Search This Blog

Thursday, August 15, 2024

Tempest Successful End-of-Phase 2 Meeting on Hepatocellular Carcinoma

 

  • Broad agreement on pivotal Phase 3 study plan, including use of current amezalpat dose and schedule
  • Overall survival, the strongest result from the Phase 2 trial, will be the primary study endpoint
  • Agreed-upon early efficacy analysis could reduce time to primary read-out significantly

Cingulate Issued European Patent for Lead Asset for the Treatment of ADHD

 Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced today that it was issued a European patent for its lead asset CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The patent application was granted on August 14, 2024, as EP Patent No. 3261625, and will include up to 30 European territories, including the United Kingdom. In addition to the European patent, Cingulate has patents in Australia, Canada and Israel, as well as pending patents in Hong Kong, the Republic of Korea, and the United States.

https://www.globenewswire.com/news-release/2024/08/15/2930828/0/en/Cingulate-Issued-European-Patent-for-Lead-Asset-CTx-1301-for-the-Treatment-of-ADHD.html

Accuray FQ4 and outlook

 14% Revenue and 8% Orders Growth in Q4

The Company is introducing guidance for fiscal year 2025 as follows:

  • Total revenue is expected in the range of $460 million to $470 million.
  • Adjusted EBITDA is expected in the range of $27.5 million to $29.5 million.

"Our fourth quarter results reflect a concerted effort by our team to drive improvements in our financial performance while delivering world class products and services to our customers. Our operating results were solid with controlled expenses and strong management of working capital that resulted in a significant decline in inventory and increase in cash. Moving into fiscal 2025, I'm excited about the year ahead and the potential of our new products to help generate revenue and growth in service," said Ali Pervaiz, Chief Financial Officer.

Conference Call Information

Accuray will host a conference call beginning at 1:30 p.m. PT/4:30 p.m. ET today to discuss results for the fourth quarter of fiscal 2024 as well as recent corporate developments. Conference call dial-in information is as follows:

  • U.S. callers: (833) 316-0563
  • International callers: (412) 317-5747

Individuals interested in listening to the live conference call via the Internet may do so by logging on to the Investor Relations section of Accuray's website, www.accuray.com. There will be a slide presentation accompanying today's event which can also be accessed on the company's Investor Relations page at www.accuray.com

https://www.prnewswire.com/news-releases/accuray-reports-fourth-quarter-and-fiscal-2024-financial-results-302222702.html

UK Man Arrested For Social Media Posts Containing "Anti-Establishment Rhetoric"

 by Paul Joseph Watson via modernity.news,

The BBC reports that a 40-year-old man has been arrested and criminally charged for social media posts that contained “anti-establishment rhetoric.”

Wayne O’Rourke becomes the latest example of the wave of authoritarian hysteria to impact free speech in the UK following the recent anti-mass migration riots.

O’Rourke was arrested on Sunday in connection with “posts made from a social media account,” according to Lincolnshire Police.

“Nottingham Magistrates’ Court heard the posts were alleged to contain anti-Muslim and anti-establishment rhetoric,” reports the BBC.

O’Rourke had nearly 100,000 followers on X and predicted his own arrest days beforehand.

So now apparently posting “anti-establishment rhetoric” in the United Kingdom is enough to get you locked up.

The report does not give any specifics of what the thought criminal actually posted, but he had “allegedly expressed support for the recent riots and offered advice on how to remain anonymous to his 90,000 followers.”

O’Rourke will appear at Lincoln Crown Court tomorrow to face charges of “publishing written material online to stir up racial hatred.”

As we highlighted yesterday, A 61-year-old man in the UK was jailed for 18 months for chanting “who the fuck is Allah” and telling police officers “you’re not English anymore” during a protest outside Downing Street.

Another man was imprisoned for 2 months merely for posting the words “coming to a town near you” alongside images of Muslim men on Facebook.

