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Overview of the UnitedHealth Group (UNH) Q2 2025

Unitedhealthcare Signage will be exhibited on July 19, 2023 in an office building in Phoenix, Arizona.

Patrick T. Fallon | AFP | Getty pictures

Unitedhealth group On Tuesday there was an outlook from 2025, which no longer declined the expectations of Wall Street, since the company's insurance unit continued to deal with higher medical costs.

The UnitedHealth Group's shares decreased by around 4% in the Premarket trade on Tuesday.

The company assumes that it will achieve adjusted profit of at least $ 16 per share, with sales of $ 445.5 billion to $ 448 billion. The analysts from Wall Street had expected adjusted profit from 2025 of $ 20.91 per share and sales of $ 449.16 billion, according to LSEG consensus estimates.

In addition to the higher medical costs, the updated outlook from “previously planned portfolio actions” that the company no longer pursues, Tim Noel, CEO of Unitedhealthcare, said during a profit on Tuesday. He did not state any details about these actions.

The Unitedhealth Group expects it to return to profit growth in 2026.

The share fell in May after the company suspended the instructions from 2025 due to increased medical costs and announced the abrupt departure of the former CEO Andrew Witty. The report on Tuesday contributes to a growing series of setbacks for the company, to which the country's largest and most powerful insurer, Unitedhealthcare, is heard and is often regarded as a Bellwether in the industry.

The company expects the medical care of the insurance unit – a measure of the entire medical expenditure compared to the collected premiums – between 89% and 89.5%. A lower ratio usually indicates that a company has collected more in premiums than was paid out in services, which leads to higher profitability.

In the second quarter, this ratio of 85.1% rose to 89.4% in the same period last year, mainly due to the medical costs. The company said that health costs in the quarter rose much faster than what it calculated in premiums. In addition, the financing cuts of Medicare deteriorated.

Analysts had expected that the ratio of Street Account was reached at 89.3% for the quarter.

The UnitedHealth Group's report signals that the medical costs in Medicare Advantage plans for the broader health insurance industry may not alleviate shortly. Unitedhealthcare, the UNITEDHEALTH GROUP's armed insurance arm, is the largest provider of this privately operated Medicare plans in the country.

The insurers set higher expenses for Medicare Advantage plans last year because more and more seniors return to hospitals to subject procedures that they had delayed during the Covid 19 pandemic such as common and hip replacement.

“When we prepared our offers from Medicare Advantage from 2025 in the first half of 2024, we significantly underestimated the accelerating medical trend and did not change the services or planned offers sufficiently to rule out the pressure that we are now experiencing,” said Noel during the call.

Noel said that the doctor and outpatient care made 70% of the pressure on medical costs this year. In the second quarter, however, inpatient care accelerated, and the company expects that it will make a “relatively large part of the pressure” throughout the year.

Unitedhealthcare continues to ensure that more patients use the stays and observation stays, with more services being offered and bundled as part of every visit, said Noel.

The Unitedhealth Group reported in the second quarter compared to the expectations of Wall Street, based on a survey of LSEG analysts:

  • Result per share: 4.08 USD adapted compared to USD 4.48
  • Sales: 111.62 billion US dollars expected compared to $ 111.52 billion

The company achieved a net result of 3.41 billion US dollars or $ 3.74 per share for the quarter. This is compared to a net result of $ 4.22 billion or $ 4.54 per share during the same period last year.

With the exception of certain items, the adjusted profits for the quarter amounted to $ 4.08 per share.

Unitedhealth generated sales of 111.62 billion US dollars in the second quarter, which increased by more than 12% compared to growth within Unitedhealthcare and the optum unit of the company in the same period last year. This segment includes optum health, which offers care and recommends providers, as well as the Pharmacy Benefit Manager Optum RX.

Despite higher medical costs, Unitedhealthcare achieved sales of $ 86.1 billion in the second quarter, which increased an increase of 17% compared to the same period in the previous year. According to StreetCcount estimates, the analysts expected that Unitedhealthcare would book 84.89 billion US dollars for this period.

While the sales of Optum RX rose by almost 19% to $ 38.46 billion, Optum Health's turnover fell by 7% to $ 25.21 billion in the second quarter compared to the previous year. The property of the company to an insurer, a pharmacy and nursing homes enabled him to dominate the industry, but the decline in the optum Health has attracted Wall Street's attention.

“We know that the performance of optum has not fulfilled expectations. We are new to a fundamental execution to ensure that we enable our potential to improve the health system for everyone,” said Dr. Patrick Conway, CEO of Optum, in publication.

The company expects the overall optum unit 2025 to achieve sales of $ 266 billion to $ 265.7 billion.

Reaction of Unitedhealth to Doj examination

In particular, the report is only a few days after Unitedhealth has shown that he complies with the investigation by the Ministry of Justice for his Medicare -Billing practices.

Noel said on Tuesday that the company was expanding its efforts to monitor its business practices and prevent additional costs for consumers.

“We have increased our tools for audit, clinical guidelines and payment integrity tools to protect customers and patients from unnecessary costs,” he said, adding that the company uses AI tools to improve patient and provider service and save costs.

During the earnings call, the new CEO of the Unitedhealth Group, Stephen Hemsley, admitted that the company and other insurers have “continued public controversy over long -term practices”.

He added that we made the “environmental factors” that influence the entire sector, “made prices and operational errors and others”.

“You get the necessary attention. Our critical processes, including risk status, care management, pharmaceutical services and others are checked by independent experts and they are checked and reported every year,” he said. “And these processes can be checked by external stakeholders at any time.

