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Friday, January 10, 2025

Insmed Business Update at 43rd Annual J.P. Morgan Healthcare Meet

 --ARIKAYCE® (amikacin liposome inhalation suspension) Exceeds the Upper End of Guidance Range for Full-Year 2024 with Unaudited Global Revenues of Approximately $363.7 Million--

--2025 Global ARIKAYCE Revenues Expected to be Between $405 Million and $425 Million, Reflecting Continued Double-Digit Growth Compared to 2024--

--NDA for Brensocatib in Bronchiectasis Submitted to FDA in December 2024, Narrowing the Timing for Expected U.S. Launch to the Third Quarter of 2025, Pending Approval Under Priority Review--

--Enrollment for Phase 2 Study of TPIP in Patients with PAH Completed in December 2024; Expected Timing for Topline Data Moved Forward to Mid-2025--

--Phase 3 ENCORE Trial for ARIKAYCE in Patients with Newly Diagnosed or Recurrent MAC Lung Disease Fully Enrolled; Topline Data Anticipated in First Quarter of 2026--

--IND Cleared for Insmed's First Gene Therapy (INS1201) for Patients with DMD; First Patient Dosing Anticipated in the First Half of 2025--

https://www.prnewswire.com/news-releases/insmed-provides-business-update-at-43rd-annual-jp-morgan-healthcare-conference-302347617.html

Morgan Stanley upgrades Gilead on HIV treatment growth

 Morgan Stanley upgraded Gilead Sciences Inc (NASDAQ:GILD) to "overweight" from "equal weight," raising its price target to $113 from $87 on HIV prevention drug Lenacapavir (PrEP) and next-gen HIV treatments.

“We see the potential for upward estimate revisions on LEN for PrEP and further multiple expansion as the company makes progress with its next-gen HIV treatment strategy,” Morgan Stanley (NYSE:MS) analyst wrote.

The brokerage highlighted Gilead’s promising pipeline, including CAR-T therapy Anito-cel for multiple myeloma, and projected revenue and EPS growth of 4.1% and 7.3% annually through 2033, outperforming peers.

Gilead’s shares, trading at about 12 times 2025 earnings, offer room for further multiple expansion, Morgan Stanley said.

Morgan Stanley view catalyst such as FDA approval and launch of LEN for PrEP in summer 2025, Phase 2 data for once-weekly oral combination of drug in 2025, initial data for the once-yearly injectable formulation of LEN and the decision on a monthly oral INSTI candidate.

The brokerage said most significant risk to its call would be any potential policy changes with respect to Medicaid budgets that impact HIV therapies


https://finance.yahoo.com/news/morgan-stanley-upgrades-gilead-hiv-154858219.html

Officials Urge Calm As LA Fire Crisis Disrupts Main Fuel Pipeline To Las Vegas

 "In an abundance of caution, due to the fires in California, the main pipeline that brings gasoline and other fuels to the Las Vegas Valley looks to face temporary disruptions in service," the City of Las Vegas announced on X late Thursday. 

The pipeline shutdown involves Kinder Morgan's SFPP West and 566-mile CalNev pipeline system, which ships gasoline, diesel, and jet fuel from Los Angeles to Las Vegas. 

According to local media outlet KLAS 8 News Now, the CalNev pipeline system is responsible for 90% of Clark County fuel supplies.

"We want to reassure you that there is no emergency or immediate cause for concern. These measures are purely precautionary," the Las Vegas Metropolitan Police Department wrote on X, adding, "We encourage everyone to stay informed through reliable sources and avoid unnecessary panic or misinformation. Together, we can ensure our community remains calm and prepared."

Now Vegas residents know there's the possibility of an impending fuel:

Clark County announced Thursday night that fuel from the pipeline will start flowing to Vegas "in the next 12-24 hours," adding, "The public is encouraged to not panic buy at the pump."

