Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. Under the Prescription Drug User Fee Act (“PDUFA”), the FDA has deemed the Company’s NDA resubmission to be a Class II complete response which has a six-month review period from the date of resubmission. As a result, the FDA has assigned a PDUFA action date of October 25, 2024.
Saturday, June 1, 2024
Autolus analysis of Pivotal Phase 2 FELIX study of obe-cel for adult r/r B-ALL
- The majority of patients that responded to obe-cel showed durable responses with the potential for a long-term plateau of survival outcomes
- 40% patients are in ongoing remission without subsequent stem cell transplant (SCT) or other intervention
- Ongoing CAR T persistence was associated with improved event-free survival
- Autolus will host a conference call and webcast to discuss the presented data on Saturday June 1, 2024 at 9:30 am EDT/8:30 am CDT/2:30 pm BST (details below)
A conference call and webcast to discuss the presented data will be held at 9:30 am EDT/8:30 am CDT/2:30 pm BST on Saturday June 1, 2024. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call.
A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website.
Nvidia soon to join Dow?
Is Nvidia about to reach a new milestone by joining the Dow Jones, the most exclusive and longest-running index on the US stock market? The question arises in view of the company's weight on the stock market and its importance in the global ecosystem. The forthcoming ten-for-one stock split may well help the decision. But nothing has yet been done.
A company's inclusion in the Dow Jones Industrial Average (DJIA) is a milestone for US-listed companies. Wall Street's oldest index comprises just 30 stocks, and changes are relatively rare (7 in the last 15 years). Inclusions and exclusions are subject to a number of criteria, not all of which are explicitly defined, as selection is partly subjective (no numerical criteria, apart from share price, as we shall see later) and carried out by a special committee of S&P Dow Jones Indices. Here are a few criteria:
- The company has an "excellent reputation".
- Sustained growth
- Attractive to a large number of investors
- Maintains "adequate" sector representation
- It must be incorporated and headquartered in the United States, and generate "a significant portion" of its revenues there.
- It does not belong to the Transportation (GICS code 2030) or Utilities (GICS code 55) sectors.
- The most expensive stock in the index must not be more than ten times more expensive than the cheapest.
Nvidia is a candidate for inclusion in the index, given its growth over the past two decades and its position as one of the fastest-growing companies in the United States. Based on current share prices (USD 1141), the operation would not have been possible under the last of the aforementioned laws. But Nvidia has announced its intention to divide the value of its stock by ten, to make it more accessible, more liquid and... perhaps to set its sights on the Dow Jones? The index is in fact weighted by price - an incongruity in modern times - and not by capitalization. S&P can't afford to include stocks whose price is too high, at the risk of giving them too much influence in the index. On the basis of the current price of USD 1141, a tenfold split would bring the price down to around USD 114, which would be much more acceptable for inclusion in the Dow Jones. Currently, the Dow's most influential stock is UnitedHealth (USD 504), ahead of The Goldman Sachs Group (USD 460) and Microsoft (USD 430).
The market had speculated that Amazon would enter the Dow in 2022, after a "split". The stock was finally added earlier this year, at the expense of Walgreens Boots (which had ousted General Electric in 2018). In the technology segment, Microsoft and Intel had joined the index in 1999, becoming the first Nasdaq-listed stocks to be included in the Dow. Apple had to wait until 2015 (replacing AT&T).
Many positive arguments
Nvidia has the potential to join the Dow Jones, but the final decision is partly discretionary, as we've seen. Changes are not that frequent in the old index. Even so, the forecasts make Intel a risky proposition. The company has not been on a roll for some time now, and is at the very bottom of the rankings in terms of share price (USD 31). What's more, it seems easier to replace a technology with a technology for the committee: it avoids having to rack your brains over sector representativeness!
The stock ticks quite a few boxes in favor of inclusion. But perhaps the committee will want to wait for the dust to settle after the stock's stratospheric rise (it can decide when it likes). On the other hand, Nvidia's entry into the Dow would enable the old index to better replicate the strength of the technology sector, since Intel hasn't been the best horse to bet on in this area in recent years. Several market insiders punctuated their comments on the subject with this mantra, which pretty much sums up the general feeling: it's not a question of if Nvidia will enter the Dow, but when.
Here it is: 'Trump supporters call for riots and violent retribution after verdict'
Supporters of former President Donald Trump, enraged by his conviction on 34 felony counts by a New York jury, flooded pro-Trump websites with calls for riots, revolution and violent retribution.
After Trump became the first U.S. president to be convicted of a crime, his supporters responded with dozens of violent online posts, according to a Reuters review of comments on three Trump-aligned websites: the former president's own Truth Social platform, Patriots.Win and the Gateway Pundit.