These experts include analysis Group and FTI Consulting, said Hemsley. He added that the company expects the review to be completed by the end of the third quarter of this year to publish a first report on the results in the fourth quarter.

“While we believe in our supervision and the integrity of these processes, wherever you are determined to differ with the prescribed practice, you will be remedied immediately and we will continue this way,” he added.

It is Unitedhealth's first winning report under Hemsley, which has the task of restoring the trust of investors and turning a fighting company that has continued to have a strong public exam in recent months. The UnitedHealth Group's shares fell by more than 44% in the year, which is partly driven by the examinations of the doj and its suspended prospects.

The company's 2024 wasn't better. Brian Thompson, the CEO of Unitedhealthcare, the murder of Unitedhealthcare, the following public setback and a historical cyber attack that affected millions of Americans.

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Unitedhealth UNH -Q2 -Winn preview

Omar Marques | Light rocket | Getty pictures

Unitedhealth Group The chairman and CEO Stephen Hemsley will be exposed to the first real test on Tuesday before the first real test if he reports the result as the greatest private US insurer.

The Dow component has reduced almost half of the share price since mid-May, with the share for the worst year for more than a decade after the income in its flagship medicare program and the optum health doctor practice. This led to the abrupt resignation of the former CEO Andrew Witty and forced the company to replace ex-CEO hemsley and to suspend the profit guidelines. In addition, the company is faced with its Medicare -Billing practices against investigations into criminal and civilian Ministry of Justice.

Since Unitedhealth faces challenges on several fronts, it is in a “perfect storm,” said Ann Hynes, analyst of Mibuho Securities. Now investors want to know how Hemsley directs the company from the vertebral storm after having assured last June that “we are humbly determined to regain their trust and trust”.

Here are three important things that investors from the company's profit report will search.

The large number: 2025 instructions

More than the numbers in the second quarter, the analysts concentrate on the prospects of Unitedhealth for the entire year. Hemsley informed investors that the company would update the profit guidelines for 2025 after it had suspended its forecast in May.

Analysts expect Unitedhealth to publish adjusted income of $ 21.26 per share according to Consensus estimates from LSEG. The estimates range from a low of $ 18 per share to a climax of $ 26.44 per share.

“Everything under $ 18 – that would be negative from the street,” said Hynes

The RBC Capital Markets Analyst Ben Hendrix has set its estimate of a consensus of $ 23.36, but said Wall Street was still a bear for Unitedhealth.

“While we rely our more optimistic prospects on the claim of management that Medicare Advantage for 2026 with the 3% low low-end-MA margins is still responsible within sight.

Medicare Advantage and Optum Health Outlook

Analysts also concentrate on how the company plans to stabilize its unity of doctors, optum health. For years, Unitedhealth helped outperform his colleagues in his flagship Medicare Advantage program by using the 90,000 employees or connected doctors to treat patients in their own plans of Unitedhealth.

“Investors really invested in United for the power of … Optum Health, the power of United, who controls their own Medicare Advantage members, and showed a considerable lead that they could not have before,” said Baird -Analyst Michael Ha.

But in the first quarter this year, Optum Health recorded a strong profit. Analysts said that the jump was partially due to a change in the Medicare refund standards of the bidea era as V28, which makes it more difficult to calculate insurers and doctors to calculate additional services.

According to Mibuho's Hynes, earlier billing coding rules left a lot more space for plans to add billing codes in connection with chronic diseases such as general heart diseases, which would be a higher risk assessment and a reimbursement rate for a higher risk. As part of the new V28 rule, the billing codes are more specific and close gaps that could increase the reimbursement.

“V28 is very black and white, so you have no ability to add codes, and many codes are removed,” she said, adding that this has now led to a structural shift of the edges for the optum health. “

But HA noticed that the V28 changes began in 2024 at a time when seniors started more care. Many of the Medicare Advantage competitors from Unitedhealth made adjustments last year to eliminate the shift. The sudden collapse of optum Health Margen in the first quarter seems to have surprised Unitedhealth.

“I think it is an example of misxecution. They knew that the headwind in the year and well before, but the offset could not find one or the other reason,” said Ha. “We are still confident that Optum Health and United can recover and rebuild the economy of the units, but we think over the next one to two years that this may be possible.”

Legal and regulatory questions

The company rose the winning report on Thursday and recognized in a SEC registration that the Medicare program was exposed to criminal and civil probes by the Ministry of Justice.

According to Unitedhealth, the company is working with the investigation that was first reported by the Wall Street Journal. In March, a statutory special champion also decided in favor of the company in March, in which similar allegations by the doj were submitted during the first Trump administration.

Hynes believes that investors' concerns about the Doj probes have been exaggerated.

“The stock acts as if the government was throwing it from Medicare and Medicaid, and in my opinion the probability is zero,” she said. “It will probably cause you to write a check and make a company integrity agreement … that has happened in the past.”

But the shooting of the death of the Unitedhealth Executive Brian Thompson last December, who was carried out by a shooter to the public prosecutor, who was motivated by insurance refusers, triggered a basis for public criticism of the practices of health insurers.

The former Whistleblower Wendell Potter, who criticized the industry practices after a career at Cigna, said that the pressure on large insurers like Unitedhealth would probably not stop. The regulatory examination in the congress has increased on both sides of the aisle, since Washington is asserted with high health and drug costs in Medicare, Medicaid and other state health programs.

“Many members of the congress who are doctors or republicans are pharmacists and see first -hand the heavy hand of these companies,” said Potter, President of the Center for Health and Democracy. “And so they see interest of Republicans, and I've never seen that before.”

