'Biden likely to talk with Netanyahu; hostage deal 'very close,' security adviser says'

 U.S. President Joe Biden will likely talk with Israeli Prime Minister Benjamin Netanyahu soon, his national security adviser said on Sunday, as U.S. officials race to reach a Gaza hostage and ceasefire deal before Biden leaves office on Jan. 20.

Jake Sullivan told CNN's "State of the Union" program that the parties were "very, very close" to reaching a deal to halt the fighting in the enclave and free the remaining 98 hostages held there, but still had to get it across the finish line.

Biden was getting daily updates on the talks in Doha, where Israeli and Palestinian officials have said since Thursday that some progress has been made in the indirect talks between Israel and militant group Hamas, Sullivan said.

"We are still determined to use every day we have in office to get this done," he said, adding that Biden "is likely, in the near term, to engage with Prime Minister Netanyahu, and we are not, by any stretch of imagination, setting this aside."

He said there was still a chance to reach an agreement before Biden leaves office, but that it was also possible "Hamas, in particular, remains intransigent."

Israel launched its assault in Gaza after Hamas fighters stormed across its borders in October 2023, killing 1,200 people and taking more than 250 hostages, according to Israeli tallies.

Since then, more than 46,000 people have been killed in Gaza, according to Palestinian health officials, with much of the enclave laid to waste and gripped by a humanitarian crisis, and most of its population displaced.

Vice President-elect JD Vance told the "Fox News Sunday" program in an interview taped on Saturday that he expects a deal for the release of U.S. hostages in the Middle East to be announced in the final days of the Biden administration, maybe in the last day or two.

President-elect Donald Trump, a staunch supporter of Israel, has strongly backed Netanyahu's goal of destroying Hamas. Hehas promised to bring peace to the Middle East, but has not said how he would accomplish that.

https://www.marketscreener.com/quote/index/ISRAEL-TA-35-39464295/news/Biden-likely-to-talk-with-Netanyahu-hostage-deal-very-close-security-adviser-says-48738910/

Ascendis Pharma Business and Strategic Roadmap Update at J.P. Morgan Healthcare

 Ascendis Pharma A/S (Nasdaq: ASND) today provided a business and strategic roadmap update, including planned 2025 key corporate milestones. Ascendis President and CEO Jan Mikkelsen will present this update tomorrow, January 13, during the 43rd Annual J.P. Morgan Healthcare Conference.

“Ascendis is well-positioned for rapid revenue growth with the launch of our first two Endocrinology Rare Disease medicines, SKYTROFA and YORVIPATH, and, following our pre-NDA meeting, planned filings for our third, TransCon CNP for achondroplasia,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. “Our expanding TransCon technology platform and partnerships demonstrate that our business model built on fast, successful drug development can create substantial stakeholder value.”

