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Merus reports promising phase 1/2 trial results for head and neck cancer therapy

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UTRECHT, The Netherlands and CAMBRIDGE, Mass. – Merus N.V. (NASDAQ:), a clinical-stage oncology company, has announced interim clinical data from its ongoing phase 1/2 trial, revealing a 67% response rate in patients with head and neck cancer treated with the combination of its bispecific antibody petosemtamab and pembrolizumab.

The data, as of March 6, 2024, includes results from 24 evaluable patients and will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 3, 2024.

The company’s president and CEO, Dr. Bill Lundberg, expressed optimism regarding the combination’s clinical activity and safety profile, which was observed across various tumor PD-L1 expression levels and HPV status. Dr. Jerome Fayette, who will be presenting the data at ASCO, also shared a positive outlook on the potential of this treatment to set a new standard of care for first-line treatment of head and neck cancer.

During the trial, 45 patients were treated, and 32 remained on treatment at the time of the data cutoff. The company observed one confirmed complete response and 12 confirmed partial responses among the 24 patients in the efficacy population. The treatment was generally well-tolerated, with most adverse events being Grade 1 or 2 in severity, and no significant overlapping toxicities with pembrolizumab were noted.

Merus plans to initiate a phase 3 registration trial by the end of 2024, aiming to further investigate petosemtamab in combination with pembrolizumab for the first-line treatment of PD-L1 expressing head and neck cancer, regardless of HPV status.

Merus, recognized for developing full-length multispecific antibodies, aims to address the unmet needs in the treatment of deadly diseases like head and neck squamous cell carcinoma. The information presented here is based on a press release statement from the company.

InvestingPro Insights

Merus N.V. (NASDAQ:MRUS) has been in the spotlight with its promising clinical data, but what does the financial picture tell us about the company’s performance and market position? According to InvestingPro data, Merus has a market capitalization of $3.52 billion, which reflects investor confidence in the company’s growth potential. The company’s Price to Book ratio stands at 10.07 as of the last twelve months leading up to Q1 2024, signaling a premium valuation that investors are willing to pay for its assets relative to the book value.

Despite the company’s significant research and development efforts, the financial metrics highlight some challenges. The company’s revenue growth has seen a decline of 11.73% over the last twelve months as of Q1 2024, and its gross profit margin has been negative, sitting at -276.6% in the same period. This underlines the company’s current stage in the clinical development cycle, where investment in research often precedes revenue generation.

However, Merus has demonstrated impressive stock performance with a substantial 1-week price total return of 37.21%, which could be a response to positive clinical trial results and future growth expectations. Investors interested in the company’s future prospects should note that analysts have revised their earnings upwards for the upcoming period, as per one of the InvestingPro Tips, indicating potential optimism in its financial outlook.

For readers looking to delve deeper into Merus’s financial data and future projections, more InvestingPro Tips can be found at https://www.investing.com/pro/MRUS, including insights on the company’s cash position, sales growth forecasts, and profitability expectations. There are 19 additional InvestingPro Tips available for Merus, offering a comprehensive analysis for informed decision-making. To access these insights, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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Sean ‘Diddy’ Combs charged with sex trafficking, racketeering

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By Luc Cohen and Jonathan Stempel

NEW YORK (Reuters) -Sean “Diddy” Combs used his fame as one of the biggest names in hip-hop to coerce women into engaging in demeaning sex acts as part of a long-running scheme of sex trafficking and racketeering, according to a three-count federal indictment unsealed on Tuesday.

Combs, 54, used the business empire he controlled, including his record label Bad Boy Entertainment, to transport women, as well as male sex workers, across state lines to take part in recorded sexual performances called “Freak Offs” in which the music mogul would watch and masturbate, prosecutors said.

The rapper and producer, arrested in Manhattan on Monday night, is expected to appear in court before U.S. Magistrate Judge Robyn Tarnofsky at 2:30 p.m. EDT (1830 GMT) on Tuesday.

Combs faces a mandatory minimum 15-year prison sentence and up to life behind bars if convicted of the three felony counts: racketeering conspiracy, sex trafficking and transportation to engage in prostitution.

The office of Manhattan U.S. Attorney Damian Williams, which brought the charges, said in a court filing that the stiff potential sentence could give Combs incentive to flee.

Prosecutors have asked Tarnofsky to order Combs to remain detained pending trial. Defense lawyers are asking to have him released on $50 million bond secured by his Miami home.

Prosecutors accused Combs of running a criminal enterprise to facilitate his exploitation of women, dating back at least 16 years.

According to the indictment, Combs enticed women by giving them drugs such as ketamine and ecstasy, financial support, or promises of career support or a romantic relationship. Combs then used surreptitious recordings of the sex acts as “collateral” to ensure that the women would remain silent, and sometimes displayed weapons to intimidate abuse victims and witnesses, prosecutors said.

“The victims did not believe they could refuse Combs without risking their security or facing more abuse,” Williams told a press conference. “This office is determined to investigate and prosecute anyone who engages in sex trafficking, no matter how powerful or wealthy or famous you may be.”