In June, Unitedhealth announced that the examiners of Third Party be hired to check the company's practices in relation to health insurance and pharmaceutical targets in order to “ensure our stakeholders transparency and trust in the company's business practices”.

The company announced CNBC that not many details on this audit would offer this audit during the win for the second quarter. It is not expected that the review will be completed by the end of the third quarter of this year.

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Bristol Myers Squibb, Pfizer, to promote Eliquis with a 40% low cost

Bristol Myers Squibb And Pfizer On Thursday, she explained to sell her blockbuster blood thinner, Eliquis, directly to patients with a discount of more than 40%.

The step comes when the Trump administration increases the pressure on the pharmaceutical industry in order to reduce drug prices and threatens to impose imposed pharmaceuticals in the USA extensive tariffs

The new efforts of companies would bypass traditional middlemen, including the managers and insurers of pharmacies, to reduce the monthly costs of the medicine from a list price from around 606 US dollars. From September 8th, insured, sub-insured and self-paid patients cannot acquire the medication directly from the Eliquis 360 support program, which sends their recipes directly to their houses.

However, the reduced price for Eliquis is still more than nine-time, the average monthly costs for the expenses of $ 38, which are paid by patients who are commercially insured. The price as part of the new program is also significantly higher than the price of $ 231 per month, which Medicare has negotiated as part of a determination of the Inflation Reducation Act of the Biden Administration. This negotiated price will come into force next year.

The negotiated price is what Medicare will pay for Eliquis, and does not determine what Medicare patients will pay for the medication now or in the future, said Bristol Myers Squibb and Pfizer in a joint explanation. They added that the negotiated price does not reflect the essential clinical and economic value of this essential medicine.

More than 90% of the Eliquis recipes in the United States are currently covered by insurance companies. However, Bristol Myers Squibb and Pfizer said that the new effort aimed to expand access to treatment, reduce the costs for the patient and to ensure transparent pricing for another group of patients.

“This program hands more savings directly to the patients and shows that we continue to concentrate on the identification of innovative solutions that promote the best results for everyone and at the same time prioritize access to care,” said Chris Boerner, CEO of Bristol Myers Squibb.

In a note on Thursday, the analyst of Leerink Partners, David Risinger, said that he believes that the move to Trump's plan for reducing the US medicinal cost costs by linking the prices with the countries paid in other industrialized countries. The president signed an executive order in this plan in May.

According to Risinger, the drug manufacturers already offer the managers of the Pharma Zu -Benefiz Manager high discounts on Eliquis, so that the company does not expect the Bristol Myers Squibb and Pfizer program to create a “net price”.

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RFK Jr. to take away mercury preservatives thimerosal from flu vaccinations

The secretary of the US Health and Human Services (HHS), Robert F. Kennedy Jr., speaks to the Agriculture Minister Broke Rollins and Senator Roger Marshall (R-KS) before a roundtable event as part of the “Make America Healthy” (Maha) Agenda on the Capitol Hill in Washington, DC, July 15, 2025.

Ken Cedeno | Reuters

The Department of Health and Human Services said on Wednesday that it would officially remove the Mercury-based preservative Thimerosal from all flu photos distributed in the USA-there are no indications of damage caused by the ingredient.

While only a few jabs still contain thimerosal, the move eliminates a vaccine option for Americans and is a victory for the anti-accacine movement that has long been aimed at the ingredient.

HHS Secretary Robert F. Kennedy Jr. passed a recommendation in June by an important state vaccine committee, which was called the advisory committee for immunization practices (ACIP) against influenza recordings with thimerosal. At the beginning of this month, Kennedy detached this panel and reorganized it with new members, including some well-known anti-Accin activists.

The decision affects around 4% to 5% of the US flu vaccine supply. This includes some multi-dose forms of Sanofi'S Fluzone and two shots from the Biotech Company CSL SEQIRUS. The rest of the nation's flu photos was free of Thimerosal, according to the CDC data last season.

Vaccination manufacturers have confirmed that they have the capacity to replace multi-dose areas that contain mercury, said HHS. This will ensure that the flu vaccine for adults and a government program that does not shoot and under -insured children are not interrupted, the agency added.

However, health experts have announced that the elimination of thimerosal-containing flu vaccinations as an option for Americans could lead to fewer people.

The move also increases long -term, unfounded fears that the substance can lead to developmental disorders such as autism. Kennedy's skepticism of vaccine closes the circle with Acip's voice: A decade before he entered his current role, he published a book that demanded the removal of Thimerosal from Schüussen and linked it to developmental disorders.

“After more than two decades of delay, this campaign fulfills a long overdue promise to protect our most endangered population groups from unnecessary Merkur exposure,” said Kennedy in a press release and asked the global health authorities to follow the expression.

More than 40 studies over several decades have not found a connection between thimerosal and developmental delays. For decades, thimerosal has often been used as a preservative to prevent the growth of harmful bacteria in several drugs and vaccines with several doses.

According to HHS, further recommendations from the committee meeting in June will be checked.

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UnitedHealth confronted with Medicare to analyze the DOJ towards Medicare

Unitedhealth Group On Thursday it reveals that the Ministry of Justice is examined via its Medicare -Billing practices, which leads to a series of setbacks for a company that has the largest and most powerful private insurer in the country.

In a securities registration, the company stated that it complied with formal criminals and civilian inquiries from the Doj and that it turned to the department after reports on the probes appeared. Unitedhealth also announced that it started a review of his business policy and performance metrics from third -party providers.

The company announced CNBC that it expected to complete this review towards the end of the third quarter.