Selected Key Updates and Milestones

• TransCon™ hGH
  (lonapegsomatropin, marketed as SKYTROFA®)
  • SKYTROFA full-year 2024 revenue, with a single indication in pediatric GHD, expected to be ~€202 million excluding sales deductions related to prior years (based on unaudited preliminary estimate of full-year 2024 SKYTROFA revenue of ~€197 million plus ~€5 million of sales deductions related to prior years).
  • U.S. SKYTROFA volume (mg) increased 84% in 2024 year-over-year resulting in an estimated 6.5% market share of the total U.S. growth hormone market for 2024 (based on third party prescription data).
  • Prescription Drug User Fee Act (PDUFA) goal date of July 27, 2025 for FDA review of supplemental BLA for the treatment of adults with growth hormone deficiency; pending approval, U.S. commercial launch planned in the fourth quarter of 2025.
  • During the third quarter of 2025, plan to submit an Investigational New Drug (IND) application or similar for a basket trial evaluating TransCon hGH in additional indications.
• TransCon PTH
  (palopegteriparatide, marketed as YORVIPATH®)
  • YORVIPATH full-year 2024 unaudited preliminary revenue estimate of ~€29 million.
  • YORVIPATH commercially available for prescription in Germany and Austria since January 2024. Outside Germany and Austria, providing product through early access routes, such as ‘named patient,’ until commercial reimbursement established. ~700 patients on treatment in our Europe Direct and International Markets at the end of 2024.
  • YORVIPATH commercially available for prescription since late December 2024 in the U.S. As of January 9, 2025, 324 patients enrolled into the Ascendis Signature Access Program or direct with specialty pharmacy, with over half of prescriptions for patients new to YORVIPATH.
  • Expect commercial launch in at least five additional Europe Direct countries in 2025.
• TransCon CNP
  (navepegritide)
  • Following pre-NDA meeting with FDA, plan to submit New Drug Application (NDA) for the treatment of children with achondroplasia during the first quarter of 2025, and submit Marketing Authorisation Application to the European Medicines Agency during the third quarter of 2025.
  • Presented new data demonstrating significant improvements in leg bowing, a common complication in achondroplasia, observed with TransCon CNP compared to worsening observed with placebo in pivotal ApproaCH Trial.
  • Topline Week 26 results from Phase 2 COACH Trial (TransCon CNP in combination with TransCon hGH) expected in the second quarter of 2025.
  • During the fourth quarter of 2025, plan to submit an IND or similar for the treatment of hypochondroplasia.
• Expanding the TransCon Platform & Pipeline
  • New TransCon protein degrader platform designed to enable efficient clearance of hormones, cytokines, and other targets. First planned TransCon protein degrader product candidate designed to normalize excess FGF-23 hormone levels for patients with X-linked hypophosphatemia.
• Financial Update
  • Unaudited preliminary estimate of total full-year 2024 product revenue of ~€226 million:
    • SKYTROFA full-year 2024 revenue expected to be ~€202 million excluding sales deductions related to prior years (based on unaudited preliminary estimate of full-year 2024 SKYTROFA revenue of ~€197 million plus ~€5 million of sales deductions related to prior years).
    • YORVIPATH full-year 2024 unaudited preliminary revenue estimate
      of ~€29 million.
  • Unaudited preliminary estimate of total full-year total 2024 revenue of ~€364 million
    • Includes $100 million Novo Nordisk milestone payment as non-product revenue.
  • December 31, 2024 pro forma cash balance of ~€655 million (based on unaudited preliminary estimate of December 31, 2024 cash balance of €560 million plus expected payment from Novo Nordisk of $100 million).
    

Presentation at J.P. Morgan Healthcare Conference on Monday, January 13
A live webcast of the event will be available via the Investors & News section of the Ascendis Pharma website at https://investors.ascendispharma.com. The presentation will begin at 11:15 a.m. Eastern Time / 8:15 a.m. Pacific Time. A webcast replay will be available for 30 days.

The Company’s slides from the J.P. Morgan presentation will be available on the same Investor Relations website at https://investors.ascendispharma.com.

https://www.marketscreener.com/quote/stock/ASCENDIS-PHARMA-A-S-20566532/news/Ascendis-Pharma-Provides-Business-and-Strategic-Roadmap-Update-at-43rd-Annual-J-P-Morgan-Healthcare-48739114/

Vertex Provides Pipeline and Business Updates in Advance of Upcoming Investor Meetings

 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced multiple program updates ahead of upcoming investor meetings in January, including the company’s scheduled webcast from the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025, at 10:30 a.m. ET/7:30 a.m. PT.

“2024 marked another year of excellent progress for Vertex, as we reached more people with CF than ever before, began a new era of commercial diversification, and advanced and broadened our clinical stage pipeline,” said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. “In 2025, we are poised to diversify our business further across multiple dimensions: our revenue, as we continue the launches of CASGEVY, ALYFTREK and potentially launch suzetrigine in acute pain; our pipeline, as we progress four potentially transformative medicines through pivotal trials; and our geographic footprint, as we expand both our commercial and clinical presence globally.”

