Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced the national launch of the company’s FDA-approved, NGS-based in vitro diagnostic device, xT CDx. Beginning today, xT CDx is now available for all ordering clinicians nationwide. xT CDx is a FDA-approved test that delivers comprehensive insights with one of the largest reported gene panels available.
xT CDx is a 648-gene next-generation sequencing test for solid tumor profiling, which includes microsatellite instability status and companion diagnostic claims for colorectal cancer patients. xT CDx leverages a normal-matched approach, which is a method of parallel DNA sequencing of a solid tumor and normal patient sample that can lead to more accurate identification of cancer-driving somatic variants. All orders for tumor + normal match tests – traditionally run on the company’s signature xT assay – will now be run as xT CDx with no changes to the current ordering workflow.
As 2025 begins, the American Association for Cancer Research (AACR)recently published forecasts from experts showcasing transformative advances in cancer research, including cutting-edge AI technologies, novel targeted therapies, and innovative cancer vaccines. With over 50 oncology drug approvals in 2024, including the first tumor-infiltrating lymphocyte cell therapy, this year holds great promise for precision medicine and immunotherapy. Amid growing expectations for anactive year for biotech stocks in 2025, developers of new cancer therapies are already releasing important developments, with recent news coming fromOncolytics Biotech Inc.(NASDAQ:ONCY) (TSX: ONC),Adaptive Biotechnologies Corporation (NASDAQ:ADPT),NeoGenomics, Inc. (NASDAQ:NEO), Elevation Oncology, Inc. (NASDAQ:ELEV), andORIC Pharmaceuticals, Inc. (NASDAQ:ORIC).
The article continued: Statista analysts project that the oncology drugs market will generate an estimated revenue of $208.9 billion in 2025. Meanwhile, Global Market Insights reports that the global oncology market, valued at approximately $320.3 billion in 2024, is expected to grow at a compound annual growth rate (CAGR) of 10.8% from 2025 to 2034, reaching $866.1 billion.
Regulatory Approval Clears Path for Oncolytics Biotech® to Advance Promising Pancreatic Cancer Treatment, Following a Review of Safety Data
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that Germany's medical regulatory body, the Paul-Ehrlich-Institute (PEI), has approved the continuation of patient enrollment into Cohort 5 of the GOBLET study. This cohort is evaluating pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq®) in newly diagnosed pancreatic ductal adenocarcinoma (PDAC) patients.
Following a positive safety review by the independent Data Safety Monitoring Board (DSMB), which recommended continuation, the PEI's approval allows Cohort 5 to progress to full enrollment. Early safety data will be presented at the upcoming 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium later this month, with initial efficacy results expected in the second half of the year.
"Pelareorep has the potential to meaningfully improve outcomes for patients with metastatic pancreatic cancer," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "Encouraging tumor response rates observed in an earlier cohort of the GOBLET study underscore pelareorep's promise in this disease. GOBLET Cohort 5 extends our evaluation by testing pelareorep with a different chemotherapy regimen, mFOLFIRINOX, which broadens the range of pancreatic cancer patients who may benefit from this innovative therapy. Positive results from this cohort may ultimately enable pelareorep to benefit the large majority of metastatic pancreatic patients for whom improved treatment options are badly needed."
The Phase 1/2 GOBLET study is testing pelareorep, an oncolytic reovirus, in combination with other treatments for advanced gastrointestinal cancers, including pancreatic, colorectal, and anal cancers. Conducted at 17 centers in Germany, the study aims to evaluate response rates, safety, and biomarkers across multiple treatment arms, with promising cohorts advancing to further testing.
AIO is a non-profit organization that evolved from the medical oncology working group within the German Cancer Society (DKG). Dedicated to advancing science and research in medical oncology, AIO has grown into a prominent sponsor and study management company. Over the years, it has established a strong reputation both within Germany and on the international stage for its contributions to oncology research and study development.
Oncolytics Biotech's work represents a significant step forward in the fight against metastatic pancreatic cancer, addressing a critical need for more effective treatment options in this aggressive disease. By leveraging the innovative potential of pelareorep in combination with established therapies, the company is paving the way for breakthroughs that could transform outcomes for patients and unlock value for investors.
The election ofDonald Trumpin November and a swing back to Republican power in Washington is already starting to make an impact in the business world, according toGoldman Sachs
CEO David Solomon.
