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Wednesday, January 8, 2025

NVDA Dips After Biden Doubles Down On AI Chip Export Ban Ahead Of Trump

 With less than two weeks to go until President Trump takes over The White House - and 24 hours after he unveiled a new $20 billion major investment from Emirati billionaire Hussain Sajwani to build new data centers across the US - the Biden administration plans one additional round of restrictions on the export of AI chips from the likes of Nvidia in a final push in his effort to keep advanced technologies out of the hands of China and Russia.

Bloomberg reports, citing people familiar with the matter, that Biden wants to curb the sale of AI chips used in data centers on both a country and company basis, with the goal of concentrating AI development in friendly nations and getting businesses around the world to align with American standards

The regulations, which could be issued as soon as Friday, would create three tiers of chip trade restrictions, said the people, who asked not to be identified because the discussions are private.

  • At the top level, a small number of US allies would maintain essentially unmitigated access to American chips.

  • A group of adversaries, meanwhile, would be effectively blocked from importing the semiconductors.

  • And the vast majority of the world would face limits on the total computing power that can go to one country.

Countries in the last group would be able to bypass their national limits - and get their own, significantly higher caps - by agreeing to a set of US government security requirements and human rights standards, one of the people said.

That type of designation - called a validated end user, or VEU - aims to create a set of trusted entities that develop and deploy AI in secure environments around the world.

Nvidia explained its dissatisfaction at Biden's decision in the most diplomatic manner:

“A last-minute rule restricting exports to most of the world would be a major shift in policy that would not reduce the risk of misuse but would threaten economic growth and US leadership,” Nvidia said.

Every data center and business is already incorporating AI through what the company calls accelerating computing, Nvidia said.

“The worldwide interest in accelerated computing for everyday applications is a tremendous opportunity for the US to cultivate, promoting the economy and adding US jobs,” the chipmaker said.

NVDA shares are down just over 1% in the after-market...

...which pushes the giant tech company into 'correction' - down over 10% from its $3 trillion-plus peak market cap.

https://www.zerohedge.com/political/nvda-dips-after-biden-doubles-down-ai-chip-export-ban-ahead-trump

Vital LA Firefighting Equipment Was Handed To Ukraine: Reports

 As of Wednesday afternoon the fast-moving, wind-driven fires sweeping through the Los Angeles area are still zero percent contained, resulting in ongoing evacuations for 80,000+ residents.

Hundreds of thousands of residential and commercial locations have been left without power in the LA area as the natural disaster has become so large in proportion that it has captured the nation's attention. Many have been naturally focused on 'thoughts and prayers' for heroic LA and California firefighters, and their hoped-for ability to push back the raging inferno. But several local headlines from prior years make clear that area firefighters could have had more resources to draw from, if significant emergency response supplies and items weren't sent to Zelensky...

"Los Angeles County fire crews are sending some of their extra equipment to firefighters in Ukraine," a local March 2022 story reads. "The plane carrying that much-needed surplus equipment, such as hoses, nozzles, turnouts, helmets, body armor and other personal protective gear, is expected to take off Friday."

This began in the opening months of the Russian invasion, and appears to have continued at various times over the last couple years, with large expensive items like firetrucks having been shipped oversees as well.

Putting America "Ukraine first" is the Biden bad foreign policy idea that keeps on giving... and taking away from American citizens caught in the throes of emergency and disaster

While supporters of such programs argue that this was all surplus and 'retired' and extra equipment, we are quite sure that in these current dire circumstances surrounding Los Angeles any such 'surplus' could have been used and is still badly needed.

President-elect Trump himself has highlighted the ongoing shortages being experienced among emergency crews in the area...

Meanwhile, as California burns Biden is rushing many billions more in taxpayer dollars out the door to go to Ukraine.

And Biden is still planning a massive final aid package for Ukraine, so that as much as possible gets into Kiev's coffers prior to Trump being sworn in on Jan.20. How about diverting some of those billions to actual US citizens in LA?

https://www.zerohedge.com/geopolitical/vital-la-firefighting-equipment-was-handed-ukraine-reports-show-americans-now-caught

Globus Medical Reports Preliminary Record Fourth Quarter and Full Year Sales Results

  Globus Medical, Inc. (NYSE: GMED), a leading musculoskeletal solutions company, today announced preliminary unaudited sales results for the fourth quarter and full year ending December 31, 2024. The company anticipates fourth quarter 2024 sales of approximately $657.0 million, an increase of 6.6 percent over the fourth quarter 2023 on an as-reported basis. Full year 2024 sales are expected to be approximately $2.52 billion, an increase of 60.6 percent over the prior year on an as-reported basis.

“2024 was an exceptional year of execution and achievement for Globus Medical. With the NuVasive merger, we believe we created the strongest sales force and best product offering in the spine industry while maintaining our lead as the most innovative company backed up by a strong patent portfolio. During our first full year post-merger, we had strong sales growth, a record number of new product launches and the highest Enabling Technology placements to date, while accelerating our merger synergies to drive value for our shareholders,” said Dan Scavilla, president and CEO. “We remain focused on delivering product innovation, superior customer service, and operational excellence as we continue to advance patient care. 2025 is expected to be a very exciting year for product launches throughout our portfolio as we position our company for sustained growth in the broader musculoskeletal market. Globus Medical remains well positioned to achieve our vision of becoming the preeminent musculoskeletal technology company in the world by developing products that promote healing in patients."