Disease Areas with Approved Medicines

Cystic Fibrosis (CF)

• ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor) approved in the U.S.: On December 20, 2024, Vertex secured FDA approval for ALYFTREK, the once-daily next-in-class combination CFTR modulator for the treatment of people with CF 6 years and older who have at least one F508del mutation or another mutation in the CFTR gene that is responsive to ALYFTREK, which includes a total of 303 mutations. Global regulatory submissions for ALYFTREK, including in the U.K. and Europe, are currently under review.
• TRIKAFTA: Also on December 20, 2024, Vertex received FDA approval for the expanded use of TRIKAFTA in patients with 94 additional non-F508del CFTR mutations. With this approval, approximately 300 people in the U.S. are newly eligible for a medicine that treats the underlying cause of their disease. TRIKAFTA is now approved for patients with a total of 272 CFTR mutations.
• VX-522: The multiple ascending dose (MAD) portion of the Phase 1/2 study of VX-522 is underway, with data expected in the first half of 2025. VX-522 is a CFTR mRNA therapeutic that Vertex is developing in collaboration with Moderna for the more than 5,000 people with CF who cannot benefit from CFTR modulators.
• Epidemiology and market opportunity update: Vertex increased its estimates for the number of people with cystic fibrosis in the U.S., Europe, Australia, and Canada from approximately 92,000 to approximately 94,000. Additionally, Vertex continues to secure formal reimbursement for eligible patients in multiple countries that collectively comprise approximately 15,000 additional patients, of whom approximately 10,000 are eligible for treatment with CFTR modulators. Vertex previously served many of these markets through named patient sales.

Sickle Cell Disease (SCD) and Transfusion-Dependent Beta Thalassemia (TDT) – CASGEVY

• As of the end of 2024, Vertex has activated more than 50 authorized treatment centers (ATCs) globally and more than 50 patients have initiated cell collection.
• On December 31, 2024, Vertex received regulatory approval for CASGEVY in the United Arab Emirates (UAE) for the treatment of both SCD and TDT.
• In the U.S., Vertex recently negotiated a first-of-its-kind, voluntary agreement with the Centers for Medicare & Medicaid Services (CMS), which will provide a single outcomes-based arrangement for CASGEVY, available to all state Medicaid programs to ensure broad and equitable access for patients.

Pipeline Disease Areas

Acute Pain

• Suzetrigine: The FDA has assigned a PDUFA target action date of January 30, 2025, for suzetrigine for the treatment of moderate-to-severe acute pain. Suzetrigine was granted Priority Review by the FDA.
• The Non-Opioids Prevent Addiction In the Nation (NOPAIN) Act became effective on January 1st, 2025. The NOPAIN Act mandates that Medicare provide a separate add-on payment in the hospital outpatient or surgical center setting for FDA-approved non-opioid treatments for pain. Vertex expects suzetrigine in acute pain to be included on the list of treatments that qualify for add-on payment under this act, following potential suzetrigine FDA approval.
• Seven states have recently enacted legislation into law for the retail setting, specifying that opioids are not preferred over non-opioid therapies for the treatment of pain.

Peripheral Neuropathic Pain (PNP)

• Suzetrigine: Vertex continues to enroll and dose patients with diabetic peripheral neuropathy (DPN) in a Phase 3 pivotal trial of suzetrigine.
• Following the December 2024 release of Phase 2 results with suzetrigine in painful lumbosacral radiculopathy (LSR), a form of peripheral neuropathic pain, Vertex plans to advance suzetrigine into pivotal development for painful LSR, pending discussions with regulators on the study design and regulatory package.

IgA Nephropathy (IgAN) and other B Cell-Mediated Diseases

• The global Phase 3 RAINIER study of povetacicept is enrolling and dosing patients with IgAN in the U.S., Europe and Asia. Vertex expects to complete enrollment in the interim analysis cohort in 2025 for potential accelerated approval in the U.S., once this cohort reaches 36 weeks of treatment.
• Vertex has entered into an exclusive collaboration and license agreement with Zai Lab for the development and commercialization of povetacicept in mainland China, Hong Kong, Macau, Taiwan, and Singapore. Zai Lab will help advance clinical trials and make regulatory submissions in the licensed territory, and they will also be responsible for all commercialization activities in the licensed territory upon potential approval of povetacicept.