The bank executive said on a conference call Wednesday that other CEOs are feeling better about the direction of the economy and their businesses since the presidential election, even though Trump has yet to take office.
“There has been a meaningful shift in CEO confidence, particularly following the results of the U.S. election,” Solomon said, according to a transcript from FactSet.
“Additionally, there is a significant backlog from sponsors and an overall increased appetite for dealmaking supported by an improving regulatory backdrop,” he continued.
The comments line up with some survey data that suggests renewed confidence among business leaders. The latest Chicago Fed Survey of Economic Conditions showed an improved outlook for the next 12 months. The NFIB Small Business Optimism Index rose to its highest level since October 2018 in December.
To be sure, executives on JPMorgan Chase’s earnings call said that the optimism among business leaders has not yet resulted in loan growth, according to a FactSet transcript.
Stocks rose sharply in the immediate aftermath of Trump’s win, as investors cheered the prospect of lower taxes and fewer regulations. However, many of those gains have since disappeared, in part due to a recent rise in interest rates.
Trump, who is set to return to the White House on Monday, is seen as broadly more business-friendly than outgoing President Joe Biden. During his campaign, Trump floated lowering taxes and reducing regulation, including around energy. However, his proposed tariffs have made some investors and business leaders nervous about the potential for higher prices and a disruptive trade war.
Solomon’s comments came on a conference call discussing Goldman’s fourth-quarter results. The bank beat estimates on the top and bottom lines for the period, with its profit roughly doubling year over year.
With just one week to go before President-elect Donald Trump is sworn into office in Washington, the FBI said there are no known threats to the Inauguration Day ceremony.
“We are not currently tracking any specific or credible threats to the inaugural ceremony or to the Capitol complex,” FBI special agent David Sundberg said in a Monday news conference alongside Washington officials. “We will continue to work closely with our partners to share information and identify and disrupt any threat that may emerge.”
The Secret Service’s special agent in charge, William McCool, said that about 25,000 law enforcement and military officials will be onsite to ensure the security of the event.
“We have a slightly more robust security plan. We’ve been planning for this event for 12 months,” he said. “All attendees will undergo screening. Designated checkpoints will be set up for members of the public interested in attending the inauguration.”
The ceremony is expected to draw about 250,000 ticketed guests, said U.S. Capitol Police Chief Thomas Manger, adding that there will also be demonstrators.
“The biggest threat, I think for all of us, remains the lone actor,” Manger said, referring to terrorism. “Just in the past week, while President [Jimmy] Carter was lying in state, we had two lone actors show up at the Capitol, one trying to bring in knives and a machete, and another one who I believe was trying to disrupt the proceedings by setting their car on fire.
“That threat of the lone actor remains the biggest justification for us maintaining this heightened state of alert throughout the next week.”
Country superstar Carrie Underwood, the performer for “Sunday Night Football’s” theme song, confirmed in a statement on Monday that she will perform “America the Beautiful” at Trump’s inauguration.
“I love our country and am honored to have been asked to sing at the Inauguration and to be a small part of this historic event,” Underwood said “I am humbled to answer the call at a time when we must all come together in the spirit of unity and looking to the future.”
The committee planning Trump’s inaugural ceremonies, meanwhile, released a schedule on Monday of four days of events centered around the Jan. 20 swearing-in ceremony, which Biden is planning to attend.
“President Trump is dedicated to uniting the country through the strength, security, and opportunity of his America First agenda,” Steve Witkoff and Kelly Loeffler, co-chairs of the inaugural committee, said in a statement.
Witkoff is Trump’s incoming Middle East envoy and Loeffler is a former Republican Georgia senator who is Trump’s nominee to run the Small Business Administration.
“The 2025 inaugural celebrations will reflect President-elect Trump’s historic return to the White House and the American people’s decisive vote to Make America Great Again,” Witkoff and Loeffler said.
After his inauguration, Trump has vowed to take a number of swift executive actions, including issuing pardons for Jan. 6, 2021, Capitol breach defendants, issuing orders rescinding bans on drilling on certain federal lands, and initiating plans to mass deport illegal immigrants.
Last week, Sen. Markwayne Mullin (R-Okla.) said Trump has prepared around 100 executive orders he plans to issue as soon as he takes office.