The legacy media continues to offer rolling, around the clock coverage of the charges being handed out to people who posted offensive content online, seemingly in an effort to act as a warning to others.

Children as young as 12-years-old have also been charged in connection with the riots, as authorities warn that merely observing a riot taking place and not even taking part in it is enough to bring criminal charges against someone.

https://www.zerohedge.com/geopolitical/uk-man-arrested-social-media-posts-containing-anti-establishment-rhetoric

SIGA NIH-Backed Mpox Study Did Not Improve Lesions

 National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) announced topline results from a preliminary analysis of the PALM 007 trial of tecovirimat for the treatment of monkeypox virus (mpox).

SIGA Technologies (NASDAQ:SIGA) sells tecovirimat under Tpoxx, an antiviral medication against orthopoxviruses such as smallpox and mpox.

NIAID reported that the study did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution within 28 days post-randomization for patients in the Democratic Republic of the Congo with mpox who were administered SIGA’s tecovirimat versus placebo.

All patients in this study were hospitalized for the entire duration of treatment.

This study was not a registration study conducted under an FDA Investigational New Drug Application.

A meaningful improvement was observed in patients receiving tecovirimat whose symptoms began seven days or fewer before randomization and those with severe disease.

“We believe these data warrant further investigation and support our view that post-exposure prophylaxis will be vital for treatment of severe cases of mpox and all cases of smallpox,” stated Dennis Hruby, Chief Scientific Officer.

Additionally, in this study, tecovirimat exhibited a safety profile comparable to that of the placebo.

These results are consistent with several prior studies in healthy volunteers and further support the strong safety profile observed with tecovirimat over the past 15 years.

The PALM 007 study was part of a globally coordinated initiative to address the 2022 mpox outbreak in the DRC and worldwide.

In PALM 007, patients in the placebo arm had much more favorable outcomes than those in the observational studies from the DRC that were used to plan this trial, which could have reduced the measured benefit of tecovirimat compared to placebo.

The exact impact of this controlled environment on the trial results is not yet known.

However, the study’s 1.7% overall mortality among enrollees, regardless of whether they received the drug or not, was much lower than the mpox mortality of 3.6% or higher reported among all cases in the DRC.

This shows that patients with mpox can achieve better outcomes when hospitalized and receive high-quality supportive care.

https://finance.yahoo.com/news/nih-cosponsored-monkeypox-virus-study-130118228.html

Massachusetts Set For Record Number Of Deportations Despite Sanctuary State Status

 by Eric Lundrum via American Greatness,

The state of Massachusetts, which considers itself to be a “sanctuary state” for illegal aliens, is set to carry out a record-high number of deportations of illegals.

As reported by the Daily Caller, the Department of Homeland Security (DHS) has filed over 44,000 deportation cases in Massachusetts in the first nine months of fiscal year 2024. If new cases continue at this pace, then the end of the fiscal year could see as many as 59,000 deportation cases. The previous record was 54,000 in fiscal year 2023, which previously set the record for the highest number of cases in about 25 years.

Despite previously voicing her support for open borders and vowing to keep the state a “sanctuary” for illegals, Governor Maura Healey (D-Mass.) declared in July that the state would limit the length of time that an illegal could stay at state-run overflow shelters, bringing it down to just five days per illegal.

This rule was implemented at all four overflow shelters, located in Cambridge, Chelsea, Lexington, and Norfolk. These shelters previously allowed illegals to stay for up to 30 days, with the option to simply re-apply for another 30 days indefinitely.

The governor’s office also pledged to pay for plane tickets and all travel expenses just to send illegals out of the state.

“I want to be clear, particularly to people outside of Massachusetts who may have gotten word that this is a place to come, that we do not have room here in Massachusetts,” said Healey during her press conference last month.

In a separate press release around the same time, Healey declared that “Massachusetts is out of shelter space, and we simply cannot afford the current size of this system.”

“That’s why we are making changes to [Emergency Assistance] prioritization and transitioning our safety-net sites to five-day temporary respite centers,” she added.

