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WOBURN, Mass., Nov. 21, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. REPL , a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that it has submitted a biologics license application (BLA) to the FDA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1 containing regimen. The submission was made under the Accelerated Approval pathway. The Company also announced that the FDA has granted Breakthrough Therapy designation to RP1 in combination with nivolumab in the same setting. Breakthrough Therapy designation is intended to expedite the development and review of therapies for serious diseases when preliminary clinical evidence indicates that the therapy may provide substantial improvement over existing available therapies on one or more clinically significant endpoints. This Breakthrough Therapy designation is based on the safety and clinical activity observed in the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial. "Today is an important milestone for Replimune and for the melanoma community as we are one step closer to having another potential treatment available for patients who have limited options after progressing on anti-PD1 containing regimens," said Sushil Patel, Ph.D., CEO of Replimune. The confirmatory Phase 3 IGNYTE-3 trial of RP1 in combination with nivolumab in advanced melanoma patients who have progressed on anti-PD1 and anti-CTLA-4 therapy, or who are not candidates for anti-CTLA-4 treatment is currently enrolling patients. For more information, visit https://replimune.com/clinical-trials/ignyte-3/ . About RP1 RP1 (vusolimogene oderparepvec) is Replimune's lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response. About Replimune Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune's proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com . Forward Looking Statements This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our belief regarding the effect that the breakthrough designation will have on the timing and development of RP1 and other statements identified by words such as "could," "expects," "intends," "may," "plans," "potential," "should," "will," "would," or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of the coronavirus as a global pandemic and related public health issues and the Russian-Ukrainian and Israel-Hamas political and military conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements. Investor Inquiries Chris Brinzey ICR Healthcare 339.970.2843 chris.brinzey@westwicke.com Media Inquiries Arleen Goldenberg Replimune 917.548.1582 media@replimune.com © 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.Erik Pratt scores 20 as Milwaukee defeats North Central College 92-57
Organisers happy with maiden Lagos Liga tourneyKyKy Tandy, FAU close out Oklahoma State in CharlestonIn 2024, the rich largely got richer as tech stocks flew and markets experienced a postelection bump. However, some luxury titans shed billions amid an industry downturn. Here are the biggest billionaire winners and losers of the year, according to their net worth. Advertisement 2024 was a good year to be a billionaire. The S&P 500 gained 25% this year, while the Nasdaq grew 33%. The uberwealthy, many of whom are invested in companies on each index, benefited greatly. Advertisement The five billionaires who gained the most wealth in 2024 saw their net worths climb a collective $542 billion, according to the Bloomberg Billionaires Index as of December 27. These billionaires all come from the tech sector, where AI fever and a postelection rally pushed many stocks to all-time highs. There were, though, those whose fortunes took a hit. Some billionaires whose money comes from luxury retail , which struggled this year, lost double-digit billions. Advertisement Here are the billionaires who gained and lost the most this year — and just how much their fortunes changed as of December 27.
WASHINGTON: US consumer spending increased in November amid strong demand for a range of goods and services, underscoring the economy’s resilience, which saw the Federal Reserve this week projecting fewer interest rate cuts in 2025 than it had in September. There was also good news on inflation last month after a series of warmer readings. The report from the Commerce Department on Friday showed moderate monthly rises in prices, with a measure of underlying inflation posting its smallest gain in six months. Nonetheless, the annual increase in core inflation, excluding food and energy, remained stubbornly well above the US central bank’s 2 percent target. There are also worries that plans by President-elect Donald Trump’s incoming administration to cut taxes, impose or raise tariffs on imports and deport millions of undocumented immigrants would stoke inflation. “The economy continues to grow from strong consumer demand as income growth and the wealth effect from higher portfolio values give consumers capacity to spend,” said Jeffrey Roach, chief economist at LPL Financial. “Inflation was more benign than expected but the stickiness of some categories supports the Fed’s hesitancy to materially lower rates next year.” Consumer