“He says he has almost 100 executive orders that will go a long way to securing the border again and also put the energy sector back in play,” Mullin told “Fox & Friends” last week.
DoubleLine Capital CEO Jeffrey Gundlach believes the Federal Reserve is missing the bigger picture again.
“The Fed looks like Mr. Magoo, driving around, bumping into things. Then became systematic, got inflation to come down,” Gundlach said in an investor webcast Tuesday evening. “But for the past five months we’ve had another rising trend. This has got the Fed back into short-termism, reacting too much to short-term data, not being strategic.”
Gundlach, a noted fixed income investor whose firm manages $95 billion, made the comments before the latest reading of the consumer price index on Wednesday. The CPI increased a seasonally adjusted 0.4% on the month, putting the 12-month inflation rate at 2.9%
Excluding food and energy, the core CPI rate came in slightly lighter than expected both on a monthly basis and an annual basis. While the numbers compared favorably to forecasts, they still show that the Fed has work to do to reach its 2% inflation target.
“CPI month-over-month change has got the Fed zigzagging,” Gundlach said. “The market has gone from an aggressive assumption of Fed cuts to just one cut in 2025.”
The Fed has cut benchmark rates by a full percentage point since September, a month during which it took the unusual step of lowering by a half point. In December, the central bank projected only two quarter-point rate cuts in 2025, fewer than the four reductions it previously forecast.
“The Fed is now in sync with the market, and the market is not given further signals for a change,” Gundlach said. “That is consistent with the Fed slowing down its change of monetary policy.”
Futures pricing continued to imply a near certainty that the Fed would stay on hold at its Jan. 28-29 meeting but leaned more toward two quarter-point rate cuts through the year, assuming quarter percentage point increments, according to CME Group.
Israeli Prime Minister Benjamin Netanyahu hasinformedrelatives of hostages kidnapped by Hamas that the end of the war in Gaza is near, amid reports that a ceasefire and hostage exchange deal has been reached. A formal deal could be announced within hours, he has said.
Axios reports Wednesday morning, "A breakthrough has been reached in the negotiations between Israel and Hamas in Doha and a deal to release hostages held by Hamas and establish a ceasefire in Gaza is imminent, three Israeli officials told Axios."
"There is a breakthrough in the hostage deal negotiations in Doha. Hamas' military leader in Gaza Mohammed Sinwar gave his OK," one Israeli official was cited as saying. And importantly, a statement from Trump's team:
'We have a deal': Trump hails Gaza peace accord
In a quick follow-up statement on Truth Social, president-elect Trump underscored the unmistakable timing, attributing the deal to his election win in November. Below is his statement in full [emphasis ZH]:
This EPIC ceasefire agreement could have only happened as a result of our Historic Victory in November, as it signaled to the entire World that my Administration would seek Peace and negotiate deals to ensure the safety of all Americans, and our Allies. I am thrilled American and Israeli hostages will be returning home to be reunited with their families and loved ones.
With this deal in place, my National Security team, through the efforts of Special Envoy to the Middle East, Steve Witkoff, will continue to work closely with Israel and our Allies to make sure Gaza NEVER again becomes a terrorist safe haven. We will continue promoting PEACE THROUGH STRENGTH throughout the region, as we build upon the momentum of this ceasefire to further expand the Historic Abraham Accords. This is only the beginning of great things to come for America, and indeed, the World!
We have achieved so much without even being in the White House. Just imagine all of the wonderful things that will happen when I return to the White House, and my Administration is fully confirmed, so they can secure more Victories for the United States!
The impending deal reportedly lays out an initial six week ceasefire phase which includes gradual withdrawal of Israeli forces from Central Gaza as well as the return of displaced Palestinians to North Gaza.
Of the some 100 hostages still held by Hamas, at least one-third are believed already deceased. Dozens were released upon an initial deal struck early in the conflict.
Like with the first hostage exchange, dozens of Palestinian prisoners are expected to be released under this new agreement in return for each Israeli hostage.
According to the latest on where things stand via Axios:
A second Israeli official said there is optimism that a deal could be announced by Thursday at the latest.
The Israeli prime minister's office said in a statement that Hamas hasn't given it's approval for the deal.
Hamas still hasn't issued an official statement, but a Palestinian source quoted by Al-Araby al-Jadeed website said the group and other factions in Gaza have a unified position and have given a positive response to the draft ceasefire agreement.