APOL1-Mediated Kidney Disease (AMKD) – Inaxaplin (VX-147)

• Vertex continues to enroll and dose patients with primary AMKD in the Phase 3 portion of the AMPLITUDE global Phase 2/3 pivotal clinical trial of inaxaplin, in which a 45 mg once-daily dose of inaxaplin is compared to placebo, on top of standard of care. Vertex expects to complete enrollment in the interim analysis cohort in 2025 for potential accelerated approval in the U.S., once this cohort reaches 48 weeks of treatment.
• Vertex plans to initiate AMPLIFIED, a Phase 2b open-label study of inaxaplin in patients with AMKD and diabetes or other co-morbidities currently not eligible for the AMPLITUDE Phase 2/3 pivotal trial, expanding the estimated potentially eligible population from 150,000 to 250,000 patients.

Type 1 Diabetes (T1D)

• Zimislecel (VX-880): Following successful end of Phase 2 meetings with the FDA, the European Medicines Agency (EMA), and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), Vertex initiated the Phase 3 portion of the Phase 1/2/3 study of zimislecel in patients with T1D with severe hypoglycemic events and impaired awareness of hypoglycemia. Vertex expects to complete enrollment and dosing of the pivotal study in 2025.
• Epidemiology update: Vertex estimates that a total of 125,000 patients have severe T1D, out of the estimated 3.8M people with T1D in North American and Europe. Vertex expects the initial zimislecel indication will address approximately 60,000 patients and is working to serve all 125,000 patients with severe diabetes over time.
• Consistent with its commitment to serial innovation and bringing transformative therapies to all patients who can benefit, Vertex is developing additional therapies for T1D that use the same cells that are used in zimislecel. This includes VX-264, currently in a Phase 1/2 study, in which the cells are encapsulated in an immunoprotective device. Vertex plans to share Part B full-dose data from the VX-264 Phase 1/2 study in 2025. Vertex is also pursuing alternative approaches to immunosuppression that could be used with zimislecel, as well as a hypoimmune program utilizing gene-edited stem-cell derived islets.

Myotonic Dystrophy Type 1 (DM1) – VX-670

• Vertex has completed the single ascending dose (SAD) portion of the global Phase 1/2 clinical trial for VX-670 in people with DM1 and initiated the MAD portion of the Phase 1/2 study, which will assess both safety and efficacy.

Autosomal Dominant Polycystic Kidney Disease (ADPKD) – VX-407

• Vertex is enrolling and dosing a Phase 1 study of healthy volunteers with VX-407. Vertex expects to advance VX-407 into a Phase 2 proof of concept study in people with ADPKD in 2025.

J.P. Morgan Healthcare Conference Presentation and Webcast

Dr. Kewalramani will present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025, at 10:30 a.m. ET/7:30 a.m. PT.

A live webcast of management's remarks will be available through the Vertex website, www.vrtx.com, in the "Investors" section under the "News and Events" page. A replay of the conference webcast will be archived on the company's website.

https://www.marketscreener.com/quote/stock/VERTEX-PHARMACEUTICALS-IN-11321/news/Vertex-Provides-Pipeline-and-Business-Updates-in-Advance-of-Upcoming-Investor-Meetings-48739181/

'UK PM Starmer to outline plan to make Britain world leader in AI'

 British Prime Minister Keir Starmer will say on Monday he wants the UK to become the world leader for artificial intelligence, promising to create special zones for data centres and encouraging more graduates to study technology-focused courses.

Starmer will say he wants to put AI at the heart of his ambition to grow the economy, while the government will claim if the technology is fully adopted it could increase productivity by 1.5% a year, worth an extra 47 billion pounds ($57 billion), annually over a decade.

Ahead of a speech in London by Starmer on AI, the government said it will adopt all the 50 recommendations set out in the report "AI Opportunities Action Plan" by venture capitalist Matt Clifford, submitted to the government last year.

This includes making it easier to build data centres by accelerating planning permission and giving them energy connections. The first such centre will be built in Culham, Oxfordshire, home to Britain's Atomic Energy Authority.

"Our plan will make Britain the world leader," Starmer was quoted as saying in a statement issued by the Department for Science, Innovation and Technology. "That means more jobs and investment in the UK, more money in people's pockets."

