-2025
- Business
- Business Upturn
Antique cuts target on Shilpa Medicare to Rs 1,090, retains ‘Buy' on long-term monetization potential
By News Desk Published on May 28, 2025, 08:31 IST Antique Broking has maintained a Buy rating on Shilpa Medicare (SLPA) while cutting the target price to ₹1,090 from ₹1,525, citing strong revenue growth in Q4FY25 but tempered expectations for the near term due to regulatory delays and cost pressures. Shilpa Medicare reported a 13% year-on-year increase in Q4FY25 revenue to ₹3,308 million, driven by an impressive 73% growth in the Finished Dosage Form (FDF) segment. The brokerage highlighted SLPA's exclusive licensing deal with Orion for recombinant human albumin in Europe, which holds significant commercial potential. Milestone-linked payments under this agreement are expected to begin in FY26. However, the firm flagged approval delays for Unicycive's NDA for Oxylanthanum Carbonate (OLC), a partnered product. The delay, caused by manufacturing issues, is expected to push associated revenues to FY27. Antique has cut its FY26/27 revenue estimates by 16%/20%, moderating its assumptions for growth in the API business and adjusting expectations for 505(b)(2) opportunities. It also lowered EBITDA margin assumptions to reflect persistent higher operating expenses. Despite these adjustments, the brokerage continues to see strong monetization potential in SLPA's product pipeline, positioning it well for medium to long-term growth. Disclaimer: The views and recommendations expressed above are those of the brokerage firm. Business Upturn does not endorse or offer any investment advice. News desk at
Business Standard
27-05-2025
- Business
- Business Standard
Shilpa Medicare slides after Q4 PAT drop 41% YoY to Rs 15-cr
Shilpa Medicare declined 1.25% to Rs 878.35 after the company's consolidated net profit fell 40.77% to Rs 14.51 crore while revenue from operations rose 13.40% to Rs 330.80 crore in Q4 FY25 over Q4 FY24. Profit before exceptional items and tax stood at Rs 43.35 crore in Q4 FY25, up 100.88% from Rs 21.58 crore posted in the corresponding quarter previous year. The firm reported exceptional items of Rs 28.08 crore during the quarter. EBITDA jumped 15% to Rs 84 crore in Q4 FY25 from Rs 73 crore in Q4 FY24. EBITDA margin remained constant at 25% in Q4 FY25 compared to Q4 FY24. Total expenses were up by 9.12% year on year to Rs 297.32 crore in the quarter ended 31 March 2025. The cost of materials consumed stood at Rs 85.14 crore (down 15.83% YoY), while employee benefits expense was at Rs 70.93 crore (up 6.72% YoY). On a full-year basis, the company's consolidated net profit surged 145.65% to Rs 78.29 crore on an 11.70% jump in revenue from operations to Rs 1,286.41 crore in FY25 over FY24. Vishnukant Bhutada, managing director of Shilpa Medicare, said, FY25 performance reflects our pursuit of a differentiated business model enabling us to grow with improved profitability. In FY25, Shilpa Medicare has emerged stronger, turning years of strategic investments and relentless perseverance into remarkable achievements in differentiated initiatives like the launch of two NDAs in US market, filing of transdermal patch product in EU, SEC clearance of Nor-UDCA in India and OLC filing by our partner with US FDA. Our unwavering commitment to innovation and R&D has borne fruit, with a significant breakthrough in out-licensing our flagship productrecombinant human albuminfor commercialization across EU region in strategic partnership with Orion Corporation. Besides this, we also saw a very successful year on the regulatory front, as we received EIR for our API Unit 1, along with EU GMP certifications for our FDF Unit 6 (having ODF & TDP manufacturing capabilities) and for our Biologics unit. I believe this will help in enabling us to further scale up our biologics CDMO platform and give us the opportunity to monetize our biosimilar pipeline for large regulated markets. With asset utilization improvement across key verticals, we remain confident of delivering improved profitability in FY26. As we advance, we remain committed to leveraging our R&D strengths, regulatory compliance, and operational agility to create long-term value. Meanwhile, the companys board has decided to pay a dividend of Rs 1 per equity share for FY 2024-2025. The final dividend, if approved by the members at the ensuing Annual General Meeting, shall be paid within the statutory timelines prescribed under applicable laws. Shilpa Medicare is a manufacturer of API, formulation, and development services. Shilpa Medicare (SML) started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka, India.
