Cigna (CI) Shares Dip on Presidential Push Against Drug Middlemen

 

• The Cigna Group (CI, Financial) stock experiences a 5% drop following policy changes targeting pharmacy benefit managers.

In a notable shift affecting The Cigna Group (NYSE: CI), the company's stock witnessed a 5% decline. This reaction followed President Trump's announcement at a White House event targeting pharmacy benefit managers. The new initiative aims to cut down on drug prices, which includes reforming intermediaries such as Cigna's Express Scripts. Notably, this policy shift also led to a 3% decrease in CVS Health's stock.

https://www.gurufocus.com/news/2854171/cigna-ci-shares-dip-on-presidential-push-against-drug-middlemen

FDA to host advisory committee meeting on UGN-102 for bladder cancer

 

• The FDA's ODAC meeting will assess UGN-102 for LG-IR-NMIBC, with a PDUFA target date of June 2025.
• The phase 3 ENVISION trial showed a 79.6% complete response rate at 3 months for UGN-102

The FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) meeting for May 21, 2025, to discuss the submitted new drug application (NDA) for UGN-102 (mitomycin) for intravesical solution, which is currently under FDA review for recurrent low-grade, intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC).

The agency previously accepted the NDA for UGN-102 in October 2024, issuing a Prescription Drug User Fee Act (PDUFA) target action date of June 13, 2025.


UroGen explained in their news release, “The ODAC meeting will provide an opportunity for independent clinicians and other experts to evaluate the UGN-102 data and make a recommendation to the FDA as to whether the NDA should be approved and under what conditions.”

The company noted that although the FDA relies on the ODAC meeting to inform their pending regulatory decisions, the agency is not bound by the consensus that the group reaches.

“We are excited to discuss our data with the Advisory Committee and broader medical community as we continue our mission to bring innovative solutions to patients suffering from bladder cancer,” said Liz Barrett, President and CEO of UroGen, in the news release.1 “We believe UGN-102 represents a meaningful advancement for patients facing the recurrent and challenging nature of LG-IR-NMIBC, and we look forward to the opportunity to discuss its potential.”
Data on UGN-102

The NDA for UGN-102 is primarily supported by findings from the phase 3 ENVISION trial (NCT05243550), which met its primary end point by demonstrating a 79.6% (95% CI, 73.9% to 84.5%) complete response rate in patients with LG-IR-NMIBC at 3 months following the first instillation of the therapy.

Updated data from the trial, which were reported in June 2024,3 showed that the 12-month duration of response (DOR) was 82.3% (95% CI, 75.9% to 87.1%) per Kaplan-Meier estimate among those patients who achieved a complete response at 3 months following the first instillation (n = 108) of UGN-102. The study also reported a DOR of 80.9% (95% CI, 73.9% to 86.2%) at both 15 (n = 43) and 18 (n = 9) months, per Kaplan-Meier estimates.

Regarding safety, the most common treatment-emergent adverse events (TEAEs) reported in the trial included dysuria, hematuria, urinary tract infection, pollakiuria, fatigue, and urinary retention. According to UroGen, TEAEs were generally mild to moderate in severity. The safety profile for UGN-102 in the ENVISION trial was consistent with previous reports.

Overall, the single-arm, multinational, multicenter, ENVISION trial is evaluating the safety and efficacy of UGN-102 as a primary chemoablative therapy in patients with LG-IR-NMIBC. In total, the study enrolled 240 adult patients across 56 sites in the US and Europe.

Patients were eligible for enrollment in the trial if they had a negative voiding cytology for high-grade disease within 8 weeks before screening, adequate organ and bone marrow function, and an anticipated life expectancy of at least the duration of the trial.4 Those included in the study received 6 once-weekly intravesical instillations of UGN-102.

The primary end point for the study was the complete response rate at 3 months following the first instillation of the therapy. Secondary outcome measures include DOR, durable complete response rate, disease-free survival, and safety outcomes, all of which will be assessed for up to 63 months.

The ENVISION trial remains ongoing, with final study completion anticipated for 2028.

https://www.urologytimes.com/view/fda-to-host-advisory-committee-meeting-on-ugn-102-for-nmibc

Iran Rejects 'Unacceptable' US Demand To Dismantle Nuclear Sites

 Iranian President Masoud Pezeshkian has thrown cold water on the possibility of dismantling its nuclear facilities, which Tehran maintains are only for peaceful domestic energy purposes.

