Latest news with #OLC
SoraNews24
an hour ago
- SoraNews24
Tokyo Disney Resort's low park attendance continues amid extreme heat
With a new temperature record set in Japan, more people than ever seem to be saying no thank you to going outdoors altogether. On July 30, Japan's highest-ever temperature of 41.2 degrees Celsius (106.16 degrees Fahrenheit) was recorded in Tamba, Hyogo Prefecture. With one local resident describing the heat as 'homicidal,' it's easy to see why more and more people have been pulling the plug on typical outdoor summer activities and plugging in the AC instead. This predicament, however, has been creating barriers for some of Japan's biggest attractions as they grapple with how to attract customers in the midst of unprecedented heat waves. For instance, it was reported last year that Tokyo Disney Resort (comprised of two main theme parks: Tokyo Disneyland and Tokyo DisneySea) was experiencing declining numbers of visitors, which resulted in Tokyo Disneyland losing its crown as the top-attended theme park in Japan for two years in a row. From April through September 2024, Tokyo Disney Resort recorded 12.2 million visitors, which is a 2.4 percent decrease compared to the same period during the previous year. It's also the first decrease in attendance since the park reopened after the COVID-19 pandemic. While the decline in numbers has been attributed to many factors, including inflation/rising costs for Japanese consumers as well as Tokyo Disneyland's decision to discontinue annual passes, the effect of the extreme heat is undeniable, especially for visitors who would be standing in long lines under the boiling sun to enter park attractions. ▼ Eventually there comes a time when not even a sports drink can help. Tokyo Disney Resort's operator, the Oriental Land Company (OLC), has implemented various measures to try to beat the heat and attract more visitors. The parks currently have a Summer Cool-Off campaign that's emphasizing water rides, parades with water sprayed over large areas, the creation of more on-site shaded spots, including temporary overhead tarps, and expanded entry times outside of the peak heat. Stores on the premises also sell misting fans and cooling towels for guests. However, despite OLC's best efforts, as of late July, its stocks have decreased more than 20 percent in the span of one year. Only time will tell if OLC manages to find a recipe for summer success–and if the global data is any indication, the summer heat is here to stay. In the meantime, if not even the lure of Tokyo Disneyland or DisneySea is enough to draw you out under the sun, you can have fun with other activities such as devouring Totoro-themed shaved ice or taking part in a nighttime taxi tour of haunted locations that will give you a different kind of chill. Source: Nikkei Business via Golden Times Top image: SoraNews24 Insert image: Pakutaso ● Want to hear about SoraNews24's latest articles as soon as they're published? Follow us on Facebook and Twitter!
Business Upturn
3 days ago
- Business
- Business Upturn
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Unicycive Therapeutics, Inc.
NEW YORK, Aug. 09, 2025 (GLOBE NEWSWIRE) — Pomerantz LLP is investigating claims on behalf of investors of Unicycive Therapeutics, Inc. ('Unicycive' or the 'Company') (NASDAQ: UNCY). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980. The investigation concerns whether Unicycive and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On June 30, 2025, Unicycive release issued a press release 'announc[ing] that the U.S. Food and Drug Administration (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 press release stated that '[a]fter 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.' On this news, Unicycive's stock price fell $2.03 per share, or 29.85%, to close at $4.77 per share on June 30, 2025. Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See Attorney advertising. Prior results do not guarantee similar outcomes. CONTACT:Danielle PeytonPomerantz LLP [email protected] 646-581-9980 ext. 7980
Business Wire
19-07-2025
- 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