Netanyahu's office has still said it has not received official word from Hamas on whether it has agreed to the deal.
"Both Reuters and AFP reported that Hamas had given verbal approval for the deal, citing Palestinian sources. According to Reuters, the terror group had not yet given a written response to the ceasefire proposal," Times of Israel also underscores. Additionally:
Channel 12 quoted an Israeli official saying that "there has been a breakthrough," and assessed that a deal could be signed later in the day.
Ministers is Netanyahu's cabinet are reportedly preparing for a possible Wednesday night vote on enacting a ceasefire deal.
Not everyone is happy. For example, Israeli National Security Minister Itamar Ben Gvir has threatened to quit the governing coalition if Netanyahu agrees to the hostage and ceasefire deal.
"Over the past year, through our political power, we have managed to prevent this deal from coming to fruition, time after time," Ben Gvir said Tuesday. Some critics both within and outside Israel have accused Netanyahu of doing precisely this. Large protests have persisted in Tel Aviv amid accusations Netanyahu has thwarted potential peace deals in the past, opting to pursue total war in Gaza.
President Joe Biden issued an executive order on Tuesday to accelerate the construction of large-scale data centers and clean power infrastructure for artificial intelligence (AI) on federal sites.
Biden, whose presidency will end when President-elect Donald Trump takes office on Jan. 20, said the order will direct the Defense Department (DOD) and Energy Department (DOE) to lease federal sites to the private sector for building AI infrastructure.
The agencies will select sites that are equipped with high-capacity transmission infrastructure and have minimal adverse effects on communities, the natural environment, and commercial resources.
The outgoing president said he aims to speed up the construction of advanced AI infrastructure in the United States “in a way that enhances economic competitiveness, national security, AI safety, and clean energy.”
“Cutting-edge AI will have profound implications for national security and enormous potential to improve Americans’ lives if harnessed responsibly, from helping cure disease to keeping communities safe by mitigating the effects of climate change,” Biden said in a statement. “However, we cannot take our lead for granted. We will not let America be out-built when it comes to the technology that will define the future, nor should we sacrifice critical environmental standards and our shared efforts to protect clean air and clean water.”
The White House stated that federal agencies will review proposals from companies seeking to build and operate large-scale AI infrastructure before granting leases for the selected sites.
The chosen developers will then be required to procure new clean energy generation resources that meet the electricity and capacity needs of their data centers, according to a White House fact sheet.
The Interior Department will also help to identify lands under its management that can be used for building clean energy facilities to power data centers on DOE and DOD sites, while also accelerating the permitting processes for geothermal projects, which could support future AI operations, the White House said.
“Agencies will prioritize and dedicate staff toward permitting this infrastructure in a timely manner, and DOD will immediately undertake environmental analyses that will improve the speed and accuracy of future site-specific reviews,” it stated.
To prevent an increase in electricity bills for consumers, the White House stated that developers will bear the full cost of building, operating, and maintaining AI data centers and power facilities. They are also required to provide “prevailing wages” to workers.
The order also requires developers to meet lab-security requirements and assess the national security implications of AI models developed on federal sites, including their safety risks and potential to advance national security objectives, the White House stated.
The Biden administration said the construction of such data centers will help prevent “adversaries from accessing powerful systems to the detriment” of the U.S. military and national security and reduce America’s reliance on other countries for access to powerful AI tools.
A senior administration official told reporters on Monday that Biden issued the order to expedite the rate at which America builds “the world’s largest, most powerful AI infrastructure” powered by clean energy. The order also seeks to preserve America’s leadership in AI and counter national security risks posed by adversaries.
“So in the coming years, we’ll face extraordinary potential national security risks, including the possibility of strategic surprise if adversaries such as the PRC [People’s Republic of China] develop and acquire these more powerful AI systems before we do,” the official stated.
Another senior official stated that China has made “substantial investments” in AI and is rapidly advancing its AI infrastructure development.
This came a day after the Biden administration proposed new rules on the exports of advanced computer chips used in AI development, which it said was aimed at ensuring that “the world’s AI runs on American rails.”
The White House said the restrictions will not apply to 18 allies and partners of the United States, including the United Kingdom. Exports to China and Russia are already subject to restrictions.