But top US officials have called for just that. Starting earlier this month Secretary of State Marco Rubio said that Iran has to 'walk away' from uranium enrichment and long-range missile development, while Trump's special envoy to the Middle East Steve Witkoff just days ago went further, asserting that Iran's uranium enrichment facilities "have to be dismantled" for Washington to trust that it does not want nuclear arms.

Pezeshkian in the fresh comments blasted the demand as "unacceptable" and framed it as a matter of national sovereignty and independent development.

"The discussion that has been raised about dismantling Iran's entire nuclear facilities is unacceptable to us," the Iranian president said, adding that "Iran will not give up its peaceful nuclear rights."

Still, the country's Foreign Minister Abbas Araqchi acknowledged Sunday that negotiations with the United States in Oman had become "much more serious and frank" - which suggests positive momentum toward restoring a deal or at least an understanding on which to build a working relationship with Washington.

Araqchi in the comments given to Iran's state-run IRIB TV characterized "forward-moving" talks with the US over an array of complex nuclear-related issues.

This is despite last Thursday's provocative comments given to Breitbart wherein bluntly stated, "They cannot have centrifuges. They have to downblend all of their fuel that they have there and send it to a far-away place.”

"An enrichment program can never exist in the state of Iran ever again. That’s our red line," the US envoy asserted further.

“I just believe they have no choice” but to accept the White House position against enrichment, continued Witkoff. "Obviously, they can say no, and they can test President Trump, but I think that would be an unwise thing to do."

Iranian leadership has tended to brush off such maximalist demands, hoping instead that they can appeal to President Trump's pragmatic deal-making side and willingness to avoid war at all costs. Israel has long threatened preemptive attack on Iran if it believes Tehran is on the cusp of achieving a nuke. Trump has clearly distanced himself from these Israeli efforts to box him into a corner towards starting a new Middle East conflict.

President Pezeshkian meanwhile has continued stressing the "peaceful" purposes of the country's nuclear sites, which include the areas of radiopharmaceuticals, healthcare, agriculture, and industry.

"We are serious in the negotiations and seek an agreement. We hold talks because we want peace," he said. Iranian officials have of late complained that it's very hard to deal with the United States, given rotating administrations which have the capability to reverse key decisions of prior presidents.

Such was the case with the Obama-brokered JCPOA nuclear deal, which Trump unilaterally pulled out of in April 2018. It's as yet unclear the degree to which that original deal's terms will be restored or held to as part of the new ongoing talks.

https://www.zerohedge.com/geopolitical/iran-rejects-unacceptable-us-demand-dismantle-nuclear-sites

Kurdish Militant Group PKK Disbands After 40-Year Conflict With Turkey

 Via Middle East Eye

The Kurdistan Workers' Party (PKK) on Monday announced its decision to disband and end its armed struggle, following a call in February by its imprisoned leader Abdullah Ocalan.

The Kurdish armed group, which has waged a war against Turkey since the 1980s, said that it had completed its "historic mission" and brought the Kurdish question to a point where it could be resolved through democratic politics.

The group said Ocalan should be allowed to manage the disbandment process. It also requested solid and integrated legal guarantees to ensure the success of their decision.

"At this stage, it is important for the Grand National Assembly of Turkey to play its role with historical responsibility," the PKK's statement said.

"Similarly, we call on all political parties represented in the parliament, especially the government and the main opposition party, and civil society organizations to take responsibility and participate in the peace and democratic society process."

This historic announcement came after a 40-year-long conflict between Turkey and the PKK. The group initially sought Kurdish independence but later shifted its goal to autonomy and greater rights for Kurds within Turkey.

Over the decades, various governments, including that of Turkish President Recep Tayyip Erdogan, attempted to resolve the issue through legal settlements, but these efforts were unsuccessful, and tens of thousands of lives were lost.

Since 2016, Ankara has managed to corner the PKK in northern Iraq by employing sophisticated technology such as drones and signal intelligence capabilities, as well as establishing dozens of military outposts that restrict the group's freedom of movement and infiltration across the border.

A source familiar with the matter told Middle East Eye that the PKK's announcement was initially set to be released on Friday, as the government had made some preparations, but internal PKK bureaucracy delayed its release.

Ocalan, 76, stated in his February address that the armed struggle was a product of a bygone era and that Kurds must seek their rights by participating in democratic societies within nation states.

Following his call, the Syrian Democratic Forces, a US-armed group led by PKK offshoots in Syria, then struck a deal with the new Damascus government, promising to return control of state institutions to the central administration.