In the submission, Unitedhealth said that it has “full confidence in its practices and is committed to cooperative with the department in this process.”

The UnitedHealth Group's shares decreased by 2% on Thursday. The company's managers will probably ask themselves questions about the probe during his profit in the second quarter on July 29.

Jared Holz, Mazoho Securities Health Care strategist, said on Thursday in an email to customers that the announcement was “not shocking”, but stated that the company had previously refused to investigate doj. He said Unitedhealth's decision to admit the probes and work with the department, “everyone sounds logical when it progresses with a new CEO”.

The company announced the abrupt departure of the former CEO Andrew Witty in May.

The announcement of Unitedhealth on Thursday, after the Wall Street Journal in May, comes that the Ministry of Justice conducts a criminal investigation by the health giant about possible medical fraud. In response to the fact that the company is “due to the integrity of our Medicare Advantage program”.

In July, the journal also reported that the Doj asked several doctors about Unitedhealth practices and whether it felt forced to raise claims for certain conditions that strengthened the payments from the Medicare Advantage program to the company.

This was the second time this year that the insurer's Medicare Advantage business was examined. The journal also reported in February that the DOJ carried out a civil law investigation as to whether the company had inflated diagnoses to trigger additional payments for its Medicare Advantage plans.

On Thursday, Unitedhealth said that independent audits of the Centers for Medicare and Medicaid Services “confirm” that the company's practices are “one of the most precise in the industry”.

More CNBC health insurance

In March, Unitedhealth also referred to a recommendation of a special master in favor of the company in a year -long legal dispute with the Doj, which started with a whistleblower, which claimed that the company had illegally held back at least 2 billion US dollars via the Medicare Advantage program. The special master assigned by a judge told the case that the Doj had no evidence.

The Medicare and Retirement segment of Unitedhealthcare, which includes the Medicare Advantage Business, is the largest sales driver of the Unitedhealth Group, which has achieved sales of $ 139 billion last year.

The update in the probe takes place after a turbulent last year for Unitedhealthcare. Shares of the parent company of Unitedhealthcare, Unitedhealth Groupare announced more than 42% for the year after it had exposed its forecast from 2025 in the midst of medical costs, Witty's surprise outcome was announced and dealt with the reported probes in his Medicare Advantage business.

The company of the company in 2024 was not easier, characterized by a historical cyber attack and the electricity of public blowback after the murder of the CEO of Unitedhealthcare, Brian Thompson.

– Bertha Coombs from CNBC contributed to this report.

Do not miss these findings from CNBC Pro

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Researchers strategy a common most cancers vaccine

Wild pixels | IStock | Getty pictures

A version of this article was first published in CNBCS Healthy Return's newsletter, in which the latest health news leads directly to their inbox. Subscribe here to get future expenses.

A universal cancer vaccine – what once seemed like a pipe dream – could approach reality.

On Friday, researchers from the University of Florida said that results from a new study could lead to the development of a universal shot that can start the immune system to combat cancer. The study of mice published in Nature Biomedical Engineering showed that an experimental MRNA vaccine increased the tumor control effects of a common cancer medication called Immun-Checkpoint inhibitors.

The vaccine is not designed for a certain virus or cancer cells, but to “wake up” the immune system against the disease “to react as if you are fighting a virus,” said a UF release.

“We found that a vaccine is used not to specifically target cancer, but to stimulate a strong immunological reaction, we were able to create a very strong reaction against cancer reaction,” said Dr. Duane Mitchell, co-author of the study and professor of neurosurgery at the medical college of Medicine at the university.

This is different from current approaches to cancer vaccines in which a goal is found that is expressed by many cancer patients or in the event of a case of Modern And MerchantDevelopment of personalized vaccines that are tailored to the specific tumor of each patient.

The universal vaccine has the potential to be used largely in cancer patients, “even a cancer-suffering cancer vaccine,” said Mitchell.

The UF researchers are still working on replicating the results in humans. If this is the case, a vaccine with a sizes could offer an alternative to operations, radiation and chemotherapy.

This is how the vaccine works: The MRNA shot essentially calls on the body to produce certain proteins that stimulate the immune system, including one that is called PD-L1 and can often be found on the surface or within cancer cells. These cells often use PD-L1 to hide from immune attacks.

By increasing PD-L1, however, the vaccine tumors can make more susceptible to immune checkpoint inhibitors that block this protein more susceptible and contribute to recognizing and destroying the immune system.

The study showed promising results on treatment-resistant tumors in skin cancer by combining the mrNA vaccine with a monoclonal antibody, a frequent immunotherapy medication that tries to draw the immune system aware that a tumor is foreign and attacked.

It also showed positive results when they were tested as a solo treatment of cancer of mouse, bones and brain test. In some cases, the tumors were completely eliminated.

“This paper describes a very unexpected and exciting observation: even a vaccine that is not specifically for a certain tumor or virus it is a mRNA vaccine-could lead to tumor-specific effects,” said the high-ranking author Dr. Elias Sayour, a pediatric oncologist from UF, in a release.

Feel free to send Annikakim.constantino@nbcuni.com tips, suggestions, ideas and data to Annika.

Latest in the healthcare system Tech: Digital Health Earning season is approaching.

We are only removed from the highlight of the digital health earnings season for a few days, and this quarter will certainly be interesting.

The two companies, the beginning of this year, went to the stock exchange, will report results for the first time since their debut. And since President Donald Trump's tax and expenditure law adopts and approaches his tariff period on August 1st, we will get an insight into the operation of digital health companies against a volatile macroeconomic and political backdrop.