The indictment did not specify how many women were alleged victims. It contained no allegation that Combs himself directly engaged in unwanted sexual contact with women, though he was accused of assaulting them by punching, kicking, dragging and throwing objects.

Also known during his career as P. Diddy and Puff Daddy, Combs founded Bad Boy records and is credited with helping turn rappers and R&B singers such as Mary J. Blige, Faith Evans, Notorious B.I.G. and Usher into stars in the 1990s and 2000s.

‘NOT A CRIMINAL’

Marc Agnifilo, a lawyer for Combs, did not immediately respond to a request for comment on Tuesday. Agnifilo on Monday expressed disappointment with the “unjust” prosecution of his client, calling Combs “an imperfect person” but “not a criminal.”

Combs is the highest-profile music industry figure charged with sexual misconduct since R&B singer R. Kelly was sentenced to a combined 31 years in prison after being convicted in New York in 2021 and Chicago in 2022 sex trafficking, racketeering, child sex crimes and other counts.

His career and reputation have been marred over the past year. Last November, his former girlfriend Casandra Ventura, an R&B singer known as Cassie, accused him in a lawsuit of serial physical abuse, sexual slavery and rape. She agreed to an undisclosed settlement one day after suing. Combs denied her allegations.

New York Mayor Eric Adams asked Combs to return a commemorative “key to the city” after a video showing him attacking Cassie surfaced in May.

BABY OIL, AR-15 RIFLES

Prosecutors said Combs and his associates used bribery and violence such as arson and kidnapping to try to keep his conduct secret.

In a March 2016 incident that resembles Cassie’s description of his alleged attack, prosecutors said Combs was captured on a hotel security video striking and dragging a woman trying to leave a “Freak Off.” Combs then offered a stack of cash to a hotel security officer who intervened, prosecutors said.

In 2011, Combs and a co-conspirator kidnapped a person at gun point to facilitate a break in, prosecutors said. Two weeks later, Combs’ co-conspirators set a car on fire, and he later bragged about his role in the arson, prosecutors said.

© Reuters. FILE PHOTO: Rapper Sean Diddy Combs arrives at the 2016 MTV Video Music Awards in New York, U.S., August 28, 2016.  REUTERS/Eduardo Munoz/File Photo

Prosecutors said Combs’ employees helped arrange the “Freak Offs” by booking hotel rooms and buying controlled substances and other items used during sex, according to the indictment.

During raids of his homes in Los Angeles and Miami Beach, Florida six months ago, authorities found drugs and 1,000 bottles of baby oil and lubricant, along with AR-15 rifles with defaced serial numbers, the indictment said.

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Wysh Collaborates with Jack Henry to Enhance Financial Protection for Credit Union Members

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Community and regional financial institutions can offer account holders embedded life insurance, increased financial security, and innovative deposit products

New York, New York–(Newsfile Corp. – September 17, 2024) – Wysh Life and Health Insurance Company, an AM Best A- rated insurance carrier offering innovative financial protection solutions, today announced that its embedded Life Benefit product is now accessible through the Jack Henry™ digital banking platform.

Wysh leveraged the Banno Digital Toolkit™, the same set of APIs the Banno Digital Platform™ is built on, to embed its technology into the digital experiences offered by community and regional financial institutions. Access to Jack Henry’s API, design, and authenticated frameworks has enabled Wysh to directly integrate Life Benefit into the digital banking platform, providing a seamless banking experience. This integration contributes to Jack Henry’s growing ecosystem of over 1,000 fintechs, providing approximately 7,500 financial institutions with relevant financial products and services for their account holders.

Life Benefit is a groundbreaking solution that embeds micro life insurance coverage equal to 10% of an account holder’s deposits, up to $10,000, providing protection directly to their account upon the holder’s death. With no opt-in, sign-up, or underwriting required, Life Benefit extends life insurance protection to demographics that have been historically overlooked due to pre-existing conditions or adverse financial histories. This innovative product helps banks and credit unions attract diverse, younger members, address net interest margin compression, and create new revenue streams through embedded affiliate programs.

“We’re thrilled to join Jack Henry’s fintech ecosystem and bring Life Benefit to more banks, credit unions and their members,” said Alex Matjanec, CEO of Wysh. “Our experience with the Banno Digital Toolkit has been excellent, allowing us to seamlessly integrate our solution into the digital banking platform. This collaboration will enable community and regional financial institutions to offer a truly innovative and inclusive financial protection product that aligns with their values while improving deposit economics.”

About Jack Henry™

Jack Henry™ (NASDAQ: JKHY) is a well-rounded financial technology company that strengthens connections between financial institutions and the people and businesses they serve. We are an company that prioritizes openness, collaboration, and user centricity – offering banks and credit unions a vibrant ecosystem of internally developed modern capabilities as well as the ability to integrate with leading fintechs. For more than 48 years, Jack Henry has provided technology solutions to enable clients to innovate faster, strategically differentiate, and successfully compete while serving the evolving needs of their account holders. We empower approximately 7,500 clients with people-inspired innovation, personal service, and insight-driven solutions that help reduce the barriers to financial health. Additional information is available at www.jackhenry.com.