Ocalan’s call came after Turkish nationalist leader and key Erdogan ally, Devlet Bahceli, asked the PKK leader last year to disband his group, potentially in return for being released into house arrest.

Talks with Kurdish DEM party

Since then, Bahceli has promised greater democratization in Turkey through phone conversations with the pro-Kurdish DEM Party. The government’s talks with Kurdish opposition groups have also divided the country’s opposition, as they come when popular Istanbul mayor Ekrem Imamoglu has been jailed and anti-Erdogan protests have been cracked down on.

“Long live the brotherhood of the Turkish and Kurdish peoples and a fully independent Turkey!”
Not once a "Long live Kurds" or "Long live Kurdistan."

Here's the full statement of the PKK.https://t.co/4JTFauBoS5

— Polla Garmiany ☀️ (@PollaGarmiany) May 12, 2025

Ankara insiders now expect the PKK and Turkish intelligence to announce specifics on how the group will return its arms and formally disband. Turkish officials, speaking on condition of anonymity earlier this year, told MEE that legal studies were underway to allow PKK members who have not participated in armed attacks to be welcomed back to the country.

Some officials speculate that the PKK leadership will either remain in northern Iraq, potentially in Sulaymaniyah, or be allowed to relocate to Europe in exile.

The DEM Party also expects the government to release thousands of its members imprisoned on non-violent charges and to end the practice of unseating its popularly elected mayors. A key demand is the release of Selahattin Demirtas, a Kurdish-Turkish politician who has been incarcerated since 2016.

https://www.zerohedge.com/geopolitical/kurdish-militant-group-pkk-disbands-after-40-year-conflict-turkey

Merck, Pfizer, Eli Lilly Stocks Rebound As Trump Targets Drug Costs With New Executive Order

 Pharmaceutical stocks, including Merck (NSE:PROR) (MRK), Pfizer (NYSE:PFE), and Eli Lilly (NYSE:LLY) traded in the green Monday morning despite declining in pre-market hours after President Donald Trump signed a new executive order that will push drugmakers to sell prescription drugs at a lower price and directly to patients.

“For the first time in many years, we’ll slash the cost of prescription drugs, and we will bring fairness to America. Drug prices will come down by… between 59% to 80%, even 90%,” Trump said during a press conference. “But actually more than that if you think about it mathematically.”

Merck’s stock rose nearly 5% in midday trade, while Pfizer’s stock was up 3%, and Eli Lilly and Bristol-Myers (BMY) shares rose around 2%.

“Starting today, the U.S. will not subsidize the healthcare of foreign countries… and will no longer profiteering and price gouging from Big Pharma,” he added, explaining that pharmaceutical companies had been putting the cost of research and development on U.S. consumers while subsidizing drug rates in other countries.

According to Trump, the new reduction in drug costs will “equalize” rates across the globe, with the U.S. getting the “most-favored nation” pricing.

He added that Big Pharma would either voluntarily abide by this principle or the federal government would use its power to ensure the U.S. pays the same price as other countries, including investigating their pricing mechanisms.

Trump also stated that the U.S. will be opening up its market to safe and legal imports of affordable drugs from other countries to put downward pressure on prices.

Trump said the savings from cutting down on Medicare, Medicaid, and drug costs will “easily pay for the Golden Dome, and we’ll have a lot of money leftover.”

The ‘Golden Dome’ is a proposed advanced missile defense system for the U.S. that Trump announced in early 2025 when he signed an executive order titled “Iron Dome For America.”

https://in.investing.com/news/stock-market-news/merck-pfizer-eli-lilly-stocks-rebound-as-trump-targets-drug-costs-with-new-executive-order-4824833

Harvard Bioscience notes product progress, revenue guidance with results

 Harvard Bioscience, Inc. (Nasdaq: HBIO) (the “Company”) today announced financial results for the first quarter ended March 31, 2025.

Jim Green, Chairman and CEO, said, “First quarter revenues were in line with our expectations, reflecting typical Q4 to Q1 seasonality as well as uncertainty surrounding NIH funding and the evolving tariff situation, especially in relation to sales to China.”

We are excited by the emerging adoption of our breakthrough MeshMEA™ organoid systems by academic and biopharma customers and encouraged by the market reception of our new SoHo™ telemetry systems. In addition, we remain focused on managing costs and expect that recently completed cost reduction actions will result in operating cost reductions of approximately $1 million per quarter beginning in the second quarter.”

