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Yahoo
23 minutes ago
- Yahoo
Kezar Life Sciences Announces FDA Has Lifted Partial Clinical Hold on PORTOLA Phase 2a Trial Evaluating Zetomipzomib for the Treatment of Patients with Autoimmune Hepatitis
SOUTH SAN FRANCISCO, Calif., July 15, 2025--(BUSINESS WIRE)--Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, today announced that the Division of Hepatology and Nutrition of the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the completed PORTOLA Phase 2a clinical trial evaluating zetomipzomib, a first-in-class selective immunoproteasome inhibitor, in patients with autoimmune hepatitis (AIH). "We are pleased that the FDA has lifted the partial clinical hold on zetomipzomib in AIH after their review of our comprehensive safety assessment of the zetomipzomib program," said Chris Kirk, PhD, CEO and co-founder of Kezar. "We continue to believe that zetomipzomib has the potential to positively transform the lives of patients living with AIH. We look forward to engaging with the FDA to align on the design of the next clinical trial of zetomipzomib in AIH." Although Kezar has suspended development of zetomipzomib in lupus nephritis (LN) to focus on AIH, the company met with the Independent Data Monitoring Committee (IDMC) for the previously terminated PALIZADE clinical trial to review the safety profile of zetomipzomib. The IDMC has provided Kezar with recommendations for conducting future clinical trials in LN. Based on this feedback and internal analysis of safety data across all clinical studies involving zetomipzomib, Kezar plans to respond to the FDA Division of Rheumatology and Transplant Medicine with a request to lift the clinical hold on zetomipzomib in LN. About Zetomipzomib Zetomipzomib is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from completed clinical trials provide evidence that zetomipzomib exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases. About Autoimmune Hepatitis Autoimmune hepatitis (AIH) is a rare chronic disease in which the immune system attacks the liver and causes inflammation and tissue damage, severely impacting patients' physical health and quality of life. Lifelong maintenance therapy is required to avoid relapse and burdensome adverse effects. If left untreated, AIH can lead to cirrhosis, liver failure and hepatocellular carcinoma. In the United States, AIH affects approximately 100,000 individuals, with incidence rates increasing. The cause of this condition remains unclear, with females affected four times as often as males. Currently, standard of care treatment for AIH is chronic, immunosuppressive treatment with corticosteroids that frequently cause life-altering side effects, including diabetes, osteoporotic fractures and cataracts. There is a significant need for treatment regimens that reduce or remove the need for chronic immunosuppression from use of corticosteroids. About Kezar Life Sciences Kezar Life Sciences is a clinical-stage biopharmaceutical company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases. Zetomipzomib, a selective immunoproteasome inhibitor, is currently being evaluated for autoimmune hepatitis. This product candidate also has the potential to address multiple chronic immune-mediated diseases. For more information, visit and follow us on LinkedIn, Facebook, Twitter and Instagram. Cautionary Note on Forward-looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "can," "should," "expect," "believe," "potential," "anticipate" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Kezar's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Kezar's clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the timing and outcome of regulatory submissions and interactions with the FDA, EMA or any other regulatory agencies with respect to zetomipzomib or Kezar's clinical trials, the initiation of an additional clinical trial of zetomipzomib in AIH, and expectations regarding the removal of the clinical hold of zetomipzomib in LN, and the likelihood of obtaining regulatory approval of zetomipzomib. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during clinical studies, difficulties enrolling and conducting our clinical trials, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Kezar's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" contained therein. Except as required by law, Kezar assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. View source version on Contacts Investor and Media Contact:Gitanjali JainSenior Vice President, Investor Relations and External AffairsKezar Life Sciences, Melden Sie sich an, um Ihr Portfolio aufzurufen.
