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Monday, August 25, 2025

Royalty Pharma buys BeOne stake in Amgen lung cancer drug sales

 

  • Royalty Pharma has grabbed rights to a share in revenue from lung cancer drug Imdelltra, announcing Monday it will pay $885 million upfront for BeOne Medicine’s royalties paid by partner Amgen for sales outside China. BeOne, formerly known as BeiGene, has rights to Imdelltra revenue because of a $2.7 billion collaboration deal it struck with Amgen in 2019.
  • Per deal terms, BeOne has the option to sell another chunk of Imdelltra royalties in the next year for $65 million, bringing the deal total to around $950 million. Royalty said the initial royalty stream amounted to “approximately 7%” of worldwide net sales.
  • Launched in 2024 for small cell lung cancer, Imdelltra earned sales of $215 million through the first six months of 2025, most of it in the U.S. under an accelerated approval from the Food and Drug Administration. Amgen recently reported data from a clinical trial showing the drug extends survival compared with chemotherapy, which should secure its place on the market.
  • BeOne is now well established as a commercial drugmaker, recording total sales of $2.4 billion through the first six months of the year from drugs it developed as well as some of Amgen’s products in China. However, it also has significant expenses, burning about $2 billion over the same time — about half on research and development of its own drugs like Brukinsa and sonrotoclax.

That profit picture for the first half looks like it will be sustained for the full year, as BeOne’s executives forecast positive operating income and cash flow even before this deal was announced. The deal will only build on that momentum, executives said Monday.

“A strong balance sheet is a hallmark of the most successful companies in our industry, and this transaction provides increased operational and strategic flexibility as we continue to execute our business strategy for the long term,” said CFO Aaron Rosenberg, in a statement.

A so-called bispecific antibody, Imdelltra triggers an immune response to cells expressing a protein called DLL-3, common among tumor cells in small cell cancer, a hard-to-treat disease that until recently has had few innovative treatments. While Merck & Co.’s immunotherapy Keytruda and Bristol Myers Squibb’s Opdivo have gained approval for small cell lung cancer, they were withdrawn when confirmatory data didn’t support their use. Roche’s Tecentriq can be used in certain patients, however.

“Imdelltra is reshaping the treatment paradigm for patients with small cell lung cancer, a highly aggressive disease with few treatment options,” said Pablo Legorreta, Royalty’s CEO, in a statement. “Today’s transaction is consistent with our strategy of acquiring royalties on highly transformative products in life sciences.”

Royalty Pharma has been active in buying revenue streams recently, striking deals with BiogenCytokineticsSanofi and Agios.

https://www.biopharmadive.com/news/royalty-beone-imdelltra-rights-drug-sales/758501/

Axogen stock falls after FDA extends review timeline for nerve graft

 Axogen (NASDAQ:AXGN) stock declined 9% after the U.S. Food and Drug Administration (FDA) extended its review timeline for the company’s Avance Nerve Graft by three months.

The FDA has pushed the Prescription Drug User Fee Act (PDUFA) goal date for Axogen’s Biologics License Application (BLA) to December 5, 2025, from the previous target. According to the company, the FDA deemed information submitted in response to an agency request as a "Major Amendment" to its BLA, which included substantial new manufacturing and facility data not previously reviewed.

The regulator also informed Axogen that it now plans to provide feedback on product labeling in November 2025, in line with standard PDUFA review procedures.

"We appreciate the FDA’s thorough review and look forward to continuing our engagement with the agency to complete the transition of Avance Nerve Graft from a tissue product to a BLA-approved biologic," said Michael Dale, Axogen’s Chief Executive Officer.

Despite the setback, analysts remain largely optimistic about the company’s prospects. Leerink analyst Mike Kratky, who maintains an outperform rating, views "the delayed PDUFA date as largely procedural but recognize that it adds some additional uncertainty on the setup through year-end."

Similarly, Cantor analyst Ross Osborn, who also rates the stock as outperform, commented that "while we are disappointed to learn of the delay in the PDUFA data, we remain confident in AXGN’s ability to transition to a BLA-approved biologic and believe the company will continue to execute ahead of approval."

https://www.investing.com/news/stock-market-news/axogen-stock-falls-after-fda-extends-review-timeline-for-nerve-graft-93CH-4209243

NWTN Inc. Transforms to Robo.ai Inc. Following Shareholder Approval

NWTN (NASDAQ:NWTN) disclosed that shareholders approved the official name change of the company to Robo.ai. The company anticipates that the Class B ordinary shares will begin trading on the Nasdaq Stock Market LLC under the new name at the open

Shares of NWTN (NASDAQ:NWTN) jumped 8.1% in Monday morning trading to $1.20 vs. the 52-week range of $0.30 to $3.48.

https://seekingalpha.com/news/4488739-meet-roboai-the-global-ai-robotics-platform-that-evolved-out-of-nwtn

 On August 12, 2025, NWTN Inc. held an extraordinary general meeting where shareholders approved several key resolutions, including changing the company’s name to Robo.ai Inc. and appointing Yehong Ji as a new independent director. These changes, along with amendments to the company’s Memorandum and Articles of Association, aim to reflect the company’s evolving focus and enhance its strategic positioning in the intelligent technology sector.