What a shitshow unfolding across the Pacific Southwest—somewhat attributed to Los Angeles Mayor Karen Bass and Governor Gavin Newsom prioritizing a radical progressive agenda instead of actually doing their jobs. 

https://www.zerohedge.com/commodities/do-not-panic-buy-la-fire-crisis-disrupts-main-fuel-pipeline-las-vegas

"Disinformation": Trudeau Offers Laughable Excuse For His Ouster

 by Luis Cornelio via Headline USA,

Canadian Prime Minister Justin Trudeau blamed “right-wing attacks” and “disinformation” on Thursday as the main causes behind his long-awaited resignation. 

Trudeau announced Monday that he would step down as the Liberal Party leader, caving to pressure from his party amid growing dissatisfaction among Canadians over inflation and immigration. 

However, during an interview with CNN’s Jake Tapper on The Lead about his politically devastating poll numbers, Trudeau blamed everyone else but himself for his fall from grace

“When you get a con - you know, I was going to say conflagration - but at least an intersection of both right-wing attacks and social media, you end up with a lot of misinformation, disinformation,” Trudeau claimed. 

“Responsible governments have to stay focused on the policies that are making a difference. And that’s what we’ve been doing,” he added. 

Trudeau’s comments followed a lengthy and incoherent response to Tapper’s question about Canadian and American voters delivering a blunt verdict against leftist governance.  

Tapper noted that Canadians are concerned about high inflation, the overall economy and immigration.  

Drawing parallels with America, he added, “Those are also issues that the left-wing party in this country has faced a lot of disapproval. … It seems like voters in both of these liberal democracies are sending a message to left-wing parties, liberal parties: ‘We don’t like how you’re doing the economy when it comes to inflation. We don’t like how you’re doing immigration.’” 

Trudeau dismissed these concerns in response, claiming the polls were driven by “a lot of emotions.” 

“I mean, if you look at the actual numbers, inflation in Canada was lower, came down quicker,” he said. Later, Trudeau expanded, “Our economy is doing very well, but when someone is paying $8 for a head of lettuce, it doesn’t matter that you’re doing better than they are in Spain or somewhere else. There’s a sense that, ‘Okay. Something’s got to give.’ And that’s where incumbents are in trouble everywhere around the world, not just in our two countries.” 

Trudeau’s decision to step down also followed his failure to persuade President-elect Donald Trump not to impose tariffs on Canadian products during the incoming U.S. administration.

Following the 2024 presidential election, Trump mocked Trudeau in social media posts, referring to him as “governor” and joking that Canada could avoid tariffs if it became the 51st U.S. state.

https://www.zerohedge.com/political/disinformation-trudeau-offers-laughable-excuse-his-ouster

Arson Eyed In LA's Kenneth Fire - Suspect Gang-Tackled By Residents

 Police believe a fifth brush fire that broke out in the fiery Los Angeles hellscape on Thursday afternoon may have been set intentionally -- and they've arrested a suspect who was captured by residents. Los Angeles District Attorney Nathan Hochman indicated the suspect in the nearly-1,000-acre Kenneth fire could face murder charges, if a loss of life is linked to that blaze. "Justice will be swift. It will be firm, and the maximum punishment will be sought," he told NewsNation's Ashleigh Banfield. 

An image said to show the suspect in the Kenneth fire being taken into police custody; consistent with witness accounts, the photo seemingly shows a torch on the hood of the police car. 

Potential swift justice was off to a strong start thanks to the initiative of local residents. Witnesses told LA's KFI News radio that the suspect was seen riding a motorbike and holding an ignited torchwith three residents chasing him down and gang-tackling him in a front yard. We pause to note that portable torches have been observed in other California criminal endeavors:   

"What we know right now is that the [fire] occurred, started here, and about 20 minutes, 30 minutes later, a suspect was detained over in Woodland Hills area by citizens," LAPD Senior Lead Officer Sean Dinsel told NewsNation's Brian Entin on the scene. Asked if the Kenneth fire was set intentionally, Dinsel said, "At this time, that's what we believe." He said the fire's suspected starting point -- at the Victory Trailhead that gives access to the Upper Las Virgenes Canyon Open Space Preserve -- was being treated as a "crime scene."  