Some called for attacks on jurors, the execution of the judge, Justice Juan Merchan, or outright civil war and armed insurrection.
“Someone in NY with nothing to lose needs to take care of Merchan,” wrote one commentator on Patriots.Win. “Hopefully he gets met with illegals with a machete,” the post said in reference to illegal immigrants.
On Gateway Pundit, one poster suggested shooting liberals after the verdict. “Time to start capping some leftys,” said the post. “This cannot be fixed by voting."
Threats of violence and intimidating rhetoric soared after Trump lost the 2020 election and falsely claimed the vote was stolen. As he campaigns for a second White House term, Trump has baselessly cast the judges and prosecutors in his trials as corrupt tools of the Biden administration, intent on sabotaging his White House bid. His loyalists have responded with a campaign of threats and intimidation targeting judges and court officials.
“This was a disgrace, this was a rigged trial by a conflicted judge who was corrupt,” Trump told reporters afterwards, echoing comments he often made during the trial.
A 12-member jury found Trump guilty on Thursday of falsifying documents to cover up a payment to silence a porn star’s account of a sexual encounter ahead of the 2016 election. Sentencing is set for July 11, days before the Republican Party is scheduled to formally nominate Trump for president ahead of the Nov. 5 election. Trump has denied wrongdoing and is expected to appeal.
Trump continued his attacks online after the verdict.
On Truth Social, he called Merchan “HIGHLY CONFLICTED” and criticized his jury instructions as unfair. One commentator responded by posting a picture of a hangman's platform and a noose with the caption: “TREASONOUS MOBSTER OF THE JUSTICES SYSTEM!!”
Jacob Ware, a co-author of the book “God, Guns, and Sedition: Far-Right Terrorism in America”, said the violent language used by Trump’s followers was testament to the former president’s “ironclad ability to mobilize more extreme supporters to action, both at the ballot box and through violence.”
“Until and unless he accepts the process, the extremist reaction to his legal troubles will be militant,” said Ware, a research fellow at the Council on Foreign Relations.
A spokesperson for Truth Social said, “It’s hard to believe that Reuters, once a respected news service, has fallen so low as to publish such a manipulative, false, defamatory and transparently stupid article as this one purely out of political spite.”
All three sites have policies against violent language, and some of the posts were later removed. Representatives of Patriots.Win and Gateway Pundit did not immediately return requests for comment. A Trump spokesperson also did not respond to an email seeking comment.
“HANG EVERYONE”
After Thursday's verdict, many of his supporters also said that his conviction was proof that the American political system was broken and that only violent action could save the country.
“1,000,000 men (armed) need to go to Washington and hang everyone. That's the only solution,” said one poster on Patriots.win. Another added: “Trump should already know he has an army willing to fight and die for him if he says the words...I’ll take up arms if he asks.”
Other posts specifically urged targeting Democrats, in some cases suggesting they be shot. “AMERICA FULLY DESTROYED BY DEMOCRATS. LOCK AND LOAD,” wrote a commentator on Gateway Pundit.
While the posts identified by Reuters all called for violence or insurrection, most fell short of the legal standard for a prosecutable threat, which typically requires evidence that the comment reflects a clear intent to act or instill fear, rather than simply suggesting a frightening outcome.
Still, one researcher who studies extremist militias said the guilty verdict could inspire violence by reinforcing a conviction among some of Trump's supporters that he's a victim of a conspiracy orchestrated by his enemies.
“I do think a lot of these folks have been looking for an excuse to maybe mobilize for a while,” said Amy Cooter of the Middlebury Institute of International Studies’ Center on Terrorism, Extremism and Counterterrorism. “I hope I’m wrong. I’ve said for a long time, though, that I would not be shocked to see violence result from a guilty verdict, either directed toward the jurors” or others connected to the case.
Friday, May 31, 2024
Pro-Palestinian protesters occupy parts of Brooklyn Museum
Pro-Palestinian protesters took over parts of the Brooklyn Museum on Friday, hanging a banner above the main entrance, occupying much of the lobby and scuffling with police, witnesses said.
The art museum in the New York City borough of Brooklyn said it closed an hour early because of the disruption, including skirmishes between police and protesters that took place inside and outside the building.
Some arrests were made but a New York Police Department spokesperson said there would be no official count until after the protest concluded. A demonstration continued outside the museum hours after the initial confrontation, but the spokesperson could not say whether any protesters remained inside.
One of the arrests was of a man who defaced an outdoor sculpture with graffiti, a Reuters witness said. Several protesters scrawled messages on the OY/YO sculpture on the plaza outside the entrance.