More about NWTN

NWTN Inc. is a UAE-headquartered global intelligent technology company that focuses on smart mobility, smart manufacturing, and smart contracts. The company integrates smart manufacturing with its global ecosystem platform and is expanding its smart technology ecosystem across markets including MENA, Southern Europe, and beyond, driving sustainable development through technological innovation.

Average Trading Volume: 1,261,681

Technical Sentiment Signal: Sell

Current Market Cap: $341.9M

https://www.msn.com/en-us/money/topstocks/nwtn-inc-transforms-to-robo-ai-inc-following-shareholder-approval/ar-AA1KsOT8

FDA Fast-Tracks Revolutionary Blood Test: Quest Diagnostics



Quest Diagnostics (NYSE:DGX) has received FDA Breakthrough Device Designation for its Haystack MRD® test, designed to identify minimal residual disease (MRD) in stage II colorectal cancer patients after surgery. The test helps determine which patients might benefit from adjuvant therapy.

The designation follows Quest's launch of a clinical laboratory-developed version of Haystack MRD in late 2024. The test utilizes circulating tumor DNA (ctDNA) technology to detect residual or recurrent cancer from solid tumors. The Breakthrough Device Program aims to accelerate development and review of medical devices for life-threatening conditions while maintaining FDA safety standards.

Revamped CDC Panel Taps Covid Vaccine Critic to Lead Task Force

 


An influential vaccine panel’s task force will be led by a member who has previously expressed distrust in the Covid vaccine, weeks after a shooting on the US Centers for Disease Control and Prevention was fueled by Covid misinformation.

Retsef Levi, an operations professor at the Massachusetts Institute of Technology, will lead the Covid-19 immunization task force, a spokesperson for Health and Human Services confirmed without offering additional comment. Levi has previously said the Covid shots should be removed from the market and has called the safety of mRNA shots into question.

https://www.bloomberg.com/news/articles/2025-08-25/revamped-cdc-panel-taps-covid-vaccine-skeptic-to-lead-task-force

Musk's xAI sues Apple, OpenAI alleging antitrust violations

 Elon Musk's companies xAI and X filed a sweeping US antitrust lawsuit Monday against Apple and OpenAI, alleging the tech giants formed an illegal partnership to stifle competition in artificial intelligence and smartphone markets.

The 61-page complaint, filed in federal court in Texas, accuses Apple and OpenAI of entering an exclusive deal that makes OpenAI's ChatGPT the only generative AI chatbot integrated into Apple's iPhone operating system, while blocking rivals like xAI's Grok.

"This is a tale of two monopolists joining forces to ensure their continued dominance in a world rapidly driven by the most powerful technology humanity has ever created: artificial intelligence," the lawsuit states.

The plaintiffs claim Apple holds 65 percent of the US smartphone market, while OpenAI controls at least 80 percent of the generative AI chatbot market through ChatGPT.

Apple and OpenAI announced their partnership in June 2024, making ChatGPT the exclusive AI assistant accessible through Apple's Siri voice assistant and other iPhone features.

The lawsuit alleges this arrangement gives ChatGPT exclusive access to "billions of user prompts" from hundreds of millions of iPhone users.

The complaint also accuses Apple of manipulating App Store rankings to favor ChatGPT while delaying approval of updates to the Grok app.

Musk's companies are seeking billions in damages and a permanent injunction to stop the alleged anticompetitive practices. They have demanded a jury trial.

"This latest filing is consistent with Mr Musk’s ongoing pattern of harassment," OpenAI said in a statement to AFP.

Apple did not immediately respond to a request for comment.

The lawsuit follows threats Musk made earlier this month that triggered a fiery exchange with OpenAI CEO Sam Altman.

Altman called Musk's accusation of ranking manipulation "remarkable," charging that Musk himself "manipulates X to benefit himself and his own companies and harm his competitors and people he doesn't like."

Musk called Altman a "liar" in the heated exchange.

Both men were original founders of OpenAI before Musk's departure in 2018 and now have a highly conflictual relationship.

Musk founded xAI in 2023 to compete with OpenAI and other major AI players that have poured billions of dollars into AI since the blockbuster launch of the first version of OpenAI's ChatGPT in late 2022.

https://finance.yahoo.com/news/musks-xai-sues-apple-openai-160219817.html

'Trump and RFK Jr. to Ban COVID-19 Vaccine ‘Within Months’': Daily Beast

 The Trump administration will move to pull the COVID vaccine off the U.S. market “within months,” one of Robert F. Kennedy Jr.’s closest associates has told the Daily Beast.

Dr. Aseem Malhotra, a British cardiologist who has repeatedly claimed in the face of scientific consensus that the vaccines are more dangerous than the virus, told the Daily Beast that Kennedy’s stance is shared by “influential” members of President Donald Trump’s family. Like Kennedy himself, no Trumps hold any scientific qualifications.