Here are some of the reports on which CNBC will be observed:

Health hinge – August 5th

  • The digital physiotherapy company HEALTH will publish its result in the second quarter on August 5, its first report since its debut at the New York Stock Exchange in May. The stocks of Hinge were opened on May 229.25 and they act on Wednesday after trading with Intraday over $ 46. In his first quarter of this year this year rose by 50% to $ 123.8 million, compared to $ 82.7 million in the previous year, and this net income for the period was $ 17.1 million compared to a loss of $ 26.5 million before the previous year.

Omada Health – August 7th

  • The Virtual Chronic Care Company, Omada Health, will report results in the second quarter on August 7, which reveals finance data for the first time since his debut in June. The stocks of Omada were opened on June 6th at 23 USD and they act on Wednesday for trade in trade with around 19 US dollars. According to the prospectus, Omada's turnover rose by 57% in the first quarter to $ 55 million compared to $ 35.1 million in the previous year.

Hims & Hers Health – August 4th

  • Telemealth Company HIMS & HERS Health Reports Reports in the second quarter on August 4th and managers will probably have questions about his short -lived cooperation with jobs Novo Nordisk. In April, Novo Nordisk said that Wegovy would offer several telemedicine companies, including HIMS & Her, to expand access to the injection of the blockbuster weight loss. But at the end of June, the deal collapsed over the sale and promotion of cheaper qualifications from HIMS & Huls. The shares of HIMS & HIS rose by more than 100% after the intraday trade on Wednesday after the intraday trade.

Doximity – August 7th

  • Doximity, a digital platform for medical professionals, was one of the few breakout stars from 2024 when the company's share price more than doubled. Investors will observe closely whether the company can maintain its dynamics if the results report on August 7 in the first quarter of 2026. The stocks of doximity rose by more than 13% this year after the intraday trade on Wednesday.

Teladoc Health – July 29th

  • The CEO of Teladoc Health, Chuck Divita, has worked after four right quarters with sales declines and an extended slump in stock burglary to turn the once high -flying company in a row. The company will publish results in the second quarter on July 29. The TELADOC shares decreased by more than 4% by the time of Intraday trading on Wednesday.

We will have a lot to dive in the coming weeks. So keep the reporting of CNBC step.

Feel free to send tips, suggestions, story ideas and data to Ashley at Ashley.capoot@nbcuni.com.

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It's all concerning the directions

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FDA Faucets Biotech Exec George Tidmarsh as a high drug regulator by RFK Jr.

FileToto: The headquarters of the US Food and Drug Administration (FDA) can be seen in Silver Spring, Maryland, November 4, 2009.

Jason Reed | Reuters

The Food and Drug Administration said on Monday that it had appointed the former biotech manager George Tidmarsh the best drug regulator of the agency.

Tidmarsh, extraordinary professor of pediatrics and neonatology at Stanford University School of Medicine, heads one of the largest and most important departments in the FDA, which checks the vast majority of the new drug applications.

The Center for Pharmaceutical Assessment and Research or Cder regulates over -the -counter and prescription treatments, including biological therapies and generics. The reigning director CDS, Jacqueline Corrigan-Curay, announced in June that she retired.

Tidmarsh will be exposed to the FDA and its regulatory process under massive upheavals in the context of the health and human service -secretary Robert F. Kennedy Jr.

Tidmarsh's extensive background in the industry and participation in the development of seven drugs that have now been approved is probably a sigh of relief for the pharmaceutical industry. His earlier comments signal that he could pursue a more difficult approach to regulating medication.

In an opinion in April, Tidmarsh struck regulatory decisions of an important civil servant who was pushed out of FDA under Kennedy, Peter Marks. This includes the support of the accelerated approval of Biogen 'S Unhappy Alzheimer's drug, Aduhelm and Repfuling FDA employee to expand the approval of Sarepta therapeutics'Duchenne muskeldystrophy treatment elegen.

Last week, the FDA asked the Sarepta therapeutic agent to stop all deliveries of ELEDYS after three patients died of liver failure after taking or similar treatment. The company later said that there would be no shipments to treat patients with the disease who can still run, and say that data “no new or changed security signals in this group show”.

In an interview with CNBC on Friday, before the Tidmarsh appointment was announced, Mark said that his earlier decisions about gene therapy were “made the best available knowledge at this time”. At that time, the debate about effectiveness, not on security, revolved, he said.

Marks said that he does not think that it was “unreasonable” to ask Sarepta, paused programs until “they checked a real evaluation of everything that is going on”.

Tidmarsh will probably have a say in this controversial accelerated approval procedure and the FDA's approach to advertise prescription drug advertising. He was CEO of La Jolla Pharmaceuticals and Horizon Pharma, from which he had previously founded Amgen Bought it for $ 28 billion. Tidmarsh also founded the threshold pharmaceutical and had leading positions at other biotech companies.

“Dr. Tidmarsh is an accomplished medical scientist and leader, whose experience extends the full arc of drug development from the bank to the bed,” said FDA commissioner Dr. Marty Makary in an explanation. “His appointment as head of Cder brings exceptional scientific, regulatory and operational expertise to the agency.”

– Angelica Peebles from CNBC contributed to this report

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Weight reduction medication might assist deal with PCOS

Wegovy injection pens arranged in Waterbury, Vermont, US, on Monday, April 28, 2025.

Shelby Knowles | Bloomberg | Getty Images

For well over a decade, Grace Hamilton, 27, experienced hair loss, heavy periods, infrequent menstrual cycles, mental health issues and difficulty losing weight without knowing why. It wasn’t until 2021 when she was diagnosed with polycystic ovary syndrome, or PCOS, a hormonal disorder common among women of reproductive age.

