Putin speaks with foreign editors at St Petersburg forum

 President Vladimir Putin met with senior editors from international news agencies at Russia's flagship annual economic forum in St Petersburg on Wednesday.

Here are highlights from his answers to their questions.

RUSSIA-U.S. RELATIONS

"For the most part, we do not care (who wins the U.S. election)."

"To say - I am speaking quite sincerely - that we believe that after the elections something will change towards Russia in American policy, I would not say so. We don't think so. We think that nothing really serious will happen."

https://www.marketscreener.com/quote/currency/US-DOLLAR-RUSSIAN-ROUBLE--2370597/news/Russia-s-Putin-speaks-with-foreign-editors-at-St-Petersburg-forum-46912618/

Unitedhealth Group Inc.: HSBC upgrades to buy from hold

  price target raised from USD 460 to USD 580.

https://www.marketscreener.com/quote/stock/UNITEDHEALTH-GROUP-INC-14750/

Abbvie Inc.: HSBC upgrades to buy from hold

  price target raised from USD 161 to USD 185.

https://www.marketscreener.com/quote/stock/ABBVIE-INC-12136589/

Cytokinetics possible acquirer backs off

 Cytokinetics CEO Robert Blum confirmed the biotechnology company held sale talks late last year, as was reported around then by The Wall Street Journal and Reuters. In comments at a conference hosted by the investment bank Jefferies Wednesday, he said Cytokinetics engaged in “good faith negotiations” with an unnamed third party regarding an acquisition. While Cytokinetics’ board was supportive of proceeding with discussions on “substantially the terms the counterparty communicated,” that company ultimately did not move forward with an acquisition.

https://finance.yahoo.com/m/3f4be246-9c45-3f4c-b612-d9946db19f8d/lilly-details-mash-data-for.html

FDA OKs Intuitive Revised da Vinci Xi and X Labeling on Radical Prostatectomy

 Intuitive (NASDAQ:ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, announced today that the U.S. Food and Drug Administration (FDA) cleared a labeling revision for da Vinci X and Xi specific to radical prostatectomy. This clearance was based on real-world evidence (RWE) collected from 2007 to 2014 that demonstrates overall five- to 10-year survival following robotic-assisted radical prostatectomy is similar to non-robotic radical prostatectomy.

In a public-private collaboration, Intuitive worked with the FDA, healthcare analytics company Aetion, and the National Evaluation System for health Technology (NEST), utilizing its NEST Mark process to support the validity of the real-world data used in the labeling revision submission. This project demonstrated the utility of this type of collaboration in generating high-quality RWE to support marketing applications to the FDA and could allow for similar comprehensive long-term survival assessments for other cancer procedures, which helps advance regulatory science.

https://www.globenewswire.com/news-release/2024/06/05/2893853/7637/en/Intuitive-Announces-FDA-Clearance-of-Revised-da-Vinci-Xi-and-X-Labeling-on-Radical-Prostatectomy.html

FDA panel to discuss Eli Lilly Alzheimer's drug on June 10

 Eli Lilly said on Tuesday a panel of independent U.S. FDA advisers will discuss its experimental Alzheimer's disease drug, donanemab, on June 10.

Donanemab has faced two separate regulatory delays in the United States, while a similar therapy by Eisai and partner Biogen, called Leqembi, received the U.S. Food and Drug Administration's approval last year.

Lilly's donanemab was declined accelerated approval by the FDA in January 2023, and on March 8, the agency said it would hold a meeting of its advisers to discuss the drug, further delaying its approval.

Before approving Leqembi, which belongs to the same class of treatment as donanemab, the FDA had also conducted a meeting of an independent panel.

Lilly's donanemab, administered via once-a-month infusions, is designed to clear a toxic Alzheimer's-linked protein called beta amyloid from the brain.

In clinical trials, the treatment slowed the progression of memory and thinking problems by 22% to 29% overall, roughly comparable to the 27% slowing seen with Leqembi.

In patients with low-to-medium levels of a second Alzheimer's related protein called tau, Lilly's drug slowed the progression of the disease by 35.1% compared to a placebo.

Experts have, however, said the drug's association with side effects such as brain swelling and bleeding could pose a challenge to its approval. Three people who were on the treatment in the company's trial died.

Analysts on average expect donanemab to clock $65.6 million in sales in 2024, rising to $630.75 million next year, according to LSEG data.

https://www.yahoo.com/news/us-fda-panel-discuss-eli-141211771.html

Lilly’s Tirzepatide Shows Positive Phase II NASH Data, Tees Up Potential Expansion

 Eli Lilly on Wednesday released new data from the Phase II SYNERGY-NASH trial, demonstrating that its top-selling GLP-1/GIP dual receptor agonist can significantly improve liver fibrosis in patients with nonalcoholic steatohepatitis.

After 52 weeks of treatment, 54.9% of patients who were treated with a 5-mg tirzepatide dose experienced at least a one-stage improvement in fibrosis without disease worsening. SYNERGY-NASH documented no dose-response effect, with 51.3% and 51% of patients in the 10-mg and 15-mg dose arms meeting this endpoint, respectively.

By comparison, only 29.7% of those in the placebo group saw at least a one-stage fibrosis improvement without worsening of nonalcoholic steatohepatitis (NASH). Tirzepatide’s treatment effect was statistically superior to placebo, with p-values less than 0.05 for all three doses.

In addition, patients treated with tirzepatide experienced substantial weight loss of up to 17.3%. Lilly’s dual agonist also reduced liver enzymes and liver fat, while lowering serum and imaging indicators of fibrosis and liver inflammation.

Lilly presented these data at the 2024 Congress of the European Association for the Study of the Liver (EASL24), held this week in Milan, Italy.

SYNERGY-NASH is a randomized, double-blinded and placebo-controlled study evaluating the efficacy and safety of tirzepatide in patients with histologically confirmed NASH with stage two or three fibrosis.

Lilly had previously reported early data for the study’s primary outcome, which is the percentage of patients in whom NASH had been resolved without the worsening of fibrosis. In its full-year 2023 business report, the pharma announced that up to 74% of tirzepatide-treated patients achieved this outcome, compared to only approximately 13% of placebo counterparts.

Wednesday’s EASL24 readout provided a more detailed look at SYNERGY-NASH’s primary endpoint. In the 5-mg dose group, 43.6% achieved NASH resolution without worsening fibrosis. This proportion rose to 55.5% in patients treated with a 10-mg dose, and to 62.4% in the 15-mg dose arm. Only 9.8% of placebo-treated participants met the primary endpoint.

Tirzepatide is a protein-based therapy that works by activating the GLP-1 receptor, inducing the secretion of insulin from the pancreas in response to blood sugar levels. It also activates the GIP receptor, which helps modulate appetite. By facilitating weight loss, tirzepatide could also be an effective treatment for NASH.

The dual agonist was first approved by the FDA in May 2022 for the treatment of type 2 diabetes, for which it carries the brand name Mounjaro. The therapy bagged another approval as Zepbound in November 2023 for weight management.

Tirzepatide has become a big seller for Lilly, bringing in more than $1.8 billion in the first quarter of 2024 as Mounjaro. Despite being on the market for just months, Zepbound generated more than $500 million in Q1. Wednesday’s data could position tirzepatide for a label expansion in NASH and further strengthen sales.

https://www.biospace.com/article/lilly-s-tirzepatide-shows-promising-phase-ii-nash-data-tees-up-label-expansion/