Countries across the world are competing to turn their countries into AI hubs, while balancing the need for some restrictions on the technology.

Britain is the third-largest AI market in the world behind the U.S. and China, when measured by indicators such as investment and patents, according to Stanford University.

However, the Labour government's decision to set out the highest tax-raising budget since 1993 has damaged some business confidence and the Bank of England estimated last month that the economy did not grow in the last quarter.

Starmer will say on Monday that AI has the power to transform the lives of people, including speeding up planning consultations, helping small businesses, and driving down admin for teachers so they can concentrate on teaching. 

"And in a world of fierce competition, we cannot stand by," he will say. "We must move fast and take action."

https://www.marketscreener.com/news/latest/UK-PM-Starmer-to-outline-plan-to-make-Britain-world-leader-in-AI-48739140/

Stellantis reaches goal of cutting U.S. inventories by 100,000 units

 Automaker Stellantis achieved its goal of cutting U.S. inventories by over 100,000 vehicles late last year, its North American chief said at the Detroit Auto Show Friday.

Antonio Filosa, who has been leading the carmaker's North American operations since last October, described its efforts to turn around a slumping business in the region in the wake of former CEO Carlos Tavares' abrupt departure.

"(This) represents a very big improvement. That cost us a lot, but was needed," Filosa said.

In September, Stellantis said it was targeting dealer inventory of no more than 330,000 vehicles by the end of 2024.

https://www.marketscreener.com/quote/stock/STELLANTIS-N-V-117814143/news/Stellantis-reaches-goal-of-cutting-U-S-inventories-by-100-000-units-48731091/

Biden spoke with families of Americans detained in Afghanistan, White House says

 President Joe Biden spoke on Sunday with the families of three Americans detained in Afghanistan by its Taliban rulers since 2022, and emphasized his commitment to bringing home Americans wrongfully held overseas, the White House said.

Biden’s administration has been negotiating with the Taliban since at least July about a US proposal to release the three Americans — Ryan Corbett, George Glezmann and Mahmood Habibi — in exchange for Muhammad Rahim al-Afghani, a high-profile prisoner held in Guantanamo Bay, Reuters reported last week, citing a source familiar with the discussions.

Efforts to secure the release of the Americans continue, a second source familiar with the initiative said on Sunday.

President Biden spoke with the families of three Americans being held captive in Afghanistan since 2022, according to the White House.Photo by Alex Wong/Getty Images

Corbett and Habibi were detained in separate incidents in August 2022 a year after the Taliban seized Kabul amid the chaotic US troop withdrawal. Glezmann was detained later in 2022 while visiting as a tourist.

Ahmad Habibi, Mahmood Habibi’s brother, who was on the call on Sunday, welcomed the discussion with Biden.

“President Biden was very clear in telling us that he would not trade Rahim if the Taliban do not let my brother go,” he said. “He said he would not leave him behind. My family is very grateful that he is standing up for my brother.”

The Taliban, which denies holding Habibi, had countered the US proposal with an offer to exchange Glezmann and Corbett for Rahim and two others, one of the sources told Reuters last week.

The White House noted that Biden has brought home more than 75 Americans unjustly detained around the world, including from Myanmar, China, Gaza, Haiti, Iran, Russia, Rwanda, Venezuela and West Africa.

The Biden administration has been working on a proposal to exchange the three Americans for Guantanamo Bay prisoner Muhammad Rahim al-Afghani.via CAGE International

His administration also brought home all Americans detained in Afghanistan before the US military withdrawal, it said.

“President Biden and his team have worked around the clock, often in partnership with key allies, to negotiate for the release of Americans held hostage or unjustly detained abroad so that they can be reunited with their families, and will continue to do so throughout the remainder of the term,” it added.

A Senate intelligence committee report on the agency’s so-called enhanced interrogation program called Rahim an “al Qaeda facilitator” and said he was arrested in Pakistan in June 2007 and “rendered” to the CIA the following month.