After she saw limited improvements from birth control, diet and exercise, Hamilton joined a trial in 2024 examining a GLP-1 drug in PCOS patients. By October, she received her first weekly dose of semaglutide, the active ingredient in Novo Nordisk‘s obesity injection Wegovy and diabetes shot Ozempic.

She said some results were almost immediate: after months without a cycle, her period resumed within two weeks of starting the drug. After 10 months on the treatment, Hamilton lost 50 pounds, saw hair regrowth and reported significant improvements in depression and anxiety

“I’m so glad that I stuck with it because it was just clear as day that it was the missing link for me,” said Hamilton, who works at a nonprofit in Arvada, Colorado, adding that she maintained diet and exercise while on the drug. 

She is just one of several women who have reported improvements in symptoms of PCOS after using GLP-1s, a growing class of obesity and diabetes treatments that have drawn massive patient demand and investor buzz over the last few years. Treating PCOS is among several new but unapproved potential uses of the blockbuster drugs beyond promoting weight loss and regulating blood sugar.

Grace Hamilton, a patient with PCOS talking GLP-1s in Galway, Ireland.

Courtesy: Addison Peacock

PCOS, which is frequently underdiagnosed, affects an estimated 5 million to 6 million women of reproductive age in the U.S., according to some estimates. 

The condition is typically characterized by higher levels of testosterone and other hormones usually associated with men called androgens, which can leads to symptoms such as irregular and painful periods, excess hair growth and acne. PCOS is the most common cause of infertility. 

The condition is strongly linked to metabolic issues, as an estimated 35% to 80% of patients experience insulin resistance. That means the pancreas pumps out more insulin to keep blood sugar in check, and high insulin levels can promote weight gain and disrupt hormone balance. A significant share of women with PCOS have obesity or Type 2 diabetes. 

Yet there’s no standard PCOS treatment. Current options like birth control, lifestyle changes and the diabetes drug Metformin may only help with certain symptoms, which could differ depending on the patient. 

But some health experts see promise in GLP-1s, particularly given their effect on improving weight loss and insulin sensitivity. 

“The unmet need is massive,” said Dr. Melanie Cree, a pediatric endocrinologist at Children’s Hospital Colorado. “Primary therapies used for PCOS symptoms haven’t changed in nearly 50 years.”

Cree has been studying the effect of GLP-1s in adolescents with PCOS for more than 10 years. She previously studied the oral form of semaglutide and has an ongoing clinical trial on the injectable version, which is what Hamilton participated in for 10 months. 

But her studies are still small in comparison to drugmakers’ previous clinical trials on GLP-1s with thousands of patients. Not all of the women who have so far completed Cree’s ongoing study lost significant weight, demonstrating that not everyone may respond to GLP-1s.

Novo Nordisk and rival Eli Lilly have been studying their GLP-1s as potential treatments for other chronic conditions like fatty liver disease, but not PCOS. Cree said that’s because the Food and Drug Administration has not established specific “endpoints” or goals drugs must meet in clinical trials to demonstrate how effective they are for PCOS. 

In a statement, a Novo Nordisk spokesperson said the company welcomes “independent research investigating the safety, efficacy and clinical utility of our products, including semaglutide.” Eli Lilly did not immediately respond to a request for comment. 

Conducting longer and larger trials to better understand the effect of GLP-1s on PCOS symptoms is crucial, said Sasha Ottey, executive director of the advocacy group PCOS Challenge. It is still unclear if GLP-1s can help address or resolve all PCOS symptoms, or whether the effect differs depending on a patient’s age or the specific drug, Ottey said. 

She added that certain patients may not lose weight on GLP-1s, and others may not need to shed pounds.

Meanwhile, insurance coverage for GLP-1s is a barrier for some PCOS patients, who are often eligible for approved uses of the drugs. Most plans cover GLP-1s for diabetes, but not for obesity or unapproved uses. The drugs can cost roughly $1,000 per month before insurance. Still, Eli Lilly and Novo Nordisk offer significant discounts on their drugs to some patients who pay for it out-of-pocket.

Why GLP-1s may address PCOS symptoms 

More research is needed to fully understand why GLP-1s may help some PCOS patients, but Cree said their effect on symptoms appears to be largely indirect. 

She said a key finding in several previous studies motivated her to start studying GLP-1s: In adults with PCOS, losing as little as 5% of body weight can improve insulin sensitivity.

That makes the body respond better to insulin, so it doesn’t need to produce as much of it to manage blood sugar. That lowers insulin levels, which Cree and some researchers believe causes the ovaries to produce less testosterone and, as a result, can help reduce symptoms such as irregular periods, acne and excess hair growth. 

“One of the questions was, what other methods do we have to improve insulin sensitivity?” Cree said. She noted that other recommended treatments for PCOS symptoms, such as food changes, increasing exercise and the diabetes drug Metformin, are based on that goal.

GLP-1s such as semaglutide improve insulin sensitivity and reduce appetite through several mechanisms. That includes slowing how quickly food leaves the stomach, prompting the pancreas to release insulin when blood sugar is high and suppressing the release of a hormone that raises blood sugar.

The weight loss caused by GLP-1s further helps improve insulin sensitivity. 

Daniel Grill | Tetra Images | Getty Images

Early results from Cree’s ongoing study support the idea that GLP-1s may lower testosterone. 

The trial, which began in 2023, follows girls and women ages 12 to 35 with obesity and PCOS who are on or off Metformin. The study is designed to administer semaglutide to patients for 10 months, and examine their weight loss, metabolic changes and improvements in reproductive function. 

