Teva’s Emrusolmin Granted U.S. FDA Fast Track Designation

 

• Teva received Fast Track designation from the U.S. Food and Drug Administration for emrusolmin (TEV-56286), an investigational treatment for Multiple System Atrophy (MSA) in Phase 2 development.
• New therapeutic options for people living with MSA, a rare and devastating neurodegenerative disorder, are urgently needed as there are no treatments available that impact disease progression.
• Emrusolmin is a small molecule that targets the alpha synuclein protein, which is believed to be pivotally involved in the pathogenesis of MSA. The U.S. FDA granted Orphan Drug designation to emrusolmin for MSA in 2022.

https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/Tevas-Emrusolmin-Granted-U-S--FDA-Fast-Track-Designation-for-Treatment-of-Multiple-System-Atrophy/default.aspx

Early Medicare Advantage stars data bodes well for UnitedHealth

 

• UnitedHealth expects to have roughly 78% of its Medicare Advantage enrollees in plans rated four stars or above next year, the healthcare behemoth disclosed Tuesday in a securities filing.
• The percentage of members in the high-performing plans — which yield valuable bonuses — has stayed largely flat compared to 2025, according to analysts. But it’s still a positive development for UnitedHealth, and a good sign for other managed care companies in MA, many of which have struggled to reach stricter star ratings thresholds.
• UnitedHealth’s stock rose roughly 9% over Tuesday’s trade following the disclosure, which also shared that the company plans to reaffirm its 2025 financial guidance in upcoming investor meetings.

The CMS rates MA plans from one to five stars based on a complex calculation of metrics that, overall, are meant to represent plan quality. Insurers jockey fiercely for higher ratings, which help their plans stand out for seniors shopping for privatized Medicare coverage — and translate directly to higher revenue from the government.

As such, insurers were generally unhappy with tweaks to star ratings methodology that tamped down on average scores for 2025, including by making it harder to reach the vaunted four-star cutoff. (Plans that receive an overall rating of four or higher receive higher bonus payments, and higher scores also result in larger rebates if plans submit bids below the CMS’ benchmark for the coming year.)

With billions of dollars in payments at stake, multiple insurers sued the government to get their ratings recalculated, with mixed results. And executives and investors in the industry have been waiting anxiously for signs of how the quality scores could come down for 2026. The CMS officially releases stars for the upcoming plan year in October, but allows plans to take a first look at their data. Payers’ second window to check out their preliminary results opened on Tuesday, and UnitedHealth is electing to share its early results with investors.

Having more than three-fourths of its more than 8 million MA members in plans with at least four stars is “consistent with our expectations and in line with historical performance,” UnitedHealth wrote in its securities filing.

Still, the results are better than some investors feared, especially amid concerns that thresholds to reach four stars could increase further for 2026.

“Our biggest takeaway is that we aren’t seeing a material upward shift in stars similar to last year,” J.P. Morgan analyst Lisa Gill wrote in a note Tuesday.

Major health insurers are currently hustling to boost margins in their MA businesses, as higher medical utilization among seniors and unfavorable policy changes cut into once-comfortable profits.

With an eye toward improving margins, payers — including UnitedHealth’s insurance division UnitedHealthcare — are culling unprofitable plans for next year. UnitedHealthcare expects to lose some 600,000 enrollees as a result of the plan exits.

Despite higher MA rates coming down the pike, where star ratings land is another major swing factor for insurers’ margin recovery plans — especially for insurers that have room for improvement in their scores.

Humana, the second-largest MA insurer after UnitedHealthcare, said during a second-quarter call with investors that it expects its star ratings to improve for 2026, though the company doesn’t plan to discuss its results until stars are officially released in October.

Elevance also said it wouldn’t explicitly comment on stars during an investor conference last week, though CFO Mark Kaye said the company was encouraged by its progress. Centene has also said it expects its stars to improve next year.

UnitedHealth, Humana, Elevance, Centene and CVS, the parent company of insurer Aetna, did not respond to a request for comment for this story by time of publication.

https://www.healthcaredive.com/news/unitedhealth-medicare-advantage-star-ratings-preview/759623/

Wall Street Giant Cantor Debuts Bitcoin Fund With Gold Insurance

 by Mat Di Salvo via Decrypt.com,

The fund will supposedly protect investors from Bitcoin's sometimes huge dips by using the precious metal...

• Cantor Fitzgerald has debuted a new Bitcoin fund.

• The fund also gives investors exposure to gold—for downside protection.

• Gold rose to a record high near $3,680 on Monday, while BTC is trading about 9% off its all-time best, set last month.

Wall Street giant Cantor Fitzgerald debuted a new fund Monday that aims to give investors exposure to Bitcoin's gains and downside protection with gold. 