Little is known about the suspect, and his name has yet to be released. LAPD issued a statement confirming the arrest, but noting "We CANNOT confirm any connection to any fire by this suspect at this time." Meanwhile, KFI News and others have posted photos and videos said to show him being arrested: 

The Kenneth fire began shortly after 2:30 pm in the the Woodland Hills area, near a neighborhood called Calabasas. Quickly spreading to more than 900 acres, it prompted mandatory evacuation orders in the immediate vicinity, along with evacuation warnings in adjacent Ventura county. The orders were subsequently downgraded to warnings, NBC News reports, after the fire's progress.

While that was a rare, encouraging development for firefighters engaged in a daunting multi-front war, it was well short of a victory: As of 8pm local time, the Kenneth fire was listed as 35% contained. Late Thursday afternoon, California Gov. Gavin Newsom said 900 additional firefighters were being deployed against the blaze. 

Demonstrating an awareness that citizens are beyond fed up with California's failure to provide safety and security, DA Hochman dished out tough-sounding rhetoric about the arrest of the arson suspect. "Our goal is to send this warning," he told Banfield." Whether it's looting, these internet scams, robbery, or future arsons. … The day and age of a DA's office standing on the sidelines is over. We want to bring justice, and we will."

via CalFire

Let's not forget what we noted on Thursday. 

. . .  https://www.zerohedge.com/weather/arson-eyed-las-kenneth-fire-suspect-gang-tackled-residents

Homeland Security Inspector General Confirms Audit Of FEMA Over Trump Sign Controversy

 by Jack Phillips via The Epoch Times,

The Department of Homeland Security’s inspector general this week confirmed it is auditing the Federal Emergency Management Agency (FEMA) over concerns that its employees avoided homes that displayed signs supporting then-presidential candidate Donald Trump in the aftermath of several hurricanes.

In a letter dated Jan. 6, the office told Reps. Sam Graves (R-Mo.) and Scott Perry (R-Pa.) that an audit of the disaster relief agency was initiated on Dec. 17, 2024, to “determine how well FEMA followed its policies and procedures when addressing safety concerns and determining community trends that impact disaster survivor assistance in response to Hurricanes Helene and Milton.”

Two months ago, a now-terminated FEMA employee, Marn’i Washington, allegedly told a FEMA team in Florida to bypass homes that display Trump signs. After reports surfaced that FEMA workers were told to avoid those homes, FEMA Director Deanne Criswell announced that the employee, Washington, was fired.

“I want to be clear to all of my employees and the American people, this type of behavior and action will not be tolerated at FEMA, and we will hold people accountable if they violate these standards of conduct,” Criswell said in a statement at the time.

But Washington later said in several media interviews that the policy was systemic and that she was being scapegoated. FEMA officials “were already avoiding these homes, based on community trends, from hostile political encounters,” she told Fox News at the time, adding that the policy had “nothing to do with the campaign sign, it just so happened to be a part of the community trend.”

“Firstly, I’m being framed,” she told NewsNation in mid-November 2024.

“There’s no violation of the Hatch Act. I was simply following orders.”

On Dec. 3, 2024, Graves and Perry, two lawmakers who sit on the House Transportation Committee, called for an investigation into the claims made by Washington and other reports “of the deliberate avoidance of homes with Trump campaign or political signs” during FEMA’s response to the two hurricanes.

“The actions taken by FEMA supervisors in directing employees to avoid homes that displayed Trump campaign signs or flags are disturbing and raise serious questions about the culture and political bias that permeates FEMA leadership,” they wrote, adding that the committee is also concerned about whether the practice was “more widespread than reported” and could have harmed hurricane victims.

In November 2024, Criswell testified before a House subcommittee and said that not providing aid to people due to political beliefs is “completely at odds with FEMA’s mission,” stressing that the incident wasn’t part of a broader FEMA trend.

FEMA had faced criticism late last year after Homeland Security Secretary Alejandro Mayorkas and Criswell suggested the relief agency would run out of funding needed to last the remainder of the 2024 hurricane season.

