Cancer screening firms Guardant Health (NASDAQ:GH), Exact Sciences (NASDAQ:EXAS), and Labcorp (NYSE:LH), as well as HIV drugmaker Gilead (NASDAQ:GILD), traded higher on Friday after the Supreme Court upheld a key Obamacare provision that required insurers to cover preventive services at no cost to patients.
In a 6-3 decision, the Supreme Court justices struck down a lower court ruling which found in 2024 that the U.S. Preventive Services Task Force, introduced under the Affordable Care Act, also known as Obamacare, in 2010, comprised invalid appointees.
The appointment of USPSTF members is consistent with the U.S. Constitution, the court found, a move that could boost providers of preventative healthcare services such as cancer screenings and HIV pre-exposure prophylaxis.
“SCOTUS ruled against Braidwood in the Kennedy v. Braidwood case, which means HIV PrEP will remain on the mandated coverage list,” Bloomberg News reported, quoting Jefferies analyst Michael Yee.
He argued that the ruling removes a key overhang for the antiviral drugmaker ahead of its upcoming launch of the recently approved twice-yearly injectable HIV PrEP therapy Yeztugo. Yee reiterated his Buy rating and $130 per share target on GILD.
FDA-approved updates for Breyanzi and Abecma reduce patient monitoring and eliminate REMS, enhancing access to CAR T-cell therapies.
Labeling changes reflect increased regulatory confidence in the safety and efficacy of CD19- and BCMA-directed CAR T-cell therapies.
Labeling updates have been approved by the U.S. Food and Drug Administration for treatment with two CAR T-cell therapies: Breyanzi (lisocabtagene maraleucel; liso-cel) in large B cell lymphoma (LBCL) and other lymphomas and Abecma (idecabtagene vicleucel; ide-cel) in multiple myeloma, according to a news release from Bristol Myers Squibb.
Currently, approximately 2 in 10 eligible patients receive cell therapy, but this announcement is expected to help eliminate unnecessary barriers for both patients and providers. These updates ease specific patient monitoring requirements and eliminate the Risk Evaluation and Mitigation Strategy (REMS) programs that were implemented at the time of each therapy’s initial approval. Moreover, the updated labeling reflects increasing real-world evidence and regulatory confidence in the safety of CD19- and BCMA-directed autologous CAR T-cell therapies, supporting ongoing efforts to improve equitable access.
“CAR-T cell therapy is a transformational, potentially life-saving option for patients living with blood cancers, and we are working to challenge current practices, assumptions and barriers that limit access,” Lynelle B. Hoch, president, Cell Therapy Organization, Bristol Myers Squibb, said in the news release. “Today's FDA-approved label updates reinforce BMS’ continued efforts to collaborate across the healthcare ecosystem, with the ultimate goal of reaching more patients and democratizing access to cell therapy.” Diving Into the Labeling Updates
Despite the benefit of cell therapy, there are still many challenges that affect both patients, the news release states, leading to benefit with this class-wide label updates. The FDA-approved label updates to Breyanzi and Abecma both reduce and remove specific patient monitoring requirements, for example. Other updates include a reduction in post-treatment driving restrictions from eight weeks to two weeks, and a shortened requirement to remain near a treatment facility from four weeks to two weeks.
Additionally, the FDA has removal of REMS from both labels is a big update. Although REMS programs are typically used to manage potential risks associated with new therapies, the FDA now recognized that current guidelines and the hematology/oncology community’s experience are sufficient to identify and address side effects, such as cytokine release syndrome and neurologic toxicities, without a formal REMS program. This change is expected to help expand the availability of CAR T into more community-based settings, the news release emphasized.
“Living with blood cancer is challenging, but patients and their loved ones still need to maintain jobs, take care of families, and plan for the future,” Sally Werner, chief executive officer, Cancer Support Community, added. “Today’s announcement reduces some of the most onerous requirements that may have previously discouraged patients, particularly those who live far from a treatment center, from seeking the potentially transformational effects of cell therapy. We applaud any and all efforts to continue to break down barriers, reduce time burden on patients and caregivers, and increase uptake of this life-saving therapy.”
