Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced that the U.S. Food and Drug Administration (FDA) extended by three months the target action date of its review of the supplemental New Drug Application (sNDA) for VTAMA® (tapinarof) cream, 1% as a treatment for atopic dermatitis (AD) in adults and children two years of age and older. The new target date is March 12, 2025, revised from the original target action date of December 12, 2024. The FDA has not raised any concerns regarding the safety and efficacy of VTAMA nor have they raised any concerns regarding the approvability of this indication.
-- 30.2-month median progression-free survival with a median follow-up of 38.1 months in the Phase 1 study of anito-cel; median overall survival not reached --
-- Preliminary results from 58 patients enrolled in the Phase 2 pivotal iMMagine-1 study demonstrated 95% ORR and 62% CR/sCR at a median follow-up of 10.3 months; additional patients with a more recent data cut will be presented during an oral presentation --
-- No delayed neurotoxicities have been observed to date with anito-cel, including no parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome across the Phase 1 and iMMagine-1 studies in the more than 140 patients dosed --
-- First patient dosed in iMMagine-3 study, manufactured by Kite; turnaround time in line with Kite's commercial products --
-- Company to host a live webcast event with an expert panel of clinicians on Monday, December 9, 2024 at 8:30 p.m. --
Webcast Event:
Arcellx will host a live webcast event with an expert panel of clinicians to discuss the clinical results on Monday, December 9, 2024 at 8:30 p.m. PT. The event will be accessible from Arcellx's website at www.arcellx.com in the Investors section. A webcast replay will be archived and available for 30 days following the event.
by Tom Ozimek via The Epoch Times,
The U.S. Supreme Court has agreed to review a key deadline affecting some noncitizens, specifically, illegal immigrants who seek protection from deportation to countries where they say they fear persecution or torture.
The decision could resolve conflicting interpretations among lower courts on how strictly the timing of deportation appeals should be enforced.
The high court agreed on Nov. 4 to hear a case brought by Pierre Riley, a Jamaican national who overstayed his visa to the United States in 1995.
In 2006, he was sentenced to 25 years in prison for possessing and intending to distribute more than 2,000 pounds of marijuana, as well as for possessing a firearm related to the drug offense.
After receiving compassionate release in 2021, Riley was taken into custody by immigration officials. The Department of Homeland Security (DHS) promptly issued a deportation order, known as a final administrative removal order, based on Riley’s aggravated felony conviction.
Saying he feared violence if returned to Jamaica, Riley applied for relief from the removal order under the Convention Against Torture (CAT), citing a credible fear of persecution or torture at the hands of a criminal who had already harmed members of his family.
Although an initial review by an asylum officer found that Riley had not shown a reasonable fear, an immigration judge later granted him protection under the CAT, deferring his deportation. DHS appealed the immigration judge’s decision to the Board of Immigration Appeals (BIA), which overturned the immigration judge’s order in May 2022 and ordered Riley’s removal to Jamaica.
Riley then appealed the BIA’s decision to the U.S. Court of Appeals for the Fourth Circuit. However, the appeals court dismissed his petition, citing lack of jurisdiction and concluding that Riley had missed the 30-day deadline mandated by immigration law. The Fourth Circuit held that the 30-day clock began with the original final administrative removal order issued in January 2021, not with the later BIA decision.
Under the Fourth Circuit’s interpretation, only the original removal order triggers the 30-day appeal period. This decision prompted Riley to appeal to the Supreme Court.
In his appeal to the high court, filed on May 31, Riley’s attorneys highlighted a split among federal circuits on two key issues.
The first is about when the 30-day deadline begins.
Some circuits, including the Fourth Circuit, require appeals to be filed within 30 days of the initial removal order. Other circuits permit illegal immigrants and other noncitizens to appeal within 30 days of the BIA’s final decision, especially when that decision is the last step in the administrative process.
The second question before the Supreme Court is whether the 30-day deadline is a strict, jurisdictional requirement, or merely a procedural “claims-processing” rule that can be interpreted flexibly under certain circumstances. If the deadline is jurisdictional, courts lack the authority to hear late appeals, but if it’s deemed to be a claims-processing rule, exceptions may be possible in some cases.
The Supreme Court’s Nov. 4 docket entry confirms that the justices will limit their review to these two questions, as framed by the Department of Justice, which is representing the government in the case.
The docket entry reads:
“The petition for a writ of certiorari is granted limited to the questions presented by the respondent’s brief.
1. Whether the 30-day deadline in 8 U.S.C. 1252(b)(1) for filing a petition for review of an order of removal is jurisdictional.
2. Whether a noncitizen satisfies the deadline in Section 1252(b)(1) by filing a petition for review challenging an agency order denying withholding of removal or protection under the Convention Against Torture within 30 days of the issuance of that order.”
It’s unclear when the Supreme Court will finalize its review.
The outcome of the case has the potential to set a nationwide standard for deportation appeals, influencing how cases involving claims of risk of harm resulting from deportation are handled across federal courts.
A decision by the Supreme Court to treat the 30-day deadline as nonjurisdictional would provide flexibility in deportation appeals, allowing some cases to be heard even if the deadline was missed.
Conversely, if the high court rules that the 30-day period is strictly jurisdictional, illegal immigrants and some other types of noncitizens facing deportation—such as those who have been granted asylum or refugee status but committed crimes that make them deportable—would face limits in accessing judicial review.
A CNN panel looked shocked after guest Marc Lotter suggested a significant shortfall in Democrat early voting vs. 2020 portends a bad time for Kamala Harris.