Cree hopes the trial will answer whether GLP-1s can improve ovulation in women with PCOS. Many women with PCOS don’t ovulate regularly, which can lead to irregular periods and difficulty getting pregnant.

Cree has initial data on 11 women who completed the 10 months on semaglutide and were not on Metformin. She said eight of them lost more than 10% of their body weight and saw a reduction in their testosterone levels. 

Five out of the eight patients had their testosterone levels reach “normal ranges,” Cree said. Meanwhile, six out of the eight patients reported more regular periods. 

Cree said her trial will eventually have data from 40 women, but she is still enrolling patients in the group that takes Metformin. She said it will likely take two years before she publishes the first results from the study, which will focus on the differences in outcomes between kids and adults who only received semaglutide. 

She said comparing the groups is crucial because hormones that control growth are released during puberty, which could change how kids respond to GLP-1s. 

Not all women with PCOS will benefit from taking a GLP-1. Cree said in her trial, three patients who completed 10 months on semaglutide did not lose at least 10% of their body weight. One of those women did not lose weight at all, she said. 

Cree said that’s consistent with previous studies on GLP-1s in adults with obesity. 

Despite the promise of GLP-1s in improving symptoms, more research is also needed on PCOS itself, said Dr. Karen Tang, an OB-GYN and founder of Thrive Gynecology. She said some people can experience hallmark symptoms of the condition, such as facial hair and acne, even though they have normal levels of testosterone. 

“There’s still a lot that’s very much unknown about PCOS and exactly how the disease kind of works,” Tang told CNBC. 

GLP-1s give some patients a big boost

Anecdotal evidence suggests GLP-1s may address more than just weight issues for people with PCOS. In a recent survey of 1,700 people by the birth control app Natural Cycles, 64% of women with PCOS who took a GLP-1 reported more predictable periods, and 20% said their bleeding days were shorter.

Some patients with PCOS may also lose more weight on GLP-1s than those without the condition, said Dr. Kerry Krauss, an OB/GYN and medical director at Natural Cycles, who has PCOS herself.

Research needs to confirm those benefits, but she said it gives hope to many PCOS patients who are frustrated with common treatments for the condition. Those options typically target just one aspect of PCOS, such as reducing androgen levels with certain types of birth control. 

Tang added that diet and exercise alone often fall short of addressing symptoms: “A lot of people can exercise very aggressively and regularly or watch what they eat and still struggle with hormone imbalances, weight, and blood sugar.”

Haley Sipes a patient with PCOS taking GLP-1s.

Courtesy: Haley Sipes

That was the case for Haley Sipes, a 31-year-old mother of three based in Western Kentucky who experienced PCOS symptoms for years without a diagnosis. In 2022, before being diagnosed, she lost 75 pounds over 10 months through diet and exercise alone. 

Her progress stalled in late 2022 despite an intense diet and exercise regimen, and her weight began to fluctuate in 2023. By mid-2024, she had regained about 30 pounds. 

Sipes sought help from her primary care provider and underwent blood work, which revealed she had a hormonal imbalance. Initial efforts to regulate her hormones with progesterone and testosterone had a limited effect.

Further bloodwork diagnosed Sipes with PCOS and insulin resistance, which she views as the root cause of her weight loss struggles. She recalled bloating, fatigue, low energy, and water retention during earlier efforts to lose weight.

Despite her history of painful, irregular periods and ovarian cysts since age 10, her providers never mentioned PCOS as a possible diagnosis.

In September 2024, her doctor prescribed Zepbound. Her insurance covered it due to her BMI and prediabetes status.

Sipes said she noticed changes within the first month: her food cravings quieted, her inflammation decreased, she experienced less joint pain, and her period became less painful and occurred more regularly. Sipes added that she has not had ovarian cysts since starting Zepbound. 

After around eight months on the medication, she lost more than 60 pounds. Sipes said those results significantly improved her emotional health.

“All the symptoms and being overweight might not seem like big things, but when you have 20 little things that are constantly nagging you, then you’re going to be in a bad mood sometimes,” Sipes said. 

“I’m just a better version of myself when I’m not controlled by food thoughts and hormonal issues that cause mood swings,” she continued. “My life does feel so much more enjoyable.”

Sipes plans to continue taking Zepbound to maintain her results, possibly at lower doses. She noted that more research is needed on whether PCOS symptoms can fully resolve.

Insurance coverage is a challenge

Insurance coverage is currently the biggest hurdle preventing PCOS patients from accessing GLP-1s, said Dr. Alyssa Dominguez, an endocrinologist with Keck School of Medicine at the University of Southern California. She said many PCOS patients are eligible to use GLP-1s for their approved uses based on BMI or related conditions, but may not have coverage. 

More than one-third of employers now cover GLP-1s for both weight loss and diabetes, while 55% only cover them for diabetes, according to a recent survey from the International Foundation of Employee Benefit Plans. 

In April, President Donald Trump rejected a Biden administration plan that would have required Medicare and Medicaid to cover obesity drugs.

Nabeelah Karim is a patient with PCOS who took GLP-1s to manage her symptoms.

Courtesy: Nabeelah Karim

Some patients, like 34-year-old California mom Nabeelah Karim, have turned to other options. 

Karim was diagnosed with PCOS at 19 and took birth control on and off until giving birth in 2021. She said she struggled with hair loss, irregular periods, debilitating cramps, facial hair growth, severe water retention and mood swings. 

Karim said her period symptoms worsened after she gave birth, and in late 2023, she began what would be a painful five-month-long period. Doctors suggested that she lose weight, take painkillers or return to birth control. 