He was kept in a secret CIA “black site,” where he was subjected to tough interrogation methods, including extensive sleep deprivation, and then sent to Guantanamo Bay in March 2008, the report said.

Biden last week sent 11 Guantanamo detainees to Oman, reducing the prisoner population at the detention center in Cuba by nearly half as part of its effort to close the facility as the president prepares to leave office on Jan. 20.

https://nypost.com/2025/01/12/us-news/biden-spoke-with-families-of-americans-detained-in-afghanistan-white-house-says/

AP News Ratted Out For Blaming Palisades Fire On Climate Change

 The Associated Press published an article titled "Climate Change Contributed to a Week of Wild Weather That Upended Life in the US," which was heavily ratioed on X for blaming the Palisades Fire solely on "climate change." 

The journalist behind the article, Melina Walling, who uses the pronouns "she/her," failed to mention arson reports and the alarming mismanagement of city fire resources by radical far-left Democrats in power, including Los Angeles Mayor Karen Bass and Gov. Gavin Newsom.

"Climate change laid the groundwork for California's megafires," Walling wrote. 

Walling's selective reporting, aimed at drumming up climate anxieties among the public to further the left's climate change agenda, is extraordinarily misleading. 

She failed to mention in her coverage that the Palisades Fire spread so quickly because the Pacific Palisades reservoir, which was supposed to provide water to extinguish the fire, was completely empty. 

On top of this, she failed to mention the very existence of the countless arson reports. 

On X, Walling's article was pushed out by AP News' account, where it was heavily ratioed on Saturday evening. 

X users responded:

Here's some FACTS to think about (via Alex Epstein from his post 'Bad Forest Management, and Not Climate Change, is the Root Cause of California Fires'):

"The solution to dangerous, out-of-control wildfires in California is addressing the root cause: 'excess fuel load' from bad forest management. Focusing on climate change, a minor variable that we 'have no near-term control over, is a craven political ploy...

[T]emperatures have risen 1 degree C in the last 150 years. Is it really possible that that amount of warming makes dangerous wildfires inevitable? No. ... The negative effect of rising global temperatures on California wildfire susceptibility in particular is dubious because past centuries had far more fire-prone climates. The Palmer Drought Index shows only a slight increase in California drought since 1900.

"Historical evidence shows us that prior to man-made CO2 emissions CA experienced regular 'megadroughts' that could last over a century. The modern era has been very lush by comparison. Even if CA could lower global CO2 levels we could easily suffer a regional drought...

"The root cause of today’s wildfires is terrible forest management. Policymakers have prevented controlled burns, debris clearing, and logging — jacking up the 'fuel load' to incredibly dangerous levels. ... The path forward is simple: focus on the main cause, forest management, which is totally within our control. Stop pretending that lowering CO2 levels would bring about some fire-free paradise–and that it is possible near-term. Stop mandating 'unreliables.' Decriminalise nuclear."

As Tom McClintock comments via The Wall Street Journal, bad forest and water management, misplaced priorities and price controls all played a role.

The left blames a changing climate.

But that doesn’t explain California’s long history with massive wildfires, or why fires became less threatening throughout most of the 20th century.

We can find a more likely culprit in the states’ recent extreme environmental and social policies.

...

Environmental leftists promised that laws such as the National Environmental Policy Act, the Wilderness Act and the Endangered Species Act would protect and improve the environment. Fifty years later we’re entitled to ask: How’s it going? Between 2012 and 2021, we lost a quarter of California’s forestland to wildfires. A UCLA study estimated that California’s 2020 fires released twice as much greenhouse gas into the atmosphere as had been prevented by the previous 18 years of primarily government-enforced restrictions.

...

Fire is a condition of nature, but how we deal with it is a choice. The tragedy in Southern California is the result of decades of self-destructive policies made by foolish politicians. We can change the policies that got us into this mess by throwing out the politicians who made them. Let’s hope we do so before the next big fire.

Selective reporting by Walling to further a far-left climate agenda (and providing cover for Democrats in the state) is why trust in media has crashed to record lows.

https://www.zerohedge.com/weather/ap-news-heavily-ratioed-blaming-palisades-fire-climate-change