"The math doesn't work. The Democrats are down 1.7 million early votes in the battleground states in urban areas," said Lotter. "They are down 1.4 million votes in the battleground states among women voters."
"Rural voters have overperformed early by 300,000," he continued, noting that "Democrats have to win their races early. Republicans generally win them on election day."
"The margins don't add up right now for the Democrats in any of these battleground states."
"The math doesn't work. The Democrats are down 1.7 million early votes in the battleground states in urban areas."
— Kyle Becker (@kylenabecker) November 5, 2024
"They are down 1.4 million votes in the battleground states among women voters."
"Rural voters have overperformed early by 300,000."
"Democrats have to win their… pic.twitter.com/zarBQ7RY7o
h/t Kyle Becker
Lotter's comments come after the Trump campaign touted bullish data showing Republicans gaining ground with the early vote in battleground states vs. the 2020 election cycle.
According to the campaign, new and infrequent voters are leaning more Republican than Democrat based on the latest indications from Arizona, North Carolina, Nevada and Pennsylvania, the NY Post reports, citing a source in the camp.
"In those states, Democrats have more than 1.4 million voters who voted before Election Day in 2020 or 2022 but have not voted yet” — despite early voting being closed in nearly every state — “and many not having even requested a mail ballot," the source said, suggesting that Democrat turnout might not be as strong this time around.
According to the Post, here's some of the data that allies of the campaign have been privately touting - mixed with early-voter information:
Arizona
Returned mail and early-vote party registration: Republicans up 8 points.
Relative to 2020: Republicans are up 9 points.
Early voting in the Grand Canyon State closed Nov. 1. Men comprised about 50% of the votes for Republicans and 40% for Democrats, according to the data shared with The Post.
Other groups have reported apparent advantages for Republicans here, too. For instance, there have been 924,524 GOP ballot returns, relative to 736,569 for Democrats, according to early-vote data compiled by UpLift Campaigns.
Georgia
The Peach State doesn’t have voter registration information for its early votes.
Looking at data from Democratic analyst Tom Bonier, the African American early vote and mail turnout dipped 7% relative to 2020.
Early voting in Georgia stopped Nov. 1. Its turnout soared to 4,004,588 both through early voting and absentee voting by mail this year, compared to the 2,697,822 early voters four years ago, according to data from the Georgia Secretary of State’s office.
Michigan
The Wolverine State similarly lacks voter registration information for its early votes.
But the Trump campaign is touting data suggesting that in-person early voters represent about 32% of the pre-Election Day votes cast and that its supporters typically favor in-person voting. In-person early voting is new in Michigan.
More than 2.58 million of the over 7 million people registered to vote in Michigan have cast early votes, according to data from the Michigan Secretary of State’s Office.
North Carolina
Returned mail and early-vote party registration: Republicans up 1 point.
Relative to 2020: Republicans are up 9 points.
This appears to be the first time Republicans have ever clinched the early vote in North Carolina.
Data from Bonier suggests that African American mail and early-vote returns have sunk 22% relative to 2020 here. Men comprised about 37% of the Democratic support and 49% of Republican support.
In-person early voting in the Old North State stopped Nov. 2.
There have been about 4.4 million early votes cast out of the roughly 7.8 million registered voters in North Carolina, including 1,478,496 for Republicans, 1,436,861 for Democrats and 1,524,094 without a party registration, according to data from the University of Florida’s Election Lab.
Nevada
Returned mail and early-vote party registration: Republicans up 4 points.
Relative to 2020: Republicans are up 8 points.
Early in-person voting was closed off Nov. 1. Roughly 42% of Democratic votes came from men and 52% from Republicans.
Across the board, Nevada saw about 1,077,441 voters turn out early, including 406,705 from Republicans and 363,595 from Democrats, according to data.
Pennsylvania
Returned mail and early-vote party registration: Democrats up 23 points
Relative to 2020: Republicans are faring 22 points better.
The Trump campaign believes that Democrats’ early-vote advantage in the Keystone State has slipped from past elections, with total absentee ballots plummeting about 29% relative to the 2020 cycle.
There have been at least 1,739,606 early votes cast in Pennsylvania, including 971,615 from Democrats and 571,725 from Democrats, per the University of Florida’s Election Lab data.
Wisconsin
The Badger State lacks voter registration information for its early votes.
Still, the Trump campaign believes that early votes and mail-in ballots have slipped 23% since 2020 and that mail-in ballot requests are down 52% from 2020.
There have been at least 1,338,728 early votes cast in Wisconsin, according to data from the University of Florida’s Election Lab. There are more than 4.7 million registered voters there.
Approximately 76 million early votes have been cast across the country, per the University of Florida's Election Lab vs. 252 million in the 2020 election, in which early voting generally favored Democrats, while in-person voting leaned Republican.
Third Quarter Results and Highlights
All comparisons are to the quarter ended September 30, 2023 unless otherwise stated.
Management Commentary
Suzanne Foster, Chief Executive Officer of AdaptHealth, stated, “I continue to be optimistic about the road ahead. We have identified growth opportunities, we are assembling a high performing team and investing in areas that allow us to serve even more patients in their homes.”
Financial Outlook
The Company is updating previous financial guidance for fiscal year 2024 as follows:
Conference Call
Management will host a teleconference today, Tuesday, November 5, 2024, at 8:30 am ET to discuss the results and business activities with analysts and investors.
Interested parties may participate in the call by dialing:
When prompted, reference Conference ID: AHCO3Q24
Webcast registration: Click Here
Following the live call, a replay will be available for six months on the Company's website, www.adapthealth.com, under “Investor Relations.”
