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Friday, November 1, 2024

Daniel Penny trial live updates: Opening arguments begin

 

Jordan Neely says 'I will kill,' prompting Daniel Penny to intervene with the homeless subway rider: lawyer

By Ben Kochman and Priscilla DeGregory

When troubled subway rider Jordan Neely threatened "I will kill" on a crowded subway train, Daniel Penny felt he had to intervene to protect other riders, defense lawyer Thomas Kenniff told jurors.

"When Neely threatened to kill, there was only one thing that Daniel Penny could do,” Kenniff said.


Daniel Penny did 'what we would want someone to do for us': defense lawyer

By Ben Kochman and Priscilla DeGregory

When Daniel Penny intervened with troubled homeless man Jordan Neely, he "did for others what we would want someone to do for us," his lawyer Thomas Kenniff told jurors.

Kenniff described Neely as a raving lunatic who was terrifying passengers when he stepped onto a train and began ranting about serving prison time and threatening to take food and money from riders if they didn't fork it over.

When Neely eventually even threatened to kill, "there was only one thing that Daniel Penny could do," Kenniff said.

Jurors will be shown bystander videos of Daniel Penny putting Jordan Neely in chokehold

By Ben Kochman and Priscilla DeGregory

Prosecutor Dafna Yoran told the jurors they will be shown videos taken by two bystanders of Daniel Penny choking Jordan Neely.

One video was taken by Yvette Rosario, 17, who recorded as Penny was on the floor with Neely "holding him in a tight chokehold," Yoran explained.

https://nypost.com/2024/11/01/us-news/daniel-penny-trial-live-updates-nov-1/

Immigrants already tip scales of US elections without even voting

 Immigrants don’t need to have the right to vote to affect elections in the United States — simply by being here, they can tip the scales.

The apportionment of House seats and votes in the Electoral College among the states is based on total population — not citizenship or legal status.

The Census Bureau is clear that naturalized citizens, as well as non-citizens such as green card holders, foreign students, guestworkers and illegal immigrants are captured in the census every 10 years.

Because the legal and illegal immigrant population is so large and unevenly distributed across the country, it causes some states to gain seats in the U.S. House of Representatives and Electoral College at the expense of others.

Equally important, immigration shifts political representation away from American citizens and toward states and districts with large non-citizen populations.

An investigation by the Center for Immigration Studies estimates that immigrants — legal and illegal — counted in the 2020 census shifted 17 seats in the House of Representatives and votes in the Electoral College.

The big winner is California, which has 8 more seats than it would have without non-citizen immigrants.

The states that lose tend to be low-immigration states in the South and Midwest such as Ohio and Tennessee. The inclusion of non-citizens alone shifts six House seats, with half the increase going to California. Illegal immigration caused two seats to change hands.

This redistribution of political power has significant partisan implications, with Democratic-leaning states experiencing a net gain of 14 seats and electoral votes due to immigration, while Republican states had 10 fewer seats. Battlegrounds had four fewer seats.

Non-citizens alone accounted for five of the seats gained by Democratic states in the last Census.

Keep in mind that the border surge had not yet occurred when the 2020 Census was taken. If the total legal and illegal immigrant population continues to grow at the current rapid pace, immigrants in the 2030 Census will redistribute 22 seats and electoral votes, while illegal immigrants will redistribute seven seats.

The settlement of so many immigrants may change the political alignment of states in unpredictable ways — though it stands to reason that as immigrants settle in larger numbers in states such as New York and California, Democrats are likely to see greater gains.

The political distortions created by immigration are even more pronounced in congressional districts.

Each district in a state has roughly the same number of people. But they don’t have the same number of legal voters.

Yet in 2022, at the time of the last election, New York’s 6th district, in Queens (represented by Democrat Grace Meng), had 169,000 fewer voting-age citizens than in the 21st congressional district in upstate (represented by Republican Elise Stefanik).

There are many districts like this throughout the country.

Not surprisingly, it takes many more votes to win in districts comprised largely of citizens. In 2022, the winning candidate received 73% more votes in the 54 districts where less than 2% of adults are non-citizens than in the two dozen districts where one in five adults is not an American citizen.

This raises important questions about the principle of “one person, one vote.”

In effect, the votes of American citizens who live around non-citizens count much more than the votes of Americans who live in high-citizen areas.

High non-citizen districts tend to vote overwhelming Democratic. Of the 24 districts where one in five adults is not an American citizen, only four were won by a Republican in 2022. In contrast, in the 54 districts where less than 2% of adults are not citizens, just five are represented by a Democrat.

The redistribution is directly proportional to the scale of legal and illegal immigration and is independent of how immigrants themselves vote.

If we want to avoid the distortions immigration creates, we have to enforce our laws against illegal immigration. We also must think long and hard about whether the enormous scale of legal immigration makes sense.