The announcement from Mayorkas did not sit well with certain Republicans. Rep. Anna Paulina Luna (R-Fla.), Texas Gov. Greg Abbott, and others highlighted two FEMA announcements last year allocating more than $1 billion to offset the costs of illegal immigrants who were flooding U.S. cities, which GOP officials said should instead have been provided to communities reeling from the hurricanes.

Helene hit the southeastern United States in late September 2024, causing widespread destruction, particularly in the Appalachian region of western North Carolina. Weeks later, Milton slammed into Florida’s west coast, causing devastation across the Tampa area.

https://www.zerohedge.com/political/homeland-security-inspector-general-confirms-audit-fema-over-trump-sign-controversy

LA Sheriff Declares Curfew Amid Arson & Looting Chaos

 Where is the National Guard?

Criminal gangs have reportedly been looting mansions in fire-ravaged areas of LA County...

... while arson suspects have been arrested.

The chaos unfolding in LA County prompted LA County Sheriff Robert Luna to impose a curfew across areas affected by the Pacific Palisades fire and the Eaton fire. 

Luna said the curfew will be "strictly enforced," adding, "We're not screwing around with this; we don't want people taking advantage of our residents that have already been victimized."

Threat number one was the fireThreat number two will be the chaos afterward.

Stay safe. 

*  *  *

As Kimberley Hayek detailed earlier via The Epoch Times, as Los Angeles is devastated by several fires burning in the city, county, and surrounding region, with seven people confirmed dead, at least 20 people have been arrested for burglary, looting, and other property crimes.

At a press conference on Thursday morning, city officials gave stern warnings to those engaging in such activity.

“We’ve all seen individuals who are targeting vulnerable communities by burglarizing and looting homes,” said Chair of the Los Angeles County Board of Supervisors Catherine Barger.

“This is simply unacceptable.”

Los Angeles County Sheriff Robert Luna said that there are more than 400 sheriff’s department personnel actively deployed to the fires, in addition to the normal staffing for patrols throughout the county.

The department continues to provide security in evacuation areas to prevent criminal behavior, such as looting, he said.

Luna clarified that when an evacuation order is in place, remaining in the affected area is a misdemeanor. If an individual commits certain crimes, that punishment could be increased to a felony.

“If you are in one of these areas and you do not belong there, you are going to be subject to arrest,” he said.

The sheriff indicated the fire death toll could rise and reminded residents to listen to orders and guidelines from local law enforcement and officials.

“I cannot emphasize enough that I urge residents that are asked to evacuate to follow our warnings,” he said.

Los Angeles Police Department Chief Jim McDonnell also shared a message to those seeking to exploit the crisis and take advantage of others.

“We’re going to be there, and we’re going to be working to hold you accountable for what you’re doing in that regard,” McDonnell said.

Newly-elected Los Angeles County District Attorney Nathan Hochman said he has never seen such destruction over the 60 years he has lived in the area.

The fires, for which no cause has been determined, have resulted in the destruction of more than 10,000 structures. Nearly 180,000 people are under evacuation orders. The fires, which began on Tuesday and have so far scorched more than 29,000 acres, are the most destructive in Los Angeles history.

“It looked apocalyptic,” Hochman said. “Not since the 1990s when Los Angeles was hit with the fires, the flood, the earthquake, and the riots, have I seen such disaster occur here in our city.” He also said he is optimistic about the city’s ability to rebuild.

Hochman had a warning for those considering criminal behavior.

“If you want to go ahead and loot, if you want to commit burglary, if you want to engage in grand theft, if you want to engage in these internet scams where you’re going to take advantage of people who are going to be seeking insurance and government benefits, you will be arrested, you will be prosecuted, and you will be punished to the full extent of the law,” he said.

On Thursday, California Gov. Gavin Newsom approved a request from the county to deploy the California National Guard to support law enforcement efforts in the region.

https://www.zerohedge.com/political/20-arrested-looting-during-los-angeles-fires