spending, which accounts for more than two-thirds of US economic activity, rose 0.4 percent last month after a downwardly revised 0.3 percent gain in October, the Commerce Department’s Bureau of Economic Analysis said. Economists polled by Reuters had forecast consumer spending advancing 0.5 percent after a previously reported 0.4 percent rise in October. The nearly broad-based increase in spending was led by new motor vehicles, likely in part as households replaced vehicles damaged during Hurricanes Helene and Milton. That accounted for the bulk of the 0.8 percent rebound in goods outlays. Spending on recreational goods and vehicles also rose as did outlays on financial services and insurance, mostly charges, fees and commissions. There was also increased spending on recreation services, healthcare, clothing and footwear, furniture as well as housing and utilities. Spending at restaurants and bars as well as on hotel and motel stays also increased. Spending on services rose 0.2 percent. When adjusted for inflation, consumer spending rose 0.3 percent after edging up 0.1 percent in October. The so-called real consumer spending is running at an annualized rate of 3.1 percent in the first two months of the fourth quarter. “That will lay the foundation for another very solid GDP number for the fourth quarter,” said Lou Crandall, chief economist at Wrightson ICAP. Consumer spending surged at a 3.7 percent pace in the third quarter, the fastest in 1-1/2 years, helping to propel the economy to a 3.1 percent growth rate following a 3.0 percent pace of expansion in the April-June quarter. The Atlanta Fed is forecasting gross domestic product increasing at a 3.1 percent rate in the fourth quarter. Fed Chair Jerome Powell on Wednesday described the economy as having “just been remarkable,” adding “I feel very good about ... the performance of the economy and we want to keep that going.” The central bank on Wednesday cut its benchmark overnight interest rate by 25 basis points to the 4.25 percent-4.50 percent range. It forecast only two rate reductions in 2025, in a nod to the economy’s continued resilience and still-high inflation. In September, Fed officials had forecast four quarter-point rate cuts next year. The shallower rate cut path in the latest projections also reflected uncertainty over policies from the incoming Trump administration. Stocks on Wall Street traded higher. The dollar slipped against a basket of currencies. US Treasury yields fell. Labor market stamina, marked by low layoffs and strong wage growth, is underpinning consumer spending. Strong household balance sheets, reflecting high stock market and home prices are also driving spending. Household savings remain supportive. Economists, however, cautioned that it was mostly middle- and higher-income households that were benefiting from the wage gains and wealth effects, noting that lower-income consumers were under financial pressure. Personal income rose 0.3 percent, with wages shooting up 0.6 percent. Income at the disposal of households after accounting for inflation rose 0.2 percent, meaning some tapped their savings to fund purchases. The saving rate dipped to 4.4 percent from 4.5 percent in October. Economists did not believe that the moderation in inflation last month would have changed the tone of the Fed’s message on Wednesday. The personal consumption expenditures (PCE) price index rose 0.1 percent after an unrevised 0.2 percent gain in October. Goods prices were unchanged after three straight monthly decreases. Motor vehicle prices increased 0.7 percent, but the cost of recreational goods and vehicles fell for the fourth consecutive month. Services prices rose 0.2 percent after gaining 0.4 percent in October. Housing inflation increased at the slowest pace since April 2021, reflecting a moderation in rents. The cost of food and accommodation services rose by the most in 10 months. In the 12 months through November, the PCE price index advanced 2.4 percent after rising 2.3 percent in October. The increase in the annual inflation rate was partly due to last year’s low readings dropping out of the calculation. Excluding the volatile food and energy components, the PCE price index climbed 0.1 percent. That was the smallest rise since May, and followed an unrevised 0.3 percent gain in October. Core inflation was running at a 2.5 percent rate in the last three months. In the 12 months through November, core prices increased 2.8 percent after advancing by the same margin in October. The Fed tracks the PCE price measures for monetary policy. It hiked its policy rate by 5.25 percentage points between March 2022 and July 2023. “The general disinflation trend, in view of the much higher US dollar, is intact for the next two months,” said Brian Bethune, an economics professor at Boston College. “However, if the incoming administration raises tariffs significantly, that will provoke retaliation and usher in a period of stagflation that will rival the stagflation of the 1970s.” — ReutersElection victories for Donald Trump and other candidates whose campaigns demeaned transgender people reinforced a widespread backlash against trans rights. For