While Karim lost some weight through diet and exercise, she was eventually prescribed Eli Lilly’s diabetes drug Mounjaro through the digital health startup Noom in April 2024. 

Her long period stopped and symptoms eased within days, and she began to lose more weight over time. 

“It had solved all the problems that I had experienced for years up until that point,” Karim said. 

But her insurance plan never formally approved or denied coverage of Mounjaro, forcing her to pay its more than $1,000 per month out-of-pocket price. She eventually found a third-party compounding pharmacy that accepted her prescription, allowing her to buy a cheaper but unapproved version of the drug. 

Karim used that compounded version for six months and continued to experience weight loss and improvements to her PCOS symptoms. 

During FDA-declared shortages, pharmacists can legally make compounded versions of brand-name medications. They can also be produced on a case-by-case basis when it’s medically necessary for a patient, such as when they can’t swallow a pill or are allergic to a specific ingredient.

But Novo Nordisk, Eli Lilly and some health experts have pushed back – and in some cases, taken legal action – against the practice, largely because the FDA does not approve compounded drugs. The FDA has declared U.S. shortages of both companies’ drugs over. 

“When people ask about how safe compounded drugs are, the answer I typically give is I don’t know,” said Dominguez from USC’s School of Medicine. She said that’s unlike branded drugs, which have clearly defined risks and benefits proven in clinical trials.

Hamilton, the 27-year-old patient who took a GLP-1 for PCOS symptoms, has never taken a compounded GLP-1. She is currently appealing her insurer’s denial of semaglutide now that she has completed Cree’s trial. 

“My whole life has been an inability to access care for my medical condition, and I’m tired of that,” she said. “If somebody would have been able to provide 11-year-old Grace with this drug, that would have saved me.”

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Health

Sarepta Inventory falls on the FDA -Gent remedy -Pidys feedback.

Douglas Ingram, President and Chief Executive Officer of Sarepta Therapeutics Inc., during the Forbes Healthcare Summit in New York, USA, on Tuesday, December 5, 2023.

Michael Nagle | Bloomberg | Getty pictures

Shares of Sarepta therapeutics More than 30%fell on Friday when the future of approved gene therapy was endangered.

The Food and Drug Administration will apply for the company to voluntarily stop all programs, Eldys, a person who is familiar with the matter, said CNBC.

Sarepta said CNBC that the FDA did not hear it.

Regardless of this, the FDA Commissioner Marty Makary said in an interview with Bloomberg News that the agency was considering whether the company's gene therapy should remain on the market.

The FDA examines two patients bound by Elefidy's deaths, which makes up more than half of the total income from Sarepta. The company also reported a third death that was bound to separate experimental gene therapy.

Eldys was involved in controversy in controversy before approval. Gent therapy must still clearly prove that it can benefit people with Duchenne muscle dystrophy, an illness that undermines muscle function over time.

After all, people with the disease lose the ability to run, and most of them die in their early 20s, which means that there is a large, uncovered need for treatment. In 2023, the FDA originally granted an elemented eligent for patients between 4 and 5 years, the group, which had the greatest benefit in clinical studies.

The following year, the agency of treatment gave patients 4 and older who still go and the approval for patients 4 and on accelerated people who could no longer run. The latter decision was particularly controversial because there was fewer indications that Elefidy's people could help people whose illness had already made so much progress.

In addition, Elefidys did not confront his goal in a phase -3 study, although the company claimed that the drug had performed promising metrics in the study. Then Peter Marks, Head of the FDA Center for Biologics, agreed with Sarepta's assessment and overlooked the FDA employee from FDA to expand the approval of Eltidys.

At the beginning of this year, Sarepta announced that two young boys died of liver failure after receiving elkae. Then this week reports that another person died during a phase -1 study in which another genetic therapies of Sarepta were examined for another disease.

The two therapies are different, although they have the same delivery method, which increases the security concerns around the element closure. The security risks of ELEDYS are particularly important in view of the uncertain benefit, said the BMO analyst Kostas Bilioouris.

For example, Novartis' gene therapy for the muscular atrophy of the spine also causes liver oxicity and death, but the benefits of this treatment is clear.

“That is why deaths here, for example, are so important to Zengensma,” said Biliouris.

And Zengensma is only a drug of many for a large company like Novartis. Elefidys is everything for Sarepta.

This week managers tried to calm investors that the therapy should bring in at least 500 million US dollars a year, even if they can only treat patients who can still run where deaths were not reported. Sarepta hired the shipping of elegips to patients who can no longer run while examining a safer way to give treatment.

At that time, the top concern for investors is whether the FDA is pulling the medication, said Biliouris. The company's share has fallen more than 87% this year.

“When the FDA moved to ELEDS on the market,” he says, “Sarepta is ready.”

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Jennifer Hand, whose son was diagnosed with Duchenne Muskeldystrophy at the end of 2020, said that it was “heartbreaking” that other patients have no treatment option to turn when the shipments are held by Eldys.

Her son Charlie was dosed in electrodes in 2022 as part of the experiment with Sarepta and found improvements in six to 12 months, including increased endurance and more liquid movements. The drug also facilitated a treacherous symptom of the disease, which is referred to as Gowers signs and causes the children to find difficulties if they get up from a seat or lying position.

She said her son was “completely stable” from his dose for three years. Handt said she was aware of the liver toxicity risks before Charlie was inscribed in the process.

“We don't have the luxury not to take the risk,” said Handt. “There are families who have dealt with this disease because this would have done something to have an option, even if there are risks.”

“Every family should have the choice to make this jump with this medication and possibly see advantages,” she added.

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