The fund, the Cantor Fitzgerald Gold Protected Bitcoin Fund, which was announced in May at the Bitcoin 2025 conference in Las Vegas, Nevada, aims to address the concerns of investors scared of Bitcoin

Monday's announcement said that the fund "minimizes the risk of short-term volatility and reduces the impact of correlation spikes while continuing to benefit from the long-term upside trend of Bitcoin." 

"This gold-protected Bitcoin strategy spans five years and tackles both risks head-on: it captures Bitcoin's upward trajectory while gold provides a safety net that historically performs well when markets decline," Global Head of Cantor Fitzgerald Asset Management Bill Ferri said. 

He added:

"With risk assets at or near all-time highs, timing and protection matter."

Decrypt reached out to Cantor Fitzgerald for comment. 

Bitcoin, the largest and oldest digital asset, has in the past made massive gains but experienced huge drops throughout its 16 year history.

Bitcoin was recently trading at under $112,182, up about 1% over the past 24 hours and more than 20% year-to-date according to cryptocurrency markets data provider CoinGecko. But the leading cryptocurrency by market cap has fallen nearly 9% since reaching an all-time high of $124,128 last month. 

To be sure, experts recently told Decrypt that with the approval of spot Bitcoin ETFs, which institutions have flooded into, the asset should experience less volatility. The digital coin's volatility has significantly dampened this year. 

But during the last bull market of 2021, the asset hit a high of over $69,000 per coin only to plunge to under $16,000 the following year. The current up cycle has likely yet to see an end, many analysts believe. 

Cantor's Bitcoin lending business has carried out its first transactions, the investment banking giant announced on Tuesday, underscoring its increasing presence in the crypto space. Prime broker FalconX and crypto lending protocol Maple Finance were the first companies to draw on the financing. The New York-based Cantor, part of Cantor Fitzgerald, expects to make up to $2 billion in financing available in this first phase, the company said. “Early on, Cantor recognized the transformative impact...

Gold, the traditional save haven asset, hit a new high Monday near $3,680 per ounce and is up more than 37% year-to-date, amid ongoing concerns about the U.S. economy, inflation and other macroeconomic uncertainties.

Cantor was among the early, vocal Wall Street supporters of Bitcoin. The firm helps custody the Treasury reserves for stablecoin giant Tether's USDT stablecoin product. Its former chairman and CEO Howard Lutnick, an advisor to Donald Trump during his 2024 presidential campaign, is now U.S. Commerce Secretary.

https://www.zerohedge.com/crypto/wall-street-giant-cantor-debuts-bitcoin-fund-gold-insurance

Worst Revision In History: BLS Admits A Record 911K Fewer Jobs Were Added Under Biden

 Two weeks ago, before both Bloomberg and Reuters, we told our subscribers to "brace for another huge negative payrolls revision"...

Brace For Another Huge Negative Payrolls Revision, Greenlighting A 50bps September Rate Cut https://t.co/RKJXliyrVq

— zerohedge (@zerohedge) August 29, 2025

... and just like one year ago when we did exactly the same, we were spot on: moments ago the BLS reported that as part of its preliminary annual benchmark revisions, a record 911K payrolls for the period April 2024-March 2025 would be revised away.  As shown in the chart below, the biggest revisions were in Leisure and Hospitality, Professional and Business services, and Retail and Wholesale trade sectors.

Some more from the full press release:

The preliminary estimate of the Current Employment Statistics (CES) national benchmark revision to total nonfarm employment for March 2025 is -911,000 (-0.6 percent), the U.S. Bureau of Labor Statistics reported today. The annual benchmark revisions over the last 10 years have an absolute average of 0.2 percent of total nonfarm employment. In accordance with usual practice, the final benchmark revision will be issued in February 2026 with the publication of the January 2026 Employment Situation news release.

Each year, CES employment estimates are benchmarked to comprehensive counts of employment from the Quarterly Census of Employment and Wages (QCEW). These counts are derived primarily from state unemployment insurance (UI) tax records that nearly all employers are required to file with state workforce agencies. 

The preliminary benchmark revision reflects the difference between two independently derived employment counts, each subject to their own sources of error. It serves as a preliminary measure of the total error in CES employment estimates from March 2024 to March 2025. Preliminary research, which is not comprehensive and is subject to updates in QCEW data, indicates that the primary contributors to the overestimation of employment growth are likely the result of two sources—response error and nonresponse error. First, businesses reported less employment to the QCEW than they reported to the CES survey (response error). Second, businesses who were selected for the CES survey but did not respond reported less employment to the QCEW than those businesses who did respond to the CES survey (nonresponse error). Estimates of other errors, such as the forecast error from the net birth-death model, are not available at this time. Information on how the net birth-death forecasts have reduced benchmark revisions historically are available on the CES Birth-Death Model Frequently Asked Questions page in question 10, www.bls.gov/web/empsit/cesbdqa.htm.