America’s LGBTQ-rights movement, it adds up to one of the most sustained setbacks in its history. For transgender Americans, it’s personal: There is palpable fear of potential Trump administration steps to further marginalize them. But there is also a spirit of resilience — a determination to persevere in seeking acceptance and understanding. “I just went through an election where I couldn’t watch a sports event on TV without seeing a commercial where trans people were portrayed as monsters,” said Jennifer Finney Boylan, a transgender author who teaches at Barnard College in New York. “This hurts more than any other moment I can remember. We’ve been knocked down before. We’ll be knocked down again. All we can do is fight.” Anti-trans momentum has been growing for several years, with Republican-governed states enacting dozens of laws restricting trans people’s options for medical care, sports participation and public restroom access. Activists fear the movement will grow, with the Trump administration taking power as many Americans question the trans-rights agenda. Overall, 55% of voters — and 85% of Trump backers — said support for transgender rights in government and society has gone too far, according to AP VoteCast, a survey of more than 120,000 people who cast ballots nationwide. “There is an urgent need to show the American people the reality of transgender lives — the ordinary people for whom being trans is not the center of their lives,” said Shannon Minter, a transgender civil rights lawyer with the National Center for Lesbian Rights. “This is a frightening moment for transgender people and their families. There is a very real possibility that the new administration may adopt policies that cause them devastating harm.” Trump won the presidential contest over Vice President Kamala Harris after a campaign that included pervasive TV advertising mocking her support for trans rights. “Kamala is for they/them,” an ad that ran over 15,000 times asserted. “President Trump is for you.” Other Democratic candidates also were targeted with anti-trans ads. On an array of issues, Trump — and other Republicans who now hold majorities in both the House and Senate — have threatened to roll back protections and civil liberties for trans people. Education: Trump has pledged to impose wide-ranging restrictions on transgender students. His administration could swiftly move to exclude them from Title IX protections, which affect school policies on students’ use of preferred pronouns, bathrooms and locker rooms. Health care: At least 26 states have adopted laws restricting or banning gender-affirming medical care for trans minors. In Texas, Attorney General Ken Paxton is filing civil lawsuits against doctors he alleges were prescribing such treatments. Trump says any doctor or hospital providing gender-affirming care should be barred from Medicaid and Medicare. Sports: Trump and other Republicans embraced the anti-trans mantra opposing “boys in girls’ sports.” At least 24 states already have laws on the books barring trans women and girls from participating in certain women’s or girls’ sports competitions. In March, 16 college athletes filed a lawsuit against the NCAA, accusing it of violating their Title IX rights by allowing transgender woman Lia Thomas to compete at the 2022 national championships, where she won the 500-yard freestyle. Military: Trans-rights activists worry that Trump may reimpose a ban on trans people serving openly in the military or — as an alternative — bar any future recruiting of trans people and curtail the availability of gender-affirming medical care for service members and veterans. Trans-rights organizations are calling for coalition-building and renewed efforts to increase public understanding. They celebrated some notable victories. Sarah McBride won Delaware’s lone seat in the House of Representatives to become the first openly trans person elected to Congress. In Montana, transgender state Rep. Zooey Zephyr won reelection and will be able to return to the House floor nearly two years after she was silenced and sanctioned by her Republican colleagues. But nationwide, anger and anxiety were dominant emotions among trans activists. “This election season has been brutal,” the leaders of Advocates for Transgender Equality wrote to their supporters. “Trump targeted trans people since his campaign launch. He targeted our existence. He targeted our rights. He promised he would continue to target trans people if he won — and we know he will keep his promise.” Shelby Chestnut, executive director of the Transgender Law Center, said trans people “have become the pawn for political groups that don’t understand our communities.” “It’s a very precarious time,” Chestnut said. “We will get through this, but we have to step up and support each other. ... How do we see the long game, not just the immediate narrow view? Because it is very daunting right now. Where do we want to be in 15 years?” Public opinion on trans rights issues isn’t uniform. According to AP VoteCast, slightly more than half of voters in the 2024 election strongly or somewhat opposed laws that ban gender-affirming medical treatment, such