Healey’s stunning reversal on immigration reflects a broader trend of prominent Democrats who once supported mass migration, asylum, and amnesty for illegals, but who have since flip-flopped and now favor crackdowns on such hordes of illegals flooding into the country.

Other examples including New York City Mayor Eric Adams (D-N.Y.), who has been facing an onslaught of illegals pouring into his city due to it being the single most popular destination for illegals who come into the United States.

https://www.zerohedge.com/political/massachusetts-set-record-number-deportations-despite-sanctuary-state-status

"It's Communism": Kamala's First Economic Plan Proposes Price Controls To "Combat Inflation"

 After the unoriginal Vice President Kamala Harris stole former President Trump's proposed 'no tax on tips' policy, she's at it again with yet another recycled idea. This time, she's echoing President Biden's actions and rhetoric to crack down on sky-high food prices by proposing the first-ever federal ban on "corporate price-gouging in the food and grocery industries"—a move that reeks of socialism.

"There's a big difference between fair pricing in competitive markets, and excessive prices unrelated to the costs of doing business," the Harris campaign wrote in a statement, adding, "Americans can see that difference in their grocery bills."

The Harris campaign said the vice president will unveil the new federal proposed ban on Friday at a campaign rally in the battleground state of North Carolina as part of a broader economic policy platform. The proposal will ensure food companies can't exploit consumers to increase profits, according to CBS News, citing Harris-Walz campaign officials. 

Harris' policy speech will also call on the Federal Trade Commission and state attorneys to examine corporations violating price-fixing rules. Her remarks are expected to echo Biden's actions and rhetoric, especially with his war against meat processing companies that he alleges are responsible for higher burger prices at the supermarket.

VP Harris' campaign argues that lowering Americans' costs is a function of socialist-style price controls. Yet this is the quickest way to understand that Harris' economic team has no actual understanding of inflation. 

Heritage Foundation's EJ Antoni explained, "Here's your "price gouging" narrative: average costs paid by businesses have risen just as much as costs charged to consumers - if businesses are being "greedy," they're doing it all wrong..." 

Instead of curbing out-of-control government spending, which debt rises $1 trillion every 100 days, and understanding that monetary inflation driven by the Federal Reserve's money creation is the root cause of inflation, Harris deflects the actual problem: The Fed. She instead goes after big corporations for 'illegal price gouging.' 

Here's a snippet of Money Metals Midweek Memo's Mike Maharrey commenting on Harris' proposed price-fixing ban on big food companies: 

The second "dumb" idea Maharrey discussed came from Vice President Kamala Harris, who was recently asked about her plan to combat inflation. Maharrey criticized her response, which he described as "word salad," pointing out that she merely acknowledged the problem without offering any concrete solutions. Instead, she promised to take on "big corporations" engaging in "illegal price gouging," corporate landlords, and big pharma.

Maharrey argued that Harris's approach misses the root cause of inflation, which is monetary inflation driven by the Federal Reserve's money creation. He cited the July budget deficit data, revealing that the Biden administration spent another $574 billion in just one month, running a $243 billion deficit. Maharrey emphasized that inflation is not caused by corporate greed but by the government's excessive spending and borrowing.

"Price inflation is a symptom of monetary inflation, which has everything to do with money creation by the Federal Reserve," Maharrey explained. He warned that Harris's proposed policies, including price controls, would likely lead to shortages and exacerbate the problem rather than solve it.

Here's what X users are saying.

And more... 

Nothing to see here... 

Kamalanomics = 'communist economics' as some X users describe... 

"We are no longer talking about hypothetical communism, we are talking about two straight up communists who want to institute a federal price ban on food and a federal minimum wage that is going to make every corporation go out of business.

...

Voting for communism is not the solution to your precious feelings."

https://www.zerohedge.com/economics/vp-harris-first-economic-plan-proposes-federal-price-controls-combat-inflation