Chicago Tribune
25 minutes ago
- Chicago Tribune
Mike Waltz pledges to make UN ‘great again' at Senate confirmation hearing
WASHINGTON — Mike Waltz painted an image for lawmakers Tuesday of what the United Nations would look like as the U.S. — its largest donor — reviews its support, opting to go 'back to basics' under a Trump administration push to 'make the U.N. great again.' During his Senate confirmation hearing to be U.S. ambassador to the United Nations, Waltz echoed the priorities of his bosses — President Donald Trump and Secretary of State Marco Rubio — of pursuing major reforms to the 80-year-old world body. It was the first time senators could grill Waltz since he was ousted as Trump's national security adviser in May after he mistakenly added a journalist to a private Signal chat used to discuss sensitive military plans. He denied Tuesday that he was removed from the post, while laying out his plans to bring 'America First' to the U.N. 'We should have one place in the world where everyone can talk — where China, Russia, Europe and the developing world can come together and resolve conflicts,' Waltz told the Senate Foreign Relations Committee about the U.N. 'But after 80 years, it's drifted from its core mission of peacemaking.' The U.N. is pursuing its own reforms while the Republican administration has spent the last six months reshaping American diplomacy and working aggressively to shrink the size of the federal government, including recent mass dismissals at the State Department. On the agenda for Waltz would be combating China's influence, reviewing U.S. funding to U.N. agencies with 'often duplicative and wasteful mandates,' as well as rooting out what Waltz called deep antisemitism within the U.N. system. The U.N. post is the last one to be filled in Trump's Cabinet following months of delay, including the withdrawal of the previous nominee. The Signal episode — in which Waltz, Defense Secretary Pete Hegseth and other high-level officials faced intense criticism — didn't come up at the hearing for more than an hour. It was revealed in March that Waltz added The Atlantic editor-in-chief Jeffrey Goldberg to a private text chain on an unclassified messaging app that was used to discuss planning for strikes on Houthi militants in Yemen. 'We both know Signal is not an appropriate and secure means of communicating highly sensitive information,' said Democratic Sen. Chris Coons of Delaware, who was first to raise the issue. He added that Waltz shared 'demonstrably sensitive information' in an improper manner. Fellow Democratic Sen. Tim Kaine of Virginia called it 'an amateurish move.' Waltz, a former Florida congressman, said the chat met the administration's cybersecurity standards, 'no classified information was shared' and the military was still conducting an ongoing investigation. Democratic Sen. Cory Booker of New Jersey blasted what he called a 'lack of accountability' from Waltz and other administration officials. 'I've watched this hearing, and I've been really disappointed,' Booker said. 'What's been troubling to me about your nomination from the beginning is your failure to just stand up and take accountability for mistakes that you made.' If confirmed, Waltz would arrive at the U.N. at a moment of great change. The world body is reeling from Trump's decision to slash foreign assistance — affecting its humanitarian aid agencies — and it anticipates U.S. funding cuts to the U.N. annual budget. Facing financial instability, the U.N. has spent months shedding jobs and consolidating projects while beginning to tackle long-delayed reforms. The U.N. is also facing growing frustration over what critics describe as a lack of efficiency and power in delivering on its mandate to end conflict. 'With Waltz at the helm, the U.N. will have what I regard as what should be its last chance to demonstrate its actual value to the United States,' said Republican Sen. Mike Lee of Utah. 'Instead of progressive political virtue signaling, the Security Council has the chance to prove its value, and settling disputes and brokering deals.' Waltz said U.N. revenue 'has quadrupled in the last 20 years' but that it hasn't been commensurate with increased peace. 'The U.S. must ensure that every foreign aid dollar and every contribution to an international organization, particularly the U.N., draws a straight and direct line to a compelling U.S. national interest,' Waltz said. He said the administration's diplomatic strategy would be focused on cutting costs to what he called 'waste, fraud, and abuse that are endemic to the U.N. system.' Waltz also accused the U.N. of 'pervasive antisemitism.' He testified that the U.N. agency for Palestinian refugees, UNRWA, has been promoting 'antisemitic hate' in its schools in Gaza. U.N. Secretary-General Antonio Guterres appointed a British human rights activist on Tuesday to carry out a strategic review of UNRWA. Israel has alleged that 19 out of UNRWA's roughly 13,000 staffers in Gaza participated in the Oct. 7, 2023, attacks that launched the war. UNRWA said it fired nine workers after an internal U.N. investigation. Israel later alleged that about 100 other Palestinians in Gaza were Hamas members but didn't provide evidence to the United Nations. Waltz has spent the last few months on the White House payroll despite departing as national security adviser. The latest list of White House salaries, current as of July 1, includes Waltz as an adviser earning an annual salary of $195,200. A White House official, granted anonymity to discuss personnel matters, said Waltz stayed on to 'ensure a smooth and successful transition given the extreme importance of the role of NSA.' Sen. Jacky Rosen, a Democrat from Nevada, questioned why Waltz was still being paid by the administration. 'Throughout this year, you've made (assertions) that, if confirmed, you would root out waste and unnecessary overhead at the U.N. So can you confirm for us whether you've been receiving a salary from the White House since being let go as the NSA?' Waltz denied the fact that he had been fired, saying he was being paid as an adviser 'transitioning a number of important activities.'