as puberty blockers and hormone therapy, for minors. Slightly less than half of voters somewhat or strongly favored them. And according to a Gallup poll conducted last year, 69% of Americans say transgender athletes should be allowed to compete only on sports teams that conform with their birth gender. Over the past 25 years, arguably the most daunting previous phase of the LGBTQ-rights movement started in 2004, after Massachusetts became the first state to legalize same-sex marriage. Between 2004 and 2008, voters in 26 states approved ballot measures defining marriage as between one man and one woman — in effect outlawing same-sex marriage. By 2012, however, public opinion was swinging in favor of same-sex marriage. The Supreme Court legalized it nationwide in 2015, and it has had the support of most Americans ever since. Boylan recalled how that long-bitter debate tilted in favor of legalization when supporters of same-sex marriage popularized the phrase “Love is love.” “That opened doors and opened hearts,” Boylan said. “The challenge for trans people is we don’t have a phrase like that. ... The issues are more complex.” Boylan noted that the anti-trans campaign seemed to make headway with issues that are not among the core concerns of most trans people: “The primary thing we’re fighting for is not the right to play with other women on a soccer team. We’re fighting for dignity, for respect, for the right to be left alone.” Maxwell Kuzma, a transgender man working as a film editor and writer in rural Ohio, said he was “worn out” by the relentless targeting of trans people and blamed Trump for perpetuating it. Looking ahead, he said life as a trans person “has forced me to learn a resiliency that I will lean on as I continue to speak out against prejudice and discrimination.” Christine Zuba, a transgender woman from New Jersey, described a recent surge of Zoom meetings enabling trans people to express their concerns and determine next steps. “One of the best recommendations I have heard throughout this discussion is to not isolate yourself; rather surround yourself with your support group — the people you love and who love you,” she said. “Do not despair. There are a lot of people who will work with you and for you.” Get local news delivered to your inbox!None
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By Costas Pitas (Reuters) -President-elect Donald Trump on Monday pledged big tariffs on the United States' three largest trading partners - Canada, Mexico and China - detailing how he will implement campaign promises that could trigger trade wars. Trump, who takes office on Jan. 20, 2025, said he would impose a 25% tariff on Canada and Mexico until they clamp down on drugs, particularly fentanyl, and migrants crossing the border, in a move that would appear to violate a free-trade deal. Trump also outlined "an additional 10% tariff, above any additional tariffs" on China, in some of his most specific comments on how he will implement his economic agenda since winning the Nov. 5 election on promises to "put America first". "On January 20th, as one of my many first Executive Orders, I will sign all necessary documents to charge Mexico and Canada a 25% Tariff on ALL products coming into the United States, and its ridiculous Open Borders," he said in a post on Truth Social. While migrant arrests reached a record during President Joe Biden's presidency, straining U.S. border enforcement, illegal crossings fell dramatically this year as Biden instituted new border restrictions and Mexico stepped up enforcement. More than 83% of exports from Mexico went to the U.S. in 2023 and 75% of Canadian exports go to the country. Trump's threatened new tariff would appear to violate the terms of the U.S.-Mexico-Canada Agreement on trade. The deal which Trump signed into law took effect in 2020, and continued the largely duty-free trade between the three countries. Mexico's finance ministry said: "Mexico is the United States' top trade partner, and the USMCA provides a framework of certainty for national and international investors." The office of Canadian Prime Minister Justin Trudeau and the Canadian foreign ministry did not immediately respond to requests for comment. Canada and the United States at one point imposed sanctions on each others' products during the rancorous talks that eventually led to USMCA. The dollar rose more than 2% against the Mexican peso and jumped 1% on the Canadian dollar after Trump posted on his social media platform. Japan's Nikkei fell 1% and U.S. stock futures dropped 0.3% in the aftermath. CHINA: NO ONE WINS TRADE WARS On China, the president-elect accused Beijing of not taking strong enough action to stop the flow of illicit drugs crossing the border into the U.S. from Mexico. "Until such time as they stop, we will be charging China an additional 10% Tariff, above any additional Tariffs, on all of their many products coming into the United States of America," Trump said. A Chinese embassy spokesperson in Washington hit back. "China believes that China-U.S. economic and trade cooperation is mutually beneficial in nature. No one will win a trade war or a tariff war," Liu Pengyu said. The embassy also cited steps it said China had taken since a 2023 U.S.