Steven Camarota is director of research at the Center for Immigration Studies.

https://nypost.com/2024/11/01/opinion/immigrants-already-tip-scales-of-us-elections-without-even-voting/

ESSA Pharma halts Phase II study of masofaniten in prostate cancer

 ESSA Pharma has terminated the Phase II clinical trial of masofaniten, a new prostate cancer treatment.

Masofaniten, previously known as EPI-7386, is an investigational oral, small-molecule androgen receptor (AR) inhibitor.

The decision to halt the trial, which was assessing masofaniten in combination with enzalutamide versus enzalutamide alone in patients with metastatic castration-resistant prostate cancer (mCRPC), was based on an interim review.


Agreed upon by the board of directors and senior management, the review indicated a higher-than-expected PSA90 response in patients treated solely with enzalutamide.

The Phase II trial was an open-label, two-arm, 2:1 randomised study which planned to enrol 120 patients.

At the time of the interim analysis, 52 patients had been enrolled and had at least one prostate-specific antigen (PSA) measurement post-baseline, with 41 patients having completed a minimum of three months follow-up.

Additionally, no clear efficacy benefit was observed when masofaniten was combined with enzalutamide. A futility analysis suggested a low probability of achieving the prespecified primary endpoint.

ESSA Pharma president and CEO David Parkinson said: "We designed this randomised study to rigorously evaluate the clinical benefit of adding masofaniten to enzalutamide.

“We made the difficult decision to terminate this Phase II study following the interim analysis because we concluded that the emerging efficacy profile of masofaniten combined with enzalutamide would not likely meet the primary endpoint of the study, nor our internal requirements for a prostate cancer therapy candidate.


https://finance.yahoo.com/news/essa-pharma-halts-phase-ii-121413142.html

Pediatrix Q3, update

 Pediatrix Medical Group, Inc. (NYSE: MD), a leading provider of physician services, today reported earnings of $0.23 per share for the three months ended September 30, 2024. On a non-GAAP basis, Pediatrix reported Adjusted EPS of $0.44.

For the 2024 third quarter, Pediatrix reported the following results:

  • Net revenue of $511 million;
  • Net income of $19 million; and
  • Adjusted EBITDA of $60 million.

“Our third quarter operating results modestly exceeded our expectations, driven primarily by strength in same-unit revenue,” said James D. Swift, M.D., Chief Executive Officer of Pediatrix Medical Group. “During the quarter, we successfully completed our previously announced transition to a hybrid revenue cycle management structure, and we remain on track to complete our portfolio management plans by the end of 2024. We believe that a more focused portfolio, with enhanced support for our affiliated practices, will enable stronger financial performance and benefit all of our stakeholders.”

Portfolio Management Update

As previously disclosed, during the second quarter of 2024, Pediatrix formalized its practice portfolio management plans, resulting in a decision to exit almost all of its affiliated office-based practices, other than maternal-fetal medicine, and during and subsequent to the end of the 2024 second quarter, the Company completed the exit of its primary and urgent care service line through two separate transactions. In aggregate, the office-based practices that the Company intends to exit and the primary and urgent care clinics that have been divested contributed net revenue of approximately $200 million in 2023. As previously disclosed, Pediatrix expects that the annualized favorable impact to Adjusted EBITDA resulting from its portfolio management plans to be approximately $30 million, based on 2023 financial information.

The Company continues to expect to complete these exits prior to the end of 2024.

2024 Outlook

Pediatrix anticipates that its 2024 Adjusted EBITDA, as defined above, will be in a range of $205 million to $215 million. This outlook reflects Adjusted EBITDA for the first nine months of 2024 of $155.3 million.

https://www.businesswire.com/news/home/20241101131596/en/

Pro-Dex Profit in Fiscal 2025 First Q

 Net sales for the three months ended September 30, 2024, increased $3.0 million, or 25%, to $14.9 million from $11.9 million for the three months ended September 30, 2023. The increase is driven primarily by $1.1 million in increased repairs of the surgical handpiece we sell to our largest customer as well as the shipment of that customer's next generation handpiece to satisfy its limited market release.

Gross profit for the threemonths ended September 30, 2024, increased $1.5 million, or 41%, compared to the year-ago period. Gross margin increased by 4 percentage points to 35% during the three months ended September 30, 2024, compared to 31% during the corresponding year-ago period, due primarily to a favorable product mix.

Operating expenses (which include selling, general and administrative, and research and development expenses) for the quarter ended September 30, 2024, increased $312,000, or 17%, to $2.1 million compared to $1.8 million for the corresponding quarter in 2023. The increase relates primarily to increased general and administrative expenses relating to higher personnel costs and higher bonus accruals.

Our operating income for the quarter ended September 30, 2024, increased $1.2 million or 64%, to $3.0 million compared to $1.8 million for the prior fiscal year's corresponding quarter. The increase reflects our increased sales and gross profit, as described above.