Malhotra is a leading adviser to the controversial lobby group Make America Healthy Again (MAHA) Action, which is seen as an external arm of Kennedy’s agenda as Health and Human Services (HHS) Secretary.

He told the Beast that many of those closest to RFK Jr. have told him they “cannot understand” why the vaccine continues to be prescribed, and that a decision to remove the vaccine from the U.S. market pending further research will come “within months,” even if it is likely to cause “fear of chaos” and bring with it major legal ramifications.

“It could [happen] in a number of stages, including learning more about the data,” said Malhotra, who said there was an ongoing review into so-called “vaccine injuries” by the Advisory Committee on Immunization Practices (ACIP). “But given the increased talk of vaccine injuries in the past few weeks among the administration, it could also come with one clean decision.”

Malhotra said skepticism among Kennedy’s circle of the COVID-19 jab is driven by a 2022 paper by a group of physicians and university professors and researchers, which appeared in the journal Vaccine.

The peer-reviewed paper examined secondary analysis of “serious adverse events reported in… clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults,” and said that those given the mRNA vaccines had a 16 percent higher risk of “excess serious adverse events” than those in the placebo group.

However, the study has been dismissed by large parts of the medical community, who say it underestimates the benefits of COVID-19 vaccines and overstates risks due to methodological flaws, biased data selection, and ignoring broader public health impacts.

Malhotra was not among the authors of the study, but said that he presented its findings during a MAHA Action team video meeting on July 9 which was attended by senior aides to Kennedy. He claimed it caused a “holy s--t” moment among many of those present.

Malhotra is known to have the ear of RFK Jr., having first drawn his attention in September 2022, when he published a paper in the Journal of Insulin Resistance on what he described as “misinformation about the COVID mRNA vaccine,” which led to a television interview.

After he walked out of the studio, Malhotra said the first person to call was RFK Jr. “He said, ‘I want to thank you for your courage,’” Malhotra said. The pair have since become close.

Malhotra helped fundraise for Kennedy’s doomed presidential campaign, and the two hiked together in the Los Angeles hills close to Kennedy’s home that he shares with his actress wife, Cheryl Hines, in October 2023.

Malhotra is now expected to meet Trump himself in September to push his anti-COVID-19 mRNA vax views, during a trip to meet Kennedy and other HHS aides.

“I think [Trump will] get it, because it’s in his interest to,” Malhotra said. “This information is only going in one direction, and there’s something really terribly wrong with the system. I think once [he] understands the situation… that will encourage him to act to change the system. He’s in a position to fix it. He can create a lasting legacy by doing so.”

The prediction of a drastic move against the COVID vaccine comes after Kennedy canceled $500 million in funding for the development of mRNA vaccines. Such vaccines use a copy of a molecule called messenger RNA (mRNA) to provoke an immune response against certain diseases. They have received much attention since the COVID-19 pandemic, where they served as the basis of the most widely used SARS-CoV-2 vaccines.

Days after canceling the funding, the HHS secretary—criticized for describing the COVID shot as “the deadliest vaccine ever made”—stated during a press conference his belief that the mRNA COVID-19 vaccine was dangerous and can cause “injuries” including myocarditis, an inflammation of the heart that can lead to health issues ranging from fatigue to cardiac arrest.

At the same time the scientifically unqualified Kennedy scion wrongly claimed there is no evidence football leads to brain damage.

Vaccine skepticism took a sinister turn earlier this month when an anti-vaxxer opened fire on the Centers for Disease Control (CDC), killing a police officer. Investigators believe the man targeted the CDC over his hatred of the COVID-19 vaccine, apparently convinced he was sick—or would become sick—because of it.

On Wednesday, more than 750 current and former staff members from the CDC, HHS and National Institutes of Health (NIH) accused Kennedy of spreading dangerous misinformation that fueled mistrust and contributed to the CDC HQ shooting, demanding by Sept. 2 that he stop, affirm CDC scientific integrity, and guarantee workforce safety.

They also argued Kennedy had jeopardized Americans’ health and undermined the nation’s readiness for public-health crises.

In a letter to Congress and Kennedy, which was posted on the Save HHS site, they wrote: “Health and Human Services Secretary Robert F. Kennedy, Jr., is complicit in dismantling America’s public health infrastructure and endangering the nation’s health by repeatedly spreading inaccurate health information.”

HHS, in response, said Kennedy was “standing firmly with CDC employees” to ensure their safety and well-being, adding: “In the wake of this heartbreaking shooting, he traveled to Atlanta to offer his support and reaffirm his deep respect. Any attempt to conflate widely supported public health reforms with the violence of a suicidal mass shooter is an attempt to politicize a tragedy.”

The Daily Beast contacted the White House, the HHS, Pfizer, and Moderna for comment.

Only the White House responded. Its spokesman, Kush Desai, said: “The Administration is relying on Gold Standard Science and is committed to radical transparency to make decisions that affect all Americans. Unless announced by the Administration, however, any discussion about HHS policy should be dismissed as baseless speculation.”

https://www.yahoo.com/news/articles/trump-rfk-jr-ban-covid-095459225.html