"There was damage to existing and newly installed artwork on our plaza," a museum spokesperson said in an email. "Protesters entered the building, and our public safety staff were physically and verbally harassed.
"Out of a concern for the building, our collections, and our staff, the decision was made to close the building an hour early," and the public was asked to vacate peacefully, the statement said.
Hundreds of demonstrators were marching through Brooklyn when some of them rushed the entrance, according to the Reuters witness. Security guards prevented many from entering but some managed to get inside.
A banner was hung from atop the neoclassical facade proclaiming, "Free Palestine, Divest From Genocide."
A pro-Palestinian organization named Within Our Lifetime urged demonstrators to "flood Brooklyn Museum for Gaza." It said activists occupied the museum to compel it to disclose any Israel-related investments and to divest any such funding.
Demonstrations against Israel's prosecution of the war in Gaza have continued in the United States, largely on university campuses.
At Columbia University in upper Manhattan, demonstrators on Friday set up an encampment on campus during an alumni reunion to show support for Palestinians. Video on social media showed campus security taking down the tents. As of Friday night, police were not involved, as they had been in taking down the camp and evicting or arresting protests twice before.
"We are aware of the encampment erected this evening and are monitoring the situation. We remain committed to hosting a successful weekend for our alumni," Columbia spokesperson Samantha Slater said in a statement.
The Israeli-Palestinian war began when Hamas militants attacked Israel on Oct. 7, killing 1,200 people.
Palestinian health authorities estimate more than 36,280 people have been killed in Gaza since Israel responded.
https://www.yahoo.com/news/pro-palestinian-protesters-occupy-parts-230954755.html
'US doubtful it could help S. Korea on nuclear-powered subs'
The United States is unlikely to help South Korea build nuclear-powered submarines at the moment, as it is stretched by AUKUS commitments to Australia, U.S. Defense Secretary Lloyd Austin said at the Shangri-La security dialogue in Singapore.
In 2021 the United States signed the AUKUS pact with Britain and Australia to share nuclear-powered submarine technology and to sell at least three Virginia-class boats to Australia in the 2030s.
Several other allies, including South Korea, have expressed interest in involvement.
Asked on Saturday at the security summit how he would respond to a direct South Korean request for help obtaining nuclear submarines, Austin said it would be "very, very difficult" for Washington to accommodate that "on top of what we do right now".
"(AUKUS) is no small endeavour," he said. "We just started down this path with Australia. (It's) highly doubtful that we could take on another initiative of this type anytime in the near future."
The two-stage security pact aims to counteract China's growing power in the Asia-Pacific region. It will be the first time Washington has shared nuclear-propulsion technology since it did so with Britain in the 1950s.
It includes a second technology-sharing "pillar", besides the submarines, which has drawn interest from New Zealand and Japan.
"We believe that AUKUS is actually a good addition to regional security," New Zealand Defence Minister Judith Collins said on the sidelines of the Shangri-La Dialogue on Friday, adding that New Zealand had enquired about the second pillar
"We've had no actual invitation to join it but it is something that we are certainly looking at," she said.
Australian Defence Minister Richard Marles said that he could imagine other countries' involvement in the future but that the focus for now was on the U.S.-UK-Australia trio getting "runs on the board" of submarine projects, which are set to last decades.
https://ca.news.yahoo.com/us-doubtful-could-help-korea-031918410.html
More evidence points to Russia-North Korea military cooperation, South Korea defence minister says
South Korean defence minister Shin Won-sik said on Saturday that more evidence suggests weapons used by Russia in the war in Ukraine were illegally imported from North Korea.
"Military cooperation between Russia and North Korea" is escalating tensions on the Korean Peninsula and "also affecting the battlefield in Europe", Shin said.
If North Korea continues to receive military technology transfers from Russia in return, a significant improvement in North Korea's conventional military capability is an imminent risk, Shin said.
The United States said in February that North Korea had delivered more than 10,000 containers of munitions and related material since September to Russia.
Both Moscow and Pyongyang have denied accusations that North Korea transferred weapons to Russia for use against Ukraine, which Russia invaded in February 2022.
Shin also called for China to take a more active role on denuclearisation on the Korean peninsula.
On questions about whether South Korea may seek nuclear weapons of its own, Shin said that South Korea trusts the global nonproliferation treaty (NPT) regime, and that a stronger U.S.-South Korean alliance is the answer to North Korea's nuclear development.
Shin was speaking during the Shangri-La Dialogue, Asia's biggest defence forum, under way in Singapore. The event ends on June 2.
https://www.yahoo.com/news/more-evidence-points-russia-north-032010661.html