Overall, these updates reflect the growing clinical and real-world understanding of these treatments, supporting the efficacy and safety of CD19- and BCMA-directed autologous CAR T-cell therapies. More than 30,000 patients have received CAR T treatment to date, and recent findings indicate that most serious side effects occur within the first two weeks of infusion.
Looking to the future, the news release says that Bristol Myers Squibb will be working closely with over 150 treatment centers who currently administer Breyanzi and Abecma to remove the REMS programs. In tandem, the company is also focusing on expanding the geographic footprint of CAR T therapy. This will, in turn, reflect a renewed effort to help community cancer centers administer Breyanzi and Abecma closer to patients, aiding in the reduction of travel time and duration of stay away from home, as well as family and work.
Reference:
“U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb’s Cell Therapy Labels,” Bristol Myers Squibb.
The Trump administration has sued California’s Orange County Registrar of Voters Robert Page for allegedly withholding information that could reveal noncitizens were registered to vote.
The lawsuit, filed in federal district court, alleges that Orange County undermined voter confidence by “refusing transparency of its voter information in violation of federal voting laws” and “concealing the unlawful registration of ineligible, noncitizen voters.”
“Voting by noncitizens is a federal crime, and states and counties that refuse to disclose all requested voter information are in violation of well-established federal elections laws” said Assistant Attorney General Harmeet Dhillon of the federal Department of Justice (DOJ) Civil Rights Division.
“Removal of noncitizens from the state’s voter rolls is critical to ensuring that the state’s voter rolls are accurate and that elections in California are conducted without fraudulent voting. The Department of Justice will hold jurisdictions that refuse to comply with federal voting laws accountable,” she said.
The lawsuit alleges that Page has refused to provide the DOJ with records pertaining to the removal of noncitizens from its voter registration list and has failed to maintain an accurate voter list in violation of the Help America Vote Act (HAVA).
U.S. Attorney Bill Essayli posted on X on June 26 that Orange County refused “to hand over records showing noncitizens are registered to vote and received ballots in federal elections.”
Page did not respond directly to a media inquiry, but media liaison Enedina Chhim stated in an email to The Epoch Times that the county “does not comment on pending or ongoing litigation.”
The lawsuit stems from a complaint received by the Attorney General’s Office from the family member of a noncitizen in Orange County “indicating that the noncitizen received an unsolicited mail-in ballot” from the OC Registrar of Voters.
On June 2, 2025, the attorney general requested documents from Page from Jan. 1, 2020, “to present” showing the number of voter registration records in Orange County canceled because registrants didn’t meet citizenship requirements to vote, according to allegations in the complaint.
Page responded to the request but redacted information such a California driver’s licenses and identification card numbers, Social Security numbers, California secretary of State-assigned voter identification numbers, language preference, and images of registrants’ signatures, according to the complaint.
The legal complaint stated that Page cited state law as the reason for the redactions, and on June 17 the DOJ responded to him indicating the data redaction prohibits the Attorney General’s Office from making an accurate assessment of the whether the OC Registrar of Voters acted in compliance with HAVA and the National Voter Registration Act (NVRA).
The Attorney General’s Office holds that such records are not exempt from the NVRA’s public disclosure provision and is seeking declaratory and injunctive relief.
The Department of Defense is establishing a new military buffer zone—known as a national defense area—along the southwestern border to curb illegal immigration.
On June 25, the U.S. Air Force announced that a 250-mile stretch of the border along the Rio Grande in Texas’s Cameron and Hidalgo counties will be designated an extension of Joint Base San Antonio.
The land was previously managed by the International Boundary and Water Commission, an agency overseeing water-sharing between the United States and Mexico.
The move is part of President Donald Trump’s broader strategy to allocate military resources for border enforcement. In an April presidential memo, Trump outlined plans to establish national defense areas, calling it a military mission “for sealing the southern border of the United States and repelling invaders.”
While the U.S. military generally does not perform civilian law enforcement, the national defense area designation grants limited legal authority for specific actions. Within these zones, servicemembers may help with setting up barriers and signs, conduct patrols—much like on any military base—and temporarily detain trespassers until they are transferred to the appropriate law enforcement authorities.