-China meeting after which Beijing agreed it would stem the export of items related to the production of the opioid fentanyl, a leading cause of drug overdoses in the United States. "All these prove that the idea of China knowingly allowing fentanyl precursors to flow into the United States runs completely counter to facts and reality," the spokesperson said. Trump has previously pledged to end China's most-favored-nation trading status and slap tariffs on Chinese imports in excess of 60% - much higher than those imposed during his first term. The Chinese economy is now in a much more vulnerable position given the country's prolonged property downturn, debt risks and weak domestic demand. In the run-up to the Nov. 5 election, Trump floated plans for blanket tariffs of 10% to 20% on virtually all imports. He also said he would put tariffs as high as 200% on every car coming across the U.S.-Mexico border. He also voiced his intent to formally invoke the USMCA's six-year review provision upon taking office. Currently, it is expected in July 2026. Economists say that Trump's overall tariff plans, likely his most consequential economic policy, would push U.S. import duty rates back up to 1930s-era levels, stoke inflation, collapse U.S.-China trade, draw retaliation and drastically reorder supply chains. They say tariffs are paid by the companies that import the products subject to the duties, and they either pass on the costs to consumers or accept lower profits. Trump frequently refers to countries paying as a consequence of his tariff plan, saying on Monday that Mexico and Canada will "pay a very big price." (Additional reporting by Kylie Madry, Jasper Ward, David Lawder, David Ljunggren and Brendan O'Boyle; Editing by Rami Ayyub and Stephen Coates)Celebrity lookalike contests are taking over the internet. But they aren't new
Ashley Coleman has resigned as executive director of the Bradbury-Sullivan LGBT Center, which will "temporarily pause" some programs.
West faces biggest threat since 1945 says Trump military adviser amid growing WW3 fears as Putin vows to keep up massive missiles attacks on UkraineCHRIS DOBEY has issued a grovelling apology for his "absolute s*** show" at the Players Championship. The darts star was thrashed 6-1 by a struggling Nathan Aspinall in the tournament on Friday. Dobey , 34, won one leg in the match to save himself the embarrassment of being whitewashed. The Northumberland-born thrower was 4-0 down in the match before he won his first leg. But it was too little too late as Aspinall won the next two legs to wrap up the match. Dobey was furious with his performance as he had entered the tournament as the top seed. He took out his frustration on social media as he apologised to his supporters. He wrote: "That was an absolute s*** show tonight. "I apologise to everyone for making you sit through that, I was abysmal. "Need to seriously get my act together before the worlds. CASINO SPECIAL - BEST CASINO WELCOME OFFERS "I dunno what’s happened to me, I just can’t seem to play on stage." Plenty of fans did show their backing for Dobey as they reacted on social media. One posted: "You’ll be back Chris, keep your head up." A second wrote: "Try and channel it out. Best wishes for the world’s mate." A third commented: "Chin up. Everyone goes through bad spells. Form is temporary, Class is permanent." A fourth said: "Every player has a blip mate, you’ll be back. We all know what you can do on your day." Another added: "Keep your head up Chris. It’ll come. Keep pushing." Dobey will now have to wait for his return to the oche at the Worlds at Alexandra Palace next month. BELOW is a list of Darts world champions by year. The list does not include winners from the pre-Professional Darts Corporation (PDC) era or BDO world champions. That means Raymond van Barneveld, for example, is only listed once - Barney also won four BDO titles - and none of Eric Bristow's five BDO titles are included. Most World TitlesA two-year-old start-up founded by a former Huawei Technologies’ recruit said it has started mass production of its humanoid robots, raising the bar in a fierce competition among Chinese firms to produce artificial intelligence (AI)-powered machines. Shanghai-based Agibot has started producing its general-purpose robot for commercial use, and has manufactured 962 units as of December 15, the company said in a recent video. Agibot has crossed a major start-up hurdle after spending two years bringing an idea into mass production, founder Peng Zhihui wrote in a post on Chinese social media platform Weibo on Monday. Peng, 31-years-old, was recruited by Huawei in 2020 under its “Genius Youth” young talent programme to work on AI projects at the company’s computing division. Peng’s posts on his inventions, including an Iron Man-inspired robotic arm, became viral sensations on Chinese social media. Agibot’s move towards mass producing its humanoid robots will further increase the stiff competition in China’s robotics industry, which has seen local government bodies racing to provide policy support for the sector.