The preliminary benchmark revisions in table 1 are calculated only for March 2025 for the major industry sectors. As is typically the case, many of the individual industry series show larger percentage revisions than the total nonfarm series, primarily because statistical sampling error is greater at more detailed levels than at an aggregated level. 

What is more remarkable about today's print is that after last year's stunning 818K negative revision, which was the second biggest since the global financial crisis (and which we also warned ahead of time was coming), virtually nobody expected this year's number to be higher. It was not only higher, but it was the biggest negative revision on record!

Taken at face value, the preliminary estimate suggests that payroll growth averaged 71k jobs/month between April 2024 and March 2025, vs. 147k jobs/month as currently reported in the payrolls statistics.

No wonder the WSJ now reports that "White House Prepares Report Critical of Statistics Agency" in what is a clear effort at kitchen-sinking all the ugly, fake jobs numbers that were "created" by the Biden admin, and saddled Trump with relentless negative revisions. Expect 1-2 more months of painful job prints, and then another powerful rally higher into the 2026 midterms under a new BLS commissioner as all of Biden's fake baggage is expunged. 

Commenting on the "data" revision, Treasury Secretary Bessent confirms what we said, namely that today's revision "brings the Biden jobs overstatement to a staggering 1.5M. The truth: President Trump inherited a far worse economy than reported, and he’s right to say the Fed is choking off growth with high rates."

.@kwelkernbc pushed back last week when I warned that the BLS jobs data would show a massive downward revision.

Now it’s official: 2024 job gains were exaggerated by nearly 1M workers, and this is on top of an already reported 577K in downward revisions. This brings the Biden… pic.twitter.com/Aaz0LirOxg

— Treasury Secretary Scott Bessent (@SecScottBessent) September 9, 2025

But VP JD Vance landed the crushing blow, saying that BLS data has become completely "useless" - something we have said since 2021 - adding that a change was necessary to restore confidence. We are all eagerly awaiting said change, which will need to be far more extensive than just a replacement of the commissioner.

It’s difficult to overstate how useless BLS data had become. A change was necessary ton restore confidence. https://t.co/RdGQcfQY8C

— JD Vance (@JDVance) September 9, 2025

So what does it all mean? Couple things and we will follow up with a more extended analysis but here is the punchline:

• Trump was absolutely correct to fire the BLS commissioner one month ago: one year of major negative revisions is happenstance; twice is coincidence; three times is enemy action... and in her case, it was just unexcusable incompetence as the most important economic data point the market uses was dead wrong. 
• There was virtually no domestic job creation in the last year of the Biden admin when one excludes the hundreds of thousands of illegal aliens who entered the work force. 
• The Fed should have started cutting rates in February, and would have started cutting rates in February if it knew the true sad state of the US labor market.

Just as remarkable: 2 million jobs from the last 3 years of the Biden admin have now been revised away. 

One thing that will never be revised away, however, is the trillions in debt accumulated over his period, and which we now learn encumbered future generations of Americans with massive amounts of debt only to create far fewer jobs than initially reported.

https://www.zerohedge.com/markets/worst-revision-history-bls-admits-record-919k-fewer-jobs-were-added

$200 M Crypto Treasury: iSpecimen Plans Solana Blockchain Investment with Staking Strategy

iSpecimen (NASDAQ: ISPC) has provided an update on its strategic initiative to integrate digital assets into its business model. The company is pursuing the development of a $200 million corporate treasury reserve based on the Solana blockchain ecosystem. Since its August announcement, ISPC has received approaches from several cryptocurrency companies presenting opportunities in tokenized real-world assets and highly ranked cryptocurrencies.

Under CEO Robert Lim's leadership, iSpecimen plans to establish a SOL-based treasury program to diversify its balance sheet and support long-term growth. The company intends to implement a "buy and HODL" strategy, including purchasing Locked SOL at a discount and utilizing staking mechanisms to generate yields. The program will be funded through future capital raises and will include the acquisition of both locked and unlocked SOL through reputable cryptocurrency institutions.

https://www.stocktitan.net/news/ISPC/i-specimen-approached-by-crypto-currency-companies-for-200-million-ei24oq4eifr9.html

Lilly eyes earlier use of blood cancer drug Jaypirca

 Eli Lilly's fast-growing blood cancer drug Jaypirca could gain additional momentum thanks to a new trial suggesting it could move into the first-line setting.

Reversible BTK inhibitor Jaypirca (pirtobrutinib) has been shown in the BRUIN CLL-313 to significantly improve progression-free survival compared to standard chemoimmunotherapy (CIT) in previously untreated patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions.