The first national defense area was designated in April, a 170-mile zone in New Mexico, attached to Fort Huachuca in neighboring Arizona. The following month, a 63-mile section was set up in West Texas under Fort Bliss.
Combined with the new Texas stretch, the total area under national defense area designation now exceeds 480 miles. The Texas–Mexico border extends 1,254 miles.
The Epoch Times has reached out to the Departments of Defense and the U.S. Navy for confirmation regarding any other national defense areas in the works.
In May, a federal judge dismissed trespassing charges against 98 illegal immigrants who had been arrested inside the New Mexico national defense area.
In his ruling, U.S. magistrate judge Gregory Wormuth said the federal government had failed to prove that the accused individuals knew they were entering a restricted military zone, despite posted signs in both English and Spanish warning that unauthorized entry was prohibited.
“As the United States concedes, the NMNDA [New Mexico National Defense Area] spans over 180 miles of ‘often difficult and mountainous terrain,’” the judge said. “The mere fact that some ’signs’ were posted in the NMNDA provides no basis on which to conclude that the defendant could have seen, let alone did see, the signs.”
The judge’s decision dismissed two misdemeanor charges faced by the 98 migrants arrested: violating a security regulation and entering military property for an unlawful purpose. A third misdemeanor charge of illegal border crossing still stands.
According to the Department of Justice, as of mid-May, at least 60 individuals have pleaded guilty to illegally entering a national defense area in a separate case related to West Texas.
New trading symbol "TAOX" effective Tuesday, July 1, 2025,
New name represents Company's strategic focus on the synergies between cryptocurrency and AI
TAO Synergies Inc. (the "Company"), formerly Synaptogenix, Inc. (NASDAQ: SNPX), today announced that it will begin trading on Nasdaq under the new ticker symbol "TAOX" on Tuesday, July 1, 2025, in accordance with its rebranding to the new name TAO Synergies Inc., effective today. The Company's new corporate identity aligns with its significant strategic focus on the leading AI token TAO as the cornerstone of its digital asset treasury strategy.
TAO is the leading AI token by market capitalization and adoption. As part of its strategy, the Company has begun staking TAO to generate revenue, capitalizing on both staking yield and the growth of the token.
"We are excited to introduce TAO Synergies Inc. and its new ticker symbol TAOX, a rebranding that aligns with our exclusive focus on TAO and its long-term growth potential," said Executive Chairman Joshua Silverman. "This transition represents a pivotal moment in our commitment to digital assets, positioning us to create long-term value for our shareholders. TAO's role in the AI ecosystem makes it an ideal asset to drive this new strategic direction."
More information about TAO Synergies and its integration with TAO will be available on the new corporate website to be launched this summer.
Carlsmed, which provides custom equipment and AI-enabled software for personalized spine fusion surgery, filed on Thursday with the SEC to raise up to $100 million in an initial public offering.
Carlsmed is focused on becoming the standard of care for spine fusion surgery. Its aprevo Technology Platform consists of AI-enabled software solutions, interbody implants custom designed for each patient's unique pathology and vertebral bone topography, and single-use surgical instruments. The company currently markets the aprevo Technology Platform for lumbar spine fusion surgery.
The Carlsbad, CA-based company was formed in 2018 and booked $32 million in sales for the 12 months ended March 31, 2025. It plans to list on the Nasdaq under the symbol CARL. Carlsmed filed confidentially on April 24, 2025. BofA Securities, Goldman Sachs, and Piper Sandler are the joint bookrunners on the deal. No pricing terms were disclosed.
California’s energy regulator on Friday issued recommendations to Governor Gavin Newsom to support timely fuel imports and explore ways to retain operations at existing refineries in the state.
Newsom had earlier this year asked the California Energy Commission to recommend changes to the state’s energy transition efforts, as it faces higher fuel costs from Phillips 66 (NYSE:PSX) and Valero’s decision to shutter refineries supplying about 20% of the state’s total fuel production capacity.
The CEC recommended the state should address regulatory and permitting barriers to allow for more timely fuel imports into the state, while engaging with market players to explore ways to keep existing refineries operational.
It also recommended stabilizing in-state crude oil output and supply to reduce costs to refineries.