About Wysh Life and Health Insurance Company

Wysh Life and Health Insurance Company is a wholly-owned subsidiary of Northwestern (NASDAQ:) Mutual. Wysh offers innovative embedded protection solutions, including Life Benefit, which helps financial institutions attract, retain, and differentiate deposits while providing valuable coverage to members. By integrating seamlessly with financial platforms, Wysh is revolutionizing the way financial institutions approach member protection and deposit growth. To learn more about Wysh, visit wysh.com or contact press@wysh.com.

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To view the source version of this press release, please visit https://www.newsfilecorp.com/release/223633

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Fifth Third Community Development Corp. President Susan E. Thomas Named Co-Chair of National Housing Crisis Task Force

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CINCINNATI–(BUSINESS WIRE)–A new bipartisan task force is tackling one of America’s most pressing problems “ the national housing crisis “ and is seeking to elevate the most innovative solutions from across the country to produce and preserve housing across all income levels in every part of the country.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240917284773/en/

Fifth Third Community Development Corporation President Susan E. Thomas (Photo: Business Wire)

This work will be led in part by Fifth Third Community Development Corporation President Susan E. Thomas, a national leader in community development banking and development. Of the four bipartisan National Housing Crisis Task Force co-chairs, Thomas is the only co-chair from the private sector.

The other co-chairs are Utah Governor Spencer Cox, Atlanta Mayor Andre Dickens, and Cleveland Mayor Justin M. Bibb.

The solutions are out there, but they are being deployed piecemeal, in individual communities, Thomas said. The task force will identify the best examples of innovative financing and land disposition tools, policies to streamline market-rate and subsidized-affordable housing development and help replicate them in communities across the country.

Thomas has seen firsthand the impact of innovation in housing through her work with Fifth Third’s Empowering Black Futures Neighborhood Program, which creates and implements innovative place-based strategies to effect positive change in nine historically disinvested neighborhoods across the Bank’s 11-state footprint.

Affordable housing is a cornerstone of Fifth Third’s Neighborhood Program, which is pioneering a new way to do community development by partnering with local organizations to build ecosystems that drive real change through both financial and social investments. This collective ecosystem approach is focused on identifying solutions to key challenges in partnership with the community, with the goal of creating lasting, transformative change.

At Fifth Third, we view safe, affordable housing as a basic human right, and helping to solve this crisis is one of our top priorities, said Kala Gibson, chief corporate responsibility officer for Fifth Third. As a regional bank, we are deeply embedded within the communities we serve, and we see firsthand every day how housing security is connected to economic mobility, financial stability, improved health outcomes and economic mobility.

Fifth Third’s Community Development Banking Group is actively helping to create housing inventory and remove barriers to affordability across the Bank’s footprint. This includes investing in low-income housing tax credits, new markets tax credits, community development financial institutions, and investment funds, as well as community-based lending for projects that create housing and provide other supportive services.

In 2023, Fifth Third provided $722 million in loans and investments to support 3,684 units of housing “ and we’re just getting started, Thomas said.

The National Housing Crisis Task Force is an ambitious, two-year project to bring the most promising innovations in housing production, preservation, and finance to communities across the country. Supported by the Nowak Metro Finance Lab at Drexel University and Accelerator for America (AFA), the bipartisan task force includes 28 government, non-profit, and business leaders who will create a platform to share and replicate what’s working locally, nationally and internationally. The task force’s work was launched Tuesday, July 23 at an in-person meeting in Washington, D.C. Its first report is expected this fall.

About Fifth Third

Fifth Third is a bank that’s as long on innovation as it is on history. Since 1858, we’ve been helping individuals, families, businesses and communities grow through smart financial services that improve lives. Our list of firsts is extensive, and it’s one that continues to expand as we explore the intersection of tech-driven innovation, dedicated people and focused community impact. Fifth Third is one of the few U.S.-based banks to have been named among Ethisphere’s World’s Most Ethical Companies ® for several years. With a commitment to taking care of our customers, employees, communities and shareholders, our goal is not only to be the nation’s highest performing regional bank, but to be the bank people most value and trust.

Fifth Third Bank, National Association is a federally chartered institution. Fifth Third Bancorp (NASDAQ:) is the indirect parent company of Fifth Third Bank and its common stock is traded on the NASDAQ ® Global Select Market under the symbol “FITB.” Investor information and press releases can be viewed at www.53.com. Deposit and credit products provided by Fifth Third Bank, National Association. Member FDIC.

Amanda Nageleisen (Media Relations)
amanda.nageleisen@53.com

Matt Curoe (Investor Relations)
matt.curoe@53.com | 513-534-2345

Source: Fifth Third

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