Overall survival (OS) data is not mature at the moment, but was trending in favour of Lilly's drug even though it has not reached statistical significance. The company said the improvement over CIT with bendamustine plus rituximab is "one of the most compelling effect sizes ever observed for a single agent BTK inhibitor in a front-line CLL study."

Lilly broke new ground for the BTK inhibitor class in 2023 when it secured FDA approval for Jaypirca as a third-line treatment for CLL/SLL, as well as mantle cell lymphoma (MCL). It was specifically designed to work in patients who develop resistance mutations to current BTK inhibitors such as AbbVie/Johnson & Johnson's Imbruvica (ibrutinib), AstraZeneca's Calquence (acalabrutinib), and BeiGene's Brukinsa (zanubrutinib), which are already options for frontline treatment of CLL/SLL.

That profile has helped the drug make steady headway in the market, with sales coming in at $337 million last year and contributing $123 million in the second quarter of this year alone, with an 85% increase in total prescription numbers compared to the same period in 2024.

It has a long way to go before it can reach the heights of its rivals, given that Calquence had sales of more than $3.1 billion last year, while Imbruvica is in decline, but still made $3.4 billion, and ahead of fast-growing Brukinsa, which generated $2 billion.

The results of the BRUIN CLL-313 study will be combined with the earlier BRUIN CLL-314 trial – which found that Jaypirca was as effective as Imbruvica in previously untreated CLL/SLL – as part of a regulatory filing to expand the label for Jaypirca later this year.

"The results from BRUIN CLL-313 are striking and provocative, across both PFS and OS endpoints, further demonstrating the potential of pirtobrutinib to be a meaningful treatment option for people with untreated CLL/SLL," said Jacob Van Naarden, head of Lilly Oncology.

"We continue to build the clinical evidence supporting the possible role of pirtobrutinib in a variety of CLL/SLL treatment settings, including treatment-naïve, BTK inhibitor-naïve, and BTK inhibitor-exposed," he added.

https://pharmaphorum.com/news/lilly-eyes-earlier-use-blood-cancer-drug-jaypirca

ICER says GLP-1s 'still have serious affordability issues'

 Novo Nordisk and Eli Lilly's weight-loss drugs offer substantial net health benefits and are also cost-effective at current prices – but will still pose an affordability challenge to US healthcare.

That is the conclusion of a draft report (PDF) from the influential Institute for Clinical and Economic Review (ICER), a US healthcare technology assessment (HTA) organisation, which notes that access to the GLP-1 drugs is already limited by "variable insurance coverage and high out-of-pocket costs."

ICER concludes in its document that Novo Nordisk's Wegovy (semaglutide) and Lilly's Zepbound (tirzepatide) are clearly a step forward in helping people lose weight and improve their metabolic health, after saying in an earlier report (PDF) that their prices needed to come down.

At the moment, most people accessing the drugs pay for them out of their own pocket, as insurance in the US has traditionally not covered weight-loss therapies, but that may change in future as studies point to benefits of GLP-1 therapies in cardiovascular disease risk reduction and other obesity-related conditions like knee osteoarthritis, metabolic-associated steatohepatitis (MASH), and chronic kidney disease (CKD).

In its report, ICER notes that Wegovy, Mounjaro, and Novo Nordisk's oral semaglutide – not yet on the market for obesity – are all cost-effective, based on their current prices and the assumption that oral semaglutide will cost the same as the injectable version.

However, "despite these therapies being highly cost-effective, their potential budget impact is large," it says.

"We estimate that fewer than 1% of eligible patients could be treated at current and assumed net prices before crossing the ICER budget impact threshold of $880,000,000 annually," according to the organisation. "This raises serious concerns about affordability."

ICER is planning to hold a webinar next week (18th September) to present the findings of the draft report, which is open for public comment until 6th October. A virtual public meeting to discuss questions raised in the document will be held on 13th November.

Around 40% of the US population is currently living with obesity, and there are racial and ethnic differences in obesity prevalence, with Black and Hispanic adults having higher rates.

In a white paper published earlier this year, ICER highlighted the tension between the scale of the benefits of new obesity medications and the magnitude of the financial implications for healthcare payers.

"Obesity treatments have the potential to transform thousands of lives, but only if we ensure sustainable access for all patients," said Sarah Emond, ICER's chief executive at the time.

"It is incumbent upon the entire health care system to focus on innovative pricing, coverage, payment, and delivery solutions, with the goal of broadening access to effective obesity medications."

Novo Nordisk and Lilly have launched direct-to-consumer sales channels to offer their obesity therapies for a fixed monthly fee, and have partnered with telehealth companies to broaden their reach. Both are, however, feeling the pinch from semaglutide and tirzepatide-based weight-loss drugs offered through compounding pharmacies.

https://pharmaphorum.com/news/icer-says-glp-1s-still-have-serious-affordability-issues