Miami Herald
26 minutes ago
- Miami Herald
Were Texas flood deaths avoidable? Here's what Americans said in a new poll
Many Americans believe the deaths caused by recent floods in Texas could have been prevented, and most think that the government's response was imperfect, according to new polling. The YouGov/Economist survey — conducted July 11-14 — comes after central Texas was pummeled by flash floods beginning on July 4, when the Guadalupe River surged over its banks, sweeping away homes and leaving at least 134 dead and about 100 missing, ABC News reported. Among the worst affected areas was Camp Mystic, a Christian camp in Kerr County, where NBC News reported 27 campers and counselors lost their lives. President Donald Trump traveled to Texas on July 11 and met with the families of victims. He said he wished to express 'the love and support and the anguish of our entire nation,' CBS News reported. 'I've never seen anything like it,' he added, 'a little narrow river that becomes a monster…' In the aftermath of the devastating disaster, multiple organizations and individuals have faced scrutiny over their preparedness. Among them were Kerr County officials, who did not install a comprehensive flood warning system despite being aware of its necessity, according to the Texas Tribune. The Federal Emergency Management Agency (FEMA) has also faced criticism over its response, and the New York Times reported that it failed to answer thousands of calls from Texas flood survivors Here is a breakdown of the findings. Were deaths avoidable? In the survey — which sampled 1,680 U.S. adults — 52% of respondents said that most of the deaths could have been prevented if the government had been more adequately prepared. Twenty-nine percent said the deaths were unavoidable, and 19% said they didn't know. On this question, there was a sizable partisan divide. Most Democrats and independents — 74% and 53%, respectively — called the deaths avoidable, while just 28% of Republicans said the same. Government response The poll — which has a margin of error of 3.4 percentage points — also asked respondents to judge the government response to the flooding. A plurality, 38%, labeled the overall government response as poor, while smaller shares described it as fair (14%), good (19%) or excellent (14%). Individual officials received somewhat similar marks. When asked about Trump's response, 42% said it was poor, while fewer said it was fair (11%), good (15%), and excellent (21%). Meanwhile, 36% said Homeland Security Secretary Kristi Noem's response was poor. Eight percent said it was fair; 14% said it was good and 13% said it was excellent. Presidents visiting disaster sites Additionally, respondents were asked about presidents visiting disaster sites (the survey began on the day Trump traveled to Texas). A majority, 64%, said presidents should visit locations of disasters because it demonstrates their solidarity. Just 17% said they should not do this 'because it takes resources away from the disaster response.' The results broke along similar lines when respondents were asked specifically about Trump. Sixty-five percent said they believed Trump 'should travel to Texas to survey the damage and meet with people affected by recent flooding.' Meanwhile, 20% said he should not do this, and 15% said they were not sure.