Net income for the quarter ended September 30, 2024, increased to $2.5 million, or $0.75 per diluted share, compared to net loss of $615,000, or $0.17 per diluted share, for the quarter ended September 30, 2023. Our net income for the quarter ended September 30, 2024, contains unrealized gains on our marketable equity investments of $433,000 while our net loss for the quarter ended September 30, 2023, includes unrealized losses on investments of $2.6 million. All of our investments are recorded at estimated fair value, and the period-to-period valuation can be highly volatile.

Biogen, Eisai Completes Rolling Submission for LEQEMBI for Subcutaneous Early Alzheimer's

  Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that Eisai has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA. LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). If the FDA accepts the BLA, the Prescription Drug User Fee Act (PDUFA) action date (target date for completion of examination) will be set. 

The BLA is based on data from the Clarity AD (Study 301) open-label extension (OLE) and modeling of observed data. If approved by the FDA, the LEQEMBI autoinjector could be used to administer LEQEMBI at home or at medical facilities, and the injection process is expected on average to take about 15 seconds. As part of the subcutaneous autoinjector 360 mg weekly maintenance regimen under review, patients who have completed the biweekly intravenous (IV) initiation phase would receive weekly doses that maintain effective drug concentrations to sustain the clearance of highly toxic protofibrils* which can continue to cause neuronal injury even after the amyloid-beta (Aβ) plaque has been cleared from the brain.

https://www.prnewswire.com/news-releases/eisai-completes-rolling-submission-to-us-fda-for-leqembi-lecanemab-irmb-biologics-license-application-for-subcutaneous-maintenance-dosing-for-the-treatment-of-early-alzheimers-disease-under-the-fast-track-status-302293541.html

BMS Delivers Q3 Beat, Raises 2024 Guidance Amid Strong Demand for Legacy and Newer Drugs

 

Bristol Myers Squibb’s third-quarter results benefited from sales of its legacy brands Eliquis and Revlimid, as well as growth portfolio products such as Abecma, Breyanzi and Reblozyl.

Bristol Myers Squibb on Thursday touted strong year-over-year growth in the third quarter of 2024, with sales handily beating the consensus estimate driven by its legacy and newer products.

On the strength of the Q3 performance, BMS raised its full-year revenue guidance, now expecting a year-over-year increase of around 5%—up from its previous forecast of the upper end of low-single-digit growth. The outlook for the company’s full-year diluted earnings-per-share (EPS) was also lifted to $0.75 to $0.95, from the previous range of $0.60 to $0.90.

“Our overall business mix is beginning to transform as our growth portfolio is becoming a bigger component,” CEO Christopher Boerner said during an investor call on Thursday, touting the combination of its pipeline—which is approaching several “near-term catalysts”—and a “disciplined focus on expense management.”

These factors, Boerner said, are key to the company’s “focus on executing in the near term while laying the groundwork for long-term sustainable growth.”

In Q3, BMS reported total global revenues of $11.9 billion–8% year-over-year growth at constant currencies—and a 6% beat versus the consensus estimate of $11.3 billion.

In an investor note, William Blair analyst Matt Phipps credited BMS’ strong quarter to the reliable performance of its legacy brands—including Revlimid and Eliquis—and the “traction” of its growth portfolio brands such as Breyanzi, Abecma and Reblozyl, which “all beat consensus estimates.”

Truist Securities analyst Srikripa Devarakonda in an investor note said the multiple myeloma drug Revlimid declined “less than anticipated.” Its sales dipped 1% in the quarter to $1.4 billion but still exceeded the consensus of $1.1 billion. The blood thinner Eliquis continues to be BMS’ top-performing asset, jumping 11% year-over-year to bring in just over $3 billion in Q3.

BMS’ earnings call was primarily focused on its newly approved schizophrenia therapy Cobenfy, which won the FDA’s nod in September 2024. Boerner said the drug had “multibillion-dollar potential” and will help the company accelerate its growth, though the company’s optimism appeared to be largely measured.

BMO Capital Markets analyst Evan Seigerman in an investor note said that “while we appreciate conservatism in neuropsych, management commentary has been somewhat muted around revenue expectations,” particularly as “launch is expected to be a slow build in schizophrenia.”

By contrast, Seigerman expects Alzheimer’s psychosis as a stronger opportunity for Cobenfy “in terms of sentiment.” Cobenfy is currently in Phase III development for this indication.

“While we are encouraged by Bristol’s progress in the quarter on top line and expenses, the transformative change Bristol needs will come from its pipeline,” Seigerman wrote.

Consensus peak sales estimate for Cobenfy is $5.4 billion. BMS expects to see a “sales ramp” for Cobenfy starting in the second half of 2025, following broad access in Medicare and Medicaid patients, Chief Commercialization Officer Adam Lenkowsky said during Thursday’s investor call.

https://www.biospace.com/business/bms-delivers-q3-beat-raises-2024-guidance-amid-strong-demand-for-legacy-and-newer-drugs