First Quarter 2025 Results

For the first quarter of 2025, the Company reported revenues of $21.8 million compared to $24.5 million in the first quarter of 2024. Gross margin for the first quarter of 2025 was 56.0%, compared to 60.3% in the first quarter of 2024.

Net loss for the first quarter of 2025 was $(50.3) million, which included goodwill impairment of $(48.0) million. This is compared to a net loss of $(4.7) million in the first quarter of 2024, which included a loss on marketable securities of ($1.3) million. Adjusted EBITDA for the first quarter of 2025 was $0.8 million compared to $1.6 million in the first quarter of the prior year. Cash provided by operations was $3.0 million during the three months ended March 31, 2025, compared to $1.4 million in the same period in 2024.

Second Quarter 2025 Guidance

The Company expects second quarter 2025 revenues of $18 million to $20 million and gross margin in the 55% to 57% range.

This press release includes certain financial information presented on an adjusted, or non-GAAP, basis. For additional information on the non-GAAP financial measures included in this press release, see “Use of Non-GAAP Financial Information” and “Reconciliation of GAAP to Non-GAAP Financial Measures” below.

Webcast and Conference Call Details

In conjunction with this announcement, Harvard Bioscience will be hosting a conference call and webcast today at 8:00 a.m. Eastern Time. A presentation that will be referenced during the webcast will be posted to the Company’s Investor Relations website shortly before the webcast begins.

Participants who would like to join the call and ask a question should dial 1-866-652-5200 and request to be connected to the Harvard Bioscience call.

Participants who would like to join the audio-only webcast should go to our events and presentations on the Investor Relations section of our website here.

https://finviz.com/news/54362/harvard-bioscience-announces-first-quarter-2025-financial-results

Products such as Credit Karma and NerdWallet benefit consumers, do not harm them: report

 As technology has advanced, various tools have been created to help people with lower credit scores or limited credit history get credit. These tools, often called "fintech," have been scrutinized by congressional Democrats and regulatory agencies such as the Consumer Financial Protection Bureau (CFPB) and the Federal Communications Commission (FCC).

 
Comparison-shopping tools, such as Credit Karma, NerdWallet, WalletHub and LendingTree, can give people a better chance of getting approved for a loan or credit card. 

Credit agencies, like Experian, also offer similar choices, including what they call a "no-ding decline" option. Customers can apply, and there is no impact on their credit score unless the application is approved. 

 
Democrats such as retiring Sen. Dick Durbin, D-Ill., and Sen. Elizabeth Warren, D-Mass., claim they use deceptive tactics and other measures to steer consumers to more "predatory" lending options. The CFPB attempted to implement regulations to eliminate practices deemed abusive or predatory despite platforms like Credit Karma and others disclosing how compensation from advertisers may influence the order of product offerings.
 
However, new research from the Southwest Public Policy Institute (SPPI) found that comparison-shopping tools and lead generators allow consumers to make more informed choices. The report determined that government intervention could be detrimental to those who have difficulty obtaining credit.

 
Entitled "Swipe Right: How Comparison Shopping Tools and Lead Generators Revolutionize Consumer Access to Products and Services," the report details the efforts of SPPI’s founder and president, Patrick Brenner, to obtain credit following his divorce.

The report details how Brenner applied directly for seven credit cards through various websites such as Wells Fargo, Capital One, Discover and others. All efforts were time-consuming and often confusing, and ultimately, all failed. However, when he used the tools supplied by Credit Karma, he was matched with an offer from Merrick Bank for a credit card with a $500 limit that would double to $1,000 after making on-time payments for seven months.
 
The CFPB created a tool for people to search for possible credit cards. However, unlike comparison-shopping tools that one can use on their mobile phone, the CFPB website only provides disclosures about fees and rates. Anyone who wants to apply for a card must navigate to the bank or credit union and apply directly. There is no indication of the chance of approval.

 
SPPI says such efforts are pointless. The report says, "Imagine the inefficiency: government agencies need help with bloated processes, outdated technology, and lackluster user experiences. If they were to develop a comparison tool, they would directly compete with highly sophisticated systems that have refined their algorithms and user interfaces over decades. Government programs do not have the resources or capacity to match the technological prowess of these tech behemoths."

The report concludes with a warning about possible over-regulation and oversight.

 
"Policymakers must recognize that these platforms provide vital alternatives to traditional banking, especially for those who lack access through conventional means. The focus should be on preserving a dynamic marketplace where consumers have the freedom to choose and the tools to make informed decisions."

https://www.foxbusiness.com/economy/products-credit-karma-nerdwallet-benefit-consumers-not-harm-them-report