“Our fourth quarter results demonstrated sustained growth and execution in our first full year post-merger,” commented Keith Pfeil, COO-CFO. “As we begin 2025, we seek to build upon the successes of the past year, further solidifying our foundation which will drive accelerated growth across our portfolio, as we move ahead in a manner that advances patient care while creating value for our shareholders.”

The Company established its full year 2025 revenue guidance range of $2.66 billion to $2.69 billion and fully diluted non-GAAP earnings per share range between $3.40 to $3.50.

These preliminary results are unaudited and are based on management’s initial analysis of operations for the periods ended December 31, 2024, and are therefore subject to change. The company expects to announce its fourth quarter and full year 2024 financial results on February 20, 2025, after the market close.

https://www.globenewswire.com/news-release/2025/01/08/3006709/0/en/Globus-Medical-Reports-Preliminary-Record-Fourth-Quarter-and-Full-Year-Sales-Results.html

Viking Starts Phase 2 VENTURE-Oral Dosing Trial of VK2735 Tablet Formulation for Obesity

 Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the initiation of a Phase 2 clinical trial of the oral tablet formulation of VK2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. VK2375 is being developed in both oral and subcutaneous formulations for the potential treatment of various metabolic disorders such as obesity.

The Phase 2 VENTURE-Oral Dosing Trial is a randomized, double-blind, placebo-controlled multicenter study designed to evaluate the safety, tolerability, pharmacokinetics and weight loss efficacy of VK2735 dosed as an oral tablet once daily for 13 weeks. The trial will enroll approximately 280 adults who are obese (BMI ≥30 kg/m2), or adults who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition. Patients will be evenly randomized to one of six dosing arms or placebo. The primary endpoint of the study is the percent change in body weight from baseline after 13 weeks of treatment. Secondary and exploratory endpoints will evaluate a range of additional safety and efficacy measures.

https://www.prnewswire.com/news-releases/viking-therapeutics-announces-initiation-of-phase-2-venture-oral-dosing-trial-of-vk2735-tablet-formulation-in-patients-with-obesity-302345159.html

Boston Scientific Expands Cardiovascular Treatment Portfolio With $440 M+ Bolt Medical Deal

 On Wednesday, Boston Scientific Corporation (NYSE:BSX) agreed to acquire Bolt Medical, Inc., the developer of an intravascular lithotripsy (IVL) advanced laser-based platform for coronary and peripheral artery disease.

Cholesterol deposits often create narrowed arteries and may also have a buildup of calcium that can increase the complexity of potential treatments. Lithotripsy is a procedure in which a physician breaks up hardened masses such as calcium to help restore blood flow.

The Bolt IVL system is designed to use lithotripsy to fracture calcium by creating acoustic pressure waves inside a balloon catheter.


The system also includes visible, directional emitters for consistent energy delivery in treating the calcified lesions.

Boston Scientific initially developed the concept for the Bolt IVL system, which helped establish Bolt Medical in 2019.

As a strategic investor in Bolt Medical, Boston Scientific has an equity stake of approximately 26%.

As a result, the transaction consists of an upfront payment of approximately $443 million for the 74% stake not yet owned and up to $221 million upon achievement of certain regulatory milestones.

On a 100% basis, before consideration of Boston Scientific’s current equity ownership in Bolt Medical, debt, and other closing adjustments, the transaction price consists of $600 million upfront and up to $300 million upon achievement of certain regulatory milestones.

Bolt Medical recently announced the completion and results of the RESTORE ATK and RESTORE BTK pivotal clinical trials investigating the Bolt IVL Above the Knee and Below the Knee systems for peripheral artery disease in patients with moderate to severely calcified lesions.

In December 2024, Bolt Medical received FDA approval to commence the global FRACTURE IDE clinical trial in the U.S., which is investigating the use of the Bolt IVL™ Coronary System for the treatment of coronary arterial disease with severely calcified lesions.

The deal is expected to be completed in the first half of 2025.

On an adjusted basis, the company expects the transaction to be slightly dilutive to adjusted EPS in 2025 and to offset via internal cost efficiencies and trade-offs.


https://finance.yahoo.com/news/boston-scientific-expands-cardiovascular-treatment-172510157.html

Agios Application Accepted for PYRUKYND® (mitapivat) in Alpha- or Beta-Thalassemia

 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental New Drug Application (sNDA) for PYRUKYND® (mitapivat) for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia. The review classification for this application is Standard and the Prescription Drug User Fee Act (PDUFA) goal date is September 7, 2025.

https://www.globenewswire.com/news-release/2025/01/08/3006111/31990/en/FDA-Accepts-Agios-Supplemental-New-Drug-Application-for-PYRUKYND-mitapivat-in-Adult-Patients-with-Non-Transfusion-Dependent-and-Transfusion-Dependent-Alpha-or-Beta-Thalassemia.html

Johnson & Johnson Gets FDA Fast-Track Designation for Posdinemab in Alzheimer's

 Johnson & Johnson on Wednesday said it has won Food and Drug Administration fast-track designation for its proposed posdinemab treatment for Alzheimer's disease.

J&J is investigating the internally discovered tau-directed monoclonal antibody in a Phase 2b study of patients with early Alzheimer's.

The New Brunswick, N.J., pharmaceutical giant said posdinemab has shown potential in targeting disease-associated phosphorylated tau in cerebrospinal fluid from treated Alzheimer's patients, and in blocking the development and spread of tau aggregates in non-clinical models of the memory-robbing disease.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

The FDA last year granted fast-track designation to J&J's anti-tau active immunotherapy JNJ-2056.

https://www.morningstar.com/news/dow-jones/202501084168/johnson-johnson-gets-fda-fast-track-designation-for-posdinemab-in-alzheimers